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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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The PPH Saliva Collection Kit is designed for use in the non-invasivation, inactivation, and stabilization of viral nucleic acids for in vitro diagnostic testing of saliva samples. The device is intended to inactivate and stabilize human clinical saliva samples from the collection site to the laboratory at room temperature. The device is intended to be used by a health care provider for the collection of saliva samples suspected of containing SARS-CoV-2. The saliva sample is stabilized and suitable for use with legally marketed molecular diagnostic devices.

The PPH Saliva Collection Device contains a plastic bulb pipette, paper cup, plastic tube with PPH Saliva collection buffer (0.3 ml). This collection device designed for the collection of human saliva samples. It is designed for use in the non-invasive collection, inactivation of viral nucleic acids for in vitro diagnostic testing of saliva samples. The device is intended to inactivate and stabilize human clinical saliva samples from the collection site to the laboratory at room temperature.

The provided text describes the performance evaluation of the PPH Saliva Collection Kit, a device for the non-invasive collection, inactivation, and stabilization of viral nucleic acids for in vitro diagnostic testing of saliva samples, specifically for SARS-CoV-2.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Limit of Detection (LoD) Study:
  • Preliminary LoD: 3 replicates for each serial dilution.
  • Confirmatory LoD: 20 replicates for each of the four concentrations tested.
• Sample Stability Study:
  • Low positive samples: 20 samples per device lot for 3 lots, totaling 60 low positive samples.
  • Negative samples: 10 samples per device lot for 3 lots, totaling 30 negative samples.
• Inactivation Assay: 6 replicates for each time point.
• Data Provenance: The document does not explicitly state the country of origin or whether the data is retrospective or prospective. It describes laboratory studies conducted to evaluate the device's performance characteristics.

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

The document does not mention the use of experts to establish ground truth for the test set. The ground truth for LoD, sample stability, and inactivation studies appears to be based on laboratory measurements (e.g., SARS-CoV-2 spiked into saliva, PCR results, plaque assays).

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1) as there is no mention of human readers or experts establishing ground truth through consensus. The ground truth is established through laboratory analyses.

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

No, an MRMC comparative effectiveness study was not done. The PPH Saliva Collection Kit is a collection and stabilization device, not an AI-assisted diagnostic tool for human interpretation.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable. The PPH Saliva Collection Kit is a physical device for sample collection and stabilization, not a software algorithm or an AI-based system. Its performance is evaluated through its ability to stabilize and inactivate viral nucleic acids, which are then processed by legally marketed molecular diagnostic devices.

7. The Type of Ground Truth Used

The ground truth for the performance studies was:

• Limit of Detection: Known concentrations of SARS-CoV-2 (inactivated and spiked) in saliva, detected via rRT-PCR.
• Sample Stability: Known concentrations of inactivated SARS-CoV-2 spiked into saliva, with stability assessed by rRT-PCR over time.
• Inactivation: Known concentrations of live SARS-CoV-2, with inactivation assessed by plaque assay (detection of live virus).

8. The Sample Size for the Training Set

The document does not mention a "training set" as it pertains to AI/machine learning. The studies described are performance validation studies for a physical medical device.

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

As there is no mention of a training set for an AI/machine learning model, this question is not applicable.

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The Sample Preservative Fluid is intended for the stabilization, and inactivation of infectious, unprocessed, upper respiratory specimens suspected of containing Influenza A virus. Specimens transported in the Sample Preservative Fluid are stable refrigerated (2-8°C) and at room temperature (20-25°C). The Sample Preservative Fluid is suitable for use with compatible legally marketed molecular diagnostic devices.

Sample Preservative Fluid is a medium for stabilization of Influenza A RNA during sample transport/storage. The fluid is composed of quanidine thiocyanate, Triton X-100, and nuclease-free water. Sample Preservative Fluid is provided in a labeled screw-cap tube.
Sample Preservative Fluid configuration:

• BSC82X1-A1: a screw-cap tube filled with 2 mL of Sample Preservative Fluid liquid ● and a prepackaged nasopharyngeal swab for sample collection
• Nasopharyngeal swab: regular size, sterile disposable sample swab (80mm . breakpoint)

Here's a summary of the acceptance criteria and study details for the Sample Preservative Fluid, based on the provided document:

