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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 Roche Scripts for COBAS 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:

• COBAS AMPLICOR™ CT/NG test for Chlamydia trachomatis
• COBAS AMPLICOR™ CT/NG test for Neisseria gonorrhoeae

The Roche Scripts for COBAS 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.

The provided text describes a 510(k) summary for the COBAS AMPLICOR CT/NG test for Chlamydia trachomatis with Roche Scripts Accessory. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria.

The document mainly focuses on:

• Device description and intended use of the COBAS AMPLICOR CT/NG test.
• Description of the Roche Scripts accessory (software) to automate sample processing.
• Comparison to a predicate device.
• The FDA's decision letter for 510(k) clearance, confirming substantial equivalence.
• Indications for Use for the Roche Scripts accessory.

There is no mention of:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for test sets, data provenance.
3. Number of experts or their qualifications for ground truthing.
4. Adjudication methods.
5. Multi-reader multi-case (MRMC) comparative effectiveness studies.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

Therefore,Based on the provided text, I cannot describe the acceptance criteria or a study that proves the device meets the acceptance criteria, as this information is not present in the document. The document primarily focuses on the description and intended use of the device and its 510(k) clearance.

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

The AMPLICOR CT/NG Test for Chlamydia trachomatis is a multiplex in vitro diagnostic test for the detection of Chlamydia trachomatis in male and female urogenital specimens. The AMPLICOR CT/NG Test for Chlamydia trachomatis also has an Internal Control that identifies specimens that contain substances inhibitory to PCR.

The AMPLICOR™ CT/NG Test for Chlamydia trachomatis is a qualitative in vitro test designed to detect Chlamydia trachomatis plasmid DNA in urine (from males and females), endocervical swab specimens (from symptomatic or asymptomatic females), and urethral swab specimens (as evidence of symptomatic or asymptomatic infection). The device utilizes Polymerase Chain Reaction (PCR) amplification and hybridization capture of the amplified target DNA.

Acceptance Criteria and Device Performance

The provided document does not explicitly state pre-defined acceptance criteria (e.g., minimum sensitivity or specificity targets). Instead, it presents the results of clinical performance evaluations against a composite reference standard (culture and DFA). The reported performance metrics are:

Study Details

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

   • Total specimens collected: 8521 from 4298 patients.
   • Specimens included in analysis: 8309 (with Internal Control results used) or 8378 (with Internal Control results not used) after excluding equivocal (143) and repeatedly inhibitory (69) specimens.
   • Data Provenance:
     • Country of origin: Not explicitly stated, though the study was conducted at "six geographically diverse sites." The submission to the FDA is from a US company.
     • Retrospective or Prospective: The clinical study appears to be prospective, as specimens were "obtained from all patients entered into the study," and specific inclusion criteria (e.g., patient not on antibiotics, valid culture result, met storage requirements) were applied.

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

   • The ground truth for the clinical study was established by standard culture with cyclohexamide treated McCoy cells stained with fluorescein-labeled monoclonal antibody for C. trachomatis, and for culture-negative swab specimens, DFA (Direct Fluorescent Antibody) for the presence of C. trachomatis.
   • The document does not specify the number of experts or their qualifications for performing these reference methods. These are laboratory-based diagnostic tests, typically performed by trained medical technologists or microbiologists.

3. Adjudication method for the test set:

   • The primary reference standard was a composite of culture and DFA.
   • When the AMPLICOR test results were positive but the composite culture/DFA was negative ("false positive"), alternate PCR testing using oligonucleotide primers targeted for a region of the C. trachomatis MOMP gene was performed. However, the MOMP test results "were not used to calculate the clinical performance characteristics of the test and are reported for information purposes only." This suggests the MOMP assay served as a secondary, confirmatory test for discordant results, but not as part of the primary ground truth adjudication for calculating sensitivity and specificity. There is no mention of a formal expert adjudication panel.

4. 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 test, not an AI system interpreted by human readers. Therefore, the concept of human readers improving with or without AI assistance is not applicable.

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

   • Yes, the data presented reflects the standalone performance of the AMPLICOR CT/NG Test for Chlamydia trachomatis as an in vitro diagnostic device. There is no human-in-the-loop element described for making the diagnostic determination.

6. The type of ground truth used:

   • The ground truth used was a composite reference standard consisting of:
     • Standard cell culture followed by immunofluorescent staining for C. trachomatis.
     • Direct Fluorescent Antibody (DFA) for C. trachomatis on culture-negative swab specimens.
   • Additionally, an alternate PCR (MOMP gene target) was used for investigational purposes to understand discordant results (AMPLICOR positive, culture/DFA negative), suggesting a form of expanded gold standard or latent class analysis was considered, though not formally incorporated into the primary performance calculations.

7. The sample size for the training set:

   • The document does not describe a "training set" in the context of an algorithm or machine learning model. This is a traditional in vitro diagnostic device. The concept of training data is not applicable here. The non-clinical performance studies (analytical sensitivity, specificity, precision) were performed on laboratory-prepared samples.

