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For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 28 is used in coniunction with VITROS Chemistry Products FS Calibrator 1 to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of antistreptolysin O (ASO).

For in vitro diagnostic use only.

VITROS Chemistry Products FS Calibrator 1 is used in conjunction with VITROS Chemistry Products Calibrator Kits 16, 17, 18, 19, and 28 to calibrate VITROS 5,1 FS Chemistry Systems.

For in vitro diagnostic use only. VITROS Chemistry Products ASO/RF Performance Verifiers are assayed controls used to monitor the performance of VITROS ASO and RF Reagent on VITROS 5,1 FS Chemistry Systems.

The quantitative measurement of antistreptolysin O is performed using the VITROS Chemistry Products ASO Reagent in conjunction with the VITROS Chemistry Products Calibrator Kit 28 and VITROS Chemistry Products FS Calibrator 1 on VITROS 5,1 FS Chemistry Systems.

VITROS Chemistry Products Calibrator Kit 28 is an aqueous solution containing processed human serum, protein, inorganic salt, and preservative.

VITROS Chemistry Products FS Calibrator 1 is composed of processed water and 0.9% w/v sodium chloride (Saline).

VITROS Chemistry Products ASO/RF Performance Verifiers contain two levels of lyophilized assayed controls for use in monitoring performance of VITROS ASO and RF Reagents on VITROS 5,1 FS Chemistry Systems. These controls are prepared from processed human serum to which purified human proteins, bovine serum albumin and preservative have been added. These controls are reconstituted with VITROS Chemistry Products FS Reconstitution Diluent that contains processed water.

The provided text is a 510(k) summary for in-vitro diagnostic devices (calibrators and performance verifiers). It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in the way a medical imaging device or AI algorithm might. Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable or available in this document.

However, I will extract the information that is present and indicate where the requested information is not provided.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or detailed reported device performance in the format typical for a clinical study comparing an AI device's output to a ground truth. Instead, the "acceptance criterion" is effectively substantial equivalence to existing predicate devices.

The tables provided (Tables 1, 2, and 3) detail similarities and differences in device characteristics (intended use, fluid matrix, analyte levels, analyte, traceability, format) between the new devices and their respective predicates. These comparisons serve as the basis for the declaration of substantial equivalence. For example:

• VITROS Calibrator Kit 28 (New) vs. VITROS Calibrator Kit 16 (Predicate):
  • Intended Use: Differs (ASO vs. RF calibration)
  • Fluid Matrix: Same (aqueous solution)
  • Analyte Levels: Differs (one level vs. five levels)
  • Analyte: Differs (ASO vs. RF)
  • Traceability: Differs (NIBSC 97/6621 vs. NIBSC 64/22)
  • Format: Same
• VITROS FS Calibrator Kit 1 (New) vs. VITROS FS Calibrator Kit 1 (Predicate):
  • Intended Use: Similar (calibration of VITROS 5,1 FS systems, but new device supports additional calibrator kits)
  • Fluid Matrix: Same
  • Analyte Levels: Same
  • Analyte: ASO (for new device's context) vs. RF (for predicate's context) - Note: The table lists ASO for the new device and RF for the predicate, which is slightly confusing as FS Calibrator 1 is a general diluent/calibrator component. The text clarifies its use with various kits.
  • Traceability: Differs (NIBSC 97/6621 vs. NIBSC 64/22)
  • Format: Same
• VITROS ASO/RF Performance Verifiers I and II (New) vs. VITROS RF Performance Verifiers I and II (Predicate):
  • Intended Use: Similar (monitoring performance, but new device includes ASO)
  • Fluid Matrix: Same
  • Analyte Levels: Same
  • Analyte: Differs (ASO and RF vs. RF)
  • Format: Same

The "reported device performance" is not a set of quantitative metrics from an independent study, but rather the claim that these devices perform equivalently to the predicate devices for their intended use, based on their design and components.

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

This document does not describe a "test set" in the context of an algorithm or imaging study. The evaluation performed is a comparison of device characteristics for substantial equivalence. There is no mention of a sample size of patient data or clinical samples tested for this submission.

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 submission (IVD calibrators/controls). There is no "ground truth" established by experts in the context of reviewing images or clinical data. The "ground truth" for the calibrators and verifiers themselves would be established through their manufacturing and quality control processes to ensure their stated values and stability.

4. Adjudication Method for the Test Set

Not applicable. No "adjudication method" is described as there is no test set in the sense of clinical cases needing expert review.

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 submission for calibrators and controls, not an AI or imaging diagnostic device.

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

The devices are reagents/calibrators used with an automated chemistry system (VITROS 5,1 FS Chemistry Systems). They are not standalone algorithms or software-only devices.

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

For IVD calibrators and controls, the "ground truth" for their values and performance characteristics is established through analytical validation processes, often traceable to international reference standards (e.g., NIBSC standards mentioned: NIBSC 97/6621 for ASO, NIBSC 64/22 for RF). This involves manufacturing controls, stability studies, and performance testing to ensure they accurately calibrate and monitor the assay. It is not an expert consensus on clinical findings, pathology, or outcomes data.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as these are physical diagnostic reagents, not machine learning algorithms.

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

Not applicable, as there is no training set for an algorithm.

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

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

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

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

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

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

4. Adjudication Method for the Test Set

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

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

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

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

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

7. The Type of Ground Truth Used

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

8. The Sample Size for the Training Set

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

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

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

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