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510(k) Data Aggregation
(155 days)
The BD ProbeTecT™ Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay, when tested with the BD Viper™ System in Extracted Mode, uses Strand Displacement Amplification technology for the direct, qualitative detection of Neisseria gonorrhoeae DNA in clinician-collected female endocervical and male urethral swab specimens, patient-collected vaginal swab specimens (in a clinical setting), and male and female urine specimens (both UPT and Neat). The assay is also intended for use with gynecological specimens collected in BD SurePath™ Preservative Fluid using an aliquot that is removed prior to processing for the BD SurePath™ Pap test. The assay is indicated for use with asymptomatic and symptomatic individuals to aid in the diagnosis of gonococcal urogenital disease.
The BD ProbeTec GC O* Amplified DNA Assay is based on the simultaneous amplification and detection of target DNA using amplification primers and a fluorescently-labeled detector probe. The reagents for SDA are dried in two separate disposable microwells: the Priming Microwell contains the amplification primers, fluorescently-labeled detector probe, nucleotides and other reagents necessary for amplification, while the Amplification Microwell contains the two enzymes (a DNA polymerase and a restriction endonuclease) that are required for SDA. The BD Viper™ System pipettes a portion of the purified DNA solution from each Extraction Tube into a Priming Microwell to rehydrate the contents. After a brief incubation, the reaction mixture is transferred to a corresponding, pre-warmed Amplification Microwell which is sealed to prevent contamination and then incubated in one of the two thermally-controlled fluorescent readers. The presence or absence of N. gonorrhoeae DNA is determined by calculating the peak fluorescence (Maximum Relative Fluorescent Units (MaxRFU)) over the course of the amplification process and by comparing this measurement to a predetermined threshold value.
In addition to the fluorescent probe used to detect amplified N. gonorrhoeae target DNA, a second labeled oligonucleotide is incorporated in each reaction. The Extraction Control (EC) oligonucleotide is labeled with a different dye than that used for detection of the N. gonorrhoeae -specific target and is used to confirm the validity of the extraction process. The EC is dried in the Extraction Tubes and is rehydrated upon addition of the specimen and extraction reagents. At the end of the extraction process, the EC fluorescence is monitored by the BD Viper System and an automated algorithm is applied to both the EC and N. gonorrhoeae -specific signals to report results as positive, negative, or EC failure.
BD ProbeTec™ Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay
1. Table of Acceptance Criteria and Reported Device Performance
| Metric | Acceptance Criteria (Implied) | Reported Device Performance (BD SurePath Specimens) |
|---|---|---|
| Clinical Performance | ||
| Sensitivity | Sufficient for diagnosis, as demonstrated by comparison to PIS. | Asymptomatic: 100.0% (32/32) (95% C.I.: 89.1% - 100.0%)Symptomatic: 100.0% (19/19) (95% C.I.: 82.4% - 100.0%)Total: 100.0% (51/51) (95% C.I.: 93.0% - 100.0%) |
| Specificity | Sufficient for diagnosis, as demonstrated by comparison to PIS. | Asymptomatic: 99.8% (1123/1125) (95% C.I.: 99.4% - 100.0%)Symptomatic: 100.0% (539/539) (95% C.I.: 99.3% - 100.0%)Total: 99.9% (1662/1664) (95% C.I.: 99.6% - 100.0%) |
| PPV | (Not explicitly defined, but results indicate high PPV) | Asymptomatic: 93.5%Symptomatic: 100.0%Total: 96.9% |
| NPV | (Not explicitly defined, but results indicate high NPV) | Asymptomatic: 100.0%Symptomatic: 100.0%Total: 100.0% |
| Analytical Performance | ||
| Limit of Detection (LOD) | Detection of N. gonorrhoeae at low concentrations. | < 100 GC cells per mL (for N. gonorrhoeae strain ATCC 19424 in BD SurePath specimens).Able to detect 17 GC strains with ≥ 95% proportion positive at a concentration of 50 cells per mL in clean diluted BD SurePath Preservative Fluid. |
| Reproducibility | Consistent proportion of correct results and low variability. | Reproducibility Panel (Positive Samples): 100.0% correct (135/135) for both GC-only and CT/GC co-infected samples containing 100-250 GC cells/mL. Low %CV for MaxRFU (4.23% to 4.42%).Reproducibility Panel (Negative Samples): 100.0% correct (135/135). |
| Interference | No interference from common vaginal substances/biologicals. | No interference observed from: Blood (≤ 1%), Seminal Fluid, Mucus, Over-The-Counter vaginal products and contraceptives, Hemorrhoidal cream, Prescription vaginal treatments, Leukocytes (1x10^6^ cells/mL), Chlamydia trachomatis (1x10^6^ EB/mL). |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set:
- Clinical Performance: 1715 compliant female subjects had evaluable BD SurePath specimen results. The study initially enrolled 1728 compliant female subjects.
- Reproducibility (LBC Specimens):
- Standard Panel: 135 replicates per panel member (9 replicates/day x 5 days x 3 sites).
- Below LOD Panel: 135 replicates per panel member (9 replicates/day x 5 days x 3 sites).
- Data Provenance: Retrospective and prospective. The clinical study involved collection of specimens from subjects attending clinics at eleven geographically diverse clinical sites in North America.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not specify the number or qualifications of experts involved in establishing the ground truth. The ground truth for clinical performance was established using a "patient infected status (PIS) algorithm" based on results from three reference endocervical swabs tested with:
- The BD ProbeTec ET CT/GC/AC assay
- The BD ProbeTec GC Qc assay
- Another commercially available NAAT (Nucleic Acid Amplification Test)
4. Adjudication method for the test set
The adjudication method for establishing the Patient Infected Status (PIS) ground truth for the clinical test set was:
- PIS-positive: At least two positive reference results from the three reference methods.
- PIS-negative: At least two negative reference results from the three reference methods.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is an automated DNA amplification assay (NAAT), not an imaging device requiring human interpretation, nor does it incorporate AI for interpretation. Its output is qualitative (positive/negative) based on a predetermined threshold value of fluorescence.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance evaluation was done. The BD ProbeTec GC Q* Amplified DNA Assay, when used with the BD Viper™ System, operates in an automated, algorithm-driven manner to provide qualitative results (positive, negative, or EC failure) without human interpretation of the primary reaction signals. The system uses an automated algorithm applied to fluorescent signals to determine the result.
7. The type of ground truth used
The ground truth used for the clinical performance evaluation was a Patient Infected Status (PIS) algorithm based on expert consensus/multiple reference test results. This is a composite reference standard using three established Nucleic Acid Amplification Tests (NAATs) performed on endocervical swabs.
8. The sample size for the training set
The document does not specify a separate training set or its sample size. The clinical study described appears to be a validation/test set for the device's performance against a reference standard. For NAATs, the "training" (i.e., algorithm development and optimization) is typically done during the assay design and analytical validation phase, not through a separate clinical "training set" as might be seen for machine learning algorithms.
9. How the ground truth for the training set was established
As no explicit "training set" is described in the provided text in the context of clinical data for algorithm development, the method for establishing its ground truth is not detailed. The assay's underlying principles (Strand Displacement Amplification and fluorescence detection) are established molecular biology techniques, and the algorithm for interpreting fluorescence signals would have been developed and validated during the assay's R&D phase using known positive and negative controls and potentially characterized clinical samples.
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