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AllTest Viral Transport Medium (VTM) is intended for collection and transport of clinical specimens containing viral agents including Influenza A, Influenza B, Respiratory Syncytial Virus (RSV), and Rhinovirus from collection site to the testing laboratory. Specimens collected in the AllTest VTM can be processed using standard clinical laboratory operating procedure for viral culture.

The AllTest Viral Transport Medium is also intended for the stabilization and transportation of an unprocessed upper respiratory clinical specimen suspected of containing SARS-CoV-2 nucleic acid. The AllTest VTM is suitable for use with compatible legally marketed molecular diagnostic devices.

The AllTest Viral Transport Medium (VTM) device is comprised of a screw cap polypropylene tube filled with 3 mL VTM. The VTM tube is tightly closed with a polyethylene cap. The AllTest VTM contains Hank's Balanced Buffer solution (HBBS), proteins, sugar, and antimicrobials to provide stability to live viruses. The AllTest VTM also contains a pH indicator (phenol red) to provide a visual check on medium pH. The VTM appears clear and red in color. The packaging also includes a biohazard specimen bag.

The FDA 510(k) clearance letter for "AllTest Viral Transport Medium" describes the acceptance criteria and study that proves the device meets those criteria. Since this is a viral transport medium and not an AI/Software as a Medical Device (SaMD), the typical acceptance criteria for AI models (like sensitivity, specificity, AUC, etc.) and evaluation methods (such as MRMC studies, expert adjudication for ground truth) are not applicable. The device's performance is assessed based on its ability to maintain viral infectivity and nucleic acid stability over time and under different storage conditions.

Here's an analysis of the provided text, focusing on the relevant acceptance criteria and study details for this type of device:

Acceptance Criteria and Reported Device Performance

The core acceptance criteria revolve around the stability and recovery of viral agents within the AllTest VTM.

Study Details

Given the nature of the device (viral transport medium), the typical elements of an AI/SaMD study are not present. However, we can extract analogous information where applicable.

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

   • Shelf-life study: 15 tubes from each of three lots were tested at each time point for physical appearance and pH. 6 tubes were tested for microbial contamination.
   • Viral Recovery study: Viral recovery was assessed using three lots of media (3-month/new, 8-month/mid, and 12-month/old age lots). Contrived viral samples (pooled negative clinical matrix spiked with known concentration of virus) were used. These were then spiked onto swabs, transferred to VTM, and held at 4°C and 23-25°C for 0 and 48 hours. The specific number of replicates per condition is not explicitly stated beyond "serial 10-fold to a 96-well plate," but the overall methodology suggests controlled laboratory samples. Data provenance is implied to be laboratory-generated (contrived samples) rather than from specific countries or being retrospective/prospective clinical data.
   • Nucleic Acid Stability study:
     • LoD Determination: 20 replicates were tested at the preliminary LoD concentration (10 GCE/reaction) to confirm LoD.
     • Specimen Stability: Both clinical and contrived samples were used. Three lots of media (3-month/new, 8-month/mid, and 12-month/old age lots) were used. 50 µl of each sample was added to nasopharyngeal (NP) swab and transferred into VTM. Samples were stored at 4℃ and 23-25℃ for 0 and 48 hours. The specific number of clinical/contrived samples or replicates per condition is not explicitly stated. Data provenance includes both "clinical and contrived samples," suggesting some real clinical samples might have been used in addition to laboratory-prepared ones. This study appears to be laboratory-based testing.

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

   • Not applicable for this type of device. The "ground truth" for viral recovery and nucleic acid stability is established through quantitative laboratory measurements (TCID50 for viral recovery, Ct values for nucleic acid presence via PCR) against known input concentrations, not through expert consensus or interpretation of images.

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

   • Not applicable. This is a quantitative laboratory performance study, not a
     human-in-the-loop diagnostic accuracy study requiring adjudication.

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 a transport medium, not an AI/SaMD for diagnostic interpretation.

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

   • Not applicable. This is not an algorithm. The performance evaluation is for the physical medium itself.

