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The AMPLICOR CT/NG test for Neisseria gonorrhoeae is a qualitative in vitro test for the detection of N. gonorrhoeae 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 of infection with N. gonorrhoeae. N. gonorrhoeae DNA is detected by Polymerase Chain Reaction (PCR) amplification of target DNA and by hybridization capture of amplified target.

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.

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 .

The AMPLICOR CT/NG test for Neisseria gonorrhoeae is a qualitative in vitro test for the detection of N. gonorrhoeae DNA in urine from symptomatic or asymptomatic males, in endocervical swab specimens from symptomatic or asymptomatic females, and in urethral swab specimens from sympotmatic males as evidence infection with N. gonorrhoeae. N. gonorrhoeae 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.

The document describes the AMPLICOR CT/NG test for Neisseria gonorrhoeae and the Roche Scripts for AMPLICOR CT/NG Test Accessory. The 'device' in question appears to be the Roche Scripts accessory which enables automated sample preparation for the existing AMPLICOR CT/NG test. The acceptance criteria and supporting studies focus on demonstrating that the automated sample preparation method (using the Roche Scripts) performs equivalently to the previously cleared manual sample preparation method.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated with numerical targets for the Roche Scripts accessory itself, but rather established through demonstrating equivalence to the performance of the predicate device (AMPLICOR CT/NG test for Neisseria gonorrhoeae with manual preparation). The acceptance is therefore implicitly based on demonstrating that the automated preparation method does not negatively impact the established performance characteristics.

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

• Analytical Sensitivity (Automated preparation): The document states "100 cfu/mL for CTM with swab specimen" without specifying the number of samples used to determine this.
• Precision (Automated preparation): "99.4% correct results for panels of CTM specimens" without specifying the number of CTM specimens or the total number of tests.
• Clinical Evaluation (Automated vs. Manual): The sample size for the clinical evaluation comparing automated and manual methods is not explicitly stated. The data provenance (country of origin, retrospective/prospective) is not specified. However, the study involved comparing results from the automated method to the manual method, implying existing clinical samples or prospectively collected samples analyzed by both methods.

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

Not applicable. This is an in vitro diagnostic device, and the ground truth for Neisseria gonorrhoeae infection is typically established via culture (a laboratory method), not by expert human interpretation of images or other subjective data. No experts for ground truth establishment are mentioned or implied.

4. Adjudication Method for the Test Set

Not applicable. As this is an in vitro diagnostic device, the results are quantitative/qualitative outputs from the assay, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This device is an in vitro diagnostic test system, not an AI-assisted diagnostic imaging or pathology tool involving human readers.

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

The device (Roche Scripts accessory) is essentially a standalone automation algorithm. Its performance is evaluated in a standalone manner by comparing its output (after automated sample prep) to the manual method's output. The "algorithm only" performance is represented by the "Automated preparation" columns in the table above and the clinical evaluation comparing automated vs. manual methods.

7. The Type of Ground Truth Used

For the original AMPLICOR CT/NG test (to which the new automated method is compared), the clinical performance ground truth was established "vs. culture." Culture is considered the gold standard for detecting viable Neisseria gonorrhoeae. For the evaluation of the Roche Scripts accessory, the "ground truth" for the clinical evaluation was implicitly the results obtained by the manual preparation method of the already cleared AMPLICOR CT/NG test, as the key objective was to show concordance.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML model that undergoes a 'training phase' in the traditional sense. The "Roche Scripts" are software instructions for a liquid handling system; they were "developed" but not "trained" on a dataset like an AI algorithm.

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

Not applicable, as there is no "training set" in the context of an AI/ML algorithm. If "training set" refers to samples used during the development and optimization of the scripts, this information is not provided. The document states "The Roche Scripts were developed and evaluated according to FDA Guidance evaluation documents." This implies standard software development and verification procedures.

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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 (CD) containing software scripts which direct the automated Tecan Genesis RSP 150 Workstation to process swab samples or control material for analysis.

Here's an analysis of the provided text regarding the COBAS AMPLICOR CT/NG test for Neisseria gonorrhoeae with Roche Scripts Accessory, focusing on acceptance criteria and supporting studies.

