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A protective cover for a mechanical breast biopsy device reusable holster / cable assembly that helps prevent contamination [blood, body fluids, ultrasound gel, etc.] of the holster control buttons, and thus allowing for reprocessing of the holster between patient uses; covers are single use, disposable.

The CIV-Flex™ Holster Cover device provides a thin, conformal protective covering for the disposable probe / reusable holster and cable assembly components of the Ethicon Endo-Surgery Mammotome® mechanical breast biopsy device. The cover is manufactured as a one-piece sleeve design that is open on both ends with a tapered fit to the holster / probe geometry. The cover material is transparent for visualization of the holster control buttons during use. Cover material is polyurethane film. Material system is free of any latex natural rubber. Covers are packaged sterile in a pouch for single patient / procedure, disposable use. Cover is supplied with latex free Kraton® thermoplastic elastomer bands for use in securing the cover to the holster and cable.

The information provided describes a 510(k) premarket notification for the CIV-Flex™ Holster Cover, focusing on demonstrating substantial equivalence to a predicate device, the CIVCO Poly [CIV-Flex™] Ultrasound Transducer Cover (K970513). As this is a submission for a protective cover, the "performance" and "acceptance criteria" are related to its physical properties, biocompatibility, and ability to act as a barrier, rather than diagnostic accuracy metrics typically found in AI/ML device studies.

Here's an analysis of the provided text, structured to address your specific points where applicable, and noting when information is not present or relevant to this type of device:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list "acceptance criteria" in a quantitative, metric-based format as one might expect for a diagnostic device. Instead, it relies on demonstrating substantial equivalence to a predicate device by comparing various parameters and highlighting that the new device meets the same performance and safety standards established for the predicate.

The "Effectiveness" section offers the closest information to performance, focusing on mechanical integrity and barrier properties.

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

This information is not provided in the document. For this type of device (a protective cover), the "test set" would refer to the samples of the cover material or the covers themselves that underwent various physical, chemical, and biological tests. The document indicates "Mechanical testing for CIV-Flex™ Holster Covers has shown that the material is adequate..." and "Experience and testing has shown that polyurethane covers: ... Provides an effective barrier...", but it does not specify the number of samples or data provenance (e.g., country of origin, retrospective/prospective). This type of detail is often found in the full test reports, which are not included in a 510(k) summary.

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

This is not applicable to this type of device submission. Ground truth is typically associated with diagnostic accuracy, where clinical experts (e.g., radiologists, pathologists) determine the true disease state for comparing against an AI algorithm's output. For a physical device like a sterile cover, "ground truth" is established through standardized laboratory tests (e.g., sterility testing, biocompatibility testing, physical strength tests), not expert consensus on medical images or diagnoses.

4. Adjudication Method for the Test Set

This is not applicable to this type of device submission for the reasons outlined in point 3. Adjudication methods (like 2+1 or 3+1) are used in clinical studies to resolve disagreements among human readers/experts when establishing ground truth for diagnostic efficacy.

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

This is not applicable to this type of device submission. MRMC studies are used to evaluate the performance of diagnostic systems (often AI-assisted) by comparing multiple readers' interpretations of multiple cases. The CIV-Flex™ Holster Cover is a physical accessory, not a diagnostic tool or an AI-powered system, so such a study would not be relevant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

This is not applicable to this type of device submission. This question pertains to AI/ML device performance, where "standalone" refers to the algorithm's performance without human interaction. The CIV-Flex™ Holster Cover is a physical medical device.

7. The Type of Ground Truth Used

For the CIV-Flex™ Holster Cover, the "ground truth" (or the basis for demonstrating safety and effectiveness) is established through:

• Standardized Sterility Testing: Validation using ANSI/AAMI/ISO 11135 (Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process) to achieve a SAL (Sterility Assurance Level) of 10-6.
• Biocompatibility Testing: In accordance with ISO 10993-Part 1 (Biological evaluation of medical devices), FDA Blue Book Memorandum #G95-1, and FDA-Good Laboratory Practices (GLP), demonstrating non-toxicity, non-sensitization, non-irritation, non-hemolysis, and non-pyrogenicity.
• Mechanical Testing: Demonstrating adequate strength and elasticity to prevent tearing or pinholing during application, removal, and use.
• Barrier Property Testing: Performance as an effective barrier to microbial migration, implicitly by being equivalent to the predicate device which had demonstrated this using a viral penetration protocol.

These are objective, laboratory-based metrics, not subjective expert consensus, pathology, or outcomes data in the clinical sense you might be referring to for diagnostic devices.

8. The Sample Size for the Training Set

This is not applicable to this type of device submission. The concept of a "training set" refers to data used to train an AI/ML algorithm. The CIV-Flex™ Holster Cover is a physical accessory and does not involve AI/ML.

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

This is not applicable to this type of device submission for the same reasons as point 8.

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