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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 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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The Xpert CT/NG Assay, performed on the GeneXpert Instrument Systems, is a qualitative in vitro real-time PCR test for the automated detection and differentiation of genomic DNA from Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) to aid in the diagnosis of chlamydial and gonorrheal urogenital disease. The assay may be used to test the following specimens from asymptomatic individuals: female and male urine, endocervical swab, and patient-collected vaginal swab (collected in a clinical setting).

Ancillary Collection Kits:

Xpert Vaginal/Endocervical Specimen Collection Kit

The Cepheid Xpert Vaginal/Endocervical Specimen Collection Kit is designed to collect, preserve, and transport Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis DNA in endocervical swab specimens (collected by a clinician) and patient-collected vaginal swab specimens (collected in a clinical setting) from symptomatic and asymptomatic women prior to analysis with the Xpert CT/NG Assay and the Xpert TV Assay.

Xpert Urine Specimen Collection Kit

The Cepheid Xpert Urine Specimen Collection Kit is designed to preserve and transport Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis DNA in first-catch female and male urine specimens from symptomatic and asymptomatic individuals prior to analysis with the Xpert CT/NG Assay and the Xpert TV Assay.

The Xpert CT/NG Assay is a rapid, automated in vitro diagnostic test for qualitative detection and differentiation of DNA from Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG). The assay is performed on the Cepheid GeneXpert Instrument Systems. The Xpert CT/NG Assay on the GeneXpert Instrument System automates and integrates sample purification, nucleic acid amplification and detection of the target sequences in simple or complex samples using real-time PCR. The system consists of an instrument, personal computer, and preloaded software for running the tests and viewing the results. The system requires the use of single-use disposable cartridges that hold the PCR reagents and host the PCR process. Because the cartridges are self-contained, crosscontamination between samples is minimized.

The Xpert CT/NG Assay includes reagents for the detection and differentiation of CT and NG. A Sample Processing Control (SPC), a Sample Adequacy Control (SAC), and a Probe Check Control (PCC) are also included. The SPC is present to control for adequate processing of the target bacteria and to monitor the presence of inhibitors in the PCR reaction. The SAC reagents detect the presence of a single copy human gene and monitor whether the specimen contains human cells. The PCC verifies reagent rehydration, PCR tube filling in the cartridge, probe integrity, and dye stability.

The GeneXpert Instrument Systems, comprised of the GeneXpert Dx Systems, the GeneXpert Infinity-48 System and the GeneXpert Infinity-80 System, have 1 to 80 randomly accessible modules, depending upon the instrument, that are each capable of performing separate sample preparation and real-time PCR tests. Each module contains a syringe drive for dispensing fluids (i.e., the syringe drive activates the plunger that works in concert with the rotary valve in the cartridge to move fluids between chambers), an ultrasonic horn for lysing cells or spores, and a proprietary I-CORE® thermocycler for performing real-time PCR and detection.

The ancillary specimen collection kits for use with the Xpert CT/NG Assay are the Cepheid® Xpert® Vaginal/Endocervical Specimen Collection kit and the Cepheid® Xpert® Urine Specimen Collection kit.

The provided text describes a 510(k) premarket notification for the Xpert CT/NG Assay, a qualitative in vitro real-time PCR test for the detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG). This submission is primarily to support the removal of a limitation statement regarding the device's performance in pregnant women, building upon a previously cleared predicate device (K121710).

It's important to note that this document does not describe an AI/ML-based device. It is a molecular diagnostic test. Therefore, many of the requested criteria related to AI/ML device validation (e.g., number of experts for ground truth, MRMC study, training set details) are not applicable to this type of medical device submission.

However, I can extract the relevant information regarding performance criteria and the study conducted to support the change in the intended use.

Here's the breakdown based on the provided document:

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for this type of submission are typically demonstrating substantial equivalence to a predicate device and showing that the device performs as intended for its specified use. In this specific case, the main goal was to re-evaluate the device's performance in pregnant women to remove a previous limitation.

Since this is a diagnostic test and not an AI/ML device, the performance is typically measured by sensitivity and specificity against a confirmed ground truth, or by demonstrating equivalent performance to a legally marketed predicate device. The document refers back to the original 510(k) (K121710) for most of the detailed analytical and clinical performance characteristics, as the core technology of the device itself has not changed.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the context of a 510(k) for a diagnostic test, particularly the focus within this document):

Note: For a molecular diagnostic test like this, the "acceptance criteria" are usually based on assay validation metrics (e.g., LOD, inclusivity, exclusivity, clinical agreement with a reference method) that would have been established in the predicate device's clearance. This submission focuses on a specific clinical population.