Acceptance Criteria and Device Performance

Study Details

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

   • Shelf-life: 3 lots of Sample Preservative Fluid. Data provenance is not explicitly stated but is implicitly from an in-house study conducted by the applicant (Hangzhou Bioer Technology Co., Ltd). The study appears to be proprietary/internal rather than retrospective or prospective clinical data.
   • Detection Limit (LoD):
     • Preliminary LoD: 5 replicates for each of 5 concentrations (0.32, 0.16, 0.08, 0.04, 0.02, 0.01 TCID50/mL) for a total of 30 replicates (though actual testing for 0.02 and 0.01 TCID50/mL ceased if a certain number of negative results were observed).
     • Confirmatory LoD: 20 replicates at 0.08 TCID50/mL (initially attempted at 0.04 TCID50/mL).
     • Data provenance is from an in-house laboratory study.
   • Specimen Stability: Replicates of four for each of three reagent lots, tested at 6 timepoints (Day 0, 1, 8, 15, 22, 35) at two different temperatures (2-4°C and 20-25°C). Total number of Ct values reported is 144 for each temperature condition (3 lots * 4 reps * 6 timepoints). Data provenance is from an in-house laboratory study.
   • Cytotoxicity Study: Not explicitly stated, but multiple dilutions (from 1:10 up to 1:8000 for preliminary, and from 1:1000 for confirmatory) were tested against a cell monolayer. This is an in-house laboratory study.
   • Viral Inactivation Study: Influenza A H3N2 virus combined with Sample Preservative Fluid and negative nasal matrix, incubated for 30 and 60 seconds. Each mixture diluted 3500x and plated into 8 wells in triplicate (total of 24 wells per condition). Positive and negative controls were also used. This is an in-house laboratory study.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The studies described are laboratory-based performance studies (shelf-life, LoD, stability, inactivation) using controlled experimental conditions and quantitative measurements (e.g., bacterial/fungal growth, leakage, density, PCR Ct values, viral titers, cell morphology), not expert interpretation of clinical data.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as expert adjudication is not used for these types of laboratory performance studies.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a sample preservative fluid, not an AI-powered diagnostic or imaging system involving human readers.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device (fluid) and does not involve an algorithm.

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

   • Shelf-life: Physical and chemical property evaluations (e.g., visual inspection, pressure tests, density measurements) and microbial growth assays.
   • Detection Limit (LoD): Defined concentration of target virus (Influenza A H3N2) in negative nasal matrix, assayed by a cleared molecular diagnostic device (Cepheid Xpert Xpress Flu/RSV Assay).
   • Specimen Stability: Defined concentration of target virus (Influenza A H3N2) in negative nasal matrix, assayed by a cleared molecular diagnostic device (Cepheid Xpert Xpress Flu/RSV Assay). Comparison of Ct values over time to a baseline (Day 0).
   • Cytotoxicity Study: Observation of cell morphology and growth status on a cell monolayer (MDCK cells).
   • Viral Inactivation Study: Measurement of viral titers (TCID50/mL) and observation of cytopathic effects on MDCK cells. Reduction in culturable virus compared to controls.

7. The sample size for the training set: Not applicable. This device does not use machine learning or AI, and therefore does not have a training set.

8. How the ground truth for the training set was established: Not applicable, as there is no training set.

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The Molecular Transport Media - MTM is intended for the stabilization, and direct lysis of infectious unprocessed nasopharyngeal samples suspected of containing SARS COV-2 virus RNA. These devices can be used for the collection transport and storage of specimens at 15-35 °C. Specimens collected and stored in a Molecular Transport Media are suitable for use with legally marketed molecular diagnostic devices.

The MTM consists of a pre-filled plastic tube containing either 2 or 3 mL of proprietary liquid medium intended for viral nucleic acid stabilization and transportation and inactivation of nasopharyngeal swab specimens suspected of containing SARS-CoV-2. MTM is intended for use with standard diagnostic/identification techniques that have been adequately validated and found to be compatible with the MTM. The formulation of the MTM includes guanidine-free inactivation buffer, salts, a buffer to maintain a neutral pH, and distilled water.

Here's an analysis of the provided text regarding the acceptance criteria and study proving device performance:

The document is a 510(k) Summary for the Molecular Transport Media - MTM. It describes non-clinical performance and shelf-life studies. No clinical studies were performed.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria for Molecular Transport Media - MTM:

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

• Shelf-Life Study (Physical & pH Stability):
  • Test Set Sample Size: Three lots, with three replicates per lot, tested at 7 time points (T=0, 3, 6, 9, 12, 15, 18 months).
  • Data Provenance: Not explicitly stated, but implies laboratory testing internal to the manufacturer or a contract lab. Prospective for the duration of the 18-month test.
• Limit of Detection (LoD) Study:
  • Preliminary LoD Test Set Sample Size: Not clearly defined as a fixed "test set." It involved serial dilutions, with triplicate testing for each concentration for three lots.
  • Confirmatory LoD Test Set Sample Size: 20 replicates for each of three SARS-CoV-2 concentrations (1.35E+04, 1.35E+03, and 1.35E+02 PFU) across different MTM lots and temperatures.
  • Data Provenance: Not explicitly stated, but implies laboratory testing. The "pooled negative clinical nasal samples" suggest human specimens were used as matrix, but the virus stock was laboratory-prepared. Retrospective for the negative clinical samples, prospective for the spiked virus testing.
• Viral Nucleic Acid Stability Study:
  • Test Set Sample Size: Not clearly defined as a fixed "test set." Triplicate rayon swabs per lot and per temperature condition (15°C and 35°C) at 4 time points (0, 7, 14, 21 days).
  • Data Provenance: Not explicitly stated, but implies laboratory testing. Uses "pooled negative clinical nasal matrix." Retrospective for the negative clinical samples, prospective for the spiked virus testing.
• Viral Inactivation Study:
  • Cytotoxicity Test Set Sample Size: Triplicate for each 10-fold serial dilution (1:10E+01 to 1:10E+08) for each of the three lots, at both 15°C and 35°C.
  • Viral Inactivation Test Set Sample Size: Triplicate for each MTM lot number at 15°C and 35°C at three time points (0, 5, and 15 minutes post inoculation). Serially diluted (10-fold) to 1:10E+01 to 1:10E+08 in triplicate for plaque assay.
  • Data Provenance: Not explicitly stated, but implies laboratory testing. Uses "pooled clinical negative nasal matrix." Retrospective for the negative clinical samples, prospective for the spiked virus testing.