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

   • For Viral Recovery: The "ground truth" or reference is the initial known concentration of the spiked virus (T=0 hour log10TCID50) to which the 48-hour recovery is compared. This is a quantitative laboratory reference.
   • For Nucleic Acid Stability: The "ground truth" or reference is the initial Ct value at T=0 hours from the spiked SARS-CoV-2 samples. This is a quantitative laboratory reference.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI device that requires a training set.

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

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

Summary of the Study Design for AllTest Viral Transport Medium:

The studies conducted for the AllTest Viral Transport Medium are primarily laboratory-based performance studies designed to demonstrate the medium's ability to preserve the integrity of viral samples over specified timeframes and storage conditions. The methodology relies on established virological and molecular diagnostic techniques (viral culture/TCID50, PCR Ct values) using both contrived samples (known concentrations of viruses spiked into a matrix) and, for nucleic acid stability, also mentions the use of clinical samples. The "ground truth" is quantitative and established by the initial measurements of the spiked samples. The focus is on demonstrating stability and recovery rates rather than diagnostic accuracy or human performance.

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Copan UriSponge™ - Urine Collection, Transport, and Preservation System is intended for the collection, transport and preservation of urine specimens from the collection site to the testing laboratory. In the laboratory, UriSponge™ specimens are processed using standard clinical laboratory operating procedures for the cultivation of uropathogenic bacteria and yeasts.

Copan's UriSponge™ - Urine Collection. Transport, and Preservation System UriSponge™ consists of screw cap self-standing plastic tube with conical shaped bottom. Inside the tube, the cap holds a plastic stick with sponges made of hydrophilic polyurethane. The sponges include preservative substances (Sodium Propionate, and Potassium Sorbate). Two sizes of product are available: the regular tube size (100 mm length X 16 mm diameter) plastic tube and the mini tube size (80 mm length x 12 mm diameter) plastic tube.

The provided text describes the 510(k) premarket notification for the UriSponge™ device, a urine collection, transport, and preservation system. It focuses on demonstrating the substantial equivalence of the UriSponge™ to a predicate device (UriSwab™), particularly highlighting the performance data related to the preservation of microorganisms.

Here's an analysis of the acceptance criteria and study as requested, derived from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Microbial Recovery Test Set:

  • For each UriSponge™ lot and ATCC strain of representative urine microorganism, 3 replicates were tested at baseline (T0), 24 hours (T24), and 48 hours (T48) at both cold (2-8°C) and room temperature (19-25°C).
  • The study utilized pooled human negative clinical urine samples, representing the intended use.
  • Testing was performed on three sets of UriSponge™ lots: within one month of manufacture, approximately 5 months after manufacture, and aged beyond 12 months (shelf-life validation).
  • Provenance: Not explicitly stated, but the submission is from Copan Italia S.p.A. in Brescia, Italy. The use of "pooled human negative clinical urine samples" suggests a clinical lab setting, not necessarily a specific country, but likely related to the company's operational region or contracted labs. The data is prospective as it's generated specifically for this pivotal study.

• Fill Volume Flex Study Test Set:

  • Conducted with 3 newly manufactured lots of UriSponge™.
  • Used three specific bacterial strains: E. coli ATCC 25922, P. aeruginosa ATCC 27853, and S. agalactiae ATCC 13813. The number of replicates for this particular study is not specified, but it refers to a "comparative microbial recovery evaluation (as described above)," implying similar methodology for replication.
  • Provenance: Similar to the microbial recovery study, linked to Copan Italia S.p.A. and likely prospective.

• Mechanical/Physical Characteristics Stability Test Set:

  • Conducted with 3 different lots of the mini version of the devices.
  • Tested at multiple timepoints: within 1 month, 5-6 months, 12 months, and 13 months after manufacture.
  • Provenance: Internal testing by the manufacturer, prospective.

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

• This device (Transport Culture Medium) is not an AI/imaging device requiring expert interpretation for ground truth.
• The "ground truth" for the performance studies is objective microbiological measurement (CFU/mL counts) and physical/chemical analyses (e.g., HPLC). These are laboratory measurements, not expert consensus on interpretations. The methodology would be overseen by qualified microbiologists and laboratory personnel. The document does not specify the number or qualifications of these individuals, as it's standard laboratory practice.

4. Adjudication Method for the Test Set

• Not applicable. The "ground truth" is established through direct, quantifiable laboratory measurements (CFU counts) and analytical chemistry (HPLC), not through subjective interpretation requiring adjudication among experts.

