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The ARX Liquid Amies Collection & Transport System (ARX) is intended for use in the collection of clinical specimens (i.e., nasal secretion/wash; lachrymal secretion/tears; auricular secretion/cerumen; urethral, rectal, or vaginal swab; wound/abscess material) potentially containing aerobic, and fastidious bacteria and their transport at 2-8°C or 25-30°C from the patient to the laboratory for bacteriological examination and culture. In the laboratory, the collected and transported clinical specimens of nasal, lachrymal, ceruminous, vaginal, urethral, rectal, and wound/abscess origin are processed using standard clinical laboratory operating procedures for bacterial culture.

The ARX Liquid Amies Collection & Transport System consists of a polypropylene screw-cap vial containing Liquid Amies transport medium and three (3) sterile peel-open pouches containing a pre-scored Microbrush nylon flocked swab for collecting specimens. The three (3) nylon flocked swabs are provided with various score points, tip sizes, and configurations to facilitate specimen collection from various sites on patients' bodies. Nylon flocked swabs facilitate quick absorption and release of clinical specimens. Proper specimen collection from the patient is critical for successful isolation and identification of infectious organisms.

Amies liquid medium is a non-nutritive balanced salt solution containing inorganic phosphates to provide buffering capability, sodium chloride, potassium chloride, and magnesium chloride to provide essential ions that help maintain osmotic balance and control permeability of bacterial cells. It also contains sodium thioglycolate to provide a reduced environment. ARX Liquid Amies transport medium is capable of maintaining the viability of aerobic, anaerobic, and fastidious bacteria (such as Neisseria gonorrhoeae) during specimen transport to the laboratory for bacteriological testing and culture.

All raw materials used in the manufacture of ARX Liquid Amies Collection & Transport System are qualified before use. Every batch of ARX Liquid Amies Collection & Transport System is tested prior to release for sterility, pH, and background count using microscopic examination. Representative samples of each batch are further evaluated for their ability to maintain the viability of selected bacterial agents over predefined time periods.

The provided text describes the performance characteristics of the ARX Liquid Amies Collection & Transport System for bacterial recovery. This information is relevant to the acceptance criteria and the study proving the device meets these criteria.

Here's an analysis of the provided information to address your request:

Device: ARX Liquid Amies Collection & Transport System

Purpose of Study: To demonstrate the ability of the device to maintain the viability of aerobic, anaerobic, and fastidious bacteria during specimen transport, and to establish shelf-life stability.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for bacterial recovery are stated as:

• Roll-Plate studies: Minimum acceptable viability of at least 2% CFU relative to time 0.
• Swab Elution studies: Maximum 3 log10 decline in CFU acceptable relative to time 0.

For shelf-life stability:

• pH within specified range (7.30 ± 0.2).
• Visual inspection (no turbidity).
• Viscosity within specified range (1.075 ± 0.015 milliPascal.Second).

Table: Acceptance Criteria and Reported Device Performance (Summary)

Conclusion from non-clinical Performance Studies: "the ARX Liquid Amies Collection & Transport System showed recovery of bacteria within the acceptance criteria comparable to the predicate device for all holding temperatures tested. This demonstrates the acceptability claim of up to 48 hours for all organisms (except 24 hours for Neisseria gonorrhoeae) in clinical samples during storage and/or transport in this transport system. Additional studies conducted with the ARX Liquid Amies Collection & Transport System support the shelf-life stability claim of 18 months."

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

The "test set" in this context refers to the bacterial strains and conditions used for the performance studies, not a patient-derived dataset.

• Sample Size (Test Set):

  • Bacterial Strains: A total of 17 bacterial strains were used:
    • 3 aerobic bacteria
    • 6 facultative anaerobic bacteria (including 1 fastidious organism, Neisseria gonorrhoeae)
    • 8 obligate anaerobic bacteria (listed in Table 2)
  • Device Samples: For each study (Roll-Plate and Swab Elution, with NCM and Saline at different temperatures):
    • 3 independent lots of ARX Liquid Amies (Old, Middle-aged, New) were tested.
    • For each combination of organism, lot, and temperature/matrix, the swabs were inoculated in triplicate.
    • Measurements were taken at 0, 24, and 48 hours (except N. gonorrhoeae only at 24 hours).
  • Shelf-life Stability: 4 manufactured lots were evaluated.

