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510(k) Data Aggregation
(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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(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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(48 days)
The GEN-PROBE APTIMA® Assay for Neisseria gonorrhoeae is a target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection of ribosomal RNA (rRNA) from Neisseria gonorrhoeae (GC) to aid in the diagnosis of gonococcal urogenital disease using the TIGRIS® DTS® Automated Analyzer or semiautomated instrumentation as specified. The assay may be used to test the following specimens from symptomatic individuals: clinician-collected endocervical, vaginal and male urethral swab specimens; and female and male urine specimens. The assay may be used to test the following specimens from asymptomatic individuals: clinician-collected endocervical, vaginal swab specimens; patient-collected 'vaginal swab specimens; and female and male urine. The assay is also intended for use with the testing of gynecological specimens, from both symptomatic and asymptomatic patients collected in the PreservCyt® Solution and processed with the Cytyc ThinPrep® 2000 System.
Clearance of this premarket notification extends the clinical performance claims of the commercially available GEN-PROBE®APTIMA® Assay for Neisseria gonorrhoeae with the testing of gynecological specimens collected in the PreservCyt® Solution and processed with the Cytyc ThinPrep® 2000 System, for use on the TIGRIS® DTS® System. The ancillary kit for this application is commercially available as the GEN-PROBE APTIMA Specimen Transfer Kit. The components of the APTIMA Specimen Transfer Kit include: (1) a transport tube containing transport media with a penetrable cap and (2) specific instructions for use regarding decontamination and specimen processing procedures. The APTIMA Transfer Kit may only be used in conjunction with the APTIMA Assays.
This document describes the GEN-PROBE APTIMA Assay for Neisseria gonorrhoeae on the TIGRIS DTS System. The goal of the submission appears to be to expand the clinical performance claims of the existing assay to include gynecological specimens collected in PreservCyt Solution and processed with the Cytyc ThinPrep 2000 System, for use on the TIGRIS DTS System.
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria provided in the document are primarily related to agreement studies and analytical performance targets rather than explicit numerical thresholds for clinical sensitivity/specificity against a gold standard for the new use case (PreservCyt specimens on the TIGRIS DTS System). The clinical studies focus on demonstrating equivalence between the TIGRIS DTS System and previously validated DTS Systems.
| Acceptance Criteria (Implied) | Reported Device Performance (for PreservCyt specimens on TIGRIS DTS) |
|---|---|
| Analytical Sensitivity (Limit of Detection) | |
| 100% positivity at 50 CFU/assay (250 fg of total GC rRNA) | 100% positive (95.1-100% CI) for N. gonorrhoeae rRNA spiked into post-processed PreservCyt liquid Pap specimen pool at 50 CFU/assay (250 fg). (N=60) |
| Analytical Specificity | |
| No cross-reactivity with closely related organisms and common flora | All 24 tested culture isolates (including 17 phylogenetically related to N. gonorrhoeae) showed no cross-reactivity when tested at 1 x 10^6 cells/mL in PreservCyt liquid Pap media and Swab Transport Media on three different TIGRIS DTS Systems. The document does not explicitly state an "acceptance criteria" but the presented data indicates 100% specificity for the tested organisms. Some Neisseria species known to cross-react in other amplification assays were noted as potential cross-reactors, which is a disclaimer, not a failure. |
| Specimen-Caused Inhibition | |
| < 5% inhibition rate for post-processed PreservCyt specimens | 0% inhibition (0/240) detected in 240 negative clinical post-processed PreservCyt liquid Pap specimens. |
| Interference by Whole Blood | |
| No interference up to 10% (v/v) blood in PreservCyt specimens | Background signals remained below the assay cut-off for negative PreservCyt liquid Pap specimens with up to 10% (v/v) blood. For spiked specimens, the presence of up to 10% (v/v) blood did not interfere with the recovery of a positive signal. |
| Clinical Equivalence (TIGRIS DTS vs. DTS Systems) | |
| Overall agreement ≥ 90% (with acceptable CI) | 100% Overall Agreement (93.0-100% CI) for all 51 PreservCyt specimens (40 positive, 11 negative) between DTS Systems and TIGRIS DTS System. |
| Positive agreement ≥ 90% (with acceptable CI) | 100% Positive Agreement (91.2-100% CI) between DTS Systems and TIGRIS DTS System. |
| Negative agreement ≥ 90% (with acceptable CI) | 100% Negative Agreement (71.5-100% CI) between DTS Systems and TIGRIS DTS System. |
| Clinical Panel Equivalence | |
| 100% agreement between TIGRIS and DTS Systems for all panel members | 100% agreement for all five panel members (0 fg, 25 fg, 250 fg, 2,500 fg, 25,000 fg rRNA/Assay) between TIGRIS and DTS Systems. Overall % Agreement between TIGRIS and DTS was 100% (97.2-100% CI) for the 250 fg (Low) panel member. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Analytical Sensitivity (LOD): N=60 for post-processed PreservCyt liquid Pap specimen. The data provenance is from laboratory spiking experiments.
