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ACE Albumin Reagent is intended for the quantitative determination of albumin concentration in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

ACE Total Protein Reagent is intended for the quantitative determination of total protein concentration in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Total protein measurements are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

ACE Calcium-Arsenazo Reagent is intended for the quantitative determination of calcium concentration in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

ACE Inorganic Phosphorus U.V. Reagent is intended for the quantitative determination of inorganic phosphorus concentration in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Measurements of inorganic phosphorus are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases and vitamin D imbalance. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

In the ACE Albumin Reagent assay, Bromcresol green binds specifically to albumin to form a green colored complex, which is measured bichromatically at 629 nm/692 nm. The intensity of color produced is directly proportional to the albumin concentration in the sample.

In the ACE Total Protein Reagent assay, cupric ions react with the peptide bonds of proteins under alkaline conditions to form a violet colored complex, which is measured bichromatically at 544 nm/692 nm. The intensity of color produced is directly proportional to the total protein concentration in the sample.

In the ACE Calcium-Arsenazo Reagent assay, calcium reacts with Arsenazo III in an acidic solution to form a blue-purple colored complex, which is measured bichromatically at 647 nm/692 nm. The intensity of color produced is directly proportional to the calcium concentration in the sample.

In the ACE Inorganic Phosphorus U.V. Reagent assay, under acidic conditions, inorganic phosphorus in serum reacts with ammonium molybdate to form an unreduced phosphomolybdate complex, which absorbs strongly at 340 nm. The increase in absorbance, measured bichromatically at 340 nm/378 nm, is directly proportional to the amount of phosphorus in the sample.

Here's an analysis of the acceptance criteria and study information for the ACE Albumin Reagent, ACE Total Protein Reagent, ACE Calcium-Arsenazo Reagent, and ACE Inorganic Phosphorus U.V. Reagent, based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The provided documentation does not explicitly state formal "acceptance criteria" with specific thresholds for each performance metric. However, it presents detailed performance data, particularly precision (within-run and total %CV) and method comparison (regression analysis, correlation coefficient), comparing the new reagents on various ACE clinical chemistry systems (ACE, ACE Alera, ACE Axcel) against existing predicate devices and among themselves. The implied acceptance is that the new reagents perform comparably to, or as effectively as, the predicate devices and demonstrate acceptable precision and linearity for clinical use.

Below is a summary of the reported device performance based on the "In-House Precision" and "In-House Matrix Comparison" tables. Since explicit acceptance criteria are not given, the performance data itself is presented as the evidence of meeting implied clinical utility and equivalence to predicate devices.

ACE Albumin Reagent

ACE Total Protein Reagent

ACE Calcium-Arsenazo Reagent

ACE Inorganic Phosphorus U.V. Reagent

2. Sample Sizes Used for the Test Set and Data Provenance

The studies mentioned are "In-House Precision," "In-House Matrix Comparison: Serum vs. Plasma," "POL - Precision," and "POL – Method Comparison."

• In-House Precision (Serum vs. Plasma):
  • Sample Size: Not explicitly stated for each "low, mid, high" concentration level, but implies multiple replicates for each level tested across the three systems (ACE, Alera, Axcel). For example, the ACE Alera precision table (pg. 16) shows 3 levels (low, mid, high) for serum, with reported mean, within-run SD, and total SD. Typically, precision studies involve running samples multiple times a day over several days.
  • Data Provenance: "In-House" suggests it was conducted by Alfa Wassermann Diagnostic Technologies, LLC, likely at their own facilities. It is a prospective study as they are performing experiments to generate data.
• In-House Matrix Comparison: Serum vs. Plasma:
  • Sample Size:
    • Albumin: ACE: 55 pairs, ACE Alera: 56 pairs, ACE Axcel: 56 pairs
    • Total Protein: ACE: 56 pairs, ACE Alera: 56 pairs, ACE Axcel: 81 pairs
    • Calcium-Arsenazo: ACE: 56 pairs, ACE Alera: 56 pairs, ACE Axcel: 81 pairs
    • Inorganic Phosphorus: ACE: 100 pairs, ACE Alera: 102 pairs, ACE Axcel: 56 pairs
  • Data Provenance: "In-House" suggests it was conducted by Alfa Wassermann Diagnostic Technologies, LLC, likely at their own facilities. The comparison between serum and plasma samples implies these were collected from human subjects. This is a prospective study.
• POL (Physician Office Laboratory) - Precision:
  • Sample Size: For each reagent and each system (ACE and ACE Alera), there are 3 "samples" (representing different concentration levels) tested at 3 different POL sites. Each sample/site combination has "Within-Run" and "Total" precision reported, implying multiple replicates for each measurement.
  • Data Provenance: Conducted at "POL 1," "POL 2," and "POL 3" sites, indicating external collection and testing beyond the manufacturer's immediate facilities. This is a prospective study.
• POL (Physician Office Laboratory) - Method Comparison:
  • Sample Size:
    • Albumin: 50 samples for each POL site (x3 POLs)
    • Total Protein: 51 samples for each POL site (x3 POLs)
    • Calcium-Arsenazo: 50 samples for each POL site (x3 POLs)
    • Inorganic Phosphorus: 50 samples for POL 1 & 3, 48 samples for POL 2
  • Data Provenance: Comparisons between "ACE In-House (x)" and "ACE POL (y)" or "ACE In-House (x)" and "ACE Alera POL (y)". This indicates the data for these studies was collected at both in-house facilities and external Physician Office Laboratories. This is a prospective study design, comparing results from different testing environments.
• Detection Limits & Linearity (ACE Alera):
  • Sample Size: Not specified for these specific studies, but typically involves a series of diluted and concentrated samples to define the measuring range.
  • Data Provenance: In-House, prospective.
• Interference (ACE Alera):
  • Sample Size: Not specified, but involves spiking samples with various interferents at different concentrations.
  • Data Provenance: In-House, prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

For these types of in vitro diagnostic (IVD) assays, the "ground truth" is typically established by reference methods or validated comparative methods, often using certified calibrators and controls. The documentation does not mention the use of human experts to establish ground truth for the test set in the traditional sense of medical image interpretation (e.g., radiologists interpreting images). Instead, the studies rely on quantitative measurements and statistical comparisons with established methods (the predicate devices or in-house reference measurements) to demonstrate performance. Therefore, no information is provided on the number or qualifications of experts for ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable. As described in point 3, the "ground truth" for these quantitative chemical assays is not established through expert consensus or adjudication in the way it would be for qualitative or interpretive diagnostic devices like medical imaging. Performance is evaluated by statistical comparison of numerical results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This device consists of chemical reagents for laboratory measurement, not an AI-assisted diagnostic tool interpreted by human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI is not relevant to this submission.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done

The performance presented for these reagents is inherently "standalone" in the sense that it reflects the direct analytical performance of the assays on the specified automated clinical chemistry systems. The results are quantitative measurements produced by the device without human interpretation of raw data beyond reading the numerical output. The "without human-in-the-loop" aspect applies here as the device itself performs the measurement and outputs a numerical value of concentration. The method comparison studies demonstrate the standalone performance of the candidate devices compared to predicate devices.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for these assays is established through reference methods and comparison to legally marketed predicate devices.

