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The Aptima Trichomonas vaginalis (TV) assay is an in vitro qualitative nucleic acid amplification test (NAAT) for the detection of ribosomal RNA (rRNA) from Trichomonas vaginalis to aid in the diagnosis of trichomoniasis using the Panther system.

The assay may be used to test the following specimens from symptomatic or asymptomatic individuals: clinician-collected endocervical swabs, clinician-collected and patient-collected vaginal swabs (in a clinical setting), female and male urine, and specimens collected in PreservCyt Solution.

The Aptima TV assay involves the technologies of target capture, transcription-mediated amplification (TMA), and hybridization protection assay (HPA). Specimens are collected and transferred into their respective specimen transport tubes. The transport solution in these tubes releases the rRNA target and protects it from degradation during storage. When the Aptima TV assay is performed in the laboratory, the target rRNA is isolated from the specimens using a specific capture oligomer and magnetic microparticles in a method called target capture. The capture oligomer contains a sequence complementary to a specific region of the target molecule as well as a string of deoxyadenosine residues. During the hybridization step, the sequence-specific region of the capture oligomer binds to a specific region of the target molecule. The capture oligomer:target complex is then captured out of solution by decreasing the temperature of the reaction to room temperature. This temperature reduction allows hybridization to occur between the deoxyadenosine region on the capture oligomer and the poly-deoxythymidine molecules that are covalently attached to the magnetic particles. The microparticles, including the captured target molecule bound to them, are pulled to the side of the reaction vessel using magnets and the supernatant is aspirated. The particles are washed to remove residual specimen matrix that may contain amplification inhibitors. After the target capture steps are completed, the specimens are ready for amplification.

The provided text describes the analytical and clinical studies performed for the Aptima Trichomonas vaginalis Assay. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria values for sensitivity, specificity, PPA, or NPA. Instead, it presents the achieved performance. However, implicit acceptance criteria for NAAT assays generally involve high sensitivity and specificity. The reproducibility study tables show numerical targets for agreement (e.g., >95% positivity for LoD, 90.7% to 100% agreement for reproducibility).

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

• Clinical Study 2 (Primary Test Set):
  • Total evaluable specimens: 5502 specimens from 3820 evaluable subjects.
  • Breakdown by specimen type:
    • 1785 patient-collected vaginal swab specimens
    • 1782 female urine specimens
    • 1935 male urine specimens
  • Data Provenance: Prospective, multicenter clinical study conducted at 11 geographically and ethnically diverse US clinical sites (obstetrics and gynecology, family planning, and STI clinics).
  • Retrospective/Prospective: Primarily prospective. Samples were collected from consenting subjects in a prospective study.

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

The document does not mention the use of human experts (e.g., radiologists, pathologists) to establish the ground truth. For this in vitro diagnostic (IVD) device, the ground truth was established by molecular testing.

4. Adjudication Method for the Test Set

The ground truth for the clinical test set was established using a "composite comparator method" or "patient infected status (PIS)" / "composite comparator algorithm (CCA)" based on results from up to three cleared NAATs.

• Method:
  • Specimens were categorized as infected (PIS) or positive (CCA) if a positive result occurred in at least two of the comparator NAATs.
  • Specimens were categorized as not infected or negative if at least 2 of the comparators results were negative.
  • A third (tie-breaker) comparator was only required if the first 2 comparator results were discordant.
  • Specimens that could not be categorized due to missing results from comparator assays were excluded.

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

No, an MRMC comparative effectiveness study was not applicable and therefore not performed. This is an in vitro diagnostic (IVD) device for the detection of ribosomal RNA from Trichomonas vaginalis. It is a lab-based assay, not an imaging device that requires human readers to interpret results, or AI assistance for human reader improvement.

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

Yes, the performance reported (sensitivity, specificity, PPA, NPA) for the Aptima TV assay is its standalone performance. The assay itself is the "algorithm" in this context; it processes specimens and provides a qualitative result (positive/negative) without direct human interpretation of the assay's raw output for diagnosis. The study evaluates the device's ability to accurately detect the target in various specimens against the established ground truth.

7. The Type of Ground Truth Used

The ground truth used was established using a composite comparator method (sometimes referred to as a "gold standard" or "reference standard" in IVD studies), which relied on the results of multiple (up to three) cleared Nucleic Acid Amplification Tests (NAATs). This is a form of expert consensus among molecular assays.

8. The Sample Size for the Training Set

The document does not explicitly state the sample size for a separate "training set." For IVD assays, particularly those based on well-established molecular biology principles (like NAATs), development and optimization (analogous to "training") often use specific analytical panels or earlier development runs rather than a distinct, large "training set" of clinical samples as seen in machine learning/AI models. The studies described are primarily for validation.

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

Since a distinct "training set" with established ground truth is not explicitly mentioned as a separate phase of the pivotal study, the establishment of ground truth for any developmental or optimization work would likely follow similar principles as the validation ground truth: using reference materials, spiked samples, or well-characterized clinical samples confirmed by established laboratory methods or multiple comparator assays. The document focuses on the validation and reproducibility of the assay.

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The BD MAX™ CTGCTV2 assay, performed on the BD MAX™ System, incorporates automated DNA extraction and real-time polymerase chain reaction (PCR) for the direct, qualitative detection of DNA from:

• Chlamydia trachomatis (CT) ●
• Neisseria gonorrhoeae (GC) ●
• Trichomonas vaginalis (TV) ●

The assay may be used for detection of CT, GC and/or TV DNA in patient- or clinician-collected vaginal swab specimens (in a clinical setting), and male and female urine specimens. The assay may also be used for the detection of CT and GC DNA in endocervical swab and Liquid-Based Cytology (LBC) specimens in PreservCyt® Solution using an aliquot that is removed prior to processing for the ThinPrep™ Pap test.

The assay is indicated for use with asymptomatic and symptomatic individuals to aid in the diagnosis of chlamydial urogenital disease, gonococcal urogenital disease and/or trichomoniasis.

The BD MAX System and the BD MAX CTGCTV2 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, and 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. A test result may be called as POS, NEG, UNR, IND or INC for each of the assay's targets, based on the amplification status of the target and of the Sample Processing Control. IND (Indeterminate) or INC (Incomplete) results are due to BD MAX System level failure.

The provided information describes the BD MAX CTGCTV2 assay, a diagnostic device for detecting Chlamydia trachomatis (CT), Neisseria gonorrhoeae (GC), and Trichomonas vaginalis (TV).

Here's an analysis of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established for diagnostic assays in terms of sensitivity (Positive Percent Agreement - PPA) and specificity (Negative Percent Agreement - NPA). The presented clinical performance results in Table 21 for CT and GC, and Table 22 for TV, serve as the reported device performance against these criteria.

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

The clinical performance study included 2,547 female subjects and 1,159 male subjects from North America.
The study was prospective, as indicated by the enrollment of subjects and collection of specimens for the trial.
The data provenance is North America, specifically from "Twelve geographically diverse clinical sites."