Based on the provided K053289 document, the submission is primarily for the Roche Scripts for COBAS AMPLICOR CT/NG Test accessory, which consists of software scripts to automate sample processing for an already cleared assay. The acceptance criteria and study detailed in the document are therefore focused on demonstrating that the use of these scripts with the automated workstation does not negatively impact the performance of the existing COBAS AMPLICOR CT/NG test.

The document states: "We claim equivalence to the currently marketed COBAS AMPLICOR CT/NG test for Neisseria gonorrhoeae cleared under K974342." This implies that the performance of the new system (Automated workstation + Roche Scripts + COBAS AMPLICOR assay) must be comparable to the performance of the predicate device (Manual sample processing + COBAS AMPLICOR assay).

However, the provided text does not explicitly state specific numerical acceptance criteria or detail a study that directly reports device performance against such criteria for the Roche Scripts accessory itself. The document acts as a 510(k) summary, which generally provides an overview rather than full study reports.

Thus, I will describe the implied acceptance criteria based on the information provided, and what kind of study would typically be performed for such a submission, even if the specific data is not present in this summary.

Acceptance Criteria and Study Information for the Roche Scripts for COBAS AMPLICOR CT/NG Test

Given that this submission is for an accessory (software scripts) to automate sample processing for an existing, cleared diagnostic test, the primary "acceptance criterion" is demonstrations of substantial equivalence to the predicate device, specifically that the automation does not compromise the accuracy, precision, or overall performance of the existing assay.

Implied Acceptance Criteria and Reported Device Performance (based on principles of substantial equivalence for an automation accessory):

Study Details (Based on typical requirements for automation accessories, and inferences from the provided text):

Since the provided document is a 510(k) Summary, it contains limited detail about the actual study methodology and results. However, we can infer the type of study that would have been conducted for such a device: a method comparison or bridging study demonstrating that the automated sample processing system performs comparably to the manual (predicate) method.

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

   • Test Set Sample Size: Not explicitly stated in the summary. For a method comparison, typically hundreds to thousands of clinical samples (both positive and negative for N. gonorrhoeae) would be tested in parallel using both the automated and manual methods, alongside analytical samples (e.g., spiked samples, controls).
   • Data Provenance: Not explicitly stated. Likely retrospective clinical samples, potentially supplemented by archived prospective samples or newly collected prospective samples. The country of origin is not mentioned, but given Roche Diagnostics' global operations, it could be multi-site, potentially including US sites.

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

   • Number of Experts/Qualifications: This information is not provided for the Roche Scripts accessory. For diagnostic tests, ground truth for sample status (N. gonorrhoeae positive/negative) would typically involve a combination of:
     • Culture: Considered a gold standard for N. gonorrhoeae. Testing a subset of samples by culture would establish definitive ground truth.
     • Discrepancy Testing: For samples with discordant results between the candidate device (automated) and the predicate device (manual), or between either and culture, secondary, highly sensitive and specific molecular methods (e.g., a another PCR assay or sequencing) would be used, often by reference laboratories, to adjudicate the true status. This would be overseen by clinical microbiologists or infectious disease specialists.

3. Adjudication method for the test set:

   • Not explicitly stated. For diagnostics comparing a new method to a predicate, and where culture or another highly reliable method isn't applied to all samples, the adjudication typically involves:
     • Discrepancy Resolution: Samples that yield different results between the new method and the predicate method, or between either method and an alternative reference method (if used), are re-tested, often using a "tie-breaker" method (e.g., a confirmatory PCR, sequencing, or a different validated assay) whose results are then used as the 'adjudicated truth' for that specific sample. There isn't typically a "2+1" or "3+1" expert consensus method as would be seen in image-based diagnostic AI.

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:

   • Not applicable. This device is an in vitro diagnostic (IVD) for detecting bacterial DNA, not an imaging device or an AI application designed to assist human readers in interpretation. There are no "human readers" interpreting images or clinical data that would be assisted by this software. The software automates a laboratory process.

