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510(k) Data Aggregation
(55 days)
HYGIA HEALTH SERVICES REPROCESSED KENDALL SCD EXPRESS SLEEVES/FOOT CUFFS
The Hygia Health Services Reprocessed Aircast Sleeves/Foot Cuffs are used in the management of lymphedema and edema which are disorders associated with venous insufficiency.
The Hygia Health Services Reprocessed Aircast Sleeves/Foot Cuffs are also a noninvasive therapeutic method for prevention of deep vein thrombosis.
The Hygia Health Services reprocessed sleeves/foot garments are compression devices that, which attached to an appropriate controller, provide intermittent, sequentially graded pressure to the patient's leg/foot for the prevention of Deep Vein Thrombosis (DVT). As the sleeves/cuffs compress the legs/feet, they collapse, forcing the blood to move upward towards the heart. After compression, the sleeves/cuffs deflate which allows the veins to reopen and bring oxygenated blood to the region. The timing and deflation of compression is determined by the controller.
The provided text describes a 510(k) premarket notification for Hygia Health Services Reprocessed Sleeves/Foot Cuffs. This submission focuses on establishing substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and performance metrics for a new device.
Therefore, many of the requested sections (e.g., acceptance criteria, detailed device performance, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) are not explicitly present in the provided document.
However, based on the information available, here's a breakdown:
Acceptance Criteria and Device Performance
The document does not specify quantitative acceptance criteria or detailed performance metrics. Instead, it relies on demonstrating that the reprocessed devices perform as intended and are safe and effective, consistent with their predicate devices. The "acceptance" is based on functional equivalence and safety verification rather than numerical performance thresholds.
Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred) | Reported Device Performance (Summarized) |
|---|---|---|
| Functional Equivalence | Device operates identically to original equipment manufacturer (OEM) devices in terms of compression mechanism, pressure delivery, and cycle. | Performs "as intended," with "sources, modes of operation, and performance characteristics no different than the original devices." |
| Cleaning Validation | Reprocessing effectively removes contaminants and renders the device safe for reuse. | "Cleaning validation demonstrates reprocessed cuffs perform as intended and are safe and effective." |
| Biocompatibility | Reprocessed materials are safe for patient contact and do not induce adverse biological reactions. | "Biocompatibility testing demonstrates reprocessed cuffs perform as intended and are safe and effective." |
| Intended Use | Retains the same indications for use as the predicate devices (prevention of deep vein thrombosis, treatment of lymphedema and edema). | Intended to be used "in the same manner as the predicate devices." |
| Safety and Effectiveness | Overall, the reprocessing process does not compromise the safety or effectiveness of the device compared to the original devices. | "Functional Testing, cleaning validation, and biocompatibility testing demonstrates reprocessed cuffs perform as intended and are safe and effective." |
| Substantial Equivalence | Demonstrates that the reprocessed device is as safe and effective as a legally marketed predicate device, and does not raise new questions of safety or effectiveness. | Conclusion: "Hygia Health Services concludes that the reprocessed sleeves are substantially equivalent to the predicate devices." |
Study Details
The provided document describes a 510(k) submission, which is a regulatory pathway to demonstrate substantial equivalence to a predicate device. It does not detail a clinical study in the traditional sense with test sets, ground truth, or statistical power calculations for performance metrics as might be found for a novel AI/diagnostic device.
1. Sample Sized used for the test set and the data provenance:
- Sample Size (Test Set): Not specified. The performance data section vaguely mentions "Functional Testing, cleaning validation, and biocompatibility testing." These are likely laboratory tests on a sample of reprocessed devices, but the exact number of units tested is not provided.
- Data Provenance: Not specified, but generally, such tests would be conducted internally by the manufacturer. The data is retrospective in the sense that the predicate devices have established performance, and the goal is to certify the reprocessed devices meet that standard.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Experts and Qualifications: Not applicable/not specified. For this type of submission, "ground truth" refers to established performance standards for the predicate devices, and the objective is to show the reprocessed devices meet those standards through various tests. It does not involve expert consensus on medical images or clinical outcomes for a "test set" in the diagnostic sense.
3. Adjudication method for the test set:
- Adjudication Method: Not applicable/not specified. No human reader review or adjudication process is mentioned for evaluating the performance of the reprocessed sleeves.
4. 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:
- MRMC Study: No. This is not an AI/diagnostic device. The submission is for reprocessed medical devices (compressible limb sleeves), not an AI-powered diagnostic tool. Therefore, an MRMC study and analysis of human reader improvement with AI assistance are irrelevant and not part of this submission.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Standalone Performance: Not applicable. This document pertains to a physical medical device. There is no "algorithm only" performance to evaluate.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Ground Truth Type: For this submission, the "ground truth" is the established safety and effectiveness of the legally marketed predicate devices. The reprocessed device's performance is compared against these established characteristics through functional, cleaning, and biocompatibility tests. It does not involve "expert consensus, pathology, or outcomes data" in the context of diagnostic accuracy.
7. The sample size for the training set:
- Sample Size (Training Set): Not applicable. There is no AI model being trained, so no "training set" exists.
8. How the ground truth for the training set was established:
- Ground Truth Establishment (Training Set): Not applicable, as there is no training set.
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