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This test system is for in vitro diagnostic use for the detection of antibodies to nuclear antigens Sm, RNP, SS-A/RO, SS-B/La, Scl-70, or Jo-1 in human serum. The results from this assay can be used as an aid in the diagnosis of autoimmune diseases.

This is an enzyme immunoassay for the detection of antibodies to extractable nuclear antigens Sm, RNP, SS-A/RO, SS-B/La, Scl-70, or Jo-1 in human serum.

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

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

Based on the provided text, the acceptance criteria are not explicitly stated as distinct criteria, but rather are inferred from the performance metrics (sensitivity, specificity, and overall agreement) presented to demonstrate substantial equivalence to a predicate device. The performance is reported in relation to the predicate device.

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

• Test set sample size:
  • The table indicates the total number of samples tested by referring to the "Immuno Concepts RELISA® Multiparameter ENA Screening Test" as the reference method.
  • Total samples = 126 (Positive) + 9 (Positive) + 5 (Positive) + 0 (Borderline) + 2 (Borderline) + 4 (Borderline) + 1 (Negative) + 2 (Negative) + 394 (Negative) = 543 samples
• Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective/prospective).

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

• This information is not provided in the text. The "ground truth" or reference method for comparison is the "Immuno Concepts RELISA® Multiparameter ENA Screening Assay (K935129)," which is another diagnostic test, not expert opinion.

4. Adjudication method for the test set

• This information is not applicable/provided. The "ground truth" was established by a predicate diagnostic device, not by human experts 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

• This is not an MRMC study. The device is an in vitro diagnostic test (enzyme immunoassay) for detecting antibodies, not an AI system for image interpretation or diagnosis by human readers. Therefore, this question is not relevant to the provided study description.

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

• Yes, this study is inherently a standalone performance evaluation of the RELISA® ENA Single Well Screen Antibody Test System. It compares the device's results directly against a predicate diagnostic device without human interpretation as part of the primary measurement.

7. The type of ground truth used

• The "ground truth" (or reference standard in this context) used was the Immuno Concepts RELISA® Multiparameter ENA Screening Assay (K935129). This is a previously cleared, legally marketed diagnostic device.

8. The sample size for the training set

• The text does not provide information on a training set. This study describes a performance comparison of a final device against a predicate, which aligns with verification/validation testing rather than a description of the model development phase.

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

• As there's no mention of a training set, this information is not applicable/provided.

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This test system is for in vitro diagnostic use for the detection of antibodies to nuclear antigens Sm (Smith) and RNP (U1-RNP or ribonucleoprotein) in human serum.

This is an enzyme immunoassay for the detection of antibodies to nuclear antigens Sm (Smith) and RNP (U1-RNP or ribonucleoprotein) in human serum.

The provided text describes a RELISA® Sm/RNP Antibody Test System which is an enzyme immunoassay for the detection of antibodies to nuclear antigens Sm (Smith) and RNP (U1-RNP or ribonucleoprotein) in human serum.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical thresholds in the provided text. Instead, the study aims to demonstrate substantial equivalence to a predicate device (RELISA® ENA Antibody Screening Tests System, K935129) by showing high relative sensitivity, relative specificity, and overall agreement. Based on the reported results, it appears the acceptance criteria were implicitly 100% for all these metrics compared to the predicate.

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

• Sample Size (Sm Autoantigen):

  • Positive: 32
  • Borderline: 4
  • Negative: 102
  • Total: 138 samples

• Sample Size (RNP Autoantigen):

  • Positive: 40
  • Borderline: 5
  • Negative: 93
  • Total: 138 samples

• Data Provenance: Not explicitly stated in the provided text (e.g., country of origin, retrospective or prospective). It is simply referred to as "human serum" used in direct comparison with the predicate device.

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

Not applicable. The "ground truth" for this study was established using a predicate device, not human experts.

4. Adjudication Method for the Test Set

Not applicable. There was no human adjudication as the comparison was made against a predicate device.

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 study does not involve AI assistance or human readers in the context of an MRMC study. It's a direct comparison of a new immunoassay device against an existing immunoassay device.

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

Yes, in a sense. The study evaluated the standalone performance of the new device (Immuno Concepts RELISA® Sm/RNP) by directly comparing its results to the standalone performance of the predicate device (Immuno Concepts RELISA® Screening Assay). There is no human interpretion involved in the comparison, only the output of the immunoassay devices.

7. The Type of Ground Truth Used

The ground truth used was the results obtained from a legally marketed predicate device (Immuno Concepts RELISA® Screening Assay, K935129). This is a form of reference method comparison, where the established performance of the predicate serves as the gold standard for evaluating the new device.

8. The Sample Size for the Training Set

Not applicable. This type of immunoassay device development and validation typically does not involve a "training set" in the machine learning sense. The device is chemical/biological in nature, and its parameters are established through laboratory optimization and validation, not through learning from a labeled dataset.

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 and study design.

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This test system is for in vitro diagnostic use for the detection of antibodies to nuclear antigen Jo-1 in human serum.

