The ACE Direct Total Iron-Binding Capacity (TIBC) Reagent is intended for the quantitative determination of total iron-binding capacity in serum using the ACE Alera Clinical Chemistry System. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia. This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only.

The ACE Total Iron Reagent is intended for the quantitative determination of iron in serum using the ACE Alera Clinical Chemistry System. Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin), and chronic renal disease. This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only.

The ACE LDH-L Reagent is intended for the quantitative determination of lactate dehydrogenase activity in serum using the ACE Alera Clinical Chemistry System. Lactate dehydrogenase measurements are used in the diagnosis and treatment of liver diseases such as acute viral hepatitis, cirrhosis, and metastatic carcinoma of the liver, cardiac diseases such as myocardial infarction and tumors of the lung or kidneys. This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only.

In the ACE Direct Total Iron-Binding Capacity (TIBC) Reagent assay, Direct TIBC Color Reagent, an acidic buffer containing an iron-binding dye and ferric chloride, is added to the serum sample. The low pH of Direct TIBC Color Reagent releases iron from transferrin. The iron then forms a colored complex with the dye. The colored complex at the end of the first step represents both the serum iron and excess iron already present in Direct TIBC Color Reagent. Direct TIBC Buffer, a neutral buffer, is then added, shifting the pH and resulting in a large increase in the affinity of transferrin for iron. The serum transferrin rapidly binds the iron by abstracting it from the dye-iron complex. The observed decrease in absorbance of the colored dye-iron complex is directly proportional to the total iron-binding capacity of the serum sample. The absorbance is measured at 647 nm.

In the ACE Total Iron Reagent assay, transferrin-bound iron in serum is released at an acidic pH and reduced from ferric to ferrous ions. These ions react with ferrozine to form a violet colored complex, which is measured bichromatically at 554 nm/692 nm. The intensity of color produced is directly proportional to the serum iron concentration.

In the ACE LDH-L Reagent assay, lactate dehydrogenase catalyzes the conversion of L-lactate to pyruvate. Nicotinamide adenine dinucleotide (NAD+) acts as an acceptor for the hydrogen ions released from the L-lactate and is converted to reduced nicotinamide adenine dinucleotide (NADH). NADH absorbs strongly at 340 nm whereas NAD+ does not. Therefore, the rate of conversion of NAD+ to NADH can be determined by monitoring the increase in absorbance bichromatically at 340 nm/647 nm. This rate of conversion from NAD+ to NADH is directly proportional to the lactate dehydrogenase activity in the sample.

The provided document describes in vitro diagnostic (IVD) reagents (ACE Direct Total Iron-Binding Capacity (TIBC) Reagent, ACE Total Iron Reagent, and ACE LDH-L Reagent) for use on the ACE Alera Clinical Chemistry System. The acceptance criteria and performance data presented relate to the analytical performance of these reagents/systems, specifically their ability to accurately and precisely measure analytes in serum samples.

Crucially, this is not a study about an AI/ML powered medical device. Therefore, many of the typical acceptance criteria and study aspects requested in your prompt regarding AI/ML (e.g., ground truth established by experts, multi-reader multi-case studies, human-in-the-loop performance, training/test set sample sizes for AI, adjudication methods) are not applicable to this type of device and submission.

The "study" described here is a series of analytical performance tests (linearity, precision, method comparison, detection limits, interference) to demonstrate that the new device (ACE Alera system with these reagents) performs comparably to the predicate device (ACE Clinical Chemistry System with the same reagents) and meets established analytical performance specifications for clinical chemistry assays.

Here's a breakdown of the relevant information from the document in the format you requested, with an explanation of why certain AI/ML-centric points are not applicable:

Device: ACE Direct Total Iron-Binding Capacity (TIBC) Reagent, ACE Total Iron Reagent, ACE LDH-L Reagent (for use on ACE Alera Clinical Chemistry System)

1. Table of acceptance criteria and reported device performance:

Since the document does not explicitly present "acceptance criteria" alongside "reported performance" in a single table, I will infer the acceptance criteria from the context of method comparison, linearity, and precision studies, which are standard for IVD device validation, often aiming for performance comparable to predicate devices or within clinically acceptable limits. The reported performance is directly extracted from the tables provided.

Interference:
The acceptance criterion for interference studies in IVD assays is typically that the interferent, up to a specified concentration, does not cause a "significant interference" (e.g., a bias exceeding a defined clinical or analytical threshold). The document lists the concentrations at which no significant interference was observed.

Precision (POL - Point of Care/Physician Office Lab):
Similar to in-house precision, specific %CV or SD limits would be the acceptance criteria. The data shows results from 3 POLs compared to in-house.

Method Comparison (POLs vs. In-House (ACE Alera (x) vs. POL ACE Alera (y))):
Similar to the in-house method comparison, the acceptance criteria are for slopes to be near 1, intercepts near 0, and high correlation coefficients (e.g., >0.99), indicating consistent performance across different lab environments.

