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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 Aardvark Medical Device is intended for use in nasal and sinus lavage. The device facilitates instillation of saline into the nasal passage and provides powered suction to either 1) directly evacuate the nasal passage, or 2) to remove the fluid and effluent by aspirating from the opposite nostril in a maneuver similar to the Proetz displacement or Aspiration Irrigation Maneuver. The device is used to treat conditions and disorders of the upper respiratory tract where homeostasis of the nasal mucosa is disturbed, resulting in symptoms such as catarrh and mucopurulent or crust secretions. Such conditions and disorders include: Rhinitis (as a symptom of colds, allergies, etc.) and both acute and chronic Sinusitis. It can also be used to collect mucus samples for subsequent testing. It is intended for use in adults and children in either the physician's office or in the home.

The Aardvark device is designed to make nasal and sinus lavage easy and convenient. The device facilitates instillation of salinc into the nasal passage. It then provides mild powered suction to remove the fluid from the nostril. Alternatively, it can bc used on the opposite nostril while intermittently occluding the sprayed nostril, i.e., the Proetz Displacement mancuver. The device consists of a hand held battery opcrated unit with a disposable tip portion. A charger is provided with the device.

This document states the device went through "verification testing under the company's Design Control Process" which "confirmed the device's conformance with specifications." However, it does not include details about specific acceptance criteria for performance, nor does it describe a study that provides objective performance data or establishes a ground truth.

Therefore, for many of the requested categories, the information is not present in the provided text.

Here's a breakdown based on the input document:

1. A table of acceptance criteria and the reported device performance
   This information is not provided in the document. The document only states: "The Aardvark device verification testing under the company's Design Control Process has confirmed the device's conformance with specifications. The specifications do not include any significant differences from those of the predicates." This indicates performance was assessed against internal specifications, but the specific criteria and results are not reported.

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 document. The document mentions "verification testing" but gives no details about sample size or data provenance for any test set.

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 in the document. There is no mention of a "test set" in the context of expert review or ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
   This information is not provided in the document. There is no mention of a "test set" in the context of 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/not provided. The device described is a powered nasal irrigator and aspirator, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
   This information is not applicable/not provided. The device described is a physical medical device, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
   This information is not provided in the document. There is no discussion of ground truth as it pertains to performance evaluation of the device against a gold standard for a specific diagnostic task. The "verification testing" mentioned would typically refer to engineering and functional performance, not clinical diagnostic accuracy.

8. The sample size for the training set
   This information is not applicable/not provided. The device is a physical medical device, not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established
   This information is not applicable/not provided. The device is a physical medical device, not a machine learning algorithm.

Summary of what is stated regarding performance:

• Acceptance Criteria/Performance Goal: The device was tested for "conformance with specifications." These specifications were considered "substantially equivalent" to those of the predicate devices. No specific quantitative criteria or performance metrics are listed in the document.
• Study Description: The document refers to "verification testing under the company's Design Control Process." No details about the study design, methodology, or results are provided beyond the statement that it confirmed conformance.

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