(125 days)
The APTIMA® Assay for Neisseria gonorrhoeae is a target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection of ribosomal RNA (rRNA) from Neisseria gonorrhoeae (GC) to aid in the diagnosis of gonococcal urogenital disease using the TIGRIS® DTS® Automated Analyzer or semi-automated instrumentation as specified. The assay may be used to test the following specimens from symptomatic individuals: clinician-collected endocervical, vaginal and male urethral swab specimens; and patient-collected female and male urine specimens. The assay may be used to test the following specimens from asymptomatic individuals: clinician-collected endocervical and vaginal swab specimens; and patient-collected vaginal swab specimens¹ and female and male urine specimens. ¹Patient-collected vaginal swab specimens are an option for screening women when a pelvic exam is not otherwise indicated. The vaginal swab specimen collection kit is not for home use.
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This document is a 510(k) clearance letter for the TIGRIS® DTS® GEN-PROBE® APTIMA Assay® for Neisseria gonorrhoeae. It confirms that the device is substantially equivalent to a legally marketed predicate device. However, this letter does not contain the detailed study results, acceptance criteria, or performance data that would typically be found in the actual 510(k) submission or a clinical study report.
Therefore, I cannot fulfill most of your request directly from this document. The information provided is primarily an FDA clearance letter and an "Indications for Use Statement."
Here's what I can extract and what is explicitly missing from the provided text:
Information Extracted from the Document:
- Device Name: TIGRIS® DTS® GEN-PROBE® APTIMA Assay® for Neisseria gonorrhoeae
- Intended Use: In vitro qualitative detection of ribosomal RNA (rRNA) from Neisseria gonorrhoeae (GC) to aid in the diagnosis of gonococcal urogenital disease, using specified specimens from symptomatic and asymptomatic individuals.
- Sample Types: Clinician-collected endocervical, vaginal, and male urethral swab specimens; patient-collected female and male urine specimens; patient-collected vaginal swab specimens.
Missing Information (Not provided in the document):
- A table of acceptance criteria and the reported device performance: This document does not include a table of acceptance criteria or performance metrics (e.g., sensitivity, specificity, PPV, NPV). These would be in the original 510(k) submission.
- Sample sizes used for the test set and the data provenance: No information on sample sizes or data provenance (country, retrospective/prospective) is present.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned. For an in vitro diagnostic (IVD) like this, the "ground truth" is typically established by well-characterized reference tests (e.g., culture, another FDA-approved NAAT), not by human experts adjudicating images.
- Adjudication method for the test set: Not applicable in the traditional sense for an IVD diagnostic assay primarily detecting genetic material. The ground truth is usually determined by reference methods.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable. This is an IVD assay, not an imaging device requiring human reader interpretation or assistance.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The device itself is a standalone assay. Its performance is measured directly against a reference standard.
- The type of ground truth used: While not explicitly stated, for Neisseria gonorrhoeae detection, the ground truth for such an assay is typically established through culture or a comparator FDA-approved nucleic acid amplification test (NAAT). The document refers to "in vitro qualitative detection of ribosomal RNA," strongly suggesting laboratory-based reference methods.
- The sample size for the training set: The concept of a "training set" as understood in machine learning (which this question implies) is generally not applicable to a traditional IVD chemical/molecular assay like this one. These assays are developed and validated using a series of laboratory experiments and clinical studies, but not typically "trained" in the AI sense.
- How the ground truth for the training set was established: See point 8.
In summary, this document is an FDA clearance letter and does not contain the detailed technical and clinical study information required to answer most of your questions. That data would be found in the actual 510(k) submission that was reviewed by the FDA, but is not included in this publicly available letter.
§ 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).