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

• Sample Sizes for analytical performance studies (Test Set):

  • Method Comparison:
    • TIBC: 50 samples
    • Iron: 48 samples
    • LDH-L: 58 (in-house comparison) / 51 (POL comparison) samples
  • Linearity: The number of samples/levels for linearity is not explicitly stated as 'n', but standard practice involves multiple levels (typically 5-7) prepared from diluted/spiked samples.
  • Precision: Standard runs (e.g., 2 runs per day for 20 days for total precision, with replicates per run for within-run precision) would involve a substantial number of measurements (e.g., 20 days x 2 runs/day x 2 replicates/run = 80 measurements per level). The POL precision data shows n=20, likely referring to 20 days of testing.
  • Interference: The number of samples used for interference studies is not explicitly stated.

• Data Provenance: "In-House" and "POL" (Physician Office Laboratories). The specific country of origin is not explicitly stated, but given the company's location (New Jersey, USA) and FDA 510(k) submission, it's highly likely to be United States. The studies are prospective analytical validation studies, meaning the data was collected specifically to demonstrate the performance of the device.

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

Not applicable. This is an in vitro diagnostic (IVD) chemistry analyzer and reagent system. "Ground truth" for IVD analytical performance is established by reference methods, certified reference materials, or highly accurate comparative methods, not by human expert consensus or radiologists. The performance is assessed against quantitative values, not qualitative interpretations requiring expert review.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (e.g., imaging studies where radiologists disagree). For analytical performance of a chemistry analyzer, the "ground truth" is typically the quantitative value obtained from a reference method or the predicate device, and differences are assessed statistically (e.g., bias, correlation).

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. MRMC studies are specific to evaluating the impact of a device on human readers' performance, typically in diagnostic imaging with AI assistance. This device is an automated chemistry analyzer, not an AI-assisted diagnostic imaging tool. There are no human "readers" in the context of this device's operation.

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

Yes, in essence. The performance data provided (linearity, precision, detection limits, interference, method comparison) represents the "standalone" analytical performance of the automated chemistry system (ACE Alera with the new reagents) in measuring the target analytes in patient samples. There isn't an "algorithm only" in the AI sense, but the chemical reactions and photometric measurements are entirely automated by the device. The data shown is the raw analytical output.

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

The "ground truth" for these analytical studies is primarily:

• Highly characterized samples: For linearity, samples with known, precise concentrations (often prepared by dilution of high-concentration materials or spiking low-concentration materials).
• Comparative method/Predicate device: For method comparison, the results generated by the predicate device (ACE Clinical Chemistry System) are treated as the reference or comparative method against which the new ACE Alera system's results are compared. This is a common and accepted "ground truth" for chemical analyzers seeking substantial equivalence.
• Reference materials/controls: For precision and detection limits, control materials with established target values are used.

8. The sample size for the training set:

Not applicable. This is a traditional IVD device (chemical reagents and analyzer), not an AI/ML device that requires a "training set" in the context of machine learning model development. The reagents perform chemical reactions, and the analyzer reads photometric changes; it does not "learn" from data.

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

Not applicable, as there is no training set in the AI/ML sense for this device.

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The S TEST Reagent Cartridge Lactate Dehydrogenase (LD) is intended for the quantitative determination of LD in serum and plasma using the HITACHI Clinical Analyzer E40. The S TEST Reagent Cartridge Lactate Dehydrogenase (LD) is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. Measurements of LD are used in the diagnosis and treatment of liver and cardiac diseases.

The S TEST Reagent Cartridge Amylase (AMY) is intended for the quantitative determination of AMY in serum and plasma using the HITACHI Clinical Analyzer E40. The S TEST Reagent Cartridge Amylase (AMY) is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. Measurements of AMY are mainly used in the diagnosis and treatment of pancreatic diseases.

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 Cartridge ALP.

Chemistry reactions: (LD) Lactate dehydrogenase in samples catalyzes the reaction of converting lactic acid to pyruvic acid. During this reaction, NAD is converted into NADH with an increase in absorbance at 340 nm. The LD activity can be determined by measuring the production rate of the resulting NADH.

(AMY) Amylase in blood samples reacts with the substrate alfa-2-chloro-4-nitropheny]galactopyranosylmaltoside (Gal-G2-CNP), and the substrate is cleaved into 4galactopyranosylmaltose (Gal-G2) and 2-chloro-4-nitrophenol (CNP). Amylase activity is determined by measuring the production rate of CNP (yellow).

Here's a breakdown of the acceptance criteria and the study details for the Hitachi Chemical Diagnostics S TEST Reagent Cartridges for Lactate Dehydrogenase (LD) and Amylase (AMY):

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implied by the reported performance and comparison to predicate devices, rather than explicitly stated as discrete pass/fail thresholds in a formal table from the provided text. However, we can infer the expected performance based on the studies conducted.