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

The document describes non-clinical laboratory studies. No human experts were used to establish ground truth in the context of clinical interpretation. The ground truth in these studies is based on quantifiable laboratory measurements (e.g., PFU counts, Ct values, pH, visual appearance) against pre-defined scientific criteria. For example, confirmation of presence/absence of virus based on TaqPath COVID-19 Combo Kit interpretation (Table 3), or visual assessment of CPE for cytotoxicity.

4. Adjudication Method for the Test Set

Not applicable. This is a non-clinical, quantifiable laboratory study, not a study involving human interpretation or adjudication of results. The results are based on direct measurements and adherence to pre-defined thresholds.

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 MRMC comparative effectiveness study was done. This is a device for molecular transport media, not an AI-assisted diagnostic tool.

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

Standalone performance was not done in the context of an AI algorithm. The device itself functions in a standalone manner as a transport medium; its performance attributes (nucleic acid stabilization, preservation, viral inactivation) are assessed directly.

7. The Type of Ground Truth Used

The ground truth used for these studies is based on:

• Quantitative Laboratory Measurements:
  • Limit of Detection: Defined by the ability to repeatedly detect SARS-CoV-2 RNA above a 95% accuracy threshold using a legally marketed molecular diagnostic kit (TaqPath COVID-19 Combo Kit) and measured Ct values.
  • Viral Nucleic Acid Stability: Defined by positive detection of SARS-CoV-2 RNA and Ct variation (ΔCt) within ±3 Ct values, measured using the TaqPath COVID-19 Combo Kit.
  • Viral Inactivation: Defined by the absence of plaque-forming units (PFUs) on Vero cells after exposure to the MTM, and by the absence of Cytopathic Effect (CPE) for cytotoxicity.
  • Shelf-Life: Defined by objective physical characteristics (color, turbidity, precipitate) and measurable pH values within a specified range.

8. The Sample Size for the Training Set

No training set was used. This device is a molecular transport medium, not a machine learning or AI algorithm.

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

Not applicable. As no training set was used, no ground truth needed to be established for it.

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InActiv Blue is intended for the stabilization, transportation and inactivation of upper respiratory specimens suspected of containing SARS-CoV-2. These devices can be used for collection transport and storage of specimens at refrigerated (2-8°C) or ambient temperatures (20-25°C). SARS-CoV-2 RNA in the specimens is stabilized for 7 days at these specified temperatures. Specimens collected and stored in an InActiv Blue collection tube are suitable for use with legally marketed molecular diagnostic devices.

InActiv Blue is a virus-inactivating and lysis solution that abrogates the infectious potential of the collected material without affecting the integrity of the RNA. Two milliliters of InActiv Blue solution are provided in a polypropylene flat bottom collection tube with a high-density polyethylene (HDPE) cap (product code IB TUB). The device is non-sterile, single use. Secondary Packaging for the collection tube configuration includes racks of 50 collection tubes and cardboard boxes with either 400 or 1200 collection tubes.

Sample types intended for collection with the device include upper respiratory swab samples. Swabs are not provided with the InActiv Blue collection tubes.

The active components of the InActiv Blue solution are guanidine thiocyanate, Nlauroylsarcosine sodium salt and EDTA. These components are formulated in a sodium phosphate buffered solution containing methylene blue.

This document describes the performance of the InActiv Blue device, a microbial nucleic acid storage and stabilization device, for stabilizing and inactivating SARS-CoV-2 in upper respiratory specimens.

Here's the breakdown of the acceptance criteria and the study results:

1. Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

The provided document does not explicitly delineate a "test set" in the context of an algorithm or AI device as it describes a physical collection device. However, the sample sizes and data provenance for the performance studies are detailed:

• Shelf-Life Stability: At least eight lots of InActiv Blue were used. Samples were stored at room temperature (15-25°C). The study appears to be retrospective in terms of analyzing existing product lots over time. The country of origin of the data is not specified, but the applicant (FertiPro NV) is based in Belgium.
• Limit of Detection (LOD):
  • Preliminary LOD: SARS-CoV-2 at 5 concentrations (5, 15, 45, 135, 405 particles/mL), each performed in triplicate. Total 15 preliminary tests.
  • Confirmatory LOD: For each concentration (15 and 45 particles/mL), 20 replicates were evaluated. Total 40 confirmatory tests.
  • The matrix used was "nasopharyngeal clinical matrix" spiked with SARS-CoV-2. The data provenance (country, retrospective/prospective) is not explicitly stated.
• Sample Stability Study: Six replicate samples containing nasopharyngeal matrix were used for each of the four lots of InActiv Blue tested (newly manufactured, middle-aged, near/recently expired, and stressed). Three replicates from each lot were stored at 2-8°C and three at 20-25°C. Total of 24 replicates (4 lots x 6 replicates). The matrix was "nasopharyngeal matrix" spiked with SARS-CoV-2. Data provenance is not explicitly stated.
• Viral Inactivation: Three lots of InActiv Blue (near expiration) were used. For each lot, the study involved mixing virus stock 1:1 with InActiv Blue and incubating for 1, 2.5, and 5 minutes. No specific "sample size" of individual viral samples is mentioned beyond the use of 3 lots and multiple exposure times for each. Data provenance is not explicitly stated.

