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NATtrol™ BV Negative Control (NATBVNEG-BD) is intended for use as an assayed quality control material to monitor the performance of in vitro diagnostic laboratory nucleic acid testing procedures for the qualitative detection of targets on the BD Vaginal Panel for BD MAX™ System. NATtrol BV Negative Control is a qualitative control containing intact and inactivated Lactobacillus crispatus and intended to be used solely with the BD Vaginal Panel for BD MAX™ System. This product is not intended to replace manufacturer controls provided in the package insert.

NATtrol™ BV Positive Control (NATBVPOS-BD) is intended for use as an assayed quality control material to monitor the performance of in vitro diagnostic laboratory nucleic acid testing procedures for the qualitative detection of targets on the BD Vaginal Panel for BD MAX™ System. NATtrol™ BV Positive Control is a qualitative control containing intact and inactivated Lactobacillus jensenii, Gardnerella vaginalis, Atopobium vaginae, and Saccharomyces cerevisiae containing BVAB2 (Bacterial Vaginosis-Associated Bacterium 2) sequence and intended to be used solely with the BD Vaginal Panel for BD MAX™ System. This product is not intended to replace manufacturer controls provided in the package insert.

NATtrol™ Candida/TV Positive Control (NATCTVPOS-BD) is intended for use as an assayed quality control material to monitor the performance of in vitro diagnostic laboratory nucleic acid testing procedures for the qualitative detection of targets on the BD Vaginal Panel for BD MAX™ System. NATtrol CandidaTV Positive Control is a qualitative control containing intact and inactivated Candida krusei, Candida glabrata, and Trichomonas vaginalis and intended to be used solely with the BD Vaginal Panel for the BD MAX™ System. This product is not intended to replace manufacturer controls provided in the package insert.

NATtrol™ BD MAX Vaginal Panel External Controls are formulated with purified, intact microorganisms that have been chemically modified to render them non-infectious and refrigerator stable. The controls are formulated in a proprietary matrix that contains Fetal Bovine Serum, Human Serum Albumin, and sodium azide.

NATtrol™ BV Positive Control contains intact and inactivated Lactobacillus jensenii, Gardnerella vaginalis, Atopobium vaginae, and Saccharomyces cerevisiae containing BVAB2 (Bacterial Vaginosis-Associated Bacterium 2) sequence.

NATtrol™ Candida/TV Positive Control contains intact and inactivated Candida albicans, Candida krusei, Candida glabrata, and Trichomonas vaginalis.

NATtrol™ BV Negative Control contains intact and inactivated Lactobacillus crispatus.

Here's an analysis of the provided text regarding the acceptance criteria and study for the NATtrol™ BD MAX Vaginal Panel External Controls.

Disclaimer: The provided text is a 510(k) Summary for a medical device (Assayed Quality Control Material). This type of device does not involve "AI" or "human readers" in the context of diagnostic interpretation. Therefore, sections related to AI/human reader performance, multi-reader multi-case studies, and specific expert qualifications/adjudication methods are not applicable to this type of product and will be marked as such. The "ground truth" here refers to the expected qualitative result for the control material based on its composition.

1. Table of Acceptance Criteria and Reported Device Performance

Study Details:

2. Sample size used for the test set and the data provenance

• BV Positive Control: 86 tests (total observations for each target).
• Candida/TV Positive Control: 104 tests (total observations for each target).
• BV Negative Control: 191 tests (total observations for each target).
• Data Provenance: Single site performance study, retrospective (data collected during multiple studies). The country of origin is not explicitly stated, but the sponsor address is Buffalo, NY, USA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. For this type of quality control material, the "ground truth" is based on the known composition of the control and the expected qualitative result (positive/negative) for each target when tested on the BD MAX System. It does not involve expert interpretation or consensus on clinical samples.

4. Adjudication method for the test set

• Not applicable. See point 3.

