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The Yumizen C1200 Glucose HK reagent is intended for the quantitative in vitro diagnostic determination of gluose in human serum, plasma, and urine using a glucose hexokinase method by colorimetry. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and pancreatic islet cell carcinoma.

The sodium electrode is an ion selective electrode that is intended for use on the ion selective electrode (ISE) unit of the Yumizen C1200 analyzer. The sodium electrode is used to quantify the concentrations of sodium ions in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.

The potassium electrode is an ion selective electrode that is intended for use on the ion selective electrode (ISE) unit of the Yumizen C1200 analyzer. The potassium electrode is used to quantify the concentrations of potassium ions in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases and conditions characterized by low or high blood potassium levels.

The chloride electrode is an ion selective electrode that is intended for use on the ion selective electrode (ISE) unit of the Yumizen C1200 analyzer. The chloride electrode is intended for use on the ion selective electrode (ISE) unit of the Yumizen C1200 analyzer. The chloride electrode is used to quantify the concentrations of chloride ions in serum, plasma, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

The Yumizen C1200 is an automatic chemistry analyzer that measures in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. Applications include colorimetric and ion selective electrode. This analyzer is intended for professional use in a laboratory environment only. Tests performed using this analyzer are intended for in vitro diagnostic use.

The Yumizen C1200 is an automatic chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. Applications include colorimetric and ion selective electrode. This analyzer is intended for professional use in a laboratory environment only. Tests performed using this analyzer are intended for in vitro diagnostic use. The system includes the Yumizen C1200 Glucose HK reagent, Sodium Electrode, Potassium Electrode, and Chloride Electrode. The analyzer uses photometric measurement and ion selective electrodes.

Here's a breakdown of the acceptance criteria and study information for the Horiba Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, and Chloride Electrode, based on the provided FDA 510(k) summary:

Horiba Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are implicitly met by demonstrating substantial equivalence to predicate devices and acceptable performance within the established ranges. The performance metrics are reported.

Yumizen C1200 Glucose HK:

ISE Module (Sodium, Potassium, Chloride Electrodes):

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

• Yumizen C1200 Glucose HK:

  • Matrix Comparison: 56 plasma samples.
  • Method Comparison: 141 serum samples, 100 urine samples.
  • Repeatability/Reproducibility: 2 level controls and 5 samples (low, middle, high concentrations), tested 20 times for repeatability. 2 level controls and 5 patient samples, tested in duplicate for 20 days (2 series per day) for reproducibility. Specific number of patient samples for these is not explicitly stated beyond "5 samples".
  • Reference Range: 50 normal samples (25 women + 25 men) in serum.
  • Data Provenance: Not explicitly stated, but typically clinical laboratory studies involve diverse populations to ensure generalizability. Given the HORIBA ABX SAS (France) and HORIBA, Ltd. (Japan) affiliations, it's possible the data originates from those regions. It is prospective data collection for the studies.

• ISE Module (Sodium, Potassium, Chloride Electrodes):

  • Matrix Comparison (vs. Olympus AU400 Plasma): NA: 171 plasma samples, K: 173 plasma samples, CL: 173 plasma samples.
  • Method Comparison (vs. Commercial ISE module): NA in serum: 165, K in serum: 170, CL in serum: 172. NA in urine: 194, K in urine: 198, CL in urine: 194.
  • Repeatability/Reproducibility: 2 level controls, 3 samples (low, middle, high concentration), and spiked samples. Tested 20 times by 3 reagent Lots for repeatability. Tested in duplicate for 20 days (2 series per day) for reproducibility. Specific number of patient samples for these is not explicitly stated beyond "3 samples".
  • Reference Range: 80 normal samples (23 women + 57 men) in serum and plasma.
  • Data Provenance: Not explicitly stated, likely similar to Glucose HK, prospective data.

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

Not applicable. These are in vitro diagnostic devices for quantitative measurements, not subject to expert interpretation of images or other subjective data. The "ground truth" or reference values are established by the predicate devices or scientifically validated methods as outlined in CLSI guidelines.

4. Adjudication method for the test set

Not applicable, as this is a quantitative analytical device. The "ground truth" is determined by reference methods (predicate devices, commercial reagents) and established analytical procedures (e.g., CLSI guidelines).

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 an IVD device for automated chemical measurement, not an AI-assisted diagnostic imaging or human-in-the-loop system.

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

Yes, the studies reported are inherently standalone performance evaluations of the analytical device (Yumizen C1200) and its associated reagents/electrodes. The performance data presented (measuring range, accuracy, precision, interferences, method comparisons) reflects the device's ability to measure analytes quantitatively without human interpretive input beyond sample loading and report generation.

7. The type of ground truth used

The "ground truth" for the performance studies is established by:

• Predicate devices: For the method and matrix comparison studies, the results from the legally marketed predicate devices (Beckman Coulter DxC 700 AU Clinical Chemistry Analyzer and HORIBA ABX PENTRA Glucose HK CP on Pentra C400 for Glucose HK; Olympus AU400 Clinical Chemistry Analyzer and a commercial ISE module for the ISE electrodes) serve as the reference for comparison.
• CLSI guidelines: Adherence to Clinical and Laboratory Standards Institute (CLSI) guidelines (e.g., EP17-A2, EP06-A, EP05-A3, EP07-A2, EP09-A3, EP28-A3c) indicates that the methods for determining limits, precision, linearity, interferences, and method comparisons follow accepted industry standards.
• Literature-cited reference ranges: For establishing the "normal" range for serum/plasma/urine concentrations, existing scientific literature is used as the reference.

8. The sample size for the training set

Not applicable. This is an analytical device for quantitative chemical measurements, not an algorithm that requires a "training set" in the context of machine learning or AI. The device's performance characteristics are determined by its physical design, chemical reactions, and operational parameters, which are validated through the performance studies described.

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

Not applicable, as there is no "training set" in the machine learning/AI sense for this type of IVD device.