Study Details:

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

   • Test Set Sample Size: The document states "Reanalysis of the clinical data from 510(k) #K121710 was performed for the specimens collected from women who were pregnant at the time of collection." The exact number of pregnant women's specimens re-analyzed is not provided in this document but would be found in the K121710 submission details.
   • Data Provenance: The data comes from the original clinical study conducted for the predicate device (K121710). The document does not specify the country of origin, nor whether the original study was retrospective or prospective, but clinical studies for FDA clearance are typically prospective.

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

   • Not Applicable in the traditional sense for a PCR test. Ground truth for diagnostic tests like this is typically established by:
     • Reference standard methods: Usually a combination of culture, a highly sensitive and specific laboratory-developed test (LDT), or another gold standard for detecting the bacterial DNA/organism.
     • Discrepancy resolution algorithms: In many PCR studies, samples that show discordant results between the investigational device and a comparator method are further tested by a third, highly reliable method (e.g., an in-house PCR with different targets, sequencing).
   • The document does not specify the ground truth method or expert involvement in establishing it, as it refers back to the K121710 submission.

3. Adjudication method for the test set:

   • Not Applicable in the traditional sense of human reader adjudication. For molecular diagnostic tests, ground truth is established by laboratory methods, not by human interpretation of images. Discrepancy resolution for discordant results between methods is a common practice, but it's not "adjudication" by experts in the context of image interpretation. The document doesn't detail this process for the K121710 data reanalysis.

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 molecular diagnostic test (PCR), not an AI-assisted imaging device. Human readers are not involved in interpreting results in the way they would be with an AI device for radiology, for example.

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

   • Partially Applicable / This is a Standalone Device. The Xpert CT/NG Assay is a fully automated, standalone in vitro diagnostic device. It performs sample purification, nucleic acid amplification, and detection without human intervention in the assay process itself. The "performance" is the direct output of the instrument.

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

   • Likely a composite reference standard or culture/validated PCR. For sexually transmitted infections (STIs) detected via nucleic acid amplification tests (NAATs), the ground truth is typically established by using a combination of other highly sensitive and specific laboratory methods (e.g., another validated NAAT, potentially culture for NG, or a rigorous discrepancy resolution algorithm). The document refers to the original K121710 for details.

7. The sample size for the training set:

   • Not Applicable / No separate "training set" for an AI/ML model. For a molecular diagnostic test, there isn't a "training set" in the sense of an AI model. The assay's performance characteristics (e.g., primer design, probe specificity, assay conditions) are optimized during development and then validated using analytical and clinical studies. The data from K121710 was likely used as a "test set" for performance evaluation, not for training a model.

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

   • Not Applicable. (As there is no "training set" for an AI/ML model here). The ground truth for the clinical validation would have been established using the accepted reference methods for CT/NG detection, as described in point 6.

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The Abbott RealTime CT/NG assay is an in vitro polymerase chain reaction (PCR) assay for the direct, qualitative detection of the plasmid DNA of Chlamydia trachomatis and the genomic DNA of Neisseria gonorthoeae. The assay may be used to test the following specimens from symptomatic individuals: female endocervical swab, clinician-collected vaginal swab, and patient-collected vaginal swab specimens; male urethral swab specimens; and female and male urine specimens. The assay may be used to test the following specimens from asymptomatic individuals: clinician-collected vaginal swab and patient-collected vaginal swab specimens; female and male urine specimens.

The Abbott multi-Collect Specimen Collection Kit is intended for the collection and transportation of male and female swab and urine specimens for the detection of Chlamydia trachomatis and Neisseria gonorrheae per instructions provided. Refer to the specimen collection procedure in the package insert for specimen collection instructions for specific sample types.

Self-collected vaginal swab specimens are an option for screening women when a pelvic exam is not otherwise indicated. The Abbott multi-Collect Specimen Collection Kit is not intended for home use.

The Abbott multi-Collect Specimen Collection Kit can be used to collect either a swab or a urine specimen. Each Abbott multi -Collect Specimen Collection Kit contains:

• . One capped Transport Tube containing 1.2 mL Specimen Transport Buffer
• . One Individually Packaged Sterile Specimen Collection Swab
• . One disposable transfer pipette.