• For precision, the "ground truth" for each replicate is assumed to be the true concentration within the sample, and the study assesses the reproducibility of the device in measuring that concentration.
• For method comparison studies (e.g., In-House vs. POL, or ACE vs. ACE Alera), one method's results (often the predicate or an established in-house method) serve as the comparative 'truth' to evaluate the new method's agreement. The reference method would itself be calibrated against known standards.
• For linearity, samples of known, graded concentrations are used.
• For detection limits, the ground truth involves samples with very low, known concentrations.

These are established analytical chemistry principles rather than "expert consensus" or "pathology" in the diagnostic interpretation sense.

8. The Sample Size for the Training Set

The concept of a "training set" is primarily relevant for machine learning or AI algorithms which are iteratively developed and optimized using data. These reagents are chemical assays with a defined photometric measurement principle. While there is a development phase that involves optimizing reagent formulations and instrument parameters, there isn't a "training set" in the computational sense. The data presented here are from formal "verification and validation studies" to demonstrate performance characteristics (precision, linearity, accuracy/comparison, interference, detection limits).

9. How the Ground Truth for the Training Set Was Established

As noted in point 8, the concept of a "training set" is not directly applicable to these chemical reagents. The "ground truth" for establishing and validating the performance of such assays is based on:

• Reference materials/calibrators: Solutions with precisely known concentrations of the analyte (albumin, total protein, calcium, phosphorus) traceable to international standards.
• Validated comparison methods: Measurements made by existing, legally marketed predicate devices or other well-established and accurate laboratory methods.
• Controlled spiking experiments: Adding known amounts of substance to samples to assess recovery, linearity, and interference.

These methods establish the quantitative "truth" against which the performance of the new reagents is measured.

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The S TEST Reagent Cartridge Total Protein (TP) is intended for the quantitative determination of TP in serum, lithium heparinized plasma, K3 EDTA plasma and sodium citrate plasma using the HITACHI Clinical Analyzer E40. The S TEST Reagent Cartridge TP is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

Total protein measurements are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders.

The S TEST Reagent Cartridge Albumin (ALB) is intended for the quantitative determination of ALB in serum, lithium heparinized plasma, K3 EDTA plasma and sodium citrate plasma using the HITACHI Clinical Analyzer E40. The S TEST Reagent Cartridge ALB is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

The Hitachi Clinical Analyzer is an automatic, bench-top, wet chemistry system intended for use in clinical laboratories or physician office laboratories. The instrument consists of a desktop analyzer unit, an operations screen that prompts the user for operation input and displays data, a printer, and a unit cover. The analyzer unit includes a single probe, an incubation rotor, carousels for sample cups and reagent cartridges, and a multi-wavelength photometer. The single-use reagent cartridges may be placed in any configuration on the carousel, allowing the user to develop any test panel where the reagent cartridges are available.

The S TEST reagent cartridges are made of plastic and include two small reservoirs capable of holding two separate reagents (R1 and R2), separated by a reaction cell/photometric cuvette. The cartridges also include a dot code label that contains all chemistry parameters. calibration factors, and other production-related information, e.g., expiration dating. The dimensions of the reagent cartridges are: 13.5 mm (W) × 28 mm (D) × 20.2 mm (H).

System operation: After the sample cup is placed into the carousel, the analyzer pipettes the sample, pipettes the reagent, and mixes (stirs) the sample and reagent together. After the sample and reagent react in the incubator bath, the analyzer measures the absorbance of the sample, and based on the absorbance of the reactions, it calculates the concentration of analyte in the sample. The test system can measure analytes in serum or plasma and results are available in approximately 15 minutes per test. This submission is for Reagent Cartridges TP and ALB.

Chemistry reactions: (TP) Proteins in samples react with the biuret reagent to form a purplered complex. The concentration of total protein can be determined by measuring the absorbance of the purple-red substance.

(ALB) Albumin in the sample combines with bromcresol green to form a blue-green dye conjugate. The albumin concentration is directly proportional to the color intensity and can be determined photometrically by measuring the absorbance of this resulting blue-green color.

The provided document is a 510(k) summary for the Hitachi S TEST Reagent Cartridge Total Protein (TP) and Albumin (ALB). It details the nonclinical and clinical studies performed to demonstrate the safety and effectiveness of these in-vitro diagnostic devices.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a singular, formal table. Instead, performance characteristics are presented as results from various studies, often implicitly comparing them to the predicate device or general industry standards (e.g., CLSI guidelines). The performance characteristics are reported as the outcome of the tests performed.

Below is a table summarizing the reported device performance for both TP and ALB, drawing from the "Technological Similarities and Differences to the Predicate" section and the "Brief Description of Nonclinical Data" and "Brief Description of Clinical Data" sections. Implicit acceptance is typically shown by these results being deemed "safe and effective for their intended uses."

Hitachi S TEST Reagent Cartridge: Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document describes test sets for various studies:

• Method Comparison (Internal):
  • TP: 115 clinical specimens
  • ALB: 118 clinical specimens
  • Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). Described as "clinical specimens."
• Matrices Comparison:
  • TP: 45 matched serum/plasma samples
  • ALB: 41 matched serum/plasma samples
  • Provenance: Not explicitly stated.
• External Site Precision Study:
  • TP: 3 "blinded serum samples" (low, middle, high) at each of 3 sites. Each sample assayed 30 times (6 times/day for 5 days). So, 3 samples * 30 replicates * 3 sites = 270 measurements per analyte for total precision.
  • ALB: 3 "blinded serum samples" (low, middle, high) at each of 3 sites. Each sample assayed 30 times (6 times/day for 5 days). So, 3 samples * 30 replicates * 3 sites = 270 measurements per analyte for total precision.
  • Provenance: "three external POL-type sites," implying clinical settings, likely within the US given the submission to the FDA. Retrospective/prospective not specified for the samples, but the testing itself was prospective within the study timeframe.
• External Method Comparison Studies (POL Accuracy Data Summary):
  • TP: Approximately 50-80 serum specimens per site (n=52, 52, 53). Total around 157.
  • ALB: Approximately 50-80 serum specimens per site (n=87, 81, 81). Total around 249.
  • Provenance: "three external POL-type sites," implying clinical settings, likely within the US. Retrospective/prospective not specified for samples but the comparative testing was prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

This document describes a diagnostic device for quantitative determination of Total Protein and Albumin. For such devices, "ground truth" is typically established by recognized reference methods, not by expert consensus (e.g., radiologists).

• Method Comparison (Internal and External): The comparison was made against a "standard laboratory system" or "comparative method as the reference method (x)." The specific details of this reference method are not given beyond its use for comparison. No information is provided about human expert involvement in establishing this ground truth.