• Data Provenance: The data appears to be from controlled laboratory studies (prospective experimental data) conducted to validate the device's performance. The document does not specify a country of origin for the data, but given it's an FDA submission, it's typically either conducted in the US or in adherence to international standards acceptable to the FDA. The matrices used were "Negative Clinical Matrix (NCM) or sterile saline," simulating clinical conditions.

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

This type of device (microbiological specimen collection and transport system) relies on established microbiological laboratory standards and quantitative measurements (CFU counts) rather than subjective expert interpretation of medical images or pathologies. Therefore, there is no mention of "experts" in the traditional sense (e.g., radiologists) establishing ground truth. The "ground truth" here is determined by the live cultures and their measured viability, following universally accepted laboratory protocols.

• Number of Experts: Not applicable in the context of expert consensus for ground truth on images or clinical outcomes.
• Qualifications of Experts: Not applicable. The "ground truth" (bacterial viability) is established by direct laboratory measurements following CLSI M40-A2 standards.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where multiple human readers or algorithms provide interpretations, and a consensus or higher-level review is needed to establish a definitive ground truth.

For this device, the "ground truth" is based on direct quantitative laboratory measurements (colony forming unit counts) of bacterial viability. These are objective measures, not subjective interpretations. Therefore:

• Adjudication Method: Not applicable. Ground truth is derived from direct quantitative microbiological assays.

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

MRMC studies are typically performed for diagnostic devices (e.g., AI-powered imaging systems) where human interpretation plays a role, and the goal is to assess how a new technology impacts diagnostic performance.

This device is a specimen collection and transport system, not a diagnostic imaging or AI-driven interpretive tool. The study focuses on the physical and biological performance of the transport medium and swabs in maintaining bacterial viability.

• MRMC Study: No, an MRMC study was not done as it is not relevant for this type of device.
• Effect Size of Human Readers: Not applicable.

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

The concept of "standalone performance" typically refers to the performance of an AI algorithm independent of human intervention. This device is not an AI algorithm. Its performance is inherent to its physical and biological properties.

• Standalone Performance: Not applicable. This is not an AI device. The studies conducted evaluate the intrinsic performance of the device itself (transport medium and swabs) in preserving bacterial samples.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the performance studies was bacterial viability/colony counts (CFU) established through controlled laboratory experiments. This is a direct, quantitative measure of the device's ability to preserve the bacteria. The studies followed FDA-recognized sections of Clinical Laboratory Standards Institute (CLSI) M40-A2:2014 Quality Control of Microbiological Transport Systems.

8. The Sample Size for the Training Set

This device is not an AI/ML device, and therefore does not have a "training set" in the computational sense. The studies described are validation and performance testing, not model training.

• Sample Size for Training Set: Not applicable, as this is not an AI/ML device.

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

As there is no training set for this device in the context of AI/ML, this question is not applicable. The device's performance is based on its material properties and chemical composition, validated through standard microbiology testing.

• How Ground Truth for Training Set Was Established: Not applicable.

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Puritan® Amies Medium Collection and Transport System is intended for use in the collection and transport of clinical specimens containing aerobic, anaerobic and fastidious bacteria from the patient to the laboratory for bacteriological examination and culture.

Puritan Amies Medium Collection and Transport System is comprised of a sterile peel pouch containing a rayon tipped swab applicator for collecting specimen and a polypropylene tube containing 4 ml of Amies medium with or without charcoal. The rayon tipped swab applicators are provided in different tip sizes to accommodate various specimen types.

Amies medium is a nonnutritive balanced salt solution containing inorganic phosphates to provide buffering capability, sodium chloride, potassium chloride, calcium chloride and magnesium chloride to provide essential ions that help maintain osmotic balance. Agar is a solidifying agent and gives a semi-solid texture to the medium. Sodium thioglycollate provides a reduced environment. It is recommended for maintaining the viability of aerobic and fastidious bacteria during the transport to the laboratory.

Here's a breakdown of the acceptance criteria and study information for the Puritan Amies Medium Collection and Transport System, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

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

   • Sample Size: The document states "known inoculum of ATCC type culture and clinically significant microorganisms" were used. It does not provide a specific number for the sample size (i.e., number of bacterial strains or replicates).
   • Data Provenance: Not explicitly stated, but the use of ATCC type cultures suggests a lab-based study rather than patient-derived retrospective or prospective data. The clinical significance of some microorganisms suggests they might be strains commonly isolated in clinical settings, but their exact provenance (e.g., country, specific source) is not detailed.

