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510(k) Data Aggregation
(100 days)
The Hygia Health Services Reprocessed Venodyne Sleeves are used in the treatment of venous leg ulcers and edema which are disorders associated with venous insufficiency. The Hygia Health Services Reprocessed Venodyne Sleeves are also a non-invasive therapeutic method for prevention of deep vein thrombosis.
The Hygia Health Services Reprocessed CTC VasoPress Compression Sleeves are used as a non-invasive therapeutic method to prevent deep vein thrombosis, and treat venous leg ulcers and edema that result from venous insufficiency.
The Hygia Health Services Reprocessed Venodyne Foot Cuffs are used in the treatment of venous leg / foot ulcers and edema which are disorders associated with venous insufficiency. The Hygia Health Services Reprocessed Venodyne Foot Cuffs are also a non-invasive therapeutic method for prevention of deep vein thrombosis.
The Hygia Health Services reprocessed sleeves/foot garments are compression devices that, when attached to an approved controller, provide intermittent, sequentially gradient pressure to a patient's leg/foot for the prevention of Deep Vein Thrombosis (DVT). As the sleeves/cuffs compress the legs/feet, veins 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 inflation and deflation sequence is predetermined by the product's specific controller. The pressure of compression is determined by the controller.
Here's a breakdown of the acceptance criteria and study information for K090074, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state quantitative acceptance criteria or detailed performance metrics. Instead, it relies on demonstrating equivalence to predicate devices through various tests.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional performance as intended (similar to OEM devices) | Functional Testing demonstrates the reprocessed sleeves/foot cuffs perform as intended. |
| Cleaning validation (safe for reuse) | Cleaning validation demonstrates the reprocessed sleeves/foot cuffs are safe and effective. |
| Biocompatibility (safe for patient contact) | Biocompatibility testing demonstrates the reprocessed sleeves/foot cuffs are safe and effective. |
| Technological characteristics identical to original OEM devices. | "The overall designs, materials, energy sources, modes of operation, and performance characteristics are no different than the original devices." |
| Substantial equivalence to predicate devices | Conclusion states the device is substantially equivalent based on the functional, cleaning, and biocompatibility testing. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of a clinical study with a defined sample size. The performance data refers to "Functional Testing, cleaning validation, and biocompatibility testing," which are typically laboratory or bench tests. Therefore:
- Sample Size for Test Set: Not explicitly stated as a clinical sample size. It would refer to the number of reprocessed devices subjected to bench testing for functional, cleaning, and biocompatibility assessments.
- Data Provenance: The document does not provide details on the country of origin of the data or whether it was retrospective or prospective. Given the nature of the tests (functional, cleaning, biocompatibility), they are almost certainly conducted in a laboratory setting, likely at Hygia Health Services, Inc.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable to the type of testing described. Ground truth established by experts is relevant for studies involving diagnosis, image interpretation, or clinical outcomes. The studies cited are laboratory-based assessments of device integrity and performance.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods (e.g., 2+1, 3+1) are used in clinical studies, particularly for subjective assessments or when there's disagreement among independent evaluators (e.g., radiologists interpreting images). The "functional testing, cleaning validation, and biocompatibility testing" are objective, measurable laboratory tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. This type of study assesses how human readers perform with and without AI assistance, which is irrelevant for this mechanical device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This device is a reprocessed medical sleeve/foot cuff, not an AI algorithm.
7. The Type of Ground Truth Used
For the functional, cleaning validation, and biocompatibility testing, the "ground truth" would be established by:
- Functional Testing: Established engineering specifications and performance benchmarks for the original OEM devices (e.g., pressure output, inflation/deflation cycles, material integrity).
- Cleaning Validation: Established standards and protocols for sterilization and removal of biological contaminants.
- Biocompatibility Testing: Established international standards for biological evaluation of medical devices (e.g., ISO 10993 series).
Essentially, the "ground truth" is adherence to predefined technical and safety standards relevant to the device's original design and intended use, as well as standards for reprocessing.
8. The Sample Size for the Training Set
This is not applicable. The device is a reprocessed medical sleeve/foot cuff and does not involve machine learning algorithms that require a "training set."
9. How the Ground Truth for the Training Set Was Established
This is not applicable, as there is no training set mentioned or implied for this device.
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(55 days)
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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