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The Aptima Chlamydia trachomatis (CT) assay is an in vitro qualitative nucleic acid amplification test (NAAT) for the detection of ribosomal RNA (rRNA) from Chlamydia trachomatis to aid in the diagnosis of chlamydia urogenital disease using the Panther System.

The assay may be used to test the following specimens from symptomatic individuals: patient-collected vaginal swab specimens1 (in a clinical setting); and female and male urine specimens.

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 has not been evaluated for home use.

The Aptima Chlamydia trachomatis assay (Aptima CT assay) is a target amplification nucleic acid probe test for in vitro qualitative detection of ribosomal RNA (rRNA) from Chlamydia trachomatis (CT). The Aptima CT assay combines 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 CT assay is performed in the laboratory, the target rRNA molecule is isolated from the specimens by use of a capture oligomer via target capture that utilizes magnetic microparticles. 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 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 micro particles, 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 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 Hologic TMA reaction replicates a specific region of the 16S rRNA from CT via DNA intermediates. A unique set of primers is used for the target molecule. Detection of the rRNA amplification product sequences (amplicon) is achieved using nucleic acid hybridization. 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).

The device reagents are identical to the Aptima CT assay reagents for use on the Tigris DTS® system but are intended for use on the Panther system with different specimen type indications. The Panther and Tigris DTS systems use the same principles of operation.

The provided document is a 510(k) summary for the Aptima Chlamydia trachomatis Assay, which focuses on demonstrating substantial equivalence to a predicate device. It details various analytical and clinical studies conducted to support the performance of the assay on the Panther system.

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

1. A table of acceptance criteria and the reported device performance

The document does not present a single, comprehensive table outlining pre-defined acceptance criteria for each study and then directly reporting the device's performance against those criteria in a tabular format. Instead, acceptance criteria are generally described within the text of each study and the conclusion states whether those criteria were met.

However, based on the descriptions, we can infer some acceptance criteria and the reported performance.

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The BD Probe Tec Chlamydia trachomatis (CT) Q* Amplified DNA Assay, when tested with either the BD Viper™ System in Extracted Mode or the BD Viper™ LT System, uses Strand Displacement Amplification technology for the direct, qualitative detection of Chlamydia trachomatis DNA in clinician-collected female endocervical and male urethral swab specimens, patient-collected vaginal swab specimens (in a clinical setting), and male and female urine specimens (both UPT and Neat). The assay is also intended for use with gynecological specimens collected in BD SurePath™ Preservative Fluid or PreservCyt™ Solution using an aliquot that is removed prior to processing for either the BD SurePath or ThinPrep™ Pap test. The assay is indicated for use with asymptomatic and symptomatic individuals to aid in the diagnosis of chlamydial urogenital disease.

The BD ProbeTec CTO Assay is based on the simultaneous amplification and detection of target DNA using amplification primers and a fluorescently-labeled detector probe The reagents for strand displacement amplification (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. In alignment with the FDA Guidance Document, "Assay Migration Studies for In Vitro Diagnostic Devices, Guidance for Industry and FDA Staff", April 25, 2013 the BD ProbeTec CTQ Assay is being migrated from the existing BD Viper System operating in extracted mode (Viper XTR) to the new BD Viper LT System. The BD Viper LT System is a table-top instrument that is designed to be fully contained on a standard laboratory bench-top. The system performs automated extraction of nucleic acids from multiple specimen types in addition to amplification and detection of target nucleic acid sequences when utilized with legally marketed in vitro diagnostic assays.

The BD ProbeTec™ Chlamydia trachomatis (CT) Q* Amplified DNA Assay on the BD Viper LT System underwent a study to demonstrate its performance and establish substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria with specific numerical thresholds for Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA). However, the clinical performance study aimed to compare the performance of the BD ProbeTec CTQ Assay on the BD Viper LT System against the existing BD Viper System in extracted mode. The presented data represents the "reported device performance."

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

• Sample Size for Clinical Performance (Test Set):
  • 617 compliant female subjects
  • 167 compliant male subjects
  • Total number of individual specimens tested on the BD Viper LT System and compared against the reference method is not explicitly stated as a single number but can be derived from the "Total" rows in Table 3:
    • Positive tests: 660 total (sum of individual specimen types)
    • Negative tests: 951 total (sum of individual specimen types)
    • This suggests a total of 1611 comparison panel tests.
• Data Provenance: The specimens were collected from clinical sites in North America. The study involved prospective collection of samples from symptomatic and asymptomatic individuals. All specimens were shipped to BD for screening, aliquoting, and comparison panel assembly.

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

The document does not describe the use of human experts to establish ground truth for the test set. Instead, the "BD Viper System in extracted mode reference results" were used as the basis for classifying specimens as positive or negative to create the comparison panels (ground truth). The nature and qualifications of personnel performing the predicate device testing are not specified beyond being part of "one internal site."

4. Adjudication Method for the Test Set

The document describes how comparison panels were assembled: "Each comparison panel consisted of randomly chosen positive and negative specimens (based on BD Viper System in extracted mode reference results). The positive and negative specimens were randomized within the panel, and labeled such that the instrument user was blinded to the specimen results." This indicates that the reference results from the predicate BD Viper System served as the adjudicated ground truth, and there was no further human expert adjudication process described for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not a multi-reader multi-case (MRMC) comparative effectiveness study involving human readers or AI assistance in interpretation. This study evaluates the performance of an in vitro diagnostic (IVD) device (the BD ProbeTec CTQ Assay on the BD Viper LT System) compared to a predicate device. The results are quantitative (Positive Percent Agreement, Negative Percent Agreement) based on instrument output, not human interpretation.

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

Yes, a standalone performance study was done. The BD ProbeTec CTQ Assay on the BD Viper LT System is an automated, qualitative molecular diagnostic test. The clinical performance data presented (Table 3) represents the performance of the device itself (algorithm and system) in detecting Chlamydia trachomatis DNA, with no direct human interpretation component in the primary outcome. The "instrument user was blinded to the specimen results," implying a standalone evaluation of the device.

7. The Type of Ground Truth Used

The ground truth used for the clinical performance study (test set) was established by the results from the predicate device, the BD Viper System in extracted mode. "Each comparison panel consisted of randomly chosen positive and negative specimens (based on BD Viper System in extracted mode reference results)."

