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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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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 Copan FecalSwab Collection, Transport and Preservation System is intended for collection of viable enteric pathogenic bacteria from rectal swabs and stool specimens during transport from the collection site to the testing laboratory. In the laboratory, FecalSwab specimens are processed using standard clinical laboratory operating procedures for culture. Stool specimens collected with the Copan FecalSwab are also suitable for use with the BD MAX Enteric Bacterial Panel and the BD MAX Extended Enteric Bacterial Panel.

The FecalSwab Collection. Transport and Preservation System (Copan FecalSwab) is supplied in a collection kit format. Each collection kit consists of a package containing a plastic tube filled with 2 mL of FecalSwab transport and preservation medium and a specimen collection flocked swab intended both for rectal and stool specimen collection. In the laboratory, rectal and stool specimen are processed using standard clinical laboratory operating procedures for culture.

The FecalSwab transport and preservation medium is a maintenance medium comprised of: Chloride salts, Sodium salts, Phosphate buffer, L-Cysteine and Agar. The medium is designed to maintain the viability of enteric pathogenic bacteria during transit to the testing laboratory

The Copan FecalSwab Collection. Transport and Preservation System was previously cleared (K142094) for the collection of rectal swab and fecal specimens and to preserve the viability of enteric pathogenic bacteria during transport from the collection site to the testing laboratory. In the laboratory, FecalSwab specimen are intended be processed using standard clinical laboratory operating procedures for culture but is not cleared for use with downstream molecular assays. The FecalSwab has been demonstrated to be suitable for testing samples with the BD MAX Enteric Bacterial Panel (EBP) and BD MAX Extended Bacterial Panel (xEBP).

The provided document describes the acceptance criteria and supporting studies for the Copan FecalSwab Collection, Transport and Preservation System when used with the BD MAX Enteric Bacterial Panel (EBP) and BD MAX Extended Bacterial Panel (xEBP).

Here's an analysis of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

• Swab Elution Method: At 2-8°C, log reduction at 72h was -0.17. At 20-25°C, log increase at 48h was 0.61.
• Roll Plate Method: At 2-8°C, log increase at 72h was 0.01. At 20-25°C, log increase at 48h was 0.92.
  All data demonstrated the ability of the FecalSwab to maintain viability within the stated criteria. |
  | Specimen Storage Stability | A minimum of 95% detection for all targets at 2-8ºC for up to 120 hours (5 days) or at 25±2ºC for up to 48 hours, when SBT was used as described in the study design. | Each organism tested for both BD MAX EBP and xEBP had ≥ 95% detection at all target storage stability time points claimed in the package insert. The lowest reported percentage positive was 96%. |
  | PCR Interfering Substances | The Sample Processing Control (SPC) target should successfully amplify, indicating no interference or inhibition from the FecalSwab components. | Amplification of the SPC target was successful for 100% of replicates tested (e.g., 48/48 at Day 0, 24/24 at Day 1, etc.) across all stability time points. The results indicate that "there was no interference or inhibition in any of the component of the FecalSwab collection, transport, and preservation system." |
  | Microbial Cross-Reactivity | No effect on the BD MAX EBP and BD MAX xEBP instruments or signal overlap when FecalSwab preserved stool specimens are used. (Implicitly, the device should not introduce new cross-reactivity not already accounted for by the BD MAX assays). | Data indicates that "the use of the FecalSwab to collect, transport and preserve stool specimens does not have any effect on the BD MAX EBP and BD MAX xEBP instruments or have any effect on signal overlap." No additional cross-reactivity studies were conducted as the assay design, reagents, workflow, algorithm, or interpretation of results for the BD MAX panels were unchanged. |

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

• Limit of Detection (LoD):

  • Sample Size: For each organism and dilution, 150 µL of inoculated stool samples were used to spike 12 tubes of FecalSwab transport medium. From each FecalSwab tube, 50 µL were transferred into a total of 24 BD MAX sample buffer tubes (SBTs) in parallel. This procedure was repeated for each dilution and mix.
  • Data Provenance: The study was conducted using a pooled negative clinical stool matrix, which was pre-tested with an FDA-cleared assay to confirm negativity for each target organism. Organisms used were ATCC strains (e.g., Salmonella typhimurium ATCC 14028). The country of origin for the clinical stool matrix is not specified, but the study implies a laboratory-based evaluation rather than field collection. This appears to be a prospective in-vitro study designed to establish analytical performance.

