Search Results

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 medical device in question is Reprocessed Compression Sleeves by Alliance Medical Corporation. The provided document is a 510(k) summary, which indicates that the device has undergone a substantial equivalence review by the FDA. This specific document primarily focuses on establishing equivalence to predicate devices and describes general performance testing, not a detailed clinical study with specific acceptance criteria and performance metrics for the reprocessed sleeves that would be typical for an AI/ML device.

Therefore, the requested information, which is highly tailored to AI/ML device studies (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details), cannot be fully extracted or accurately inferred from the provided 510(k) summary.

Here's an analysis based on what can be extracted and why other parts cannot be:

1. A table of acceptance criteria and the reported device performance:

• Acceptance Criteria: The document states that "Performance testing demonstrates that Reprocessed Compression Sleeves perform as originally intended." The criteria are implicitly tied to the performance of the predicate devices. However, no specific quantitative or qualitative acceptance criteria (e.g., pressure output within X% of original, no leakage above Y, durability for Z cycles) are explicitly listed in this summary.
• Reported Device Performance:
  • Bench and laboratory testing: Conducted to demonstrate "performance (safety and effectiveness)."
  • Biocompatibility: No specific results or metrics are given, only that it was tested.
  • Function Test(s): No specific results or metrics are given, only that it was tested.
  • Validation of Processing: This implies that the reprocessing steps (cleaning, decontamination, individual sleeve testing) were validated, but no specific data or metrics are provided.
  • Overall Conclusion: "Reprocessed Compression Sleeves perform as originally intended."

Without specific numerical or descriptive criteria, a table like the one requested cannot be constructed meaningfully. The document indicates that the reprocessed sleeves perform identically to the predicate devices in terms of "standard mechanical design, materials and sizes," and there are "no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation." This implies the performance criteria are simply "meets the original specifications of the new device."

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

• Sample Size for Test Set: Not specified. The document mentions "individual compression sleeve is tested," but does not provide the number of sleeves tested.
• Data Provenance: Not applicable in the context of the provided information, as this refers to a reprocessed physical device, not an AI/ML algorithm's data.

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

• Not applicable. This device is a reprocessed physical medical device, not an AI/ML diagnostic or assistive tool where human expert ground truth would be established for image or data interpretation. The "ground truth" for this device would be its physical and functional specifications.

4. Adjudication method for the test set:

• Not applicable. This refers to how discrepancies in expert opinions are resolved, which is relevant for AI/ML diagnostic studies, not for the functional testing of a physical device.

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 type of study is specifically for AI/ML systems that assist human readers (e.g., radiologists interpreting images). The Reprocessed Compression Sleeves are physical items.

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

• Not applicable. This refers to the performance of an AI/ML algorithm without human intervention. The device is a physical compression sleeve.

7. The type of ground truth used:

• For this physical device, the "ground truth" would be the original specifications and performance characteristics of new, unadulterated compression sleeves (the predicate devices). Each reprocessed sleeve is tested against these established functional parameters.

8. The sample size for the training set:

• Not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.

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

• Not applicable. See point 8.

In summary of what can be inferred for the Reprocessed Compression Sleeves:

The study proving the device meets its acceptance criteria involves bench and laboratory testing to demonstrate biocompatibility, function, and validation of processing. The inherent acceptance criterion is that the reprocessed sleeves perform identically to the new, predicate compression sleeves in all relevant aspects (design, materials, sizes, intended use, clinical applications, performance specifications, method of operation). The 510(k) summary indicates that these tests were sufficient to conclude "substantial equivalence." However, it does not provide the granular detail requested for AI/ML device studies.

Ask a specific question about this device