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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. |
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(155 days)
The BD ProbeTec™ 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 Q* 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 10 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. gonorrhoede -specific signals to report results as positive, negative, or EC failure.
Here's an analysis of the BD ProbeTec™ Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay based on the provided document, focusing on acceptance criteria and supporting study details:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined "acceptance criteria" in a numerical format that the device must meet. Instead, it presents the results of its clinical performance study and concludes that these results "support the determination of substantial equivalence." Therefore, the reported performance itself, particularly sensitivity and specificity, serves as the de-facto measure of whether the device is considered acceptable for its intended use.
| Metric | Acceptance Criteria (Implicit) | Reported Device Performance (BD SurePath Specimens) |
|---|---|---|
| Sensitivity | Sufficiently high to detect N. gonorrhoeae in positive cases (exact threshold not stated, but 90%+ would be typical for diagnostics) | Total: 100.0% (51/51) |
| Symptomatic: 100.0% (19/19) | ||
| Asymptomatic: 100.0% (32/32) | ||
| Specificity | Sufficiently high to correctly identify negative cases (exact threshold not stated, but 95%+ would be typical for diagnostics) | Total: 99.9% (1662/1664) |
| Symptomatic: 100.0% (539/539) | ||
| Asymptomatic: 99.8% (1123/1125) | ||
| Limit of Detection (LOD) | Max. 100 GC cells per mL (based on predicate/similar devices) | ≤ 100 GC cells per mL (with > 95% proportion positive at 50 cells/mL) |
| Interference | No significant interference from common substances | No interference observed from various substances (Blood, Seminal Fluid, Mucus, OTC vaginal products, etc.) |
| Reproducibility | Consistent results across runs, sites, and systems | High percentage of correct results (100%) and low %CV for MaxRFU values for positive and negative controls. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Clinical Performance):
- Female Subjects: 1728 compliant female subjects enrolled, 1715 included in final data analysis.
- Specimens:
- 3 randomized endocervical swab specimens per subject (for reference methods).
- 1 BD SurePath specimen per subject (for the device under evaluation).
- Data Provenance:
- Country of Origin: North America (specifically, "eleven geographically diverse clinical sites in North America").
- Retrospective or Prospective: The study describes specimen collection from "subjects attending family planning, OB/GYN, and sexually transmitted disease clinics," implying a prospective collection for the purpose of this study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of "experts" to establish ground truth in the traditional sense of a human review panel. Instead, the ground truth was established using a Patient Infected Status (PIS) algorithm rather than expert consensus on individual cases.
4. Adjudication Method for the Test Set
The adjudication method for establishing the Patient Infected Status (PIS) was algorithmic, not human adjudication:
- Method: A PIS algorithm based on the results of three reference endocervical swab methods:
- BD ProbeTec ET CT/GC/AC assay
- BD ProbeTec GC Q* assay (the predicate device)
- Another commercially available NAAT (Nucleic Acid Amplification Test)
- Criteria:
- PIS-positive: At least two positive reference results were required.
- PIS-negative: At least two negative reference results were required.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done. This device is an in vitro diagnostic (IVD) assay that directly detects DNA using a machine (BD Viper System), not an image-based AI system that assists human interpretation.
6. Standalone Performance
Yes, the study primarily evaluates the standalone performance of the BD ProbeTec GC Q* Amplified DNA Assay integrated with the BD Viper System. The clinical performance table (Table 4) presents the sensitivity and specificity of the device against the "Patient Infected Status" (ground truth). This is the algorithm's performance without a human in the loop interpreting the results, as the output is a "positive, negative, or EC failure."
7. Type of Ground Truth Used
The ground truth used was a Patient Infected Status (PIS) algorithm derived from the results of multiple established reference Nucleic Acid Amplification Tests (NAATs) on endocervical swab specimens. While not direct pathology (like tissue biopsy), it represents a "composite reference standard" or "latent class analysis" approach, which is common and often considered highly accurate for infectious disease diagnostics when a single gold standard is imperfect or invasive.