S TEST Reagent Cartridge Lactate Dehydrogenase (LD)

S TEST Reagent Cartridge Amylase (AMY)

2. Sample Size and Data Provenance for the Test Set

• 10-day In-house Precision (LD, AMY):
  • Sample Size: Three levels of samples were tested. Each level was tested in two runs, twice a day, for 20 days. This implies a significant number of replicates (e.g., 3 levels * 2 runs/day * 2 times/day * 20 days = 240 measurements per analyte, though typically results are grouped for analysis). The text explicitly states 30 replicates per sample per site for the external precision studies.
  • Data Provenance: Not explicitly stated, but "in-house" implies from the manufacturer's laboratory. "Clinical specimens" for method comparison suggest human samples.
• Method Comparison (LD):
  • Sample Size (Test Set): 106 clinical specimens.
  • Data Provenance: Not explicitly stated, but "clinical specimens" implies human samples, presumably retrospective or prospectively collected for the study. No country of origin is mentioned.
• Method Comparison (AMY):
  • Sample Size (Test Set): 105 clinical specimens.
  • Data Provenance: Not explicitly stated, but "clinical specimens" implies human samples, presumably retrospective or prospectively collected for the study. No country of origin is mentioned.
• Matrices Comparisons (LD):
  • Sample Size (Test Set): 39 matched serum/plasma samples.
  • Data Provenance: Not explicitly stated; "clinical samples" implies human.
• Matrices Comparisons (AMY):
  • Sample Size (Test Set): Approximately 43 matched serum/plasma samples.
  • Data Provenance: Not explicitly stated; "clinical samples" implies human.
• External Site Precision (LD, AMY):
  • Sample Size (Test Set): Three blinded serum samples (low, middle, high concentrations for each analyte). Each sample was assayed six times per day for five days, yielding 30 replicates per sample per site. This was done at three external sites.
  • Data Provenance: "three external POL-type sites" (Physician Office Laboratory-type sites). Implies human serum samples.
• External Site Method Comparison (LD):
  • Sample Size (Test Set): Approximately 70-80 serum specimens (specifically, 87 for Site 1, 78 for Site 2, 86 for Site 3).
  • Data Provenance: "three external POL-type sites" using "serum specimens with LD values". Implies human serum samples.
• External Site Method Comparison (AMY):
  • Sample Size (Test Set): Approximately 70-80 serum specimens (specifically, 76 for Site 1, 69 for Site 2, 71 for Site 3).
  • Data Provenance: "three external POL-type sites" using "serum specimens with AMY values". Implies human serum samples.

3. Number of Experts and Qualifications for Ground Truth

This device is a quantitative diagnostic test for measuring enzyme levels (LD and AMY) in blood samples, typically analyzed by laboratory equipment. The "ground truth" for such devices is established by validated reference methods or predicate devices, not typically by expert review of images or clinical assessments in the same way an AI diagnostic imaging device would use radiologists.

• For Method Comparison studies, the "ground truth" or reference method was "a standard laboratory system" (in-house studies) or "a comparative method as the reference method" (external POL studies). These are assumed to be legally marketed and validated laboratory instruments. No human experts are described as establishing "ground truth" in this context.

4. Adjudication Method for the Test Set

Not applicable for this type of quantitative diagnostic device. Adjudication methods like 2+1 or 3+1 are used in interpretation tasks (e.g., radiology for AI devices) where human judgment is pooled to establish a consensus ground truth. Here, the "ground truth" is determined by the output of a reference laboratory instrument or method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC study is not relevant for this type of device, which is an automated quantitative assay. This device does not involve human readers interpreting images or clinical data with or without AI assistance. The studies performed compare the device's quantitative output to established reference methods or predicate devices.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, the studies described are standalone performance assessments of the device (Hitachi E40 Clinical Analyzer with S TEST Reagent Cartridges). The performance characteristics (analytical sensitivity, linearity, precision, interference, method comparison, matrices comparison) evaluate the instrument and reagent system's ability to accurately and precisely measure the target analytes entirely autonomously. There is no human interaction in producing the raw quantitative result from the device.

7. Type of Ground Truth Used

The ground truth used for performance evaluation was:

• Validated Reference Methods / Predicate Devices: For linearity, analytical sensitivity, and method comparison studies, the Hitachi E40 system results were compared against established reference methods or legally marketed predicate devices (Roche cobas c systems LDHI2 and AMYL2). The specific details of these reference methods are not provided but are generally understood to be highly accurate and precise laboratory assays.
• Known Concentrations: For precision studies, samples with "low, middle, and high concentrations" were used, implying that the approximate target concentrations were known or characterized.
• Spiked Samples: For interference studies, substances were added to samples at known concentrations to assess their impact on the assay (e.g., "50 mg/dL bilirubin").

8. Sample Size for the Training Set

This information is not provided in the summary. For a medical device like this (a reagent cartridge and analyzer), there isn't typically a "training set" in the sense of machine learning. The device's operational parameters, algorithms (for calculation), and calibration are established during its design and development, likely using extensive internal testing and optimization. Manufacturers establish operating procedures and calibration protocols based on R&D, not a discrete "training set" in the AI sense.

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

Given that this is a traditional in-vitro diagnostic device and not a machine learning algorithm, the concept of a "training set" and establishing "ground truth" for it, as typically understood in AI/ML, does not directly apply. The "ground truth" for developing the device itself would stem from fundamental principles of analytical chemistry, enzyme kinetics, and rigorous laboratory validation processes using primary calibrators and reference materials. The device's calibration curves and internal calculations are based on well-established scientific principles and extensive validation during its development phase.

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The ACE Axcel Clinical Chemistry System is an automated, discrete, bench-top, random access analyzer that is intended for in vitro diagnostic use in the quantitative determination of constituents in blood and other fluids.

