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The cobas® liat SARS-CoV-2 v2 nucleic acid test is an automated real-time reverse transcription polymerase chain reaction (RT-PCR) test intended for the qualitative detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleic acids in anterior nasal (nasal) and nasopharyngeal swab specimens collected from individuals exhibiting signs and symptoms of respiratory tract infection (i.e., symptomatic). Additionally, this test is intended to be used with nasal and nasopharyngeal swab specimens collected from individuals without signs and symptoms of COVID-19 (i.e., asymptomatic).

The cobas® liat SARS-CoV-2 v2 nucleic acid test is intended for use as an aid in the diagnosis of COVID-19 if used in conjunction with other clinical and epidemiological information and laboratory findings. SARS-CoV-2 RNA is generally detectable in nasal swab and nasopharyngeal swab specimens during the acute phase of infection.

Positive results are indicative of the presence of SARS-CoV-2 RNA. Positive results do not rule out co-infection with other microorganisms. Negative results do not preclude SARS-CoV-2 infection. Negative results must be combined with clinical observations, patient history, and epidemiological information. The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.

A negative result from an asymptomatic individual is presumptive. Additionally, a negative result obtained with a nasal or nasopharyngeal swab collected from an asymptomatic individual should be followed up by testing at least twice over three days with at least 48 hours between tests.

The cobas® liat SARS-CoV-2 v2 nucleic acid test is performed on the cobas® liat analyzer which automates and integrates sample purification, nucleic acid amplification, and detection of the target sequence in biological samples using real-time PCR assays. The assay targets both the ORF1 a/b non-structural region and membrane protein gene that are unique to SARS-CoV-2. An Internal Control (IC) is included to control for adequate processing of the target virus through all steps of the assay process and to monitor the presence of inhibitors in the RT-PCR processes.

The provided text is a 510(k) Clearance Letter for a medical device which does not include information about AI/ML models. Therefore, it's not possible to extract the information you requested about Acceptance Criteria and a study proving an AI/ML device meets those criteria.

The device described, the "cobas liat SARS-CoV-2 v2 nucleic acid test," is an in vitro diagnostic (IVD) device based on real-time RT-PCR technology. It directly detects viral targets and its performance is evaluated through analytical and clinical studies common for IVDs, not against AI/ML performance metrics like sensitivity, specificity, MRMC studies, or multi-reader reviews.

Here's a breakdown of why your requested information isn't present in this document:

• No AI/ML Component: The document describes a traditional RT-PCR assay. There is no mention of algorithms, machine learning, deep learning, or any AI component.
• Performance Metrics Differ: The performance metrics provided (Limit of Detection, Inclusivity, Cross-reactivity, Reproducibility, Positive Percent Agreement, Negative Percent Agreement) are standard for IVD assays. They are not analogous to metrics used for evaluating AI/ML models (e.g., AUC, F1-score, accuracy in image classification, or diagnostic improvement from AI-assistance).
• No Human Reader Interaction: Since it's an automated lab test, there's no "human reader" (like a radiologist) involved in interpreting the device's output in a way that an AI would assist. The output is qualitative (Detected/Not Detected).
• No Ground Truth Experts in the AI Sense: Ground truth for this IVD is established by a "comparator" (another FDA-cleared NAAT) and clinical/epidemiological information, not by multiple human experts reviewing AI outputs or images.
• No Training/Test Set Split for AI: The "test set" and "training set" concepts described in your request are fundamental to AI/ML model development and validation. For this IVD, there's a "clinical performance evaluation" using prospective and retrospective samples, which serves as the validation dataset, but it's not structured as a training/test split for an AI.

Therefore, I cannot provide the requested table and detailed points because the provided document does not pertain to an AI/ML device.

If you have a document describing an AI/ML medical device, please provide that, and I can attempt to extract the relevant information.

