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The Reprocessed Kendall SCD™ Express Foot Cuff is a single patient use garment that connects to an intermittent pneumatic controller via a tubing set to deliver a set amount of pressure to the foot in order to promote blood flow.

AI/ML Overview

The provided document, K163055, describes the reprocessing of the Kendall SCD Express Foot Cuff. Since this is a reprocessed device and not a new diagnostic or prognostic tool, the acceptance criteria and study information typically sought for AI-powered devices or novel medical technologies are not directly applicable in the same way.

However, I can extract the information relevant to the reprocessing validation and present it in a format that aligns with your request where possible.

Acceptance Criteria and Device Performance for Reprocessed Kendall SCD™ Express Foot Cuff

This document describes the validation of a reprocessed medical device, the Kendall SCD™ Express Foot Cuff, not a novel diagnostic AI system. Therefore, the "acceptance criteria" and "device performance" are focused on demonstrating that the reprocessed device maintains the same safety and effectiveness as the original predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Performance Metric	Acceptance Criteria (from context)	Reported Device Performance (from context)
Functional Integrity	Hook and Loop Simulated Use	Not explicitly quantified, but implied to maintain functionality over simulated use.	Tested to demonstrate appropriate functional characteristics.
	Leak Testing	Not explicitly quantified, but implied to prevent leaks.	Tested to demonstrate appropriate functional characteristics.
	System Compatibility	Compatibility with intermittent pneumatic controller.	Tested to demonstrate appropriate functional characteristics.
Biocompatibility	Biological Safety	Meet ISO 10993-1 requirements.	Biocompatibility testing conducted in accordance with ISO 10993-1.
Cleaning Validation	Effectiveness of Cleaning Process	Meet AAMI TIR 30:2011 requirements.	Cleaning process validated in accordance with AAMI TIR 30:2011 requirements.
Manufacturing Quality	Visual Inspection	Free from visible defects.	Visual and functional testing of all reprocessed products prior to release.
	Functional Testing	Operates as intended.	Visual and functional testing of all reprocessed products prior to release.

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

Sample Size: Not explicitly stated for each test. The document mentions "Representative samples of the reprocessed foot cuffs were tested."
Data Provenance: The testing appears to be prospective benchtop validation conducted by Covidien. The country of origin for the data is implicitly the United States, given the FDA submission.

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

This type of information is generally not applicable for a Class II reprocessed medical device's benchtop validation. "Ground truth" in the context of device reprocessing refers to adherence to established engineering, biocompatibility, and sterilization standards, rather than expert interpretation of clinical data. The validation relies on objective measurements against these standards.

4. Adjudication Method for the Test Set

Not applicable. The validation involves objective measurements and adherence to specified performance standards rather than expert adjudication of qualitative outputs.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. This type of study is for evaluating diagnostic performance with human readers, which is not relevant for the reprocessing of a limb sleeve.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

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

7. Type of Ground Truth Used

The "ground truth" for this reprocessing validation is based on established industry standards and regulatory requirements (e.g., ISO 10993-1 for biocompatibility, AAMI TIR 30:2011 for cleaning validation) and the design and performance specifications of the original predicate device. Benchtop tests measure against these objective standards.

8. Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a training set. The "training" here refers to the development of the reprocessing procedures, which would involve process development and validation, not data-driven machine learning.

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

Not applicable, as no training set in the AI sense was used. The "ground truth" for developing the reprocessing protocols would be based on scientific principles of cleaning, disinfection/sterilization, material integrity, and functionality, developed through engineering and scientific experts to ensure that the reprocessed device performs identically to the new device and meets all safety requirements.

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