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

   • As there is no training set for an algorithm described, this question is not applicable. The non-clinical performance studies used known quantities of C. trachomatis IFU (Inclusion Forming Units) or other microbial isolates as their "ground truth" to determine analytical characteristics.

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The COBAS AMPLICOR CT/NG Test for Chlamydia trachomatis is a qualitative in vitro test for the detection of C. trachomatis plasmid DNA in urine from males and females, in endocervical swab specimens, and in male urethral swab specimens as evidence of symptomatic or asymptomatic 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 COBAS AMPLICOR Analyzer.

The COBAS AMPLICOR CT/NG Test for Chlamydia trachomatis is a multiplex in vitro diagnostic test performed on the COBAS AMPLICOR Analyzer. The COBAS AMPLICOR Analyzer automates the annolification, the nucleic acid hybridization, and the colorimetric detection procedures of the Test. The COBAS AMPLICOR CT/NG Test for Chlamydia trachomatis also has an Internal Control that identifies. specimens that contain substances inhibitory to PCR.

Here's a breakdown of the acceptance criteria and study details for the COBAS AMPLICOR™ CT/NG Test for Chlamydia trachomatis, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined "acceptance criteria" in terms of specific sensitivity and specificity thresholds that needed to be met. Instead, it presents the device's performance in comparison to existing gold standards (culture and DFA). The reported performance across various patient groups and specimen types allows implicit evaluation against generally accepted standards for diagnostic tests.

2. Sample Size and Data Provenance (Clinical Study)

• Test Set Sample Size:
  • Total Patients: 4277
  • Total Specimens (initially collected): 8523 (both swab and urine from 4201 patients; urine only from 76 patients)
  • Specimens included in primary analysis (with IC): 8397
  • Specimens included in analysis (without IC): 8478 (after excluding initial equivocal and repeatedly inhibitory results)
• Data Provenance: Retrospective, collected from six geographically diverse sites. Specific countries are not mentioned, but "US Highway 202 Somerville, New Jersey" for Roche suggests the study was likely conducted in the United States.

3. Number of Experts and Qualifications for Ground Truth

• The document does not specify the "number of experts" or their "qualifications" involved in establishing the ground truth.
• The ground truth method used was standard cell culture with immunofluorescent staining for C. trachomatis for positive samples.
• For swab specimens that were culture negative by the COBAS test, DFA (Direct Fluorescent Antibody) testing was performed for the presence of C. trachomatis. These are established laboratory methods.

4. Adjudication Method for the Test Set

• The document describes a hierarchical adjudication method for establishing the ground truth, rather than a traditional consensus by independent experts on the device's results.
• Primary Ground Truth: C. trachomatis cell culture (with cyclohexamide treated McCoy cells stained with fluorescein-labeled monoclonal antibody).
• Secondary Ground Truth (for culture-negative COBAS-positive swabs): DFA (Direct Fluorescent Antibody) for C. trachomatis.
• Tertiary Check (for information only): Alternate PCR testing (MOMP gene target) was performed on COBAS AMPLICOR positive, culture/DFA negative specimens, but these results were explicitly not used to calculate the clinical performance characteristics. This indicates a strict reliance on the established culture/DFA as the ground truth.

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

• No MRMC comparative effectiveness study was done in the context of human readers directly interacting with or improving with AI assistance. This document describes the performance of a standalone in vitro diagnostic (PCR-based) test. The "readers" here are the laboratory technicians conducting and interpreting the instrument's output.

6. Standalone Performance

• Yes, a standalone study was done. The entire clinical performance section (Tables 3-7 and associated text) describes the performance of the COBAS AMPLICOR CT/NG Test as a diagnostic device without human-in-the-loop assistance in its interpretation beyond standard laboratory procedures (e.g., reading optical density and confirming results). It directly compares the device's output to the established gold standard.

7. Type of Ground Truth Used

• The primary ground truth used was a combination of expert-performed laboratory methods:
  • Cell Culture (with immunofluorescent staining) for C. trachomatis.
  • Direct Fluorescent Antibody (DFA) for C. trachomatis (used for culture-negative COBAS-positive samples).
• The MOMP PCR assay was an investigational check for false positives, but its results were not incorporated into the official performance metrics, highlighting adherence to established methods for ground truth.

8. Sample Size for the Training Set

• The document does not provide details on a separate "training set" as would be typical for machine learning algorithms. This device is an in vitro diagnostic (IVD) test, and its development typically involves internal validation and optimization against characterized samples, followed by clinical validation. The data presented is primarily for the clinical validation.

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

• As there is no explicit "training set" discussed in the context of this 510(k) summary for an IVD, the method for establishing its ground truth is not detailed. However, for a device like this, the development process would have involved using characterized C. trachomatis strains and clinical samples with known infection status (determined by culture, etc.) to optimize the assay's primers, probes, and reaction conditions.

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