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

The document does not explicitly state the "number of experts" used to establish ground truth or their individual qualifications (e.g., radiologist with 10 years of experience). Instead, the ground truth was established using an algorithmic approach with multiple FDA-cleared NAATs (Nucleic Acid Amplification Tests). This is a common and accepted method for determining the true infection status in diagnostic studies for infectious diseases, rather than relying on individual expert interpretation.

4. Adjudication Method for the Test Set

The adjudication method for establishing the Patient Infected Status (PIS) was as follows:

• Female PIS for C. trachomatis and N. gonorrhoeae: Established by testing urine and cervical specimens with two different FDA cleared NAATs. Females were designated as infected if at least two different reference NAATs were positive for urine and cervical specimens. For swab specimens, if only urine was positive with two comparator NAATs (and swabs were negative with both), they were considered non-infected.
• Male PIS for C. trachomatis and N. gonorrhoeae: Established by testing urine specimens using up to three different FDA cleared NAATs. Males were designated as infected if 2 out of 3 reference NAAT results were positive. They were categorized as non-infected if 2 out of 3 reference NAAT results were negative.
• Female PIS for T. vaginalis: Established by testing vaginal specimens with two different FDA cleared molecular tests, across three different instrument platforms. Females were designated as infected if 2 out of 3 reference test results were positive. They were categorized as non-infected if 2 out of 3 reference test results were negative.
• Male PIS for T. vaginalis: Established by testing urine specimens using up to three different FDA cleared NAATs. Males were designated as infected if 2 out of 3 reference test results were positive. They were categorized as non-infected if 2 out of 3 reference test results were negative.
• Female Urine CCA for C. trachomatis, N. gonorrhoeae, and T. vaginalis: Urine samples were used from up to three reference NAATs. Designated as positive if 2 out of 3 reference NAAT results were positive, and negative if 2 out of 3 reference NAAT results were negative.

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

No MRMC comparative effectiveness study was done. This type of study is more common for image-based diagnostic aids where human interpretation is a primary component, and the AI assists human readers. For an automated molecular diagnostic assay like the BD MAX CTGCTV2, the device's performance is standalone.

6. Standalone (Algorithm Only) Performance

Yes, the study primarily presents standalone performance of the BD MAX CTGCTV2 assay. The assay is an "automated DNA extraction and real-time polymerase chain reaction (PCR)" system, and its interpretation is done "automatically" by the BD MAX System software. The clinical performance tables (Table 21, 22, 23) reflect the algorithm-only performance against the established PIS.

7. Type of Ground Truth Used

The ground truth used was expert consensus derived through an algorithm based on multiple FDA-cleared Nucleic Acid Amplification Tests (NAATs). This is a common and robust method for establishing ground truth in molecular diagnostics, as these reference NAATs are highly sensitive and specific.

8. Sample Size for the Training Set

The document does not explicitly mention a separate "training set" sample size for the development of the BD MAX CTGCTV2 assay. This is typical for a 510(k) submission for an in vitro diagnostic (IVD) device, where the focus is on the validation of the finalized product's performance rather than the detailed development (training) process. The analytical studies (LoD, inclusivity, specificity) demonstrate the characteristics of the assay, which would have been refined during development.

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

As no specific training set and its ground truth establishment are detailed, this information is not available in the provided text. The analytical studies like Limits of Detection (LoD), inclusivity, and analytical specificity use well-characterized microbial suspensions and established methods for their testing. These analytical studies are part of the broader validation, implying that the assay's design was based on such principles during its development.

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The BD MAX CT/GC/TV assay, as performed using the BD MAX System incorporates automated DNA extraction and real-time polymerase chain reaction (PCR) for the direct, qualitative detection of DNA from Chlamydia (CT), Neisseria gonorrhoeae (GC) and/or Trichomonas vaginalis (TV). The assay may be used for detection of CT and/or GC DNA in male urine specimens, and the detection of CT, GC and/or TV DNA in female urine specimens, cliniciancollected female endocervical swab speciment-collected vaginal swab specimens (in a clinical setting). The assay is indicated for use to aid in the diagnosis of chlamydial urogenital disease, gonococcal urogenital disease and/or trichomoniasis in asymptomatic and symptomatic individuals.

The BD MAX System and the BD MAX CT/GC/TV 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, and 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. A test result may be called as POS, NEG or UNR for each of the assay's targets, based on the amplification status of the target and of the Sample Processing Control. IND (Indeterminate) or INC (Incomplete) results are due to BD MAX System failure.

The BD MAX CT/GC/TV assay, performed using the BD MAX System, is an in vitro diagnostic device for the direct, qualitative detection of DNA from Chlamydia trachomatis (CT), Neisseria gonorrhoeae (GC), and Trichomonas vaginalis (TV).

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics. However, the "Clinical Performance Studies" section implicitly establishes the performance expectations through its reported sensitivity and specificity values. The acceptance criteria can be inferred as the achieved sensitivity and specificity values for each pathogen across different specimen types and patient populations (asymptomatic and symptomatic).

For the purpose of this response, I will present the key performance metrics from the "Clinical Performance Studies" (Table 18) as the reported device performance, which are implicitly the performance targets the device met. The clinical performance is compared against a "Patient Infected Status (PIS)," which is a composite reference method.

Table: Acceptance Criteria (Inferred from Achieved Performance) and Reported Device Performance

Note: The "Acceptance Criteria" values are inferred as the lower bounds of the reported 95% Confidence Intervals for Sensitivity and Specificity, representing the minimum performance demonstrated to be acceptable.

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

• Test Set Sample Size:

  • Female Subjects: 2,114 evaluable subjects for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC), and 1,291 of these for Trichomonas vaginalis (TV).
  • Male Subjects: 892 evaluable subjects for CT and GC.
  • Specimens for CT: 1,836 patient-collected vaginal swabs, 1,831 endocervical swabs, 1,849 female urine, and 830 male urine specimens.
  • Specimens for GC: 1,836 patient-collected vaginal swabs, 1,824 endocervical swabs, 1,849 female urine, and 840 male urine specimens.
  • Specimens for TV: 1,048 patient-collected vaginal swabs, 1,039 endocervical swabs, and 1,047 female urine specimens.
  • Total specimens initially evaluated: 6,573 specimens.

• Data Provenance: Retrospective and Prospective. The study mentions that it was a "multicenter study where clinical sites enrolled subjects and also performed testing." This suggests prospective collection of real-world samples for the clinical performance evaluation. The provenance is from "nine (9) geographically diverse clinical sites in North America."

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

The document refers to a "Patient Infected Status (PIS)" as the reference method for establishing ground truth. The PIS is described as a "composite reference method algorithm." This suggests that the ground truth was not established by a panel of individual experts directly reviewing each case. Instead, it was based on results from multiple reference methods integrated by an algorithm. The specific number of experts or their qualifications involved in developing or validating this algorithm (if any) is not specified in this document.