4. Adjudication Method for the Test Set

Not applicable. Diagnostic devices like this establish their accuracy against a reference method, not through human adjudication of results.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No. This is an in-vitro diagnostic device that provides quantitative measurements. MRMC studies are relevant for imaging devices or those requiring human interpretation.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, all studies described (analytical sensitivity, linearity, precision, interference, method comparisons, matrices comparisons) represent the standalone performance of the device (Hitachi Clinical Analyzer E40 with S TEST Reagent Cartridges) in measuring TP and ALB concentrations in samples. These are automated processes without direct human interpretation of results for the purpose of the measurement itself. Human operators are involved in running the analyzer, but the "performance" here refers to the device's analytical capability.

7. The Type of Ground Truth Used

The ground truth for the performance studies was established using:

• Reference Methods/Standard Laboratory Systems: For method comparison studies, the device's results (Y) were compared to a "standard laboratory system" or "comparative method" (X). This is a common approach for establishing accuracy of new in-vitro diagnostic devices.
• CLSI Guidelines: Studies like Analytical Sensitivity, Linearity, and Precision followed CLSI (Clinical and Laboratory Standards Institute) guidelines (e.g., EP17-A, EP-6A, EP5-A2). These guidelines define how to determine these performance characteristics, often involving reference materials or established statistical methods for calculation rather than external ground truth.
• Defined Concentrations: For precision and interference studies, samples were used that represented specific (low, middle, high) or known concentrations of the analytes.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI. This is a traditional in-vitro diagnostic device based on chemical reactions and photometric measurements. Its "development" would involve optimizing reagents and calibration, not "training" an algorithm in the AI sense. Therefore, the concept of a training set as understood in AI/ML is not applicable here.

9. How the Ground Truth for the Training Set Was Established

As noted in #8, there is no "training set" in the context of AI/ML for this device. The ground truth for developing and calibrating such devices typically relies on:

• Primary Reference Materials: Highly characterized materials with known concentrations of analytes.
• Secondary Reference Materials: Materials traceable to primary reference materials.
• Validated Reference Methods: Established and highly accurate methods, often more complex or expensive, used to assign values to control or calibration materials.

The document implicitly refers to these as part of "assay performance claims were established on the HITACHI Clinical Analyzer."

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The ACE Albumin Reagent is intended for the quantitative determination of albumin concentration in serum using the ACE Axcel Clinical Chemistry System. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE Total Protein Reagent is intended for the quantitative determination of total protein concentration in serum using the ACE Axcel Clinical Chemistry System. Total protein measurements are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE Calcium-Arsenazo Reagent is intended for the quantitative determination of calcium concentration in serum using the ACE Axcel Clinical Chemistry System. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE Inorganic Phosphorus U.V. Reagent is intended for the quantitative determination of inorganic phosphorus concentration in serum using the ACE Axcel Clinical Chemistry System. Measurements of inorganic phosphorus are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases and vitamin D imbalance. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

In the ACE Albumin Reagent assay, Bromcresol green binds specifically to albumin to form a green colored complex, which is measured bichromatically at 629 nm/692 nm. The intensity of color produced is directly proportional to the albumin concentration in the sample.

In the ACE Total Protein Reagent assay, cupric ions react with the peptide bonds of proteins under alkaline conditions to form a violet colored complex which is measured bichromatically at 544 nm/692 nm. The intensity of color produced is directly proportional to the total protein concentration in the sample.

In the ACE Calcium-Arsenazo Reagent assay, calcium reacts with Arsenazo III in an acidic solution to form a blue-purple colored complex, which is measured bichromatically at 647 nm/692 nm. The intensity of color produced is directly proportional to the calcium concentration in the sample.

In the ACE Inorganic Phosphorus U.V. Reagent assay, under acidic conditions, inorganic phosphorus in serum reacts with ammonium molybdate to form an unreduced phosphomolybdate complex, which absorbs strongly at 340 nm. The increase in absorbance, measured bichromatically at 340 nm/378 nm, is directly proportional to the amount of phosphorus in the sample.

The ACE Albumin Reagent consists of a single reagent bottle. The reagent contains Bromcresol green and acetate buffer.

The ACE Total Protein Reagent consists of a single reagent bottle. The reagent contains copper sulfate, sodium potassium tartrate, potassium iodide and sodium hydroxide.

The ACE Calcium-Arsenazo Reagent consists of a single reagent bottle. The Reagent contains Arsenazo III.

The ACE Inorganic Phosphorus U.V. Reagent consists of a single reagent bottle. The reagent contains ammonium molybdate and sulfuric acid.

Acceptance Criteria and Device Performance Study for ACE Reagents

The provided 510(k) summary (K113374) describes the performance of four reagents: ACE Albumin Reagent, ACE Total Protein Reagent, ACE Calcium-Arsenazo Reagent, and ACE Inorganic Phosphorus U.V. Reagent, when used with the Alfa Wassermann ACE Axcel Clinical Chemistry System. The study establishes the substantial equivalence of these devices to their predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in numerical terms (e.g., "CV must be < X%"). Instead, the performance is reported and compared to the established performance of the predicate device (implied through correlation studies). The key performance metrics are precision (within-run CV and total CV), accuracy (correlation coefficient, standard error estimate, confidence intervals for slope and intercept from regression analysis against a predicate device), and detection limit.

Note: For each analyte, the "acceptance criteria" can be inferred from the reported performance, which demonstrates that the new device performs comparably to the predicate device and within acceptable analytical limits for clinical use. The confidence intervals for the slope and intercept being close to 1 and 0 respectively for accuracy, and low CVs for precision, suggest good performance. A direct numerical acceptance criterion for each metric is not specifically stated in this summary but is inherent in the demonstration of substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

The studies are retrospective in nature, as they involve testing samples on both the new device (ACE Axcel System with new reagents) and a predicate device (Alfa Wassermann ACE Clinical Chemistry System).

The data provenance is not explicitly stated regarding country of origin, but the testing was conducted at "three separate Physician Office Laboratory (POL) sites" in addition to the primary laboratory testing. This suggests the data is from a clinical laboratory environment.

Test Set Sample Sizes:

• ACE Albumin Reagent: 118 samples (correlation study)
• ACE Total Protein Reagent: 121 samples (correlation study)
• ACE Calcium-Arsenazo Reagent: 111 samples (correlation study)
• ACE Inorganic Phosphorus U.V. Reagent: 110 samples (correlation study)

These sample sizes were used for the accuracy/correlation studies comparing the new device to the predicate. The precision studies involved testing at 4 levels for 22 days in the main lab and at 3 levels over 5 days at the three POL sites, without specifying the exact number of individual samples for precision.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This type of submission (IVD reagent for clinical chemistry) does not typically involve human experts establishing ground truth for individual measurements in the same way an imaging AI might. The "ground truth" for the test set is established by the predicate device, the Alfa Wassermann ACE Clinical Chemistry System. The performance of this predicate device is assumed to be accurate and clinically acceptable, serving as the comparative standard. Therefore, no external experts are explicitly mentioned for ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable. This is a quantitative chemical assay, not an assessment requiring human interpretation or adjudication. The comparison is between quantitative measurements from two different analytical systems.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a clinical chemistry reagent, not an AI imaging or diagnostic algorithm that involves human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, the studies evaluate the standalone performance of the ACE Axcel Clinical Chemistry System using the new reagents. The measurements are automated, and the results are directly compared to those obtained from the predicate device. There is no "human-in-the-loop" aspect to the analytical process itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for these studies is the quantitative measurements obtained from the legally marketed predicate device, the Alfa Wassermann ACE Clinical Chemistry System. This is a common approach for demonstrating substantial equivalence for in vitro diagnostic devices, where the performance of the new device is validated against an already approved method.