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The Carolina Liquid Chemistries CLC 6410 chemistry analyzer is an automated clinical analyzer for in vitro diagnostic use only in clinical laboratories. It is intended to be used for a variety of assay methods. The analyzer provides in vitro quantitative determinations for glucose, sodium, potassium, and chloride in serum and plasma samples.

The Carolina Liquid Chemistries Glucose Reagent is for use with the Carolina Liquid Chemistries CLC 6410 Chemistry Analyzer for the measurement of glucose in serum and plasma. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and of pancreatic islet cell carcinoma.

The Carolina Liquid Chemistries ISE Kit is intended to be used with the Carolina Liquid Chemistries CLC 6410 Chemistry Analyzer for measurement of sodium, potassium, and chloride in serum and plasma. The ISE Kit consists of ISE Buffer, internal reference solution, and reference solution. Sodium measurements are used in the diagnosis and treatment of diseases involving electrolyte imbalance. Potassium measurements monitor electrolyte balance and in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used for the diagnosis and treatment of electrolyte and metabolic disorders.

The Carolina Liquid Chemistries ISE Calibrator Kit consists of Calibrator 1, Calibrator 2, and Selectivity Check. It is used with the ISE Module on the Carolina Liquid Chemistries CLC 6410 Chemistry Analyzer for the calibration of the Sodium, Potassium and Chloride assays.

For in vitro diagnostic use only.

Not Found

This document is an FDA 510(k) clearance letter for the Carolina Liquid Chemistries CLC 6410 Chemistry Analyzer, along with associated reagents and calibrators, for measuring glucose, sodium, potassium, and chloride in serum and plasma. The letter does not contain the detailed study information (acceptance criteria, performance data, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies) that would typically be required to fully answer your request.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..." This means the FDA has deemed the device substantially equivalent to existing devices, implying that the performance presented in the 510(k) submission met the acceptance criteria by demonstrating performance comparable to the predicate device. However, the specific acceptance criteria and detailed study findings are not included in this publicly available letter.

Therefore,Based on the provided document, I cannot fulfill your request as it does not contain the detailed study information regarding acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, type of ground truth, or how ground truth was established for training and test sets.

The document is a 510(k) clearance letter from the FDA, stating that the device is substantially equivalent to legally marketed predicate devices. It includes the indications for use but does not provide the underlying performance studies or the specific acceptance criteria and results from those studies.

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The XL-200 Clinical Chemistry Analyzer is an automated random access, computer controlled, bench top, clinical analyzer for clinical chemistry tests. The instrument provides in vitro quantitative measurements for glucose, sodium, potassium and chloride in serum. This device is intended for clinical laboratory use.

The JAS Glucose Reagent is intended for the in vitro quantitative measurement of glucose in serum on the XL-200 clinical chemistry analyzer. This device is intended for clinical laboratory use. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia and idiopathic hypoglycemia and of pancreatic islet cell Carcinoma.

The ISE Reagent Pack is intended for the in vitro quantitative measurement of sodium, and chloride concentrations in serum on the XL-200 clinical chemistry analyzer. This device is intended for clinical laboratory use.

Sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus and other diseases involving electrolyte imbalance.

Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.

Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

The XL-200 Clinical Chemistry Analyzer is an automated bench top, random access, open analyzer for clinical chemistry and immunoturbidimetric analysis on serum, urine, and other body fluids. The analyzer mainly uses colorimetric, turbidimetric, and ion selective electrode methods for analysis of samples.

The instrument includes of the following main parts;

• . Sampling Arm (for sample addition to cuvettes)
• Reagent Arm (for reagent addition to cuvettes) .
• Reaction Station (cuvettes) .
• Sample Plate Station (for loading samples) .
• Reagent Plate Station (for on board reagents) .
• . Photometer (for reaction analysis reading)
• Wash Station (for cleaning of reaction cuvettes) .
• Electronic Boards (for controlling the open functions) .

The JAS Glucose Reagent is intended for the quantitative measurement of glucose in serum on the XL-200 Clinical Chemistry Analyzer. The Reagent is a single vial liquid that is placed for use on the XL-200 Clinical Chemistry Analyzer reagent carousel. The reagent uses the enzymatic (Hexokinase/G-6-P) UV (340nm) method. This device is for clinical laboratory use.

The JAS ISE Module consists of ion selective electrodes for sodium, potassium, and chloride, a reference electrode and accessory reagents.

Here's a breakdown of the acceptance criteria and study information for the JAS XL-200 Clinical Chemistry Analyzer, JAS Glucose Reagent, and ISE Reagent Pack, based on the provided text:

Important Note: The provided document is a 510(k) summary for a medical device. This type of document focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical trials. Therefore, information regarding human reader studies (MRMC), standalone AI performance, and expert qualifications for ground truth in the traditional sense of AI/ML studies are not typically found in these submissions as the device is not an AI/ML diagnostic tool. The "ground truth" here refers to established, validated reference methods or materials in clinical chemistry.

1. Table of Acceptance Criteria and Reported Device Performance

Device: XL-200 Clinical Chemistry Analyzer, JAS Glucose Reagent, ISE Reagent Pack
Tests: Glucose, Sodium, Potassium, Chloride

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

• Glucose Correlation (Test Set): 103 sample pairs (serum), multiple days, various glucose levels.
  • Data Provenance: Not explicitly stated, but clinical laboratory use is mentioned, suggesting human serum samples. The testing was comparative against a predicate device.
• Sodium Correlation (Test Set): 101 sample pairs (serum), multiple days, various analyte levels.
  • Data Provenance: Not explicitly stated, but clinical laboratory use is mentioned, suggesting human serum samples. The testing was comparative against a predicate device.
• Potassium Correlation (Test Set): 90 sample pairs (serum), multiple days, various analyte levels.
  • Data Provenance: Not explicitly stated, but clinical laboratory use is mentioned, suggesting human serum samples. The testing was comparative against a predicate device.
• Chloride Correlation (Test Set): 88 sample pairs (serum), multiple days, various analyte levels.
  • Data Provenance: Not explicitly stated, but clinical laboratory use is mentioned, suggesting human serum samples. The testing was comparative against a predicate device.
• Precision (Test Set): Three glucose, sodium, potassium, and chloride sample levels, each run 20 times in duplicate over 20 days.
  • Data Provenance: In-house laboratory testing.

