(16 days)
The Syva MicroTrak II Chlamydia EIA is a n enzyme immunoassay intended for use in the qualitative detection of Chlamydia in female endocervical, male urethral, male urine and ocular specimens. The assay may be used to detect the presence of chlamydia where infection is suspected or likely to exist
The Syva MicroTrak II Chlamydia EIA has been modified in that the preservative system in the Enzyme/Antibody reagent has been changed to meet USP Challenge test requirements and to be effective against pseudomonads and staphylococci. The modified preservative system meets those design requirements without affecting the performance characteristics, claims, and labeling of the assay as compared to the product with the unmodified preservative system.
The provided text describes a 510(k) submission for a device modification, specifically a change in the preservative system of the Syva MicroTrak II Chlamydia EIA. The core statement in the summary is: "The modified preservative system meets those design requirements without affecting the performance characteristics, claims, and labeling of the assay as compared to the product with the unmodified preservative system."
This indicates that the acceptance criteria for this modification are that the new device's performance is non-inferior or substantially equivalent to the previous version of the device. The study would have demonstrated that the change in preservative did not adversely affect the analytical performance (sensitivity, specificity, accuracy) of the EIA.
However, the provided text does not contain the detailed study information required to fill out the requested table and answer all questions comprehensively. It only states that the performance characteristics were not affected.
Based on the available information, here's what can be inferred and what is missing:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (Modified Device vs. Unmodified Device) |
|---|---|
| Primary Goal: Maintain equivalent performance characteristics (sensitivity, specificity, accuracy) to the unmodified device. | "meets those design requirements without affecting the performance characteristics, claims, and labeling of the assay as compared to the product with the unmodified preservative system." |
| Secondary Goal: Meet USP Challenge test requirements for the preservative system. | The modified preservative system "has been changed to meet USP Challenge test requirements and to be effective against pseudomonads and staphylococci." |
Study Details (Based on Inference and Missing Information)
Since this is a 510(k) for a device modification, the study would primarily be a comparative study demonstrating that the modified device performs equivalently to the predicate (unmodified) device.
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Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified in the provided text. A typical comparative study for an EIA would involve a sufficient number of positive and negative clinical samples to demonstrate equivalent analytical performance.
- Data Provenance: Not specified in the provided text (e.g., country of origin of the data, retrospective or prospective). Historically, such studies often involve multi-center prospective or retrospective clinical sample testing.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- Not specified. For Chlamydia EIA, ground truth is typically established by:
- Confirmatory laboratory methods (e.g., PCR, culture, or another validated reference method) on the same samples.
- Clinical diagnosis, sometimes supplemented by expert adjudication if discordant results occur.
- The term "experts" in the context of establishing ground truth for an in vitro diagnostic (IVD) device like an EIA usually refers to the reference method itself and the laboratory personnel performing and interpreting the reference tests, rather than clinical experts adjudicating images.
- Not specified. For Chlamydia EIA, ground truth is typically established by:
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Adjudication Method for the Test Set:
- Not specified. If there were discrepancies between the EIA results and the ground truth method(s), an adjudication process would typically involve retesting or further confirmatory testing to resolve conflicts. The specific method (e.g., 2+1) is not mentioned.
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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:
- No. This device is an Enzyme Immunoassay (EIA) for the qualitative detection of Chlamydia. It is an in vitro diagnostic (IVD) device, not an imaging device or an AI-based diagnostic tool that would involve human readers interpreting AI outputs. Therefore, an MRMC study is not applicable.
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If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, indirectly. An EIA device, by its nature, is a standalone analytical test. Its performance (sensitivity, specificity, accuracy) is determined by the reaction occurring in the MTP-wells, the spectrophotometric reading, and the interpretation criteria. There is no "human-in-the-loop" once the assay is run and read, other than the initial sample preparation and final interpretation of the numerical results against established cutoffs. The "algorithm" here is the assay's chemistry and readout interpretation.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated, but for Chlamydia EIA, the ground truth would most likely be established by confirmatory laboratory methods such as:
- Nucleic Acid Amplification Tests (NAATs) like PCR.
- Cell culture (historically a gold standard for Chlamydia).
- Potentially, a combination of clinical diagnosis and a reference laboratory method for discordant results.
- Not explicitly stated, but for Chlamydia EIA, the ground truth would most likely be established by confirmatory laboratory methods such as:
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The Sample Size for the Training Set:
- Not applicable as this is an EIA, not a machine learning or AI-based device that requires a training set in the typical sense. The "training" for an EIA occurs during its initial design, optimization, and validation by the manufacturer using internal characterization studies, not through external data sets in an AI context.
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How the Ground Truth for the Training Set was Established:
- Not applicable for the reasons mentioned above.
§ 866.3120 Chlamydia serological reagents.
(a)
Identification. Chlamydia serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to chlamydia in serum. Additionally, some of these reagents consist of chlamydia antisera conjugated with a fluorescent dye used to identify chlamydia directly from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genusChlamydia and provides epidemiological information on these diseases. Chlamydia are the causative agents of psittacosis (a form of pneumonia), lymphogranuloma venereum (a venereal disease), and trachoma (a chronic disease of the eye and eyelid).(b)
Classification. Class I (general controls).