8. The Sample Size for the Training Set

The document implies that the BD ProbeTec CTQ Assay formulation for the BD Viper LT System has not changed from that used with the existing BD Viper System. Therefore, there isn't a "training set" in the context of an algorithm learning from data. The device itself (reagents, amplification, detection) is pre-established. The studies conducted are for "migrating" the assay to a new instrument platform (BD Viper LT). Thus, the concept of a training set for algorithm development is not directly applicable here.

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

As explained in point 8, a training set for an algorithm is not described or applicable in this context. The "ground truth" for the original development and validation of the BD ProbeTec CTQ Assay on the predicate BD Viper System would have been established through a combination of well-characterized positive and negative clinical specimens, spiked samples, and potentially confirmatory testing methods, but details are not provided in this submission for the predicate device's original development.

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The cobas® CT/NG Test is an in vitro nucleic acid amplification test that utilizes Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the qualitative detection of Chlamydia trachomatis (CT) and/or Neisseria gonormoeae (NG) DNA to aid in the diagnosis of chlamydial and gonococcal disease. The test may be used with vaginal swab specimens self-collected in a clinical setting and male urine from both symptomatic and asymptomatic individuals. Specimens to be tested should be collected in cobas® PCR Media.

Ancillary Collection Kits

The cobas® PCR Female Swab Sample Kit is used to collect and transport self-collected vaginal swab specimens in a clinical setting. The cobas® PCR Media serves as a nucleic acid stabilizing transport and storage medium for gynecological specimens. Use this collection kit only with the cobas CT/NG Test. NOTE: This collection kit should not be used for collection of alternative gynecological specimens.

The cobas® PCR Urine Sample Kit is used to collect and transport male urine specimens.

The cobas® PCR Media serves as a nucleic acid stabilizing transport and storage medium for urine specimens. Use this collection kit only with the cobas® CT/NG Test. NOTE: This collection kit should not be used for collection of female urine specimens.

The Roche Molecular Systems (RMS) cobas® CT/NG Test consists of five reagent kits:

• cobas® 4800 System Sample Preparation Kit .
• cobas® 4800 CT/NG Amplification/Detection Kit .
• cobas® 4800 CT/NG Controls Kit .
• . cobas 4800 System Wash Buffer Kit
• . cobas® 4800 System Control Diluent Kit

Sample Collection Kits to be used for the cobas® CT/NG Test are:

• . cobas® PCR Female Swab Sample Kit
• cobas® PCR Urine Sample Kit .

The cobas® CT/NG Test for Chlamvdia trachomatis (CT) and Neisseria gonorrhoeae (NG) is based on two major processes: (1) automated sample preparation to obtain nucleic acids. including CT and NG DNA; (2) simultaneous PCR amplification of target DNA sequences using both CT and NG specific complementary primer pairs and real-time detection of cleaved fluorescent-labeled CT and NG specific oligonucleotide detection probes. Internal control, containing CT and NG DNA, is added to all samples during automated sample preparation and is amplified and detected simultaneously with each sample to monitor the entire process.

The cobas 4800 System utilizes the cobas x 480 Instrument for automated sample preparation, and the automated cobas z 480 Analyzer for automated amplification and detection. The cobas 4800 system software integrates the sample preparation with nucleic acid amplification and detection to generate test results.

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

cobas® CT/NG Test: Acceptance Criteria and Study Details

The cobas® CT/NG Test is an in vitro nucleic acid amplification test for the qualitative detection of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) DNA.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes both non-clinical performance evaluations (analytical sensitivity, inclusivity, specificity, interference, precision) and clinical performance evaluations (reproducibility and a clinical specimen study). The acceptance criteria for analytical and reproducibility studies are generally indicated by the achieved performance (e.g., ≥ 95% detection for LOD, 100% agreement for negative controls, high positive percent agreement for reproducibility). For clinical performance, the reported sensitivity and specificity serve as the primary metrics.

• Urine: 0.75 IFU/mL
• Vaginal Swabs: 10.00 IFU/mL

N. gonorrhoeae (NG):

• Urine: 2.25 CFU/mL
• Vaginal Swabs: 100.00 CFU/mL |
  | Inclusivity: Detection of additional CT serovars/variants and NG strains around LOD levels with high positive hit rates. | CT: Analytical sensitivity for 14 serovars + nvCT ranged from 0.125 IFU/mL to 5.0 IFU/mL (PCR Media + urine) and all showed 100% positive hit rates at 10 IFU/mL in stabilized negative vaginal specimens.
  NG: Analytical sensitivity for 44 strains ranged from 3.0 CFU/mL to 20 CFU/mL (PCR Media) and was 3.75 CFU/mL (PCR Media + urine). All showed 100% hit rates at 100 CFU/mL in stabilized negative vaginal specimens. |
  | Analytical Specificity: No interference with CT/NG detection or false positives from various microorganisms. | No interference with CT/NG detection or false positive results were observed from 184 bacteria, fungi, and viruses, including those commonly found in urogenital tracts. |
  | Interference: No or minimal interference from common OTC products and endogenous substances. | - Replens® vaginal moisturizer produced invalid/false negative results in urine panels, but no interference in vaginal swab specimens.
• Maximum allowable concentrations of whole blood (> 0.35% v/v in urine, none in vaginal), PBMC cells (> 1 x 10^5 cells/mL), and routine levels of cervical mucus showed no interference. |
  | Precision: Anticipated hit rates (e.g., 100% for positive and 0% for negative at LOD levels) and low CVs for Ct values. | CT & NG (PCR Media & PCR Media + Urine):
• Negative levels: 0% hit rate
• 1x LOD / Neg: 100% hit rate (CT & NG)
• 1x LOD / 2.5x LOD: 100% hit rate (CT & NG)
• 2.5x LOD / 1x LOD: 100% hit rate (CT & NG)
• Overall CV (%) for Ct values: 1.1% to 1.5% (urine panel, CT); 1.6% to 1.8% (swab panel, CT); 1.2% to 1.5% (urine panel, NG); 1.4% to 1.9% (swab panel, NG). |
  | Reproducibility: High percent agreement across lot, site, operator, run, and day. | CT (Urine & Swab Panels):
• Negative Percent Agreement (NPA): 100%
• Positive Percent Agreement (PPA): 100%
  NG (Urine & Swab Panels):
• NPA: 100%
• PPA: Lowest overall was 99.52%. |
  | Clinical Sensitivity (Overall): | CT: 95.7% (246/257) (95% CI: 92.5%, 97.6%)
  NG: 99.0% (103/104) (95% CI: 94.8%, 99.8%) |
  | Clinical Specificity (Overall): | CT: 99.7% (2585/2594) (95% CI: 99.3%, 99.8%)
  NG: 99.9% (2744/2747) (95% CI: 99.7%, 100.0%) |
  | Clinical Positive Predictive Value (PPV) at study prevalence: | CT: 96.5%
  NG: 97.2% |
  | Clinical Negative Predictive Value (NPV) at study prevalence: | CT: 99.6%
  NG: 100.0% |