The ACE Alkaline Phosphatase Reagent is intended for the quantitative determination of alkaline phosphatase activity in serum using the ACE Axcel Clinical Chemistry System. Measurements of alkaline phosphatase are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE Amylase Reagent is intended for the quantitative determination of a-amylase activity in serum using the ACE Axcel Clinical Chemistry System. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas). This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE LDH-L Reagent is intended for the quantitative determination of lactate dehydrogenase activity in serum using the ACE Axcel Clinical Chemistry System. Lactate dehydrogenase measurements are used in the diagnosis and treatment of liver diseases such as acute viral hepatitis, cirrhosis, and metastatic carcinoma of the liver, cardiac diseases such as myocardial infarction and tumors of the lung or kidneys. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE Axcel Clinical Chemistry System consists of two major components, the chemistry instrument and an integrated Panel PC. The instrument accepts the physical patient samples, performs the appropriate optical or potentiometric measurements on those samples and communicates that data to an integral Panel PC. The Panel PC uses keyboard or touch screen input to manually enter a variety of data, control and accept data from the instrument, manage and maintain system information and generate reports relative to patient status and instrument performance. The Panel PC also allows remote download of patient requisitions and upload of patient results via a standard interface.

In the ACE Alkaline Phosphatase Reagent assay, alkaline phosphatase in serum catalyzes the hydrolysis of colorless p-nitrophenyl phosphate to p-nitrophenol and inorganic phosphate. In an alkaline solution (pH 10.5), p-nitrophenol is in the phenoxide form and has a strong absorbance at 408 nm. The rate of increase in absorbance, monitored bichromatically at 408 nm/486 nm, is directly proportional to the alkaline phosphatase activity in the sample.

In the ACE AST Reagent assay, a-amylase hydrolyzes the 2-chloro-p- nitrophenyl-a-D-maltotrioside substrate to release 2-chloro-p- nitrophenol and form 2-chloro-p- nitrophenyl-a-D-maltoside, maltotriose and glucose. The rate of increase in absorbance, monitored bichromatically at 408 nm/ 647 nm, is directly proportional to the a- amylase activity in the sample.

In the ACE LDH-L Reagent assay, lactate dehydrogenase catalyzes the conversion of L-lactate to pyruvate. Nicotinamide adenine dinucleotide (NAD+) acts as an acceptor for the hydrogen ions released from the L- lactate and is converted to reduced nicotinamide adenine dinucleotide (NADH). NADH absorbs strongly at 340 nm whereas NAD+ does not. Therefore, the rate of conversion of NAD+ to NADH can be determined by monitoring the increase in absorbance bichromatically at 340 nm/647 nm. This rate of conversion from NAD+ to NADH is directly proportional to the lactate dehydrogenase activity in the sample.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

Acceptance Criteria and Device Performance for ACE Alkaline Phosphatase, Amylase, and LDH-L Reagents on the ACE Axcel Clinical Chemistry System

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets in the provided text. Instead, the study aims to demonstrate substantial equivalence to a predicate device (Alfa Wassermann ACE Clinical Chemistry System and ACE Reagents, K931786) by showing a high degree of correlation and acceptable precision. The reported device performance is compared to the predicate device.

ACE Alkaline Phosphatase Reagent

ACE Amylase Reagent

ACE LDH-L Reagent

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

• ACE Alkaline Phosphatase Reagent:

  • Accuracy (Correlation Study): 112 samples.
  • Accuracy (POL Patient Correlation): Not specified (implied to be numerous patient samples tested at 3 POL sites).
  • Precision (Central Lab): Data collected over 22 days, with 4 alkaline phosphatase levels tested. The exact number of individual samples run per level/day is not specified but is typical for precision studies (e.g., n=2 or n=3 replicates).
  • Precision (POL Sites): Data collected over 5 days at 3 separate Physician Office Laboratories (POLs), with 4 alkaline phosphatase levels tested. The exact number of individual samples run per level/day is not specified.
  • Data Provenance: Not explicitly stated, but the mention of "Central Lab" and "Physician Office Laboratory (POL) sites" suggests clinical laboratory settings. It does not specify country of origin or if retrospective/prospective, but stability studies and clinical accuracy studies usually involve prospective collection or use of banked clinical samples. Given it is a 510(k) submission, it is likely representing real-world clinical samples.

• ACE Amylase Reagent:

  • Accuracy (Correlation Study): 111 samples.
  • Accuracy (POL Patient Correlation): Not specified (implied to be numerous patient samples tested at 3 POL sites).
  • Precision (Central Lab): Data collected over 22 days, with 4 amylase levels tested.
  • Precision (POL Sites): Data collected over 5 days at 3 separate POL sites, with 4 amylase levels tested.
  • Data Provenance: Similar to Alkaline Phosphatase, suggesting clinical laboratory settings in the US, likely using prospective or banked clinical samples.

• ACE LDH-L Reagent:

  • Accuracy (Correlation Study): 121 samples.
  • Accuracy (POL Patient Correlation): Not specified (implied to be numerous patient samples tested at 3 POL sites).
  • Precision (Central Lab): Data collected over 22 days, with 4 LDH levels tested.
  • Precision (POL Sites): Data collected over 5 days at 3 separate POL sites, with 4 LDH levels tested.
  • Data Provenance: Similar to the previous reagents, suggesting clinical laboratory settings in the US, likely using prospective or banked clinical samples.

