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OmniTrans™ Transport System is intended for use in the collection of clinical specimens (i.e., sputum, throat/ oropharyngeal swab, whole blood, urine, skin lesion material or exudate) potentially containing viruses, chlamydiae, mycoplasma, or ureaplasma and in their transport from the collection site to the testing laboratory. The system can be processed using standard clinical laboratory operating procedures for culture of clinical specimens.

OmniTrans™ Transport System includes a screw-cap tube containing transport medium, which can be supplied alone, or in a kit with one of two possible collection swab options in a sterile peel pouch or with two collection swabs in sterile peel pouches.

The in-tube-only format contains labeled screw-cap tubes pre-filled with 1 mL, 1.5 mL, or 3 mL of transport medium. The in-kit screw-cap tube format is pre-filled with 1 or 3 mL of transport medium for safe transportation of biological specimens.

The format in kit is supplied in pre-packaged collection sets containing one of the two swab types or both of two swab types:

Minitip flocking swab with 8 cm breaking point.

Regular flocking swab with 3 cm breaking point.

A specimen bag, with appropriate biosafety warning labels, is also provided with the device for safe transportation of clinical specimens in the transport medium.

The provided text describes the OmniTrans Transport System, a device for collecting and transporting clinical specimens. The key acceptance criteria and performance data are primarily focused on the device's ability to maintain the viability of various microorganisms (viruses, chlamydiae, mycoplasma, and ureaplasma) over time and temperature during transport.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as a single number. The shelf-life stability tests involved "all lots tested at each time point," "five replicates from each lot," and "medium lots of serial post-production ages (0-, 6-, 12-, 18-, and >18-months) and "an old (>18 months at test) and a new (<3 months) lot." For microbial recovery studies, "each dilution was transferred with a swab into OmniTrans™ Transport System in triplicate."
• Data Provenance:
  • Country of Origin: Shenzhen Dakewe Bio-engineering Co., Ltd. is based in Shenzhen, Guangdong, China. The clinical matrices were obtained from "donors testing negative for respective target pathogens." No specific country of origin for these donors is mentioned, but it's likely where the company operates or conducts its studies.
  • Retrospective or Prospective: The shelf-life stability tests were prospective in nature, involving "serially conducted real-time aging performance tests at post-production time points." The microbial recovery studies also appear to be prospective laboratory studies using laboratory-created inocula and negative clinical matrices.

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

This type of information (number of experts, their qualifications, and their role in establishing ground truth) is not applicable to this device. The OmniTrans Transport System is a transport medium, and its performance is evaluated based on the viability of microorganisms, which is determined through laboratory assays (fluorescent foci counts and CFU counts), not expert interpretation of clinical images or data.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used when human interpretation (e.g., radiology reads) is involved and discrepancies need to be resolved to establish ground truth. For this device, ground truth is established by quantitative laboratory measurements of microbial viability.

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

No, an MRMC comparative effectiveness study was not done. This type of study relates to human interpretation, often in the context of AI assistance, which is not relevant for a microorganism transport medium.

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

This is not applicable. The device is not an algorithm or AI system. Its performance is entirely "standalone" in that it's a physical transport medium designed to maintain microbial viability.

7. The Type of Ground Truth Used

The ground truth used for evaluating the OmniTrans Transport System is laboratory-based quantitative microbial viability data. This includes:

• Fluorescent Foci Counts: For viruses and chlamydiae, indicating the number of infectious particles.
• Colony Forming Units (CFUs): For mycoplasma and ureaplasma, indicating the number of viable bacteria.
• Qualitative and Quantitative Measures for Physical/Chemical Stability: Visual inspection for appearance, volumetric measurements for net content, and pH measurements.
• Microbial Growth/No Growth: For sterility testing.
• Microbial Count Changes: For microbial stasis testing.

8. The Sample Size for the Training Set

This is not applicable. The OmniTrans Transport System is a physical product (a transport medium), not a machine learning model. Therefore, there is no "training set" in the context of AI/ML.

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

This is not applicable as there is no training set for this device.

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BioSci™ Disposable Virus Sampling Tube is intended for the collection and transport of clinical specimens containing viruses or chlamydiae from the collection site to the testing laboratory. The system can be processed using standard clinical laboratory operating procedures for culture of clinical specimens.

BioSci Disposable Virus Sampling Tube includes a screw-cap tube containing transport medium which is divided into two formats – in kit and tube. The format in kit is supplied in pre-packaged collection sets containing one of the two swab types or both of two swabs types: 1. Minitip (2.5 mm tip) flocking swab with 8 cm breaking point, for nasopharyngeal specimen collection 2. Regular (5 mm tip) flocking swab with 3 cm breaking point, for oropharyngeal specimen collection The screw-cap tube in kit format is pre-filled with 1 or 3 mL of transport medium for safe transportation of biological specimen. The format in tube only contains labeled screw-cap tubes pre-filled with 1 mL, 1.5mL, 2 mL and 3 mL of transport medium.

The input provided describes a 510(k) premarket notification for a medical device called "BioSci Disposable Virus Sampling Tube." It outlines the device's intended use, description, comparison with a predicate device, shelf-life stability, and performance data from recovery studies.