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

Not applicable. This is a clinical chemistry analyzer, not an image-based diagnostic AI/ML device requiring expert interpretation for ground truth. The "ground truth" for the test set is established by the measurements from the predicate device (Olympus AU400 Clinical Chemistry Analyzer) or by reference materials/methods (e.g., Verichem Laboratories Matrix Plus Chemistry Reference Kit, NIST-traceable materials).

4. Adjudication method for the test set

Not applicable. As this is a clinical chemistry device, adjudication in the sense of reconciling human expert opinions is not relevant. The comparison is between the device's measurements and those of a predicate device/reference standard.

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/ML diagnostic device involving human readers.

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

Yes, the studies presented are for the standalone performance of the device (XL-200 Analyzer with its reagents). The device itself performs the quantitative measurements without human-in-the-loop diagnostic interpretation of results in the context of an AI/ML algorithm. The results are reported as numerical values.

7. The type of ground truth used

The ground truth for the performance studies is primarily established by:

• Predicate Device Measurements: For correlation studies, the measurements from the legally marketed Olympus AU400 Clinical Chemistry Analyzer (using Olympus reagents) served as the reference standard.
• Reference Materials: For calibrator traceability studies, Verichem Laboratories Matrix Plus Chemistry Reference Kit (9500), verified and lot certified using National Institute of Standards and Technology (NIST) traceable standard reference materials, was used.
• Theoretically Prepared Standards: For linearity studies, serial dilutions of stock standards with known concentrations were used.
• Established Analytical Methods: The hexokinase/G-6-P enzymatic method for glucose and ion-selective electrodes for electrolytes are well-established analytical principles in clinical chemistry.

8. The sample size for the training set

Not applicable. This device is a traditional clinical chemistry analyzer and reagent system, not an AI/ML device that requires a "training set" in the machine learning sense. The device's performance characteristics (e.g., linearity, precision, interference) are determined to define its operating range and robustness, not to train an algorithm.

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

Not applicable, as there is no "training set" for this type of device. The ground truth for validating the device's performance is established as described in point 7.

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The RX Daytona Plus Chemistry analyzer is a bench top fully automated random access clinical chemistry analyzer intended for use in clinical laboratories. It is intended to be used for a variety of assay methods. The RX Daytona Plus includes an optional Ion Selective Electrode (ISE) module for the measurement of sodium, potassium and chloride in serum and urine. The RX Daytona Plus is not for Point-Of-Care testing.

Sodium measurements are used in the diagnosis and treatment of diseases involving electrolyte imbalance.

Potassium measurements monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.

Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders.

The RX Daytona Plus AST reagent is for the quantitative in vitro diagnostic determination of the activity of the enzyme Aspartate aminotransferase (AST) in human serum. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart diseases.

The RX Daytona Plus is a bench-top fully automated random access clinical analyser intended for use in clinical laboratories.

The RX Daytona Plus contains an ISE .module for the measurement of Potassium, Chloride and Sodium. The RX Daytona Plus has the capacity to perform up to 270 photometric tests or 450 tests per hour with ISE's and offers primary tube sampling, on-board sample dilution and a cooled reagent compartment.

• Cuvette wash system .
• STAT facility .
• Direct interface with host computer .
• . Automatic re-run and pre-dilution functions

The RX Daytona Plus uses dedicated software for easy access to all system facilities and functions. operating functions and provides a comprehensive data management system.

Reagents:
AST reagent is supplied in a kit containing:

• . 4 x 20.0 mL Buffer/ enzyme
• . 4 x 7.0 mL α-οχοςlutarate/Coenzyme.

The primary reagent contains L-Aspartic acid, MDH, Tris Buffer and preservative, The secondary reagent contains a-oxoglutarate, NADH and preservatives.

ISE Electrodes, Sodium, Potassium and Chloride are comprised of ISE Calibrator H and L, ISE diluent, ISE reference solution and ISE etching solution.

Here's a summary of the acceptance criteria and study information for the RX Daytona Plus Instrument, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implied by the results of the precision, linearity, detection limit, analytical specificity, and method comparison studies. The device aims to demonstrate substantial equivalence to its predicate devices for each analyte (AST, Sodium, Potassium, Chloride) in the relevant sample types (serum, urine). The performance metrics reported directly represent if these implied criteria were met.

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

• Precision/Reproducibility:

  • AST, Sodium, Potassium, Chloride (Serum): Two levels of control material, calibration material, unaltered human serum samples, and altered human serum samples. Tested twice per day for 20 non-consecutive days, with two replicates per sample. This totals approximately 80 test points per sample type for control/calibrator, and 40 test points per patient pool (20 days * 2 replicates).
  • Sodium, Potassium, Chloride (Urine): Two levels of urine controls and two urine patient pools. Tested twice per day for 20 non-consecutive days, with two replicates per sample. Totals approximately 80 test points per control, and 40 test points per patient pool.
  • Data Provenance: Not explicitly stated, but the submission is from Randox Laboratories Limited in the United Kingdom, suggesting the studies were likely conducted there. The samples were human serum and urine. Retrospective or prospective nature is not specified, but the "non-consecutive days" suggests prospective testing over a period.

• Linearity/Assay Reportable Range:

  • AST, Sodium, Potassium, Chloride (Serum & Urine): Studies performed at 11 levels.
  • Data Provenance: Implied to be derived from the UK.

• Detection Limit (AST):

  • 360 determinations, with 1 blank and 2 low-level samples.
  • Data Provenance: Implied to be derived from the UK.

• Analytical Specificity (Interference):

  • Interferents (Hemoglobin, Bilirubin, Triglycerides, Intralipid, various drugs) were "spiked" into relevant control/sample solutions. The number of samples/replicates isn't specified beyond this.
  • Data Provenance: Implied to be derived from the UK.