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

This device is a clinical chemistry analyzer, not an imaging or diagnostic AI device that requires expert adjudication for "ground truth." The "ground truth" for the accuracy studies is established by the performance of the predicate device (Alfa Wassermann ACE Clinical Chemistry System). The predicate device itself would have been validated against established reference methods or clinical outcomes when it was initially cleared/approved. Therefore, no human experts directly establish "ground truth" in the way it might for image interpretation.

4. Adjudication Method for the Test Set

Not applicable for this type of device (clinical chemistry analyzer). Adjudication methods like 2+1 or 3+1 are used for subjective interpretations or classifications (e.g., by radiologists or pathologists) to reach a consensus "ground truth." For quantitative measurements, the "truth" is typically a measurement from a reference method or a well-established, previously validated method (in this case, the predicate device).

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

No. This type of study is typically for evaluating the performance of AI algorithms in conjunction with human readers, often in image interpretation tasks. This submission is for a clinical chemistry analyzer and reagents.

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

Yes, the studies presented are essentially "standalone" performance evaluations of the new ACE Axcel Clinical Chemistry System with the specific reagents. The system measures analyte concentrations automatically, and its performance (precision, accuracy, detection limit) is assessed without direct human intervention in the measurement process itself, although human operators load samples and maintain the system. The "comparison" is to the predicate device, which is also a standalone automated system.

7. The Type of Ground Truth Used

The "ground truth" used for accuracy (correlation) studies is the measurement result from the legally marketed predicate device: the Alfa Wassermann ACE Clinical Chemistry System and its corresponding ACE Reagents (K931786). This is a common approach for demonstrating substantial equivalence for in vitro diagnostic devices when a recognized gold standard method might not be readily available for routine testing or if the goal is to show equivalence to an existing market performer.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set in the conventional sense. The device is a traditional clinical chemistry analyzer based on established photometric and enzymatic reaction principles. The "training" for such a system would involve instrument calibration (which uses control materials, not a "training set" of patient data) and reagent manufacturing/quality control.

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

Not applicable, as there is no "training set" for an AI algorithm. For instrument calibration, the "ground truth" for calibrators would be established by the manufacturer using reference methods or certified reference materials, and then verified through quality control materials.

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The Nova StatStrip Lactate Hospital Meter System is intended for in vitro diagnostic use by health care professionals for clinical and for point-of-care usage for the quantitative determination of Lactate (Lac) in fresh venous and arterial whole blood specimens. It is not for use on capillary blood specimens. It is intended to provide plasma equivalent results to laboratory methods. The Nova StatStrip Lactate Hospital Meter System is indicated for use in a clinical setting by healthcare professionals as an aid to evaluate the acid-base status of patients suspected of having lactic acidosis.

Nova StatStrip Lactate Test Strips are intended for use only with Nova StatStrip Lactate Hospital Meter for quantitative determination of lactate in fresh venous and arterial whole blood specimens. It is not for use on capillary blood specimens. The performance characteristics of the device for lactate measurements on capillary specimens have not been established. Nova StatStrip Lactate Test Strips are for testing outside the body (in vitro diagnostic use only).

Nova StatStrip Lactate Control Solutions are intended for use with the Nova StatStrip Family of Meters and Nova StatStrip Lactate Test Strips as a quality control check to verify the accuracy of blood lactate test results. There are 2 levels of controls. (Level 1 and Level 2).

Nova StatStrip Lactate Linearity Kit solutions are used to check the linearity of the Nova StatStrip Family of Meters. There are 4 levels of lactate linearity solutions: Level 1, Level 2, Level 3, and Level 4.

The Nova StatStrip Lactate Hospital Meter System consists of:

1. Nova StatStrip Lactate Hospital Meter
2. Nova StatStrip Lactate Test Strips
3. Nova StatStrip Lactate Control Solutions (Levels 1 and 2)
4. Nova StatStrip Lactate Linearity Solutions (Levels 1,2,3 and 4)
5. Meter Docking Station

The provided text does not contain specific acceptance criteria or detailed performance data from a study that would allow for a direct numerical comparison in a table. The document is a 510(k) summary and approval letter, stating that performance studies were conducted and the device was found substantially equivalent to predicate devices. However, it does not provide the raw performance data, acceptance thresholds, or detailed methodology of these studies.

Therefore, many of the requested fields cannot be filled with specific information from the provided document.

Here's an attempt to answer based on the available information, with clear indications where information is not provided:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not provided. The document mentions "Laboratory and clinical testing was performed" but does not specify the number of samples or patients included in these studies.
• Data Provenance: Not provided specific details. The studies were described as "Laboratory and clinical testing," implying data collected for the purpose of this submission. The country of origin is not specified, but the submitter is a U.S. company. It's likely prospective data collected for the purpose of the 510(k) submission, given the nature of performance studies for new devices, but this is an inference.

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

• Not provided. The document states "substantially equivalent to the current methods for blood lactate measurements" and "plasma equivalent results to laboratory methods," implying comparison to established methods or gold standards, but the process of establishing ground truth for the specific test set is not detailed.

4. Adjudication method for the test set

• Not provided. Given that the ground truth establishment method is not described, the adjudication method is also not mentioned.

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 medical device for quantitative determination of lactate in whole blood, not an imaging or diagnostic AI device that involves human reader interpretation. Therefore, an MRMC study is not relevant to this type of device.