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

   • Yes, effectively. The primary "performance" studied for the Roche Scripts accessory would be its standalone ability to correctly direct the Tecan Genesis RSP 150 Workstation to prepare samples, and for the prepared samples to yield results comparable to manually processed samples when run on the COBAS AMPLICOR assay. The scripts themselves are not making diagnostic interpretations; they are automating a physical sample preparation process that leads to a result from the COBAS AMPLICOR instrument. The "algorithm" (scripts) performance is evaluated by the outcome of the sample preparation it controls.

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

   • Likely a composite reference standard involving clinical culture, possibly combined with an alternative validated molecular diagnostic test (e.g., a different PCR assay), especially for samples with discordant results between the automated and manual methods, or for samples where culture is not feasible or sensitive enough (e.g., for certain N. gonorrhoeae sample types or low titers). The status of the patient (symptomatic/asymptomatic) is also considered in the context of the intended use, but the N. gonorrhoeae positivity is based on laboratory results.

7. The sample size for the training set:

   • The provided document does not mention a training set sample size. For an automation accessory like this, there isn't a "training set" in the machine learning sense. The scripts are deterministic instructions. Development and verification of the scripts would involve internal testing, debugging, and validation using a variety of engineered and clinical samples, but this isn't typically termed a "training set" for statistical performance evaluation like a machine learning model.

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

   • Not applicable as there is no "training set" in the context of machine learning for these deterministic software scripts. The functionalities directed by the scripts would have been verified during software development against engineering specifications and the known correct sequence of operations for sample processing.

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The AMPLICOR® CT/NG Test for Neisseria gonorrhoeae is a qualitative in vitro test for the detection of Neisseria gonorrhoeae in clinical specimens. The test utilizes polymerase chain reaction (PCR) for the multiplex nucleic acid amplification of Neisseria gonorrhoeae and Chlamydia trachomatis DNA in endocervical and male urethral swab specimens and in male and female urine specimens from symptomatic and asymptomatic patients, and target-specific probe hybridization capture for the detection of the amplified Neisseria gonorrhoeae DNA.

The AMPLICOR CT/NG Test for Neisseria gonorrhoeae is a multiplex in vitro diagnostic test that enables the simultaneous amplification of Neisseria gonorrhoeae, Chlamydia trachomatis and an Internal Control sequence in a sample. The Test is designed for use with the Perkin Elmer 2400 or the Perkin Elmer 9600 thermal cycler for nucleic acid amplification of target DNA by polymerase chain reaction, and colorimetric detection using a conventional microwell plate washer and reader. The AMPLICOR CT/NG Test also incorporates an Internal Control for the identification of specimens that contain inhibitory substances to the PCR amplification reaction.

Here's an analysis of the acceptance criteria and study detailed in the provided K974503 submission for the Roche AMPLICOR® CT/NG Test for Neisseria gonorrhoeae:

Acceptance Criteria and Device Performance for Roche AMPLICOR® CT/NG Test for Neisseria gonorrhoeae

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria in a table format. However, based on the clinical performance data presented, the implicit acceptance criteria would relate to demonstrating substantial equivalence to culture methods, with acceptable sensitivity and specificity values across different specimen types and patient populations.

The reported device performance metrics are as follows:

Analytical Performance (Limit of Detection):

• Sensitivity (LoD): 5 CFU/test for each of 15 isolates tested. The device gave positive results for all strains at 20, 10, and 5 CFU/test. At 1 CFU/test, at least one replicate was positive for all 15 strains, and at 2 CFU/test, all three replicates were positive for 14 of 15 strains.

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

• Test Set Sample Size: A total of 5374 specimens were collected and tested in the clinical study. After excluding 33 repeatedly inhibitory specimens, 5341 specimens were used in the primary analyses (when the Internal Control result was used).
• Data Provenance: The clinical study was conducted at six geographically diverse sites. The document does not specify the country of origin, but given the submission to the US FDA, it is highly likely the data includes, or is primarily from, studies conducted in the United States. The study appears to be prospective, as it describes the evaluation of the test comparing its results to culture, implying these were collected and processed specifically for this evaluation.

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

• The ground truth was established by Neisseria gonorrhoeae culture results. The document does not specify the number of individuals or "experts" involved in performing and interpreting these culture results, nor their specific qualifications (e.g., medical technologists, microbiologists). However, culture with confirmation by biochemical and immunologic assays is referred to as "the international gold standard methods," implying established and accepted laboratory practices were followed.

