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The ClearScan™ ultrasound probe cover is intended to be used as a sterile, single-use protective cover with fluid coupling between the eye or skin and an ultrasonic transducer.

The ClearScan™ ultrasound probe cover is indicated when it is necessary to have a sterile, single-use protective sheath with fluid coupling between the examined sufface and an ultrasonic transducer.

The ClearScan™ ultrasound probe cover is intended to be used as a sterile, single-use protective cover with fluid coupling between the examined surface and an ultrasonic transducer. The device provides a microbial barrier between the probe and the patient's tissue, helping to prevent the transfer of microorganisms, body fluids and particulate material to the patient and healthcare personnel. It provides a water path between the trausducer and the surface scanned.

The ClearScan™ material that contacts the eye or skin tissue is made of a soft pliable plastic film. The JlearScan is a sealable plastic sac that encloses the transducer and holds water to make the water path for scanning.

The ClearScan is made of a biologically-compatible, non-latex membrane. It has a special collar that permits it to be sealed around the body of the transducer.

Here's an analysis of the provided text regarding the ESI ClearScan Transducer Cover, focusing on acceptance criteria and study details:

Overall Assessment:

The provided document (K080119) is a 510(k) submission for a device that is essentially a non-latex cover for ultrasound transducers. The primary purpose of this device is to provide a sterile barrier and a water path for ultrasound scanning.

Crucially, this submission does NOT contain acceptance criteria or a study proving that the device meets those criteria, as typically understood for diagnostic or therapeutic efficacy. Instead, it focuses on demonstrating substantial equivalence to a legally marketed predicate device (Civco Poly Ultrasound Transducer Cover K970573, K992152) and safety through biocompatibility.

Therefore, many of the requested sections below will indicate "Not applicable" or "Not provided" because the nature of this device and its 510(k) submission does not require comprehensive clinical performance studies to establish diagnostic accuracy or treatment effectiveness.

Acceptance Criteria and Reported Device Performance

Given the nature of the device (a sterile cover) and the 510(k) submission type, the "acceptance criteria" are primarily related to safety, sterility, and functional equivalence to its predicate. No specific performance metrics like sensitivity, specificity, or accuracy are provided as this is not a diagnostic algorithm.

Study Details

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

   • Sample Size: Not applicable / Not provided. The submission states "Non-clinical tests" (biocompatibility and distortion assessment) but does not detail sample sizes for these tests within the provided summary. No clinical test set involving patients or data sets is described, as the submission states "Clinical tests: Not required."
   • Data Provenance: Not applicable / Not provided. Since clinical tests were deemed not required, there is no patient data provenance (e.g., country of origin, retrospective/prospective). Non-clinical tests would typically be laboratory-based.

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

   • Not applicable. No "ground truth" in the diagnostic or performance sense was established for a test set, as no clinical efficacy study was conducted. The main "truth" being established was around biocompatibility and functional equivalence, which don't typically involve expert panels in this manner for this type of device.

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

   • Not applicable. No test set requiring expert adjudication was described.

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 passive, non-AI-powered accessory (an ultrasound probe cover). No MRMC or AI-related studies were conducted or are relevant.

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

   • Not applicable. This is not an algorithm or AI device.

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

   • The "ground truth" for this type of device primarily relates to whether the material is indeed biocompatible and if the cover functions as intended (e.g., provides a sterile barrier, holds water, doesn't cause artifact for imaging). For biocompatibility, this is typically established by recognized standards (e.g., ISO 10993 series) and laboratory testing. For functional aspects, it's engineering and material science validation. No clinical "ground truth" (e.g., disease presence/absence) was established for this submission.

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device that requires a training set.

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

   • Not applicable. No training set for an algorithm was used.

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