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

• Not applicable. This device is a quality control material for an in vitro diagnostic (nucleic acid testing) system, not an AI software or a device interpreted by human readers for diagnostic purposes.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• This question is framed for AI/algorithm performance. In the context of this device, the "standalone" performance is essentially what is reported: the control material's behavior when run on the BD MAX System as intended. The BD MAX System itself is an automated diagnostic platform, so the control material is tested by the algorithm/system without human interpretative input beyond setting up the test correctly. Therefore, the reported performance is the standalone performance of the control material with the BD MAX system.

7. The type of ground truth used

• Known Composition / Expected Qualitative Result: The positive and negative ground truths for each target for each control were established by the known composition of the control material (e.g., BV Positive Control contains Lactobacillus jensenii, Gardnerella vaginalis, Atopobium vaginae, and BVAB2 sequence, so it's expected to be positive for BV and negative for the other targets).

8. The sample size for the training set

• Not applicable. This device itself is a quality control material; it is not an algorithm that requires a training set in the conventional machine learning sense. The manufacturer would have developed and optimized the control formulation, but there isn't a "training set" like for a diagnostic algorithm.

9. How the ground truth for the training set was established

• Not applicable. See point 8.

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The BD MAX Vaginal Panel performed on the BD MAX System is an automated qualitative in vitro diagnostic test for the direct detection of DNA targets from bacteria associated with bacterial vaginosis (qualitative results reported based on detection and quantitation of targeted organism markers), Candida species associated with vulvovaginal candidiasis, and Trichomonas vaginalis from vaginal swabs in patients who are symptomatic for vaginitis/vaginosis. The test utilizes real-time polymerase chain reaction (PCR) for the amplification of specific DNA targets and utilizes fluorogenic target-specific hybridization probes to detect and differentiate DNA from:

• · Bacterial vaginosis markers (Individual markers not reported)
  Lactobacillus spp. (L. crispatus and L. jensenii) Gardnerella vaginalis Atopobium vaginae Bacterial Vaginosis Associated Bacteria-2 (BVAB-2) Megasphaera-1
• Candida spp. (C. albicans, C. tropicalis, C. parapsilosis, C. dubliniensis)
• Candida glabrata
• Candida krusei
• Trichomonas vaginalis
  The BD MAX Vaginal Panel is intended to aid in the diagnosis of vaginal infections in women with a clinical presentation consistent with bacterial vaginosis, vulvovaginal candidiasis, and trichomoniasis.

The BD MAX System and the BD MAX Vaginal Panel are comprised of an instrument with associated hardware and accessories, disposable microfluidic cartridges, master mixes, unitized reagent strips, and extraction reagents. The instrument automates sample preparation including target lysis, DNA extraction and concentration, reagent rehydration, target nucleic acid amplification and detection using real-time PCR. The assay includes a Sample Processing Control (SPC) that is present in the Extraction Tube. The SPC monitors DNA extraction steps, thermal cycling steps, reagent integrity and the presence of inhibitory substances. The BD MAX System software automatically interprets test results. For the BD MAX Vaginal Panel, a test result may be called as POS, NEG or UNR (Unresolved) based on the amplification status of the targets and of the Sample Processing Control. IND (Indeterminate) or INC (Incomplete) results are due to BD MAX System failure.

This document describes the 510(k) premarket notification for the BD MAX Vaginal Panel for use with the BD MAX System. The purpose of this submission is to demonstrate the substantial equivalence of the modified device, particularly the BD Molecular Swab Collection Kit, to its predicate device, the BD MAX Vaginal Panel (DEN160001 and K191957) which used the BD MAX UVE Specimen Collection Kit.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text focuses on demonstrating the substantial equivalence of the collection kit for an already cleared device, rather than establishing initial performance for a novel diagnostic device. Therefore, explicit acceptance criteria in terms of sensitivity, specificity, PPV, and NPV for the BD MAX Vaginal Panel itself are not directly stated in this section, as those would have been established during the original clearances (DEN160001 and K191957).