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

• Clinical Specimen Study:
  • Sample Size: A total of 2,851 evaluable male and female subjects were enrolled for the clinical specimen study.
  • Data Provenance: The study was a multi-center clinical investigation conducted in the United States. Specimens were collected at 12 geographically diverse sites, including OB-GYN practices, public and private STD clinics, and family planning centers. The study was prospective in nature, as subjects were enrolled, and specimens were collected and tested.

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

The ground truth ("Patient Infected Status") was established using a combination of two commercially available nucleic acid amplification tests (NAATs) for CT and NG, as reference assays. The number and qualifications of experts involved in the interpretation of these reference assays or in establishing a consensus based on them are not explicitly stated in the provided document. The ground truth was primarily based on the concordance of these reference NAAT results.

4. Adjudication method for the test set

The adjudication method for determining "Patient Infected Status" (PIS) was based on the combined results from two reference NAATs.

• A subject was categorized as infected for CT or NG if a minimum of two positive results (at least one from each reference NAAT) was reported across relevant specimen types (e.g., endocervical swab/urethral swab and/or urine specimen).
• Specific rules were applied for certain situations, such as females being categorized as non-infected for swab specimens if reference swab and PreservCyt were negative, but urine specimens were positive.
• A subject was classified as non-infected if at least one of the reference NAATs reported negative results for all sample types.
• If PIS could not be determined due to missing and/or indeterminate results from the reference tests, the subject was excluded from the analysis. This method implies a form of "consensus" or "composite reference standard" based on the agreement of the two predicate devices, rather than a direct expert panel adjudication in the typical sense of 2+1 or 3+1 for imaging.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is a fully automated in vitro diagnostic test (nucleic acid amplification test) and does not involve human readers interpreting results. Therefore, there is no AI assistance or effect size on human reader performance to report. The comparison is between the new device and established reference assays.

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

Yes, the primary clinical performance evaluation is a standalone (algorithm only) performance study. The cobas® CT/NG Test is an automated system for sample preparation, amplification, and real-time detection, generating results without human interpretive input. The reported sensitivity, specificity, and predictive values are for the device operating as a standalone diagnostic system.

7. The type of ground truth used

The ground truth used was a composite reference standard (CRS) or "patient infected status" (PIS). PIS was determined based on the combined results from two different, commercially available nucleic acid amplification tests (NAATs) which served as reference assays. A subject was considered infected if at least two positive results were obtained, with at least one from each reference NAAT, across various relevant specimen types.

8. The sample size for the training set

The document does not explicitly describe a separate training set for the clinical performance evaluation in the context of machine learning or AI. Diagnostic devices like the cobas® CT/NG Test typically undergo analytical validation (e.g., LOD, inclusivity, specificity) and then clinical validation with a distinct set of clinical samples. The "training" for such devices is inherent in their design and optimization prior to the formal validation studies, and not usually characterized by a distinct "training set" of patient data in the way an AI model would have. The data described (analytical and clinical) are primarily for performance evaluation and validation.

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

As noted above, a distinct "training set" in the AI sense is not described. For the general development of the assay, the "ground truth" would be established through highly characterized reference materials (quantified cultures of CT and NG), which were used extensively in the analytical performance studies (LOD, inclusivity, analytical specificity).

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The BD ProbeTecT™ Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay, when tested with the BD Viper™ System in Extracted Mode, uses Strand Displacement Amplification technology for the direct, qualitative detection of Neisseria gonorrhoeae DNA in clinician-collected female endocervical and male urethral swab specimens, patient-collected vaginal swab specimens (in a clinical setting), and male and female urine specimens (both UPT and Neat). The assay is also intended for use with gynecological specimens collected in BD SurePath™ Preservative Fluid using an aliquot that is removed prior to processing for the BD SurePath™ Pap test. The assay is indicated for use with asymptomatic and symptomatic individuals to aid in the diagnosis of gonococcal urogenital disease.

The BD ProbeTec GC O* Amplified DNA Assay is based on the simultaneous amplification and detection of target DNA using amplification primers and a fluorescently-labeled detector probe. The reagents for SDA are dried in two separate disposable microwells: the Priming Microwell contains the amplification primers, fluorescently-labeled detector probe, nucleotides and other reagents necessary for amplification, while the Amplification Microwell contains the two enzymes (a DNA polymerase and a restriction endonuclease) that are required for SDA. The BD Viper™ System pipettes a portion of the purified DNA solution from each Extraction Tube into a Priming Microwell to rehydrate the contents. After a brief incubation, the reaction mixture is transferred to a corresponding, pre-warmed Amplification Microwell which is sealed to prevent contamination and then incubated in one of the two thermally-controlled fluorescent readers. The presence or absence of N. gonorrhoeae DNA is determined by calculating the peak fluorescence (Maximum Relative Fluorescent Units (MaxRFU)) over the course of the amplification process and by comparing this measurement to a predetermined threshold value.

In addition to the fluorescent probe used to detect amplified N. gonorrhoeae target DNA, a second labeled oligonucleotide is incorporated in each reaction. The Extraction Control (EC) oligonucleotide is labeled with a different dye than that used for detection of the N. gonorrhoeae -specific target and is used to confirm the validity of the extraction process. The EC is dried in the Extraction Tubes and is rehydrated upon addition of the specimen and extraction reagents. At the end of the extraction process, the EC fluorescence is monitored by the BD Viper System and an automated algorithm is applied to both the EC and N. gonorrhoeae -specific signals to report results as positive, negative, or EC failure.

