(57 days)
The ReNu Medical Reprocessed Aircast VenaFlow calf, thigh and foot DVT garments are to be used by patients in both the home and institutional settings as a non-invasive therapeutic method to prevent deep vien thrombosis and resulting pulmonary embolism.
The ReNu Medical Reprocessed Aircast VenaFlow calf, thigh and foot DVT garments. (All sizes)
Acceptance Criteria and Device Performance Study for ReNu Medical Reprocessed Aircast VenaFlow DVT garments
This document describes the acceptance criteria and the study conducted to demonstrate that the ReNu Medical Reprocessed Aircast VenaFlow Calf, Thigh, and Foot DVT garments meet these criteria, as presented in K121145.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Bladder integrity (no leaks) | 100% verification of bladder integrity performed. Bladders pressurized to 52mmHg with no leaks detected. |
| Velcro adhesion intact at 52mmHg pressure | Velcro evaluated and found to have adhesion intact at 52mmHg pressure. |
| Biocompatibility unaffected by reprocessing | Reprocessing does not affect the biocompatibility of the device. (Stated as a characteristic, not a measured performance against a pre-defined threshold). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific numerical sample size for the bench testing. However, it mentions "100% verification of bladder integrity," which implies that all reprocessed Aircast VenaFlow DVT garments underwent leak testing.
- Sample Size for Test Set: Not explicitly stated as a number, but "100% verification" implies all reprocessed devices were tested for bladder integrity. The number of devices tested for Velcro adhesion is not specified but is part of the general "bench testing."
- Data Provenance: The data is generated from retrospective reprocessing of Aircast VenaFlow DVT garments by ReNu Medical, Inc. The country of origin of the data is implied to be the United States (specifically, Everett, WA, where ReNu Medical, Inc. is located).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This study does not involve human experts establishing ground truth for a test set in the conventional sense of clinical trials or image interpretation. The testing performed is physical bench testing. Therefore, this question is not applicable to the provided information.
4. Adjudication Method for the Test Set
The concept of "adjudication method" (like 2+1, 3+1) typically applies to expert review of medical cases, often for establishing ground truth in clinical studies involving interpretation. Since this study is focused on physical bench testing of reprocessed medical devices, no adjudication method as described is applicable or mentioned. The testing involves objective measurements (pressure, leak detection, adhesion) rather than subjective expert consensus.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. This study focuses on the physical performance and safety of a reprocessed medical device through bench testing, not on the interpretative performance of human readers, with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No standalone algorithm-only performance study was done. This device is a physical medical garment, not an algorithm or AI system. The "performance" being evaluated is the physical functionality of the reprocessed device.
7. Type of Ground Truth Used
The "ground truth" for this study is based on objective physical measurements and standards for medical device functionality after reprocessing. Specifically:
- Bladder integrity: Verified by the absence of leaks when pressurized to 52mmHg.
- Velcro adhesion: Verified by the Velcro remaining intact at 52mmHg pressure.
- Biocompatibility: Stated as unaffected, implying adherence to a prior established biocompatibility profile of the original device. This is a characteristic that reprocessing aims not to alter, rather than a dynamic ground truth established for each reprocessed unit.
8. Sample Size for the Training Set
This information is not applicable. The device is a physical medical garment, not a machine learning model or algorithm. Therefore, there is no "training set" in the context of AI or statistical model development. The manufacturing and reprocessing process can be considered analogous to a "training" phase where procedures are refined, but specific data for a "training set" as understood in AI is not relevant here.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. As there is no "training set" for an algorithm, there is no ground truth established for it in this context. The "ground truth" for the manufacturing and reprocessing process would be the design specifications and performance requirements for the original and reprocessed devices, established through engineering design, regulatory standards, and predicate device performance.
§ 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).