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

   • This information is not provided in the document. The study's ground truth for microbial recovery would typically be established by laboratory methods (e.g., colony counting) rather than expert interpretation in the way, for example, a radiology study would use expert readers.

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

   • This concept is not applicable to this type of microbiology recovery study. Adjudication methods like 2+1 or 3+1 are typically used in clinical imaging or diagnostic studies where human readers interpret results and consensus is needed. For microbial recovery studies, quantitative measures (e.g., colony-forming units) are the primary endpoint.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. The Puritan Amies Medium is a specimen collection and transport device, not an AI diagnostic tool.

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

   • No, a standalone algorithm performance study was not done. This device is a physical medical device (collection and transport medium), not an algorithm or AI system.

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

   • The ground truth for the recovery testing was established by quantitative microbiological methods, specifically by comparing the recovery (viability) of known inoculums of ATCC type cultures and clinically significant microorganisms in the Puritan Amies Medium versus a predicate device. This would involve standard laboratory techniques like plating and colony counting to quantify viable organisms.

7. The sample size for the training set:

   • Not applicable. This device is a physical medical device, not an AI model or algorithm, so there is no "training set."

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

   • Not applicable. As there is no training set for this type of device, this question is not relevant.

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Puritan Liquid Amies Collection and Transport System is intended for use in the collection and transport of clinical specimens containing aerobic and fastidious bacteria from the patient to the laboratory for bacteriological examination and culture.

Puritan Liquid Amies Collection and Transport System is comprised of a sterile peel pouch containing a polyester flock swab applicator for collecting specimen and a polypropylene vial containing 1 ml of modified Amies liquid transport medium. The polyester flock swab applicators are provided in two different tip sizes to accommodate various specimen types. Amies liquid medium is a nonnutritive balanced salt solution containing inorganic phosphates to provide buffering capability, sodium chloride, potassium chloride, calcium chloride and magnesium chloride to provide essential ions that help maintain osmotic balance. Sodium thioglycollate provides a reduced environment. It is recommended for maintaining the viability of aerobic, anaerobic and fastidious bacteria during the transport to the laboratory.

The Puritan Liquid Amies Collection and Transport System is intended for the collection and transport of clinical specimens containing aerobic, anaerobic, and fastidious bacteria. The pivotal study demonstrating its performance is the "Recovery Testing" described in section 5.8 of the 510(k) summary. This study compared the Puritan system to a predicate device (BD (Copan) Liquid Amies Collection and Transport System, K061301) to demonstrate substantial equivalence.

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 the data provenance:

• Sample Size: The document mentions "known inocula of ATCC type culture and clinically significant microorganisms" were inoculated. It also states "random samples from three different lots of Puritan Liquid Amies Collection and Transport System" were used for pH stability. However, the exact number of microorganisms tested, replicates per microorganism, or total sample size for the core bacterial recovery study is not explicitly stated in the provided text.
• Data Provenance: The origin of the data is from laboratory testing (in vitro) comparing the Puritan device to a predicate device. It is not patient or country-specific data, but rather controlled experimental data. The study is prospective in the sense that the experiments were conducted specifically to evaluate the device.

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

This information is not applicable and not provided for this type of device (microbiological transport system). The ground truth for bacterial viability is established through quantitative laboratory methods (e.g., colony counting) and comparison to established standards (CLSI M40-A), not by expert consensus or interpretation of images/clinical data.

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

This information is not applicable and not provided. Adjudication methods are typically used in studies involving human interpretation (e.g., radiology for diagnostic devices) where multiple readers disagree. For this in vitro microbiological test, the results are quantitative and objective, eliminating the need for 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:

This information is not applicable. The Puritan Liquid Amies Collection and Transport System is a medical device for specimen collection and transport, not an AI-powered diagnostic tool involving human readers. Therefore, an MRMC study or AI assistance is irrelevant to its evaluation.

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

This information is not applicable. This device is not an algorithm. Its performance is evaluated independently (standalone in a laboratory setting) by assessing its ability to maintain bacterial viability, followed by subsequent testing by laboratory personnel. There is no human-in-the-loop aspect for the function of the transport medium itself.