BD ProbeTec™ Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay

1. Table of Acceptance Criteria and Reported Device Performance

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The BD ProbeTec™ Chlamydia trachomatis (CT) 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 Chlamydia trachomatis DNA in clinician-collected female endocervical and male urethral swab specimens, patient-collected vaginal swab specimens (in a clinical setting), and male and female urine specimens (both UPT and Neat). The assay is also intended for use with gynecological specimens collected in PreservCyt® Solution using an aliquot that is removed prior to processing for additional gynecological testing. The assay is indicated for use with asymptomatic and symptomatic individuals to aid in the diagnosis of chlamydial urogenital disease.

The BD Viper System, when used with the BD ProbeTec amplified nucleic assay(s), is intended for the in vitro detection of targeted organisms from specimens as identified in the assay-specific reagent package insert(s).

The BD ProbeTec CT Q* Amplified DNA Assay is based on the simultaneous amplification and detection of target DNA using amplification primers and a fluorescently-labeled detector probe (8, 9). The reagents for SDA are dried in two separate disposable microwells: the Priming Microwell contains the amplification primers, fluorescently-labeled detector probe, nucleotides and other reagents necessary for amplification, while the Amplification Microwell contains the two enzymes (a DNA polymerase and a restriction endonuclease) that are required for SDA. The BD Viper™ System pipettes a portion of the purified DNA solution from each Extraction Tube into a Priming Microwell to rehydrate the contents. After a brief incubation, the reaction mixture is transferred to a corresponding, pre-warmed Amplification Microwell which is sealed to prevent contamination and then incubated in one of the two thermally-controlled fluorescent readers. The presence or absence of C. trachomatis 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 C. trachomatis target DNA, a second labeled oligonucleotide is incorporated in each reaction. The Extraction Control (EC) oligonucleotide is labeled with a different dye than that used for detection of the C. trachomatisspecific 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 C. trachomatis-specific signals to report results as positive, negative, or EC failure.

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

Acceptance Criteria and Device Performance

The document doesn't explicitly state "acceptance criteria" as a separate, pre-defined set of thresholds. Instead, it presents clinical performance characteristics (sensitivity and specificity) that are implicitly the targets for the device to be considered effective. The reported device performance is then compared against these implied expectations.

Study Details

1. Sample sized used for the test set and the data provenance:

• Sample Size: 2071 female subjects were evaluated in the clinical study.
• Data Provenance: The data was collected from prospective clinical sites in North America. Specifically, specimens were collected from female subjects attending family planning, OB/GYN, and sexually transmitted disease clinics at eleven geographically diverse clinical sites in North America.

2. 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 for establishing the ground truth. It refers to a "patient infected status (PIS) algorithm" which relied on results from three reference methods.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• The adjudication method was based on a "patient infected status (PIS) algorithm".
  • 2+1: At least two positive reference results were required to establish a subject as PIS-positive.
  • 2+1: At least two negative reference results were required to establish a subject as PIS-negative.
  • This implies a 2-out-of-3 consensus approach using results from the three reference endocervical swabs (BD ProbeTec ET CT/GC/AC assay, BD ProbeTec CT Q* assay, and another commercially available NAAT).

4. 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study evaluates the performance of an in vitro diagnostic (IVD) device (DNA assay) and not an AI-assisted diagnostic system where human readers would be involved in interpreting AI output.

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

• Yes, this was a standalone study in the context of an IVD device. The BD ProbeTec CT Q* Amplified DNA Assay, when used with the BD Viper System, automatically processes and reports results (positive, negative, or EC failure) based on fluorescence measurements and an automated algorithm. There is no human interpretation step being evaluated as part of results generation within the device's operational workflow.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• The ground truth was established by expert consensus based on multiple reference methods. Specifically, it was determined by a Patient Infected Status (PIS) algorithm which required at least two concordant results (positive or negative) from three different commercially available NAATs on endocervical swab specimens.

7. The sample size for the training set:

• The document does not specify a training set size. This is typical for a traditional IVD assay development, where "training" in the machine learning sense isn't applicable. The assay's parameters would have been optimized during earlier development (e.g., analytical performance characteristics like LOD, specificity for serovars, interfering substances), but a distinct "training set" as understood in AI/ML is not part of this documentation.

8. How the ground truth for the training set was established:

• As no "training set" in the AI/ML sense is explicitly mentioned, the method for establishing ground truth for such a set is not applicable/not provided. The analytical performance characteristics were established using controlled laboratory experiments (e.g., seeding known concentrations of C. trachomatis serovars).

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The BD ProbeTec Chlamydia trachomatis (CT) Q* Amplified DNA Assay, when tested with the BD Viper™ System in Extracted Mode, uses Strand Displacement Amplification (SDA) technology for the direct, qualitative detection of Chlamydia trachomatis DNA in cliniciancollected female endocervical and male urethral swabs, patient-collected vaginal swab specimens (in a clinical setting), and female and male urine specimens. The assay is indicated for use with asymptomatic and symptomatic individuals to aid in the diagnosis of chlamydial urogenital disease.

The BD ProbeTec CT Q Amplified DNA Assay is based on the simultaneous amplification and detection of target DNA using amplification primers and a fluorescently-labeled detector probe. The reagents for SDA are dried in two separate disposable microwells: the Priming Microwell contains the amplification primers, fluorescently-labeled detector probe, nucleotides and other reagents necessary for amplification, while the Amplification Microwell contains the two enzymes (a DNA polymerase and a restriction endonuclease) that are required for SDA. The BD Viper™ System pipettes a portion of the purified DNA solution from each Extraction Tube into a Priming Microwell to rehydrate the contents. After a brief incubation, the reaction mixture is transferred to a corresponding, pre-warmed Amplification Microwell which is sealed to prevent contamination and then incubated in one of the two thermallycontrolled fluorescent readers. The presence or absence of C. trachomatis 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 C. trachomatis target DNA, a second labeled oligonucleotide is incorporated in each reaction. The Extraction Control (EC) oligonucleotide is labeled with a different dye than that used for detection of the C. trachomatis-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 C. trachomatis-specific signals to report results as positive, negative, or EC failure.