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

• The device itself is a standalone system (meter and test strips) that provides a quantitative lactate reading. The performance studies described would inherently be standalone, assessing the device's ability to measure lactate accurately. There isn't a separate "algorithm only" component beyond the device's inherent operation.

7. The type of ground truth used

• The ground truth would implicitly be reference laboratory methods for lactate measurement, as the device aims to provide "plasma equivalent results to laboratory methods" and demonstrate "substantial equivalence to the current methods for blood lactate measurements."

8. The sample size for the training set

• Not applicable/Not provided. This device is a measurement system (meter and test strips), not a machine learning or AI-based diagnostic tool that typically involves a distinct "training set" for model development in the same way. Its performance is based on its electrochemical detection principle and manufacturing precision, not on being "trained" on a dataset. The performance studies mentioned are for validation or verification, not training.

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

• Not applicable/Not provided, as there isn't a "training set" in the context of this type of device.

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The S-Test Lactate Dehydrogenase Reagent is intended for the quantitative determination of lactate dehydrogenase activity in serum using the S40 Clinical Analyzer. Lactate Dehydrogenase measurements are used in the diagnosis and treatment of liver diseases such as acute viral hepatitis, cirrhosis, and metastatic carcinoma of the liver, cardiac diseases such as myocardial infarction, and tumors of the lung or kidneys. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The S-Test Lactate Dehydrogenase (LD) reagent cartridge, used with the S40 Clinical Analyzer, is intended for the quantitative in vitro diagnostic determination of LD activity in serum based on a photometric test measuring the rate of conversion of NADH from NAD in an enzyme assay. It is composed of a bi-reagent cartridge, and is intended for use in clinical laboratories or physician office laboratories.

The S-Test LD Reagent cartridge is intended for the quantitative in vitro diagnostic determination of LD activity in serum, used with the S40 Clinical Analyzer. Lactate Dehydrogenase measurements are used in the diagnosis and treatment of liver diseases (e.g., acute viral hepatitis, cirrhosis, metastatic carcinoma of the liver), cardiac diseases (e.g., myocardial infarction), and tumors of the lung or kidneys.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

• Correlation coefficient: 0.9857
• Standard error estimate: 19.8
• Confidence interval slope: 0.934 to 1.008
• Confidence interval intercept: -13.3 to 2.7
  POL sites (4 sites):
• Correlation coefficients: 0.9971 to 0.9989
• Standard error estimates: 6.4 to 10.5
• Confidence interval slopes: 0.941 to 1.001
• Confidence interval intercepts: -11.1 to 11.0 |
  | Detection Limit | Low (e.g., clinically relevant lower bound) | 9 U/L |

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

• Sample Size for Accuracy Study (In-house): 81 samples
• Sample Size for Accuracy Studies (POL sites): Not explicitly stated, but implies multiple samples were tested at each of the four separate POL sites.
• Sample Size for Precision Study (In-house): Not explicitly stated how many individual measurements contributed to the CVs, but involved testing at three LD levels over 22 days.
• Sample Size for Precision Study (POL sites): Not explicitly stated, but involved testing at three separate POL sites over 5 days.
• Data Provenance: The studies were conducted "in-house" (presumably by Alfa Wassermann Diagnostic Technologies, LLC, in the US) and at "three separate Physician Office Laboratory (POL) sites" and "four separate POL sites," indicating that data was collected from various clinical settings. Given the submitter's location in New Jersey, USA, and the FDA submission, it's highly probable the data is from the United States. The studies appear to be prospective as performance specific to this device and its use with the S40 Clinical Analyzer was generated.

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

Not applicable. This is an in vitro diagnostic (IVD) device for quantitative biochemical measurement. The "ground truth" for the test set is established by a comparative, legally marketed method (Alfa Wassermann ACE plus ISE/Clinical Chemistry System ACE Lactate Dehydrogenase Reagent), not by expert human interpretation.

4. Adjudication Method for the Test Set

Not applicable. As this is an IVD device measuring a biochemical marker against a comparative method, there is no human adjudication involved in establishing the "ground truth." The comparison is a direct numerical correlation between the S-Test LD and the predicate device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This device is an in vitro diagnostic test for quantitative determination of an analyte (LD activity). MRMC studies are typically performed for diagnostic imaging or pathology devices where human readers interpret medical images or samples.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, this describes the primary performance evaluation. The S-Test LD Reagent cartridge, when used with the S40 Clinical Analyzer, performs the quantitative measurement of LD activity without human interpretation in the results generation. The performance data presented (precision, accuracy, detection limit) are direct technical performance characteristics of the device itself.

7. Type of Ground Truth Used

The ground truth for the performance studies was established by comparison to a legally marketed predicate device (Alfa Wassermann ACE plus ISE/Clinical Chemistry System ACE Lactate Dehydrogenase Reagent) using the "comparative method." This is a common and accepted method for establishing the performance equivalence of new IVD assays.

8. Sample Size for the Training Set

Not applicable. This is a biochemical reagent and analyzer system, not a machine learning or AI-based device that requires a "training set" in the conventional sense of artificial intelligence. The device's operational parameters and calibration procedures are established through manufacturing and quality control, not through a data training pipeline.