The Specimen Transport Buffer is used to stabilize DNA until sample preparation. The individually packaged sterile Specimen Collection Swab is used for swab sample collection and placed directly into the Transport Tube. The transfer pipette is used to add approximately 3 mL of urine to the Transport Tube. The Abbott multi -Collect Specimen Collection Kit is for single use only.

The Abbott multi-Collect Specimen Collection Kit Swab is approximately 14 cm in length with a polyester fiber tip. The swab shaft has a polystyrene solid core that is orange in color. The swab has a molded score completely around the shaft, between 7.86 cm and 7.89 cm from the swab tip, to provide a clean break-point. The polyesterfiber swab tip is approximately 1.3 cm in length and less than 3.28 mm in diameter.

This document describes the regulatory submission for a modification to the Abbott multi-Collect Specimen Collection Kit, specifically a change in the swab fiber component. The submission focuses on demonstrating that the new swab is substantially equivalent to the previously cleared swab and does not impact the performance of the Abbott RealTime CT/NG assay.

1. Table of Acceptance Criteria and Reported Device Performance

The submission doesn't explicitly state "acceptance criteria" in a numerical, threshold-based format. Instead, the studies demonstrate performance relative to the existing device and expected assay performance (e.g., detection rates approaching 100% for low positive samples). The goal of these studies is to confirm that the new swab material does not negatively impact the assay's performance.

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

• Biocompatibility: The specific sample sizes for cytotoxicity, irritation, and sensitization tests are not provided in the summary.
• 90-Day Specimen Stability: Not explicitly stated, but involved testing "simulated high and low positive swab specimens."
• Sample Freeze-Thaw Stability: 90 CT analyte samples and 90 NG analyte samples (total 180 samples) were tested.
• LOD Confirmation: 234 samples were tested for both CT and NG.
• Reproducibility: 189 replicates were tested for each panel member. There were 4 panel members (3 concentrations + 1 negative) for each analyte (CT and NG). This suggests a total of 189 replicates/panel member * 4 panel members * 2 analytes = 1512 individual tests for quantification, or more accurately, 189 replicates per panel member across the different conditions. Seven replicates of each panel member were tested in each run, with nine runs performed across three m2000 instrument systems.
• Accelerated Stressed Swab Stability: Not explicitly stated, but involved "testing simulated low positive swab specimens containing a target concentration of 320 copies of CT and 320 copies of NG in each 400 uL sample preparation input volume."
• Provenance: All data appears to be retrospective experimental data generated in a laboratory setting using simulated specimens rather than prospective clinical samples. The country of origin of the data is not explicitly stated but is implicitly associated with Abbott Molecular Inc. in the USA.

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

No human experts were used to establish the "ground truth" in these studies. The studies are analytical performance studies, not clinical studies involving patient diagnoses. The "ground truth" (e.g., presence and concentration of CT/NG DNA) was established by spiking known concentrations of target analytes into simulated specimens in a laboratory setting.

4. Adjudication Method for the Test Set

Not applicable. As described above, the ground truth was established by precise laboratory spiking of analytes, not by expert consensus or clinical adjudication.

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

No. This is not an MRMC study. The device is a specimen collection kit the performance of which is measured using an in vitro assay (Abbott RealTime CT/NG assay). There are no human readers or interpretation involved in the performance evaluation of the collection device itself. The studies focus on the analytical performance of the kit to collect and preserve DNA for subsequent automated testing.

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

Yes, this is an algorithm-only (assay-only) performance evaluation. The "device" being evaluated is the Abbott multi-Collect Specimen Collection Kit, specifically its swab component. Its performance is assessed by how effectively it allows the Abbott RealTime CT/NG assay (an automated PCR assay) to detect targets. Therefore, the performance demonstrated is that of the collection kit in conjunction with the fully automated assay, without any human interpretation steps directly related to the collection kit's function.

7. The Type of Ground Truth Used

The ground truth used was based on known concentrations of spiked target analytes (DNA for Chlamydia trachomatis and Neisseria gonorrhoeae) in simulated laboratory specimens. This is a form of analytical truth or definitive measurement through controlled experimental design.

8. The Sample Size for the Training Set

These studies are analytical validation studies for a medical device modification (swab component), not a machine learning or AI model development. Therefore, there is no concept of a "training set" in the context of these studies. The experiments described are test/validation studies for the physical collection device.

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

Not applicable, as there was no training set for an AI model.