• Bacterial Recovery (Viability):

  • Sample Size: Not explicitly stated as a distinct number of samples for the P. shigelloides study (which was the only new viability study). However, the tables show "Average CFU recovered from three lots," indicating at least three lots of FecalSwab were tested. Measurements were taken at T=0, 6h, 24h, 48h, and 72h.
  • Data Provenance: Laboratory study using ATCC 14029 (Plesiomonas shigelloides). This is a prospective in-vitro study.

• Specimen Storage Stability:

  • Sample Size: The study included four panels, each consisting of two different organisms mixed into clinical matrix and contrived at a concentration of 2 x LoD. For each time point and organism, the percentage positive was determined from replicates (e.g., 23/24, 24/24), implying 24 replicates per test condition.
  • Data Provenance: Clinical matrix (stool) spiked with ATCC strains (e.g., Campylobacter jejuni ATCC 43429). The origin of the clinical matrix is not specified. This is a prospective in-vitro study.

• PCR Interfering Substances:

  • Sample Size: The number of replicates tested ranged from 24 to 48, depending on the storage condition and time point (e.g., 48 replicates at Day 0, 24 replicates for most other time points).
  • Data Provenance: The study assessed the FecalSwab components using spiked samples within the context of the Specimen Storage Stability studies. This is a prospective in-vitro study.

• Microbial Cross-Reactivity:

  • Sample Size: No new studies were conducted.
  • Data Provenance: Refers to previous studies for the original BD MAX EBP and BD MAX xEBP clearance. No specific details about those studies are provided here.

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

The document does not mention the use of experts or their qualifications for establishing ground truth for the test sets. The studies described are analytical performance studies (LoD, viability, stability, interference) that rely on laboratory measurements (CFU/mL, % detection, SPC amplification) against predefined criteria, not expert interpretation of clinical data.

4. Adjudication method for the test set

Not applicable. The studies are analytical performance evaluations based on quantitative measurements or clear positive/negative detection, not subjective assessments requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a pre-analytical collection and transport system for molecular diagnostic assays, not an AI-powered diagnostic imaging or interpretation device that would involve human readers or AI assistance in a clinical diagnostic workflow.

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

This refers to the performance of the Copan FecalSwab system itself, specifically its ability to preserve the viability of pathogens and not interfere with downstream molecular assays.

• Standalone aspects evaluated:
  • Viability: Demonstrated the FecalSwab's ability to maintain bacterial viability over time and temperature (Tables 3 & 4).
  • Non-interference/Compatibility: Demonstrated that the FecalSwab does not negatively influence the LoD of the BD MAX assays (Tables 1 & 2), does not interfere with PCR (Table 7), and ensures nucleic acid stability (Table 6).

The studies described are essentially "standalone" evaluations of the FecalSwab's analytical performance and compatibility with the BD MAX systems, as opposed to evaluating an AI algorithm's performance.

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

The ground truth for these analytical studies was established through:

• Known concentrations of microorganisms: For LoD studies, organisms were serially diluted to known CFU/mL concentrations. For stability studies, samples were contrived at 2xLoD.
• Reference strains: ATCC strains were used (e.g., Salmonella typhimurium ATCC 14028, Plesiomonas shigelloides ATCC 14029).
• Pre-tested clinical matrix: Pooled negative clinical stool matrix was confirmed negative using an FDA-cleared assay before spiking with target organisms.
• Manufacturer's specifications/historical data: The LoD, stability, and cross-reactivity of the BD MAX EBP and xEBP panels themselves were previously established in their respective clearances. This submission evaluates the FecalSwab's compatibility with those established performance characteristics.

8. The sample size for the training set

Not applicable. This device is a physical collection and transport system, not an AI/ML algorithm that requires a "training set." The studies performed are analytical performance validations.