- Analytical Specificity: 24 culture isolates. The data provenance is from laboratory testing of known organisms.
- Specimen-Caused Inhibition: N=240 negative clinical post-processed PreservCyt liquid Pap specimens. Data provenance is from clinical specimens presumably collected in the US (not explicitly stated for this part, but the clinical study below is multi-center in the US).
- Interference by Whole Blood: Not specified as a precise "test set" size, but involved three negative PreservCyt liquid Pap specimen pools, tested in the absence and presence of N. gonorrhoeae and varying blood concentrations. Data provenance is from laboratory spiking experiments.
- Clinical Specimen Study: N=51 PreservCyt specimens (34 symptomatic, 17 asymptomatic female subjects).
- Data Provenance: Prospective, multi-center clinical study. Patients were enrolled from family planning, OB/GYN, public health, and STD clinics. While not explicitly stated, multi-center studies for FDA submissions are typically conducted in the USA.
- Clinical Panel Study: 132 replicates (30 aliquots for each of 4 positive panel members, and 12 aliquots for the negative panel member). These were created from pooled residual negative PreservCyt specimens from female subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no mention of "experts" in the context of establishing ground truth for the test sets in this submission.
- Clinical Specimen Study: The "ground truth" or reference method for comparison was the AGC Assay performed on the previously validated DTS Systems, following an initial screening with FDA-cleared APTIMA COMBO 2 (AC2) Assay. The AC2 Assay results determined whether specimens were selected for the clinical specimen or panel study. This is a comparison between two automated systems rather than expert interpretation of a gold standard.
- Clinical Panel Study: The "ground truth" for the panel members was their known N. gonorrhoeae ribosomal RNA (rRNA) concentration (spiked or not spiked).
- Analytical Studies: Ground truth was based on known concentrations of spiked organisms or rRNA, or confirmed negative samples.
4. Adjudication Method for the Test Set
Not applicable in the typical sense of expert adjudication of imaging or clinical findings.
- For the Clinical Specimen Study, the comparison was made between the results of the AGC Assay on the DTS Systems (predicate) and the TIGRIS DTS System (new system). No explicit adjudication process between discordant results from these two systems is described; rather, the agreement between them was calculated.
- For the Analytical Studies and Clinical Panel Study, the "ground truth" was established by experimental design (e.g., spiking known quantities of analyte, using confirmed negative samples), not through adjudication of expert opinions.
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
This submission is for an in vitro diagnostic (IVD) assay, specifically a nucleic acid amplification test (NAAT) for Neisseria gonorrhoeae. It is a standalone diagnostic device with no "human reader" component in the interpretation of results in the way an imaging AI device would have. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, the studies presented are essentially standalone performance evaluations of the GEN-PROBE APTIMA Assay on the TIGRIS DTS System. The assay generates a qualitative (positive/negative) result without human interpretation of raw data beyond confirming valid assay run parameters. The purpose of this submission was to demonstrate equivalence of this assay on a new automated platform (TIGRIS DTS) for a new specimen type (PreservCyt).
7. The Type of Ground Truth Used
- Analytical Sensitivity: Known spiked concentrations of N. gonorrhoeae rRNA.
- Analytical Specificity: Known culture isolates.
- Specimen-Caused Inhibition and Interference: Known negative samples and known spiked concentrations (for inhibition/recovery).
- Clinical Specimen Study: The results of the AGC Assay on the predicate DTS Systems, following initial screening with the FDA-cleared APTIMA COMBO 2 (AC2) Assay. This acts as a reference method for the comparison between the old and new platforms.
- Clinical Panel Study: Known spiked concentrations of N. gonorrhoeae ribosomal RNA (rRNA) into confirmed negative PreservCyt specimens.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of device development or algorithm training. This is a molecular diagnostic assay, not a machine learning or AI algorithm in the conventional sense that would require a dedicated training set. The assay's parameters (e.g., cut-offs) would have been established during its initial development and validation, which is not detailed in this specific 510(k) summary, as this submission is an extension of claims for an already cleared assay.
9. How the Ground Truth for the Training Set Was Established
As no specific "training set" for an AI/ML algorithm is mentioned or applicable here, this question is not relevant to the provided documentation. The assay relies on target amplification and detection of rRNA, with predetermined analytical characteristics, rather than learning from a training dataset.
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