• Method Comparison with Predicate Device:

  • AST (Serum): 92 serum patient samples.
  • Sodium (Serum): 50 serum patient samples.
  • Sodium (Urine): 42 urine patient samples.
  • Potassium (Serum): 56 serum patient samples.
  • Potassium (Urine): 43 urine patient samples.
  • Chloride (Serum): 61 serum patient samples.
  • Chloride (Urine): 44 urine patient samples.
  • All samples were tested in singlicate across 5 working days.
  • Data Provenance: Not explicitly stated, but given the submitter's location (UK), the data is most likely from the UK. The studies used "patient samples," which suggests real-world specimens, likely collected prospectively for the purpose of the study or retrospectively from a patient cohort.

• Expected Values/Reference-range Verification:

  • Sodium, Potassium, Chloride (Serum): Human serum from 30 normal donors, tested in singlicate.
  • Data Provenance: Implied to be derived from the UK.

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

Not applicable. This device is a clinical chemistry analyzer. The "ground truth" for the test set values (e.g., concentrations of AST, sodium) is established by reference methods or validated laboratory procedures, not by human expert interpretation like in imaging studies. The predicate device's performance also serves as a benchmark.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth in subjective diagnostic tasks, such as radiology image interpretation. In this context, the "ground truth" values for chemical analytes are obtained through highly standardized and quantitative laboratory methods (e.g., reference methods, predicate device results).

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

No. An MRMC study is relevant for evaluating the impact of AI on human readers' performance in diagnostic tasks (e.g., radiology). This device is a fully automated chemistry analyzer, not an AI-assisted diagnostic tool for human readers.

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

Yes, essentially all the performance data (precision, linearity, detection limits, analytical specificity, method comparison) reflects the standalone performance of the RX Daytona Plus Chemistry Analyzer as an automated instrument. There is no human-in-the-loop aspect for the analysis itself; human intervention is only involved in loading samples and interpreting the final results generated by the machine.

7. The Type of Ground Truth Used

The ground truth for the performance studies was established using a combination of:

• Reference materials/control materials: For precision and linearity studies.
• Validated methods/Predicate device results: For method comparison studies, where the results from the RX Daytona Plus were compared against a legally marketed predicate device (Randox RX Imola Chemistry Analyzer with ISE, Randox AST assay).
• Gravimetric preparation from purified salts: For ISE (Sodium, Potassium, Chloride) calibrators traceability.
• Standardized reference procedures (JSCC TS01): For AST traceability.
• Clinical literature: For establishing expected values/reference ranges.

8. The Sample Size for the Training Set

Not applicable. This is a traditional automated chemistry analyzer, not a machine learning or AI-driven device that requires a training set in the typical sense. The "parameters" and "algorithms" (e.g., Nernst equation for ISE, kinetic reaction for AST) are based on established chemical and physical principles, not learned from a large dataset.

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

Not applicable, as there is no "training set" for this type of device. The operating principles are based on fundamental scientific laws and established chemical diagnostic assays.

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The Dimension® EXL™ with LM system is an in vitro diagnostic device that is intended to measure a variety of analytes in human body fluids. The system utilizes photometric, turbidimetric, chemiluminescence and integrated ion selective multisensor technology for chemical and immunochemical applications for clinical use.

The FT4L method is an in vitro diagnostic test for the quantitative measurement of Free Thyroxine in human serum and plasma on the Dimension® EXL™ with LM system. Measurements of free thyroxine are used in the diagnosis and monitoring of thyroid disease.

The Dimension EXL with LM system is a floor model, fully automated, microprocessorcontrolled, integrated instrument which uses prepackaged Siemens Dimension Flex® reagent cartridges to measure a variety of analytes in human body fluids. The system can process samples in random access, batch or STAT modes. The instrument has a heterogeneous module (HM) for processing chromium-based heterogeneous immunoassays and a LOCI® module for chemiluminescent immunoassays. The instrument can also perform photometric, turbidimetric and ACMIA tests. This 510(k) is being submitted because a new photomultiplier (from a different vendor) will be used to count the signal for the chemiluminescent methods (LOCI).

The Dimension® FT4L Flex® regent cartridge consists of prepackaged liquid reagents containing two synthetic beads, and a biotinvlated anti-T4 mouse monoclonal antibody in a plastic eight-well cartridge.

The FT4L method is a homogeneous, sequential, chemiluminescent immunoassay based on. LOCI® technology. The LOCI® reagents include two synthetic bead reagents and a biotinylated anti-T4 mouse monoclonal antibody. The first bead reagent (Chemibeads) is coated with trijodothyronine (T3), a naturally occurring, weaker binding analog of T4, and contains chemiluminescent dye. The second bead reagent (Sensibeads) is coated with streptavidin and contains a photosensitizer dye. In a first step, sample is incubated with biotinylated antibody which allows T4 from the sample to saturate a fraction of the biotinylated antibody that is directly related to the free thvroxine (FT4) concentration. In a second step, T3 Chemibeads are added and form bead/biotinylated antibody immunocomplexes with the nonsaturated fraction of the biotinylated antibody. Sensibeads are then added and bind to the biotin to form bead pair immunocomplexes. Illumination of the complex at 680 nm generates singlet . oxygen from Sensibeads which diffuses into the Chemibeads, triggering a chemiluminescent reaction. The resulting signal is measured at 612 nm and is an inverse function of the FT4 concentration in the sample.

Here's an analysis of the acceptance criteria and study detailed in the provided 510(k) summary for the Siemens Dimension® EXL™ with LM system and FT4L Flex® reagent cartridge.

Note: This submission focuses on a change in a photomultiplier tube (PMT) vendor for an existing device. Therefore, the "acceptance criteria" discussed are primarily related to demonstrating that the new PMT does not negatively impact the performance of a representative assay (FT4L) compared to the previously cleared system. This is a comparative effectiveness study rather than assessing absolute performance against disease diagnosis benchmarks.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and the Reported Device Performance

Notes on Acceptance Criteria: The document primarily states that the acceptance criteria for precision are either "as follows" (referring to the table provided) or "must be determined to be substantially equivalent to the predicate device." Since the new PMT system demonstrated precision values well within the specified limits, and also showed very similar performance to the current PMT system (data for current PMT also provided in the document, which are very close), it successfully met these criteria. The method comparison's strong correlation, slope near 1, and intercept near 0 directly support "substantially equivalent" performance.

