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510(k) Data Aggregation
(77 days)
The assay is intended for use in detecting antibodies to Jo-1 antigen in a single human serum sample. The results of the assay are to be used as an aid in the diagnosis of autoimmune disorders.
The Is-anti-Jo-1 Test Kit System is an enzyme-linked immunosorbent assay (ELISA) for the detection and semi-quantitation of IgG to Jo-1 antigen in human serum.
Acceptance Criteria and Study for Diamedix Is-anti-Jo-1 Test System
1. Table of Acceptance Criteria & Reported Device Performance
The provided summary does not explicitly state pre-defined acceptance criteria with numerical targets. However, based on the Comparison Testing section, we can infer the performance metrics that were evaluated and achieved. The study demonstrates performance by comparing the device against a predicate device.
| Performance Metric | Implied Acceptance Criteria (Inferred from Predicate's Performance) | Reported Device Performance (Manual) | Reported Device Performance (MAGO) |
|---|---|---|---|
| Relative Sensitivity | High sensitivity (e.g., in the range of the predicate device, 95%) | 95% (18/19) | 95% (18/19) |
| Relative Specificity | High specificity (e.g., in the range of the predicate device, 99%) | 99% (142/144) | 99% (141/143) |
| Agreement | High agreement (e.g., in the range of the predicate device, 98%) | 98% (160/163) | 98% (159/162) |
| Linearity (R-squared) | High linearity (e.g., >0.99) | 0.9962 (Figure 1), 0.9911 (Figure 2) | Achieved (Figure 2 mentions MAGO linearity) |
| Precision (Intra-assay CV%) | Low variability (e.g., 0.85) | Not applicable (comparison between manual and MAGO) | 0.87 (Pearson) |
2. Sample Size and Data Provenance for Test Set
- Sample Size: 163 serum samples were used for comparison testing. This consisted of 100 sera from normal blood donors and 63 sera from autoimmune patients.
- Data Provenance: The origin of the data (e.g., country) is not specified. It is likely a retrospective collection of existing serum samples. The summary states "63 sera from autoimmune patients," implying these were pre-diagnosed individuals.
3. Number of Experts and Qualifications for Ground Truth - Test Set
The document does not indicate the use of "experts" in the sense of clinicians or radiologists to establish ground truth for individual samples in the comparison testing. The autoimmune patient samples were "clinically characterized sera," implying their autoimmune status was determined through standard clinical diagnostic procedures, rather than by individual expert consensus on the specific test results within the study.
4. Adjudication Method for Test Set
The document does not describe an adjudication method for the test set. Instead, it compares the performance of the sponsor's device (Is-anti-Jo-1 Test Kit) to a predicate device (another commercially available anti-Jo-1 ELISA test kit). For discordant results, it mentions testing by a "third method," but this is not an adjudication process by experts to establish a definitive ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is an in-vitro diagnostic (IVD) assay, not an imaging device typically evaluated with MRMC studies comparing human readers with and without AI assistance. The "MAGO" system mentioned appears to be an automated assay platform or reading system rather than an AI in the sense of an algorithm interpreting complex data alongside a human.
6. Standalone Performance
Yes, a standalone performance of the algorithm (the Diamedix Is-anti-Jo-1 Test System) was done. The entire study describes the performance of this device in detecting and semi-quantitating anti-Jo-1 antibodies. The "Manual" results directly represent the standalone performance of the assay when manually processed.
7. Type of Ground Truth Used
The ground truth for the comparison testing was based on:
* Clinical Characterization: For the "63 sera from autoimmune patients," their status as autoimmune patients (and presumably Jo-1 positive or negative) was based on their clinical diagnosis, independent of the assay being tested.
* Normal Blood Donors: The 100 normal blood donor sera served as a negative control group, with the presumption that they are negative for anti-Jo-1 antibodies.
* Predicate Device/Third Method Comparison: The primary method of assessing sensitivity and specificity was by comparing results against a "commercially available anti-Jo-1 ELISA test kit" (the predicate device). In cases of discordance, a "third method" was used for further investigation, implying a hierarchical or confirmatory testing approach rather than a single definitive ground truth method by experts.
8. Sample Size for Training Set
The document does not explicitly mention a separate "training set" or "test set" in the context of machine learning or AI development. The samples discussed appear to be part of a single validation study for the device's performance. The device is an ELISA kit, not an AI algorithm that typically has distinct training and testing phases.
9. How Ground Truth for Training Set Was Established
As there is no explicit mention of a training set as understood in AI/machine learning contexts, this question is not directly applicable. The device's development and validation relied on established laboratory procedures and comparisons to existing methods for characterization.
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