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VascuComp™ AI Mode: The VascuComp™ compression system in AI Mode is used as an adjunct therapy for patients with ischemic disease of the lower extremities, due to one or more of the following causes: Minor Amputations, Angioplasty / Stent Failure, Arteriopathic Wounds, Graft Failure, Intermittent Claudication, Ischemia, Night Pain, Rest Pain, Small Vessel Discase, Ulcers. VascuComp™ DVT Mode: Decrease the risk of deep venous thrombosis (DVT). Aids the blood flow back to the heart. Treat and assist healing of cutaneous ulceration (wounds), reduce wound healing time, enhance arterial circulation (blood flow), reduce compartmental pressures, reduce edema (swelling), reduce the need for anticoagulant (blood thinning) medications. VascuComp™ L Mode: Treatment of Venous disorders and dysfunction of the "muscle pump".

The VascuComp™ device is comprised of a reusable air-pump with user adjustable pressures, and various single-patient sleeves or garments containing discrete, segmental inflatable chambers to be externally applied over the affected extremity of the pationt. The Vascu Comp™ provides calibrated, intermittent, sequential compression.to the treatment site for optimum therapy for patients with ischemic disease of the lower extremities, by increasing arterial circulation, and to reduce the risk of the formation of DVT and to reduce or control peripheral edema. The Vascu Comp™ systems utilize microprocessor control with multiple sensors to ensure patient safety and system functionality, and to provide consistent and repeatable therapy modalities. Alarms are both visual on the unit display and audible. Alarms are in place to detect a potentially unsafe situation and to terminate therapy to protect the patient and the system.

The ThermoTek VascuComp™ is an intermittent, sequential pneumatic compression device. The provided text describes non-clinical performance testing to demonstrate substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria in a clinical context.

The "acceptance criteria" in this context are the published and observed therapy modalities (pressure levels and cycle times) and safety standards of the predicate devices. The "reported device performance" is the VascuComp™'s ability to match these parameters.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document describes non-clinical performance testing.

• Sample Size: The testing for the pneumatic compression therapy functionality (pressure and cycle times) involved "a minimum of 2 compression cycles" for the L Mode, "a minimum of two compression cycles" for the DVT Mode, and "a minimum of three compression cycles" for the AI Mode.
• Data Provenance: The data is generated from laboratory testing of the VascuComp™ device and its accessories. It is considered prospective in the context of this specific device's evaluation, as the tests were conducted specifically to demonstrate its performance against established predicate device parameters. The country of origin of the data is not specified but is implicitly the location of ThermoTek, Inc. (Flower Mound, Texas).

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

Experts were not used to establish ground truth for this non-clinical performance test. The "ground truth" (acceptance criteria) was derived from the published and observed therapy modalities and technical specifications/standards of the predicate devices (BioArterial Plus K072666, VascuTherm K061866, and PBS Model 701A K060220).

4. Adjudication Method for the Test Set

No adjudication method was mentioned as this was non-clinical performance testing, not a clinical study involving human assessment or interpretation. The performance was measured against quantitative specifications.

5. 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 MRMC comparative effectiveness study was done. This device is an intermittent pneumatic compression machine, not an AI-assisted diagnostic or interpretive tool that would involve human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is a standalone device in the sense that its performance was measured directly based on its outputs (pressure and cycle times). There is no "algorithm only" performance separate from the device's physical operation, as it is a mechanical device, not a software-only product.

7. The Type of Ground Truth Used

The ground truth used was pre-established physical specifications and performance characteristics of legally marketed predicate devices, along with international electrical safety and electromagnetic compatibility standards (IEC 60601-1, IEC 60601-1-2, UL and CAN/CSA equivalents).

8. The Sample Size for the Training Set

There is no "training set" in the context of this device evaluation. The device's operation is based on electromechanical principles, not machine learning or AI that requires a training dataset.

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

Not applicable, as there is no training set for this type of device.

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NanoTherm Indications:

• Treatment of disorders associated with vascular or lymphatic insufficiency such as Chronic Venous Insufficiency (CVI), venous stasis ulcers, post-mastectomy edema and chronic lymphedema.
• Reduction of edema associated with soft tissue injuries such as burns, postoperative edema, and ligament sprains.
• Localized thermal therapy (hot or cold) for post traumatic and post surgical medical and/or surgical conditions.

