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Synthetic polyisoprene probe covers are indicated for use during diagnostic ultrasound procedures in cases where patient sensitivity to natural rubber latex is speculative.

The Sheathing Technologies, Inc CIS-Isoprene Ultrasound Transducer Cover provides a thin, conformal covering to fit various and specific ultrasound transducer shapes. The cover is made by dipping to form a general cylindrical shape. It is closed at the proximal end and open at the distal end for insertion of the ultrasound transducer. This device is an accessory used on diagnostic probes to help minimize cross contamination. The cover material is a Cis-1,4-polyisoprene, a synthetic version of natural rubber latex made without using natural rubber latex in the formulation. Various sizes and shapes of covers are offered to address the variations in Ultrasound Transducer configurations. Product categories/models include General Purpose SheathesISO Ultrasound Transducer Covers (sterile and non-sterile). Covers are packaged in both sterile and nonsterile, individually wrapped or in bag/box quantities, as well as in "procedure kit" form for single patient/procedure, disposable use. The "procedure kit" may include elastic fasteners, with or without coupling gel packets. Transducer covers are also combined with disposable needle guide devices into kits.

This document is a 510(k) premarket notification for a Synthetic Polyisoprene Ultrasound Transducer Cover. The information provided does not describe a study involving AI or complex statistical analysis for diagnostic accuracy. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing and biocompatibility assessments. Therefore, many of the requested categories related to AI performance, expert ground truth, and comparative effectiveness studies are not applicable.

Here's an analysis of the provided text based on your request:

Acceptance Criteria and Reported Device Performance

The document describes the device's characteristics and the non-clinical tests performed to demonstrate its safety and effectiveness relative to predicate devices. The "acceptance criteria" here are implied by successful completion of these tests in comparison to established standards and the predicate device's performance.

Non-AI Specific Study Information

This submission is for a medical device (ultrasound transducer cover), not an AI algorithm. Therefore, many of the requested AI-centric points are not applicable to the provided text.

1. Sample size used for the Test Set and the data provenance:

   • Not applicable. This is a physical device, and testing involved bench tests and biocompatibility, not a "test set" of data for an algorithm. The "samples" would be units of the transducer cover subjected to physical and chemical tests. The document doesn't specify the exact number of units tested for each non-clinical test (e.g., how many covers were used for viral penetration testing).

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

   • Not applicable. There's no "ground truth" establishment in the context of an AI algorithm's performance. The results of the bench tests and biocompatibility tests are assessed against established industry standards (e.g., ISO 10993-1:2003) and internal specifications.

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

   • Not applicable. This is for an AI algorithm performance evaluation, not for physical device testing.

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 for an AI algorithm, not a physical medical device.

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

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

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

   • Not applicable in the AI sense. For the physical device, the "ground truth" for compliance relied on:
     • Standardized Test Methods: e.g., viral penetration tests, stretch tests, pinhole tests, gel compatibility tests.
     • Biocompatibility Standards: ISO 10993-1:2003.
     • Comparison to Predicate Device: Implicitly, the performance of the predicate devices in these categories served as a benchmark for substantial equivalence.

7. The sample size for the training set:

   • Not applicable. This is not an AI algorithm requiring a training set.

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

   • Not applicable. This is not an AI algorithm.

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