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The cobas® SARS-CoV-2 Nucleic acid test for use on the cobas® SARS-CoV-2) is an automated, realtime reverse transcriptase polymerase chain reaction (RT-PCR) test intended for the rapid in vitro qualitative detection of nucleic acid from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in anterior nasal (nasal) and nasopharyngeal swab specimens collected from individuals with signs and symptoms of respiratory tract infection (i.e., symptomatic). Additionally, this test is intended to be used with nasal and necimens collected from individuals without signs and symptoms suspected of COVID-19 (i.e., asymptomatic).

The cobas® SARS-CoV-2 performed on the cobas® Liat® System is intended for use as an aid in the diagnosis of COVID-19 if used in conjunction with other clinical, epidemiologic, and laboratory findings. SARS-CoV-2 RNA is generally detectable in nasal and nasopharyngeal swab specimens during the acute phase of infection.

Positive results are indicative of the presence of SARS-CoV-2 RNA. Positive results do not rule out co-infection with other microorganisms.

A negative result from an asymptomatic individual is presumptive. Additionally, a negative result obtained with a nasal swab collected from an asymptomatic patient should be followed up by testing at least twice over three days with at least 48 hours between tests.

Negative results do not preclude SARS-CoV-2 infection.

The results of this test should not be used as the sole basis for diagnosis, treatment management decisions.

This test is intended for prescription use only and can be used in Point-of-Care settings.

The cobas® SARS-CoV-2 Nucleic acid test for use on the cobas® Liat® System (cobas® SARS-CoV-2) uses real-time reverse transcriptase polymerase chain reaction (RT-PCR) technology to rapidly (approximately 20 minutes) detect SARS-CoV-2 virus from nasopharyngeal and nasal swabs. The automation, small footprint, and easy-to-use interface of the cobas® Liat® System enable performance of this test to occur at the POC or in a clinical laboratory setting.

The cobas® SARS-CoV-2 assay is performed on the cobas® Liat® Analyzer which automates and integrates sample purification, nucleic acid amplification, and detection of the target sequence in biological samples using real-time RT-PCR assays. The assay targets both the ORF1 a/b nonstructural region and nucleocapsid protein gene that are unique to SARS-CoV-2. An Internal Process Control (IPC) is also included. The IPC is present to control for adequate processing of the target virus through steps of sample purification, nucleic acid amplification, and to monitor the presence of inhibitors in the RT-PCR processes.

Here's an analysis of the acceptance criteria and study findings for the "cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System" based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the clinical performance evaluation results, specifically the Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) with a composite comparator method. While explicit acceptance criteria values are not stated (e.g., "PPA must be >X%"), the device's performance is presented to demonstrate its effectiveness.

Study Information

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

   • Clinical Performance Evaluation (Test Set):
     • Evaluable NPS samples: 1874 (fresh and frozen)
       • Symptomatic: 673 NPS
       • Asymptomatic: 1201 NPS (413 suspected, 788 no suspicion)
     • Evaluable NS samples: 1872 (fresh and frozen, including 1 indeterminate result)
       • Symptomatic: 674 NS
       • Asymptomatic: 1198 NS (411 suspected, 787 no suspicion)
     • Frozen Samples (included in above totals): 23 positive and 23 negative NPS specimens, and 23 positive and 23 negative NS specimens.
     • Data Provenance: Prospectively collected clinical specimens from February-June 2022 (fresh samples) and earlier during the COVID-19 pandemic (March-June 2021) for frozen samples. The document does not specify the country of origin, but it implies collection within "10 point-of-care healthcare facilities" without further geographic detail.

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 test set was established using a composite comparator method consisting of "three highly sensitive FDA-EUA-authorized laboratory-based RT-PCR assays."
   • The document does not specify the number or qualifications of human experts involved in establishing this ground truth. The ground truth relies on the performance of these reference RT-PCR assays.

3. Adjudication method for the test set:

   • The text describes a "composite comparator method" using "three highly sensitive FDA-EUA-authorized laboratory-based RT-PCR assays." This implies a form of consensus or a predefined algorithm for combining the results of these three assays to establish the definitive positive or negative status. However, the specific adjudication rules (e.g., "2 out of 3 positive for overall positive") are not explicitly described.

