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Protective cover or sheath is placed over an ultrasound transducer / probes / scanbead instruments. The cover allows use of the transdacer in Naming and intra-operative uitesound, while helping to proven transfer of microorganisms, body fluids, and and intra-operative uitesound, while helping to proven during rease of the tearile and non-sterile covers). The cover also provides a means for maintenance of a sterile fold (sterile covers only). non-sterile covers). The cover also provides a modis for manished sterile and non-sterile, single use patient / procedure, disposable.

The Synthetic Polyisoprene Ultrasound Transducer Cover provides a thin, conformal covering to fit various and specific ultrasound transducer geometries. The cover is manufactured as either a one-or two-piece design that provides a covering that helps prevent the transmission of pathogens as the ultrasound transducer is reused from one patient to another. The cover material is polyisoprene synthetic rubber similar to that of non-latex medical examination / surgical gloves. Various sizes and shapes of covers are offered in order to customize the fit to specific transducer geometries. Product categories / models include: General Purpose Synthetic Polyisoprene Transducer Covers (sterile and non-sterile) Endocavity Synthetic Polyisoprene Transducer Covers (sterile and non-sterile) Surgi-Tip™ Intraoperative* Synthetic Polyisoprene Transducer Covers (sterile) *Polyethylene cord cover w/ Synthetic Polyisoprene tip Covers are packaged in both sterile and non-sterile "procedure kit" form for single patient / procedure, disposable use. Cover kits are supplied with fasteners, and with or without coupling gel packet. Transducer covers are also combined with disposable needle guide devices into custom kits that CIVCO builds for ultrasound OEMs and end users.

The provided text describes a 510(k) submission for a Synthetic Polyisoprene Ultrasound Transducer Cover, arguing for its substantial equivalence to a legally marketed predicate device, the CIVCO NeoFlex™ Ultrasound Transducer Cover (K991236).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets for performance metrics (e.g., "tear strength > X MPa"). Instead, the criteria are qualitative and comparative, demonstrating that the new device performs "effectively similar" to the predicate device in key areas.

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

The document does not explicitly state sample sizes for specific tests within an "effectiveness" study or "test set" in the context of clinical performance. Instead, it refers to "testing for Synthetic Polyisoprene covers" and "biocompatibility tests" demonstrating compliance with the criteria.

• Sample Size: Not specified.
• Data Provenance: Not specified. The studies appear to be laboratory-based and focused on material properties and barrier effectiveness. There's no mention of human subject data, clinical trials, or retrospective/prospective studies involving patients.

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

• Number of Experts: Not applicable. The "ground truth" for the performance evaluation of this medical device (a transducer cover) is based on established scientific and engineering standards, material properties, and biological compatibility testing, not on expert consensus from clinical cases for diagnostic accuracy.
• Qualifications of Experts: Not specified. Given the nature of the evaluation, these would likely be material scientists, microbiologists, and engineers involved in the testing and validation processes.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This type of device evaluation does not involve diagnostic interpretation or clinical scenarios requiring adjudication of expert opinions. The assessment is based on objective measurements and compliance with standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

• MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging algorithms to assess how AI impacts the performance of human readers on a set of clinical cases. The device in question is a physical medical accessory, not an AI algorithm.

6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Study: Yes, in a sense, the conducted studies for biocompatibility, strength, elasticity, and microbial barrier are "standalone" in that they evaluate the device's intrinsic properties without human-in-the-loop performance influencing the primary outcome metrics. This is not referring to "algorithm only" in the context of AI, but rather the device's physical and biological performance attributes.

7. The Type of Ground Truth Used

The "ground truth" for this device evaluation comprises:

• Biocompatibility Standards: Compliance with ISO 10993-Part 1, FDA Blue Book Memorandum #G95-1, and FDA-Good Laboratory Practices (GLP) for non-toxicity, non-sensitization, non-irritation, non-hemolysis, and non-pyrogenicity.
• Material Strength and Elasticity Specifications: Implicitly, the material must meet certain physical property thresholds (tensile strength, elongation, etc.) to ensure it doesn't tear or pinhole during use, as demonstrated by "effectively similar" performance to the predicate.
• Ultrasound Imaging Quality: The device must not "impair ultrasound imaging," which would be assessed objectively.
• Microbial Barrier Effectiveness: Demonstrated by testing "adapted from that used to evaluate the barrier properties/resistance of surgical gloves and endoscope sheaths to penetration by bloodborne pathogens using viral penetration as a test system."

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is a physical product, not an artificial intelligence or machine learning algorithm that requires a training set.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.

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