3. Number of Experts and Qualifications for Ground Truth

This information is not applicable as the device is a physical sample collection and stabilization device, not an AI or imaging device requiring expert interpretation for ground truth establishment. The ground truth for the performance studies (e.g., viral load, RNA integrity) is established through laboratory assays (e.g., Roche cobas SARS-CoV-2 assay) and cell culture methods.

4. Adjudication Method for Test Set

This information is not applicable. The studies described are laboratory performance studies, not clinical studies requiring adjudications of diagnoses or interpretations by experts.

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

This information is not applicable. This device is not an AI or imaging device used by human readers, so an MRMC comparative effectiveness study is not relevant.

6. Standalone (Algorithm Only) Performance

This information is not applicable. The InActiv Blue is a physical medical device, not an algorithm, so the concept of "standalone performance" for an algorithm does not apply.

7. Type of Ground Truth Used

The ground truth used for these studies is scientific and laboratory-based:

• Shelf-Life Stability: Physical and chemical properties of the solution (pH, osmolarity, visual inspection, evaporation) against predefined specifications.
• Limit of Detection: Quantification of viral particles (SARS-CoV-2) using a legally marketed molecular diagnostic device (Roche cobas SARS-CoV-2 assay) and determining the concentration at which a specified percentage of positive results are achieved.
• Sample Stability: Detection and quantification of SARS-CoV-2 RNA using a molecular diagnostic device (Roche cobas SARS-CoV-2 assay) and monitoring the change in Ct values over time, demonstrating RNA integrity.
• Viral Inactivation: Measurement of residual infectivity of SARS-CoV-2 using cell culture (Vero E6 cells) and determining the cytopathic effect and TCID50 (Tissue Culture Infectious Dose 50%) via the Reed and Muench method to quantify log reduction in infectivity.

8. Sample Size for the Training Set

This information is not applicable. This device is a physical collection and stabilization device and does not involve AI or machine learning models that require a training set. The development of such a device relies on chemical formulation, engineering, and manufacturing process control, rather than data-driven algorithm training.

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

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

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The Zhejiang GENE SCIENCE Co., Ltd.'s Sample Preservation Solution is intended for the collection, inactivation, preservation/stabilization, and transport of unprocessed upper respiratory clinical specimens from individuals suspected of influenza A infection by their healthcare provider. Specimens collected with the Sample Preservation Solution can be stored and transported at 4 °C or at room temperature (20-25°C) for preservation of microbial nucleic acid until the sample is processed and used with compatible molecular diagnostic assays.

The Zhejiang GENE SCIENCE Co., Ltd.'s Sample Preservation Solution consists of a plastic, polypropylene screw-cap collection tube filled with non-sterile sample preservation medium. The tubes are pre-filled with either 2 mL (suitable for swabs with flocking length of 20-24 mm) or 3 mL (suitable for swabs with flocking length of 24-30 mm) of solution. The device is nonsterile, for single use. Swabs are not included.

The provided document is a 510(k) summary for the Zhejiang GENE SCIENCE Co., Ltd.'s Sample Preservation Solution, which is a microbial nucleic acid storage and stabilization device. It details the device's intended use, description, principles of operation, and a comparison to a predicate device. Crucially, it includes performance data related to shelf-life stability, limit of detection (LoD), nucleic acid stability, and viral inactivation.

However, the document does not describe acceptance criteria in the format of a table with specific thresholds and reported performance against those thresholds, nor does it detail a study proving the device meets acceptance criteria per se in the context of an AI/human-in-the-loop diagnostic system. This document is a regulatory submission demonstrating substantial equivalence for a medical device (a sample preservation solution), not for an AI algorithm or a diagnostic test involving human readers.

Therefore, many of the requested points are not applicable to the provided text. I will address the relevant points based on the information available in the document.

Acceptance Criteria and Device Performance (as inferred from the context of a sample preservation solution):

Since this is not an AI diagnostic device, the "acceptance criteria" here refer to the performance benchmarks demonstrated for the sample preservation solution itself, such as stability of the nucleic acid, effective viral inactivation, and physical/chemical stability over time.

