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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 Aptima Combo 2® assay is a target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection and differentiation of ribosomal RNA (rRNA) from Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) to aid in the diagnosis of chlamydial and/or gonococcal disease using the Panther® system as specified.
On the Panther system, the assay may be used to test the following specimens from symptomatic and asymptomatic individuals: clinician-collected endocervical, PreservCyt® Solution liquid Pap specimens, vaginal, throat, rectal, and male urethral swab specimens; patient collected vaginal swab specimens , and female and male urine specimens.
¹Patient-collected vaginal swab specimens are an option for screening women when a pelvic exam is not otherwise indicated. The Aptima Multitest Swab Specimen Collection Kit has not been evaluated for home use.

The Aptima Combo 2® assay is a target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection and differentiation of ribosomal RNA (rRNA) from Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) to aid in the diagnosis of chlamydial and/or gonococcal urogenital disease using the Tigris® DTS® Automated Analyzer. The assay may be used to test the following specimens from symptomatic individuals: clinician-collected endocervical, vaginal and male urethral swab specimens; and female and male urine specimens. The assay may be used to test the following specimens from asymptomatic individuals: clinician-collected endocervical, vaginal and male urethral swab specimens; patient-collected vaginal swab specimens'; and female and male urine specimens. The assay is also intended for use with the testing of gynecological specimens, from both symptomatic and asymptomatic patients, collected in the PreservCyt® Solution.
1 Patient-collected vaginal swab specimens are an option for screening women when a pelvic exam is not otherwise indicated. The Aptima Multitest Swab Specimen Collection Kit is not for home use.

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 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 Aptima Combo 2 Assay (AC2) combines the technologies of target capture, TMA, and DKA. Specimens are collected and transferred into their respective specimen transport tubes. The transport solutions in these tubes release the rRNA targets and protect them from degradation during storage. When the Aptima Combo 2 Assay is performed in the laboratory, the target rRNA molecules are isolated from specimens by use of capture oligomers via target capture that utilizes magnetic microparticles. The capture oligomers contain sequences complementary to specific regions of the target molecules as well as a string of deoxyadenosine residues. A separate capture oligomer is used for each target. During the hybridization step, the sequence specific regions of the capture oligomers bind to specific regions of the target molecules. 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 polydeoxythymidine molecules that are covalently attached to the magnetic particles. The microparticles, including the captured target molecules 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 reaction inhibitors. After the target capture steps are completed, the specimens are ready for amplification.
Target amplification assays are based on the ability of complementary oligonucleotide primers to specifically anneal and allow enzymatic amplification of the target nucleic acid strands. The Aptima Combo 2 Assay replicates a specific region of the 23S rRNA from CT and a specific region of the 16S rRNA from GC via DNA intermediates. A unique set of primers is used for each target molecule. Detection of the rRNA amplification product sequences (amplicon) is achieved using nucleic acid hybridization. Single-stranded nucleic acid chemiluminescent probes, which are complementary to a region of each target amplicon, are labeled with different acridinium ester molecules. The updated version of the Aptima Combo 2 assay incorporates a second CT probe, complementary to a unique region of the existing CT amplicon. This tandem probe provides detection coverage for the variant strains of C. trachomatis that emerged in 2019. The labeled probes combine with amplicon to form stable hybrids. The Selection Reagent differentiates hybridized from unhybridized probe, eliminating the generation of signal from unhybridized probe. During the detection step, light emitted from the labeled hybrids is measured as photon signals in a luminometer and are reported as Relative Light Units (RLU). In DKA, differences in the kinetic profiles of the CT and GC labeled probes allow for the differentiation of signal; kinetic profiles are derived from measurements of photon output during the detection read time. The chemiluminescent detection for CT signal has very rapid kinetics and has the "flasher" kinetic type. The chemiluminescent detection for GC signal is relatively slower and has the "glower" kinetic type. Assay results are determined by a cut-off based on the total RLU and the kinetic curve type.

The Aptima Trichomonas vaginalis Assay (ATV) 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 Trichomonas vaginalis Assay is performed in the laboratory, the target rRNA is isolated from the specimens by the use of 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.
Target amplification assays are based on the ability of complementary oligonucleotide primers to specifically anneal and allow enzymatic amplification of the target nucleic acid strands. The Hologic TMA reaction amplifies a specific region of the small ribosomal subunit from T. vaginalis via DNA and RNA intermediates and generates RNA amplicon molecules. Detection of the rRNA amplification product sequences is achieved using nucleic acid hybridization (HPA). A single stranded chemiluminescent DNA probe, which is complementary to a region of the target amplicon, is labeled with an acridinium ester molecule. The labeled DNA probe combines with amplicon to form stable RNA:DNA hybrids. The Selection Reagent differentiates hybridized from unhybridized probe, eliminating the generation of signal from unhybridized probe. During the detection step, light emitted from the labeled RNA:DNA hybrids is measured as photon signals in a luminometer and are reported as Relative Light Units (RLU).