8. The sample size for the training set

Not applicable. These are chemical reagents and an associated analyzer system, not a machine learning or AI model that requires a "training set" in the conventional sense. The performance characteristics were determined through analytical studies.

9. How the ground truth for the training set was established

Not applicable, as there is no "training set" in the context of this device technology.

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Creatinine and Total Protein reagents, with associated calibrators and controls, are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer to measure a variety of analytes.

ABX PENTRA Creatinine 120 CP reagent, with associated calibrator and controls, is a diagnostic reagent for quantitative in vitro determination of Creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffé method). Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

ABX PENTRA Total Protein 100 CP reagent, with associated calibrator and controls, is a diagnostic reagent for quantitative in-vitro determination of Total Proteins in serum and plasma by colorimetry.

Measurements obtained by this device are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders.

The ABX PENTRA Multical is a calibrator for use in the calibration of quantitative Horiba ABX methods on Horiba ABX clinical chemistry analyzers.

The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision.

The ABX PENTRA P Control is for use in quality control by monitoring accuracy and precision.

The ABX PENTRA Urine Control L/H is for use in quality control by monitoring accuracy and precision.

All the reagents, controls and calibrators included in this submission are for use on the ABX PENTRA 400 (K052007), which is a discrete photometric benchtop clinical chemistry analyzer.

The ABX PENTRA Creatinine 120 CP is an in vitro diagnostic assay for the quantitative determination of creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffé method). It is composed of a 27 ml monoreagent cassette. Reagent is a chemical solution with additives.

The ABX PENTRA Total Protein 100 CP is an in vitro diagnostic assay for the quantitative determination of total proteins in human serum and plasma based on a colorimetric test (Biuret reaction). It is composed of a 28 ml mono-reagent cassette. Reagent is a chemical solution with additives.

The ABX PENTRA Multical is a lyophilized human serum calibrator with chemical additives and materials of biological origin.

The ABX PENTRA N Control and ABX PENTRA P Control are quality control products consisting of lyophilized human serum with chemical additives and materials of biological origin added as required to obtain given component levels.

The ABX PENTRA Urine Control L/H is a two-level (Low and High) quality control consisting of liquid solutions prepared from human urine with chemical additives and materials of biological origin added as required to obtain given component levels.

Here's a breakdown of the acceptance criteria and study information for the ABX PENTRA Creatinine 120 CP and ABX PENTRA Total Protein 100 CP devices, based on the provided text:

Acceptance Criteria and Device Performance

The devices are in vitro diagnostic assays, and their performance is described in terms of analytical characteristics. The stated performance data implicitly serve as the acceptance criteria for the devices to be considered substantially equivalent to their predicate devices.

ABX PENTRA Creatinine 120 CP

ABX PENTRA Total Protein 100 CP

Study Information

The document describes the performance data for in vitro diagnostic reagents. The studies performed are analytical performance studies, not clinical studies involving human patients or ground truth established by medical experts for diagnostic interpretation.

1. Sample size used for the test set and the data provenance:

   • ABX PENTRA Creatinine 120 CP:
     • Serum/Plasma correlation study: n=122 samples.
     • Urine correlation study: n=119 samples.
   • ABX PENTRA Total Protein 100 CP:
     • Correlation study: n=178 samples.
   • Data Provenance: The document states "HORIBA ABX, FRANCE" as the company location, implying the studies were conducted or samples sourced from France. The data is retrospective in the sense that it's laboratory performance data generated to characterize the assay, not new prospective patient data collected for a clinical trial.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. For in vitro diagnostic reagents, "ground truth" is typically established by reference methods or validated comparative assays. The correlation studies are comparing the performance of the new device against a comparative method. The text does not specify the comparative method used, nor does it mention any human experts establishing ground truth for these analytical measurements.

3. Adjudication method for the test set:

   • Not applicable. Analytical studies for these types of reagents do not typically involve human adjudication of results. The "truth" or reference values for the samples would be determined by the comparative method.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Not applicable. These are in vitro diagnostic reagents that measure chemical analytes. They are not AI-powered image analysis devices or clinical decision support tools that would involve human readers or AI assistance.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Yes, these are standalone analytical performance studies of reagents and their performance on an automated analyzer (ABX PENTRA 400). The "algorithm" here refers to the chemical reaction and measurement process of the diagnostic assay itself. Human intervention is limited to sample loading, instrument operation, and quality control, but the measurement itself is automated.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for these analytical performance studies is implicitly the results obtained from a comparative method or reference method against which the new device's measurements are correlated. The document states "Correlation" with r² values, indicating a comparison against another measurement method. The nature of this comparative method (e.g., another FDA-cleared creatinine assay) is not explicitly detailed but is standard practice for IVD submissions.

7. The sample size for the training set:

   • Not applicable. These are chemical reagents following established principles (Jaffé method, Biuret reaction). They are not machine learning or AI-based algorithms that require "training sets" in the conventional sense. The development of such reagents involves extensive research and development, but not "training data" in the AI context.

8. How the ground truth for the training set was established:

   • Not applicable (as explained above).

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In vitro test for the quantitative determination of protein in urine and cerebrospinal fluid on Roche automated clinical chemistry analyzers.

Measurements obtained by this device are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney or bone marrow as well as metabolic or nutritional disorders.

Protein measurements in urine are used in the diagnosis and treatment of disease conditions such as renal or heart diseases, or thyroid disorders, which are characterized by proteinuria or albuminuria.

CSF protein measurements are used in diagnosis and treatment of conditions such as meningitis, brain tumors and infections of the central nervous systems.

The Roche/Hitachi Urinary/CSF Protein reagent is an in vitro test for the quantitative determination of protein in urine and cerebrospinal fluid on Roche automated clinical chemistry analyzers.

The modified device includes both the original endpoint assay and the additional rate assay. The new rate assay was developed to provide absorbance limits that will flag high protein samples with high absorbance, thus eliminating the need for prescreening samples for high protein levels. The endpoint assay still requires sample prescreening or inspection of the Reaction Monitor display after completion of the reaction to ensure that high samples are detected and appropriately diluted for rerun. The attached labeling provides a more complete description of this potential high sample / prozone effect.