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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Copan eNAT- molecular collection and preservation medium- is intended for the stabilization, transportation and inactivation of an unprocessed upper respiratory clinical specimen suspected of containing influenza A virus RNA. eNAT- molecular collection and preservation medium- is intended for use with compatible molecular assays.

The primary purpose of nucleic acids amplification techniques is to screen for a wide range of infectious diseases, so nucleic acid integrity of clinical specimens during transport and storage should be preserved.

eNAT® medium contains a detergent and a protein denaturant to prevent microbial proliferation and to maintains the integrity of the nucleic acids from cells or pathogens collected from patients and inactivates pathogen viability, thus eNAT® is not intended to be used for culture-based techniques.

Copan eNAT® has 3 different configurations:

Ref. 6U072S: a plastic screw-cap tube filled with 2 ml of Molecular Preservation and Transport medium.

Ref. 6U073S01: a plastic screw-cap tube filled with 2 ml of Molecular Preservation and Transport medium and a regular size tip nylon flocked swab for sample collection.

Ref. 6U074S01: a plastic screw-cap tube filled with 2 ml of Molecular Preservation and Transport and a minitip nylon flocked swab for sample collection.

The provided text details the 510(k) summary for the Copan eNAT® molecular collection and preservation medium. The document compares its performance to a predicate device, PrimeStore™ MTM, focusing on the inactivation and stabilization of Influenza A virus RNA.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

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

The text explicitly mentions the following sample sizes and aspects of data provenance for the performance studies:

• Flu A Inactivation Study:

  • Test Set Description: High concentrations of Flu A in nasal matrix were inoculated into eNAT® using Copan's regular nasal-type FLOQSwabs®.
  • Sample Size: Not explicitly stated as a number of distinct "samples." The study describes inoculating "aliquots" onto MDCK cell lines.
  • Data Provenance: The study design "followed the study design described by Longhorn in the PrimeStore MTM Decision Summary, DEN170029." This suggests an in-house laboratory study. The country of origin for the data is not specified, but the applicant is Copan Italia S.p.A.
  • Retrospective/Prospective: These appear to be prospective laboratory studies designed to evaluate the eNAT® device.

• Analytical Sensitivity Study (LoD):

  • Test Set Description: Flu A was diluted to 0.180 TCID50/ml (in the matrix) for testing with eNAT® in combination with the Cepheid Xpert® Xpress Flu/RSV assay.
  • Sample Size: 24 replicates for the eNAT® samples.
  • Data Provenance: Not explicitly stated but implied to be an in-house laboratory study.
  • Retrospective/Prospective: Prospective laboratory study.

• Flu A RNA Stability Study:

  • Test Set Description: Flu A spiked into eNAT® medium.
  • Sample Size: 24 replicates for each storage condition (Time zero, 4 weeks at 2-8°C, 4 weeks at 25°C).
  • Data Provenance: Not explicitly stated but implied to be an in-house laboratory study.
  • Retrospective/Prospective: Prospective laboratory study.

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

The provided text does not mention the involvement of experts (such as radiologists) to establish ground truth for the test sets. The studies described are analytical performance studies conducted in a laboratory setting, rather than clinical studies requiring expert interpretation of diagnostic images or results. The "ground truth" for these studies is based on quantitative laboratory measurements of viral load or RNA levels.

4. Adjudication Method for the Test Set

As the studies are analytical performance assessments based on quantitative laboratory measurements (e.g., log reduction, TCID50/ml, PCR Ct values), adjudication methods (like 2+1 or 3+1 often used in clinical image interpretation studies) are not applicable and therefore not mentioned. The results are determined by the outcome of the laboratory assays.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done or is described. The studies detailed are analytical performance evaluations of the device's ability to inactivate and stabilize viral RNA, not clinical studies involving human readers and their diagnostic accuracy with or without AI assistance.

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

The device itself is a molecular collection and preservation medium, not an algorithm. Therefore, the concept of "standalone performance" in the context of an algorithm does not apply here. The studies conducted evaluated the standalone performance of the medium in terms of its chemical and biological effects on the virus and its RNA.

