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510(k) Data Aggregation
(325 days)
The NeuMoDx CT/NG Assay 2.0, as implemented on the NeuMoDx 96 Molecular System and NeuMoDx 288 Molecular System, is an automated, qualitative test for the direct detection of Chlamydia trachomatis (CT) and or Neisseria gonorrhoeae (NG) DNA as an aid in the diagnosis of chlamydial and gonococcal urogenital disease in symptomatic and asymptomatic individuals. The Assay utilizes real-time Polymerase Chain Reaction (PCR) and may be used to test male and female urine, and self-collected vaginal swab specimens (collected in a clinical setting).
The NeuMoDx CT/NG Assay 2.0 is an automated in vitro diagnostic test for the direct detection of Chlamydia trachomatis and Neisseria gonorrhoeae (CT/NG) DNA from asymptomatic and symptomatic patient specimens. The assay utilizes real-time polymerase chain reaction (PCR) for the amplification of CT and/or NG DNA and fluorogenic targetspecific TaqMan probes for the detection of the amplified DNA. At the end of the test, a determination of the presence/absence of CT and/or NG DNA in the specimen is automatically made based on the amplification status of the CT and/or NG DNA and/or Sample Process Control sequences using pre-established decision criteria. The NeuMoDx CT/NG Assay 2.0 is intended as an aid to diagnose CT and NG infections in symptomatic or asymptomatic individuals, but not to guide or monitor treatment for CT and NG infections. Concomitant cultures may be necessary to recover organisms for epidemiological typing or for further susceptibility testing.
The NeuMoDx CT/NG Assay 2.0 is an automated, qualitative test for the direct detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) DNA, designed to aid in the diagnosis of chlamydial and gonococcal urogenital disease in symptomatic and asymptomatic individuals.
Here's an analysis of its acceptance criteria and the study proving its performance:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for sensitivity and specificity are not explicitly stated as distinct acceptance criteria in the provided text. However, the FDA review process implies that the observed performance must be deemed acceptable. We will present the observed clinical performance as the reported device performance.
Chlamydia trachomatis (CT) Performance
| Specimen Type | Symptom Status | Prevalence | Sensitivity (95% CI) | Specificity (95% CI) |
|---|---|---|---|---|
| Male Urine (MU) | Asymptomatic | 8.5% | 98.1% (93.3%, 99.5%) | 100.0% (99.7%, 100.0%) |
| Male Urine (MU) | Symptomatic | 18.5% | 95.3% (88.6%, 98.2%) | 99.7% (98.5%, 100.0%) |
| Male Urine (MU) | All | 11.2% | 96.8% (93.3%, 98.5%) | 99.9% (99.6%, 100.0%) |
| Female Urine (FU) | Asymptomatic | 4.1% | 93.0% (81.4%, 97.6%) | 99.9% (99.4%, 100.0%) |
| Female Urine (FU) | Symptomatic | 6.4% | 91.8% (82.2%, 96.4%) | 99.7% (99.0%, 99.9%) |
| Female Urine (FU) | All | 5.2% | 92.3% (85.6%, 96.1%) | 99.8% (99.5%, 99.9%) |
| Self-Collected Vaginal Swab (SCVS) | Asymptomatic | 4.1% | 100.0% (91.8%, 100.0%) | 99.8% (99.3%, 99.9%) |
| Self-Collected Vaginal Swab (SCVS) | Symptomatic | 6.3% | 95.1% (86.5%, 98.3%) | 99.2% (98.4%, 99.6%) |
| Self-Collected Vaginal Swab (SCVS) | All | 5.2% | 97.1% (91.9%, 99.0%) | 99.5% (99.1%, 99.8%) |
Neisseria gonorrhoeae (NG) Performance
| Specimen Type | Symptom Status | Prevalence | Sensitivity (95% CI) | Specificity (95% CI) |
|---|---|---|---|---|
| Male Urine (MU) | Asymptomatic | 0.9% | 100.0% (74.1%, 100.0%) | 99.9% (99.5%, 100.0%) |
| Male Urine (MU) | Symptomatic | 17.6% | 98.8% (93.4%, 99.8%) | 99.7% (98.5%, 100.0%) |
| Male Urine (MU) | All | 5.5% | 98.9% (94.2%, 99.8%) | 99.9% (99.5%, 100.0%) |
| Female Urine (FU) | Asymptomatic | 2.3% | 91.7% (74.2%, 97.7%) | 100.0% (99.6%, 100.0%) |
| Female Urine (FU) | Symptomatic | 2.2% | 95.2% (77.3%, 99.2%) | 99.9% (99.4%, 100.0%) |
| Female Urine (FU) | All | 2.2% | 93.3% (82.1%, 97.7%) | 99.9% (99.7%, 100.0%) |
| Self-Collected Vaginal Swab (SCVS) | Asymptomatic | 2.3% | 100.0% (86.2%, 100.0%) | 100.0% (99.6%, 100.0%) |