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 MRMC comparative effectiveness study involving human readers or AI assistance is described. This study focuses on the standalone performance of the cobas SARS-CoV-2 test.

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

   • Yes, a standalone performance study was done. The entire clinical performance evaluation section (Section 7) describes the performance of the "cobas SARS-CoV-2 test" (the device/algorithm) against a composite comparator method (ground truth) without human intervention in the result interpretation of the device. The device itself is an automated RT-PCR test.

6. The type of ground truth used:

   • The ground truth used was a composite comparator method based on the results from "three highly sensitive FDA-EUA-authorized laboratory-based RT-PCR assays." This is a form of laboratory reference standard.

7. The sample size for the training set:

   • The document describes a clinical performance evaluation (test set) and analytical studies. It does not provide information about the sample size of a specific "training set" for the device, as it is a molecular diagnostic test rather than a machine learning algorithm that typically undergoes explicit training on large datasets in the way an AI image analysis product would. The development (implied "training" in a broader sense for assay optimization) would have used various samples, but these are not explicitly detailed as a distinct training set in the provided text.

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

   • As no explicit "training set" with established ground truth is described in the context of typical AI/ML development, this question cannot be answered from the provided text. The assay development would involve extensive analytical validation using characterized viral samples and clinical specimens validated by reference methods, which broadly contribute to optimizing the assay's performance.

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ID NOW COVID-19 2.0 performed on the ID NOW Instrument is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology (NAAT) intended for the qualitative detection of nucleic acid from SARS-CoV-2 in direct anterior nasal (nasal) or nasopharyngeal swabs from individuals with signs and symptoms of respiratory tract infection. ID NOW COVID-19 2.0 performed on the ID NOW Instrument is intended for use as an aid in the diagnosis of COVID-19 if used in conjunction with other clinical, epidemiologic, and laboratory findings. SARS-CoV-2 RNA is generally detectable in nasal and nasopharyngeal swab specimens during the acute phase of infection.

Positive results are indicative of the presence of SARS-CoV-2 RNA. Positive results do not preclude co-infection with bacteria or other viruses and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.

A negative test result is presumptive, and it is recommended these results be confirmed by another molecular SARS-CoV-2 assay. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. This test is intended for prescription use only and can be used in Pointof-Care settings.

ID NOW COVID-19 2.0 is a rapid, instrument-based isothermal test for the qualitative detection of nucleic acid from SARS-CoV-2 viral RNA in direct nasal or nasopharyngeal swabs. The ID NOW COVID-19 2.0 System utilizes isothermal nucleic acid amplification technology and is comprised of:

• Sample Receiver single use, disposable containing the elution buffer.
• Test Base single use, disposable comprising two sealed reaction tubes, each containing a lyophilized pellet.
• Transfer Cartridge - single use, disposable for transfer of the eluted sample to the Test Base
• Patient Swabs sterile anterior nasal swabs (foam) for anterior nasal swab collection and for use as a Negative Control Swab
• Positive Control Swab - single use, to ensure that test reagents are working properly and that the test is correctly performed, and
• ID NOW Instrument

The reaction tubes in the Test Base contain lyophilized reagents required for amplification of the target nucleic acid and an internal control. ID NOW COVID-19 2.outilizes a pair of templates (similar to primers) for the specific amplification of RNA from SARS-CoV-2 and a fluorescently labeled molecular beacon designed to specifically identify the amplified nucleic acid targets. ID NOW COVID-19 2.0 is performed within the confinement of the Test Base, and no other part of the ID NOW Instrument has contact with the sample during the amplification process. This minimizes the risk of instrument contamination and sample carry-over between measurements.

To perform the assay, the Sample Receiver and Test Base are inserted into the ID NOW Instrument. The sample is added to the Sample Receiver and transfer Cartridge to the Test Base, resuspending the lyophilized pellets contained within the Test Base and initiating viral lysis and target amplification. Heating, mixing and detection by fluorescence is provided by the instrument, with results automatically reported.