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

BD ProbeTec™ Chlamydia trachomatis (CT) Q* Amplified DNA Assay

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined "acceptance criteria" with numerical targets for sensitivity and specificity. Instead, it presents the results of clinical performance studies, implying that these results met the internal or regulatory expectations for substantial equivalence. For a medical device, the ultimate acceptance criterion for performance is typically demonstrating substantial equivalence to a legally marketed predicate device through clinical performance.

However, based on the clinical performance table, we can infer the achieved performance:

Analytical Sensitivity (Limit of Detection):

• ≤ 15 CT elementary bodies (EB) per mL for neat and UPT treated urine (serovar H)
• ≤ 30 CT EB per mL for expressed vaginal and endocervical swab specimens (serovar H)
• Able to detect 16 CT serovars with ≥ 95% proportion positive at 15 EB per mL in Q* Swab Diluent.

Analytical Specificity:

• Did not cross-react with any of the 141 organisms tested (Table 1 lists a comprehensive range of bacteria, viruses, and fungi).

Interfering Substances:

• No interference observed for a wide range of substances in swab and urine (Table 2).
• Potential for extraction control (EC) failures with blood (> 60%) in swabs.

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

• Sample Size (Clinical Performance Test Set):
  • Female Subjects: 994 compliant subjects (initially 1059 collected).
  • Male Subjects: 472 compliant subjects (initially 479 collected).
  • Total BD ProbeTec CT Q Assay results used for calculations:* 5388 individual assay results across various specimen types.
• Data Provenance:
  • Country of Origin: North America (United States is implied by the FDA submission, but "North America" is explicitly stated).
  • Retrospective or Prospective: Prospective. Subjects were recruited and specimens collected from OB/GYN, sexually transmitted disease (STD), and family planning clinics.

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

The ground truth was established by a "patient infected status (PIS) algorithm" based on the results of two commercially available NAATs (Nucleic Acid Amplification Tests):

• BD ProbeTec ET CT/AC assay (predicate device, K984631)

• Another unspecified commercially available NAAT.

• Number of Experts: Not applicable in the traditional sense of human expert review. The ground truth was determined algorithmically by comparing results from the two reference NAATs.

• Qualifications of Experts: Not applicable, as the ground truth was based on the performance of existing, validated commercial assays rather than human expert opinion.

4. Adjudication Method for the Test Set

• Adjudication Method: Algorithmic consensus.
  • "Subjects were considered infected with CT if two of the four endocervical swab and urine specimens (or two of the three or four urethral swab and urine specimens) tested positive in the BD ProbeTec ET CT/AC assay AND the other reference NAAT (one specimen testing positive in each NAAT)." This effectively describes a 2/2 consensus or a complex majority rule across different specimen types and reference assays.
  • "Subjects were considered non-infected if less than two reference NAAT results were positive."

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

No, an MRMC comparative effectiveness study was not done. This device is an in-vitro diagnostic (IVD) assay where the result is generated by the instrument (BD Viper System) based on DNA amplification and detection, not by human readers interpreting images or data. The study compares the device's performance to established reference laboratory methods, not to human interpretation with or without AI assistance.

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

Yes, the device's performance, as reported in the clinical performance section, is a standalone (algorithm only) performance. The BD ProbeTec CT Q* Amplified DNA Assay is an automated test performed on the BD Viper™ System. The system "monitors" fluorescence and applies an "automated algorithm" to report results (positive, negative, or EC failure). There is no human interpretation involved in generating the primary result for comparison to the ground truth.

7. The Type of Ground Truth Used

The ground truth used was a composite reference standard or patient infected status (PIS) algorithm based on the results of two other commercially available and legally marketed nucleic acid amplification tests (NAATs). It is not pathology, a definitive gold standard, or outcome data in the traditional sense, but a robust consensus based on highly sensitive and specific molecular methods.

8. The Sample Size for the Training Set

The document does not explicitly mention a separate "training set" or its sample size for the clinical performance evaluation. The clinical study described appears to be a validation study for the assay. For IVDs, "training" might refer to internal development and optimization phases, which are typically not detailed in 510(k) summaries. The data presented in the clinical performance section represents the results from the final, evaluated test set.

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

As there is no explicitly defined "training set" presented in the document, information on how its ground truth was established is not available. The ground truth for the validation set was established using the PIS algorithm based on the two reference NAATs, as described in point 4.

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The Abbott RealTime CT/NG assay is an in vitro polymerase chain reaction (PCR) assay for the direct, qualitative detection of the plasmid DNA of Chlamydia trachomatis and the genomic DNA of Neisseria gonorrhoeae. The assay may be used to test the following specimens from symptomatic individuals: clinician-collected vaginal swab and male urethral swab specimens; patient-collected vaginal swab specimens; and female and male urine specimens. The assay may be used to test the following specimens from asymptomatic individuals: male and female urine.

The Abbott multi-Collect Specimen Collection Kit is intended for the collection and transportation of malc and female swab and urine specimens for the detection of Chlamydia trachomatis and Neisseria gonorrheae per instructions provided.

Self-collected vaginal swab specimens are an option for screening women when a pelvic exam is not otherwise indicated. The Abbott multi-Collect Specimen Collection Kit is not intended for home use.

Abbott RealTime CT/NG consists of two reagent kits:

• . Abbott RealTime CT/NG Amplification Reagent Kit (List No. 8L07-90)
• Abbott RealTime CT/NG Control Kit (List No. 8L07-80) .

The Abbott RealTime CT/NG assay uses PCR technology with homogenous real-time fluorescence detection on the m2000 System. The Abbott m2000 System consists of the Abbott m2000sp and Abbott m2000rt instruments. The Abbott m2000 System integrates sample preparation with nucleic acid amplification and detection to generate assay rcsults. The Abbott m2000sp is used for processing samples and the Abbott m2000rt is used for amplification and detection.

