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Medline ReNewal Reprocessed Compression Limb Sleeves are designed to be used with a pump system to apply sequential compression to the lower limbs to prevent deep vein thrombosis.

Medline ReNewal Reprocessed Compression Limb Sleeves are used with a pump system to apply sequential compression to the lower limbs (leg and foot). They are made of a variety of materials and come in various sizes. They are originally manufactured as single use devices.

I am sorry, but the provided text is a 510(k) summary for a medical device and does not contain the detailed information required to describe the acceptance criteria and the comprehensive study that proves the device meets those criteria. The document explicitly states:

• "The functional characteristics of the proposed devices have been evaluated and found to be equivalent to the predicate devices after the specified number of reprocessing cycles."
• "Testing included: bioburden testing; biocompatibility testing (cytotoxicity, irritation, sensitization); cleaning process validation; equipment qualification; and visual inspection."

While these are types of tests performed, the document does not provide:

1. A table of acceptance criteria and reported device performance: It lists types of tests but not specific criteria (e.g., "bioburden must be

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The compression limb sleeves are designed to be used with a pump system to apply sequential compression to the lower limbs to prevent deep vein thrombosis.

The devices that are the subject of this submission are used with a pump system to apply sequential compression to the lower limbs. They are made of a variety of materials and come in various sizes. Some are leg wraps and some are foot wraps. They come from several different original equipment manufacturers as single use devices. Reprocessing includes cleaning, testing, packaging, and sterilization. It allows the compression limb sleeves to be used several times rather than just once.

The provided 510(k) summary for Surgical Instruments Servicing & Savings, Inc. regarding "Reprocessed Compression Limb Sleeves" indicates that no comparative performance testing or clinical evaluations were conducted as part of this submission. Therefore, the document does not contain information about acceptance criteria or a study proving the device meets them in the way typically expected for novel devices or those with significant performance claims.

Here's a breakdown based on the information provided in the document, and where details are missing:

Acceptance Criteria and Device Performance Study

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: The document explicitly states that "Comparative performance testing and clinical evaluations were not included as part of this 510(k)." This means there are no acceptance criteria related to clinical effectiveness, user performance, or comparative performance against the original single-use devices, nor are there any reported performance metrics for such criteria. The acceptance is based on demonstrating substantial equivalence through material and functional identity, and successful reprocessing/sterilization validation.

2. Sample size used for the test set and the data provenance

• For functionality testing during reprocessing: Not specified. This typically would involve testing a sample from each reprocessing batch.
• For sterility validation: Not specified. Sterility validation usually involves a defined sample size and method (e.g., sterilization overkill method, bioburden reduction validation), but details are absent.
• For comparative performance/clinical effectiveness: N/A (no such testing was reported).

Data Provenance: N/A for comparative performance/clinical effectiveness studies, as none were conducted. For internal "functionality during reprocessing" and "sterility validation," the data would originate internally from the reprocessor (Surgical Instruments Servicing & Savings, Inc.).

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

N/A. Given that no comparative performance or clinical effectiveness studies were conducted, there was no need for expert ground truth establishment for such purposes.

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

N/A. No comparative performance or clinical effectiveness studies were conducted that would require an adjudication method.

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

N/A. This device is a medical accessory (compression limb sleeve), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study is not applicable.

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

N/A. This device is a medical accessory, not an algorithm or AI system.

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

N/A. No clinical or comparative performance studies were conducted that would require a ground truth of this nature. The "ground truth" for the submission's claims revolves around the physical and functional identity to the predicate device and the successful execution of reprocessing and sterilization.

8. The sample size for the training set

N/A. This device is a reprocessed physical medical accessory, not a machine learning model, so there is no "training set."

9. How the ground truth for the training set was established

N/A. As stated above, there is no "training set" for this device.

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