Table of Acceptance Criteria and Reported Device Performance (Inferred):

• 3 Day: -0.43 ΔCt
• 6 Day: -2.76 ΔCt
  Room Temperature (20-25°C) Storage:
• 3 Day: 0.57 ΔCt
• 6 Day: 0.44 ΔCt
  All values met the +/- 3.0 Ct pre-defined acceptance criteria. Stability claimed for up to 6 days at both 4°C and room temperature. |
  | Viral Inactivation | Inactivation leading to >4.0 log reduction in concentration (predicate's performance indicated) or a specific log reduction as determined to be effective. The document states "meeting the pre-defined acceptance criteria" for nucleic acid stability, implying a pre-defined target. | >6.2 log reduction in Influenza A concentration at 5 minutes (equivalent to >99.99% inactivation for all lots at 5 and 10 minutes). For Lot#1 and Lot#2, inactivation was already >6.97 log reduction at 0 minutes. For Lot#3, it was 3.28 log reduction at 0 minutes, but increased to >6.20 at 5 and 10 minutes. The conclusion states "inactivates Influenza A virus when incubated for at least 5 minutes." |

Regarding the specific points for AI/diagnostic studies:

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

• Test Set Description: The document describes performance testing for a sample preservation solution, not an AI model.
  • LoD Study: 4 replicates for preliminary LoD determination at each of 5 concentrations; 20 replicates for LoD confirmation.
  • Nucleic Acid Stability: Triplicate samples of 3 lots (total 9 samples per time point/temperature combination).
  • Viral Inactivation: Triplicate samples of 3 lots (total 9 samples per time point/exposure time combination) for cytotoxicity; triplicate samples of 3 lots for Test, Positive, and Negative Control groups (total 27 samples per exposure time for viral inactivation).
• Data Provenance: Not explicitly stated beyond "upper respiratory matrix." It's not clinical patient data but rather spiked laboratory samples. No country of origin is mentioned for the data itself, only for the manufacturer (China). The study design is laboratory-based (spiking known quantities of virus).

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

• Not applicable. Ground truth for these studies (LoD, nucleic acid stability, viral inactivation) is established by the known concentration of spiked virus and quantitative molecular assays (RT-PCR) or cell culture-based infectivity assays (TCID50), rather than expert human interpretation.

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

• Not applicable. This is not a study requiring human adjudication of images or clinical cases.

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 performance study for a sample preservation solution, not a diagnostic device involving human readers or AI assistance.

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

• Not applicable. There is no algorithm being tested in this context. The "device" is a physical solution.

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

• Quantitative Laboratory Measurements: Ground truth is established by:
  • Known concentrations of spiked Influenza A virus.
  • RT-PCR Ct values: Quantitative measure of nucleic acid presence.
  • TCID50 (Tissue Culture Infectious Dose 50%): Quantitative measure of live virus infectivity.

7. The sample size for the training set:

• Not applicable. There is no "training set" as this is not an AI/machine learning model.

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

• Not applicable. See point 7.

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The DNA/RNA Shield™ SafeCollection Kit is intended for the collection, inactivation, stabilization, and transportation, of unprocessed saliva specimens suspected of containing SARS-CoV-2. The DNA/RNA Shield™ SafeCollect Saliva Collection Kit is intended to transport and store saliva specimens at ambient temperature (20-25°C) from the collection site to the laboratory. Specimens collected and preserved in a DNA/RNA Shield™ Saliva Collection kit sample collection tube are suitable for use with legally marketed molecular diagnostic devices.

The DNA/RNA Shield SafeCollect Saliva Tube consists of a tube pre-filled with DNA/RNA Shield transport media. DNA/RNA Shield is a transport media that ensures stability of SARS-CoV-2 RNA during sample transport/storage at ambient temperatures (20-25 ℃) and is intended to inactivate SARS-CoV-2, effectively lyses cells from collected saliva specimens. The DNA/RNA Shield SafeCollect Saliva Tube contains a foil seal barrier that sequesters the DNA/RNA Shield transport media inside of the tube, until the cap, with a Safe Puncture tip is used to seal the DNA/RNA Shield SafeCollect Saliva tube. When the foil seal barrier is broken by the Safe Puncture Tip, the specimen is then, and only then mixed with the DNA/RNA Shield™ transport media. The DNA/RNA Shield SafeCollect Saliva Collection Kit consists of a DNA/RNA Shield SafeCollect Saliva Tube, a funnel designed for the collection of human saliva samples, and a cap with a Safe Puncture tip. Sample collection is conducted under the supervision of a healthcare provider. The user deposits their saliva into the collection tube with the aid of the attached funnel, the user removes the funnel and replaces it with the cap. Upon twisting and closing the Safe Puncture tip cap, the DNA/RNA Shield is released into the tube and mixes with the saliva.

The provided text describes the performance data for the DNA/RNA Shield SafeCollect Saliva Collection Kit, specifically for its ability to detect and stabilize SARS-CoV-2 in saliva specimens, and to inactivate the virus. This information is typically presented as part of a 510(k) submission to the FDA to demonstrate substantial equivalence to a predicate device.

However, the document is NOT an AI/ML medical device submission. It describes a physical medical device (a saliva collection kit) and its performance, using laboratory-based analytical studies, not an AI algorithm. Therefore, many of the requested criteria in the prompt, such as those related to AI/ML specific studies (e.g., MRMC studies, standalone algorithm performance, AI assistance effect size, training set details, expert ground truth establishment for AI/ML) are not applicable to this device.