| Self-Collected Vaginal Swab (SCVS) | Symptomatic | 2.2% | 95.2% (77.3%, 99.2%) | 99.8% (99.2%, 99.9%) |
| Self-Collected Vaginal Swab (SCVS) | All | 2.2% | 97.8% (88.4%, 99.6%) | 99.9% (99.6%, 100.0%) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- Male Urine (CT): 1691
- Male Urine (NG): 1698
- Female Urine (CT): 2007
- Female Urine (NG): 2006
- Self-Collected Vaginal Swabs (SCVS) (CT): 2016
- Self-Collected Vaginal Swabs (SCVS) (NG): 2016
- Data Provenance: The study was a "multicenter, pivotal, prospective urogenital specimen collection study" conducted at "14 geographically and demographically diverse U.S. sites."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The ground truth was established by a "patient infected status (PIS) algorithm" based on results from two FDA-cleared, legally marketed Nucleic Acid Amplification Tests (NAATs). The text does not mention the involvement of human experts (e.g., radiologists, clinicians) for establishing the ground truth directly. It relies on the performance of existing, cleared diagnostic devices.
4. Adjudication Method for the Test Set
The adjudication method was a pre-specified patient infected status (PIS) algorithm rather than human expert adjudication:
- Female PIS: Established from the results of female urine (FU) and clinician-collected vaginal swab (CCVS) specimens tested by two FDA-cleared NAAT comparator assays. Females were classified as infected if at least one positive result was obtained by each assay. Any other combination was considered non-infected.
- Male PIS: Established using urine results from two FDA-cleared comparator NAATs. If the male urine results were conflicting (one positive, one negative), a third FDA-cleared NAAT method was performed as a tie-breaker to adjudicate male infection status.
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
No MRMC comparative effectiveness study was done. The study evaluated the standalone performance of the NeuMoDx CT/NG Assay 2.0 against a PIS algorithm and did not involve human readers interpreting results with or without AI assistance.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, a standalone performance study was done. The clinical performance characteristics (sensitivity and specificity) were established by comparing the results of the NeuMoDx CT/NG Assay 2.0 (an automated molecular test, essentially an algorithm-only device in its interpretation of PCR data) directly to the patient infected status algorithm. No human interpretation of the device's output and subsequent diagnosis was explicitly included in the reported performance metrics.
7. The Type of Ground Truth Used
The type of ground truth used was an expert consensus (of NAATs) / composite reference standard, referred to as a "patient infected status (PIS) algorithm," which was derived from the results of multiple (two, sometimes three) FDA-cleared, legally marketed Nucleic Acid Amplification Tests (NAATs).
8. The Sample Size for the Training Set
The document does not explicitly state a training set sample size. This device is a diagnostic assay (molecular test), not typically an AI/machine learning algorithm that undergoes a distinct training phase in the same way an image recognition AI would. The "training" or development of the assay (e.g., primer design, cutoff optimization) would have utilized various analytical studies, but a 'training set' in the context of machine learning is not reported here.
9. How the Ground Truth for the Training Set Was Established
As noted above, a distinct "training set" with ground truth established for it in the context of machine learning is not described. The assay's analytical performance (e.g., Limit of Detection, linearity, exclusivity) was characterized using contrived samples (spiked with known concentrations of CT/NG) and known negative samples. For example, the LoD was determined by testing separate dilutions of CT elementary bodies and NG cells in negative matrices, confirming 95% positivity. Inclusivity and cross-reactivity studies used known strains and organisms.
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