Study Details

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

• Method Comparison Test Set Sample Size: 45 patient samples
• Precision Test Set Sample Size: 3 commercial quality controls (BioRad Liquichek Immunoassay QC - 3 levels) and 2 patient serum pools.
• Data Provenance:
  • Country of Origin: Not explicitly stated, but the studies were conducted "internally by Siemens Healthcare Diagnostic Inc. R & D organization personnel," suggesting a US or European location where Siemens R&D is prominent. Given the FDA submission, the data is likely intended to be representative for the US market.
  • Retrospective or Prospective:
    • Method Comparison: Retrospective. "Remnant de-identified human serum samples were tested." This implies samples were collected previously for other purposes.
    • Precision: Prospective. Testing was performed "over twenty (20) days, one (1) run per day for each test material." This indicates systematic, planned testing for this study.

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 (IVD) device measuring a quantitative biomarker (Free Thyroxine). The ground truth for such devices is established through laboratory methods and reference materials, not expert human interpretation (like in imaging or clinical diagnosis). The "test set" and "ground truth" here refer to the accurate measurement of FT4L concentrations.
• The "ground truth" for the comparative study is the measurement obtained from the predicate device (Dimension® EXL™ with LM system with the current PMT), which is the standard of comparison for demonstrating substantial equivalence. The study aims to show that the new device yields the same results as the predicate.

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

• None. Adjudication methods like 2+1 or 3+1 are typical for studies involving human interpretation or subjective assessments (e.g., in radiology studies where multiple readers interpret images, and discrepancies need resolution). For quantitative IVD devices, analytical measurements are directly compared.

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

• No. This is not a multi-reader multi-case (MRMC) comparative effectiveness study. This type of study is relevant for AI-powered diagnostic tools that assist human readers in interpreting complex data (e.g., medical images).
• This submission is for a change in a component of an automated laboratory analyzer that measures a quantitative biomarker. There is no human "reader" involved in the direct output of the Free Thyroxine measurement, nor is there AI assistance to a human for interpretation in the context of this device's function.

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

• Yes, effectively (for the measurement component). The device itself is an automated analyzer. The "algorithm only" performance is the measurement output by the instrument. The study directly compares the numerical results from the device with the new PMT to the device with the current PMT. There is no "human-in-the-loop" once the sample is loaded; the instrument performs the analysis automatically.

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

• Reference Method/Predicate Device Performance: The primary "ground truth" for demonstrating substantial equivalence in this context is the performance of the previously cleared predicate device (Dimension® EXL™ with LM system with the original PMT). The study aims to show that the new device produces results that are statistically indistinguishable from those produced by the predicate device.
• For the precision study, commercial quality controls and patient pools with known, stable concentrations serve as the reference materials monitored for consistency.
• For traceability, "USP-grade thyroxine spiked into stripped human serum" and a "Master Pool" calibrated against an "Anchor Pool" are used for defining the FT4L values.

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 in vitro diagnostic analyzer. While the instrument and assay are developed and optimized (which involves internal testing and calibration), the concept of a "training set" as understood in AI studies does not apply here.

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

• Not Applicable. As explained above, there is no "training set" in the context of AI/ML. The device's underlying principles are based on established chemical and immunoassay reactions, not trained algorithms. The "ground truth" for calibrating the system and ensuring its accuracy is established through stringent analytical chemistry practices, including the use of reference materials, calibrators, and validation against established methods (as mentioned in the traceability section).

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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 measurement of general chemistry assays for clinical use in physician office laboratories or clinical laboratories.

The ACE Axcel Clinical System includes an Ion Selective Electrode (ISE) module for the measurement of sodium, potassium and chloride in serum. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

• Sodium measurements are used in the diagnosis and treatment of diseases involving electrolyte imbalance
• Potassium measurements are used to monitor electrolyte balance and in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.
• Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

The ACE Glucose Reagent is intended for the quantitative determination of glucose concentration in serum using the ACE Axcel Clinical Chemistry System. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. 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 Glucose Reagent assay, glucose in serum reacts with adenosine triphosphate in the presence of hexokinase and magnesium with the formation of glucose-6-phosphate and adenosine diphosphate. Glucose-6-phosphate dehydrogenase catalyzes the oxidation of glucose-6-phosphate with NAD+ to form 6-phosphogluconate and NADH. NADH absorbs strongly at 340 nm, whereas NAD+ does not. The total amount of NADH formed is proportional to the concentration of glucose in the sample. The increase in absorbance is measured bichromatically at 340 nm/378 nm.

The ACE Ion Selective Electrode (ISE) Module is used with ACE CAL A and CAL B Calibration Solutions in the performance of a two-point calibration in order to measure concentrations of sodium, potassium and chloride in undiluted serum. The ISE module uses a potentiometric method to simultaneously measure sodium, potassium and chloride in undiluted serum. Each electrode uses an ion-specific membrane to measure the difference in ionic concentration between an inner electrolyte solution and the sample. This difference causes an electro-chemical potential to form on the membrane of the active electrode. The connection of the amplifier and ground (reference electrode) to the ion selective electrode forms the measuring system. The two-point calibration with CAL A and CAL B with precisely known ion concentrations (two-point calibration) and the measured voltage difference of the sample and CAL A are used to determine the ion concentration in the sample.

Here's a summary of the acceptance criteria and study information for the Alfa Wassermann ACE Axcel Clinical Chemistry System, ACE Ion Selective Electrode (ISE) Module, and ACE Glucose Reagent, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the "Accuracy" data, where the device (y) is compared to a predicate device (x). The close correlation, with slopes near 1 and intercepts near 0, along with high correlation coefficients, indicates acceptable accuracy. Precision is evaluated by the Coefficient of Variation (CV%).