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

• No, an MRMC study was not done. This type of study is primarily relevant for diagnostic imaging AI devices where human readers interpret images. This device is a sample collection and transport system, evaluated by its ability to preserve microbial viability, not by how it assists human interpretation of medical images.

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

• Not applicable. This is not an algorithm or AI device. The "performance" refers to the physical and chemical properties of the device in preserving biological samples.

7. The Type of Ground Truth Used

• The ground truth relies on objective laboratory measurements:
  • Colony Forming Units (CFU) counts: To quantify viable microorganisms in the samples over time, representing the gold standard for microbial viability.
  • Physical and Mechanical Testing: To evaluate the integrity of the device components.
  • Chemical Analysis (HPLC): To measure preservative content.
  • Sterility Testing: To confirm SAL.

8. The Sample Size for the Training Set

• Not applicable. This device does not involve machine learning or AI, so there is no "training set." The studies performed are performance and stability validation studies.

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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The Ensol EnTM Collection and Transport System is intended for the collection of clinical samples containing upper respiratory viruses including Influenza A, Human Coronavirus 229E, and Respiratory Syncytial Virus (RSV) from the collection site to the testing laboratory to be used with standard diagnostic identification techniques that utilize stable recoverable infectious viral particles.

The EnTM Collection and Transport System medium consists of a polypropylene conical tube filled with 2 ml of the transport medium (pale brown to red color medium solution), affixed with a polyethylene screw cap. The bottom part of the tube has a self-standing shape. Tubes are provided in a paper rack. The media tubes can be provided with one or two kinds of sterile specimen collection swabs, one for oropharyngeal (OP) oral use and the other nasopharyngeal (NP) for nasal use. The swab shaft is polystyrene with a breaking point, and the swab tip is flocked nylon fibers. The media is provided in two different configurations with and without the sterile peel pouch containing swabs.

The provided text describes the Ensol EnTM Specimen Collection and Transport System, a viral transport medium, and its non-clinical performance evaluation. It does not contain information about an AI/ML powered device, therefore, many of the requested categories are not applicable.

Here's an analysis of the provided information:

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

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Physical Stability and Sterility: The study used three lots of the Ensol EnTM Collection and Transport System. The provenance of the data (country of origin, retrospective/prospective) is not explicitly stated.
• Culture-Based Viral Recovery Study:
  • Sample Size: Three lots of VTM (ENTM-2001, ENTM-22003, and ENTM-23001) were used. For each lot and each virus (Influenza A, Human Coronavirus 229E, and Respiratory Syncytial Virus), aliquots were stored at 4°C for 0, 24, and 48 hours. The number of replicates for each viral sample is not specified beyond "aliquots of each replicate".
  • Data Provenance: The study was conducted in a laboratory setting using specific viral strains and host cells. The country of origin of the data and whether it was retrospective or prospective is not explicitly stated, but it implicitly describes a prospective study designed to evaluate the device's performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not applicable as the device is a viral transport medium, not an AI/ML powered diagnostic device that requires expert ground truth establishment for image or data interpretation. The "ground truth" in this context refers to the controlled viral titers and their expected viability, which are established through standard laboratory techniques and biological assays.

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

This information is not applicable. Adjudication methods are typically used in clinical studies involving multiple readers or assessors to resolve discrepancies in subjective interpretations, which is not relevant for the objective measurements performed on a viral transport medium.

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 information is not applicable. The device is a viral transport medium, not an AI-assisted diagnostic tool. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant.

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

This information is not applicable. The device is a viral transport medium and does not involve any algorithm or AI for standalone performance evaluation.

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

The ground truth for the viral recovery study was based on laboratory-established viral titers (TCID50). This involves:

• Using established, characterized viral strains (Influenza A, Human Coronavirus 229E, and RSV).
• Determining the initial viral concentration at 0 hours using standard cell culture infectivity assays (Reed-Muench method calculation of TCID50).
• Comparing the viral titers at 24 and 48 hours to the initial titers to assess changes in viability.

8. The sample size for the training set

This information is not applicable. The device is a physical medical device (viral transport medium), not an AI/ML model that requires a training set.