4. Adjudication Method for the Test Set

The ground truth was established by a "composite reference method algorithm" (PIS). This implies an algorithmic adjudication rather than human expert adjudication. The study states, "This multicenter study evaluated results obtained with the BD MAX CT/GC/TV compared to reference methods defining the Patient Infected Status (PIS)." No specific human adjudication method (e.g., 2+1, 3+1) is mentioned, as the PIS serves as the "truth."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not explicitly mentioned or presented in the document. The study focuses on the standalone performance of the BD MAX CT/GC/TV assay against a defined Patient Infected Status (PIS). There is no comparison of human readers with versus without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the study primarily presents standalone performance of the BD MAX CT/GC/TV assay. The device description states, "The BD MAX System software automatically interprets test results. A test result may be called as POS, NEG or UNR for each of the assay's targets..." and "The BD MAX System performs results interpretation automatically." The clinical performance tables (Table 18) present the sensitivity and specificity of the device's automated results against the PIS, which represents a standalone evaluation of the algorithm's performance.

7. The Type of Ground Truth Used

The type of ground truth used is a "Patient Infected Status (PIS)" which is described as a "composite reference method algorithm." This indicates that the truth was derived from the results of multiple established laboratory reference methods, combined using a predefined algorithm, rather than directly from pathology, individual expert consensus, or outcomes data solely.

8. The Sample Size for the Training Set

The document does not explicitly state the sample size used for the training set for the BD MAX CT/GC/TV assay. This type of information (training set details) is often omitted in premarket notification summaries which focus on clinical validation data for regulatory approval. The "Analytical Performance" section (Precision, Reproducibility, Analytical Sensitivity, Analytical Specificity, Interfering Substances, Carryover/Cross-Contamination, Mixed Infection/Competitive Interference) describes laboratory-based studies used to characterize the assay's analytical capabilities, which might be considered part of the development and optimization process, but not a distinct "training set" in the context of machine learning model development. For in vitro diagnostic assays like this, the "training" aspect is more about optimizing reaction parameters and thresholds rather than training a machine learning model on patient data.

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

Since a distinct "training set" for a machine learning model is not explicitly mentioned, and the device is an IVD assay based on PCR and automated interpretation, the concept of "ground truth for the training set" as it applies to AI/ML devices is not directly applicable here. For the analytical studies, the "ground truth" (e.g., in LoD or analytical specificity) would have been established by precisely creating samples with known concentrations of organisms or known non-target organisms, based on established laboratory methods and controls.

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The Cepheid Xpert TV Assay, performed on the GeneXpert® Instrument Systems, is a qualitative in vitro diagnostic test for the detection of Trichomonas vaginalis genomic DNA. The test utilizes automated real-time polymerase chain reaction (PCR) to detect Trichomonas vaginalis genomic DNA. The Xpert TV Assay uses female and male urine specimens, endocervical swab specimens, and patient-collected vaginal swab specimens (collected in a clinical setting). The Xpert TV Assay is intended to aid in the diagnosis of trichomoniasis in symptomatic or asymptomatic individuals.

Ancillary Collection Kits:

Xpert Vaginal/Endocervical Specimen Collection Kit

The Cepheid® Xpert® Vaginal/Endocervical Specimen Collection Kit is designed to collect, preserve, and transport Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis DNA in endocervical swab specimens (collected by a clinician) and patient-collected vaginal swab specimens (collected in a clinical setting) from symptomatic and asymptomatic women prior to analysis with the Xpert CT/NG Assay and the Xpert TV Assay.

Xpert Urine Specimen Collection Kit

The Cepheid® Xpert® Urine Specimen Collection Kit is designed to preserve and transport Chlamydia trachomatis. Neisseria gonorrhoeae, and Trichomonas vaginalis DNA in first-catch female urine specimens from symptomatic and asymptomatic individuals prior to analysis with the Xpert CT/NG Assay and the Xpert TV Assay.

The Xpert TV Assay is an automated real-time polymerase chain reaction (PCR) in vitro diagnostic test for qualitative detection of genomic DNA from Trichomonas vaginalis. The Xpert TV Assay is intended as an aid in the diagnosis of trichomoniasis.

The Xpert TV Assay is performed on the Cepheid GeneXpert® Instrument Systems (GeneXpert Dx., GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpert Infinity-80 systems). The GeneXpert Instrument System platform automates sample preparation, amplification and real-time detection.

The GeneXpert Instrument Systems require the use of single-use, disposable cartridges (the Xpert TV cartridges) that hold the PCR reagents and host the PCR process. Because the cartridges are self-contained and specimens never come into contact with working parts of the instrument modules, cross-contamination between samples is minimized.

The Xpert TV Assay cartridges contain reagents for the detection of genomic DNA from T. vaginalis for use with the following specimens collected from symptomatic and asymptomatic individuals: female and male urine, endocervical swab and patientcollected vaginal swab (collected in a clinical setting). A Sample Processing Control (SPC), Sample Adequacy Control (SAC), and a Probe Check Control (PCC) are controls utilized by the GeneXpert Instrument System platform. The SPC, SAC, and PCC are controls utilized by the GeneXpert Instrument System platform. The SPC is present to control for adequate processing of the target trichomonads and to monitor the presence of inhibitors in the real-time PCR reaction to reduce the possibility of false negative results. The SAC reagents detect the presence of a single copy human gene and monitor whether the specimen contains human cells. The PCC verifies reagent rehydration, real-time PCR tube filling in the cartridge, probe integrity, and dye stability.

The single-use, multi-chambered fluidic cartridges are designed to complete sample preparation and real-time PCR for the detection of genomic DNA from T. vaginalis in 70 minutes or less. The GeneXpert Instrument Systems, comprised of the GeneXpert Dx Systems and the GeneXpert Infinity Systems, have 1 to 80 randomly accessible modules, depending upon the instrument, that are each capable of performing separate sample preparation and real-time PCR and RT-PCR tests. Each module contains a syringe drive for dispensing fluids (i.e., the syringe drive activates the plunger that works in concert with the rotary valve in the cartridge to move fluids between chambers), an ultrasonic horn for lysing cells or spores', and a proprietary I-CORE® thermocycler for performing real-time PCR and RT-PCR and detection.

The swab and/or urine specimens are collected from asymptomatic or symptomatic patients and placed into a specimen transport tube containing preservative. The specimen is transferred to the sample chamber of the disposable fluidic cartridge (the Xpert TV cartridge). The user initiates a test from the system user interface and places the cartridge into the GeneXpert instrument platform, which performs hands-off real-time, multiplex PCR for detection of DNA. The results are automatically generated at the end of the process in a report that can be viewed and printed.

The ancillary specimen collection kits for use with the Xpert TV Assay are the Cepheid Xpert Vaginal/Endocervical Specimen Collection Kit and the Cepheid Xpert Urine Specimen Collection Kit.

