(76 days)
Reprocessed Compression Sleeves are intended to help prevent deep vein thrombosis and pulmonary embolism by supplying a measured, intermittent pressure into the compression sleeves worn on the lower extremities of a recumbent patient, resulting in a gradient, sequential, repetitive squeezing and relaxing action, simulating normal muscle contractions.
When coupled with an appropriate inflation system, compression devices are intended for use in preventing deep vein thrombosis (DVT), diminishing post-operative pain and swelling, enhancing blood circulation, and reducing wound healing time.
Compression sleeves are part of an external compression system, in which intermittent or sequential compression is provided using a pump/controller and limb garment. The system consists of the following three main components: a control unit, inflatable limb sleeves and conduit tubing with detachable connections. Only the compression sleeves are reprocessed.
The provided text is a 510(k) summary for Reprocessed Compression Sleeves. It describes the device, its intended use, and the testing conducted to demonstrate its substantial equivalence to a predicate device. However, it does not contain the detailed information necessary to fully answer all aspects of your request, particularly regarding specific numerical acceptance criteria, detailed study designs, or expert qualifications for ground truth establishment.
Here's a breakdown of the available information and where details are missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance (Summary) | Numerical Acceptance Criteria (if available) |
|---|---|---|
| Biocompatibility | Demonstrated performance | Not specified |
| Function Test(s) | Demonstrated performance | Not specified |
| Validation of Processing | Demonstrated performance | Not specified |
Explanation of Device Performance: The document states, "Performance testing demonstrates that Reprocessed Compression Sleeves perform as originally intended." It also mentions, "Each individual compression sleeve is tested for appropriate function of its components prior to packaging, labeling, and EO exposure operations." However, specific numerical targets or detailed metrics for "appropriate function" are not provided.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set in the performance studies (biocompatibility, function tests, validation of processing). It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective nature). The studies appear to be bench and laboratory tests, implying they were conducted in a controlled environment rather than involving patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided. The studies described are bench and laboratory tests, not clinical studies requiring expert interpretation of medical images or patient outcomes to establish ground truth. The "ground truth" here would likely be defined by engineering specifications and objective measurements of device function and material properties.
4. Adjudication Method for the Test Set
This information is not applicable and not provided as the tests are not observational studies requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating the performance of the reprocessed sleeves itself and its substantial equivalence to the predicate, not on human-in-the-loop performance or the effect of AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the studies described are standalone performance tests of the device itself (biocompatibility, function, and processing validation). There is no "algorithm" in the context of this device; it is a physical medical device. The "standalone" performance refers to the device's inherent functional and material characteristics without human intervention during the test aside from operating the test equipment.
7. The Type of Ground Truth Used
For the performance studies (biocompatibility, function tests, validation of processing), the ground truth would be established based on:
- Engineering Specifications/Standards: Performance metrics likely compared against established design specifications for new compression sleeves and relevant industry standards.
- Material Science Properties: For biocompatibility, adherence to material safety standards.
- Functional Parameters: Objective measurements of pressure, inflation/deflation cycles, integrity of components, etc., compared against the predicate device's known performance or design criteria.
8. The Sample Size for the Training Set
This information is not applicable and not provided. The device is a physical medical device, not an AI/machine learning algorithm, so there is no "training set" in the computational sense. The studies focused on verifying the reprocessing methods and the resulting device's performance.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this type of 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).