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Protective cover placed over diagnostic ultrasound transducer/ probe/scanhead instruments.The cover allows use of the transducer in scanning procedures for body surface, endocavity, and intra-operative diagnostic ultra-sound, while helping to prevent transfer of microorganisms, body-fluids, and material to the patient and healthcare worker during reuse of the transducer.

Ultra-Cover® PU-transducer covers are furnished sterile; single use patient/procedure, disposable.

The intended use and indications for use place Ultra-Cover® PU-transducer covers in device body contact categories as follows:

• a) surface devices, intact skin/mucosal membranes/ breached surfaces, limited contact duration . (< 24 hours)
• b) external communicating devices, blood path indirect/tissue communicating, limited contact duration (<24 hours).

Ultra-Cover® PU-transducer covers provides an efficient, conformal covering to fit various & specific ultrasound transducer geometries. The cover helps prevent the transmission of pathogens from one patient to another.

Ultrasound imaging is not impaired by use of the cover as it is intended. Adequate coupling between the cover and the transducer is required transmission gel onto the transducer face or into open end of cover, inserting ultrasound transducer into closed end of cover. The removal process is a reverse method from the application.

Various sizes and shapes of covers are offered in order to customize the fit to specific transducer geometries.

Covers are packaged in both sterile and non-sterile procedure kit form for single patient/procedure, disposable use.

Product categories/models include:

General Purpose Ultra-Cover® PU-transducer covers (sterile and non sterile) Intraoperative Ultra-Cover® PU-kits (sterile)

The document provided is a 510(k) summary for a medical device called "Ultra-Cover® PU-transducer cover." It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study outlining acceptance criteria and performance against those criteria in the way a clinical study would for efficacy.

Therefore, much of the requested information (like specific quantitative acceptance criteria for device performance, sample sizes for test/training sets, expert qualifications for ground truth, adjudication methods, or MRMC studies) is not typically found in this type of regulatory submission for a device like a transducer cover. The "performance" here is primarily related to safety (biocompatibility) and functional aspects (material strength, elasticity, and not impairing ultrasound imaging).

However, I can extract the information that is present and indicate where the requested information is not applicable or not provided in the document.

Acceptance Criteria and Device Performance for Ultra-Cover® PU-transducer cover (K981069)

The provided submission primarily focuses on establishing "substantial equivalence" to a legally marketed predicate device (Civco Medical Instruments Poly Ultrasound Transducer Cover, K970513), as such, the "acceptance criteria" are more about demonstrating that the new device shares fundamental safety and efficacy characteristics with the predicate.

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 the data provenance:

• Sample Size for Test Set: Not explicitly mentioned in terms of quantitative testing for device performance. The testing mentioned (biocompatibility, material strength) would typically involve specific test samples, but the number is not provided.
• Data Provenance: The biocompatibility testing was "executed by NamSa USA and Wickham Laboratories GB," indicating testing conducted by accredited laboratories. The document does not specify if these were retrospective or prospective studies; these are typically lab-based validation tests of material properties.

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

• Number of Experts: Not applicable or specified. For a device like a transducer cover, "ground truth" doesn't typically involve expert interpretation of diagnostic images or clinical outcomes in the same way an AI diagnostic tool would. The "truth" is based on objective material and functional testing standards.
• Qualifications of Experts: N/A. The "experts" would be the personnel at NamSa USA and Wickham Laboratories GB conducting the ISO 10993 tests, whose qualifications are implicit in the accreditation of these labs.

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

• Adjudication Method: Not applicable. This concept is typically used in clinical studies for diagnostic accuracy involving human interpretation. The reported tests are objective material and functional assessments.

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:

• MRMC Study: No, an MRMC study was not done. This type of study is relevant for diagnostic imaging AI tools, not for a medical device like an ultrasound transducer cover.
• Effect Size of Human Readers Improvement with AI: Not applicable.

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

• Standalone Performance: Not applicable. This refers to the performance of an AI algorithm, which is not relevant to this device.

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

• Type of Ground Truth: The "ground truth" for this device's performance is based on objective material property testing (e.g., tensile strength, elasticity tests) and biocompatibility testing against international standards (ISO 10993). For the claim of "no impairment of ultrasound imaging," this would imply testing with an ultrasound phantom or similar methods, though specifics are not detailed.

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable. This device does not involve machine learning or AI that would require a training set.

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

• How Ground Truth for Training Set was Established: Not applicable.

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