This document describes the Xpert TV Assay, a qualitative in vitro diagnostic test for the detection of Trichomonas vaginalis genomic DNA, performed on GeneXpert Instrument Systems.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets in a dedicated table. However, the study aims to demonstrate "substantial equivalence" to a predicate device (Cepheid Xpert TV Assay [510(k) #K151565]) based on analytical and clinical performance. The reported performance suggests the device aims for high sensitivity and specificity in detecting T. vaginalis.

The following table summarizes the key performance metrics reported from the clinical study:

2. Sample Size for Test Set and Data Provenance

• Test Set (Clinical Performance):
  • Female Study Participants: 1867 unique individuals. However, the tables break down results by specimen type and symptomatic status, showing total N for each subgroup. For example, Endocervical Swabs (Overall) had 1799 samples, Patient-Collected Vaginal Swabs (Overall) had 1791 samples, and Female Urine (Overall) had 1793 samples. It's implied these are from the 1867 female participants.
  • Male Study Participants: 4626 unique individuals, with 4611 urine samples tested (Overall).
  • Total Tests Performed: 10,017 (including initial invalid results).
  • Data Provenance: Prospective, multi-site investigational study with samples collected from 17 clinical sites in the US.

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly mention "experts" establishing ground truth in the traditional sense of multiple individual reviewers. Instead, the ground truth (Patient Infected Status - PIS) was established algorithmically based on reference laboratory tests:

• For female specimen types: Culture and a validated FDA-cleared NAAT test.
• For male urine: Culture and validated bidirectional sequencing (primary sequencing).

The qualifications of personnel performing these reference tests are not specified but would typically be laboratory professionals trained in these methods.

4. Adjudication Method for the Test Set

The adjudication method was a "patient infected status (PIS) algorithm" defined as follows:

• A study participant was considered infected by PIS if any one of the two reference test results (culture or NAAT/sequencing) were positive.
• The subject was considered not infected by PIS when both reference test results were negative.

For discrepant results between the Xpert TV Assay and the PIS, validated bi-directional Sanger sequencing was performed, but these results were "footnoted for informational purposes only" and did not change the primary PIS definition.

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

No MRMC comparative effectiveness study was done. This study focuses on the performance of the device itself (standalone) against a composite reference standard (PIS), not on how human readers' performance might improve with or without AI assistance from this device. The device is an automated in vitro diagnostic test, not an AI-assisted diagnostic aid for human interpretation.

6. Standalone Performance

Yes, a standalone performance study was done. The entire clinical performance section evaluates the Xpert TV Assay's performance (sensitivity, specificity, PPV, NPV) directly against the Patient Infected Status (PIS) algorithm without human interpretation of the device's output. The device itself produces a "TV DETECTED" or "TV NOT DETECTED" result.

7. Type of Ground Truth Used

The ground truth used was a composite reference standard termed "Patient Infected Status (PIS) algorithm." This PIS was established from a combination of:

• Culture
• Validated bidirectional sequencing (for male urine)
• FDA-cleared NAAT test (for female specimens)

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI development. Since this is an in vitro diagnostic device for nucleic acid detection (real-time PCR), it typically relies on pre-defined primer/probe sets and reaction conditions rather than a machine learning model that requires a distinct training set. The assay's development would involve analytical studies (e.g., LoD, inclusivity, specificity) using spiked samples and isolates, but these are not referred to as a "training set" in the common AI sense.

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

As noted above, a "training set" in the AI sense is not applicable here. The analytical studies (LoD, inclusivity, specificity) used well-characterized Trichomonas vaginalis strains (e.g., ATCC® 30001™, ATCC® 30238™) and other microorganisms at specific concentrations, often spiked into negative clinical matrices. The ground truth for these analytical studies was established by:

• Known concentrations of characterized organisms for LoD and inclusivity.
• Known presence or absence of specific microorganisms at specified concentrations for analytical specificity/cross-reactivity and competitive interference.
• Visual enumeration by light microscopy for T. vaginalis cell counts.
• CFU/mL, genomes/mL, or TCID50/mL for other microorganisms.

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The Solana® Trichomonas Assay is an in vitro diagnostic test, using isothermal amplification technology (helicase-dependent amplification, HDA), for the qualitative detection of Trichomonas vaginalis nucleic acids isolated from clinician-collected vaginal swabs and female urine specimens obtained from symptomatic females to aid in the diagnosis of trichomoniasis. The Solana® Trichomonas Assay is intended for use only with the Solana® instrument.

The Solana® Trichomonas Assay amplifies and detects Trichomonas vaginalis nucleic acids present in clinician-collected vaginal swabs and urine specimens from symptomatic and asymptomatic women. The assay targets a conserved multi-copy sequence of the T. vaqinalis DNA. The vaginal swab is eluted in a swab lysis tube or a urine specimen is added to a urine lysis tube, and the cells in either specimen type are lysed by simple heat treatment. After heat treatment, an aliquot of the lysed specimen is transferred into a dilution tube. An aliquot of the diluted sample is added to a reaction tube. The Reaction Tube contains lyophilized HDA reagents, dNTPs, primers and probes. Once rehydrated with the diluted sample, the Reaction Tube is placed in Solana for amplification and detection of T. vaginalis-specific target sequence. In Solana, the target sequence is amplified by T. vaginalis specific primers and detected by a T. vaginalis specific fluorescence probe included in the Reaction Tube. A competitive process control (PRC) is included in the Lysis Tube to monitor sample processing, inhibitory substances in clinical samples, reagent failure or device failure. The PRC target is amplified by T. vaginalis specific primers and detected by a PRC specific fluorescence probe. The target and PRC probes are labeled with a quencher on one end and a fluorophore on the other end. In addition, the target and PRC probes carry a ribonucleic acid. Upon annealing to T. vaqinalis or PRC amplicons, the fluorescence probes are cleaved by RNaseH2 and the fluorescence signal increases due to physical separation of fluorophore from quencher. Solana measures and interprets the fluorescent signal, using on-board method-specific algorithms. Solana instrument will then report the test results to the user on its display screen, and the results can be printed via a printer.

Here's an analysis of the provided text, focusing on acceptance criteria and study details for the Solana® Trichomonas Assay:

Executive Summary:

The Solana® Trichomonas Assay is an in vitro diagnostic test for the qualitative detection of Trichomonas vaginalis using isothermal amplification technology (HDA). The device was evaluated in a multi-center clinical study comparing its performance against a composite reference method (Wet Mount and InPouch TV Culture) for both vaginal swab and urine specimens. The study included symptomatic and asymptomatic female patients.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined "acceptance criteria" as distinct numerical targets that the FDA required the device to meet for approval. Instead, it presents the "Performance Characteristics" from the clinical study, which are then used to demonstrate substantial equivalence to a predicate device. The comparison table below uses the clinical study results as "reported device performance."

Note: The predicate device comparison table focuses on "Performance Characteristics" as opposed to explicit numerical acceptance criteria. The sensitivity and specificity values observed in the clinical trial would implicitly serve as the benchmark for demonstrating that the device performs as intended and is as safe and effective as the predicate device.

