(157 days)
The APTIMA COMBO 2 Assay is a target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection and differentiation of ribosomal RNA (rRNA) from Chlamydia trachomatis and/or Neisseria gonorrhoeae in clinician-collected endocervical, vaginal and male urethral swab specimens, patientcollected vaginal swab specimens', female and male urine specimens and gynecological specimens collected in the PreservCyt Solution and processed with the Cytyc ThinPrep 2000 System. The assay may be used to test specimens from symptomatic and asymptomatic individuals to aid in the diagnosis of gonococcal and/or chlamydial urogenital disease using the TIGRIS DTS Automated Analyzer or semi-automated instrumentation as specified.
The APTIMA COMBO 2 Assay is a target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection and differentiation of ribosomal RNA (rRNA) from Chlamydia trachomatis and/or Neisseria gonorrhoeae.
This document is an FDA 510(k) clearance letter for an in vitro diagnostic device, not an AI/ML medical device. Therefore, the requested information about acceptance criteria, study design, and performance metrics (especially those related to AI/ML such as multi-reader multi-case studies, human reader improvement with AI, or standalone algorithm performance) is not applicable or cannot be extracted from this document.
The document discusses the substantial equivalence of the TIGRIS® DTS® GEN-PROBE® APTIMA COMOBO 2® Assay to a legally marketed predicate device for the qualitative detection and differentiation of ribosomal RNA from Chlamydia trachomatis and/or Neisseria gonorrhoeae.
Here's the information that can be extracted, noting the limitations related to your AI/ML specific questions:
1. Table of Acceptance Criteria and Reported Device Performance:
This document does not provide a table of quantitative acceptance criteria (e.g., sensitivity, specificity thresholds) or specific performance metrics (e.g., reported sensitivity, specificity values) from a clinical study. It is a clearance letter acknowledging substantial equivalence to a predicate device, not a detailed performance report. Such data would typically be found in the 510(k) submission itself, not the clearance letter.
2. Sample size used for the test set and the data provenance:
- Test set sample size: Not specified in this document.
- Data provenance: Not specified. Clinical studies supporting clearance typically involve multiple sites, which could be domestic or international, and data could be retrospective or prospective. This information is usually detailed in the submission, not the clearance letter.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is irrelevant for an in vitro diagnostic assay like the APTIMA COMBO 2 Assay. The "ground truth" for such assays is typically established by reference laboratory methods (e.g., culture, NAATs) or clinical diagnosis, not by human expert interpretation of images or other data. Therefore, there's no concept of "experts establishing ground truth" in the way described for AI/ML imaging devices.
4. Adjudication method for the test set:
Not applicable for an in vitro diagnostic assay. Adjudication methods (like 2+1 or 3+1) are used to resolve disagreements among human readers, typically in image interpretation, which is not the function of this 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 is an in vitro diagnostic test for direct pathogen detection, not an AI-assisted diagnostic imaging or decision support system. Therefore, MRMC studies and the concept of human readers improving with AI assistance are irrelevant to this device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The device itself is a standalone assay. It performs the detection of rRNA from Chlamydia trachomatis and/or Neisseria gonorrhoeae without human interpretation influencing the result of the assay itself. However, this is not an "algorithm only" in the sense of an AI model; it's a biochemical assay for pathogen identification. The results are typically interpreted by laboratory personnel. Performance studies for such devices evaluate the accuracy of the device's output against a reference standard.
7. The type of ground truth used:
While not explicitly stated in this clearance letter, for in vitro diagnostic assays detecting pathogens, the ground truth is typically established by:
- Culture: For bacterial infections like N. gonorrhoeae.
- Other highly sensitive and specific Nucleic Acid Amplification Tests (NAATs): Often used as a gold standard or "truth" for comparison, especially for C. trachomatis where culture is difficult.
- Clinical diagnosis: Supported by other laboratory findings and patient symptoms.
8. The sample size for the training set:
Not applicable. This document refers to a molecular diagnostic assay, not an AI/ML model that requires a training set. The development of such assays involves analytical studies (assay optimization, limit of detection, cross-reactivity) and clinical studies (evaluating performance on patient samples), but there's no "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
Not applicable, as there is no "training set" in the AI/ML sense for this device. Ground truth in the context of assay development is established through rigorous analytical and clinical validation against established reference methods.
§ 866.3390
Neisseria spp. direct serological test reagents.(a)
Identification. Neisseria spp. direct serological test reagents are devices that consist of antigens and antisera used in serological tests to identifyNeisseria spp. from cultured isolates. Additionally, some of these reagents consist ofNeisseria spp. antisera conjugated with a fluorescent dye (immunofluorescent reagents) which may be used to detect the presence ofNeisseria spp. directly from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genusNeisseria, such as epidemic cerebrospinal meningitis, meningococcal disease, and gonorrhea, and also provides epidemiological information on diseases caused by these microorganisms. The device does not include products for the detection of gonorrhea in humans by indirect methods, such as detection of antibodies or of oxidase produced by gonococcal organisms.(b)
Classification. Class II (performance standards).