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

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

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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 (

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Hardy Diagnostics' Viral Transport Medium (VTM) is intended for the collection and transport of clinical specimens for the preservation of viral agents influenza A, Influenza B, Adenovirus, and Echovirus from the collection site to the testing laboratory. Hardy Diagnostics' VTM is a culture-based media that is intended to be used in standard laboratory procedures for virus culture and diagnostic assays that utilize stable recoverable infectious viral particles.

Hardy Diagnostics' Viral Transport Medium (VTM) is a non-propagating culture-based transport media used for the collection and transport of specimens suspected of containing viruses including Influenza A, Influenza B, Adenovirus, and Echovirus for downstream laboratory test methods. The VTM includes a screw-cap polypropylene tube with skirted conical bottom containing 3mL of transport medium. VTM tubes can be supplied alone, or in a kit format with a mini-tip flocked swab in a sterile peel-pouch. Hardy Diagnostics' VTM is not claimed to be sterile nor is it intended to be sterilized by the end user. Hardy Diagnostics' VTM vials are single use devices.

The product is supplied in multiple configurations described in more detail in table 1 below: tubes alone, or in a kit format with a swab.

The provided text is a 510(k) Premarket Notification summary for a Viral Transport Medium (VTM), a Class I device. It describes the design, intended use, and studies conducted to demonstrate its substantial equivalence to a predicate device.

It's important to note that this document is not for an AI/ML-based medical device. Therefore, many of the requested elements for describing the acceptance criteria and study that proves an AI device meets acceptance criteria (such as MRMC studies, ground truth establishment by experts, and training set details) are not applicable to this type of medical device submission.

However, I can extract the relevant information regarding the device's performance studies and acceptance criteria as provided for this specific product, which focuses on viral recovery performance and shelf-life stability.

Here's a breakdown based on the provided document:

Acceptance Criteria and Device Performance for Viral Transport Medium (VTM)

The studies presented focus on demonstrating the VTM's ability to preserve viral agents over time and under various storage conditions.

1. Table of Acceptance Criteria and Reported Device Performance

For Viral Recovery Performance:

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The Avantik VTM is intended for the collection and transport of upper respiratory clinical specimens containing respiratory viruses, from the collection site to the testing laboratory. The collection system is a culture-based media that is intended to be used with standard laboratory examination, culture or with other assays that utilize stable recoverable infectious viral particles.

The Avantik VTM is a Non-Propagating Transport Medium Device designed to facilitate the secure collection and transportation of biological samples for diagnosing viral infections. The device contains a transport medium that maintains the viability and infectivity of clinically significant viruses en route to testing laboratories. The device can be stored between 2 - 25°C for up to 12 months and is only for use by Health Care Professionals. Upon collection, samples should be immediately placed in the transport tube to maintain optimal conditions. It is recommended to refrigerate the samples between 2 - 8°C or store them on wet ice to maintain a temperature of 2 - 8°C during transit. Post-collection, the specimen can be transported at 2 - 25°C and should be processed within 48 hours. The transport system allows for specimen collection, maintenance through a buffered medium, and contains a pH indicator. The liquid medium consists of a mixture of Hank's balanced salt solution, BSA (Bovine Serum Albumin), L-cysteine, Gelatin, Sucrose, L-glutamic acid, HEPES, Vancomycin, Amphotericin B, Colistin, and Phenol Red. The liquid medium inhibits the growth of competing bacteria and fungus, is non-toxic to mammalian host cells, and supports viral viability during transportation. The device includes a conical polypropylene vial filled with 3 ml of culture medium, secured with a high-density polyethylene screw-on cap.

The document describes the Avantik VTM, a viral transport medium, and its performance data to support substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

Note: The document does not explicitly state numerical "acceptance criteria" for viral recovery in terms of a maximum allowable percentage reduction. It presents the "reported device performance" as the observed percentages of reduction. The conclusion states that the device "meets the requirements that are considered essential for its intended use," implying these results were deemed acceptable.

