Search Results

The GEN-PROBE 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 semiautomated 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 female and male urine specimens. The assay may be used to test the following specimens from asymptomatic individuals: clinician-collected endocervical, vaginal swab specimens; patient-collected 'vaginal swab specimens; and female and male urine. The assay is also intended for use with the testing of gynecological specimens, from both symptomatic and asymptomatic patients collected in the PreservCyt® Solution and processed with the Cytyc ThinPrep® 2000 System.

Clearance of this premarket notification extends the clinical performance claims of the commercially available GEN-PROBE®APTIMA® Assay for Neisseria gonorrhoeae with the testing of gynecological specimens collected in the PreservCyt® Solution and processed with the Cytyc ThinPrep® 2000 System, for use on the TIGRIS® DTS® System. The ancillary kit for this application is commercially available as the GEN-PROBE APTIMA Specimen Transfer Kit. The components of the APTIMA Specimen Transfer Kit include: (1) a transport tube containing transport media with a penetrable cap and (2) specific instructions for use regarding decontamination and specimen processing procedures. The APTIMA Transfer Kit may only be used in conjunction with the APTIMA Assays.

This document describes the GEN-PROBE APTIMA Assay for Neisseria gonorrhoeae on the TIGRIS DTS System. The goal of the submission appears to be to expand the clinical performance claims of the existing assay to include gynecological specimens collected in PreservCyt Solution and processed with the Cytyc ThinPrep 2000 System, for use on the TIGRIS DTS System.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria provided in the document are primarily related to agreement studies and analytical performance targets rather than explicit numerical thresholds for clinical sensitivity/specificity against a gold standard for the new use case (PreservCyt specimens on the TIGRIS DTS System). The clinical studies focus on demonstrating equivalence between the TIGRIS DTS System and previously validated DTS Systems.

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

• Analytical Sensitivity (LOD): N=60 for post-processed PreservCyt liquid Pap specimen. The data provenance is from laboratory spiking experiments.
• Analytical Specificity: 24 culture isolates. The data provenance is from laboratory testing of known organisms.
• Specimen-Caused Inhibition: N=240 negative clinical post-processed PreservCyt liquid Pap specimens. Data provenance is from clinical specimens presumably collected in the US (not explicitly stated for this part, but the clinical study below is multi-center in the US).
• Interference by Whole Blood: Not specified as a precise "test set" size, but involved three negative PreservCyt liquid Pap specimen pools, tested in the absence and presence of N. gonorrhoeae and varying blood concentrations. Data provenance is from laboratory spiking experiments.
• Clinical Specimen Study: N=51 PreservCyt specimens (34 symptomatic, 17 asymptomatic female subjects).
  • Data Provenance: Prospective, multi-center clinical study. Patients were enrolled from family planning, OB/GYN, public health, and STD clinics. While not explicitly stated, multi-center studies for FDA submissions are typically conducted in the USA.
• Clinical Panel Study: 132 replicates (30 aliquots for each of 4 positive panel members, and 12 aliquots for the negative panel member). These were created from pooled residual negative PreservCyt specimens from female subjects.

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

There is no mention of "experts" in the context of establishing ground truth for the test sets in this submission.

• Clinical Specimen Study: The "ground truth" or reference method for comparison was the AGC Assay performed on the previously validated DTS Systems, following an initial screening with FDA-cleared APTIMA COMBO 2 (AC2) Assay. The AC2 Assay results determined whether specimens were selected for the clinical specimen or panel study. This is a comparison between two automated systems rather than expert interpretation of a gold standard.
• Clinical Panel Study: The "ground truth" for the panel members was their known N. gonorrhoeae ribosomal RNA (rRNA) concentration (spiked or not spiked).
• Analytical Studies: Ground truth was based on known concentrations of spiked organisms or rRNA, or confirmed negative samples.

4. Adjudication Method for the Test Set

Not applicable in the typical sense of expert adjudication of imaging or clinical findings.

• For the Clinical Specimen Study, the comparison was made between the results of the AGC Assay on the DTS Systems (predicate) and the TIGRIS DTS System (new system). No explicit adjudication process between discordant results from these two systems is described; rather, the agreement between them was calculated.
• For the Analytical Studies and Clinical Panel Study, the "ground truth" was established by experimental design (e.g., spiking known quantities of analyte, using confirmed negative samples), not through adjudication of expert opinions.

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 submission is for an in vitro diagnostic (IVD) assay, specifically a nucleic acid amplification test (NAAT) for Neisseria gonorrhoeae. It is a standalone diagnostic device with no "human reader" component in the interpretation of results in the way an imaging AI device would have. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this device.

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

Yes, the studies presented are essentially standalone performance evaluations of the GEN-PROBE APTIMA Assay on the TIGRIS DTS System. The assay generates a qualitative (positive/negative) result without human interpretation of raw data beyond confirming valid assay run parameters. The purpose of this submission was to demonstrate equivalence of this assay on a new automated platform (TIGRIS DTS) for a new specimen type (PreservCyt).

7. The Type of Ground Truth Used

• Analytical Sensitivity: Known spiked concentrations of N. gonorrhoeae rRNA.
• Analytical Specificity: Known culture isolates.
• Specimen-Caused Inhibition and Interference: Known negative samples and known spiked concentrations (for inhibition/recovery).
• Clinical Specimen Study: The results of the AGC Assay on the predicate DTS Systems, following initial screening with the FDA-cleared APTIMA COMBO 2 (AC2) Assay. This acts as a reference method for the comparison between the old and new platforms.
• Clinical Panel Study: Known spiked concentrations of N. gonorrhoeae ribosomal RNA (rRNA) into confirmed negative PreservCyt specimens.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of device development or algorithm training. This is a molecular diagnostic assay, not a machine learning or AI algorithm in the conventional sense that would require a dedicated training set. The assay's parameters (e.g., cut-offs) would have been established during its initial development and validation, which is not detailed in this specific 510(k) summary, as this submission is an extension of claims for an already cleared assay.

9. How the Ground Truth for the Training Set Was Established

As no specific "training set" for an AI/ML algorithm is mentioned or applicable here, this question is not relevant to the provided documentation. The assay relies on target amplification and detection of rRNA, with predetermined analytical characteristics, rather than learning from a training dataset.

Ask a specific question about this device