However, the provided text does not contain information typically found in acceptance criteria or a study proving device performance in the context of AI/ML-driven diagnostics, which is what your query implies. The device is a "Transport Culture Medium," a physical product for specimen collection and transport, not a diagnostic algorithm.

Therefore, I cannot extract the following information from the provided text:

• A table of acceptance criteria and the reported device performance in the context of diagnostic accuracy.
• Sample size used for the test set or data provenance for a diagnostic algorithm.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for a test set.
• MRMC comparative effectiveness study or effect size.
• Standalone (algorithm only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data) for a diagnostic AI.
• Sample size for the training set of an AI.
• How ground truth for the training set was established for an AI.

The performance data included in the document relates to the recovery of viruses and chlamydiae in the transport medium over time and at different temperatures, which is relevant to the physical device's function, not an AI algorithm's performance.

Here's what I can extract related to the physical device's performance:

1. A table of (physical device) performance metrics:

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

• For shelf-life: Three lots of the BioSci Disposable Virus Sampling Tube were evaluated.
• For recovery studies: Four lots of media representing newly manufactured and older media were evaluated.
• Provenance: The studies were conducted by Shenzhen Dakewe Bio-engineering Co., Ltd. (China). The type of study (retrospective or prospective) is not explicitly stated, but performance tests for medical devices are typically prospective evaluations of the device's capabilities.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth here refers to the actual viral/chlamydial titer, measured by standard laboratory methods (Fluorescent Foci Count), not expert opinions on images or clinical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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: Not applicable, as this is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is not an AI/ML device.

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

• For recovery studies: The "ground truth" was the initial infectious particle count (Fluorescent Foci Count) at 0 hours, and subsequent counts were compared against this baseline. This relies on quantitative laboratory assays.
• For shelf-life stability: Visual inspection (appearance), volume measurement (net content), and pH measurement were used as objective ground truths.

8. The sample size for the training set: Not applicable, as this is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.

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Biosci™ Inactivated Transport Medium (Biosci™ ITM) is intended for the collection, stabilization and transportation of an unprocessed upper respiratory clinical specimen suspected of containing influenza A virus RNA from the collection site to the testing laboratory. The specimen collected in Biosci™ ITM is suitable for use with compatible molecular assays.

Biosci™ ITM contains a detergent and a protein denaturant to inactivate Flu A, lyse cells, disrupt lipid membranes, denature proteins and enzymes, and stabilize influenza A RNA. Therefore, Biosci™ ITM is not intended to be used for culture-based techniques. A specimen bag is also provided for safe transportation of specimens, as well as providing appropriate biosafety warning. Biosci™ ITM has different configurations: - A screw-cap tube filled with 1.0, 2.0, or 3.0 mL of Biosci™ ITM . - A screw-cap tube filled with a range of media and package with an oropharyngeal swab for . oropharyngeal specimen collection - . A screw-cap tube filled with a range of media and package with a nasopharyngeal swab for nasopharyngeal specimen collection - . A screw-cap tube filled with a range of media and package with a mid-turbinate swab for mid-turbinate specimen collection

Here's a breakdown of the acceptance criteria and study details for the Biosci™ Inactivated Transport Medium, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Limit of Detection: 24 positive replicates were used.
• Viral Stability: Not explicitly stated as a number of replicates per time point for the stability study, but Flu A was diluted at 5x LoD and spotted onto swabs. The study involved incubation at two temperatures (2-8ºC and 25ºC) for 0, 7, and 14 days. This implies multiple samples for each time point and condition.
• Inactivation: Multiple starting concentrations of Flu A (1.2 x 10^7, 1.2 x 10^8, 1.2 x 10^9 TCID50/mL) were tested. For each concentration, samples were incubated for 10, 20, and 30 seconds. Control groups included Flu A only, Flu A and matrix, matrix only, and Biosci™ ITM only.
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It refers to "negative pooled nasopharyngeal clinical matrix," suggesting the use of clinical samples, but the study design is analytical (laboratory-based) rather than clinical.

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

• This device is a transport medium for stabilizing microbial nucleic acids, not an interpretative diagnostic device that requires expert review for ground truth in the same way an imaging AI algorithm would.
• The ground truth for the analytical studies (LoD, Viral Stability, Inactivation) was established based on laboratory assays (RT-PCR and cell culture-based assay for CPE), not human expert consensus. Therefore, no "experts" in the traditional sense of human readers for images or clinical diagnoses were used.

4. Adjudication Method for the Test Set

• Not applicable. The ground truth was established by laboratory measurements, not human interpretation requiring adjudication.

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. This is an analytical study for a transport medium device, not an AI diagnostic algorithm, so an MRMC study is not relevant or applicable.

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

• Not applicable. This device is a transport medium, not an algorithm. Its performance is evaluated in standalone, laboratory-based analytical studies as described above.

7. The Type of Ground Truth Used

• The ground truth for the studies was established through laboratory assays:
  • LoD and Viral Stability: Quantified Flu A RNA using a "validated RT-PCR assay."
  • Inactivation: Measured viral viability by observing the "cytopathic effect (CPE)" on MDCK cell lines.

8. The Sample Size for the Training Set

• Not applicable. This is a transport medium device, not an AI/machine learning algorithm, so there is no concept of a "training set" in this context.

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

• Not applicable, as there is no training set for this type of device.

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