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

• Sample Size for Test Set: The viral recovery study was conducted using three lots of the candidate device. For each lot, three viral strains (Influenza A, RSV, Human Coronavirus NL63) were evaluated at two temperatures (4°C and 22°C) for two time points (0h and 48h). The document does not specify the number of replicates per virus/temperature/timepoint test condition, but the presentation of mean ± standard deviation for percentage reduction suggests multiple measurements were taken for each condition.
• Data Provenance: The document does not explicitly state the country of origin of the data. It is associated with HanChang Medic Co., Ltd. from Republic of Korea, which implies the studies were conducted in relation to this company. The studies are described in a factual manner without indicating whether they were retrospective or prospective, but performance studies for device clearance are typically prospective to gather specific data for the submission.

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

This section is not applicable as the device is a viral transport medium, not an AI or diagnostic imaging device requiring expert interpretation for ground truth. The "ground truth" for the viral recovery study is the quantitative measurement of virus infectivity (e.g., titer) after specific incubation times and temperatures, compared to time 0. This is an objective laboratory measurement, not based on expert consensus or interpretation.

4. Adjudication method for the test set

This section is not applicable for the same reasons as point 3. No expert adjudication was involved in determining the quantitative viral infectivity measurements.

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 section is not applicable. The Avantik VTM is a viral transport medium, not a diagnostic AI system or an imaging device. Therefore, MRMC studies and assessments of human reader improvement with AI assistance are irrelevant to this device.

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

This section is not applicable. The Avantik VTM is a physical transport medium, not an algorithm.

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

For the viral recovery study, the "ground truth" was established by quantitative measurement of virus infectivity. This is typically done through techniques like plaque assay (PFU/mL) or Tissue Culture Infectious Dose 50% (TCID50/mL), which objectively determine the concentration of viable virus. The "percent reduction in virus infectivity" is calculated based on these measurements at different time points (0h vs 48h).

8. The sample size for the training set

This section is not applicable. This is a physical medical device (viral transport medium), not an AI/machine learning model that requires a training set.

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

This section is not applicable for the same reason as point 8.

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The ALB Luz Viral Transport Media is intended for the collection and transport of upper respiratory clinical specimens containing Influenza A, Influenza B, Respiratory Syncytial Virus (RSV), and Rhinovirus from the collection site to the testing laboratory. The Viral Transport Media is a culture-based media that is intended to be used with standard diagnostic/identification techniques that utilize stable recoverable infectious viral particles.

The Viral Transport Medium (VTM) is a non-propagating transport device composed of a culturebased media without swabs. The VTM is designed to preserves upper respiratory samples collected from a patient by placing the sample into the polymer tube containing 3 mL of media. The sample and media are then secured with a leak-proof screwcap for transportation.

The VTM maintains cellular integrity and preservation of viruses when properly stored. Prior to use, vials should be stored at 2℃ to 35℃. After specimen collection, the transport tube containing the specimen can be stored for up to 48 hours at either 2-8°C or 20-25°C, for transportation to the laboratory and storage. The medium has been evaluated for storage of the following respiratory viruses, Influenza A, Respiratory Syncytial Virus (RSV), and Rhinovirus, for viral recovery.

The provided text describes the 510(k) premarket notification for the ALB Luz Viral Transport Media (VTM). This document details the device's characteristics, intended use, and performance testing to demonstrate substantial equivalence to a predicate device.

However, the provided text does not contain the kind of information typically associated with acceptance criteria and clinical study results for an AI-powered medical device, such as:

• Accuracy metrics: Sensitivity, specificity, AUC, F1 score.
• Study design details: Retrospective/prospective, number of patients/cases in the test set.
• Expert ground truth: Number of experts, their qualifications, adjudication methods.
• Comparative effectiveness: MRMC study details, human reader improvement with AI.
• Standalone algorithm performance.
• Training set details: Size, ground truth establishment.

Instead, the document focuses on performance testing relevant to a viral transport medium, specifically:

• Shelf-life studies: Physical stability (appearance, volume) and pH stability over 18 months.
• Sterilization checks: Absence of microbial growth.
• Viral recovery studies: Using plaque forming assays to show the device maintains viral viability for specific viruses (Influenza A, RSV, Rhinovirus) at different temperatures and time points (0, 24, 48 hours).

Therefore, I will interpret the request in the context of the provided document, defining "acceptance criteria" and "device performance" based on the characteristics and tests described for the Viral Transport Media, rather than an AI-powered device.

