(11 days)
The Flexitouch® system is intended for use by medical professionals and patients at home who are under medical supervision in treating many conditions such as:
- Primary lymphedema .
- Post mastectomy edema .
- Edema following trauma and sports issues .
- Post immobilization edema .
- Venous insufficiencies .
- Lymphedema .
- . Reducing wound healing time
- Treatment and assistance in healing: stasis dermatitis; venous stasis ulcers; . arterial and diabetic leg ulcers
The Flexitouch® system is a prescription pneumatic compression system consisting of a garment set and a pneumatic sequential controller. The garments are wrapped around the affected body regions so that the garment fits snugly. The garments have multiple chambers that are filled with air to provide for low-level compression in the treated areas.
The provided text is a 510(k) summary for the Flexitouch® system. It outlines the device's characteristics and its comparison to a predicate device but does not contain information about acceptance criteria or a specific study designed to prove the device meets acceptance criteria in the format typically associated with diagnostic or AI/ML device validation.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device. This means the primary "study" is a comparison to an already legally marketed device, asserting that the new device is as safe and effective as the existing one.
Therefore, the following table and explanations are derived from the available information and will highlight the absence of certain requested details, as they are not typically part of a 510(k) summary for this type of device.
Acceptance Criteria and Device Performance
| Criterion Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Technological Equivalence | The device should have the same technological characteristics (intended use, performance, design, materials, construction, energy source, sterility, labeling) as the predicate device, raising no new safety and/or effectiveness concerns. | The Flexitouch® system has the same technological characteristics as the predicate device and raises no new safety and/or effectiveness concerns. |
| Safety Standards | Compliance with relevant international safety and quality management standards (IEC 60601-1, EN 60601-1-2, ISO 13485, 93/42/EEC). | The Flexitouch® system has been tested and certified compliant to these standards. |
| Performance Testing | Successful completion of comparative performance testing to verify substantial equivalence, including: Software validation, Device performance testing, Device Hazard Analysis (Risk assessment, Design and process FMEA), Product shipping tests. | Comparative performance testing and evaluation was successfully completed to verify substantial equivalence, including all listed tests. |
Study Details (Based on available 510(k) summary)
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Sample size used for the test set and the data provenance:
- Test set sample size: Not specified. The document refers to "Comparative performance testing and evaluation" but does not provide details on the number of devices, components, or clinical subjects involved in these tests. For a device like a pneumatic compression system, "performance testing" might involve bench testing or engineering verification rather than a traditional clinical test set of patient data.
- Data provenance: Not specified. Given the nature of a 510(k) for a physical medical device, the "data" would likely originate from internal engineering and manufacturing tests. No information about country of origin, retrospective or prospective data is provided, as these terms are more relevant to clinical studies involving patient data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable and not provided. The "ground truth" for this type of device is typically established by engineering specifications, safety standards, and functional requirements, rather than expert clinical consensus on a "test set" of patient data. Performance is assessed against these established technical benchmarks.
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Adjudication method for the test set:
- Not applicable and not provided. Adjudication methods like 2+1 or 3+1 are used in clinical studies where expert readers resolve discrepancies in interpretations of medical images or diagnoses. This type of review is not relevant for the engineering and functional tests reported in this 510(k).
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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. An MRMC comparative effectiveness study was not done. This type of study is specifically for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. The Flexitouch® system is a pneumatic compression device, not a diagnostic AI tool, so this type of study is irrelevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable to the Flexitouch® system. It is a physical medical device, not an algorithm. The "software validation testing" mentioned would focus on the correct functioning of the embedded software within the device to control its pneumatic operations, not on its performance as a standalone interpretive algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" in this context is implicitly engineering specifications, international safety standards, and the validated performance of the predicate device. For example, "software validation testing" would compare the software's output to its design requirements. "Device performance testing" would compare the physical performance (e.g., pressure, cycle times) to specified ranges and the predicate device's performance.
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The sample size for the training set:
- Not applicable and not provided. This device does not use a "training set" in the machine learning sense. Its functionality is based on established engineering principles and control logic, not learned from data.
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How the ground truth for the training set was established:
- Not applicable. As there is no training set, there is no ground truth established for it.
§ 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).