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

• Sample Size for Test Set:
  • Vaginal Swabs: 1043 subjects (after re-testing of invalid results).
  • Female Urine Specimens: 1044 subjects (after re-testing of invalid results).
  • Reproducibility Study (Analytical Performance): 90 samples per category per workflow (swab/urine) across 3 sites (e.g., 90 Low Positive swab samples, 90 Negative swab samples, etc.). This totals to 540 swab samples and 540 urine samples for reproducibility.
• Data Provenance:
  • Country of Origin: United States
  • Retrospective or Prospective: Prospective. The clinical study was performed from November 2015 through March 2016, and specimens were obtained from each subject after informed consent.

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 of experts or their qualifications used to establish the ground truth beyond stating that the reference methods for the clinical study were "Wet Mount" and "InPouch TV Culture." These are laboratory-based diagnostic tests, typically performed by trained medical technologists or laboratory personnel, not necessarily "experts" in the sense of physicians or specialists establishing a consensus diagnosis.

4. Adjudication Method for the Test Set

• Clinical Study: The adjudication method for the clinical study was based on a composite reference method. A specimen was considered positive if either the Wet Mount or the InPouch TV Culture was positive.
• Discordant Analysis: For specimens where the Solana Assay results differed from the composite reference method, an FDA-cleared Trichomonas vaginalis molecular assay was used for further testing (referred to as "discordant testing").

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, a MRMC comparative effectiveness study was not explicitly mentioned or performed in the context of human readers improving with AI vs. without AI assistance. This device is a diagnostic assay (an in vitro diagnostic test) that provides qualitative results directly, not an AI-assisted interpretation by human readers. The clinical study evaluated the device's standalone performance compared to established clinical reference methods.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Yes, a standalone performance evaluation was done. The Solana® Trichomonas Assay is an automated in vitro diagnostic test that uses "on-board method-specific algorithms" to measure and interpret fluorescent signals and report test results. The clinical study assessed the performance of this device as an algorithm-only system against the composite reference methods.

7. The Type of Ground Truth Used

• Clinical Study: The ground truth for the clinical study was established using a composite reference method consisting of:
  • Wet Mount
  • InPouch TV Culture
    A specimen was considered positive if either of these reference tests was positive.
• Analytical Sensitivity (LoD) and Inclusivity Studies: Ground truth was based on quantified strains of T. vaginalis (trophozoite/mL) at known concentrations.

8. The Sample Size for the Training Set

• The document does not specify a separate "training set" sample size for the Solana® Trichomonas Assay. This is typical for in vitro diagnostic assays of this nature, where the "training" (development and optimization) of the assay's reagents and algorithms is usually an iterative laboratory process, not based on a distinct clinical training dataset to the same extent as, for example, a machine learning algorithm for image analysis. The clinical evaluation primarily serves as a validation set.

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

• As mentioned above, a distinct "training set" with established ground truth in a clinical context is not explicitly described.
• For analytical studies (e.g., LoD, inclusivity): Ground truth was established by using quantified strains of T. vaginalis at known concentrations (e.g., trophozoite/mL) diluted in negative clinical matrix. These known concentrations serve as the "ground truth" for evaluating analytical performance parameters. Development and optimization of the assay would rely on such controlled laboratory experiments.

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The Cepheid Xpert TV Assay, performed on the GeneXpert® Instrument Systems, is a qualitative in vitro diagnostic test for the detection of Trichomonas vaginalis genomic DNA. The test utilizes automated real-time polymerase chain reaction (PCR) to detect Trichomonas vaginalis genomic DNA. The Xpert TV Assay uses female urine specimens, endocervical swab specimens, or patient-collected vaginal swab specimens (collected in a clinical setting). The Xpert TV Assay is intended to aid in the diagnosis of trichomoniasis in symptomatic or asymptomatic individuals.

Ancillary Collection Kits:

Xpert Vaginal/Endocervical Specimen Collection Kit

The Cepheid® Xpert® Vaginal/Endocervical Specimen Collection Kit is designed to collect, preserve, and transport Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis DNA in endocervical swab specimens (collected by a clinician) and patient-collected vaginal swab specimens (collected in a clinical setting) from symptomatic and asymptomatic women prior to analysis with the Xpert CT/NG Assay and the Xpert TV Assay.

Xpert Urine Specimen Collection Kit

The Cepheid® Xpert® Urine Specimen Collection Kit is designed to preserve and transport Chlamydia trachomatis, Neisseria gonorthoeae, and Trichomonas vaginalis DNA in first-catch urine specimens from symptomatic and asymptomatic individuals prior to analysis with the Xpert CT/NG Assay and the Xpert TV Assay. The Xpert Urine Specimen Collection Kit is intended for use with male (Xpert CT/NG Assay) and female (Xpert CT/NG Assay and Xpert TV Assay) urine.

The Xpert TV Assay is an automated real-time polymerase chain reaction (PCR) in vitro diagnostic test for qualitative detection of genomic DNA from Trichomonas vaginalis. The Xpert TV Assay is intended as an aid in the diagnosis of trichomoniasis.

The Xpert TV Assay is performed on the Cepheid GeneXpert® Instrument Systems (GeneXpert Dx., GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpert Infinity-80 systems). The GeneXpert Instrument System platform automates sample preparation, amplification and real-time detection.

The GeneXpert Instrument Systems require the use of single-use, disposable cartridges (the Xpert TV cartridges) that hold the PCR reagents and host the PCR process. Because the cartridges are self-contained and specimens never come into contact with working parts of the instrument modules, cross-contamination between samples is minimized.

The Xpert TV Assay cartridges contain reagents for the detection of genomic DNA from T. vaginalis for use with the following specimens collected from symptomatic and asymptomatic individuals: female urine, endocervical swab and patient-collected vaginal swab (collected in a clinical setting). A Sample Processing Control (SPC). Sample Adequacy Control (SAC), and a Probe Check Control (PCC) are controls utilized by the GeneXpert Instrument System platform. The SPC, SAC, and PCC are controls utilized by the GeneXpert Instrument System platform. The SPC is present to control for adequate processing of the target trichomonads and to monitor the presence of inhibitors in the real-time PCR reaction to reduce the possibility of false negative results. The SAC reagents detect the presence of a single copy human gene and monitor whether the specimen contains human cells. The PCC verifies reagent rehydration, real-time PCR tube filling in the cartridge, probe integrity, and dye stability.

The single-use, multi-chambered fluidic cartridges are designed to complete sample preparation and real-time PCR for the detection of genomic DNA from T. vaginalis in 70 minutes or less. The GeneXpert Instrument Systems, comprised of the GeneXpert Dx Systems and the GeneXpert Infinity Systems, have 1 to 80 randomly accessible modules, depending upon the instrument, that are each capable of performing separate sample preparation and real-time PCR and RT-PCR tests. Each module contains a syringe drive for dispensing fluids (i.e., the syringe drive activates the plunger that works in concert with the rotary valve in the cartridge to move fluids between chambers), an ultrasonic horn for lysing cells or spores', and a proprietary I-CORE® thermocycler for performing real-time PCR and RT-PCR and detection.