Acceptance Criteria and Study Proving Device Meets Criteria

The ALB Luz Viral Transport Media (VTM) is a Class I, reserved medical device (Product Code JSM) intended for the collection and transport of upper respiratory clinical specimens containing specific viruses. The study presented in the 510(k) summary (K232454) demonstrates the device's ability to maintain the viability of these viruses over time and under specified storage conditions, thereby proving its suitability for its intended use.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this Viral Transport Media are based on its ability to maintain physical and chemical stability, minimize contamination, and crucially, maintain the viability of specific viruses over a defined transport/storage period. The performance is assessed against these criteria.

• 2-8°C: Percent changes for 24 hours range from 0% to -9%; for 48 hours, -35% to -38%.
• 20-25°C: Percent changes for 24 hours range from -7% to -20%; for 48 hours, -33% to -39%.
  Respiratory Syncytial Virus (RSV):
• 2-8°C: Percent changes for 24 hours range from -11% to 7%; for 48 hours, -38% to -50%.
• 20-25°C: Percent changes for 24 hours range from -15% to 0%; for 48 hours, -36% to -43%.
  Rhinovirus:
• 2-8°C: Percent changes for 24 hours range from 0% to 5%; for 48 hours, -33% to -52%.
• 20-25°C: Percent changes for 24 hours range from -21% to -18%; for 48 hours, -29% to -46%.
  All reported percent changes are well within the ±90% acceptance criterion. |

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

• Sample Size (Test Set): For the viral recovery studies, "Three lots of VTM with newly manufactured, mid-range lot and close to expiry lots were used." For each lot, virus stock was serially diluted, transferred into VTM, and stored at two temperatures (2-8°C and 20-25°C) for three time points (0, 24, 48 hours). For each condition, viral samples were serially diluted and "added to the monolayer in triplicate."
  • This implies a sample size of 3 lots x 2 temperatures x 3 time points x 3 replicates = 54 measurements per virus strain. Since three virus strains were tested, the total number of primary viral recovery measurements would be 162 (excluding the initial virus stock titrations and cell culture maintenance).
• Data Provenance: The study appears to be an in-vitro laboratory validation study rather than a clinical trial with patient data. The specific origin of the "pooled negative clinical nasal matrix" is not explicitly stated in terms of country, but the sponsor is based in Brazil.
• Retrospective or Prospective: The study design described (testing newly manufactured, mid-range, and close-to-expiry lots, and specific time points) indicates a prospective laboratory validation study for performance characteristics, particularly viral recovery and shelf-life.

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

This section is not applicable in the context of this device and study. The "ground truth" for Viral Transport Media performance is established through direct laboratory measurements of viral viability (Plaque-Forming Units/mL) and physical/chemical properties (pH, appearance). No human expert interpretation of images or clinical data for diagnosis is involved.

4. Adjudication Method for the Test Set

This section is not applicable for the reasons stated above. There is no human interpretation or diagnostic decision-making that would require adjudication.

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

No. An MRMC study is relevant for AI (or other diagnostic) devices where human readers interpret medical images or data. This is a laboratory performance validation for a transport medium.

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

No. This section pertains to AI algorithms. The device under review is a physical transport medium, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for the performance evaluation of the Viral Transport Media is based on direct laboratory measurements of viral viability (Plaque-Forming Units/mL) through plaque assays and physical/chemical measurements (pH, visual inspection for appearance/volume). This is an objective, quantitative, and directly observable ground truth.

8. The Sample Size for the Training Set

This section is not applicable. This is not an AI/machine learning device that requires a "training set." The performance evaluation is based on laboratory testing of the manufactured product.

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

This section is not applicable for the same reason as above.

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Copan Universal Transport Medium (UTM-RT) System is intended for the collection and transport of clinical specimen containing viruses, chlamydiae, mycoplasma or ureaplasma from the to the testing laboratory. UTM-RT can be processed using standard clinical laboratory operating procedures for viral, chlamydial, mycoplasma and ureaplasma culture.

UTM-RT is intended for the stabilization and transportation of an unprocessed upper respiratory clinical specimen suspected of containing respiratory viruses' nucleic acids. UTM-RT is intended for use with compatible molecular assays.