7. The Type of Ground Truth Used

The ground truth used for these studies is analytical/laboratory-based:

• Flu A Inactivation: The ground truth for viral viability was determined by MDCK (Madin-Darby Canine Kidney) cell culture to measure cytopathic effect (CPE) and determine TCID50/ml (Tissue Culture Infectious Dose 50%).
• Analytical Sensitivity (LoD) and RNA Stability: The ground truth for the presence and quantity of Flu A RNA was established using a molecular assay (Cepheid Xpert® Xpress Flu/RSV assay), which provides quantitative PCR Ct values. The initial concentration of Flu A (TCID50/ml) was also a part of the ground truth for LoD.

8. The Sample Size for the Training Set

The provided text does not mention a training set as this device is a physical sample collection and preservation medium, not an AI/ML algorithm that requires training data. The studies are for performance validation of the medium itself.

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

Since there is no training set mentioned for an AI/ML algorithm, this question is not applicable.

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Copan UriSwab™ - 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. UriSwab™ specimens are processed using standard clinical laboratory operating procedures for the cultivation of uropathogenic bacteria and yeasts.

Copan's UriSwab™ - Urine Collection, Transport and Preservation System (UriSwabTM) consists of screw cap self-standing tube with conical shaped bottom. Inside the tube, the cap holds a plastic stick with sponges made of hydrophilic polyurethane. The sponges incorporate preservative substances. Two types of collection systems are available: the regular size (100 mm length X 16 mm diameter) plastic tube and the mini size (80 mm length x 12 mm diameter) plastic tube.

This document describes the performance data for the Copan UriSwab™ - Urine Collection, Transport and Preservation System, focusing on its ability to maintain the viability of uropathogenic bacteria and yeasts in urine specimens for transport and preservation.

Acceptance Criteria and Reported Device Performance

Study Details:

1. Sample Size and Data Provenance:

   • Test Set Sample Size: Triplicate analyses were performed for each microorganism and initial concentration (10^2, 10^3, 10^4 CFU/ml) in the viability and recovery testing. This also applied to the organism release verification and non-saturated sponge studies, which involved specific microorganisms and three production lots. The exact total number of samples is not explicitly stated, but it involves multiple microorganisms, concentrations, storage conditions, and replicates.
   • Data Provenance: The study used ATCC® cultures of potential urinary tract pathogens spiked into sterile synthetic urine. The origin of the synthetic urine is not specified. The study appears to be prospective as it involves controlled laboratory experiments.

2. Number of Experts and Qualifications for Ground Truth:

   • This study did not involve human interpretation of medical images or clinical data that would require experts to establish ground truth in the traditional sense of a diagnostic device. The ground truth was established by laboratory methods.

3. Adjudication Method for the Test Set:

   • Not applicable, as this was a laboratory study comparing quantitative microbiological recovery against a predefined acceptance criterion (+/- 1 log from original spiked concentration).

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

   • No, an MRMC study was not conducted as this is not an AI-based diagnostic imaging device requiring human-in-the-loop performance measurement.

5. Standalone Performance Study:

   • Yes, a standalone study was performed. The device's performance (UriSwab™) was evaluated independently against the CLSI M40-A2 standard for its ability to maintain microbial viability and allow for recovery.

6. Type of Ground Truth Used:

   • The ground truth was established through laboratory measurements of initial spiked concentrations of various microorganisms in sterile synthetic urine. The performance of the UriSwab™ was then compared to these initial concentrations.

7. Sample Size for the Training Set:

   • Not applicable. This device is a collection and transport system, not an algorithm that requires a training set. The microorganisms used for testing were ATCC® cultures.

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

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

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The Copan FecalSwab Collection, Transport and Preservation System is intended for the collection of rectal swab and fecal specimens and to preserve the viability of enteric pathogenic bacteria during transport from the collection site to the testing laboratory. In the laboratory, FecalSwab specimens are processed using standard clinical laboratory operating procedures for culture.