The acceptance criteria and performance data provided are for the analytical validity of a diagnostic aid, specifically:

• Detection Limit (LoD): The lowest concentration of SARS-CoV-2 that the device (in combination with a specified RT-PCR kit) can reliably detect.
• Stability: How long SARS-CoV-2 RNA remains stable in the collected saliva at a specific temperature within the device.
• Inactivation: The device's ability to inactivate SARS-CoV-2.

Here's an attempt to extract and present the relevant information based on the provided text, while acknowledging that many AI/ML specific criteria are not present.

Acceptance Criteria and Device Performance (Based on Analytical Studies)

Given that this document describes a physical sample collection device and not an AI/ML algorithm, the nature of "acceptance criteria" and "study" are focused on analytical performance rather than clinical or AI/ML-specific validation.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Detection Limit (LoD) Study:
  • Preliminary LoD Determination: 5 replicates per concentration level.
  • Confirmatory LoD Study: 20 replicates per concentration level (at and around the preliminary LoD).
  • Data Provenance: Not explicitly stated, but implies laboratory-controlled spiking experiments (inactivated SARS-CoV-2 spiked into negative saliva). The data is analytical/experimental, not from patient samples.
• Stability Study: 3 replicates per time point (Day 0, 1, 2, 3, 4, 5, 6, 7, 14, and 21).
• Inactivation Study: Replication not explicitly stated for individual samples, but the study was "replicated three independent times" in a BSL-3 facility.

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

• N/A. This is an analytical/laboratory study, not a clinical study involving human judgment or interpretation of medical images/data by experts. Ground truth is established by quantitative laboratory measurements (e.g., viral concentration, presence/absence of signal from RT-PCR, plaque formation).

4. Adjudication Method for the Test Set

• N/A. As this is a laboratory-based analytical study, there is no human adjudication process involved in establishing ground truth. The results are based on objective assay readings (Ct values for PCR, plaque counts for infectivity).

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

• N/A. This device is a sample collection kit, not an AI/ML algorithm that assists human readers.

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

• N/A. This is a physical device, not an algorithm. Its "standalone" performance refers to its direct analytical capabilities (e.g., stabilizing RNA, inactivating virus) as measured by laboratory assays.

7. The Type of Ground Truth Used

• Analytical Ground Truth:
  • Detection Limit & Stability: Defined by spiking known concentrations of inactivated SARS-CoV-2 (measured in GEC/mL) into negative saliva and then performing a legally marketed molecular diagnostic test (Quick SARS-CoV-2 rRT-PCR Kit). The RT-PCR results (Ct values, positive/negative calls) serve as the ground truth against the known spiked viral load.
  • Inactivation Study: Defined by the quantifiable reduction in infectious virus (plaque-forming units, PFU/mL) using a plaque assay after exposure to the collection medium, compared to an untreated control.

8. The Sample Size for the Training Set

• N/A. This is not an AI/ML device that requires training data. The studies are analytical performance validation studies for a physical product.

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

• N/A. No training set exists for this type of device.

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CLEARinse CTS is intended to collect and transport clinical nasal wash aspirate specimens that may contain influenza A or influenza B virus, by health care professionals, from the collection site to a laboratory or testing site. CLEARinse CTS specimens are suitable for use with legally marketed lateral flow immunoassays and molecular assays. CLEARinse CTS is for professional in-vitro diagnostic use.

CLEARinse CTS is intended to collect and transport clinical nasal wash aspirate specimens that may contain influenza A or influenza B virus, by health care professionals, from the collection site to a laboratory or testing site. CLEARinse CTS specimens are suitable for use with legally marketed lateral flow immunoassays and molecular assays. CLEARinse CTS is for professional in-vitro diagnostic use.

The product is an extension of the CLEARinse Pro device, a 510(k)-cleared (K082762) professional use medical device with indications for nasal lavage as well as mucus sample collection for subsequent testing. The CLEARinse Pro Handle and Instructions for Use are required for use of the CLEARinse CTS.

The CLEARinse CTS is comprised of two component assemblies: a revision to the 510(k)cleared Wash Head and a Transport Container to protect the Wash Head and specimen during transit. The CLEARinse CTS. used with the CLEARinse Pro Handle, will allow a nasal wash aspirate specimen to be collected by a medical professional, protected for transit, and ground shipped to a testing site. The user mounts the CLEARinse CTS Wash Head onto the CLEARinse Pro Handle and adds sterile saline as directed. The tip of the Wash Head is inserted into the patient's nostril and sterile saline is introduced. The irrigated saline and nasal secretions are then aspirated back into the Wash Head, collecting the specimen to be tested. The CLEARinse CTS Wash Head is removed from the Handle and placed into the Transport Container assembly (Container Cup, Filter Seal, Silicone Seal, and Container Lid) and then back into the CLEARinse CTS box for ground transportation of the specimen to a laboratory for testing.

The Wash Head is manufactured from inert, biocompatible plastics and is supplied as a sterile, single use device. The Transport Container is also manufactured from inert, biocompatible plastics and is a single use device but is not supplied sterile.