However, the performance is evaluated in comparison to the predicate's collection kit. The reported performance for the comparison study between the cleared collection device (BD MAX UVE Specimen Collection Kit) and the new collection device (BD Molecular Swab Collection Kit) demonstrated the following:

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Comparison Study: The document states that a "comparison study of performance between the cleared collection device and the new collection device tested with the BD MAX Vaginal Panel on the BD MAX System with clinical specimens" was conducted. However, the exact number of clinical specimens used in this comparison study is not explicitly provided in the text.
• Data Provenance: The data used for the comparison study are from "clinical specimens." The country of origin is not specified, and it is stated as a retrospective or prospective study.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

The document does not describe the establishment of a ground truth by experts for the comparison study of the collection kits. For molecular diagnostic assays like the BD MAX Vaginal Panel, the "ground truth" for the original device's performance validation is often established using methods such as:

• Culture: For culturable organisms like Candida species or Trichomonas vaginalis.
• Microscopy (e.g., Amsel's criteria, Nugent scoring): For bacterial vaginosis.
• Reference molecular methods: For organisms difficult to culture or quantify.

Since the focus here is on the collection kit equivalence, the ground truth would inherently refer to the original diagnostic results obtained using the predicate device's collection kit, which are then compared to the results from the new collection kit. The text does not mention any independent expert panel establishing ground truth specifically for these comparison studies.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method (such as 2+1, 3+1, or none) for the test set used in the comparison study. The comparison is between the performance of two collection kits with the same diagnostic panel, suggesting a direct comparison of results rather than an adjudication process involving multiple human readers to establish a reconciled truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for imaging or interpretation tasks where human readers play a significant role. The BD MAX Vaginal Panel is an automated in vitro diagnostic test, and its results are interpreted by the BD MAX System software, not human readers in a diagnostic capacity that would warrant an MRMC study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

Yes, the BD MAX Vaginal Panel operates as a standalone (algorithm-only) device. The device description explicitly states: "The BD MAX System software automatically interprets test results." There is no human-in-the-loop performance described for the interpretation of the test results themselves. The studies confirm the analytical and clinical performance of the automated system with the new collection kit.

7. The Type of Ground Truth Used

For the comparison study, the "ground truth" for evaluating the new collection kit's performance would implicitly be the results obtained when the same clinical specimens were tested using the predicate device's collection kit (BD MAX UVE Specimen Collection Kit) with the BD MAX Vaginal Panel. This is because the study aims to show the collections kits are equivalent and the performance of the BD MAX Vaginal Panel is already established with the predicate kit.

The initial ground truth for the diagnostic panel itself (BD MAX Vaginal Panel, cleared as DEN160001 and K191957) would have been established through a combination of:

• Clinical diagnosis and criteria: For example, Amsel's criteria or Nugent score for bacterial vaginosis, or clinical signs and symptoms for vaginitis.
• Culture: For culturable pathogens.
• Reference molecular methods: For specific DNA targets.

8. The Sample Size for the Training Set

The document does not provide information regarding a "training set" or its sample size. This is typical for an IVD device submission that is demonstrating substantial equivalence of a component (collection kit) for an already cleared diagnostic system. The algorithms for the BD MAX System and the Vaginal Panel would have been developed and "trained" (in a broad sense of model development) prior to the original 510(k) clearances (DEN160001 and K191957). This document does not detail the development phase of the assay.

9. How the Ground Truth for the Training Set Was Established

As no training set is discussed in this document, the method for establishing its ground truth is also not described. As mentioned above, the development and establishment of ground truth for the original assay would have occurred during its prior 510(k) clearances.

Ask a specific question about this device

The BD MAX Vaginal Panel performed on the BD MAX System is an automated qualitative in vitro diagnostic test for the direction of DNA targets from bacteria associated with bacterial vaginosis (qualitative results reported based on detection and quantitation of targeted organism markers), Candida species associated with vulvovaginal candidiasis, and Trichomonas vaginalis from vaginal swabs in patients who are symptomatic for vaginitis/vaginosis. The test utilizes real-time polymerase chain reaction (PCR) for the amplification of specific DNA targets and utilizes fluorogenic target-specific hybridization probes to detect and differentiate DNA from:

• . Bacterial vaginosis markers (Individual markers not reported)
  Lactobacillus spp. (L. crispatus and L. jensenii) Gardnerella vaginalis Atopobium vaginae Bacterial Vaginosis Associated Bacteria-2 (BVAB-2) Megasphaera-1
• . Candida spp. (C. albicans, C. tropicalis, C. parapsilosis, C. dubliniensis)
• Candida glabrata
• Candida krusei
• . Trichomonas vaginalis

The BD MAX Vaginal Panel is intended to aid in the diagnosis of vaginal infections in women with a clinical presentation consistent with bacterial vaginosis, vulvovaginal candidiasis and trichomoniasis.

The BD MAX System and the BD MAX Vaginal Panel are comprised of an instrument with associated hardware and accessories, disposable microfluidic cartridges, master mixes, unitized reagent strips, and extraction reagents. The instrument automates sample preparation including target lysis, DNA extraction and concentration, reagent rehydration, target nucleic acid amplification and detection using real-time PCR. The assay includes a Sample Processing Control (SPC) that is present in the Extraction Tube. The SPC monitors DNA extraction steps, thermal cycling steps, reagent integrity and the presence of inhibitory substances. The BD MAX System software automatically interprets test results. For the BD MAX Vaginal Panel, a test result may be called as POS, NEG or UNR (Unresolved) based on the amplification status of the targets and of the Sample Processing Control. IND (Indeterminate) or INC (Incomplete) results are due to BD MAX System failure.

This is an FDA 510(k) summary for the BD MAX Vaginal Panel for detecting microorganisms associated with vaginitis and bacterial vaginosis. The document describes the device, its intended use, and its equivalence to a predicate device. While it mentions performance standards, it does not contain detailed acceptance criteria, device performance data, information on the study design (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods), or any multi-reader multi-case (MRMC) study results.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can be extracted and what is missing:

1. Table of acceptance criteria and the reported device performance:

• Acceptance Criteria: Not explicitly stated in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy thresholds). The document broadly refers to "Performance Standards" based on the Class II Special Controls Guideline for NAAT assays for Trichomonas vaginalis.
• Reported Device Performance: Not provided in this document. This summary focuses on substantial equivalence based on technological characteristics and intended use.

2. Sample size used for the test set and the data provenance: Not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not mentioned.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.

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: Not applicable. This is a molecular diagnostic test, not an AI-assisted imaging device or a test involving human readers in the interpretation loop.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device is a standalone molecular diagnostic assay. The results are "automatically interpreted" by the BD MAX System software, which indicates algorithm-only performance. However, specific standalone performance metrics (sensitivity, specificity etc.) are not provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not mentioned for the studies supporting this 510(k) submission. For molecular tests, ground truth typically involves culture or a validated composite reference method.

8. The sample size for the training set: Not mentioned.

9. How the ground truth for the training set was established: Not mentioned.

Summary Table of Available Information:

Ask a specific question about this device

The BD MAX Vaginal Panel performed on the BD MAX System is an automated qualitative in vitro diagnostic test for the direct detection of DNA targets from bacteria associated with bacterial vaginosis (qualitative results reported based on detection and quantitation of targeted organism markers), Candida species associated with vulvovaginal candidiasis, and Trichomonas vaginalis from vaginal swabs in patients who are symptomatic for vaginitis/vaginosis. The test utilizes real-time polymerase chain reaction (PCR) for the amplification of specific DNA targets and utilizes fluorogenic target-specific hybridization probes to detect and differentiate DNA from:

• Bacterial vaginosis markers (Individual markers not reported)
  • O Lactobacillus spp. (L. crispatus and L. jensenii)
  • Gardnerella vaginalis о
  • o Atopobium vaginae
  • Bacterial Vaginosis Associated Bacteria-2 (BVAB-2) o
  • o Megasphaera-1
• Candida spp. (C. albicans, C. tropicalis, C. parapsilosis, C. dubliniensis) ●
• Candida glabrata
• Candida krusei ●
• Trichomonas vaginalis

The BD MAX Vaginal Panel is intended to aid in the diagnosis of vaginal infections in women with a clinical presentation consistent with bacterial vaginosis, vulvovaginal candidiasis and trichomoniasis.

