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This test system is for in vitro diagnostic use for the detection of antibodies to nuclear antigen Scl-70 in human serum.

This is an enzyme immunoassay for the detection of antibodies to nuclear antigen Scl-70 in human serum.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Immuno Concepts RELISA® Scl-70 Antibody Test System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state pre-defined acceptance criteria. Instead, it presents the performance of the new device relative to a predicate device. Therefore, the "acceptance criteria" are implied to be a level of performance that demonstrates substantial equivalence to the predicate. Based on the conclusion, the implied acceptance was met.

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

• Test Set Sample Size: The total sample size can be calculated from the
  contingency table: 37 (Pos) + 3 (Bor) + 0 (Neg) + 0 (Pos) + 7 (Bor) + 0
  (Neg) + 0 (Pos) + 1 (Bor) + 129 (Neg) = 177 samples.
• Data Provenance: Not explicitly stated. There is no information
  regarding the country of origin of the data or whether it was retrospective
  or prospective.

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

• Number of Experts: Not applicable in this context. The ground truth for
  the new device's performance was established using a predicate device
  (Immuno Concepts RELISA® Screening Assay, K935129) as the reference method,
  not human experts.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The comparison was directly against
  a reference method (predicate device), not against multiple human
  interpretations requiring adjudication. The text mentions an assumption: "If
  we assume that "borderline" results are actually positive," which is a data
  interpretation choice, not an adjudication method by experts.

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

• MRMC Study: No, an MRMC study was not performed. This study compares
  a new diagnostic assay to a predicate diagnostic assay, not the performance
  of human readers.

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

• Standalone Performance: Yes, this is essentially a standalone performance
  study for the diagnostic device. The RELISA® Scl-70 Antibody Test System
  is a laboratory assay, and its performance (sensitivity, specificity) is
  measured directly against a reference method (the predicate device) without
  human intervention in the final result interpretation for the purpose of
  this comparison.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for this study was established
  using a predicate device (Immuno Concepts RELISA® Screening Assay,
  K935129). This is a form of "reference standard" or "comparator method"
  ground truth.

8. The Sample Size for the Training Set

• Training Set Sample Size: The document does not mention a training
  set or how the device was developed/trained. This is a traditional immunoassay
  kit, not an AI/ML algorithm that typically requires a training set. The data
  provided is solely for the validation/comparison of the new device against its
  predicate.

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

• Ground Truth for Training Set: Not applicable, as there is no mention of
  a training set for this device.

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