Here's a breakdown of the acceptance criteria and the study details for the CLEARinse CTS Specimen Collection and Transport System, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• LoD Testing (PCR and LFA):

  • Preliminary Test Set: Various concentrations were tested, typically with 3 replicates for each concentration.
  • Confirmatory Test Set: 20 replicates were used for each influenza strain (H1N1, H3N2, FluB) at their respective 1X LoD (for PCR) or determined LoD (for LFA).
  • Data Provenance: The data appears to be prospective as it involves controlled spiking of viral strains into a negative clinical matrix and subsequent testing with the device. The origin of the clinical nasal wash matrix (NWA) is not explicitly stated but is described as "pooled negative clinical nasal wash matrix." The tests were conducted using commercially available assays (Cepheid Xpert Xpress SARS-CoV-2/Flu/RSV and PBM BioSign Flu A+B).

• Sample Stability Testing (PCR and LFA):

  • Test Set: Each stability study evaluated triplicate samples for each influenza strain (H1N1, H3N2, FluB) per time point (0-hr, 4-hr, 6-hr, 24-hr, 48-hr) and per storage condition (4°C, 27°C). This means, for PCR, 3 strains * 5 time points * 2 temperatures * 3 replicates = 90 tests. Similarly for LFA, though the 0-hr was a baseline, and some time points appear a little different in the table headers.
  • Data Provenance: Similar to LoD, this is prospective testing using spiked contrived samples in a negative clinical nasal wash matrix.

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

• The study in this 510(k) summary focuses on analytical performance (Limit of Detection and Stability) rather than diagnostic accuracy against a clinical ground truth established by experts.
• The "ground truth" for the test sets was derived from known concentrations of spiked viral strains (TCID50/mL) determined by established laboratory methods, and then assessed using commercially available and validated diagnostic assays (Cepheid Xpert Xpress SARS-CoV-2/Flu/RSV for PCR and PBM BioSign Flu A+B for LFA).
• No human experts (e.g., radiologists) were used to establish the ground truth for these particular analytical studies.

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

• For the analytical studies described, no adjudication method (like 2+1 or 3+1) was used or required.
• The results for LoD and stability were primarily quantitative (Ct values for PCR) or categorical (positive/negative for LFA) based on the output of the reference diagnostic assays. The "ground truth" for the spiked samples was the known concentration of the viral load.

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 Multi-Reader Multi-Case (MRMC) comparative effectiveness study was conducted or presented in this 510(k) summary.
• The CLEARinse CTS is a specimen collection and transport system, not an AI-powered diagnostic imaging device or an AI-assisted detection tool where human reader performance would be a relevant metric. The studies focus on the ability of the device to preserve and recover viral nucleic acids and antigens for downstream testing.

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

• The performance described in this 510(k) is essentially standalone performance of the collection and transport system.
• The device itself (CLEARinse CTS) is not an "algorithm" in the typical sense of AI/ML. Its performance is evaluated by its ability to maintain the integrity of spiked samples, which are then analyzed by already cleared in vitro diagnostic assays (the Cepheid PCR and PBM BioSign LFA). These assays operate independently to detect the target. The studies demonstrate the device's contribution to maintaining sample quality for these standalone diagnostic tests.

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

• The ground truth for both the LoD and stability studies was based on contrived samples with known concentrations of viral pathogens. These concentrations were quantified using standard laboratory methods (TCID50/mL).
• The "true" positivity or negativity of a sample at a given concentration was determined by the performance of the established reference nucleic acid (PCR) and antigen (LFA) diagnostic assays, and compared against their expected LoDs.

8. The sample size for the training set:

• As this submission pertains to an in vitro diagnostic specimen collection and transport device and not an AI/ML algorithm that requires training, there is no "training set" in the context of machine learning.
• The performance data provided is for verification and validation of the device's analytical capabilities.

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

• Again, since this is not an AI/ML device, the concept of a "training set" and establishing its ground truth for machine learning does not apply.
• The ground truth for the test samples used in the analytical studies was established by spiking known concentrations of influenza strains into a negative clinical matrix (as described in point 7).

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The iSWAB-Respiratory Tract Sample Collection Media-Extraction device is intended for the stabilization and inactivation of upper respiratory and saliva human specimens suspected of containing SARS-CoV-2. This device can be used for the collection, transport, and storage of specimens at ambient temperature. Specimens collected in the iSWAB-Respiratory Tract Sample Collection Media-Extraction Less collection device are suitable for use with legally marketed molecular diagnostic tests.

The iSWAB™-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB™ -RC-EL) collection device consists of a collection tube that is pre-filled with 800 µL of the iSWAB™-RC-EL nontoxic, stabilizing buffer and fitted with a proprietary insert. The insert is designed to optimize the release of specimens collected with swabs into the stabilizing buffer, creating a minimal footprint and allowing for swab-free transport of specimens. The iSWAB™-RC-EL collection device eliminates the costly and timeconsuming RNA isolation step from diagnostic workflows.

The provided text describes the Mawi DNA Technologies iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL) device, a microbial nucleic acid storage and stabilization device. However, this document does not describe the acceptance criteria of a device or a study that proves the device meets the acceptance criteria in the context of an AI/ML device.