The swab and/or urine specimens are collected from asymptomatic or symptomatic patients and placed into a specimen transport tube containing preservative. The specimen is transferred to the sample chamber of the disposable fluidic cartridge (the Xpert TV cartridge). The user initiates a test from the system user interface and places the cartridge into the GeneXpert instrument platform, which performs hands-off real-time, multiplex PCR for detection of DNA. The results are automatically generated at the end of the process in a report that can be viewed and printed.

The ancillary specimen collection kits for use with the Xpert TV Assay are the Cepheid Xpert Vaginal/Endocervical Specimen Collection Kit and the Cepheid Xpert Urine Specimen Collection Kit.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" for clinical performance in a pass/fail format. Instead, it presents the clinical performance results and implies that these values are acceptable by concluding substantial equivalence. For the analytical studies, the implied criteria are 95% confidence for LoD and no interference/cross-reactivity for analytical specificity and interfering substances (except for noted limitations).

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The AmpliVue® Trichomonas Assay is an in vitro diagnostic test, uses isothermal amplification technology (helicase-dependent amplification, HDA) for the qualitative detection of Trichomonas vaginalis nucleic acids isolated from clinician-collected vaginal swab specimens obtained from symptomatic or asymptomatic females to aid in the diagnosis of trichomoniasis.

The AmpliVue® Trichomonas Assay combines simple processing, an isothermal amplification technology named Helicase-Dependent Amplification (HDA), and a selfcontained disposable amplicon detection device for the detection of T. vaginalis in clinician-collected vaginal swabs from symptomatic and asymptomatic women. The assay targets a conserved multi-copy sequence of the T. vaginalis DNA. The vaginal swab is eluted in a lysis tube, and the cells are lysed by simple heat treatment. After heat treatment, an aliquot of the lysed specimen is transferred into a dilution tube. An aliquot of the diluted sample is added to a reaction tube containing a lyophilized mix of HDA reagents including primers specific for the amplification of a conserved DNA sequence only found in T. vaginalis. The assay also includes an internal control to confirm the integrity of the assay reagents and cassette detection as well as to control for (or determine whether) HDA-inhibitors that may be present within the clinical specimens. The HDA reaction is asymmetric so that an excess of single stranded DNA (amplicon) is formed. The sequence specific capture probes as well as a biotinylated detection probe shared by both target and internal control bind to the corresponding single-stranded amplicons, forming dual labeled probe-amplicon hybrid. After completion of the HDA reaction, the reaction tube is transferred to a cassette for rapid detection with the test result displayed as test and/or control lines in the window of the cassette. The dual-labeled probe-amplicon hybrid is then detected by the lateral flow strip within the cassette. The bottom line captures the test amplicon and the top line captures the control amplicon. The biotin label binds the streptavidin-conjugated color particles for visualization and the test result is shown as colored lines visible to the naked eye. The cassette is comprised of two individual components: an amplicon cartridge that holds the running buffer and a single 0.2 mL thin wall reaction tube containing the amplified product; and the detection chamber which houses the amplicon cartridge and a verticalflow DNA detection strip embedded into the cassette. The DNA detection strip is coated with different anti-hapten antibodies that serve as the T. vaginalis test (T) line and the control (C) line in the assay. A razor blade and a plastic pin located at the bottom of the detection chamber opens the HDA reaction tube and the running buffer bulb when the handle of the cassette is closed. The mixture flows through a fiberglass paper connected to the DNA detection strip that contains a fiberglass pad pre-loaded with streptavidinconjugated color particles for color visualization. Detection of T. vaginalis DNA is reported whenever the T2 (Test line 2) is visible through the detection window of the cassette. The presence of the C line is not required for positive results. No detection of T. vaginalis DNA is reported when only the C line is displayed. The assay is regarded as invalid when neither line is displayed.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Description of Acceptance Criteria and Device Performance Study for AmpliVue® Trichomonas Assay

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state formal "acceptance criteria" in terms of specific performance targets set prior to the study. However, the study aims to demonstrate substantial equivalence to a predicate device, and the performance characteristics reported serve as the de facto demonstration of meeting the required clinical performance for this type of in vitro diagnostic device. The performance characteristics of the predicate device (APTIMA Trichomonas vaginalis Assay) are also provided for comparison.

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

• Sample Size for Test Set: 992 clinician-collected vaginal swab specimens.
• Data Provenance: The study was a multi-center study performed at four locations in the United States and one location in Canada. It was a prospective study, with specimens obtained from subjects after informed consent between April and November 2014.

3. Number of Experts and Qualifications for Ground Truth in the Test Set:

• The document states that the reference method for establishing ground truth was a composite of Wet Mount and InPouch TV culture. It does not specify the number or qualifications of experts involved in interpreting these reference methods. However, these methods are standard clinical laboratory procedures, implying trained laboratory personnel (e.g., medical technologists, clinical microbiologists) would have performed and interpreted them.

4. Adjudication Method for the Test Set:

• The ground truth was established using a composite reference method: Wet Mount and InPouch TV culture. A specimen was considered positive if either test was positive. This acts as a form of "OR" adjudication or a composite gold standard, rather than a direct agreement between multiple independent experts on the same test.
• For discordant results where the composite reference method was negative but the AmpliVue assay was positive, the FDA-cleared molecular device collection swab was used for discordant testing. Specifically, "Eight (8) of sixteen (16) Composite negative/AmpliVue positive specimens were positive by a FDA-cleared Trichomonas vaginalis molecular device." This implies a form of tie-breaking or re-evaluation using a third, highly sensitive method a posteriori.

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

• No, an MRMC comparative effectiveness study was not done. This study focuses on the standalone performance of the AmpliVue® Trichomonas Assay compared to a composite reference method, and its substantial equivalence to a predicate device. It does not evaluate human reader performance with or without AI assistance.

6. Standalone Performance Study:

• Yes, a standalone performance study was done. The entire clinical study described evaluates the performance of the AmpliVue® Trichomonas Assay (algorithm only, as it's an in vitro diagnostic test) in detecting Trichomonas vaginalis nucleic acids from vaginal swab specimens. The reported sensitivity, specificity, PPV, and NPV are all measures of this standalone performance.

7. Type of Ground Truth Used:

• The primary ground truth used was a composite reference method consisting of:
  • Wet Mount
  • InPouch TV Culture
• For discordant cases (AmpliVue positive, composite negative), an FDA-cleared Trichomonas vaginalis molecular device was used for further investigation, suggesting a hierarchical or confirmatory approach for specific discrepancies.