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

Not applicable. As mentioned above, there is no "training set" for this type of IVD device in the context of machine learning. The operational characteristics and performance specifications are inherent to the chemical reactions and instrumental design, validated through standard analytical performance studies.

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Dimension Vista™ Carbon Dioxide (CO2) Flex® reagent cartridge: The CO2 method is an in vitro diagnostic test for the quantitative measurement of carbon dioxide in human serum and plasma on the Dimension Vista 100 System. The Dimension Vista™ Carbon Dioxide (CO2) Flex® reagent cartridge is a device intended to measure carbon dioxide in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.

Dimension VistaTM Creatinine (CREA) Flex® reagent cartridge: The CREA method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma, and urine on the Dimension Vista 100 System. The Dimension Vista™ Creatinine (CREA) Flex® reagent cartridge is a device intended to measure creatinine levels in serum, plasma and urine. 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.

Dimension Vista™ Lactate dehydrogenase (LDH) Flex® reagent cartridge: The LDH method is an in vitro diagnostic test for the quantitative measurement of lactate dehydrogenase in human serum and plasma on the Dimension Vista 100 System. The Dimension Vista™ Lactate dehydrogenase (LDH) Flex® reagent cartridge is a device intended to measure the activity of the enzyme lactate dehydrogenase in serum and plasma. Lactate dehydrogenase measurements are used in the diagnosis and treatment of liver diseases such as acute viral hepatitis, cirrhosis, and metastatic carcinoma of the liver, cardiac diseases such as myocardial infarction, and tumors of the lung or kidneys.

Dade Behring Dimension Vista™ Flex® reagent cartridges are prepackaged in-vitro diagnostic test methods (assays) that are specifically designed to be used on the Dade Behring Dimension Vista™ Integrated system, a floor model, fully automated, microprocessor-controlled, integrated instrument system. The Dimension Vista™ system was previously cleared with seven associated test methods (K 051087).

This Special 510(k) is submitted for a packaging modification to in-vitro diagnostic devices that have been cleared under the 510(k) process for use on Dimension® clinical chemistry systems. The packaging change is to allow use on the Dimension Vista™ system.

The CO2. CREA, and LDH reagents contained in the Dimension Vista™ Flex® reagent cartridges are the same as those contained in the Flex® reagent cartridges manufactured for the Dimension® clinical chemistry systems, another family of Dade Behring analyzers. The packaging modification, does not affect the intended use of the devices, nor does it alter the fundamental scientific technology of the devices.

The provided 510(k) summary for K061238 describes the clearance of three reagent cartridges (CO2, CREA, and LDH) for the Dade Behring Dimension Vista™ system. This is a "Special 510(k)" submission, which is used for modifications to existing devices where the fundamental scientific technology and intended use remain unchanged. In this case, the modification is a packaging change to allow the use of pre-existing, cleared reagents on a new instrument system (Dimension Vista™).

Because this is a packaging modification for reagents already cleared on other Dimension® systems, the "acceptance criteria" and "device performance" in the traditional sense of a diagnostic algorithm's accuracy are not explicitly detailed in terms of sensitivity, specificity, or AUC. Instead, the focus is on demonstrating substantive equivalence in performance between the new packaging/instrument combination and the previously cleared predicate devices when using the same reagents.

The study described is a comparative testing study to demonstrate equivalent performance.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical "acceptance criteria" in the format of thresholds for sensitivity, specificity, or similar metrics for a diagnostic device that performs classification or detection. Instead, the acceptance criterion for this packaging modification submission is "equivalent performance" to the predicate device.

The "device performance" reported is that the comparative testing "demonstrates equivalent performance" and "substantially equivalent performance". This implies that the results obtained using the Dimension Vista™ with the new Flex® reagent cartridges for CO2, CREA, and LDH are comparable to those obtained with the predicate Dimension® systems using the same reagents.

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

The document states: "Comparative testing described in the protocol included in this submission demonstrates equivalent performance." However, it does not provide any details regarding:

• The specific sample size used for the comparative testing.
• The data provenance (e.g., country of origin, retrospective or prospective nature of the samples).

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

This information is not applicable or not provided in this 510(k) summary. For a submission focused on equivalent analytical performance of clinical chemistry reagents, ground truth is typically assessed against established reference methods or by comparing results from the test device to the predicate device using patient samples or quality control materials. It does not involve expert readers establishing ground truth for diagnostic images or complex interpretations.

4. Adjudication Method for the Test Set

This information is not applicable or not provided. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation (e.g., radiology studies) to resolve discrepancies in expert opinions. This submission is for analytical chemistry reagents.

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

No, an MRMC comparative effectiveness study was not done. This type of study assesses how human readers' performance improves with or without AI assistance, which is irrelevant for a submission concerning in-vitro diagnostic reagents.

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

This submission is for IVD reagents used on an automated analyzer. The "standalone" performance here refers to the analytical performance of the combined reagent/instrument system. The document confirms that "Comparative testing...demonstrates equivalent performance," which implies the system's standalone analytical performance was evaluated against the predicate system. However, it's not an "algorithm-only" performance in the sense of AI.

