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This in vitro diagnostic procedure is intended to quantitatively measure RF in human serum on the Cobas Mira chemistry analyzer. Such measurements are used in the diagnosis and treatment of rheumatoid arthritis.

The RF-LATEX "SEIKEN" is a reagent system for the quantitation of the concentration of rheumatoid factor (RF) in human serum. It is based on the agglutination of RF in serum with latex particles coated with anti-RF (human IgG). It employs the absorbance change observed as the basis for quantitation and calculates the amount of RF by interpolation from a calibration curve prepared from calibrators of known concentration. It is intended for use with the Cobas Mira chemistry analyzer (or other suitable analyzer).

Here's an analysis of the provided information regarding the acceptance criteria and study for the RF-LATEX "SEIKEN" device:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to the predicate device, "quantex RF plus," and the general performance expectations for in vitro diagnostic assays. The reported device performance for "RF-LATEX 'SEIKEN'" is directly provided.

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Accuracy/Correlation (Test Set): 92 serum samples.
• Data Provenance: The origin of the 92 serum samples is not explicitly stated beyond being "obtained." The data was "prepared at and which is on file at Denka Seiken, Co. Inc." It is a retrospective study as samples were "obtained" and tested. The country of origin for the data generation is implied to be Japan, given "Denka Seiken, Co. Inc."

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

• Not applicable/provided. For this type of in vitro diagnostic device, the "ground truth" for each sample is the actual RF concentration as measured by a reference method or the comparative device, not an expert panel's interpretation.

4. Adjudication Method for the Test Set

• Not applicable. This is not an imaging or diagnostic interpretation task requiring adjudication of expert opinions. The comparison is quantitative based on assay measurements.

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

• No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This study focuses on the performance of an in vitro diagnostic reagent system, not on human reader performance with or without AI assistance.

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

• Yes, this study is a standalone performance evaluation of the RF-LATEX "SEIKEN" reagent system. The device operates as a laboratory assay, providing a quantitative result without direct human interpretation in its primary function. There is no human-in-the-loop component for the device's measurement process itself.

7. The Type of Ground Truth Used

• The ground truth for the accuracy/correlation study was established by comparing the measurements of the RF-LATEX "SEIKEN" device against those obtained from another commercially available, FDA-cleared device (quantex RF plus), which serves as a reference or predicate method. For precision, linearity, and stability, the ground truth is based on the known concentrations of quality control materials and calibrators, and the expected performance characteristics of a well-functioning assay.

8. The Sample Size for the Training Set

• Not applicable. This is a chemical reagent system, not a machine learning algorithm that requires a "training set" in the conventional sense. The development of such assays involves formulation, optimization, and characterization experiments, but not a distinct "training set" for an algorithm.

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

• Not applicable, as there is no training set mentioned in the context of an algorithm. The development of the reagent system itself (e.g., optimizing reagent concentrations, reaction conditions) would have involved extensive R&D, likely using characterized samples and analytical methods to achieve desired performance, but this is not characterized as "ground truth for a training set."

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This in vitro diagnostic procedure is intended to quantitatively measure CRP in human serum on the Cobas Mira chemistry analyzer . Such measurements are used in the diagnosis and treatment of bacterial infections and inflammation.

Are reagent systems for the quantitation of the concentration of CRP in human serum. Are based on the agglutination of CRP in serum with latex particles coated with anti-CRP. Employ the absorbance change observed as the basis for quantitation. Are intended for use with the Cobas Mira chemistry analyzer.

Here's an analysis of the provided text regarding the acceptance criteria and study for the CRP-LATEX "SEIKEN" XR device:

Acceptance Criteria and Device Performance Study

The submission focuses on establishing substantial equivalence to a predicate device (quantex CRP plus) rather than setting distinct acceptance criteria for the new device as a standalone product. The performance characteristics of the CRP-LATEX "SEIKEN" XR are presented in comparison to the predicate device, demonstrating similarity in key areas.