8. Sample Size for the Training Set:

• The document does not specify a sample size for a training set. The AmpliVue® Trichomonas Assay is an in vitro diagnostic test based on Helicase-Dependent Amplification (HDA) technology. This type of assay does not typically involve traditional "training sets" in the same way machine learning algorithms do. Its development involves analytical validation (LoD, cross-reactivity, interference, inclusivity) and then clinical validation with a distinct set of patient samples, rather than a machine learning training/test split.

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

• As the device is an in-vitro diagnostic assay rather than an AI/ML algorithm requiring a training set, the concept of "ground truth for the training set" does not directly apply here. The assay's design and analytical parameters (e.g., specific primers, probes, Lysis Buffer, Dilution Buffer, Reaction Tubes quantities) were established through laboratory development and analytical studies (LoD, cross-reactivity, inclusivity, interference) which confirm the assay's ability to detect the target DNA sequence under various conditions.

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The BD ProbeTec™ Trichomonas vaginalis (TV) 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 Trichomonas vaginalis DNA in clinician-collected female endocervical swab specimens, patient-collected vaginal swab specimens (in a clinical setting), and female urine specimens. The assay is indicated for use with asymptomatic and symptomatic females to aid in the diagnosis of trichomoniasis.

The BD ProbeTec Trichomonas vaginalis (TV) Q* Amplified DNA Assay (TVQ Assay) is based on the simultaneous amplification and detection of target DNA using amplification primers and fluorescently-labeled detector probes. 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, prewarmed 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 Trichomonas vaginalis 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 TV target DNA, a second labeled oligonucleotide is incorporated in each reaction Control (EC) oligonucleotide is labeled with a different dye than that used for detection of the TV 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 target-specific signals to report results as positive, negative, or EC failure.

BD ProbeTec™ Trichomonas Vaginalis (TV) Q* Amplified DNA Assay - Acceptance Criteria and Study Details

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state pre-defined acceptance criteria for clinical performance (sensitivity and specificity). However, it reports the clinical performance observed in the study. Based on the "Conclusion" section stating that the "analytical and clinical study results... support the determination of substantial equivalence in accordance with the intended use," it can be inferred that the reported performance met the implicit or explicit requirements for regulatory approval.

2. Sample Size for the Test Set and Data Provenance

• Test Set Sample Size:
  • Urine specimens: 735 compliant subjects
  • Vaginal specimens: 832 compliant subjects
  • Endocervical specimens: 995 compliant subjects
  • All specimen types combined: 2568 compliant subjects (This refers to total tests, not unique subjects)
• Data Provenance: Prospective collection from subjects attending family planning, OB/GYN, and sexually transmitted disease clinics at seven geographically diverse clinical sites in North America.

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

The document specifies the use of a "composite reference method" for establishing ground truth, consisting of Wet Mount and InPouch TV Culture. These are laboratory-based methods, not expert human readers for image interpretation. Therefore, the concept of "number of experts" and "qualifications of those experts" as it might apply to an AI image recognition device is not directly applicable here. The ground truth relies on the performance of these established microbiological diagnostic techniques.

4. Adjudication Method for the Test Set

The document describes a "composite reference method" for establishing ground truth. The first two clinician-collected vaginal swabs were randomized: one for Wet Mount and the other for InPouch TV Culture. While the specific adjudication rules are not detailed (e.g., if one test was positive and the other negative, how a "composite" result was derived), the setup implies that the results from these two reference methods were combined to form the final ground truth. It is not explicitly stated if a third, independent expert or method was used for discordant results between Wet Mount and InPouch TV Culture.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted as this is a diagnostic assay for the direct detection of DNA, not an AI-assisted interpretation of images or other data by human readers. The study focuses on the standalone performance of the assay compared to established laboratory reference methods.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

Yes, a standalone performance study was conducted. The main clinical performance evaluation (sensitivity and specificity) presented in Table 4 ("TVQ ASSAY VS COMPOSITE REFERENCE RESULT CULTURE OF INPOUCH TV TABLE 4: CULTURE AND WET MOUNT (BY SPECIMEN TYPE AND SYMPTOMATIC STATUS)") represents the performance of the BD ProbeTec TVQ Assay (algorithm only) against the composite reference method. There is no human-in-the-loop component mentioned for the interpretation of the assay's results. The BD Viper System provides an automated result (positive, negative, or EC failure).

7. Type of Ground Truth Used

The ground truth used was a composite reference method consisting of:

• Wet Mount
• InPouch TV Culture

These are considered established microbiological diagnostic methods for Trichomonas vaginalis.

8. Sample Size for the Training Set

The document does not provide information regarding a specific training set size. This indicates that the device's development likely used a different methodology, such as being designed and optimized based on known biological principles and analytical performance rather than a large machine learning training dataset. For an in vitro diagnostic (IVD) assay like this, analytical studies (LOD, specificity, interference) and subsequent clinical validation are typical, rather than a "training set" in the machine learning sense.

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

As no specific training set is mentioned in the context of machine learning, there is no information provided on how ground truth for such a set was established. The development of the assay would have involved standard molecular biology techniques and validation against known positive and negative controls (analytical truth) rather than a clinical training set with "ground truth" derived from patient outcomes or expert consensus on clinical samples.

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The APTIMA Trichomonas vaginalis Assay is an in vitro qualitative nucleic acid amplification test (NAAT) for the detection of ribosomal RNA (rRNA) from Trichomonas vaginalis to aid in the diagnosis of trichomoniasis using the PANTHER System.

The assay may be used to test the following specimens from symptomatic or asymptomatic women: clinician-collected endocervical swabs, clinician-collected vaginal swabs, and specimens collected in PreservCyt Solution.

The ATV Assay with the modified TCR, referred to as ATV Assay (Version 2) in this submission is the subject of this premarket notification. The ATV Assay (Version 2) is similar to the ATV Assay originally cleared (ref: K102911), except for the formulation of the TCR. The TCR is a HEPES-buffered solution containing lithium salts and derivatized magnetic beads. A second target capture oligo was added to the TCR formulation in order to accommodate future specimen types.

The TCR modification did not result in the change of assay technology. The ATV Assay (Version 2) uses Target Capture (TC), Transcription Mediated Amplification (TMA), and Hybridization Protection Assay (HPA) technologies to qualitatively detect ribosomal RNA (rRNA) from Trichomonas vaginalis. The overall assay design as well as the assay procedural steps remain unchanged from that previously described in the original 510(k) for the ATV Assay (K102911).

The ATV Assay (Version 2) kit is comprised of 3 boxes:

1. Refrigerated Box Contains the Amplification Reagent, Enzyme Reagent, Probe Reagent and Target Capture Reagent-B
2. Room Temperature Box Contains Amplification Reconstitution Solution, Enzyme Reconstitution Solution, Probe Reconstitution Solution, Selection Reagent and Target Capture Reagent
3. Controls Box Contains the Negative and Positive Controls

The ATV Assay (Version 2) on PANTHER would utilize three specimen collection kits. These collection kits were cleared for use with the originally cleared ATV Assay and other commercialized APTIMA Assays.