Here's an analysis of the provided 510(k) summary regarding the Roche/Hitachi Urinary/CSF Protein test, focusing on acceptance criteria and supporting study details:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document is a 510(k) Special Modification submission, which focuses on comparing a modified device (with an added "rate" application) to a predicate device (the original "endpoint" application). Therefore, the "acceptance criteria" discussed are largely implicit in demonstrating substantial equivalence to the predicate, with performance characteristics being compared directly.

2. Sample Sizes Used for the Test Set and Data Provenance

• Precision:
  • Urine:
    • Within-run: n=21 (Modified device) compared to n=120 (Predicate device).
    • Between-run: n=10 (Modified device).
  • CSF:
    • Within-run: n=20 (Modified device) compared to n=120/119 (Predicate device).
    • Between-run: n=10 (Modified device).
• Method Comparison:
  • Urine samples: n=60 (Modified device vs. Endpoint application). Concentrations between 1.7 and 3286.5 mg/dL.
  • CSF samples: n=50 (Modified device vs. Endpoint application). Concentrations between 5.8 and 110.2 mg/dL.
• Data Provenance: Not explicitly stated (e.g., country of origin, specific institution, retrospective/prospective). However, the study involves comparisons against an existing, cleared device, implying lab-based performance verification. It is implied to be retrospective analysis of performance characteristics, likely from laboratory testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of submission (modification to an in vitro diagnostic test kit) does not typically involve expert review for "ground truth" in the way, for example, an imaging AI device would. The "ground truth" for the performance studies (precision, method comparison) is based on the quantitative results generated by the laboratory instruments themselves, often using reference methods or the predicate device as a comparator. Therefore, this section is not applicable to this type of device.

4. Adjudication Method for the Test Set

As this is a quantitative in vitro diagnostic device, there is no "adjudication method" in the human-centric sense typically applied to image-based AI or complex diagnostic interpretations. The results are numerical values, and their accuracy is assessed against accepted laboratory standards or comparative methods. Therefore, this section is not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers' Improvement with AI vs. Without AI Assistance

This is an in vitro diagnostic device for laboratory use, not an AI device for interpretation by human readers. Therefore, an MRMC study is not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device itself is a reagent and an application on an automated clinical chemistry analyzer. The performance characteristics reported (precision, method comparison) represent the standalone performance of this "rate application" on the analyzer. The results are quantitative outputs from the instrument. So, in essence, the performance studies reflect the standalone performance of the modified application.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for the performance studies relied on:

• Reference Methods/Predicate Device: For method comparison, the modified rate application was compared against the original endpoint application (which was previously cleared based on comparison with the DuPont ACA method, standardized against NBS Reference Material SRM 927a using the biuret method).
• Known Concentrations: For precision studies, control materials and human samples with referenceable concentrations (though not explicitly stated whether these were clinically confirmed pathology or outcome data) were used. The controls themselves serve as a form of "ground truth" for expected values.

8. The Sample Size for the Training Set

This is a chemical reagent and an application for an automated analyzer, not a machine learning or AI model that requires a "training set" in the typical sense. The original development of the rate application would have involved optimization and testing, but it's not described as a formal "training set" like in AI. Therefore, this section is not applicable for an AI training set, but the development likely involved numerous samples for internal optimization.

9. How the Ground Truth for the Training Set Was Established

Since there is no "training set" in the AI sense, this question is not applicable. The "ground truth" for the predicate device's original clearance (K913615, which this modification refers back to) was established by standardizing against the National Bureau of Standards Reference Material SRM 927a using the biuret method for protein quantitation. The current submission demonstrates the equivalence of the modified rate application to this established methodology.

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In vitro test for the quantitative determination of the total protein in urine and cerebrospinal fluid on the COABS INTEGRA systems.

Measurements obtained by this device are used in the diagnosis and treatment of a variety of diseases involving the liver, kidnev or bone marrow as well as metabolic or nutritional disorders.

Protein measurements in urine are used in the diagnosis and treatment of disease conditions such as renal or heart diseases, or thyroid disorders, which are characterized by proteinuria or albuminuria.

CSF protein measurements are used in diagnosis and treatment of disease conditions such as meningitis, brain tumors and infections of the central nervous systems.

C.f.a.s. (Calibrator for automated systems) TPUC 200 is for use in the calibration of quantitative determination of protein in urine (U) and cerebrospinal fluid (CSF) on COBAS INTEGRA analyzers and Roche/Hitachi cobas c systems.

The COBAS INTEGRA Total Protein Urine/SCG Gen. 3 reagent is intended for use on the COBAS INTEGRA systems for the quantitative determination of protein in urine and cerebrospinal fluid.

Here's a breakdown of the acceptance criteria and study information for the Total Protein Urine/CSF Gen. 3 device, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria in a dedicated table format. Instead, it compares the performance of the modified device (Total Protein Urine/CSF Gen. 3 on COBAS INTEGRA and Roche/Hitachi platforms) against its predicate device (Roche/Hitachi Total Protein Urine/CSF K913615) for various features. The implicit acceptance criterion is "Substantial Equivalence" to the predicate device, meaning the new device performs as well as or better than the predicate for key parameters.

Here's a table summarizing the reported device performance, with the understanding that for most parameters, the 'acceptance' is that the modified device's performance aligns with or improves upon the predicate.

2. Sample Sizes Used for the Test Set and Data Provenance

The document describes method comparison studies for the COBAS INTEGRA platform against the Roche/Hitachi 917 analyzer.

• Urine Test Set: Sample size (n) = 54
• CSF Test Set: Sample size (n) = 68
• Data Provenance: The text does not explicitly state the country of origin or if the data was retrospective or prospective. It refers to "human urine and CSF samples," suggesting clinical samples were used.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the document. The method comparison relies on comparing the device's measurements against a predicate device's measurements, which are assumed to be "ground truth" for the purpose of demonstrating substantial equivalence. There is no mention of independent experts assessing the "accuracy" of the total protein levels.

4. Adjudication Method for the Test Set

This information is not applicable as the ground truth was established by comparison to a predicate device's quantitative measurements, not through subjective expert review and adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. An MRMC comparative effectiveness study is not relevant for this type of quantitative biochemical assay. This study is about the performance of an automated diagnostic test, not about human readers interpreting images or data.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes. The entire study describes the standalone performance of the Total Protein Urine/CSF Gen. 3 reagent on automated COBAS INTEGRA systems. This is a fully automated test system, and its performance characteristics (precision, linearity, detection limit, interference) are assessed in a standalone manner without human intervention in the interpretive process. The "human-in-the-loop" aspect would be a laboratory technician operating the instrument and reporting results, but the analytical performance itself is standalone.

7. The Type of Ground Truth Used

The ground truth for the method comparison studies (the primary study described for the modified device) was established by the measurements from the predicate device (Roche/Hitachi 917 analyzer) using the same reagent. The predicate device itself was "Standardized against National Bureau of Standards Reference Material SRM 927 using the biuret method for the quantitation of protein." This suggests a chain of traceability to a recognized standard.