The BD MAX System and the BD MAX Vaginal Panel are comprised of an instrument with associated hardware and accessories, disposable microfluidic cartridges, master mixes, unitized reagent strips, and extraction reagents. The instrument automates sample preparation including target lysis. DNA extraction and concentration, reagent rehydration, target nucleic acid amplification and detection using real-time PCR. The assay includes a Sample Processing Control (SPC) that is present in the Extraction Tube. The SPC monitors DNA extraction steps, thermal cycling steps, reagent integrity and the presence of inhibitory substances. The BD MAX System software automatically interprets test results. For the BD MAX Vaginal Panel, a test result may be called as POS, NEG or UNR (Unresolved) based on the amplification status of the targets and of the Sample Processing Control. IND (Indeterminate) or INC (Incomplete) results are due to BD MAX System failure.

Acceptance Criteria and Study for BD MAX Vaginal Panel

The BD MAX Vaginal Panel is an automated qualitative in vitro diagnostic test for the direct detection of DNA targets from bacteria associated with bacterial vaginosis, Candida species associated with vulvovaginal candidiasis, and Trichomonas vaginalis from vaginal swabs in symptomatic patients. The device's performance was evaluated through a prospective clinical study and various analytical studies.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are not explicitly stated as distinct numerical thresholds in the provided document for all metrics. Instead, the document presents detailed performance characteristics from various studies, implying that the observed performance was acceptable for De Novo classification. For the purpose of this response, I will infer "acceptance criteria" where possible from general regulatory expectations for diagnostic devices and the context of the reported results (e.g., successful detection, high agreement). The "Reported Device Performance" will reflect the results from the clinical and analytical studies.

2. Sample Sizes Used for the Test Set and Data Provenance

Test Set (Clinical Study):

• Total subjects enrolled: 1763
• Compliant subjects: 1740
• Compliant specimens with reportable results:
  • Bacterial Vaginosis: 1559 (clinician-collected), 1582 (self-collected)
  • Candida: 1618 (clinician-collected), 1628 (self-collected)
  • Trichomonas vaginalis: 1600 (clinician-collected), 1610 (self-collected)
• Asymptomatic Women (separate evaluation): 202 women
• Contrived Specimens for C. glabrata and C. krusei: 50 strains each, developed at various concentrations, plus 50 true negative specimens for each organism.

Data Provenance:

• The data for the primary clinical study was prospective.
• Specimen collection occurred at 10 geographically diverse specimen collection sites. Seven sites performed collection only, and three performed both collection and testing with the BD MAX Vaginal Panel. (The country of origin is not explicitly stated but is implicitly the US given FDA submission context).
• Analytical studies (Precision, LoD, Inclusivity, Interference, Stability, Specificity) used simulated vaginal matrix and/or natural negative vaginal matrix, and commercially available organisms/plasmid DNA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The document specifies the reference methods used to establish ground truth but does not explicitly state the number or qualifications of experts involved in the interpretation of these reference methods.

• BV status: Determined using a combination of Nugent Score and Amsel's criteria. These methods typically involve microscopic evaluation by trained laboratory personnel or clinicians, but specific expert qualifications (e.g., years of experience, specific certifications) are not detailed.
• Candida spp. status: Determined by selective (Candida) chromogenic medium and Sabouraud Dextrose Emmons plate cultures. PCR amplification targeting the its2 gene was performed followed by bi-directional sequencing to identify yeast isolates. Interpretation of cultures and sequencing results would be performed by trained microbiologists or laboratory specialists.
• Trichomonas vaginalis status: Determined by a composite of microscopic visualization of motile trichomonads in saline wet mounts of vaginal secretion and by culture. A positive result by either method categorized the patient as positive. Microscopic visualization implies examination by trained personnel.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method for discordant results between the reference methods themselves or between the device and reference methods.

