(90 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.
Reprocessed Compression Sleeves are indicated for use in providing external compression therapy to reduce the incidence of deep vein thrombosis and resulting pulmonary embolism in patients at risk for thrombosis formation.
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.
Alliance Medical Corporation's reprocessing of compression sleeves includes removal of adherent visible soil and decontamination. Each individual compression sleeve is tested for appropriate function of its components prior to packaging, labeling, and sterilization operations.
The provided text is for a 510(k) premarket notification for reprocessed compression sleeves. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel clinical effectiveness through extensive clinical trials. Therefore, much of the typical information requested for AI/ML device studies (like sample sizes for test sets with ground truth, expert qualifications, adjudication methods, MRMC studies, and training set details) is not applicable in this context.
Here's an analysis based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Cleaning | Adherent visible soil removed. |
| Decontamination | Decontamination performed. |
| Functionality | Each individual compression sleeve is tested for appropriate function of its components. Performance testing demonstrates that Reprocessed Compression Sleeves perform as originally intended. The design, materials, and intended use are identical to predicate devices. Mechanism of action is identical (standard mechanical design, materials, and sizes). No changes to claims, intended use, clinical applications, patient population, performance specifications, or method of operation. |
| Biocompatibility | Bench and laboratory testing was conducted to demonstrate biocompatibility. |
| Sterilization Validation | Bench and laboratory testing was conducted to demonstrate sterilization validation. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the document. The filing is for a reprocessed medical device, where the focus is on maintaining the original device's performance through reprocessing steps. "Bench and laboratory testing" is mentioned, but specific sample sizes for these tests are not detailed. It's highly likely this was internal, retrospective testing, but the document does not specify.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not applicable/not provided. For device reprocessing, the "ground truth" is typically the performance specifications of the original device. The testing conducted (biocompatibility, sterilization, function) are objective engineering and laboratory tests, not subjective expert assessments.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable/not provided. Adjudication methods are relevant for subjective assessments (e.g., image interpretation by multiple readers) to establish a consensus ground truth. The tests for reprocessed sleeves are objective performance measurements.
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
This information is not applicable. This is not an AI/ML device, and no MRMC study was conducted or required for this type of submission.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
This information is not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the reprocessed compression sleeves is based on:
- Original Device Specifications: The reprocessed devices are compared against the performance of the legally marketed predicate devices, ensuring "identical" design, materials, intended use, and mechanism of action. The implicitly accepted "ground truth" is that the original, new device performed safely and effectively.
- Objective Performance Metrics: For the specific tests mentioned (biocompatibility, sterilization validation, function tests), the ground truth would be established by validated test methods and predefined quantitative specifications inherent to those tests (e.g., sterility assurance levels, material integrity, pressure output ranges).
8. The sample size for the training set
This information is not applicable/not provided. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
This information is not applicable/not provided. As there is no training set for an AI/ML model, this question is irrelevant to 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).