8. The Sample Size for the Training Set

The document does not specify a separate "training set" sample size. For an IVD reagent modification submission like this, the focus is typically on validation testing of the final product. Any internal development or training of algorithms (if applicable for such a device, though unlikely for a turbidimetric assay) would be part of the manufacturer's internal design control process and not usually detailed in a 510(k) summary unless explicitly part of the new functionality being validated.

9. How the Ground Truth for the Training Set Was Established

As no training set is explicitly mentioned or detailed, the method for establishing its ground truth is not provided.

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Proteins reagents, with associated calibrators and controls, are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer to measure a variety of analytes.

ABX PENTRA Albumin CP reagent, with associated calibrators and controls, is a diagnostic reagent for quantitative determination of Albumin in serum and plasma by colorimetry.

Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

ABX PENTRA Total Protein CP reagent, with associated calibrators and controls, is a diagnostic reagent for quantitative in-vitro determination of Total Proteins in serum and plasma by colorimetry.

Measurements obtained by this device are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders.

ABX PENTRA Micro-albumin CP reagent, with associated calibrators and controls, is a diagnostic reagent for quantitative in-vitro determination of Albumin in urine (µALB) at low concentration by immunoturbidimetric assay.

Measurements of albumin aids in the diagnosis of diabetic nephritis and other kidney and intestinal diseases.

The ABX PENTRA µ-Alb Cal is a calibrator for use in the calibration of quantitative Horiba ABX PENTRA Micro-albumin CP method on Horiba ABX clinical chemistry analyzers.

The ABX PENTRA u-Alb Control L/H is for use in quality control by monitoring accuracy and precision for the quantitative ABX PENTRA Micro-albumin CP method.

The ABX PENTRA Multical is a calibrator for use in the calibration of quantitative Horiba ABX methods on Horiba ABX clinical chemistry analyzers.

The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision.

The ABX PENTRA P Control is for use in quality control by monitoring accuracy and precision.

All the reagents, controls and calibrators included in this submission are for use on the ABX PENTRA 400 (K052007), which is a discrete photometric benchtop clinical chemistry analyzer.

The ABX PENTRA Albumin CP is an in vitro diagnostic assay for the quantitative determination of albumin in human serum and plasma based on a colorimetric test using Bromocresol Green (BCG). It is composed of a 99 ml mono-reagent cassette.

The ABX PENTRA Total Protein CP is an in vitro diagnostic assay for the quantitative determination of total proteins in human serum and plasma based on a colorimetric test (Biuret reaction). It is composed of a 61 ml mono-reagent cassette.

The ABX PENTRA Multical is a lyophilized human serum calibrator with chemical additives and materials of biological origin. The assigned values of the calibrator components are given in the enclosed annex, ensuring optimal calibration of the appropriate HORIBA ABX methods on the ABX PENTRA 400 analyzer. This calibrator is provided in ten vials of 3 ml.

The ABX PENTRA N Control and ABX PENTRA P Control are quality control products consisting of lyophilized human serum with chemical additives and materials of biological origin added as required to obtain given component levels. The assigned values of the control components are given in the enclosed annexes, ensuring control of the appropriate HORIBA ABX methods on the ABX PENTRA 400 analyzer. Each control is provided in ten vials of 5 ml.

The ABX PENTRA Micro-albumin CP is an in vitro diagnostic assay for the quantitative determination of albumin in human urine based on an immunoturbidimetric test. It is composed of a bi-reagent cassette, with 19 ml and 4.5 ml compartments.

The ABX PENTRA u-Alb Cal is a liquid calibrator prepared by adding purified human albumin to a chemical buffer solution. It has 5 levels to be used for the calibration of the urinary albumin assay. The assigned values are given on the calibrator vials. This calibrator is provided in five vials of 1 ml.

The ABX PENTRA u-Alb Control L/H is a liguid assayed control prepared by adding purified human albumin to a chemical buffer solution. It has 2 levels (Low and High) to be used for the quality control of the urinary albumin assay. The assigned values are given in the enclosed annex. Each level of this calibrator is provided in two vials of 1 ml.

The provided text describes performance data for a set of reagents, controls, and calibrators used with the ABX PENTRA 400 clinical chemistry analyzer. The studies conducted are in vitro diagnostic assay performance evaluations, not studies involving human readers or clinical outcomes in the same way an AI-powered diagnostic device would be evaluated. As such, several requested items (MRMC study, expert ground truth, adjudication methods) are not applicable to this type of submission.

Here's a breakdown of the available information:

Acceptance Criteria and Reported Device Performance

The provided tables summarize the performance characteristics. The document states that "The performance testing data conclude that the safety and effectiveness of the devices are not compromised, and that they met all acceptance criteria, demonstrating that the devices are substantially equivalent to their respective predicate devices." While specific numeric acceptance criteria for each metric (e.g., "CV Total must be < X%") are not explicitly listed, the "Reported Device Performance" column represents the results achieved, which are implied to have met the predefined criteria for substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance:

(Note: "Acceptance Criteria (Implied)" is marked as '-' because specific target values for each metric were not explicitly stated in the provided text, only that the reported performance "met all acceptance criteria.")

2. Sample size used for the test set and the data provenance:

• ABX PENTRA Albumin CP:
  • Test Set Sample Size: n=272 for correlation study.
  • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). Standard in vitro diagnostic assay validation typically uses a mix of native human samples, spiked samples, and control materials.
• ABX PENTRA Micro-albumin CP:
  • Test Set Sample Size: n=252 for correlation study.
  • Data Provenance: Not explicitly stated.
• ABX PENTRA Total Protein CP:
  • Test Set Sample Size: n=230 for serum samples and n=262 for plasma samples in correlation studies.
  • Data Provenance: Not explicitly stated.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. This is an in vitro diagnostic device for quantitative chemical analysis, not an imaging or diagnostic AI device requiring expert interpretation of clinical data for ground truth. The "ground truth" for these assays would typically be established by reference methods or validated comparative methods, and the accuracy evaluated against those.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not Applicable. As per point 3, there is no expert adjudication process involved for establishing ground truth in this type of in vitro assay performance study.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not Applicable. This is not an AI/human-in-the-loop diagnostic device but a chemical analyzer with associated reagents, controls, and calibrators.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Yes, effectively. The performance data presented (accuracy, precision, linearity, stability, correlation) are for the device (reagent/analyzer system) operating in a standalone analytical capacity. The "performance data" discussed are the results generated solely by the ABX PENTRA 400 system using these components.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For the correlation studies ("Y = ... x + ... with a correlation coefficient r² = ..."), the device's measurements (Y) are being correlated against measurements from another method (x), which serves as the comparative or "ground truth" method. The text does not explicitly name the specific comparative methods used for albumin, micro-albumin, and total protein but relies on the concept of "substantial equivalence" to predicate devices, implying these predicate devices' methods serve as the benchmark. Precision, linearity, and stability are evaluated intrinsically against standardized methods and statistical metrics.