Copan Universal Transport Medium (UTM-RT®) System is composed of a tube with 3mL of UTM-RT® transport medium, which may be supplied in bulk or as a kit with a sterile specimen collection flocked swab. UTM-RT® medium is designed to maintain viability of viruses, chlamydiae, mycoplasma or ureaplasma during transport from the collection site to the testing laboratory for subsequent culture and to maintain the integrity of respiratory viruses' nucleic acids for testing with a compatible molecular assay.

The provided text is for a 510(k) premarket notification for a medical device called "Copan Universal Transport Medium (UTM-RT) System". This type of document describes the device, its intended use, and comparative performance data against a predicate device to demonstrate substantial equivalence, rather than a clinical trial or study in the traditional sense involving human readers or sophisticated AI algorithms.

Therefore, the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/machine learning device is not fully applicable here. This document focuses on the stability and preservation of viral nucleic acids in a transport medium.

However, I can extract the relevant "acceptance criteria" and "study" details as they pertain to the chemical and biological stability performance of the transport medium, which is the device in question.

Here's the breakdown of the information as it relates to the device's performance in preserving viral nucleic acids:

1. Table of Acceptance Criteria and Reported Device Performance

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The Azer Scientific Universal Transport Medium is for the collection and transport of upper respiratory clinical specimens. containing respiratory viruses from the to the testing laboratory. The Azer Scientific Universal Transport Medium is a culture-based media that can be processed usincal laboratory operating procedures for the isolation and detection of upper respiratory viruses including Influenza A, Respiratory Syncytial Virus (RSV) and Adenovirus.

The Azer Scientific Universal Transport Medium includes a plastic screw-cap tube with conical bottom containing 3 mL of transport medium and three, 3 mm size glass beads. Azer Scientific Universal Transport Medium tubes can be supplied alone or in a kit format with one of three different collection swab options in a sterile peel pouch.

The provided document is a 510(k) Premarket Notification for the Azer Scientific Universal Transport Medium. It does not describe an AI/ML powered device, but rather a universal transport medium for the collection and transport of respiratory clinical specimens containing viruses. Therefore, many of the requested sections related to AI/ML device performance and testing (e.g., human reader studies, AI effect size, training set details, expert qualifications for ground truth) are not applicable.

However, I can provide the available information regarding the acceptance criteria and the study proving the device meets these criteria, focusing on the device's intended function: viral recovery and stability.

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

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Description: The performance testing for viral recovery involved "three (3) lots of test kits." Each viral strain (Influenza A, Adenovirus, RSV) was spiked into "pooled, human nasopharyngeal swab sample matrix tested as negative using an FDA cleared RT-PCR assay." Serial dilutions (10⁻¹, 10⁻², 10⁻³, and 10⁻⁴) of each virus were used, and samples were tested "in triplicate."
• Sample Size Calculation (Implied): While an explicit sample size calculation is not provided, the "in triplicate" testing for each dilution, across 3 lots, for 3 viruses, at 2 temperatures, and 3 time points (0, 24, 48 hours) suggests a robust experimental design.
• Data Provenance: The origin of the "pooled, human nasopharyngeal swab sample matrix" is not explicitly stated (e.g., country of origin). The study appears to be a prospective laboratory study designed to evaluate the viral transport medium's performance under controlled conditions.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is not an AI/ML device relying on expert-reviewed imagery or clinical interpretation. The ground truth for viral recovery studies is established by laboratory methods, specifically:

• Inoculation of known viral strains at specific concentrations.
• Measurement of viral titers (TCID50/mL) using established cell culture techniques.
• Observation of cytopathic effect (CPE) under a microscope, which is a standard laboratory endpoint.

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

Not applicable. This is not an AI/ML device where human interpretation or consensus is required for establishing ground truth from complex data. The evaluation relies on quantitative laboratory measurements of viral titers and qualitative observations of cell culture effects.

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. 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. This is not an AI/ML device. The device itself is the transport medium, and its performance is evaluated in a standalone manner without human-in-the-loop assistance for its primary function.

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

The ground truth for the performance study (viral recovery) was established by:

• Known Viral Stocks: Using well-characterized and quantified viral strains (Influenza A, Adenovirus, HRSV).
• Laboratory Assays: Measuring viral viability and infectivity through cell culture techniques (cytopathic effect - CPE) and calculating viral titers (TCID50/mL) using the Reed-Muench method. This is a scientific, quantitative ground truth.