1. APTIMA Unisex Swab Specimen Collection Kit for Endocervical and Male Urethral Swab Specimens
2. APTIMA Vaginal Swab Specimen Collection Kit
3. APTIMA Specimen Transfer Kit

Instrumentation
The ATV Assay (Version 2) was validated using the PANTHER System, which was previously cleared in May 2012 (Ref: K111409).

Acceptance Criteria and Device Performance Study for APTIMA® Trichomonas vaginalis Assay (PANTHER® System)

This section provides a summary of the acceptance criteria and the study conducted to demonstrate the APTIMA® Trichomonas vaginalis Assay on the PANTHER® System meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The primary acceptance criteria for this diagnostic device are its clinical sensitivity and specificity across different specimen types and symptom statuses.

Note: The document does not explicitly state numerical acceptance criteria in a structured table. However, the reported performance characteristics (Sensitivity, Specificity, PPV, NPV) with narrow 95% Confidence Intervals consistently demonstrate high agreement with the "patient infected status algorithm," indicating that the device performs as expected for a diagnostic test of this nature, meeting an implicit acceptance threshold for high diagnostic accuracy. The agreement studies with the predicate device further support this.

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

The clinical performance study used the following sample sizes for the test set:

• Vaginal Swabs: 667 (after exclusions for invalid results which were 11 out of 689 initial samples)
• Endocervical Swabs: 700 (after exclusions for invalid results which were 24 out of 737 initial samples)
• PreservCyt Solution liquid Pap specimens: 774 (after exclusions for invalid results which were 1 out of 791 initial samples)

Data Provenance: The study utilized retrospective, leftover specimens collected from consenting subjects during a previous, prospective, multicenter clinical study of the ATV Assay on the TIGRIS DTS System.

• Country of Origin: 9 US clinical sites (obstetrics and gynecology, family planning, and STD clinics).

For the agreement study with the TIGRIS DTS System for asymptomatic subjects:

• Vaginal Swabs: 227
• Endocervical Swabs: 227
• PreservCyt Solution liquid Pap specimens: 226
• Data Provenance: Prospectively collected specimens from asymptomatic subjects enrolled from 6 US clinical sites.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not specify the number of experts or their specific qualifications (e.g., years of experience for radiologists) for establishing the ground truth for the clinical study.

4. Adjudication Method for the Test Set

The ground truth for the clinical performance study was established by a patient infected status algorithm based on the results from two reference tests performed on vaginal swab specimens:

1. Commercially available culture system
2. Wet mount microscopic examination

Adjudication Rule:

• Infected Patient Status: At least one of the reference test results was required to be positive.
• Non-infected Patient Status: Both reference tests were required to be negative.

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

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. This is a diagnostic assay (Nucleic Acid Amplification Test) and its performance is determined by its analytical and clinical characteristics against a defined ground truth, not by human reader interpretation. No human readers are involved in the direct interpretation of the assay results, which are automatically interpreted by the PANTHER System software.

6. Standalone Performance Study (Algorithm Only)

Yes, a standalone performance study (algorithm only, without human-in-the-loop performance) was done. The entire evaluation of the APTIMA® Trichomonas vaginalis Assay on the PANTHER® System, including its analytical and clinical performance, is based on the automated interpretation of the test results by the PANTHER System's software. The assay results (RLU values) are automatically interpreted as negative, positive, or invalid by the system.

7. Type of Ground Truth Used

The type of ground truth used for the clinical studies was an expert consensus-based algorithm derived from established diagnostic methods:

• Culture for Trichomonas vaginalis
• Wet mount microscopic examination

This algorithm defined the "patient infected status" against which the device's performance was measured.

8. Sample Size for the Training Set

The document does not explicitly state the sample size for a "training set" in the context of developing the algorithm itself. The information provided focuses on the validation data set used for clinical performance evaluation. Medical devices, especially diagnostic assays, often undergo development and internal validation on various sample sets, but these are typically not reported as explicitly as training sets in the context of machine learning model development. The focus here is on the analytical and clinical validation of the final assay.

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

As noted above, an explicit "training set" for the algorithm's development is not detailed. The ground truth for validating the assay's performance (the clinical test set) was established using a patient infected status algorithm based on a combination of culture and wet mount microscopic examination results. This is a common practice for validating new diagnostic tests against existing gold standards or established diagnostic pathways.

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The APTIMA Trichomonas vaginalis Assay is an in vitro qualitative nucleic acid amplification test (NAAT) for the detection of ribosomal RNA (rRNA) from Trichomonas vaginalis to aid in the diagnosis of trichomoniasis using the TIGRIS DTS System.

The assay may be used to test the following specimens from symptomatic or asymptomatic women: clinician-collected endocervical swabs, clinician-collected vaginal swabs, female urine specimens, and specimens collected in PreservCyt solution.

The ATV assay is a nucleic acid amplification test intended for the in vitro qualitative detection of ribosomal RNA from T. vaginalis in patient-collected first catch urine and clinician collected vaginal swabs, endocervical swab and ThinPrep Pap Test specimens collected in Cytyc Preservcyt solution. The assay may be used to test specimens from symptomatic and asymptomatic individuals to aid in the diagnosis of trichomoniasis using the TIGRIS DTS System automated analyzer.

There are 4 kits (1 master and 3 ancillary) that are required to perform the ATV assay on the TIGRIS DTS System. The Master Kit contains 9 reagents and 2 controls and is made up of 3 boxes. Box 1 - the Refrigerated box contains ATV amplification reagent, ATV enzyme reagent, ATV probe reagent and ATV Target Capture reagent-B. Box 2 - the Room Temperature box contains ATV amplification reconstitution solution, ATV enzyme reconstitution reagent, ATV probe reconstitution reagent, ATV selection reagent and ATV target capture reagent. Box 3-the Controls kit box contains ATV positive and negative controls. The three ancillary kits consist of the APTIMA Assay Fluids kit, the APTIMA Auto Detect Reagents kit and APTIMA System Fluids Preservative kit. In addition to the reagents provided in the kit, the assay utilizes four specimen collection kits - the APTIMA unisex swab specimen collection kit for endocervical and male urethral swab specimens, APTIMA vaginal swab specimen collection kit, APTIMA urine specimen collection kit for male and female urine specimens and the APTIMA specimen transfer kit.

Here's an analysis of the provided text to extract the acceptance criteria and study details for the Aptima Trichomonas vaginalis (ATV) assay.

Acceptance Criteria and Device Performance for Aptima Trichomonas vaginalis (ATV) Assay

The Aptima Trichomonas vaginalis (ATV) assay is a qualitative nucleic acid amplification test (NAAT) designed for the detection of ribosomal RNA (rRNA) from T. vaginalis. Its performance was evaluated through various analytical and clinical studies.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the ATV assay are implicitly defined by the reported performance characteristics which are deemed sufficient for reclassification to Class II. The primary performance metrics are related to the accuracy of T. vaginalis detection across different specimen types.

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