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

• ACE Glucose Reagent:

  • Accuracy (Correlation Study): 122 samples (ranging from 6 to 729 mg/dL).
  • Accuracy (Patient Correlation Studies): Data from three separate Physician Office Laboratory (POL) sites. Specific sample numbers per POL site are not provided, but the combined sites yielded multiple correlation coefficients, standard error estimates, and confidence intervals for slope and intercept.
  • Provenance: Not explicitly stated, but likely from a laboratory setting and Physician Office Laboratories, presumably within the US given the submission to the FDA. The nature of the samples (e.g., patient samples, control materials) is not specified as prospective or retrospective.

• ACE Axcel Sodium ISE:

  • Accuracy (Correlation Study): 113 samples (ranging from 45.1 to 194.0 mmol/L).
  • Accuracy (Patient Correlation Studies): Data from three separate Physician Office Laboratory (POL) sites.
  • Provenance: Same as Glucose – likely US lab/POL, nature of samples not specified.

• ACE Axcel Potassium ISE:

  • Accuracy (Correlation Study): 115 samples (ranging from 1.57 to 14.20 mmol/L).
  • Accuracy (Patient Correlation Studies): Data from three separate Physician Office Laboratory (POL) sites.
  • Provenance: Same as Glucose – likely US lab/POL, nature of samples not specified.

• ACE Axcel Chloride ISE:

  • Accuracy (Correlation Study): 111 samples (ranging from 63.4 to 176.0 mmol/L).
  • Accuracy (Patient Correlation Studies): Data from three separate Physician Office Laboratory (POL) sites.
  • Provenance: Same as Glucose – likely US lab/POL, nature of samples not specified.

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

Not applicable. For this type of in vitro diagnostic device, "ground truth" is established by comparing the performance of the new device to a legally marketed predicate device (Alfa Wassermann ACE Clinical Chemistry System and ACE Reagents) using quantitative measurements, not by expert interpretation. The predicate device itself acts as the reference method in these correlation studies.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this is a quantitative comparison against a predicate device, not an interpretation-based ground truth requiring adjudication.

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 is a clinical chemistry analyzer, an automated system for measuring analytes in samples. It does not involve human readers interpreting images or data where AI assistance would be relevant in the context of MRMC studies.

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

Yes, the performance studies described are inherently "standalone" in the sense that they evaluate the performance of the ACE Axcel Clinical Chemistry System (including its reagents and ISE module) in producing quantitative results independently. The accuracy studies compare its output directly against a predicate device's output. There isn't a "human-in-the-loop" aspect to the core measurement performance itself.

7. The Type of Ground Truth Used

The "ground truth" for the accuracy studies is the quantitative result obtained from the predicate device (Alfa Wassermann ACE Clinical Chemistry System and ACE Reagents). The studies are correlation studies comparing the new device's measurements (y) to the predicate device's measurements (x).

8. The Sample Size for the Training Set

Not applicable. This document describes a traditional medical device (clinical chemistry analyzer), not a machine learning or AI-based device that typically has a "training set." The device is intended to perform measurements based on established chemical and electrochemical principles.

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's development as described in the provided text.

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The Dimension ® clinical chemistry system is an in vitro diagnostic device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids.

The Dimension system chemical and immunochemical applications utilize photometric, turbidimetric, and integrated ion selective multisensor technology for clinical use.

Sodium measurements are used for monitoring electrolyte imbalances.

Potassium measurements are used for diagnosis in diseases with high and low Potassium levels.

Chloride measurements are primarily use to detect and treatment of metabolic disorders.

Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Thyroid stimulating hormone measurements are used in diagnosis of thyroid or pituitary disorders.

Aspartate aminotransferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.

The Siemens Healthcare Diagnostics Dimension® clinical chemistry analyzers are floor model, fully automated, microprocessor-controlled, integrated instrument systems that use prepackaged Flex® reagent test cartridges to measure a variety of analytes in human body fluids. The systems can process samples in random access, batch and stat modes. The systems are multi-functional analytical tools that process chemical and immunochenical methodologies, utilizing photometric, and integrated ion selective multisensor detection technologies for clinical use. The Dimension systems include the ability to communicate and connect with laboratory information system (LIS) networks.

With revision 10.0 software, the Operating System of the Dimension clinical chemistry analyzers, RxL/ RxLMax (K963498), Xpand Plus (K010061), will change from QNX to Linux.

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

Device: Dimension® RxL/RxL Max clinical chemistry analyzer (with Linux Operating System)

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantified, pass/fail manner. Instead, the acceptance criteria for this 510(k) submission are implicitly tied to demonstrating substantial equivalence to the predicate device. The key performance metrics evaluated were Method Comparison and Precision (within run, within lab) for specific representative assays. The performance is reported as meeting this equivalency.

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

• Sample Size: The document states that "representative methods were tested" and compares "the same samples and methods" on predicate and test instruments. However, the specific number of samples (sample size) used for the test set for Method Comparison and Precision studies is not provided.
• Data Provenance: Not explicitly stated (e.g., country of origin). The study appears to be prospective in the sense that samples were deliberately run on both the predicate and test devices for comparison purposes.

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

Not applicable. This device is an in vitro diagnostic chemistry analyzer, and its performance is evaluated against itself (predicate device performance) using quantitative measurements, not against expert human interpretations or diagnoses. The ground truth would be the actual concentration of analytes in the samples.

4. Adjudication Method for the Test Set:

Not applicable. As noted above, this is a quantitative analytical device comparison, not a diagnostic interpretation where adjudication of expert opinions would be necessary.

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

No. This type of study (MRMC) is typically performed for diagnostic imaging or similar devices where multiple human readers interpret cases. This submission is for a clinical chemistry analyzer, which does not involve human interpretation of outputs in the same way. The evaluation is purely based on instrument performance.

6. Standalone (Algorithm Only) Performance:

Yes, an equivalent of a "standalone" performance was done. The study directly compared the analytical results obtained from the Dimension® clinical chemistry system with the Linux operating system (test device) against the analytical results obtained from the Dimension® clinical chemistry system with the QNX operating system (predicate device). The evaluation focuses solely on the output of the instrument itself, without human intervention in the result generation.

