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These devices are reprocessed compression sleeves from various original equipment manufacturers (OEM.) Compression sleeves are designed to provide external intermittent or sequential limb compression to artificially imitate the pumping action of the lower limbs to: prevent deep vein thrombosis, enhance venous and arterial circulation, and reduce lower limb pain and swelling.

Reprocessed Compression Sleeves are inflatable devices that are fitted to a patient's foot and/or leg. They are connected to a separate pneumatic compressor, which provides intermittent, graduated pressure. When the sleeve compresses, the veins collapse, forcing blood to flow. When pressure is reduced, the sleeve deflates, allowing the veins to fill with blood. The cycle is then repeated. It should be noted that this submission applies to the compression sleeve only. It does not include any other components in a compression system such as the pneumatic compressor.

Here's an analysis of the provided text regarding the acceptance criteria and study for the SterilMed Reprocessed Compression Sleeves:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state numerical acceptance criteria in a dedicated section. Instead, the performance is demonstrated through a claim of "substantial equivalence" to predicate devices. The functional and safety testing described aims to show that the reprocessed devices perform as well as or similarly to the original, new devices.

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

• Sample Size for Test Set: The document states "Representative samples" were used for bench testing and process validation. However, no specific number or size of the test set is provided.
• Data Provenance: The data is generated internally by SterilMed, Inc. during their "bench testing" and "process validation testing." The document does not specify country of origin for the data (beyond SterilMed's location in Minneapolis, MN) nor explicitly state if it's retrospective or prospective. Given it's for a 510(k) submission, it's almost certainly prospective testing conducted specifically for this submission.

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

This information is not provided in the document. The testing described (bench testing, process validation, visual inspection, functional testing) does not typically involve expert "ground truth" establishment in the same way clinical studies or diagnostic AI algorithms do. The "truth" here is based on engineering specifications and performance benchmarks against predicate devices.

4. Adjudication Method for the Test Set:

This information is not applicable to the type of testing described. Adjudication methods like 2+1 or 3+1 are used for human review of cases, typically in clinical studies, to establish a consensus ground truth for diagnostic decisions. The described testing is primarily engineering and process validation.

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:

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices that assist human readers. The SterilMed Reprocessed Compression Sleeves are physical medical devices, not AI software, and therefore this type of study is not relevant or performed.

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

Not applicable. This device is not an algorithm or AI system. Its performance is inherent to the physical device itself.

7. The Type of Ground Truth Used:

The "ground truth" for this submission is established through engineering specifications and performance characteristics of the predicate devices. The reprocessed devices are compared against these known, legally marketed, and established predicate devices (Kendall Company and Huntleigh Technology Inc. models). The claim of substantial equivalence is based on the reprocessed devices being "essentially identical to the predicate devices in terms of functional design, materials, indications for use, construction, and principles of operation."

8. The Sample Size for the Training Set:

Not applicable. This is a physical reprocessed medical device, not an AI/ML model that requires a training set.

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

Not applicable. As the device is not an AI/ML model, there is no training set or corresponding ground truth establishment process in this context.

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