8. The sample size for the training set:

• Not Applicable in the context of machine learning. These are chemical assays, not machine learning algorithms that require explicit "training sets" in the modern AI sense. The development of such assays involves formulation optimization and internal validation, which could be considered analogous, but the term "training set" doesn't directly apply.

9. How the ground truth for the training set was established:

• Not Applicable. See point 8. The "ground truth" for developing and validating these types of assays involves adherence to established chemical principles, analytical standards, and comparison to validated reference measurement procedures or existing, legally marketed predicate devices.

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The Precision Systems™ ANALETTE™ Chemistry Analyzer is intended for the quantitative determination of Calcium, Creatinine, Phosphorus, Albumin, Total Protein, Glucose, Urea Nitrogen, Magnesium, Creatine Kinase, Alkaline Phosphatase, Cholesterol(includes HDL), Triglycerides, Total Bilirubin, Direct Bilirubin, Uric Acid, Lactate Dehydrogenase L, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Chloride, and etc. analytes in solution such as serum, plasma, or urine. It is an "open" System, which can use a variety of commercially manufactured reagents such as but not limited to Synermeds® Reagents, Medical Analysis Systems Reagents and STANBIO Laboratory Reagents. It is used to monitor various physiological diseases or conditions. Precision Systems Inc will distribute, recommend and sales STANBIO Reagents without any modification of STANBIO packaging using PSI Applications sheets.

The ANALETTE™ Chemistry Analyzer is an in vitro diagnostic automated clinical chemistry analyzer for the analysis of analytes in solution. It is an "open" System, which can use a variety of commercially manufactured reagents.

The document describes the acceptance criteria and the study conducted to demonstrate the substantial equivalence of the Precision Systems™ ANALETTE™ Chemistry Analyzer using STANBIO Laboratory Reagents to its predicate devices (ANALETTE™ using Synermed® Reagents and ANALETTE™ using Medical Analysis Systems Inc® Reagents).

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states: "Performance specifications: None established under Section 514." Instead, it refers to "Acceptance Criteria" (Exhibit E and F) but does not detail the specific numerical acceptance criteria within the provided text.

However, the "Results" section (G.) provides the reported performance relative to "acceptable/equivalent results" or "Manufacturers' claim."

2. Sample Size Used for the Test Set and Data Provenance:

• Imprecision: Two control serums were used for both within-run and total precision.
  • Within-run: Up to 20 repeats.
  • Total precision: Duplicates for up to 20 days.
• Correlation: "about 100 serums" were used.
• Linearity: "Commercially available linearity material" was assayed.
• Recovery: "Commercial available Controls with assigned values" were used.

Data Provenance: The document does not specify the country of origin for the data or explicitly state if it was retrospective or prospective. However, the nature of the tests (using control serums, commercial linearity material, and patient serums for correlation by assaying them) suggests it was a prospective study conducted for the purpose of this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not provided in the document. The "ground truth" for the test set appears to be established by comparing the performance of the STANBIO Laboratory Reagents on the ANALETTE™ to the performance of predicate reagents (Synermed® and Medical Analysis Systems Inc® Reagents) on the same ANALETTE™ or to manufacturer's claims for linearity and recovery. This is a comparison study, not a ground truthing exercise with independent experts reviewing clinical cases.

4. Adjudication Method for the Test Set:

This information is not applicable as the study described is a laboratory performance study comparing reagent efficacy, not a human reader or image-based diagnostic study requiring adjudication. The performance is assessed against established laboratory methods or manufacturer claims for the predicate reagents.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, If So, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable as the device is a chemistry analyzer and reagents, not an AI-assisted diagnostic tool for human readers. No MRMC study was conducted.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done:

This is an algorithm-only (standalone) performance study in the sense that it evaluates the analytical performance of the ANALETTE™ Chemistry Analyzer with STANBIO reagents. The purpose is to demonstrate that the device produces accurate measurement results independently. Human intervention is limited to operating the analyzer and interpreting the numerical output.

7. The Type of Ground Truth Used:

The "ground truth" in this context is established by:

• Comparison to Predicate Devices/Reagents: For imprecision and correlation, the performance of the STANBIO reagents is compared to the performance of legally marketed Synermed® and Medical Analysis Systems Inc® reagents on the ANALETTE™ device (which effectively act as the reference standard).
• Manufacturer's Claims/Expected Values: For linearity and recovery, the results are compared against the manufacturer's claims for the reagents or assigned values for commercial controls.

This is therefore a form of comparative analytical performance against established and accepted methods/claims, rather than clinical outcomes or pathology reports.

8. The Sample Size for the Training Set:

This information is not applicable as the ANALETTE™ is a chemistry analyzer, not a machine learning or AI-based device that requires a "training set" in the conventional sense. The "training" for such a system would involve instrument calibration and quality control procedures, which are standard for laboratory devices.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable for the reasons stated above (not an AI/ML device requiring a training set with established ground truth).

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The Precision Systems™ ANALETTE™ Chemistry Analyzer is intended for the quantitative determination of Calcium, Creatinine, Phosphorus, Albumin, Total Protein, Glucose, Urea Nitrogen, Magnesium, Creatine Kinase, Alkaline Phosphatase, Carbon Dioxide, Amylase, Cholesterol(includes HDL), Triglycerides, Total Bilirubin, Direct Bilirubin, Uric Acid, Lactate Dehydrogenase L, Lactate Dehydrogenase P, Alanine Aminotransferase. Aspartate Aminotransferase; Gamma Glutamyl Transferase, Lipase, Chloride, and etc. analytes in solution such as serum, plasma, or urine. It is an "open" System, which can use a variety of commercially manufactured reagents such as but not limited to Synermeds® Reagents and Medical Analysis Systems Reagents. It is used to monitor various physiological diseases or conditions. Precision Systems Inc will distribute, recommend and sales MAS Reagents without any modification of MAS packaging using PSI Applications sheets.

An in vitro diagnostic automated clinical chemistry analyzer for the analysis of analytes in solution.

Here's an analysis of the provided text regarding the acceptance criteria and study for the ANALETTE™ clinical chemistry analyzer and Medical Analysis Systems Reagents:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text describes a submission for substantial equivalence (510(k)) for the ANALETTE™ clinical chemistry analyzer using Medical Analysis Systems (MAS) Reagents, comparing it to the same ANALETTE™ analyzer using Synermeds® 072 reagents (the predicate device). The core of the acceptance criteria here is the demonstration of "substantial equivalence" of the new reagent system to the predicate. Specific quantitative acceptance criteria are not explicitly detailed in the provided text in the form of numerical thresholds for accuracy, precision, or comparison studies. Instead, the performance section broadly states:

2. Sample Size Used for the Test Set and Data Provenance

The document states that "comparative studies" were conducted. However, it does not provide any details regarding the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. For a clinical chemistry analyzer, the ground truth is typically established by reference methods or highly accurate laboratory instruments rather than expert adjudication in the way it would be for image-based diagnostics.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not applicable in the context of a clinical chemistry analyzer's performance evaluation as described. Ground truth is established through analytical measurements, not through human adjudication of diagnostic findings. Therefore, no adjudication method like 2+1 or 3+1 would be used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done for this device. MRMC studies are typically used for diagnostic imaging devices where human interpretation is a critical component, often comparing human readers with and without AI assistance. This device is a clinical chemistry analyzer, which provides quantitative measurements directly.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The performance described for the ANALETTE™ clinical chemistry analyzer with MAS reagents is inherently a standalone performance in the context of the instrument measuring analyte concentrations. There is no "human-in-the-loop" performance component in the direct measurement by the analyzer. The comparison is between two reagent systems on the same analyzer, assessing the analytical performance.

