(94 days)
The Vasculaire Compression System is a mobile, intermittent pneumatic compression system intended to provide sequential compression therapy to the lower limb(s) in the clinical setting or home environment.
The Vasculaire Compression System is indicated for use in:
- Preventing deep vein thrombosis (DVT)
- Enhancing blood circulation
- Diminishing post-operative pain and swelling
- Reducing wound healing time
- Treatment and assistance in healing: stasis dermatitis; venous stasis ulcers; arterial and diabetic leg ulcers
- Treatment of chronic venous insufficiency
- Reducing edema
The Vasculaire Compression System is a mobile, intermittent pneumatic compression system intended to provide compression therapy to the lower limb(s) in the clinical setting or home environment. The Vasculaire Compression System includes three components: the Controller, the Sleeve and the Charger.
The Sleeve is a multiple-cell bladder intended to be attached directly to the lower limb(s). It is intended to provide compression to the tissue surrounding the vasculature. The Sleeve is provided in two configurations. The first configuration is a foot and calf Sleeve that provides sequential compression to the foot and calf. The second configuration is a calf only Sleeve that provides sequential compression to the calf. The Controller is connected to the Sleeve using two flange ports and can be mounted directly onto the Sleeve for a fully mobile system. The flange ports allow the air from the Controller to effect compression on the foot and calf zones independently. The Controller allows the user to select between foot and calf compression or a calf only compression. The Controller also allows the user to select compression cycles of approximately one to three cycles per minute. The Controller is a lightweight (less than 1 lb.), battery-powered, electromechanical control unit intended to provide and monitor the inflation cycle for enhanced circulation therapy. The Charger consists of a medical grade power supply and the table top docking station.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Vasculaire Compression System:
Summary of Acceptance Criteria and Device Performance:
The document provided does not contain specific quantitative "acceptance criteria" for device performance in terms of clinical efficacy (e.g., a specific percentage reduction in DVT or improved blood flow measurement). Instead, the document focuses on demonstrating substantial equivalence to predicate devices. This means that the device is considered acceptable if it performs similarly to already legally marketed devices and does not raise new safety or efficacy concerns.
The "device performance" reported is primarily in relation to meeting various regulatory and safety standards, and mitigating hazards, rather than quantifiable clinical outcomes directly.
Here's a table summarizing the "acceptance criteria" inferred from the document and the "reported device performance":
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Substantial Equivalence: | The Vasculaire Compression System's indications for use are equivalent to the predicate devices. Differences in technological characteristics do not raise new safety or efficacy issues. The device is deemed substantially equivalent to the predicate. |
| Risk Management: | Complies with ISO 14971:2007 (Medical Devices-Application of Risk Management). Includes Home Use & Design Risk analysis. |
| Biocompatibility: | Complies with BS EN ISO 10993-1:2009 (Biological Evaluation of Medical Devices) and FDA Guidance Document "Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices (G95-1)." |
| Usability/Human Factors: | Complies with ANSI/AAMI/IEC 62366:2007 (Medical devices - Application of usability engineering to medical devices). A Human Factors and Usability validation study was performed for home environment use. |
| Home Use Safety: | Identified and mitigated home use hazards through design (e.g., elimination of external air tubing and controller attached power cords to prevent tethered trips & falls, and tubing induced skin injury). Conducted MAUDE review and market surveillance search for use hazards. Performed a Home Use/User Failure Modes Effects Analysis (HUFMEA). Conducted a Home Usability Validation Study. |
Study Details:
The document describes several essential tests and analyses conducted to support the substantial equivalence claim, rather than a single large-scale clinical efficacy study with specific test sets, ground truths, or expert adjudications in the typical sense of AI/diagnostic device evaluation.
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Sample sizes used for the test set and the data provenance:
- The document does not specify sample sizes for a "test set" in the context of clinical performance data. The studies mentioned (Biocompatibility, Usability, Risk Analysis) involve different types of samples relevant to their specific methodologies (e.g., materials for biocompatibility, users for usability testing, potential failure modes for risk analysis).
- Data provenance: Not explicitly stated as "country of origin" for clinical data. The tests are general regulatory compliance tests. The Human Factors and Usability validation was for the "home environment" which implies a realistic use context. It is a retrospective analysis of MAUDE data. The usability validation study would be prospective.
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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 provided in the document. The studies listed are regulatory and engineering compliance tests, not studies requiring expert consensus on a diagnostic outcome. For instance, biocompatibility involves laboratory testing, and usability involves observing users, not clinical experts establishing a ground truth for a medical condition.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not applicable/provided for the types of tests described. These tests do not involve diagnostic or interpretive outcomes that would require adjudications.
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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. The Vasculaire Compression System is a physical medical device (intermittent pneumatic compression system), not an AI-powered diagnostic tool that assists human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not relevant to this device.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a treatment device, not a diagnostic algorithm. Its performance is inherent in its physical operation and effect on the limb, not in an independent algorithm's output.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Again, this concept of "ground truth" (in the context of diagnostic accuracy) is not applicable here. The "truth" for the various tests would be:
- Risk Management: Identification of potential hazards and successful mitigation through design changes.
- Biocompatibility: Material properties meeting established safety standards (e.g., non-cytotoxic, non-irritating).
- Usability: Observation of users successfully and safely operating the device in the intended environment, without critical errors.
- Substantial Equivalence: A determination made by the FDA based on comparison to predicate devices, not an empirically established clinical ground truth.
- Again, this concept of "ground truth" (in the context of diagnostic accuracy) is not applicable here. The "truth" for the various tests would be:
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The sample size for the training set:
- This information is not provided and not applicable as there is no "training set" in the context of an AI or machine learning model for this physical medical device.
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How the ground truth for the training set was established:
- This information is not applicable for the same reasons as #7.
§ 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).