8. Sample Size for the Training Set
The document does not explicitly state the sample size for a "training set." This is typical for in vitro diagnostic assays like this one. Unlike machine learning algorithms that require distinct training and test sets, the development of IVD assays often involves an iterative process of reagent optimization and analytical validation (LOD, interference, etc.) using spiked samples and smaller initial specimen panels, followed by a larger, independent clinical validation set (which is what is described here). The "training" in this context refers to the development and optimization of the assay itself and its algorithm, which is not typically quantified by a specific "training set" sample size in the same way an AI model would be.
9. How the Ground Truth for the Training Set Was Established
As noted above, a distinct "training set" with a formally established ground truth, as understood in machine learning, is not described for this IVD assay. The development and optimization of the assay's internal algorithms (e.g., for calculating MaxRFU and applying the automated algorithm for positive/negative/EC failure) would have been based on analytical studies and perhaps smaller, internal clinical sample sets where results were correlated with known positive and negative samples, often confirmed by reference methods or culture. The document focuses on the validation of the final assay on a robust clinical test set.
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(60 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 (SDA) technology for the direct, qualitative detection of Neisseria gonorrhoeae DNA in cliniciancollected female endocervical and male urethral swabs, patient-collected vaginal swab specimens (in a clinical setting), and female and male urine specimens. The assay is indicated for use with asymptomatic and symptomatic female and male individuals to aid in the diagnosis of gonococcal urogenital disease.
The BD Viper System, when used with the BD ProbeTec amplified nucleic assay(s), is intended for the in vitro detection of targeted organisms from specimens as identified in the assay-specific reagent package insert(s).
The BD ProbeTec GC Q* 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 "M 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.
Here's an analysis of the acceptance criteria and study detailed in the provided text for the BD ProbeTec™ Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the clinical performance results, where high sensitivity and specificity are demonstrated across various specimen types and patient asymptomatic/symptomatic statuses. While explicit numerical acceptance criteria (e.g., "sensitivity must be >95%") are not explicitly stated as 'acceptance criteria' in the document, we can infer the achieved performance as the criteria met for substantial equivalence.
| Specimen Type & Symptomatic Status | Acceptance Criteria (Implied by Achieved Performance) | Reported Device Performance (Sensitivity) | Reported Device Performance (Specificity) |
|---|---|---|---|
| Female Endocervical Swab (FS) | High Sensitivity & Specificity | A: 96.3% (26/27) | |
| S: 100.0% (38/38) | |||
| Total: 98.5% (64/65) | A: 99.5% (421/423) | ||
| S: 99.8% (503/504) | |||
| Total: 99.7% (924/927) | |||
| Female Vaginal Swab (FV) | High Sensitivity & Specificity | A: 100.0% (27/27) | |
| S: 100.0% (38/38) | |||
| Total: 100.0% (65/65) | A: 98.6% (416/422) | ||
| S: 99.6% (504/506) | |||
| Total: 99.1% (920/928) | |||
| Female Neat Urine (FNU) | High Sensitivity & Specificity | A: 96.3% (26/27) | |
| S: 97.4% (37/38) | |||
| Total: 96.9% (63/65) | A: 99.3% (420/423) | ||
| S: 99.6% (503/505) | |||
| Total: 99.5% (923/928) | |||
| Female Urine in Q UPT (FUPT)* | High Sensitivity & Specificity | A: 100.0% (27/27) | |
| S: 97.4% (37/38) | |||
| Total: 98.5% (64/65) | A: 99.5% (421/423) | ||
| S: 99.8% (504/505) | |||
| Total: 99.7% (925/928) | |||
| Male Urethral Swab (MS) | High Sensitivity & Specificity | A: 100.0% (12/12) | |
| S: 100.0% (100/100) | |||
| Total: 100.0% (112/112) | A: 99.2% (492/496) | ||
| S: 98.7% (155/157) | |||
| Total: 99.1% (647/653) | |||
| Male Neat Urine (MNU1) | High Sensitivity & Specificity | A: 100.0% (12/12) | |
| S: 100.0% (100/100) | |||
| Total: 100.0% (112/112) | A: 99.2% (501/505) | ||
| S: 98.1% (154/157) | |||
| Total: 98.9% (655/662) | |||
| Male Urine in Q UPT (MUPT1)* | High Sensitivity & Specificity | A: 100.0% (12/12) | |
| S: 100.0% (100/100) | |||
| Total: 100.0% (112/112) | A: 99.2% (501/505) | ||
| S: 98.7% (155/157) | |||
| Total: 99.1% (656/662) | |||
| Overall (Total) | High Sensitivity & Specificity | 99.3% (592/596) | 99.3% (5650/5688) |
A = Asymptomatic, S = Symptomatic
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- Female subjects: 994 (eligible)
- Male subjects: 774 (eligible)
- Total BD ProbeTec GC Q* assay results used for performance calculations: 6284
- Data Provenance:
- Country of Origin: North America (seven geographically diverse clinical sites).