7. Type of Ground Truth Used:

The ground truth implicitly used for the performance comparison is the analytical result produced by the predicate device. The goal was to show that the new device (with Linux OS) produces equivalent results to the established predicate device (with QNX OS) when processing the same samples. The underlying ground truth for the analytes themselves would be the true concentration in the human body fluids, likely measured by a highly accurate validated method, but the comparison here is between two versions of the same product.

8. Sample Size for the Training Set:

Not applicable. This device is a measurement instrument, not an AI or machine learning model that requires a training set in the conventional sense. The "training" of such a system would involve instrument calibration and quality control procedures, but not a data-driven training set like an AI algorithm.

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

Not applicable, for the same reasons as point 8.

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The Thermo Scientific Indiko Clinical Chemistry Analyzer is a fully automated random access analyzer used to measure a variety of analytes that may be adaptable to the analyzer depending on the reagent used.

The Indiko Glucose (HK) test system, is intended for in vitro diagnostic use in the quantitative determination of the glucose concentration in human plasma on the Indiko analyzer.

Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

The Indiko is automated random access discrete photometric analyzer, capable of performing up to 30 photometric tests.

The sample disk has an integrated barcode reader which allows cup/tube recognition. The barcode reader can read the following codes: code 128, USS Codabar, interleaved 2 of 5 and code 39 with check digit.

Reaction cells are discrete disposable (single use) multicell cuvettes with 10 reaction measurement cells in a row. On-board capacity of 36 multicell cuvettes (equal to 360 reaction cells), with continuous loading capability, typically 2 hours walk-away time. The quality of the reaction cells is checked at the start of the routine work automatically. The measurements are performed at 37℃.

The analyzer incorporates robotics, computer, and communication technology to render simple and reliable long-term operation. The operating system works with Windows® 7. The user interface software is graphical. The data input can be done online or by touch screen or mouse or keyboard.

Reagents are liquid, the reagent bottles are placed on the reagent/sample disk, which holds maximum 30 positions, the reagent/sample disk is cooled 10℃ below ambient temperature.

Here's a breakdown of the acceptance criteria and study details for the Indiko Glucose (HK) system, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size and Data Provenance for Test Set

• Sample Size for Method Comparison: 117 samples (n = 117).
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It is a "method comparison study" comparing the new device to a predicate device, which typically involves running the same samples on both instruments. Given the manufacturer's location (Finland), it's reasonable to infer the study could have been conducted there, but this is not definitively stated.

3. Number of Experts and Qualifications for Ground Truth of Test Set

• This device is a clinical chemistry analyzer with a specific assay for glucose. The "ground truth" for such devices is established by quantitative laboratory measurements, not by expert interpretation of images or clinical cases. Therefore, the concept of "experts establishing ground truth" in the manner of radiologists or pathologists does not directly apply here. Instead, the accuracy of the measurements is compared against a reference (predicate device) and validated against known standards and expected performance.

4. Adjudication Method for Test Set

• Not applicable. As this is a quantitative measurement device, there is no "adjudication" in the sense of resolving disagreements between human readers or interpreters. The comparison is objective, based on numerical results.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., imaging studies) and is not applicable to an automated clinical chemistry analyzer.

6. Standalone Performance Study

• Yes, a standalone performance study was done in the sense that the device's performance characteristics (precision, linearity, limits, interference) were evaluated independently against predefined acceptance criteria. The "method comparison" also evaluates the standalone performance of the Indiko against the predicate device.

7. Type of Ground Truth Used

• The ground truth for the performance evaluation of the Indiko Glucose (HK) system is largely established through:
  • Comparison to a Predicate Device: The DPC T60i Clinical Chemistry Analyzer (Konelab 60i) was used as a reference for method comparison.
  • Internal Validation and Standards: Precision, linearity, limits, and interference studies rely on established laboratory methods, controls, and known concentrations of analytes and interferents.

8. Sample Size for Training Set

• The document does not specify a separate "training set" sample size. For clinical chemistry analyzers, the "training" usually refers to the development and calibration of the assay and instrument, which is typically done by the manufacturer during product development, using various internal samples and standards. Unlike AI/ML models, there isn't a distinct "training set" in the context of this 510(k) summary for a traditional analytical instrument.

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

• Since a distinct "training set" as understood in AI/ML is not explicitly mentioned for this device, the concept of establishing ground truth for it is not detailed. However, the development of such assays and instruments involves rigorous internal testing, calibration using certified reference materials, and validation across various sample types and concentrations to ensure accuracy and reliability. This process establishes the "ground truth" that the instrument is designed to measure.

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The TC Matrix Clinical Chemistry Analyzer is a discrete photometric chemistry analyzer for clinical use. The device is intended to duplicate manual analytical procedures by automatically various steps such as pipetting, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes of clinical interest in serum, plasma samples.

TECO MULTI Calibrator is intended for the calibration of quantitative assays.

Teco Albumin reagent is intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

Teco ALT reagent is intended to measure the activity of the enzyme alanine amino transferase (ALT) (also known as a serum glutamic pyruvic transaminase or SGPT) in serum and plasma. Alanine amino transferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.

Teco Glucose reagent is intended for the quantitative determination of total glucose in human serum or plasma. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Teco BUN reagent is intended to measure urea nitrogen (an end-product of nitrogen metabolism) in serum or plasma. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.

The TC Matrix Clinical Chemistry Analyzer is a discrete photometric chemistry analyzer for clinical use. The device is intended to duplicate manual analytical procedures by automatically various steps such as pipetting, heating, and measuring color intensity.

This FDA 510(k) clearance letter pertains to the TC Matrix Clinical Chemistry Analyzer and several associated reagents. It does not contain a study that proves the device meets acceptance criteria, nor does it provide details on specific acceptance criteria and device performance.

The letter primarily confirms that the FDA has reviewed the premarket notification and determined that the device is substantially equivalent to legally marketed predicate devices. This determination is based on the indications for use stated in the enclosure.

