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Puritan PurSafe Plus Collection and Transport System is an enclosed system intended for the collection, inactivation, and preservation of human upper respiratory specimens suspected of containing SARS-CoV-2. Puritan PurSafe Plus Collection and Transport System can be used for collection, transport, and storage of specimens at 2-4°C and 25-30°C. Specimens collected and stored in the PurSafe Plus Collection and Transport System are suitable for use with legally marketed molecular diagnostic devices.

Puritan PurSafe Plus Collection and Transport System is comprised of a peel pouch containing a sterile polyester flock swab applicator for collecting clinical specimens and a polypropylene vial containing 1mL PurSafe Plus buffer. PurSafe Plus MK buffer ensures stability of Sars Cov-2 during sample transport/storage at refrigerated to ambient temperature (4-30°C) and is intended to inactivate Sars Cov-2.

Acceptance Criteria and Device Performance Study for Puritan PurSafe Plus Collection and Transport System

This document outlines the acceptance criteria and reports on the study that demonstrates the Puritan PurSafe Plus Collection and Transport System meets these criteria, based on the provided FDA 510(k) clearance letter.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • LOD Study: N=24 for the initial assessment (6 concentrations x 2 replicates x 2 lots). N=20 for the confirmatory LOD (20 replicates at 64 genome copies/mL).
  • Stability Study: N=72 (4 lots x 5 time points x 2 incubation temperatures x 2 replicates).
• Data Provenance: The data was generated using heat-inactivated SARS-CoV-2 virus (BEI Resources; ATCC # VR-1986HK) spiked into clinically negative human nasal matrix (Lee Biosolutions, Maryland Heights, MO). This suggests retrospective analysis on a prepared sample matrix rather than prospective patient samples. The country of origin of the data is not explicitly stated, but the vendors for the virus and nasal matrix are US-based.

3. Number of Experts and Qualifications for Ground Truth

• The document does not mention the use of human experts to establish ground truth for the performance studies.
• The ground truth for the studies was based on the known concentration of spiked heat-inactivated SARS-CoV-2 virus and the analytical performance of the Cepheid GeneXpert® IV system and droplet digital PCR.

4. Adjudication Method for the Test Set

• No adjudication method is described. The studies rely on quantitative measurements of viral RNA detection using laboratory instruments (Cepheid GeneXpert® IV and ddPCR) and direct observation of viral inactivation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study was done. This device is a collection and transport system, not an interpretive diagnostic AI algorithm that would typically involve human readers. Therefore, the effect size of human readers improving with or without AI assistance is not applicable.

6. Standalone Algorithm Performance Study

• A standalone performance study was done. The studies described (LOD, Stability, Inactivation) assess the performance of the Puritan PurSafe Plus Collection and Transport System (the "device" or "algorithm" in this context) directly, without human interpretation or intervention in the diagnostic process beyond laboratory procedures. The system's ability to preserve and inactivate the virus, and not interfere with downstream molecular detection, is evaluated independently.

7. Type of Ground Truth Used

• The type of ground truth used was analytical ground truth and virological ground truth.
  • Analytical Ground Truth: For the LOD and Stability studies, known concentrations of heat-inactivated SARS-CoV-2 (quantified in genome copies/mL) were spiked into confirmed clinically negative nasal matrix. The expected outcome was the detection of this known concentration by the downstream molecular diagnostic device.
  • Virological Ground Truth: For the Inactivation study, the presence or absence of viable SARS-CoV-2 virus after exposure to the buffer was the ground truth, assessed by exposing VeroE6 cells to the treated virus.

8. Sample Size for the Training Set

• The document does not specify a training set sample size. This is because the device is a physical collection and transport system, not an AI or machine learning model that typically requires a separate training set. The performance studies described are for validation, not model training.

9. How Ground Truth for the Training Set Was Established

• As there is no explicit training set for an AI/ML model, the concept of establishing ground truth for a training set is not applicable to this device. The ground truth described in point 7 is for the validation of the device's functional performance.

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Puritan Fecal Opti-Swab Collection and Transport System is intended for use in the collection and transport of clinical fecal and rectal swab specimens to preserve the viability of enteric bacteria during transport from the collection site to the testing laboratory for bacteriological examination and culture.

Puritan Fecal Opti-Swab Collection and Transport System is comprised of a sterile peel pouch containing a sterile polyester flock swab applicator for collecting clinical fecal and rectal specimens and a polypropylene vial containing 2 ml of Fecal Opti-Swab medium.

