(261 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.
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 and labeling operations.
The provided document is a 510(k) summary for a reprocessed medical device, specifically compression sleeves, and does not contain the detailed information typically found in a study report for novel device performance or AI/software validation. Therefore, many of the requested elements for acceptance criteria and study details cannot be fully extracted.
Based on the available text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria (Inferred) | Reported Device Performance (as stated) |
|---|---|---|
| Functional Equivalence | Perform "as originally intended" (of predicate devices) | "Performance testing demonstrates that Reprocessed Compression Sleeves perform as originally intended." |
| Safety | No adverse impact on patient safety from reprocessing | Implied by "demonstrate performance (safety and effectiveness)" and substantial equivalence conclusion |
| Effectiveness | Maintain original therapeutic effect from reprocessing | Implied by "demonstrate performance (safety and effectiveness)" and substantial equivalence conclusion |
| Material Integrity | Maintain design, materials, and mechanical characteristics | "The design, materials, and intended use of Reprocessed Compression Sleeves are identical to the predicate devices." |
| Component Function | Individual compression sleeve components function appropriately | "Each individual compression sleeve is tested for appropriate function of its components prior to packaging and labeling operations." |
| Cleanliness/Decontamination | Removal of adherent visible soil and decontamination | "Alliance Medical Corporation's reprocessing of compression sleeves includes removal of adherent visible soil and decontamination." |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified. The document only mentions "Bench and laboratory testing was conducted." It does not provide the number of reprocessed sleeves tested.
- Data Provenance: Not specified. It's bench and laboratory testing, so it's not patient data from a specific country, nor is it explicitly stated as retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This was bench testing, not a study requiring expert clinical assessment for ground truth.
4. Adjudication method for the test set:
- Not applicable. This was bench testing, not a study requiring adjudication of expert opinions.
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. This is a 510(k) for a reprocessed physical medical device (compression sleeves), not an AI-powered diagnostic or assistive technology.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This device is not an algorithm.
7. The type of ground truth used:
- The ground truth for the performance claim appears to be the original intended performance of the predicate device. The testing confirms that the reprocessed device performs to these established specifications.
8. The sample size for the training set:
- Not applicable. This is a reprocessed physical device, not an AI/ML algorithm requiring a training set. The "reprocessing" procedure could be considered analogous to a "training" process for maintaining device specifications, but it's not a data-driven training set in the AI sense.
9. How the ground truth for the training set was established:
- Not applicable. (See #8)
§ 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).