The Abbott multi-Collect Specimen Collection Kit can be used to collect either a swab or a urine specimen. Each Abbott multi -Collect Specimen Collection Kit (List No. 9K12) contains:

• One Transport Tube containing 1.2 mL Specimen Transport Buffer .
• . One Individually Packaged Sterile Specimen Collection Swab (Part No. CD650)
• . One disposable transfer pipette.

The Specimen Transport Buffer consists of guanidine thiocyanate, a chaotropic salt, in Tris buffer and is used to stabilize DNA until sample preparation. The individually packaged sterile Specimen Collection Swab is used for swab sample collection and placed directly into the Transport Tube. The transfer pipette is used to add approximately 3 mL of urine to the Transport Tube. The Abbott multi -Collect Specimen Collection Kit is for single use only.

Here's an analysis of the acceptance criteria and supporting studies for the Abbott RealTime CT/NG assay and Abbott multi-Collect Specimen Collection Kit, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implied by the reported clinical performance. The goal is to achieve high sensitivity and specificity compared to reference methods. The specific acceptance thresholds are not explicitly stated as numerical targets for sensitivity and specificity in the provided text, but the reported performance values are presented as demonstrating effective detection.

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

• Sample Size for Test Set: A total of 3,832 male and female subjects were enrolled in the multi-center clinical study.
• Data Provenance: The data was collected prospectively from subjects at 16 geographically diverse sites in the United States. The sites included physician private practices, public and private STD clinics, and a hospital emergency room.

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

The document does not specify the number of experts or their qualifications for establishing the ground truth. It states that the ground truth was "determined based on the combined results from the reference assays." While these reference assays are commercially available NAATs and culture, the interpretation or consensus process by human experts is not described.

4. Adjudication Method (for the test set)

The adjudication method used to establish the "patient infected status" (ground truth) was a consensus-based approach using multiple reference assays:

• For females: A subject was categorized as infected for CT or NG if a minimum of two positive results (at least one from each reference NAAT) were reported.
• For males: A subject was categorized as infected for CT or NG if a minimum of two positive results were reported.
• For NG specifically (both sexes): If the reference NG culture assay result was positive, the subject was categorized as infected regardless of NAAT results.
• Not infected status:
  • Female: At least one of the reference NAATs reported negative results for all sample types.
  • Male: A total of at least two negative results were reported by the reference NAATs.
• Subjects with missing and/or indeterminate results from reference assays were excluded (33 for CT, 35 for NG).

This represents a form of consensus ground truth, leaning towards a "2 out of X positive" rule for infection status, with culture having overriding power for NG.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an in vitro diagnostic (IVD) assay designed for direct, qualitative detection using PCR technology, not an AI-assisted diagnostic tool that would involve human readers interpreting AI output. Therefore, there is no discussion of human reader improvement with or without AI assistance.

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

Yes, the clinical performance data presented (sensitivity and specificity tables) represents the standalone performance of the Abbott RealTime CT/NG assay (algorithm/device only). The assay itself performs the detection and reporting of qualitative results without a human interpretation loop of the assay's direct output.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth used was expert consensus based on multiple reference assays, specifically a combination of:

• Two commercially available nucleic acid amplification tests (NAATs) for CT and NG.
• Culture for NG.

8. The Sample Size for the Training Set

The document does not explicitly state a "training set" size for the clinical studies. For IVD assays like this, the development process typically involves internal analytical verification and validation, possibly using characterized samples or spiked samples, but these are generally not referred to as a "training set" in the same way as machine learning models. The reported clinical study of 3,832 subjects serves as the test set for performance evaluation.

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

Since a "training set" in the machine learning sense is not explicitly described or used for this IVD assay according to the provided text, the method for establishing its ground truth for training is not applicable. The device's "training," if interpreted as its development and optimization, would have involved extensive analytical studies (e.g., analytical sensitivity, specificity, interference) using well-characterized samples, which are distinct from the clinical performance evaluation.

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The AMPLICOR CT/NG test for Chlamydia trachomatis is a qualitative in vitro test for the detection of C. trachomatis DNA in urine from symptomatic or asymptomatic males, in endocervical swab specimens from symptomatic or asymptomatic females, and in urethral swab specimens from symptomatic males as evidence infection with C. trachomatis. C. trachomatis DNA is detected by Polymerase Chain Reaction (PCR) amplification of target DNA and by hybridization capture of amplified target using the AMPLICOR analyzer.

Roche Scripts for AMPLICOR CT/NG Test: The Roche Scripts for AMPLICOR CT/NG Test are intended to provide software scripts to direct the automated Tecan Genesis RSP 150 Workstation to process swab samples or control material for analysis using either of the following 510(k)-cleared assay test systems:

• AMPLICOR® CT/NG test for Chlamydia trachomatis
• AMPLICOR® CT/NG test for Neisseria gonorrhoeae

Sample and control preparation can either be accomplished manually or automated using the optional Roche Scripts for AMPLICOR CT/NG Test accessory to direct the Tecan Genesis RSP 150 workstation. Urine specimens are not indicated for use with the automated sample preparation option.

The AMPLICOR CT/NG test for Chlamydia trachomatis is a qualitative in vitro test for the detection of C. trachomatis DNA in urine from symptomatic or asymptomatic males, in endocervical swab specimens from symptomatic or asymptomatic females, and in urethral swab specimens from symptomatic males as evidence infection with C. trachomatis. C. trachomatis DNA is detected by Polymerase Chain Reaction (PCR) amplification of target DNA and by hybridization capture of amplified target using the AMPLICOR analyzer. The Roche Scripts for AMPLICOR CT/NG Test accessory consists of a compact disc (CDs) containing scripts to direct the automated Tecan Genesis RSP 150 workstation to process swab samples or control material for analysis.

This document focuses on the AMPLICOR CT/NG test for Chlamydia trachomatis with optional Roche Scripts for AMPLICOR CT/NG Test Accessory. The primary purpose of the Roche Scripts accessory is to automate the specimen preparation procedure for the existing AMPLICOR CT/NG test. The study therefore aims to demonstrate that the automated preparation method yields equivalent performance to the manual preparation method for the detection of C. trachomatis.

