(89 days)
The AMPLICOR CT/NG test for Neisseria gonorrhoeae is a qualitative in vitro test for the detection of N. gonorrhoeae DNA in urine from symptomatic or asymptomatic males, in endocervical swab specimens from symptomatic or asymptomatic females, and in urethral swab specimens from symptomatic males as evidence of infection with N. gonorrhoeae. N. gonorrhoeae DNA is detected by Polymerase Chain Reaction (PCR) amplification of target DNA and by hybridization capture of amplified target.
Sample and control preparation can either be accomplished manually or automated using the optional Roche Scripts for AMPLICOR CT/NG Test Accessory to direct the Tecan Genesis RSP 150 Workstation Urine specimens are not indicated for use with the automated sample preparation option.
Roche Scripts for AMPLICOR CT/NG Test: The Roche Scripts for AMPLICOR CT/NG Test are intended to provide software scripts to direct the automated Tecan Genesis RSP 150 Workstation to process swab samples or control material for analysis using either of the following 510(k)-cleared assay test systems:
- AMPLICOR ® CT/NG test for Chlamydia trachomatis .
- AMPLICOR ® CT/NG test for Neisseria gonorrhoeae .
The AMPLICOR CT/NG test for Neisseria gonorrhoeae is a qualitative in vitro test for the detection of N. gonorrhoeae DNA in urine from symptomatic or asymptomatic males, in endocervical swab specimens from symptomatic or asymptomatic females, and in urethral swab specimens from sympotmatic males as evidence infection with N. gonorrhoeae. N. gonorrhoeae DNA is detected by Polymerase Chain Reaction (PCR) amplification of target DNA and by hybridization capture of amplified target using the AMPLICOR analyzer.
The Roche Scripts for AMPLICOR CT/NG Test accessory consists of a compact disc (CDs) containing scripts to direct the automated Tecan Genesis RSP 150 workstation to process swab samples or control material for analysis.
The document describes the AMPLICOR CT/NG test for Neisseria gonorrhoeae and the Roche Scripts for AMPLICOR CT/NG Test Accessory. The 'device' in question appears to be the Roche Scripts accessory which enables automated sample preparation for the existing AMPLICOR CT/NG test. The acceptance criteria and supporting studies focus on demonstrating that the automated sample preparation method (using the Roche Scripts) performs equivalently to the previously cleared manual sample preparation method.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated with numerical targets for the Roche Scripts accessory itself, but rather established through demonstrating equivalence to the performance of the predicate device (AMPLICOR CT/NG test for Neisseria gonorrhoeae with manual preparation). The acceptance is therefore implicitly based on demonstrating that the automated preparation method does not negatively impact the established performance characteristics.
| Performance Characteristic | Predicate Device (Manual Preparation) Performance (Acceptance Criteria Based On) | Current Device (Automated Preparation with Roche Scripts) Performance |
|---|---|---|
| Analytical Sensitivity | 5 IFU/test; equivalent to 100 IFU/mL for urine, 400 IFU/mL for CTM with swab | 100 cfu/mL for CTM with swab specimen |
| Precision | 100% correct results for CTM panel; 3/30 negative results for one urine panel member | 99.4% correct results for panels of CTM specimens |
| Clinical Performance | Sensitivity vs. culture: 95.9% (females), 96.5% (males); Specificity vs. culture: 98.7% (females), 97.3% (males) | 99.0% concordance with manual method |
| Analytical Specificity | Negative results from 130 bacteria, 6 fungal, 1 protozoan, 11 viral strains (some N. cinerea and N. subflava may give false positives) | Same (as expected since the assay chemistry is unchanged) |
| Cross-Contamination | Not explicitly quantified for predicate, but implied none. | Evaluation performed (results are stated as "equivalent to those obtained with manual specimen preparation") |
| Non-clinical Specificity | Not explicitly quantified for predicate, but implied no issues. | Evaluation performed (results are stated as "equivalent to those obtained with manual specimen preparation") |
2. Sample Size Used for the Test Set and Data Provenance
- Analytical Sensitivity (Automated preparation): The document states "100 cfu/mL for CTM with swab specimen" without specifying the number of samples used to determine this.
- Precision (Automated preparation): "99.4% correct results for panels of CTM specimens" without specifying the number of CTM specimens or the total number of tests.
- Clinical Evaluation (Automated vs. Manual): The sample size for the clinical evaluation comparing automated and manual methods is not explicitly stated. The data provenance (country of origin, retrospective/prospective) is not specified. However, the study involved comparing results from the automated method to the manual method, implying existing clinical samples or prospectively collected samples analyzed by both methods.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is an in vitro diagnostic device, and the ground truth for Neisseria gonorrhoeae infection is typically established via culture (a laboratory method), not by expert human interpretation of images or other subjective data. No experts for ground truth establishment are mentioned or implied.
4. Adjudication Method for the Test Set
Not applicable. As this is an in vitro diagnostic device, the results are quantitative/qualitative outputs from the assay, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This device is an in vitro diagnostic test system, not an AI-assisted diagnostic imaging or pathology tool involving human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device (Roche Scripts accessory) is essentially a standalone automation algorithm. Its performance is evaluated in a standalone manner by comparing its output (after automated sample prep) to the manual method's output. The "algorithm only" performance is represented by the "Automated preparation" columns in the table above and the clinical evaluation comparing automated vs. manual methods.
7. The Type of Ground Truth Used
For the original AMPLICOR CT/NG test (to which the new automated method is compared), the clinical performance ground truth was established "vs. culture." Culture is considered the gold standard for detecting viable Neisseria gonorrhoeae. For the evaluation of the Roche Scripts accessory, the "ground truth" for the clinical evaluation was implicitly the results obtained by the manual preparation method of the already cleared AMPLICOR CT/NG test, as the key objective was to show concordance.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML model that undergoes a 'training phase' in the traditional sense. The "Roche Scripts" are software instructions for a liquid handling system; they were "developed" but not "trained" on a dataset like an AI algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of an AI/ML algorithm. If "training set" refers to samples used during the development and optimization of the scripts, this information is not provided. The document states "The Roche Scripts were developed and evaluated according to FDA Guidance evaluation documents." This implies standard software development and verification procedures.
§ 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).