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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":

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.

1. 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.

2. 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.

3. 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.

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:

   • 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.

5. 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.

6. 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.

7. 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.

8. How the ground truth for the training set was established:

   • This information is not applicable for the same reasons as #7.

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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 sequential compression therapy to the patient's lower limb(s). The Controller is battery powered, provides selectable compression cycles and system monitoring of the compression therapy. The Sleeves are provided in a foot & calf or a calf only configuration for selectable lower limb(s) compression therapy.

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 Ib.), 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.

The provided text describes a 510(k) submission for the Vasculaire Compression System, which is a mobile, intermittent pneumatic compression system. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than robust, clinical performance studies with detailed acceptance criteria as one might see for novel technologies. Therefore, many of the requested details about acceptance criteria, specific study designs, and ground truth are not present in this summary.

Based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance results in the manner typically associated with clinical efficacy or diagnostic accuracy studies. Instead, it lists the types of testing conducted to support substantial equivalence.

Note: The document explicitly states, "There is no FDA performance standard required for the Vasculaire Compression System." This implies that the 'acceptance criteria' were primarily internal benchmarks derived from the predicate devices and relevant industry standards for safety and basic functionality.

2. Sample Size for the Test Set and Data Provenance

The document does not describe a clinical "test set" in the context of human subjects or patient data. The testing mentioned (bench testing, software verification, etc.) would be performed on the device itself or its components. Therefore, information on sample size and data provenance (country, retrospective/prospective) is not applicable or provided for such testing.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

This information is not applicable and not provided. The testing described does not involve expert adjudication or ground truth establishment by clinical experts in the sense of reviewing patient data. The 'ground truth' for bench testing would be the engineering specifications and established standards.

4. Adjudication Method

Not applicable and not provided. There was no clinical data requiring adjudication by experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. The submission is for a physical medical device (compression system), not an AI or imaging diagnostic tool that would typically involve a multi-reader study. The stated purpose of the 510(k) is to demonstrate substantial equivalence to predicate devices based on safety and performance characteristics, not to quantify improvements in human reader performance with AI assistance.

6. Standalone Performance Study (Algorithm Only)

Not applicable and not provided. The device is a physical medical system, not a software algorithm or AI model that would have a standalone performance.

7. Type of Ground Truth Used

For the various bench and engineering tests, the "ground truth" would be established by:

• Engineering Specifications: Designed parameters for airflow, pressure, leakage, etc.
• Industry Standards: Requirements specified in ISO, IEC, and BS EN standards for medical devices (e.g., electrical safety, electromagnetic compatibility, biocompatibility).
• Predicate Device Characteristics: Performance parameters of the legally marketed predicate devices to which the Vasculaire System is claiming substantial equivalence.

There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for this device's testing.

8. Sample Size for the Training Set

Not applicable and not provided. This device is not an AI/ML system that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

Not applicable and not provided, as there is no training set for this device.

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The Vasculaire Compression System is indicated for use in:

• Preventing deep vein thrombosis (DVT) .
• . Enhancing blood circulation
• Diminishing post-operative pain and swelling .
• t 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 an ambulatory, intermittent pneumatic compression system intended to provide sequential compression therapy to a patient's lower limbs. The Vasculaire Compression System includes three components: the Patient Sleeve, the Controller, and the Charger.

The Patient Sleeve is a multiple-cell bladder intended to be attached directly to the patient's lower limb. It is intended to provide compression action to the tissue surrounding the venous vasculature in the foot and calf of a patient. The Controller is connected to the Patient Sleeve using two independent Flange Ports and can be mounted directly onto the Patient Sleeve for a completely ambulatory system. The Flange Ports allow the air from the Controller to control the compression action on the Calf go Foot Zones independently. The Controller is a lightweight (less than 1 Ib), battery-powered, electromechanical control unit intended to provide and monitor the inflation cycle for enhanced circulation therapy.

Here's an analysis of the provided 510(k) summary regarding the Vasculaire Compression System, focusing on the absence of acceptance criteria and a study proving their fulfillment:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The provided 510(k) summary does not contain any explicit acceptance criteria for the Vasculaire Compression System, nor does it present specific performance metrics from a study against such criteria. The submission focuses on demonstrating substantial equivalence to a predicate device based on indications for use and technological characteristics, rather than meeting quantitative performance targets.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the given 510(k) summary. The document mentions "clinical testing" but does not detail the nature of these tests, including sample sizes or data provenance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not provided in the given 510(k) summary. Given the absence of detailed clinical study results, there's no mention of ground truth establishment by experts.

4. Adjudication Method for the Test Set

This information is not provided in the given 510(k) summary.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed or reported in the provided 510(k) summary. The device is a physical compression system, not an AI or imaging diagnostic tool that would typically involve human reader performance comparison with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This concept is not applicable to the Vasculaire Compression System. This device is a physical, electromechanical system and does not involve an "algorithm only" component in the way a diagnostic AI would. Its performance is inherent in its mechanical operation and physiological effects, not in a standalone algorithmic assessment.

7. Type of Ground Truth Used

This information is not provided in the given 510(k) summary. As no specific clinical study data is presented, the type of ground truth used is not mentioned.

8. Sample Size for the Training Set

This information is not provided in the given 510(k) summary. The term "training set" is typically associated with AI algorithm development, which is not the primary focus or nature of this device's submission.

9. How the Ground Truth for the Training Set Was Established

This information is not provided in the given 510(k) summary. As mentioned above, the concept of a "training set" and its associated ground truth establishment is not relevant to the described device and its substantial equivalence submission.

Summary of the Document's Focus:

The provided 510(k) summary for the Vasculaire Compression System focuses on demonstrating substantial equivalence to an existing predicate device (Medical Compression Systems, ActiveCare + System - K060146). This type of submission relies on showing that the new device has the same intended use and similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness.

Rather than providing detailed clinical study results with specific acceptance criteria and performance metrics, the document lists preclinical testing categories such as:

• Reliability testing of component interactions
• Physical bench testing (specification verification and transit testing)
• Software verification and validation
• Electrical safety and electromagnetic compatibility testing
• Cytotoxicity testing

These tests are typically conducted to ensure the device functions as intended and safely, but they are not presented as meeting specific, predefined acceptance criteria with reported performance values in the context of a clinical outcome study. The FDA's clearance is based on the determination of substantial equivalence, not necessarily on a comparative effectiveness study with quantitative acceptance criteria for clinical outcomes.

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