Here's the breakdown of the acceptance criteria and study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list "acceptance criteria" in a quantitative format with specific thresholds to be met. Instead, it states that the performance characteristics were "evaluated" and "results were equivalent to those obtained with manual specimen preparation." The table below summarizes the listed performance characteristics from the "Comparison - similarities" section, indicating that these were similar or equivalent to the predicate device, which used manual preparation. For the "Current Device (automated preparation)" column, the provided values are the reported performance characteristics where they differ or are newly reported for the automated process.

Note: The phrase "Results were equivalent to those obtained with manual specimen preparation" in the "Performance Evaluation" section suggests the overarching acceptance criterion was non-inferiority or equivalence to the established manual method.

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

The document does not explicitly state the sample size used for the clinical evaluation test set where the automated preparation method was compared to the manual method. It only states "A clinical evaluation was performed".

Data Provenance: The document does not specify the country of origin. It is a premarket notification to the FDA, suggesting the studies were conducted to support US regulatory approval. The studies are retrospective, comparing the automated preparation method with the established manual preparation method.

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

This information is not provided in the document. For diagnostic tests like this, the 'ground truth' for clinical samples would typically be established by culture or a combination of clinical diagnosis and other accepted laboratory methods, not usually by a panel of experts reviewing images or results. The analytical studies would have ground truth established by known concentrations of organisms.

4. Adjudication Method for the Test Set

The document does not explicitly describe an "adjudication method" in the context of expert review. Clinical performance is assessed against a comparator (manual method and potentially culture), not through adjudicated expert consensus on each case.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically for image-based diagnostic aids where human readers interpret results. The AMPLICOR CT/NG test is an in vitro diagnostic test that provides a qualitative (positive/negative) result; therefore, an MRMC study is not applicable. The comparison here is between two sample preparation methods for the same assay.

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

This device is an in vitro diagnostic test for detecting DNA. The "Roche Scripts accessory" automates a part of the sample preparation process for an existing, already cleared assay. Therefore, the "algorithm" (scripts) performs an automated laboratory task, not an independent diagnostic interpretation that would involve a "human-in-the-loop" once the assay is run. The overall test is an "algorithm only" in the sense that the assay itself generates a direct result. The study effectively evaluated the standalone performance of the automated sample preparation system in generating results that are equivalent to manual preparation.

7. The Type of Ground Truth Used

For the analytical studies (analytical sensitivity, specificity, precision), the ground truth is established by known concentrations or presence/absence of C. trachomatis (or other organisms for specificity) in laboratory-prepared samples.

For the clinical evaluation, the ground truth for C. trachomatis infection status in patient samples is likely based on:

• Comparison to the manual preparation method of the AMPLICOR CT/NG test itself (labeled as "98.5% concordance with manual method"). This serves as a reference for equivalence, assuming the manual method's clinical performance is validated.
• The predicate device's clinical performance also references "Sensitivity vs. culture" and "Specificity vs. culture". This indicates that bacterial culture was a key ground truth method for validating the diagnostic accuracy of the PCR test itself.

8. The Sample Size for the Training Set

The document does not specify a separate "training set" or its sample size. This is a premarket submission for an in vitro diagnostic (IVD) device, where the focus is on validation and verification of analytical and clinical performance through predefined studies, not typically on machine learning model training. The "Roche Scripts" are software for automation, not an AI/ML diagnostic algorithm that would require a distinct training phase.

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

As there is no distinct "training set" in the context of an AI/ML model for this IVD device (the scripts automate a lab process), the concept of ground truth for a training set does not directly apply here. The existing knowledge and performance characteristics of the manual AMPLICOR CT/NG test would have informed the development and optimization of the automated scripts to ensure equivalent performance.

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The GEN-PROBE APTIMA® Assay for Chlamydia trachomatis is a target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection of ribosomal RNA (rRNA) from Chlamydia trachomatis (CT) to aid in the diagnosis of chlamydial urogenital disease using the TIGRIS® DTS® Automated Analyzer or semiautomated instrumentation as specified. The assay may be used to test the following specimens from symptomatic individuals: clinician-collected endocervical, vaginal and male urethral swab specimens and female and male urine specimens. The assay may be used to test the following specimens from asymptomatic individuals: clinician-collected endocervical, vaginal 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 and processed with the Cytyc ThinPrep® 2000 System.

Clearance of this premarket notification extends the clinical performance claims of the commercially available GEN-PROBE®APTIMA® Assay for Chlamydia trachomatis with the testing of gynecological specimens collected in the PreservCyt® Solution and processed with the Cytyc ThinPrep® 2000 System, for use on the TIGRIS® DTS® System. The ancillary kit for this application is commercially available as the GEN-PROBE APTIMA Specimen Transfer Kit. The components of the APTIMA Specimen Transfer Kit include: (1) a transport tube containing transport media with a penetrable cap and (2) specific instructions for ruse regarding decontamination and specimen processing procedures. The APTIMA Transfer Kit may only be used in conjunction with the APTIMA Assays.

Acceptance Criteria and Device Performance for APTIMA® Assay for Chlamydia trachomatis

The APTIMA® Assay for Chlamydia trachomatis (CT) on the TIGRIS® DTS® System extends the clinical performance claims for testing gynecological specimens collected in PreservCyt® Solution and processed with the Cytyc ThinPrep® 2000 System. The study aimed to demonstrate equivalent performance between the previously validated DTS Systems and the TIGRIS DTS System.

1. Table of Acceptance Criteria and Reported Device Performance

• Positive % Agreement: 100% (94.4-100% CI)
• Negative % Agreement: 100% (93.2-100% CI)
• Overall % Agreement: 100% (96.9-100% CI) |
  | Clinical Performance Equivalence (Clinical Panel Study) | The ACT Assay on the TIGRIS System should show 100% agreement with expected CT results for panel members with varying CT rRNA concentrations (including 0 fg/assay and various positive concentrations) in PreservCyt liquid Pap specimens, and demonstrate equivalence to the DTS Systems. | The percent agreement for each level of rRNA in PreservCyt liquid Pap specimens with the expected CT results for both the TIGRIS System and the DTS Systems was 100% for all panel members. The overall % agreement between TIGRIS and DTS was 100% (97.2-100% CI). |

2. Sample Sizes and Data Provenance

• Analytical Sensitivity: 60 replicates of C. trachomatis rRNA spiked into post-processed PreservCyt liquid Pap specimen pool.
• Analytical Specificity: 24 culture isolates tested.
• Specimen-Caused Inhibition: 239 negative clinical post-processed PreservCyt liquid Pap specimens.
• Interference by Whole Blood: Clinical post-processed PreservCyt liquid Pap specimen pools, tested with 0% and 10% whole blood, both unspiked and spiked with CT rRNA.
• Clinical Specimen Study: 116 PreservCyt specimens from female subjects (81 symptomatic, 35 asymptomatic).
• Clinical Panel Study: 5 panel members, including a negative control and 4 positive concentrations of CT rRNA, prepared by spiking. Total of 132 replicates (12 for negative, 30 for each positive concentration).

