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The Aptima Neisseria gonorrhoeae (GC) Assav is an in vitro qualitative nucleic acid amplification (NAAT) the detection of ribosomal RNA (rRNA) from Neisseria gonorrhoeae (GC) to aid in the diagnosis of gonocccal urogenital disease using the Panther System. The assay may be used to test male urine specimens from symptomatic and asymptomatic individuals.

The Aptima GC assay is a target amplification nucleic acid probe test for in vitro qualitative detection of ribosomal RNA (rRNA) from Neisseria gonorrhoeae (GC). The Aptima Neisseria gonorrhoeae Assay combines the technologies of target capture, transcription-mediated amplification (TMA), and hybridization protection assay (HPA). Specimens are collected and transferred into their respective specimen transport tubes. The transport solution in these tubes releases the rRNA target and protects it from degradation during storage. When the Aptima Neisseria gonorrhoeae Assay is performed in the laboratory, the target rRNA molecule is isolated from the specimens by use of a capture oligomer via target capture that utilizes magnetic microparticles. The capture oligomer contains a sequence complementary to a specific region of the target molecule as well as a string of deoxyadenosine residues. During the hybridization step, the sequence specific region of the capture oligomer binds to a specific region of the target molecule. The capture oligomer:target complex is then captured out of solution by decreasing the temperature of the reaction to room temperature. This temperature reduction allows hybridization to occur between the deoxyadenosine region on the capture oligomer and the poly-deoxythymidine molecules that are covalently attached to the magnetic particles. The micro particles, including the captured target molecule bound to them, are pulled to the side of the reaction vessel using magnets and the supernatant is aspirated. The particles are washed to remove residual specimen matrix that may contain amplification reaction inhibitors. After the target capture steps are completed, the specimens are ready for amplification. Target amplification assays are based on the ability of complementary oligonucleotide primers to specifically anneal and allow enzymatic amplification of the target nucleic acid strands. The Hologic TMA reaction replicates a specific region of the 16S rRNA from GC via DNA intermediates. A unique set of primers is used for the target molecule. Detection of the rRNA amplification product sequences (amplicon) is achieved using nucleic acid hybridization. A single-stranded chemiluminescent DNA probe, which is complementary to a region of the target amplicon, is labeled with an acridinium ester molecule. The labeled DNA probe combines with amplicon to form stable RNA:DNA hybrids. The Selection Reagent differentiates hybridized from unhybridized probe, eliminating the generation of signal from unhybridized probe. During the detection step, light emitted from the labeled RNA:DNA hybrids is measured as photon signals in a luminometer, and are reported as Relative Light Units (RLU). The device reagents are identical to the Aptima Neisseria gonorrhoeae Assay reagents for use on the Tigris DTS system but are intended for use on the Panther system with different specimen type indications. The Panther and Tigris DTS systems use the same principles of operation.

Here's a breakdown of the acceptance criteria and study details for the Aptima Neisseria gonorrhoeae Assay, based on the provided FDA 510(k) summary:

This device is an in vitro qualitative nucleic acid amplification test (NAAT) for the detection of Neisseria gonorrhoeae (GC) rRNA to aid in the diagnosis of gonococcal urogenital disease in male urine specimens using the Panther System. It does not appear to involve AI assistance or human reader studies.

1. Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state pre-defined acceptance criteria for clinical performance (sensitivity and specificity) as a set of numerical thresholds. Instead, it states that the study data demonstrate that performance of the Aptima Neisseria gonorrhoeae Assay on the Panther system is substantially equivalent to that of currently FDA-cleared assays for male urine specimens.

However, analytical studies do present performance metrics that implicitly act as acceptance criteria, for example, for Limit of Detection (LoD), precision, and specificity (no interference).

Here's a summary of reported device performance based on the provided text:

Table of Reported Device Performance

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

• Clinical Test Set:
  • Total Enrolled Subjects: 2085 male subjects.
  • Evaluable Subjects: 1959 male subjects (126 subjects not evaluable).
  • Specimens Included in Performance Analysis: 1958 male urine specimens (one specimen with final GC equivocal result was excluded).
  • Data Provenance: Prospective, multi-center clinical study conducted at 11 geographically and ethnically diverse US clinical sites.
    • Sites included obstetrics and gynecology, family planning, and STI clinics.
    • Specimens were collected from symptomatic and asymptomatic men.

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

• The document does not explicitly state the number of experts used to establish ground truth for the clinical test set.
• The ground truth (Patient Infected Status - PIS) was established using up to 3 FDA-cleared NAATs (Nucleic Acid Amplification Tests). This implies that a consensus or reference standard approach using multiple existing, cleared diagnostic methods was used, rather than individual expert review or pathological examination for individual cases.

4. Adjudication Method for the Test Set

• The document states that the Patient Infected Status (PIS) was established using "up to 3 FDA-cleared NAATs". This indicates a composite reference standard approach.
• The specific adjudication rule (e.g., 2/3 positive, 3/3 positive) is not detailed, but the use of multiple FDA-cleared methods implies a robust, multi-test consensus for the ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done.
• This device is an in vitro diagnostic (IVD) assay (a qualitative nucleic acid amplification test), not an imaging AI device that assists human readers. Therefore, there is no "human-in-the-loop" component or an effect size for human readers improving with AI assistance.

6. Standalone Performance

• Yes, standalone performance was done.
• The described clinical study evaluates the performance of the "Aptima Neisseria gonorrhoeae Assay on the Panther System" directly against a composite reference standard (PIS derived from FDA-cleared NAATs). This is a standalone performance assessment of the algorithm/device itself, without human intervention in the result interpretation.

7. Type of Ground Truth Used

• The ground truth used for the clinical test set was a composite reference standard, referred to as "Patient Infected Status (PIS)".
• PIS was established by testing male urine specimens with "up to 3 FDA-cleared NAATs". This is a highly robust method, relying on multiple well-validated diagnostic tests to determine the true infection status.

8. Sample Size for the Training Set

• The document does not specify the sample size for the training set.
• This document is a 510(k) summary for premarket notification, focusing on the validation of the device for its intended use. Information regarding the development and training of the assay (e.g., specific molecular sequences, probe design) is generally proprietary and not included in this type of submission. The focus is on the performance of the final, locked version of the device.

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

• The document does not specify how the ground truth for any potential training set was established, nor explicitly mention a distinct training set.
• For an IVD such as this, the "training" (or development and optimization) typically involves extensive analytical studies (e.g., primer design, probe specificity, optimization of reaction conditions, LoD determination, cross-reactivity testing) rather than machine learning-style "training data" with a "ground truth" in the same sense as an AI imaging algorithm. The core of the assay relies on well-established molecular biology principles and target identification.

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