7. The Type of Ground Truth Used

The "ground truth" for this type of submission is typically established by:

• Comparison to a legally marketed predicate device: The results from the new device are compared to those obtained from the predicate device using the same patient samples. Equivalence would be demonstrated through statistical methods (e.g., method comparison studies, regression analysis, bias analysis).
• Spiked samples or reference materials: To assess accuracy and linearity across the measuring range.

The summary states, "Comparative testing also demonstrates substantially equivalent performance," which strongly implies comparison to the predicate device using relevant samples.

8. The Sample Size for the Training Set

This information is not applicable or not provided. This submission is for IVD reagents, not a machine learning algorithm that requires a training set. The reagents themselves don't "learn" from data.

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

This information is not applicable. As stated above, this is not an AI/machine learning device that requires a training set and associated ground truth.

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The Piccolo Lactate Dehydrogenase Test System (presently contained on the Piccolo Basic Metabolic Panel Plus Reagent Disc) used with the Piccolo Point-of-Care Chemistry Analyzer is intended to be used for the in vitro quantitative determination of lactate dehydrogenase activity in heparinized plasma or serum in a clinical laboratory setting or point-of-care location.

Lactate dehydrogenase measurements are used in the diagnosis and treatment of liver diseases such as acute viral hepatitis and cirrhosis; cardiac diseases such as myocardial infarction; malignant diseases; and tissue alterations of the heart, kidney, liver, and muscle.

The Piccolo Basic Metabolic Panel Plus Reagent Disc (which contains the Piccolo Lactate Dehydrogenase Test System) is designed for heparinized plasma and serum, only. The disc meters the required quantity of sample and diluent, mixes the sample with diluent, and delivers the mixture to the reaction cuvettes along the disc perimeter. The diluted samples mixes with the reagent beads, initiating the chemical reactions that are then monitored by the analyzer. Alternately, the disc may also be used with serum.

Here's an analysis of the provided text to extract information about the device's acceptance criteria and the supporting study, formatted as requested:

Device: Piccolo® Lactate Dehydrogenase Test System

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined "acceptance criteria" in terms of specific performance targets (e.g., "linearity must be >0.99"). Instead, it presents the results of linearity and precision studies. The implicit acceptance criteria would be for these results to demonstrate performance comparable to the predicate device and suitable for its intended use.

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

• Linearity: Sample size not explicitly stated beyond the reported slope, intercept, and correlation coefficient.
• Precision:
  • Sample Size: n = 80 for both within-run and total precision studies.
• Sample Type Comparison: Sample size not explicitly stated.
• Data Provenance: Not explicitly stated as retrospective or prospective, or country of origin. Given it's a 510(k) submission for a US market, studies would typically be conducted to meet US regulatory requirements. It is a non-clinical study since it involves comparing the device to a predicate device in a laboratory setting.

3. Number of Experts Used and Their Qualifications for Ground Truth

Not applicable. This is a non-clinical study evaluating the performance of a laboratory diagnostic device, not a diagnostic imaging or AI algorithm requiring expert interpretation for ground truth. The "ground truth" for linearity and precision would be derived from certified reference materials or established high-accuracy laboratory methods.

4. Adjudication Method for the Test Set

Not applicable, as this is a non-clinical laboratory device performance study, not a clinical trial or AI study involving human interpretation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This study focuses on the analytical performance (linearity, precision) of a laboratory assay, not on the effectiveness of human readers with or without AI assistance.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop)

Yes, the studies reported (Linearity, Precision, Sample Type Comparison) represent the standalone performance of the Piccolo® Lactate Dehydrogenase Test System. These are analytical studies of the device itself, without human interpretation as part of the performance metric.

7. Type of Ground Truth Used

• Linearity, Precision, and Sample Type Comparison: The ground truth would be established using reference methods or certified calibrators/control materials with known concentrations/activities of Lactate Dehydrogenase. For precision, the "true" value is the mean value obtained over multiple runs. For sample type comparison, the "true" value is derived from a comparative method or the predicate device if it's considered the reference.

8. Sample Size for the Training Set

Not applicable. This is a non-AI/ML medical device submission. Therefore, there is no "training set" in the context of machine learning. The device's calibration is based on "Bar code with factory calibrated lot specific data."

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

Not applicable, as there is no training set for an AI/ML algorithm. The device uses "factory calibrated lot specific data" for its calibration, which would be established during manufacturing and quality control processes using reference materials and established laboratory standards.

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The SPOTCHEM II LDH test is intended to measure the activity of the enzyme lactate dehydrogenase in serum, plasma, and whole blood. Lactate dehydrogenase measurements are used in the diagnosis and treatment of liver diseases such as acute viral hepatitis, cirrhosis, and metastatic carcinoma of the liver, cardiac diseases such as myocardial infarction, and tumors of the lung or kidneys.

Not Found

The provided text is a 510(k) substantial equivalence letter from the FDA for a medical device (Arkray SPOTCHEM II LDH test). It does not contain any information about acceptance criteria, device performance details, specifics of a study, sample sizes, expert qualifications, or ground truth establishment relevant to the listed questions.

This document is a regulatory approval letter, not a scientific study report or a summary of performance data. Therefore, I cannot extract the requested information from the given text.

To answer your questions, I would need a different type of document, such as:

• A clinical study report
• A performance evaluation report
• A detailed 510(k) submission document (beyond just the decision letter)
• A scientific publication describing the device's validation.

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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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