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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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MSwab is a Collection, Transport and Preservation System intended for the collection and transport of clinical specimens containing Gram positive aerobic and facultative anaerobic bacteria, HSV 1 and HSV 2 from the collection site to the testing laboratory. In the laboratory, MSwab specimens are processed using standard clinical laboratory operating procedures for culture.

Copan MSwab Collection, Transport and Preservation System is supplied in two different formats: a collection kit format and a tube only format. Each collection kit consists of a package containing a plastic screw-cap tube with conical shaped bottom filled with 1 ml or 1.6 ml of MSwab transport and preservation medium and a small sterile peel pouch containing one specimen collection swab that has a tip flocked with soft nylon fiber. The tube only format consists of a plastic screw-cap tube with conical shaped bottom filled with 1 ml or 1.6 ml of MSwab transport and preservation medium. The MSwab is intended for single use. MSwab transport and preservation medium is a maintenance medium comprising TRIS HCl. EDTA. TRIS Base, Dimethyl Sulfoxide (DMSO) and Bovine Serum Albumin. The medium is designed to maintain the viability of Gram positive aerobic and facultative anaerobic bacteria. HSV 1 and HSV 2 during transit to the testing laboratory. The nylon flocked specimen collection swab provided in each collection kit of the Copan MSwab Collection. Transport and Preservation System has a solid plastic shaft with a molded breakpoint site.

Here's a breakdown of the acceptance criteria and study details for the Copan MSwab Collection, Transport and Preservation System, as extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Bacterial Recovery Studies:
  • For each of the 12 bacterial strains, the test set involved inoculating swabs in triplicate for measurement at 0, 24, and 48 hours. This was done for the MSwab device and relevant predicate devices, across two temperature ranges (4-8°C and 20-25°C). The text also mentions "three representative lots" for stability and pH studies, implying that the recovery studies were conducted across these lots as well, but the specific number of test samples (swabs) per organism per lot for the primary recovery study is explicitly stated as triplicate.
• Viral Recovery Studies:
  • For each of the 2 viral strains, the test set involved inoculating swabs in triplicate for measurement at 0, 24, and 48 hours. This was done for the MSwab device and relevant predicate devices, across two temperature ranges (4-8°C and 20-25°C).
• Recovery Stability, pH Stability, Cytotoxicity: Mention "three representative lots."
• Data Provenance: The document does not specify the country of origin of the data. The studies are described as prospective laboratory recovery studies, where organisms were purposefully inoculated onto the collection systems and then tested for viability over time.

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

• The ground truth in this context is the viability of microorganisms (CFU counts for bacteria, fluorescing foci counts for viruses) after storage in the transport medium.
• The document does not report the number of experts or their qualifications used to establish this ground truth. This is a standard laboratory study where the measurement of CFU or foci counts is a direct, quantifiable outcome, typically performed by trained laboratory personnel following established protocols (like CLSI M40-A). It is not a subjective assessment requiring expert consensus in the same way an imaging study might.

4. Adjudication Method for the Test Set

• No adjudication method is explicitly described. The determination of "acceptable recovery" is based on quantitative thresholds applied to the CFU counts (for bacteria) or the presence of viral recovery (for viruses), as defined in the acceptance criteria. These are objective measures rather than subjective interpretations requiring adjudication.

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

• No, an MRMC comparative effectiveness study was not done. This device is a specimen collection, transport, and preservation system, not an AI-powered diagnostic imaging or interpretation system that would involve human "readers" or AI assistance. The study focuses on the device's ability to maintain microorganism viability, not on improving human diagnostic accuracy.

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

• Yes, in concept, this is a standalone performance study for the device. The "algorithm" here isn't a software algorithm but rather the physical and chemical properties of the MSwab system (medium, swab material, etc.) in preserving organisms. The studies directly measure the performance of the device itself (its ability to maintain viability) without human intervention in the preservation process or interpretation stage beyond the initial inoculation and final enumeration.

7. The Type of Ground Truth Used

• The ground truth used is direct microbial enumeration:
  • Colony Forming Units (CFU) counts for bacteria.
  • Fluorescing foci counts for viruses.
  • For viral recovery at -70°C, the ground truth was simply "any viral recovery" (implying detectability).
• This is a form of direct measurement of biological viability rather than expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

• This information is not applicable to this type of study. The device is a physical collection and transport system, not a machine learning or AI algorithm that requires a "training set" in the computational sense. The reported studies are performance validation studies.

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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