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

The ground truth used for the bacterial recovery test is based on quantitative microbiological methods, specifically the known initial inoculum of ATCC type cultures and clinically significant microorganisms, and their subsequent viability over time. The Clinical and Laboratory Standards Institute (CLSI) M40-A guidelines likely define the acceptable range of recovery, acting as the reference standard.

8. The sample size for the training set:

There is no training set in the context of this device. This is a laboratory-tested medical device, not a machine learning model.

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

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

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Medical Wire & Equipment Σ-Transwab (Sigma-Transwab ) Specimen Collection and Transport System is intended to preserve the viability and infectivity of microbiological specimens after their collection and during transport from the collection site to the testing laboratory. Σ-Transwab specimens are processed using standard clinical laboratory operating procedures for microbiological specimens.

Not Found

This is an FDA 510(k) clearance letter for a medical device (a specimen collection and transport system), not a study report or clinical trial. Therefore, most of the requested information regarding acceptance criteria, device performance, study design, and ground truth establishment is not typically found in this type of document.

A 510(k) clearance indicates that the FDA has determined the device is substantially equivalent to a legally marketed predicate device. This process primarily relies on demonstrating that the new device is as safe and effective as a predicate device, often through comparison of technical characteristics and performance data that align with generally accepted methods for that device type. It does not typically involve the detailed study protocols, acceptance criteria tables, expert reviews, or MRMC studies that would be present in a comprehensive clinical study report for a novel or higher-risk device.

Here's an attempt to answer the questions based on the provided document, with the understanding that much of the requested detail is not available here:

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

This document does not contain a table of acceptance criteria or reported device performance metrics in the format requested. The FDA has reviewed the "premarket notification of intent to market" and determined the device is "substantially equivalent" to predicate devices. This implies that the performance characteristics presented by the manufacturer (though not detailed here) met the FDA's criteria for equivalence for this type of device.

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

This information is not provided in the FDA clearance letter. The document mentions a "premarket notification," which usually includes data, but the specifics of the sample size, data provenance, and study design are not detailed in this public clearance letter.

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 provided.

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

This information is not provided.

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 type of study is not relevant to this device. The device is a "Microbiological specimen collection and transport device," not an AI-powered diagnostic or imaging tool that would involve human readers or AI assistance in interpretation.

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

This question is not applicable. The device is a physical specimen collection and transport system, not an algorithm.

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

For a microbiological specimen collection and transport device, the "ground truth" would typically involve demonstrating:

• Maintenance of viability and infectivity of various microorganisms over specified timeframes and temperatures.
• Comparability of recovery rates to predicate devices.
• Absence of inhibitory substances.

However, the specific "type of ground truth" used in the manufacturer's submission to the FDA is not detailed in this clearance letter. It would likely have involved laboratory-based challenge studies with known microbial cultures.

8. The sample size for the training set

This information is not provided and is generally not applicable to the evaluation of this type of device in the way it would be for an AI/ML diagnostic. Training sets are relevant for machine learning models, which this device is not.

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

Not applicable, as this is not an AI/ML device requiring a training set.

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Medical Wire & Equipment Virocult® Virus Collection and Transport System is intended to preserve the viability and infectivity of viral specimens for viral culture after their collection and during transport from the collection site to the testing laboratory. Virocult specimens are processed using standard clinical laboratory operating procedures for viral and cell culture.

Each Virocult® device comprises a sterile peel pouch containing a rayon- tipped swab used to collect the sample and a tube containing an open cell polyurethane pad soaked with Virocult® virus transport medium. After sampling, the swab applicator is placed inside the tube, where the bud is bathed with the liquid from the foam pad.

Virocult® medium consists of a phosphate-buffered balanced salt solution, glucose, lactalbumin hydrolysate to stabilise the virus particles, and antibiotics to inhibit the growth of other microorganisms that may be present in the clinical specimen.

The rayon- tipped swab will suit most general applications such as mouth, nose, throat and skin.

To use Virocult®, the sterile peel pouch is opened, and the cap removed from the transport tube. The applicator swab is removed from the pouch and used to collect the clinical specimen. During specimen collection, the applicator should only fouch the area where the infection is suspected.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Medical Wire Virocult® Virus Collection and Transport System:

Based on the provided 510(k) summary, the device is a virus collection and transport system, not an AI-powered diagnostic device. Therefore, many of the typical acceptance criteria and study designs associated with AI medical devices (like those involving expert adjudication, multi-reader multi-case studies, or AI standalone performance) are not applicable to this submission.