Fecal Opti-Swab medium is a nonnutritive balanced salt solution containing phosphates to provide buffering capability, chloride salts to provide essential ions that help maintain osmotic balance. Agar is a solidifying agent that increases the viscosity of the medium. Sodium thioglycolate and L-cysteine provides an oxygen-reduced environment. It is recommended for maintaining the viability of enteric bacteria during the transport to the laboratory.

The document describes the Puritan Fecal Opti-Swab Collection and Transport System, a device for collecting and transporting fecal and rectal swab specimens to preserve the viability of enteric bacteria. The study presented is a substantial equivalence comparison with a predicate device, not a comparative effectiveness study with human readers or a standalone algorithm performance study.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list "acceptance criteria" in a typical quantitative sense (e.g., target sensitivity/specificity). Instead, it states that the Puritan Fecal Opti-Swab Collection and Transport System was compared to a predicate device, and "No notable differences in recovery were detected" and that the performance "is not adversely affected by fecal material." It also reports on pH stability, cytotoxicity, and sterilization.

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

• Sample Size: The document does not explicitly state the specific number of samples (e.g., number of swabs, fecal samples, or bacterial cultures) used for each recovery and stability test. It mentions "known inoculum of ATCC type culture and clinically significant microorganisms" and "three representative challenge organisms," but not specific quantities.
• Data Provenance: The study appears to be prospective in nature, as it involves preparing inocula and conducting experiments in a controlled lab setting to compare the Puritan device with a predicate. The specific country of origin for the data is not mentioned, but the sponsor is Puritan Medical Products LLC from Guilford, ME, USA.

The study compares the device to the predicate following CLSI M40-A2 guidelines, which are standard for microbiological transport systems.

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

• This information is not provided as the study focuses on the performance of a transport medium for microbial viability, not on diagnostic interpretation by human experts. The "ground truth" here is the known quantity and viability of bacterial cultures established through standard microbiology laboratory techniques.

4. Adjudication Method for the Test Set:

• An adjudication method is typically used when human interpretation is involved and discrepancies arise. As this study is a laboratory-based evaluation of microbial viability in a transport medium, an adjudication method for a test set is not applicable and therefore not described.

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

• No, an MRMC comparative effectiveness study was not done. This type of study assesses the effect of a device (like AI software) on human reader performance. The Puritan Fecal Opti-Swab is a physical collection and transport system, not an AI-powered diagnostic tool. Therefore, the concept of human readers improving with or without AI assistance is not relevant to this device or study.

6. 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 manual collection and transport system, not an algorithm or software.

7. The Type of Ground Truth Used:

• The ground truth used was based on known bacterial ATCC type cultures and clinically significant microorganisms with known concentrations (inoculum). This is a laboratory-established ground truth, typically validated by quantitative plating methods to determine viable colony-forming units (CFUs). For the fecal matrix experiment, "clinical fecal material" was used, and presumably, spiked with known organisms to assess recovery.

8. The Sample Size for the Training Set:

• This device is a physical product (collection and transport system) and not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The stability and recovery tests are analogous to validation or performance testing for a traditional device.

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

• As there is no training set for an algorithm, this question is not applicable.

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Puritan Opti-Tranz Cary-Blair Collection and Transport System is intended for use in the collection and transport of clinical fecal and rectal swab specimens to preserve the viability of enteric bacteria during transport from the collection site to the testing laboratory for bacteriological examination and culture.

Puritan Opti-Tranz Cary-Blair Collection and Transport System is comprised of a sterile peel pouch containing a rayon tipped swab applicator for collecting specimens and a polypropylene tube containing 5 ml of Cary-Blair medium.

Cary-Blair medium is a nonnutritive balanced salt solution containing disodium phosphate to provide buffering capability, sodium chloride and calcium chloride to provide essential ions that help maintain osmotic balance. Agar is a solidifying agent and gives a semisolid texture to the medium. Sodium thioglycollate provides a reduced environment. It is recommended for maintaining the viability of enteric bacteria during the transport to the laboratory.

The document describes the Puritan Opti-Tranz Cary-Blair Collection and Transport System, a device for collecting and transporting clinical fecal and rectal swab specimens to preserve enteric bacteria viability for bacteriological examination and culture.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated for specific tests (e.g., microbial recovery, pH stability). For microbial recovery, "known inoculum of clinically significant ATCC type culture microorganisms" were used, along with "three representative challenge organisms" for the fecal material impact test. For pH stability, "random samples from three different lots" were used.
• Data Provenance: Not explicitly stated as "country of origin" or "retrospective/prospective." All studies appear to be laboratory-based performance tests conducted by the manufacturer, Puritan Medical Products LLC, for regulatory submission purposes.

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

• This information is not applicable as the device is not an AI/diagnostic device that requires expert-derived ground truth from an image or clinical assessment. The ground truth for this device's performance relates to objective laboratory measurements (e.g., microbial viability, pH levels, cytotoxicity, sterility).