• For BV, "Specimens with normal flora as per the Nugent Score were considered negative: those positive for BV flora were considered positive while those with intermediate BV flora were segregated into positive or negative categories using Amsel's criteria." This implies a defined algorithm for combining the reference standards rather than a separate expert adjudication panel.
• For Trichomonas vaginalis, "A positive result either by wet mount or by culture was sufficient to categorize the patient as positive." This constitutes a composite reference standard.
• For analyses of discordant results (e.g., for T. vaginalis false negatives and false positives, or C. glabrata false negatives), the document mentions further evaluation with an "FDA-cleared molecular method" or assessing growth levels from chromagar, which indicates further diagnostic investigation rather than expert consensus adjudication of initial reference results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is an automated, standalone molecular diagnostic test. It does not involve human readers interpreting images or data to make a diagnosis that would then be compared with and without AI assistance. Therefore, there is no effect size reported for human readers improving with vs. without AI assistance.

6. Standalone Performance Study

Yes, a standalone (i.e., algorithm only without human-in-the-loop performance) was done. The entire premise of the clinical and analytical studies is to evaluate the BD MAX Vaginal Panel's performance on its own, comparing its direct output (qualitative detection of DNA targets) to established reference methods. The system automates sample preparation, DNA extraction, amplification, detection, and interpretation of test results (POS, NEG, or UNR). The clinical performance metrics (sensitivity, specificity, PPV, NPV) presented in Tables 17-36 represent the standalone performance of the device.

7. Type of Ground Truth Used

The ground truth used for the clinical study was a composite reference standard:

• Bacterial Vaginosis: A combination of Nugent Score and Amsel's criteria.
• Candida spp.: Culture (chromogenic medium and Sabouraud Dextrose Emmons plate cultures) followed by PCR amplification targeting the its2 gene and bi-directional sequencing for species identification.
• Trichomonas vaginalis: A composite of microscopic visualization of motile trichomonads in saline wet mounts of vaginal secretion and culture.

This approach combines multiple diagnostic methods to establish the most accurate possible "true" status for each patient's sample.

8. Sample Size for the Training Set

The document does not explicitly state the sample size for a separate "training set" in the context of machine learning or AI model development. The BD MAX Vaginal Panel is described as a nucleic acid-based test utilizing real-time PCR with fluorogenic target-specific hybridization probes, and software for automated interpretation based on amplification status. While there's an "Assay Cut-off" section mentioning use of pre-clinical studies and prospective clinical study data to "validate these cut-offs" and "ROC curve analysis was performed to confirm the optimal cutoffs," this typically refers to refining analytical thresholds based on observed performance from early testing rather than training a complex AI model in the conventional sense.

The "pre-clinical studies" and "LoD confirmation study" using simulated and natural vaginal matrices, as well as the "multi-site prospective clinical study" mentioned for validation of cut-offs, represent data used to establish and confirm the device's operational parameters. However, calling these a "training set" in the context of advanced AI algorithms (like those in machine learning) might be a misinterpretation given the nature of a PCR-based diagnostic with defined analytical cut-offs. The largest dataset mentioned for performance evaluation is the prospective clinical study (1763 enrolled subjects).

9. How the Ground Truth for the Training Set Was Established

As noted above, a distinct "training set" for an AI model (in the sense of supervised learning) is not explicitly described. However, if we interpret "training set" broadly as the data used to initially establish and refine the device's operational parameters and cut-offs, the ground truth was derived from the following:

• Pre-clinical studies: Utilized targeted organisms (or plasmid DNA) spiked into simulated vaginal matrix at varying, known concentrations (e.g., for LoD determination, precision studies). The "expected result" in these analytical studies served as the ground truth.
• Prospective clinical study data: Data from the 1763 enrolled subjects (used to "validate these cut-offs" and performing ROC analysis) employed the composite reference standards described in section 7 (Nugent/Amsel for BV, Culture/Sequencing for Candida, Wet Mount/Culture for T. vaginalis). These reference methods collectively established the ground truth for clinical specimens against which the device's performance, including its cut-offs, was evaluated and confirmed.

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