The "acceptance criteria" for a device like this would primarily revolve around its ability to preserve viral viability and infectivity, its stability over time, and its pH, recovery, and toxicity characteristics as a transport medium. The study done proves its performance against these criteria.

Acceptance Criteria and Reported Device Performance

Study Details

Given this is a 510(k) for a physical medical device (transport medium), the study details differ significantly from those for AI/Software as a Medical Device (SaMD).

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

   • The document does not specify exact sample sizes (e.g., number of swabs, number of viral strains, number of tests conducted) for the performance testing. It generally states that "Tests were done to simulate transport" and "Stability studies were performed."
   • Data Provenance: The studies were conducted by the manufacturer, Medical Wire & Equipment Company (Bath) Ltd., as part of their 510(k) submission. The country of origin for the testing would presumably be the UK, where the company is based. The studies appear to be laboratory-based performance evaluations rather than clinical trials with patient data, so they are prospective in the sense of being planned experiments.

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

   • Not Applicable. This is a physical device used to collect and transport biological samples, not an AI system making diagnostic interpretations. "Ground truth" in this context would be defined by the known initial viral concentration in the samples used for testing, and the known conditions (temperature, time) that the samples were subjected to. These would be laboratory-controlled parameters, not expert-adjudicated diagnoses.

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

   • Not Applicable. No human adjudication of diagnostic outcomes is involved. The evaluation relies on laboratory measurements of viral viability/recovery.

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 is a physical collection and transport device, not an AI system or an AI-assisted diagnostic tool. There are no "human readers" (e.g., radiologists, pathologists) whose performance would be improved by this device in a diagnostic context, nor is there any AI involved.

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

   • Not Applicable. This is a physical medical device, not an algorithm or AI.

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

   • For the performance testing (viral recovery, stability), the ground truth is primarily established through laboratory standards and controls. This would involve:
     • Known initial concentrations of specific viruses (reference strains).
     • Standardized methods for viral culture and quantification (e.g., plaque assays, PCR measurement of viral load) to determine recovery rates after transport.
     • Measurement against established benchmarks for acceptable viral viability post-transport (likely derived from CLSI guidelines or internal validation against predicate devices).

7. The sample size for the training set:

   • Not Applicable. This is a physical medical device, not an AI/machine learning model that requires a "training set."

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

   • Not Applicable. As there is no AI or machine learning model, there is no "training set" or ground truth for it. The product's formulation and specifications are based on scientific principles of viral preservation and chemical stability, not trained data.

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Coproset Salmonella: In vitro Disposable diagnostic device with Selenite Broth intended for the collection and transport, from the collection site to the testing laboratory, of stool samples and for the enrichment of Salmonella spp.

Coproset Shigella: In vitro Disposable diagnostic device with GN Broth intended for the collection and transport from the collection site to the testing laboratory of stool samples and for the enrichment of Shigella spp

Uriset preservative tubes: Disposable in vitro diagnostic device for the collection and transport of urine samples from the collection site to the testing laboratory.

Swab set General Use: Disposable in vitro diagnostic device with Eugon Broth, intended for the collection and transport of pathogenic agents collected by swabs from the collection site to the testing laboratory and for enrichment of Streptococcus pyogenes, Staphylococcus aureus, Candida spp., Streptococcus agalactiae.

Coproset: disposable in vitro diagnostic device for the collection and transportation of stool samples and the enrichment of pathogenic organisms present in the sample.

Coproset Salmonella: In vitro Disposable diagnostic device with Selenite Broth intended for the collection and transport, from the collection site to the testing laboratory, of stool samples and for the enrichment of Salmonella spp.

Coproset Shigella: In vitro Disposable diagnostic device with GN Broth intended for the collection and transport from the collection site to the testing laboratory of stool samples and for the enrichment of Shigella spp.

Uriset Preservative tubes with holder: Disposable in vitro diagnostic device for the collection and transport of urine samples from the collection site to the testing laboratory.