7. The Type of Ground Truth Used

The ground truth for this type of device (a clinical chemistry analyzer) would typically be established by:

• Reference standard methods: Highly accurate and precise laboratory methods, often more complex or expensive than routine clinical tests.
• Certified reference materials: Samples with known, validated concentrations of the analytes.
• Comparison to the predicate device: For a 510(k) submission seeking substantial equivalence, the performance of the new device (or reagent system) is directly compared to the legally marketed predicate device using patient samples and/or quality control materials. The predicate device's results serve as the pragmatic "ground truth" for demonstrating equivalence in a clinical setting.

The document implies the latter, stating "Substantially equivalence was established in comparative studies," meaning performance was compared against the predicate system.

8. The Sample Size for the Training Set

This information is not provided in the document. Clinical chemistry analyzers and their associated reagents are developed through analytical validation, which involves extensive testing, but the term "training set" is more commonly associated with machine learning algorithms. If there were any computational models or algorithms within the analyzer's software that required training (which is not explicitly indicated as relevant here beyond basic instrument calibration), the details of such a training set are absent.

9. How the Ground Truth for the Training Set Was Established

Since no "training set" in the machine learning sense is explicitly mentioned or detailed, and the focus is on analytical performance comparison (substantial equivalence), the method for establishing ground truth for a training set is not applicable or provided. The development of a clinical chemistry reagent kit involves rigorous analytical validation, where performance characteristics like accuracy, precision, linearity, and interference are established using known standards and patient samples, rather than a "ground truth for training" in the way an AI model would be trained.

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The Olympus AU5400 Clinical Chemistry Analyzer is a fully automated photometric analyzer intended for clinical laboratory use. Applications include colorimetric, turbidimetric, latex agglutination, and homogeneous enzyme immunoassay.

The Olympus AU5400 Clinical Chemistry Analyzer is a fully automated photometric analyzer.

While the provided document is a 510(k) clearance letter for the Olympus AU5400 Clinical Chemistry Analyzer, it does not contain the detailed performance study results, acceptance criteria, or ground truth information typically found in the actual 510(k) submission or a scientific publication.

The letter confirms that the device has been found substantially equivalent to predicate devices, meaning it is considered safe and effective for its indicated use. However, it does not explicitly state the specific performance metrics (like sensitivity, specificity, accuracy), the thresholds for acceptance of those metrics, or the specifics of the validation study.

Therefore, I cannot populate all the requested fields from the given text. I can only infer some information based on the nature of a 510(k) submission for a clinical chemistry analyzer.

Here's what I can convey based on the provided document and general understanding of 510(k) submissions for similar devices:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated in the provided letter. For a clinical chemistry analyzer, acceptance criteria would typically involve demonstrating analytical performance similar to or better than a predicate device across various parameters, including:

  • Accuracy: Agreement with a reference method.
  • Precision (Reproducibility & Repeatability): Consistency of results.
  • Linearity: Accuracy across the analytical measurement range.
  • Detection Limits: Lowest concentration that can be reliably measured.
  • Interference: Lack of significant impact from common interfering substances.
  • Carry-over: Minimal contamination between samples.
  • Stability: Reagent and calibration stability.
  • Correlation: Strong correlation with predicate device or reference method.

• Reported Device Performance: Not explicitly stated in the provided letter. The 510(k) submission would have contained data supporting these performance characteristics, demonstrating that the device meets the established acceptance criteria. The FDA's clearance implies that this evidence was found satisfactory.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not specified in the provided letter. For a clinical chemistry analyzer, test sets would include a variety of patient samples (normal, abnormal) and spiked samples to assess different analytical aspects.
• Data Provenance: Not specified in the provided letter. Typically, clinical chemistry analyzer validation involves prospective collection of patient samples, often from multiple sites to ensure representativeness, as well as characterization of control materials.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Experts and Qualifications: Not specified in the provided letter. For clinical chemistry analyzers, "ground truth" for analytical performance is typically established through:
  • Reference interval studies: Involving a statistically significant number of healthy individuals.
  • Comparison studies: Against a recognized reference method or a legally marketed predicate device, where the predicate device's results serve as the comparison standard.
  • Control materials and calibrators: With known, certified values.
  • Analytical experts (e.g., clinical chemists, laboratory directors) would be involved in designing and overseeing these studies, and interpreting the results.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable in the traditional sense for analytical performance of a clinical chemistry analyzer. Adjudication methods (like 2+1, 3+1) are typically used for subjective interpretations, such as image analysis or pathology review, where expert opinion is directly establishing "ground truth." For an automated analyzer, the output is quantitative, and performance is assessed against established analytical standards or comparison methods.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: Not applicable. MRMC studies are used to evaluate human reader performance, often with AI assistance, for tasks involving interpretation (e.g., radiology). The Olympus AU5400 is an automated clinical chemistry analyzer that produces quantitative results, not an AI-assisted diagnostic imaging tool with human interpretation.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Performance: As an automated analyzer, the device's performance is inherently "standalone" in generating the quantitative results. The entire 510(k) submission would be focused on demonstrating this standalone analytical performance. However, there's no "algorithm only without human-in-the-loop" contrast needed, as the device's function is to perform the chemical analysis automatically.

7. The Type of Ground Truth Used

• Ground Truth Type: For a clinical chemistry analyzer, the "ground truth" is typically established through:
  • Reference methods: Highly accurate and validated analytical methods.
  • Certified reference materials/calibrators: Materials with known, traceable analyte concentrations.
  • Comparison to a legally marketed predicate device: Demonstrating equivalent performance to a device already on the market.
  • Pathology/Outcomes data: Would generally not be the primary "ground truth" for the analytical performance of the analyzer itself, though the results generated by the analyzer would be used in conjunction with such data for clinical decision-making.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable in the conventional machine learning sense. This device is a traditional analytical instrument, not a machine learning or AI model that requires a "training set" to learn its function. Its operational parameters are determined by its design, engineering tolerances, and chemical principles, not by training on a dataset.

9. How the Ground Truth for the Training Set Was Established

• Ground Truth for Training Set: Not applicable, as there is no "training set" for a traditional clinical chemistry analyzer. The device's calibration involves using calibrator materials with known concentrations, but this is part of routine operation and quality control, not "training" in the ML sense.

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