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510(k) Data Aggregation
(330 days)
RENU MEDICAL REPROCESSED ALP 1 CALF GARMENT, MODEL ALP1
The ReNu Medical Reprocessed ALP®1 is to be used by patients in both the home and institutional settings as a non-invasive therapeutic method to:
- Prevent deep vein thrombosis and resulting pulmonary embolism.
- Intra-operative compression therapy.
The ReNu Medical Reprocessed (up to 18" calf circumference)
The provided text describes a 510(k) submission for a reprocessed medical device, the ReNu Medical Reprocessed ALP®1 Calf Garment. It focuses on demonstrating substantial equivalence to predicate devices and the impact of reprocessing.
Based on the provided text, the following information can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Overall design | Identical |
| Materials | Identical |
| Energy source | Identical |
| Mode of operation | Identical |
| Performance techniques | Identical |
| Reprocessing methodology | Identical |
| Biocompatibility | Reprocessing does not affect biocompatibility |
| Performance after reprocessing | Bench testing conducted to ensure reprocessing did not compromise performance |
| Safety after reprocessing | Validation information provided to demonstrate device safety is not impacted by reprocessing |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated. The text mentions "Bench testing was conducted" but does not give a specific number of units tested.
- Data Provenance: Not explicitly stated. Given the context of a 510(k) submission from a US company (Everett, WA), it is highly likely the testing was conducted in the US. The testing appears to be internal (bench testing) rather than clinical.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable as the study described is a bench study comparing a reprocessed device to its original and predicate devices, not a study involving human interpretation or subjective assessment of medical conditions by experts. The "ground truth" here refers to the physical and functional properties of the device.
4. Adjudication method for the test set
This section is not applicable for the same reasons as point 3. There is no human interpretation requiring adjudication.
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 section is not applicable. The device is a physical medical device (compression sleeve), not an AI diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This section is not applicable. The device is a physical medical device, not an algorithm.
7. The type of ground truth used
The ground truth used for the acceptance criteria was based on the physical and performance characteristics of the predicate devices and the original (unreprocessed) ALP™1 Calf Garment. The goal was to demonstrate that the reprocessed device remained "identical" in key aspects and that reprocessing did not compromise its safety or performance.
8. The sample size for the training set
This section is not applicable. There is no "training set" as this is a physical device re-processing validation, not an AI or machine learning model development.
9. How the ground truth for the training set was established
This section is not applicable for the same reason as point 8.
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