4. Adjudication Method for the Test Set

• This information is not applicable for this type of device and study. Adjudication methods like 2+1 or 3+1 are used for reconciling discrepancies among human readers in diagnostic studies.

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. This is a medical device for specimen collection and transport, not an AI diagnostic tool or software.

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

• This information is not applicable. This device is a physical product, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for the performance claims of this device is established through:
  • Objective laboratory measurements: Microbial counts/viability for recovery testing.
  • Predicate device comparison: Performance is compared against a legally marketed predicate device (Copan Venturi Transystem Cary-Blair Medium product (132C)).
  • Standardized methods: Adherence to guidelines like CLSI M40-A2 for microbial recovery and ANSI/AAMI/ISO 11137:2006 for sterilization.
  • Physicochemical tests: pH measurements, cytotoxicity assays.

8. The Sample Size for the Training Set

• This information is not applicable. This is a physical medical device, not an AI algorithm that requires a training set.

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

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

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

Puritan OptiTranz Collection and Transport System is comprised of a sterile peel pouch containing a rayon or flock tipped swab applicator for collecting specimen and a polypropylene vial containing 1 ml of Stuart liquid medium.

Puritan OptiTranz Liquid Stuart Medium is a nonnutritive balanced salt solution containing phosphates to provide buffering capability and calcium chloride to provide essential ions that help maintain osmotic balance. Mercaptoacetic acid provides a reduced environment. It is recommended for maintaining the viability of aerobic and fastidious bacteria during the transport to the laboratory.

The provided document describes the Puritan OptiTranz™ Liquid Stuart Collection and Transport System, a device for collecting and transporting clinical specimens containing aerobic and fastidious bacteria. The study conducted to demonstrate its effectiveness is primarily a recovery testing study, comparing its performance to a predicate device.

Here's an 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 inoculum of ATCC type culture and clinically significant microorganisms" but does not specify the exact number of samples or isolates used in the recovery testing.
• Data Provenance: The study was conducted by the manufacturer, Puritan Medical Products LLC, as part of their 510(k) submission. It appears to be a prospective study designed to evaluate the new device against an established predicate within a laboratory setting. The country of origin of the data is not explicitly stated but would likely be the USA, where the manufacturer is located.

3. 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 recovery testing relies on direct measurement of microbial viability after transport, not on expert interpretation of results.

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

This information is not applicable as the study did not involve human interpretation or adjudication of outcomes in the traditional sense of medical imaging or diagnostic tests. The performance was measured directly through microbiological viability assays.

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 specimen collection and transport system, not an AI-powered diagnostic tool. Therefore, an MRMC study related to human readers and AI assistance would not be relevant.

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

Not applicable. This device is a physical product for specimen collection and transport, not a standalone algorithm.

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

The ground truth for the recovery testing was established by comparing the viability of known inoculum of ATCC type culture and clinically significant microorganisms after transport in the Puritan OptiTranz system versus the predicate device. This is a microbiological ground truth based on controlled inoculation and subsequent quantitative recovery.

8. The sample size for the training set:

Not applicable. This device is not an AI/ML model, and therefore, there is no "training set" in the context of machine learning. The studies described are performance evaluations of a physical product.

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

Not applicable. See point 8.

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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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Puritan UTM – RT Collection and Transport System is intended for the collection and transport of clinical samples containing viruses, chlamydiae, mycoplasmas and ureaplasmas from the collection site to the testing laboratory. The specimen transported in the Puritan UTM - RT can be used in the laboratory to perform viral, chlamydial, mycoplasmal and ureaplasmal culture.

Puritan UTM-RT is an enclosed system recommended for the collection and transport of viruses, chlamydiae, mycoplasmas and ureaplasma. The osmotically balanced and buffered culture medium contains Hank's balanced salt solution with a pH indicator, sucrose as a preservative, protein and gelatin as stabilizers. Antimicrobial agents are incorporated to minimize commensal bacterial and fungus contamination.