The Copan FecalSwab Collection, Transport and Preservation System (Copan FecalSwab System) is supplied in a sterile collection kit format. Each collection kit consists of a package containing a plastic screw-cap tube with conical shaped bottom filled with 2ml of FecalSwab transport and preservation medium and a specimen collection swab that has a tip flocked with soft nylon fiber. The FecalSwab transport and preservation medium is a maintenance medium comprised of: Chloride salts, Sodium salts, Phosphate buffer, L-Cysteine and Agar. The medium is designed to maintain the viability of enteric pathogenic bacteria during transit to the testing laboratory. The nylon flocked specimen collection swabs provided with the Copan FecalSwab Collection, Transport and Preservation System have a solid plastic shaft with a molded breakpoint site.

The provided document is a 510(k) premarket notification for a medical device (Copan FecalSwab Collection, Transport and Preservation System). This type of document is for regulatory approval and focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific clinical acceptance criteria in the same way a new drug or novel medical device might through a large-scale clinical trial.

Therefore, many of the requested elements are not applicable in this context, as the study presented is a non-clinical performance study designed to show the device functions similarly to an already approved device.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the performance of the predicate device and the general expectation for transport media to maintain organism viability. The study aims to demonstrate that the Copan FecalSwab performs at least as well as the predicate device in terms of bacterial viability.

"Acceptance Criteria" Explanation: For a 510(k) submission, the "acceptance criteria" for performance studies like this are typically that the new device performs at least as well as or is comparable to the predicate device. The CLSI M40-A2 guideline mentioned (which details standards for transport media) would define what constitutes acceptable recovery and viability for such devices. The positive LOG increases for many organisms suggest that the transport medium not only preserves but in some cases, may even support proliferation, which is generally acceptable as long as it doesn't lead to overgrowth that masks other pathogens. For C. difficile and C. jejuni, where there were LOG reductions, the criteria would be that a sufficient number of viable organisms remain for detection within the specified timeframe. The document states "Viability of target micro-organisms up to 48 hours at room temperature and 72 hours at 2°C-8°C. For C. difficile, up to 48 hours at 2 – 8 °C and up to 24 hours at 20 – 25 °C" as the performance characteristic of the FecalSwab, implying these were the targets to be met to demonstrate equivalence.

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

• Sample Size: The tables indicate "N = 3 LOTS TESTED" for all bacterial recovery experiments. This refers to 3 different manufacturing lots of the Copan FecalSwab device being tested. For each organism and condition (temperature/time point), there would have been multiple replicates per lot.
• Data Provenance: The study is non-clinical (laboratory-based). The organisms used are specific ATCC (American Type Culture Collection) strains, which are standardized reference microorganisms. Therefore, there is no country of origin for human data or retrospective/prospective designation in the human sense.

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

• N/A. This was a laboratory performance study of bacterial viability in a transport medium, not a study requiring expert interpretation of clinical data or images. The "ground truth" was established by quantitative microbiological methods (CFU recovery).

4. Adjudication Method for the Test Set

• N/A. As this was a microbiology laboratory study, there was no adjudication method involving human experts interpreting results in a consensus manner. Results were quantitative Colony Forming Unit (CFU) counts.

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

• N/A. This is not an AI or imaging device, and no human reader study was conducted.

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

• N/A. This is a physical medical device (transport medium and swab), not an algorithm or software. The "standalone" performance here refers to the device's ability to maintain bacterial viability on its own, without human intervention affecting the measurement of viability post-collection. The reported CFU counts are precisely this type of standalone performance.

7. The Type of Ground Truth Used

• Quantitative Microbiological Culture (CFU counts): The ground truth for bacterial viability was established by performing standard quantitative microbiological culture methods to determine Colony Forming Units (CFU) per milliliter or per sample at various time points and temperatures. This is a direct measure of viable bacterial cells. The organisms were diluted in either Phosphate Buffered Saline (PBS) or a fecal matrix.

8. The Sample Size for the Training Set

• N/A. This is not a machine learning or AI device that requires a "training set." The study involved testing the physical device’s performance.

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

• N/A. See point 8.

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