The provided text pertains to a sample collection and stabilization device for SARS-CoV-2, which is a physical diagnostic device, not an AI/ML device. Therefore, the questions related to AI/ML specific criteria (e.g., ground truth, MRMC study, training set, human-in-the-loop performance) are not applicable to the information contained in this document.

The document discusses performance data related to:

• Sterilization & Shelf-life Testing: Stability studies for bacterial/fungal growth, appearance, pH, voltage resistance, and density over time.
• Biocompatibility Testing: Not applicable as it's an IVD with no patient contact.
• Electrical safety and electromagnetic compatibility (EMC): Not applicable as it's a passive device.
• Software Verification and Validation Testing: Not applicable as it's a passive device.
• Mechanical and acoustic Testing: Not applicable.
• Animal Study: Not required.
• Human Clinical Performance Testing: Not required.

The performance data that was provided and could be interpreted as "proving the device meets acceptance criteria" for a sample collection device includes:

• Inactivation Study: Demonstrated inactivation of the SARS-CoV-2 virus.
• Limit of Detection (LoD): An analytical sensitivity study to determine the LoD of SARS-CoV-2 collected using the iSWAB-RC-EL in combination with a specific RT-PCR kit.
• Specimen Stability: A study demonstrating stabilization of SARS-CoV-2 at ambient temperature for specified durations (e.g., 28 days for nasal, 33 days for saliva at 15-30°C).
• Precision/Reproducibility: Studies conducted for lot-lot, day-day, and operator-operator reproducibility.
• Compatibility: Demonstrated compatibility with various legally marketed molecular diagnostic tests (e.g., CDC 2019-nCoV RT-PCR Diagnostic Panel, BGI Real-Time Fluorescent RT-PCR Kit).

Since the requested information pertains to an AI/ML device and the provided document is about a physical sample collection device, it is not possible to fully answer the prompt's specific questions.

However, I can extract information relevant to the performance studies conducted for this specific medical device (iSWAB-RC-EL), even though it does not fit the AI/ML context:

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

The document doesn't explicitly state "acceptance criteria" values for each test, but rather describes that the tests were performed and implies successful outcomes for substantial equivalence. I will infer the performance reported based on the study descriptions.

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

• The document does not specify the exact sample sizes for the LoD, inactivation, stability, or reproducibility studies. It only mentions "3 lots" for shelf-life testing.
• Data provenance for the performance studies is not explicitly stated (e.g., country of origin, retrospective/prospective). It refers to internal studies conducted by the submitter (Mawi DNA Technologies).

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

• Not applicable to this type of device. Ground truth as typically defined for AI/ML models (e.g., expert consensus on image reads, pathology reports) is not relevant for a sample collection and stabilization device. The "truth" here is determined by laboratory assays (e.g., viral load detection, stability measurements, inactivation efficacy assays).

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

• Not applicable to this type of device. Adjudication methods are typically used for reconciling disagreements among human readers/experts in diagnostic evaluations for AI/ML 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

• Not applicable. This is a physical sample collection device, not an AI/ML diagnostic software, and therefore MRMC studies with human readers are not relevant.

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

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

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

• The "ground truth" for this device's performance is established by analytical laboratory measurements using reference methods and controls to demonstrate:
  • Viral inactivation efficacy (e.g., cell culture assays, qPCR to confirm no viable virus).
  • Stability of nucleic acids over time (e.g., RT-PCR cycle threshold (Ct) values over incubation periods).
  • Limit of Detection (e.g., serial dilutions of viral RNA analyzed by RT-PCR).
  • Reproducibility of measurements (e.g., statistical analysis of results across different lots, days, operators).

8. The sample size for the training set

• Not applicable. This classification is for AI/ML model development. This device does not involve a training set.

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

• Not applicable. No training set is involved for this physical device.

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The Spectrum Solutions Saliva Collection Device is designed for use in the non-invasive collection, and stabilization of viral nucleic acids for in vitro diagnostic testing of saliva samples. The device is intended to inactivate and stabilize human clinical saliva samples from the collection site to the laboratory at room temperature. The saliva sample is stabilized and suitable for use with legally marketed molecular diagnostic device is intended to be used by a health care provider for samples suspected of containing SARS-CoV-2.

The Spectrum Solutions Saliva Collection device consists of a plastic tube designed for the collection of human saliva samples, a funnel, a cap with a stem flare, and a fluid chamber containing Spectrum's inactivating media. Sample collection is conducted under the supervision of a Health care provide. The user deposits their saliva into the collection tube with the aid of the attached funnel, the user removes the funnel and replaces it with the cap. Upon twisting and closing the cap, the stabilizing solution is released into the tube and mixed with the saliva.

The Spectrum Solutions Saliva Collection Device is a microbial nucleic acid storage and stabilization device designed for the non-invasive collection, inactivation, and stabilization of viral nucleic acids for in vitro diagnostic testing of saliva samples, specifically for SARS-CoV-2.

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

1. Table of Acceptance Criteria and Reported Device Performance:

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