Data Provenance: The report indicates a "prospective, multi-center clinical study" was conducted for the clinical performance data. Patient enrollment occurred at "family planning, OB/GYN, public health, and STD clinics." This suggests the clinical data is prospective and collected from various clinical sites. The country of origin is not explicitly stated but implied to be the USA given the FDA 510(k) submission.

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly state the "number of experts" or their specific "qualifications" used to establish ground truth in the traditional sense of expert review for image interpretation or diagnosis.

• For the Clinical Specimen Study, specimens were first screened using "FDA-cleared applications of the APTIMA COMBO 2 (AC2) Assay." The results from this FDA-cleared assay served as the reference standard (ground truth proxy) for comparing the DTS Systems and TIGRIS System results.
• For the Clinical Panel Study, negative PreservCyt specimens were pooled and confirmed negative by testing with the ACT Assay on the DTS Systems. Then, CT ribosomal RNA (rRNA) was spiked at known concentrations to create panel members. The "expected CT results" based on the known spiked concentrations served as the ground truth.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method like 2+1 or 3+1. For the clinical specimen study, the "ground truth" was established by prior testing with an "FDA-cleared" assay (APTIMA COMBO 2 Assay), implying it was considered a reliable reference. Discrepancies, if any, between the test systems (TIGRIS vs. DTS) were analyzed for percent agreement, rather than adjudicated by independent readers. "Specimens with final invalid or equivocal screening results were not selected for testing," suggesting a pre-screening step to ensure data quality.

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

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed as this is an in vitro diagnostic (IVD) assay detection system, not an imaging device requiring human reader interpretation. The study compares the performance of two automated systems (TIGRIS DTS System vs. DTS Systems) for detecting Chlamydia trachomatis. There is no human-in-the-loop component for which an improvement effect size with AI assistance would be relevant.

6. Standalone Performance Study

Yes, a standalone performance study was done for the algorithm (the APTIMA Assay on the TIGRIS DTS System). The entire document describes the analytical and clinical performance of the device on its own, comparing it against a reference standard or a previously cleared device. The "overall % agreement" in the clinical studies directly reflects the standalone performance of the TIGRIS DTS System relative to the DTS system and the expected results.

7. Type of Ground Truth Used

• Analytical Studies (Sensitivity, Specificity, Inhibition, Interference): Ground truth was established by known concentrations of C. trachomatis rRNA or culture isolates, or by the absence of target/interfering substance in controlled laboratory settings.
• Clinical Specimen Study: Ground truth was established by results from a previously FDA-cleared assay (APTIMA COMBO 2 Assay), acting as the reference standard.
• Clinical Panel Study: Ground truth was established by known spiked concentrations of CT ribosomal RNA (rRNA) into confirmed negative PreservCyt specimens.

8. Sample Size for the Training Set

The document describes an analytical validation and clinical performance study for a diagnostic assay, not a machine learning or AI algorithm in the context of a "training set." Therefore, a "training set" as understood in AI/ML development is not applicable here. The assays are based on target amplification nucleic acid probe technology.

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

As explained in point 8, there is no explicit "training set" as this is not an AI/ML device that requires machine learning for its core function. The assay's parameters and cut-offs would have been established during earlier development and validation phases (not detailed in this 510(k) summary), likely using characterized positive and negative samples, similar to the "panel" approach seen in the clinical panel study.

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The APTIMA Assay for Chlamydia trachomatis is a target amplification nucleix acid probe test that utilizes target capture for the in vitro qualitative detection of ribosomal RNA (rRNA) from Chlamydia trachomatis (CT) in clinician-collected endocervical, vaginal and male urethral swab specimens, patient-collected vaginal swab specimens1, and female and male urine specimens. The assay may be used to test specimens from symptomatic and asymptomatic individuals to aid in the diagnosis of chlamydial urogenital disease using the TIGRIS DTS Automated Analyzer or semi-automated instrumentation as specified.

1 Patient-collected vaginal swab specimens are an option for screening women when a pelvic exam is not otherwise indicated. The vaginal swab specimen collection kit is not for home use.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA to Gen-Probe Incorporated regarding their TIGRIS® DTS® Automated Analyzer APTIMA® Assay for Chlamydia trachomatis. While it outlines the device's indications for use and classification, it does not contain the detailed acceptance criteria or the study data that proves the device meets those criteria.

Therefore, I cannot fulfill most of your request directly from this document. The information typically found in a 510(k) summary (which is a separate document often submitted alongside the initial notification) would contain such details.

However, based on the information provided in this letter, I can extract the following:

• Device Name: TIGRIS® DTS® Automated Analyzer APTIMA® Assay for Chlamydia trachomatis
• Indications for Use: The APTIMA Assay for Chlamydia trachomatis is a target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection of ribosomal RNA (rRNA) from Chlamydia trachomatis (CT) in clinician-collected endocervical, vaginal and male urethral swab specimens, patient-collected vaginal swab specimens¹, and female and male urine specimens. The assay may be used to test specimens from symptomatic and asymptomatic individuals to aid in the diagnosis of chlamydial urogenital disease using the TIGRIS DTS Automated Analyzer or semi-automated instrumentation as specified.
  • ¹Patient-collected vaginal swab specimens are an option for screening women when a pelvic exam is not otherwise indicated. The vaginal swab specimen collection kit is not for home use.

To answer the rest of your questions, I would need access to the full 510(k) submission, specifically the sections detailing the performance data and clinical studies.

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