- Retrospective or Prospective: Prospective. The study involved collecting various specimens (endocervical swabs, male urethral swabs, vaginal swabs, and urine) from symptomatic and asymptomatic subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Explicit details on the number of experts or their qualifications (e.g., radiologist with 10 years of experience) for establishing ground truth are not provided. The ground truth was established using an algorithm based on results from two commercially available Nucleic Acid Amplification Tests (NAATs) (the BD ProbeTec ET GC/AC assay and another commercially available NAAT). This method relies on the established performance of these reference NAATs rather than individual expert review of each case.
4. Adjudication Method for the Test Set
The adjudication method used to establish the "patient infected status" (PIS) for the ground truth was a 2-out-of-N rule (where N refers to the number of reference tests performed).
- For Female subjects (endocervical swab and urine specimens): Subjects were considered infected if "two of the four endocervical swab and urine specimens (or two of the three or four urethral swab and urine specimens) tested positive in the BD ProbeTec ET GC/AC assay and the other reference NAAT (one specimen testing positive in each NAAT)."
- For Male subjects (urethral swab and urine specimens): Similar algorithm applied.
- Non-infected: Subjects were considered non-infected if "less than two reference NAAT results were positive."
This implies specimens were tested by at least two reference NAATs (BD ProbeTec ET GC/AC and another commercial NAAT).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study evaluates the performance of an assay (device) directly against a ground truth, not the comparative improvement of human readers with or without AI assistance. The device is for direct detection of N. gonorrhoeae DNA, not for aiding human interpretation of images or other data.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, a standalone study was performed. The BD ProbeTec GC Q* Amplified DNA Assay is a fully automated system that detects N. gonorrhoeae DNA and reports results as positive, negative, or EC failure. The performance data presented (sensitivity and specificity) is based on the algorithm's direct output compared to the established patient infected status, without human intervention in result interpretation. The "BD Viper™ System and an automated algorithm is applied to both the EC and N. gonorrhoeae -specific signals to report results."
7. Type of Ground Truth Used
The ground truth used was a composite reference standard or patient infected status (PIS) algorithm, derived from the results of two different commercially available Nucleic Acid Amplification Tests (NAATs): the BD ProbeTec ET GC/AC assay and another commercially available NAAT. It is based on the concordance of these reference molecular tests, rather than pathology (histology), expert consensus of clinical symptoms, or long-term outcomes data.
8. Sample Size for the Training Set
The document does not explicitly state a separate training set size. The clinical performance characteristics are reported from a single clinical study dataset. In diagnostic assay development, initial algorithm development and optimization might occur using internal datasets, but this document describes the validation study for regulatory submission. It's common in IVD submissions for the entire clinical study population to be used for performance evaluation against the ground truth without a separate "training set" as understood in machine learning (where the algorithm learns from the data). If an algorithm's parameters were tuned on this specific dataset, it would be a form of internal validation rather than a truly independent test set. However, the text focuses on the device's performance measurement, implying that the algorithm's parameters were fixed by the time this validation study was conducted.
9. How the Ground Truth for the Training Set Was Established
As noted above, a separate "training set" is not explicitly mentioned. For the test set, the ground truth was established by a patient infected status (PIS) algorithm based on the concordance of two distinct commercially available NAATs (BD ProbeTec ET GC/AC assay and another commercially available NAAT) on various patient specimens.
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