Results are displayed by the ID NOW Instrument and are also stored in an on-board archive and are assigned to a sample ID that has been entered into the ID NOW Instrument by the operator either manually or using barcode scanner. Data can be retrieved and downloaded by the operator at any time after testing. An external Universal Printer can be attached via USB to the ID NOW Instrument to print test results.

The provided text describes the performance of the ID NOW COVID-19 2.0 device, which is an in vitro diagnostic test for SARS-CoV-2.

Here's an analysis addressing your questions, keeping in mind that this is a diagnostic test and not an AI-assisted imaging device, so some questions (like MRMC studies) are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

For diagnostic tests, "acceptance criteria" are typically defined by performance targets for sensitivity (Positive Agreement) and specificity (Negative Agreement). These are assessed against a highly accurate comparator method (Ground Truth).

Acceptance Criteria (Implied by High Performance and Clinical Utility for a Molecular Test) and Reported Device Performance:

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

• Sample Size for Clinical Test Set: 914 specimens (460 anterior nasal swabs and 454 nasopharyngeal swabs).
• Data Provenance:
  • Country of Origin: United States (US). The study was conducted at twenty-one (21) US sites.
  • Retrospective or Prospective: Prospective clinical study. Specimens were collected from individuals showing signs and symptoms of upper respiratory infection at the time of enrollment.

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

This is a diagnostic test based on molecular detection, not an imaging device requiring expert reader interpretation for ground truth.

• Number of "Experts": Not applicable in the context of human readers for establishing ground truth for individual cases. The ground truth was established by a composite comparator method using three (3) FDA Emergency Use Authorized real-time Polymerase Chain Reaction (RT-PCR) assays. This method is considered the "gold standard" for SARS-CoV-2 detection.
• Qualifications of Experts: N/A for individual case ground truth. The RT-PCR assays are performed by laboratory personnel following established protocols.

4. Adjudication Method for the Test Set

The ground truth was established by a composite comparator method using three (3) FDA Emergency Use Authorized real-time Polymerase Chain Reaction (RT-PCR) assays. This implies that the consensus or outcome of these highly sensitive and specific molecular tests served as the ground truth. The document does not describe a human adjudication process, as the ground truth is derived from objective molecular testing results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• Was it done?: No, an MRMC study was not conducted for this device.
• Effect Size of Human Readers Improvement with AI vs. without AI assistance: This question is not applicable as the ID NOW COVID-19 2.0 is a standalone molecular diagnostic test, not an AI-assisted diagnostic tool for human readers.

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

• Was it done?: Yes, the clinical performance study evaluated the standalone performance of the ID NOW COVID-19 2.0 device. The results are automatically reported by the ID NOW Instrument (see Device Description), meaning there is no human interpretation of the raw signal or algorithm output before a result is given. Results are "Positive," "Negative," or "Invalid."

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the clinical study was established using a composite comparator method consisting of three (3) FDA Emergency Use Authorized real-time Polymerase Chain Reaction (RT-PCR) assays for the detection of SARS-CoV-2. This is considered a molecular gold standard or definitive diagnostic method.

8. The Sample Size for the Training Set

The document does not explicitly state the sample size for a "training set" in the context of machine learning model development. This is a traditional IVD device, not an AI/ML diagnostic. The analytical studies (LoD, Inclusivity, Cross-Reactivity, Interference) and clinical study are part of the validation process, not "training" of an AI model.

• Training Set Size: Not applicable/not explicitly stated as this is not an AI/ML device that undergoes a discrete training phase with labeled data in the same way. The development and optimization of the assay itself would involve iterative testing, but this is different from an AI "training set."

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

• How Ground Truth for Training was Established: Not applicable as this is a molecular diagnostic test, not an AI/ML device requiring a distinct training set with established ground truth labels in the typical AI sense. The assay's analytical characteristics and performance are established through experiments and clinical trials.

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