Puritan UTM-RT is comprised of a conical polypropylene vial filled with three 3-mm glass beads and 1.5ml or 3 ml of the transport medium, affixed with a high density polyethylene cap. Each unit of Puritan UTM-RT is provided in a peel pouch containing one of the following swab combinations:

1ml UTM with ultrafine tip HydraFlock® Swab .
3ml UTM with one elongated tip HydraFlock® and one ultrafine tip swab
3ml UTM with elongated tip HydraFlock®® swab .
. 3ml UTM with mini-tip HydraFlock® swab, scored shaft
3ml UTM with ultrafine HydraFlock® tip swab
. 3ml UTM vial with 2 reg polyester tip swabs, scored shaft
3ml UTM vial with regular polyester tip and one wire/plastic shaft with polyester tip

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

Device: Puritan UTM-RT Collection and Transport System (UTM-RT)

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Microbial Recovery:
  • Microorganisms: Adenovirus, Cytomegalovirus, Echovirus Type 30, Herpes Simplex Virus Type II, Influenza A, Respiratory Syncytial Virus, Parainfluenza Type 3, Varicella Zoster Virus, Herpes Simplex Virus Type I (9 viruses), Chlamydia pneumonia Strain CM-1, Chlamydia trachomatis Type 1 Strain UW-12/UR (2 chlamydiae), Mycoplasma hominis, Mycoplasma pneumonia, Ureaplasma urealyticum (3 mycoplasmas/ureaplasmas). A total of 14 specific strains/organisms.
  • Replicates: For each organism, "100 µl were directly inoculated onto swabs in triplicate." This means 3 swabs per organism per dilution.
  • Dilutions: "Two different dilutions of neat stock suspensions were prepared."
  • Storage Conditions: "held at both 4° C and room temperature (20-25° C)."
  • Time Points: "At key time points following inoculation (0, 24, and 48 h)."
  • Total for Microbial Recovery (excluding initial stock prep variations): 14 organisms * 3 replicates * 2 dilutions * 2 storage temperatures * 3 time points = 1008 test samples.
• Sample Size for Shelf Life Stability:
  • Lots: "Three lots of the test device beyond the expiration point and one newly prepared lot" = 4 lots.
  • Microorganisms: Cytomegalovirus, Herpes Simplex Virus Type II, Respiratory Syncytial Virus, Chlamydia pneumonia, Mycoplasma pneumonia (5 specific strains).
  • Swabs: "spiking swabs that accompanied each transport system with the chosen test dilution."
  • Storage Temperatures: "stored at different temperatures (refrigerated and room temperature)."
  • Time Points: "held at 0, 24 and 48 hours."
  • Total (excluding replicates which are not explicitly stated for stability but would typically be used): 4 lots * 5 organisms * 2 storage temperatures * 3 time points = 120 test conditions.
• Sample Size for pH Stability: "random samples from three different lots of Puritan UTM-RT." (Number of samples not specified, but multiple samples per lot).
• Sample Size for Antibiotics Stability Test: "3 expired lots and a new lot of test device" = 4 lots.
• Sample Size for Cytotoxicity: "three lots of test devices."
• Data Provenance: The study appears to be a prospective bench study conducted by Puritan Medical Products LLC, an American company. The country of origin of the data is therefore USA (Guilford, ME).

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

• The document does not specify the number of experts or their qualifications used to establish the ground truth for the test set.
• The ground truth in this context (viability/recovery of microorganisms) is established through laboratory-based culture methods and microscopic examination (immunostaining and enumeration of fluorescent foci or colony forming units). While these methods require trained personnel, the document refers to "standard laboratory techniques" and does not imply a consensus panel of clinical experts for interpretation.

4. Adjudication Method for the Test Set

• The document describes laboratory-based assays, such as shell vial assay followed by immunostaining and enumeration of fluorescent foci, or direct culture methods followed by enumeration of colony-forming units.
• There is no mention of an adjudication method involving multiple human readers/experts for the interpretation of results. The assessment appears to be based on objective lab measurements.

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

• No, a MRMC comparative effectiveness study was not done.
• This type of study is typically used for diagnostic devices that involve human interpretation of images or other data to assess the impact of AI on reader performance. The Puritan UTM-RT is a specimen collection and transport system, and its performance is evaluated through direct microbial recovery, not by assessing human reader accuracy.

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

• This question is not applicable to the Puritan UTM-RT device.
• The device itself is a collection and transport medium, not an algorithm. The performance tests are for the ability of the physical medium and swabs to preserve biological samples.

7. The Type of Ground Truth Used

• The ground truth used is primarily direct microbial viability/culturability.
  • For viruses and chlamydiae: Viability determined by shell vial assay followed by immunostaining and enumeration of fluorescent foci.
  • For mycoplasmas and ureaplasmas: Viability determined using direct culture methods onto appropriate growth media followed by enumeration of colony forming units (CFU).
  • For pH: Direct measurement using a calibrated pH meter.
  • For cytotoxicity: Sulforhodamine B assay for cellular toxicity.

8. The Sample Size for the Training Set

• The Puritan UTM-RT is a physical collection and transport system, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The studies described are performance validation studies for the physical product.

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

• As there is no AI/ML component, the concept of a "training set" and its associated ground truth establishment is not applicable.

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