(274 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| (Not explicitly stated for comparative performance or clinical efficacy) | (Not explicitly stated for comparative performance or clinical efficacy) |
| Functionality during reprocessing | "Each compression limb sleeve is tested for functionality during reprocessing." (Pass/Fail criteria not detailed, but implies successful reprocessing) |
| Sterility | "Validation testing of the sterility protocols have also been completed." (Implies successful validation, but specific sterility assurance levels or criteria are not detailed) |
| Materials and dimensions identical to original | "The materials and dimensions are identical." (Met by design) |
| Technical characteristics, method of use, and compatibility with pump systems identical to original | "The technical characteristics, method of use, and compatibility with pump systems are also identical." (Met by design) |
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.
§ 870.5800 Compressible limb sleeve.
(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).