Swab set General use: Disposable in vitro diagnostic device with Eugon Broth, intended for the collection and transport of pathogenic agents collected by swabs from the collection site to the testing laboratory and for enrichment of Streptococcus pyogenes, Staphylococcus aureus, Candida spp., Streptococcus agalactiae.

The provided text describes a 510(k) summary for several microbiological specimen collection and transport devices, namely Coproset Salmonella, Coproset Shigella, Uriset Preservative tubes, and Swab set General Use. The document details the device descriptions and general information but does not contain detailed information regarding acceptance criteria, specific study designs, or performance data in the format requested.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about sample sizes for test/training sets, ground truth establishment, expert involvement, adjudication methods, or MRMC studies.

The document states: "Performance evaluation, further demonstrate the substantial equivalence and the safety and effectiveness of Diesse Devices when compared with the respective Predicate Device: in the case of Coproset devices and Swab set device viability of pathogen is maintained and the results obtained are comparable with those obtained for predicate device; Uriset preservative tubes with holder have the same intended use, Indication for use, material and design than its predicate device and thus it possible to conclude that they are substantially equivalent. The results obtained in the comparison between Uriset preservative tube and Vacutainer demonstrate that DIESSE Uriset give a good performance in terms of sample preservation and data are comparable with those obtained for the predicate device."

This statement indicates that performance evaluations were conducted, and the results were found to be "comparable" with predicate devices, suggesting the device does meet certain performance expectations. However, the specific metrics, criteria, and detailed study results demonstrating this comparison are not included in this summary.

In summary, the input text lacks the specific details required to answer your questions about acceptance criteria, study design, and performance metrics.

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REMEL's Bacti-Swab™ Dry collection and transport system is comprised of a sterile, rayon-tipped plastic shaft swab in a plastic sleeve for use in collection and transportation of a variety of samples to the laboratory for microbiological examination when dry swab collection is appropriate.

comprised of a sterile, rayon-tipped plastic shaft swab in a plastic sleeve

This is an FDA Premarket Notification (510(k)) letter for a microbiological specimen collection and transport device, the Bacti-Swab™ Dry. Based on the provided text, there is no information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone studies, or how ground truth was established for this device.

The letter explicitly states:

• "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976..."
• "This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed device is an authorization for your device and thus, permits your device to proceed to the market."

This indicates that the device was cleared based on substantial equivalence to a predicate device, rather than through a new clinical performance study demonstrating specific acceptance criteria with detailed performance metrics. The 510(k) process often relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, without necessarily requiring new clinical trials that would generate the type of data you're asking for.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, or performance because that information is not present in the provided FDA letter. The letter is a clearance notification, not a study report.

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The Entero-Test® HP is an in-vitro diagnostic device to be used for the collection of fluid/mucous containing Helicobacter pylori from the upper gastrointestinal tract of adults. The device consists of a nylon thread, 90cm in length, coiled inside a #00 gelatin pharmaceutical capsule.

The Entero-Test® HP is collection device encased in a gelatin capsule. It can be used to collect fluids/mucous in the upper gastrointestinal tract of adults. A pH stick and a color chart are included in each package for the purpose of identifying the pH of the fluids/mucous.

Here's an analysis of the acceptance criteria and study details based on the provided text for the Entero-Test® HP device.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the exact sample sizes for the clinical tests conducted in the U.S. and China. It only refers to "the studies" and "both study sites."

The data provenance is stated as: U.S. and China (indicating different geographical locations for the studies). The studies were conducted to compare the device's performance to an established "gold standard," implying they were prospective in nature for data collection related to device performance.

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

The document states that Biopsy is considered the "gold standard" for determining the presence of Helicobacter pylori. While biopsy interpretation typically involves pathologists, the document does not specify the number or qualifications of experts consulted for interpreting the biopsy results that served as the ground truth.

4. Adjudication method for the test set

The document does not mention any specific adjudication method used for establishing the ground truth (biopsy results) for the test set.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device described (Entero-Test® HP) is a specimen collection device, not an AI-powered diagnostic tool requiring human reader interpretation in the context of AI assistance. The study compared the device's collection effectiveness against a gold standard (biopsy).

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

The Entero-Test® HP is a physical specimen collection device. Its "performance" refers to its ability to collect a sample, not an algorithm's classification or diagnostic ability. Therefore, the concept of a "standalone (algorithm only without human-in-the-loop performance)" study does not apply to this device. The study evaluated the device's effectiveness in collecting a good sample.