Acceptance Criteria and Device Performance for Aptima Combo 2 Assay and Aptima Trichomonas Vaginalis Assay (RMR Probe Reagent Update)

This document describes the acceptance criteria and the studies that demonstrate the device meets those criteria, specifically concerning the manufacturing change to the Ready-Made Reagents (RMR) Probe Reagent for the Aptima Combo 2 Assay (AC2) and Aptima Trichomonas Vaginalis Assay (ATV). The core of this submission is to prove that the removal of the lyophilization step for the RMR Probe Reagent does not negatively impact assay performance compared to the previously cleared predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by demonstrating comparability to the predicate devices. The key performance metrics evaluated are Intended Use (overall agreement with expected positivity) and Limit of Detection (LoD). For clinical performance, the acceptance criteria are 100% agreement between the predicate and the modified RMR assay. For LoD, the acceptance criterion is that the RMR assay's LoD is within ½ log of the predicate assay's LoD.

2. Sample Size for the Test Set and Data Provenance

Intended Use Study:

• Aptima Combo 2 Assay (Panther): Negative and positive panels (exact number of panels or individual samples not specified, but stated to include CT positive, FI-nvCT positive, and CT/GC dual positive panels).
• Aptima Combo 2 Assay (Tigris): Negative and positive panels (exact number of panels or individual samples not specified, but stated to include CT positive, FI-nvCT positive, and CT/GC dual positive panels).
• Aptima Trichomonas Vaginalis Assay (Panther): Negative, TV positive, and TV low positive panels (exact number of panels or individual samples not specified).
• Aptima Trichomonas Vaginalis Assay (Tigris): Negative, TV positive, and TV low positive panels (exact number of panels or individual samples not specified).
• Data Provenance: Not explicitly stated, but these appear to be contrived panels (controlled positive and negative samples) rather than directly clinical specimens for this specific study.

Limit of Detection (LoD) Study:

• Aptima Combo 2 Assay (Panther & Tigris): Stocks of CT and GC organisms, and FI-nvCT in vitro transcript. These were run in negative clinical liquid pap specimens collected in PreservCyt solution (ThinPrep).
• Aptima Trichomonas Vaginalis Assay (Panther & Tigris): Stocks of TV organisms in negative clinical liquid pap specimens collected in PreservCyt solution (ThinPrep).
• Data Provenance: The base matrix used for spiking was "negative clinical liquid pap specimens," suggesting these are retrospective clinical samples from an unspecified origin, used in a prospective manner for LoD determination.

Clinical Performance Study:

• Aptima Combo 2 Assay (Panther): 219 remnant clinical swab specimens.
• Aptima Combo 2 Assay (Tigris): 200 remnant clinical swab specimens.
• Data Provenance: "remnant clinical swab specimens". This indicates these are retrospective samples collected from prior clinical testing, with the country of origin not specified.

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

The ground truth for these studies is established by the performance of the predicate AC2 assay or ATV assay, which was previously cleared by the FDA. The document does not describe the involvement of additional human experts for the ground truth of these specific comparability studies, as the goal is to show the new RMR Probe Reagent performs equivalently to the already established predicate. The reliability of the predicate assays themselves would have been established through prior studies reviewed by the FDA, presumably involving expert consensus or validated methods.

4. Adjudication Method for the Test Set

Adjudication methods were not applicable in these studies. The assessment compares the performance of the modified AC2/ATV RMR assays directly against the predicate AC2/ATV assays. The predicate assay's result is used as the reference/ground truth for comparison. There is no mention of a separate expert adjudication process for discordant results between the predicate and the modified device in these comparability studies. In the LoD studies, the ground truth for spiked samples is defined by the known concentration of the spiked organisms/transcripts.

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

No MRMC comparative effectiveness study was done. This study concerns an in vitro diagnostic (IVD) device (nucleic acid amplification test) for direct detection of pathogens, not an AI-assisted diagnostic tool for human readers. Therefore, there is no human-in-the-loop performance to evaluate, and thus no effect size for human reader improvement with AI assistance.

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

The studies presented are effectively standalone performance evaluations of the modified IVD assays. The assays are fully automated on the Panther and Tigris systems, and the results are interpreted based on predefined cut-offs (Relative Light Units and kinetic curve type). There is no human intervention in the result determination process once the assay is run. The comparison is between two versions of an automated assay.

7. Type of Ground Truth Used

• Intended Use Study: The "expected positivity results" indicate that calibrated positive and negative control panels (contrived ground truth) were used. These panels simulate clinical conditions but are created in a controlled laboratory setting.
• Limit of Detection (LoD) Study: The ground truth for LoD was spiked negative clinical specimens with known concentrations of target organisms/transcripts. This is a form of contrived ground truth based on quantitative standards.
• Clinical Performance Study: The ground truth for the clinical comparability study was the result of the predicate AC2 assay. This means the predicate assay's output was considered the reference standard, rather than an independent expert consensus or pathology review of the remnant specimens themselves for this specific comparability study. The performance of the predicate itself would have been validated against clinical outcomes or a gold standard during its initial clearance.

8. Sample Size for the Training Set

No training set is explicitly mentioned or relevant for this submission. This submission describes a manufacturing change to a reagent component of already cleared IVD assays. The assays are based on established molecular biology principles and do not involve machine learning algorithms that require a training set to "learn" patterns or make predictions. The "development activities" mentioned relate to design control and verification testing, not algorithmic training.

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

As there is no training set for an algorithm, this question is not applicable.

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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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