8. The sample size for the training set

Not applicable. This is not an AI/ML device requiring a training set.

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

Not applicable. This is not an AI/ML device requiring a training set.

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ARX Viral Transport Media Collection & Transport System (ARX-VTM) is intended for the collection and transport of clinical specimens containing viruses from the collection site to the testing laboratory. The ARX-VTM is a culture-based media that is intended to be used in the laboratory to perform viral culture or diagnostic assays for viruses including, Influenza A, Parainfluenza type 3, Coronavirus OC43, Respiratory Syncytial Virus (RSV) A, Herpes Simplex virus 1 & 2, Echovirus, and Cytomegalovirus.

ARX Viral Transport Media Collection and Transport System (ARX-VTM) is a specialized systems for collecting and transporting viruses at 2-8 ºC or 20-25 ºC. The ARX-VTM is for use in laboratories to aid in the diagnosis of infections, especially when there is a delay between specimen collection and processing for up to 72 hrs. ARX Viral Transport Media Collection & Transport System (ARX-VTM) is intended for the collection and transport of clinical specimens containing viruses from the collection site to the testing laboratory. The ARX-VTM is a culturebased media that is intended to be used in the laboratory to perform viral culture or diagnostic assays for viruses including, Influenza A, Parainfluenza type 3, Coronavirus OC43, Respiratory Syncytial Virus (RSV) A, Herpes Simplex virus 1 & 2, Echovirus, and Cytomegalovirus.

Device Specifications: The ARX-VTM contains a non-propagating media supplied in a polypropylene (PP) tube individually with 1 or 3 mL of transport medium and as a kit. The kit contains a PP tube with 1 or 3 mL of transport medium and a sterile peel pouch containing a nylon flocked swab applicator for collecting specimens. Nylon flocked swabs are available in various score points and configurations to facilitate specimen collection from various anatomical sites.

The provided document describes the ARX Viral Transport Media Collection and Transport System (ARX-VTM) and its performance characteristics for viral recovery.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

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

• Sample Size for Viral Recovery: For each virus and each temperature condition (2-8°C and 25-30°C), tests were conducted with swabs in triplicate at time points 0, 24, 48, and 72 hours. While the exact number of swabs per time point isn't explicitly stated beyond "in triplicate," this would mean at least 3 swabs per virus per time point per temperature. The total 'n' would be 8 viruses * 2 temperatures * 4 time points * 3 replicates = 192 samples (excluding additional replicates for baseline).
• Sample Size for Shelf-Life: Three lots of ARX-VTM samples were tested, with duplicate samples from each lot for visual inspection, pH, and osmolarity.
• Data Provenance: The document does not specify the country of origin of the data. The study appears to be a prospective laboratory study, where the performance of the ARX-VTM was measured under controlled conditions.

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

The ground truth for viral recovery was established via visual enumeration of fluorescent foci units (FFU) by researchers. The document does not specify the number or qualifications of experts involved in this enumeration. It appears to be a standard laboratory method rather than expert consensus on clinical cases.

4. Adjudication method for the test set

The document does not describe an adjudication method for the test set, as the ground truth was established through quantitative laboratory measurements (FFU counts). Adjudication methods like "2+1" typically apply to subjective assessments requiring multiple readers, which is not the case here.

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. The device is a viral transport medium, not an AI-assisted diagnostic tool. Therefore, the concept of human readers improving with or without AI assistance is not applicable to this submission.

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

This is not applicable as the device is a viral transport medium, not an algorithm or software. The performance assessment focused on the medium's ability to maintain viral viability.

7. The type of ground truth used

The type of ground truth used for viral recovery studies was quantitative laboratory measurement of viral viability, specifically the visual enumeration of fluorescent foci units (FFU) after inoculation into monolayer cells and immunostaining. For shelf-life, the ground truth involved quantitative measurements of pH and osmolarity, and qualitative visual inspection.

8. The sample size for the training set

This is not applicable. The ARX-VTM is a physical medical device (transport medium) and not an AI/ML algorithm that requires a training set.

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

This is not applicable for the same reason as above; there is no training set for this type of device.

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