4. Adjudication Method for the Test Set:

• For specimens with discrepant results between the AMPLICOR CT/NG Test and the Neisseria gonorrhoeae culture, an alternate primer (16S rRNA) PCR test was used.
• Crucially, the alternate primer PCR test results were not used to calculate the clinical performance characteristics (sensitivity, specificity) of the AMPLICOR test. They were reported "for information purposes only," primarily to investigate apparent false positives and potential true positives missed by culture. This suggests a form of modified discrepant analysis, where the third method (16S rRNA PCR) helped to understand discrepancies but did not directly alter the primary performance calculations derived solely from comparison to culture.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as part of this submission. This is a diagnostic test where the output is directly reported by the instrument based on molecular detection, not interpreted by a human reader in the traditional MRMC sense. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

6. Standalone Performance:

• Yes, a standalone performance study was done. The entire clinical performance section describes the algorithm-only performance (AMPLICOR CT/NG Test) against the culture-based ground truth. There is no human-in-the-loop component for interpretation or decision-making inherent in the device described.

7. Type of Ground Truth Used:

• The primary ground truth used was Neisseria gonorrhoeae culture results. This is considered the "international gold standard methods for detection" at the time of the submission.
• For discrepant analysis, an alternate primer (16S rRNA) PCR test was used, but its results did not directly modify the primary calculation of sensitivity and specificity based on culture.

8. Sample Size for the Training Set:

• The document does not explicitly state a separate training set sample size. This is common for older diagnostic assay submissions, where a "discovery" or "development" phase dataset might have been used but is not formally disclosed as a "training set" in the same way machine learning models typically define it. The non-clinical performance (analytical sensitivity, specificity, precision) demonstrates rigorous characterization of the assay's fundamental properties.

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

• As a dedicated "training set" is not explicitly mentioned, the establishment of ground truth specifically for it cannot be detailed. However, for the analytical studies (non-clinical performance), ground truth was established by:
  • Known concentrations of Neisseria gonorrhoeae CFU/test for analytical sensitivity and precision studies.
  • Known organisms (bacteria, fungi, protozoa, viruses) at specified genomic DNA concentrations for analytical specificity studies. These would have been characterized externally (e.g., from American Type Culture Collection) to confirm their identity.

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The COBAS AMPLICOR™ CT/NG Test for Neisseria gonorrhoeae is a qualitative in vitro diagnostic test for the detection of Neisseria gonorrhoeae in clinical specimens. The test is intended for use with the COBAS AMPLICOR Analyzer (K964506). The test utilizes polymerase chain reaction (PCR) for the multiplex nucleic acid amplification of Neisseria gonorrhoeae and Chlamydia trachomatis DNA and target-specific probe hybridization capture for the detection of the amplified Neisseria gonorrhoeae DNA in endocervical swab specimens obtained from asymptomatic and symptomatic female patients, urethral swab specimens obtained from symptomatic male patients and urine specimens obtained from asymptomatic and symptomatic male patients. Testing of male urine specimens may only be performed in conjunction with the use of the Internal Control.

The COBAS AMPLICOR CT/NG Test for Neisseria gonorthoeae is a qualitative in vitro test for the detection of N. gonorrhoeae 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 of infection with N. gonorrhoeae. N. gonorrhoeae 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 Neisseria gonorrhoeae is a multiplex in vitro diagnostic test performed on the COBAS AMPLICOR Analyzer. The COBAS AMPLICOR Analyzer automates the amplification, the nucleic acid hybridization, and the colorimetric detection procedures of the Test. The COBAS AMPLICOR CT/NG Test for Neisseria gonorrhoeae also has an Internal Control for the identification of specimens that contain PCR inhibitors.