Therefore, most of the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment cannot be found in the provided document.

Here's a breakdown of what can be inferred or is explicitly stated:

1. A table of acceptance criteria and the reported device performance:

• Not available in the provided document. The letter makes a determination of substantial equivalence based on the indications for use, but it does not present a table of specific performance criteria or the results of a study demonstrating these. Such information would typically be in the 510(k) submission itself, not the FDA's clearance letter.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

• Not available in the provided document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

• Not available in the provided document.

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

• Not available in the provided document.

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/available. This device is a clinical chemistry analyzer, not an AI-assisted diagnostic imaging system that involves human readers in the way an MRMC study would measure.

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

• Not applicable in the context of an "algorithm only". The device itself is an automated analyzer. Its performance is inherent to the analyzer's function, not a standalone "algorithm" in the typical sense of AI. The performance comparison would be between this analyzer and a predicate device or established reference methods. While the letter confirms substantial equivalence, it doesn't detail the studies.

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

• Not available in the provided document. For a chemistry analyzer, ground truth would typically be established by comparing results to a recognized reference method or a predicate device.

8. The sample size for the training set:

• Not applicable/available. As a clinical chemistry analyzer, this device does not typically have a "training set" in the machine learning sense. Its calibration and performance are established through analytical verification and validation studies using known controls, calibrators, and patient samples.

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

• Not applicable/available. See point 8.

Summary from the document:

• Device Name: TC Matrix Clinical Chemistry Analyzer
• Function: A discrete photometric chemistry analyzer intended to automate manual analytical procedures (pipetting, heating, measuring color intensity) for measuring various analytes in serum and plasma samples.
• Intended Use of specific reagents mentioned:
  • TECO MULTI Calibrator: For calibration of quantitative assays.
  • Teco Albumin reagent: To measure albumin concentration in serum and plasma for diagnosing liver or kidney diseases.
  • Teco ALT reagent: To measure alanine amino transferase (ALT) activity in serum and plasma for diagnosing liver and heart diseases.
  • Teco Glucose reagent: For quantitative determination of total glucose in human serum or plasma for diagnosing and treating carbohydrate metabolism disorders (e.g., diabetes mellitus).
  • Teco BUN reagent: To measure urea nitrogen in serum or plasma for diagnosing and treating renal and metabolic diseases.
• FDA Determination: Substantially equivalent to legally marketed predicate devices. This means the FDA believes it performs as intended and is as safe and effective as existing devices on the market for its stated indications.

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The VITROS Chemistry Products dHDL assay is intended for the in vitro quantitative measurement of HDL cholesterol in human serum or plasma. The VITROS 5,1 FS Chemistry System with enGen™ Laboratory Automation System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.) The VITROS Chemistry Products dHDL Reagent Pack, VITROS Chemistry Products Calibrator Kit 19 and VITROS Chemistry Products FS Calibrator 1 are used for the quantitative measurement of HDL cholesterol in serum or plasma.

The modified device is the VITROS Chemistry Products dHDL Reagent Pack, VITROS Chemistry Products Calibrator Kit 19 and VITROS Chemistry Products FS Calibrator 1 which are combined by the VITROS 5,1 FS Chemistry System with enGen Laboratory Automation System to perform the VITROS dHDL assay for HDL cholesterol. The VITROS HDL assay has not been changed. The VITROS 5.1 FS Chemistry System (instrumentation, which provides automated use of chemistry reagents) is interfaced to a Laboratory Automation System, which conducts pre-analytical and post-analytical sample and data management.

The provided text is a 510(k) summary for a medical device and does not contain the detailed study information required to answer all parts of your request. This document is a regulatory submission, not a scientific study report.

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

This information is not present in the provided 510(k) summary. A 510(k) often asserts substantial equivalence to a predicate device rather than providing extensive performance data against specific acceptance criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not present in the provided 510(k) summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not present in the provided 510(k) summary.

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

This information is not present in the provided 510(k) summary.

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

A multi-reader multi-case (MRMC) study is typically performed for imaging devices where human interpretation is involved. This device is a clinical chemistry system (in vitro diagnostic device) for measuring HDL cholesterol. Therefore, an MRMC study is not applicable and was not performed. The device is an automated system, not one that assists human readers in interpreting images.

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

The device is an automated clinical chemistry system. Its performance is inherently "standalone" in the sense that it performs quantitative measurements without human intervention in the measurement process itself, beyond loading samples and reagents. The 510(k) claims substantial equivalence for the "VITROS dHDL assay performed on the VITROS® 5,1 FS Chemistry System with enGen™ Laboratory Automation System" to "the VITROS dHDL assay performed on the VITROS® 5,1 FS Chemistry System." This implies performance was assessed for the automated system. However, specific details of this assessment are not provided.

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

For a quantitative clinical chemistry assay, the "ground truth" would typically be established by a reference method or a highly accurate laboratory method for measuring HDL cholesterol. However, the specific method used as ground truth for the equivalence study is not mentioned in this summary.

8. The sample size for the training set

This information is not present in the provided 510(k) summary. This document is for a traditional IVD device, not an AI/ML medical device as commonly understood for "training sets." The device is a reagent pack and calibrators used with a chemistry system.

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

Not applicable as this is an IVD device, not an AI/ML medical device with "training sets" in the conventional sense.

Summary of what is available from the text:

• Device: VITROS Chemistry Products dHDL Reagent Pack, Calibrator Kit 19, FS Calibrator 1, used with VITROS 5,1 FS Chemistry System and enGen Laboratory Automation System.
• Intended Use: In vitro quantitative measurement of HDL cholesterol in human serum or plasma.
• Study described (implicitly): A substantial equivalence study comparing the modified system (with enGen Automation) to the predicate system (without enGen Automation) for the dHDL assay.
• Claim of equivalence: The modified device has the same intended use, fundamental scientific technology, and operating principle as the predicate device. The dHDL assay performed on the modified system is substantially equivalent to the dHDL assay performed on the predicate system. This suggests that the study aimed to show performance comparability rather than meeting specific performance criteria against a clinical gold standard.

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