7. The type of ground truth used

The type of ground truth used was Biopsy results, explicitly stated as the "gold standard" for determining the presence of Helicobacter pylori.

8. The sample size for the training set

The document does not mention a training set as this device is a specimen collection tool, not a machine learning algorithm that requires training data. The studies described are performance validation studies.

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

As there is no training set for this type of device, this question is not applicable.

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REMEL's Par-One™ is a medium recommended for use in qualitative procedures for the transportation, preservation, and examination of stool specimens for intestinal parasites. Concentration, permanent stained smear, and immunoassay procedures can be performed from this single vial transport system.

Not Found

This document is a marketing clearance letter from the FDA for the Remel Inc. Par-One™ device, which is a medium for the transportation, preservation, and examination of stool specimens for intestinal parasites. As a 510(k) clearance letter, it primarily focuses on establishing "substantial equivalence" to a predicate device rather than providing a detailed study report with acceptance criteria and comprehensive performance data in the format requested.

Therefore, many of the specific details regarding acceptance criteria, study design, expert qualifications, sample sizes, and ground truth establishment are not present in this type of regulatory document. The FDA clearance is based on the submission demonstrating the device is as safe and effective as a legally marketed predicate device.

However, I can extract what information is available or infer from the context:

Here's an attempt to answer your questions based on the provided document, with an acknowledgment of what information is missing:

1. Table of acceptance criteria and the reported device performance

This document does not provide a table of acceptance criteria or specific reported device performance metrics (e.g., sensitivity, specificity, accuracy) from a clinical study. The FDA clearance is based on "substantial equivalence" to a predicate device. This implies that the device's performance was deemed to be at least as good as the predicate's for its intended use, but the specific numerical performance data and acceptance criteria from the company's internal studies are not detailed here.

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

• Sample Size for Test Set: Not specified in this document.
• Data Provenance: Not specified in this document. Typically, for a device like this, studies would involve human stool samples. Whether they were retrospective or prospective, or the country of origin, is not mentioned.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. For parasite identification in stool, ground truth would typically be established by experienced clinical microbiologists or parasitologists.

4. Adjudication method for the test set

• Adjudication Method: Not specified.

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

• MRMC Study: Not applicable. This device is a transport medium for specimens, not an AI or imaging diagnostic tool that would typically involve human readers interpreting images. Therefore, improvement of human readers with AI assistance is not relevant to this device.

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

• Standalone Performance: Not applicable. This is a specimen collection and transport medium, not an algorithm.

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

• Type of Ground Truth: While not explicitly stated, for a device used to detect intestinal parasites from stool specimens, the ground truth would most likely be established by a combination of:
  • Expert microscopic examination: Highly trained laboratory personnel identifying parasites directly.
  • Molecular methods: PCR or other genetic tests for specific parasites (if available and used as a gold standard).
  • Culture: For specific parasites that can be cultured.
    This document does not specify which methods were used.

8. The sample size for the training set

• Sample Size for Training Set: Not specified. For a physical medical device like a transport medium, the concept of a "training set" as understood in machine learning is not directly applicable. If studies were performed to optimize the medium's composition or shelf-life, those would involve separate experimental designs, not a "training set" in the AI sense.

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

• How Ground Truth for Training Set was Established: Not applicable in the AI sense. For the development and validation of the transport medium itself, "ground truth" would relate to its ability to preserve parasite morphology, viability, or antigenicity over time, which would be established through controlled laboratory experiments. These experiments would involve known positive and negative specimens and subsequent evaluation by appropriate diagnostic methods. However, the specific methodologies are not detailed in this clearance letter.

Summary of what can be gleaned from the document:

• Device Name: Par-One™
• Manufacturer: Remel Inc.
• Intended Use: "Recommended for use in qualitative procedures for the transportation, preservation, and examination of stool specimens for intestinal parasites. Concentration, permanent stained smear, and immunoassay procedures can be performed from this single vial transport system."
• Regulatory Status: 510(k) clearance, indicating "substantial equivalence" to a predicate device.
• Regulatory Class: Class I
• Product Code: LIO
• Prescription Use: Yes

The document is a regulatory approval, not a scientific study report. Therefore, it does not contain the detailed study design and performance metrics typically found in a peer-reviewed publication or a comprehensive technical report for a device.

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