{
  "acceptance_criteria_and_performance_table": {
    "title": "Clinical Performance of COBAS AMPLICOR CT/NG Test for Neisseria gonorrhoeae (Internal Control Used)",
    "columns": [
      {
        "header": "Metric",
        "data_keys": ["metric"]
      },
      {
        "header": "Female - Asymptomatic CTM",
        "data_keys": ["female_asymptomatic_ctm_sensitivity", "female_asymptomatic_ctm_specificity"]
      },
      {
        "header": "Female - Symptomatic CTM",
        "data_keys": ["female_symptomatic_ctm_sensitivity", "female_symptomatic_ctm_specificity"]
      },
      {
        "header": "Total for Females",
        "data_keys": ["total_female_sensitivity", "total_female_specificity"]
      },
      {
        "header": "Male - Symptomatic CTM",
        "data_keys": ["male_symptomatic_ctm_sensitivity", "male_symptomatic_ctm_specificity"]
      },
      {
        "header": "Male - Asymptomatic Urine",
        "data_keys": ["male_asymptomatic_urine_sensitivity", "male_asymptomatic_urine_specificity"]
      },
      {
        "header": "Male - Symptomatic Urine",
        "data_keys": ["male_symptomatic_urine_sensitivity", "male_symptomatic_urine_specificity"]
      },
      {
        "header": "Total for Males",
        "data_keys": ["total_male_sensitivity", "total_male_specificity"]
      }
    ],
    "rows": [
      {
        "metric": "Sensitivity (95% CI)",
        "female_asymptomatic_ctm_sensitivity": "98.0% (89.3-99.9)",
        "female_symptomatic_ctm_sensitivity": "94.5% (86.6-98.5)",
        "total_female_sensitivity": "95.9% (90.8-98.7)",
        "male_symptomatic_ctm_sensitivity": "99.4% (97.9-99.9)",
        "male_asymptomatic_urine_sensitivity": "75.0% (42.8-94.5)",
        "male_symptomatic_urine_sensitivity": "96.0% (93.9-98.1)",
        "total_male_sensitivity": "97.3% (96.1-98.5)"
      },
      {
        "metric": "Specificity (95% CI)",
        "female_asymptomatic_ctm_specificity": "98.7% (98.1-99.4)",
        "female_symptomatic_ctm_specificity": "98.7% (98.0-99.4)",
        "total_female_specificity": "98.7% (98.2-99.2)",
        "male_symptomatic_ctm_specificity": "96.2% (95.0-97.5)",
        "male_asymptomatic_urine_specificity": "99.6% (98.8-99.9)",
        "male_symptomatic_urine_specificity": "97.6% (96.6-98.6)",
        "total_male_specificity": "97.7% (97.1-98.3)"
      }
    ],
    "acceptance_criteria_stated": "The document does not explicitly state numerical acceptance criteria for sensitivity and specificity. However, the FDA's acceptance of the 510(k) submission ([K974342](https://510k.innolitics.com/search/K974342)) implies that the demonstrated clinical performance was deemed satisfactory for substantial equivalence."
  },
  "study_information": {
    "test_set_sample_size": "5442 specimens (after excluding 44 repeatedly inhibitory specimens from an initial 5486)",
    "data_provenance": {
      "country_of_origin": "Not explicitly stated, but the study was conducted at six geographically diverse sites.",
      "retrospective_or_prospective": "Prospective (clinical study conducted at multiple sites)"
    },
    "number_of_experts_ground_truth": "Not specified for establishing ground truth from culture results.",
    "qualifications_of_experts": "Not specified, but the ground truth was established by Neisseria gonorrhoeae culture results, which are considered a 'gold standard'.",
    "adjudication_method": "For discrepant results between the device and culture, an 'alternate primer (16S rRNA) PCR test' was used. However, the results of this alternate PCR test were explicitly *not* used to calculate the clinical performance characteristics of the device but were reported for informational purposes only. This indicates a form of reconciliation, but not a full adjudication where the adjudicator's result defines the final ground truth for original performance calculation.",
    "mrmc_comparative_effectiveness_study": {
      "performed": false,
      "effect_size": "N/A"
    },
    "standalone_performance": true,
    "type_of_ground_truth": "Neisseria gonorrhoeae culture results were considered the primary ground truth. For discrepant results, an alternate primer (16S rRNA) PCR test was used for informational purposes.",
    "training_set_sample_size": "Not specified in the provided text.",
    "training_set_ground_truth_establishment": "Not specified in the provided text."
  }
}

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