This is an enzyme immunoassay for the detection of antibodies to nuclear antigen Jo-1 in human serum.

Here's a breakdown of the acceptance criteria and study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" with numerical thresholds. Instead, it justifies substantial equivalence based on the comparison to a predicate device. I've inferred the performance metrics used for this justification.

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

• Sample Size:
  • Positive Cases (from predicate): 21 + 2 + 0 = 23 (assuming "borderline" on the predicate is not explicitly categorized but contributes to comparison)
  • Borderline Cases (from predicate): 1 + 4 + 0 = 5
  • Negative Cases (from predicate): 0 + 1 + 140 = 141
  • Total Sample Size Analyzed: 23 (positive by predicate) + 5 (borderline by predicate) + 141 (negative by predicate) = 169 samples (implied from the sum of the table cells).
• Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).

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

Not applicable. The ground truth was established by a predicate device (Immuno Concepts RELISA® Screening Assay K935129), not by human experts for this specific comparative study.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by a predicate device, not by human adjudication of individual results.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a comparison between two immunoassays, an "algorithm" as described in your prompt for AI is not involved.

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

Yes, in a sense. The "device" being evaluated is essentially an automated immunoassay test system (RELISA® Jo-1 Antibody Test System). Its performance is measured directly against a predicate immunoassay system (RELISA® ENA Antibody Screening Tests System) without human interpretation as part of the core measurement. The output of both devices is quantitative/qualitative (positive, borderline, negative).

7. The type of ground truth used

The ground truth used for this study was the results from a legally marketed predicate device: the Immuno Concepts RELISA® Screening Assay (K935129).

8. The sample size for the training set

Not applicable. This is not a machine learning model, but a traditional immunoassay. Therefore, there is no "training set" in the context of AI.

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

Not applicable, as there is no training set for a machine learning model.

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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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This test system is for in vitro diagnostic use for the detection of antibodies to nuclear antigens SS-A/Ro and SS-B/La in human serum.

This is an enzyme immunoassay for the detection of antibodies to nuclear antigens SS-A/Ro and SS-B/La in human serum.

This document describes the Immuno Concepts RELISA® SS-A/Ro and SS-B/La Antibody Test System, an enzyme immunoassay for detecting antibodies to nuclear antigens SS-A/Ro and SS-B/La in human serum.

Acceptance Criteria and Device Performance:

The study aimed to demonstrate substantial equivalence to a predicate device (RELISA® ENA Antibody Screening Tests System, K935129) by comparing relative sensitivity, specificity, and overall agreement.

Study Details:

1. Sample Size and Data Provenance:

   • Test Set (SS-A/Ro): 160 samples (62 Positive, 2 Borderline, 96 Negative based on predicate device classification).
   • Test Set (SS-B/La): 160 samples (34 Positive, 5 Borderline, 121 Negative based on predicate device classification).
   • Data Provenance: Not explicitly stated, but given context of FDA submission, likely from a laboratory setting. The data is retrospective, as it compares the new device's results against those obtained previously with the predicate device.

2. Number of Experts and Qualifications for Ground Truth:

   • The ground truth was established by the predicate device (Immuno Concepts RELISA® Screening Assay (K935129)). No specific human experts or their qualifications are mentioned as being involved in establishing the ground truth for this comparison study, beyond the implied expertise in developing and using the predicate assay.

3. Adjudication Method for the Test Set:

   • No explicit adjudication method (like 2+1 or 3+1) is mentioned. The comparison is direct between the new device and the predicate device's results. For the SS-B/La data, two samples initially classified as "Borderline" by the screening assay were re-classified as "Positive" based on the SS-B(La) specific assay (the new device), which essentially served as an adjudication logic for those specific cases, driven by the new device's result.

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

   • No, an MRMC comparative effectiveness study was not conducted as this is an in-vitro diagnostic device (immunoassay) and not an image-based AI system requiring human reader interpretation. The comparison is between two assays.

5. Standalone Performance:

   • Yes, this study effectively assesses the standalone performance of the new RELISA® SS-A/Ro and SS-B/La Antibody Test System by comparing its results directly against the predicate device. The performance metrics (sensitivity, specificity, agreement) reflect the algorithm's (or assay's) ability to correctly classify samples on its own.

6. Type of Ground Truth Used:

   • The "ground truth" for this study was the results obtained from a legally marketed predicate device (Immuno Concepts RELISA® Screening Assay, K935129). This is a form of comparative ground truth, where the established performance of an existing, approved method serves as the reference.

7. Sample Size for the Training Set:

   • The document does not specify a separate "training set" in the context of machine learning. This is an immunoassay, not a machine learning model that undergoes training on data. The samples mentioned are for evaluating the performance of the developed assay.

8. How Ground Truth for Training Set was Established:

   • Not applicable, as this is an immunoassay evaluation, not a machine learning model where a training set with established ground truth would typically be used. The assay itself embodies the "learned" principles of antigen-antibody detection.

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