1. Table of Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" here is primarily demonstrated by showing that the CRP-LATEX "SEIKEN" XR performs similarly to or better than the predicate device for several metrics. The table below compiles the directly comparable performance characteristics.

Note: The submission aims to show "substantial equivalence" rather than predefined numerical acceptance criteria specific to the new device itself. The "acceptance criteria" here are implied by the existing performance of the cleared predicate device. For precision, the "less than 10%" is likely a general industry or internal acceptance for CV, and the new device performs well within this.

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

• Sample Size for Test Set:
  • Accuracy/Correlation: 122 serum samples.
  • Within-run Precision: 10 replicates for each of 5 levels of control serum.
  • Between-run Precision: 1 sample ("commercial control serum") analyzed once per day for 10 days for 3 levels (Sample 1, Sample 2, Sample 3).
  • Linearity: A series of 12 calibrators for each of 3 separate lot numbers of reagents.
  • Stability: 3 levels of commercial control serum analyzed at 3-month intervals over the shelf life for 2 lot numbers of reagents.
• Data Provenance: The data was prepared at and is on file at Denka Seiken Co., Inc. This suggests the data was generated internally by the manufacturer. No specific country of origin for the samples (e.g., patient demographics, serum source) is mentioned, nor is it specified if the studies were retrospective or prospective, though clinical diagnostic device performance studies are generally considered prospective assessments of the device under controlled conditions.

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

N/A. This is an in-vitro diagnostic (IVD) device for quantitative measurement of C-Reactive Protein (CRP) in human serum. The "ground truth" for IVD devices is typically established through reference methods, calibrated standards, or comparative testing against another established assay (the predicate in this case) rather than expert interpretation of images or other subjective assessments. Therefore, "expert qualifications" in the sense of medical image interpretation are not applicable here. The "experts" would be laboratory scientists and technicians following established protocols.

4. Adjudication Method for the Test Set

N/A. Adjudication methods like 2+1 or 3+1 are typically used in studies where human readers interpret data (e.g., medical images) and their interpretations need to be reconciled to establish a consensus ground truth. For this IVD device, the measurements are quantitative and objective, so no such adjudication process is needed for the outputs of the device or the predicate.

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

No. An MRMC study is not applicable. This is an in-vitro diagnostic device, not a device requiring human reader interpretation (e.g., an AI-assisted imaging device). The comparison is between two quantitative assays.

6. Standalone Performance (Algorithm only without Human-in-the-loop)

Yes, the study presents standalone performance of the CRP-LATEX "SEIKEN" XR. This device is an automated reagent system for a chemistry analyzer. Its performance metrics (precision, linearity, accuracy/correlation) are intrinsic to the assay and the analyzer's measurement capabilities, operating without human interpretive input altering the result. The device itself is the "algorithm" and it functions entirely on its own to produce a quantitative result.

7. The Type of Ground Truth Used

The "ground truth" for the test set is established by:

• Comparison to a Predicate Device: For accuracy, the CRP-LATEX "SEIKEN" XR results were correlated against the results obtained from the predicate device, quantex CRP plus. This establishes the predicate device's measurements as the reference for comparison.
• Commercial Control Sera/Calibrators: For precision and linearity, commercial control sera and calibrators with known or expected values were used. These are typically manufactured to precise specifications with assigned values.

8. The Sample Size for the Training Set

N/A. This documentation describes a conventional IVD reagent system, not a machine learning or AI-driven device that requires a "training set" in the context of algorithm development. The "training" for such a system involves calibrating the assay and establishing its performance characteristics, not iteratively training a predictive model.

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

N/A. As mentioned above, there is no "training set" in the sense of data used to develop a machine learning model. The ground truth for calibrators and control materials used in the development and ongoing use of the assay would typically be established through an unbroken chain of traceability to reference materials and/or international reference methods.

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