VascuTherm Indications:

• Treatment of disorders associated with vascular or lymphatic insufficiency such as Chronic Venous Insufficiency (CVI), venous stasis ulcers, post-mastectomy edema and chronic lymphedema.
• Reduction of edema associated with soft tissue injuries such as burns, postoperative edema, and ligament sprains.
• Localized thermal therapy (hot or cold) for post traumatic and post surgical medical and/or surgical conditions.
• Decrease the risk of deep venous thrombosis (DVT).
• Aids the blood flow back to the heart.
• Treat and assist healing of cutaneous ulceration (wounds), reduce would healing time, enhance arterial circulation (blood flow), reduce compartmental pressures, reduce edema (swelling), reduce the need for anticoagulant (blood thinning) medications.

The NanoTherm device is comprised of a reusable pump (NanoTherm unit) and various single patient use inflatable wraps (NanoTherm Wraps). The VascuTherm device consists of a reusable pump (VascuTherm unit) and various single-patient use inflatable wraps (VascuTherm Wraps). The VascuTherm unit has additional equipment installed and specially designed wraps specifically for the preventive treatment of DVT.

The NanoTherm unit thermal control therapy provides chilled fluid and heated fluid to the therapy site to reduce pain and swelling and compresses the extremity to enhance performance and fluid transfer and treatment of edema and lymphedema.

The VascuTherm unit contains a DVT mode that is not present on the NanoTherm unit. This therapy mode is for air-only DVT compression therapy using air-only DVT wraps.

The NanoTherm and VascuTherm systems utilize microprocessor control with multiple sensors to ensure safety and system functionality, and to provide consistent and repeatable therapy modalities. Alarms are both visual on the unit display and audible. Alarms are in place to detect a potentially unsafe situation and to terminate therapy to prevent patient injury. Possible unsafe situations are listed in the risk and hazard analysis covered in Appendices 16.3.A and 16.3.B.

This is a 510(k) premarket notification for the NanoTherm and VascuTherm systems, seeking to demonstrate substantial equivalence to predicate devices. It does not contain information about a study proving the device meets specific acceptance criteria in the way a clinical trial would for novel efficacy claims. Instead, it focuses on comparing the new device's technological characteristics and intended use to existing, legally marketed predicate devices.

Therefore, many of the requested points regarding acceptance criteria and studies are not applicable or cannot be extracted directly from this document.

Here's a breakdown of what can be inferred or stated based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document doesn't provide a direct "acceptance criteria" table for the new devices in the sense of performance metrics to be met by a study. Instead, it presents a comparison of the new devices' characteristics (NanoTherm and VascuTherm) against predicate devices to demonstrate substantial equivalence. The acceptance criterion for a 510(k) is typically substantial equivalence, meaning the device is as safe and effective as a legally marketed predicate device.

The tables (Table 1, Table 3, and Table 5) provide comparisons of various parameters:

Indications for Use (NanoTherm):

• Treatment of disorders associated with vascular or lymphatic insufficiency such as Chronic Venous Insufficiency (CVI), venous stasis ulcers, post-mastectomy edema and chronic lymphedema.
• Reduction of edema associated with soft tissue injuries such as burns, postoperative edema, and ligament sprains.
• Localized thermal therapy (hot or cold) for post traumatic and post surgical medical and/or surgical conditions.

Indications for Use (VascuTherm):

• Treatment of disorders associated with vascular or lymphatic insufficiency such as Chronic Venous Insufficiency (CVI), venous stasis ulcers, post-mastectomy edema and chronic lymphedema.
• Reduction of edema associated with soft tissue injuries such as burns, postoperative edema, and ligament sprains.
• Localized thermal therapy (hot or cold) for post traumatic and post surgical medical and/or surgical conditions.
• Decrease the risk of deep venous thrombosis (DVT).
• Aids the blood flow back to the heart.
• Treat and assist healing of cutaneous ulceration (wounds), reduce would healing time, enhance arterial circulation (blood flow), reduce compartmental pressures, reduce edema (swelling), reduce the need for anticoagulant (blood thinning) medications.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document is a 510(k) summary, which typically involves demonstrating substantial equivalence through comparison of technological characteristics and safety/performance data with predicate devices. It does not describe a clinical study or a test set with a specified sample size, data provenance, or patient population in the context of demonstrating performance against acceptance criteria for a novel therapeutic claim. The patient population for intended use is stated as "non-ambulatory adult".

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The document does not describe a study involving expert assessment to establish ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. The document does not describe a study involving adjudication.

5. 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

Not applicable. The devices are intermittent, external pneumatic compression devices, not AI-powered diagnostic tools, so MRMC studies and AI assistance are irrelevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm-based device. "Standalone performance" in this context would refer to the device operating as intended, which is implied by the comparison to predicate devices and adherence to safety standards.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The submission is based on demonstrating substantial equivalence to predicate devices, focusing on design, materials, and intended use, rather than a clinical study requiring ground truth for novel performance claims.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/machine learning device.

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