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Therm-X (Therm-X Home and Therm-X AT) combines cold, heat contrast, and compression therapy. Therm-X (Therm-X Home and Therm-X AT) is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated. It is intended to treat post traumatic and post-surgical medical and/or surqical conditions for which localized thermal therapy (hot or cold) are indicated. The Therm-X (Therm-X Home and Therm-X AT) is also intended for treatment of disorders associated with vascular or lymphatic insufficiency, such as lymphedema and chronic venous insufficiency (CVI).

Therm-X Home systems also provide DVT therapy. Therm-X Home systems with DVT therapy are intended to reduce the risk of the formation of deep venous thrombosis (DVT) by aiding blood flow back to the heart via lower extremity limb compression.

Therm-X (Therm-X Home and Therm-X AT) is intended to be used by, or on the order of, licensed health care professionals in rehabilitation facilities, outpatient clinics, athletic training settings, and home settings.

Therm-X is an AC powered, software-controlled multimodality device, designed to be used in a clinical or home-use setting, and under the direction, prescription, or supervision of a licensed healthcare professional. The device is available in two configurations: Therm-X Home and Therm-X AT.

Therm-X (Therm-X Home and Therm-X AT) features iceless cold therapy, heat therapy, and contrast (alternating heat and cold) therapy. The Therm-X Home system also provides DVT prophylaxis therapy and continuous therapy for users who wish to receive treatment over an extended period of time.

Therm-X (Therm-X Home and Therm-X AT) consists of various reusable inflatable wraps for thermal treatment of the back, elbow, hand/wrist, shoulder, ankle, hip, lower leg, or knee and DVT prophylactic treatment applied to the foot or calf. Multi-patient use garments are available for all anatomical areas that can be cleaned and disinfected in between uses to be reused for different patients. Single-patient use garments are available for thermal treatment of the back, hand/wrist, shoulder, neck, ankle, hip, and knee and can be disposed of after patient treatment is concluded. The thermal garments are flexible coolant circulating garments that apply to the body to deliver cold, heat, or contrast therapy in combination with or without pneumatic compression. The foot and calf DVT prophylactic garments apply pneumatic compression alone and are intended for use by the Therm-X Home system only.

Therm-X (Therm-X Home and Therm-X AT) is controlled by an intuitive touch screen computer interface, allowing the user to manage the therapy modalities as well as easily adjust and monitor treatment times, temperature, and compression settings. Therm-X AT and Therm-X Home models provide an optional password protection feature that allows for a user to use only stored cycles, giving health care providers an ability to ensure compliance to a chosen cycle. The device also provides functionality to allow the health care provider to assign a date at which the user will be able to access a second stored cycle instead of the first. The Therm-X device also allows users to chanqe treatment pressure and temperatures to less extreme therapies (e.g. changing a warm cycle to a lower warm temperature or changing a cold cycle to a higher cold temperature).

Therm-X (Therm-X Home and Therm-X AT) is approximately 15 lbs. when filled with coolant and has a handle placed on the top of the device. It has a centralized coolant reservoir accessible through a cap located at the back of the device that supplies its coolant and radiator systems. The reservoir, pumps, fans, circuit board, and other components of the Therm-X are located inside a covered enclosure made out of plastic and metal components, accessible only using a specialized tool.

The provided text describes the 510(k) premarket notification for the Therm-X device, which is a therapeutic device combining cold, heat, contrast, and compression therapies. The document focuses on demonstrating that the Therm-X device is substantially equivalent to legally marketed predicate devices, particularly the previous Therm-X (K231912) and the VascuTherm™ (K061866).

The context of the document is a regulatory submission for a medical device seeking FDA clearance, not a study proving a device meets specific acceptance criteria in the context of an AI/ML product where the acceptance criteria would be metrics like accuracy, sensitivity, specificity, etc., with corresponding ground truth and expert adjudication. The "acceptance criteria" discussed in this document refer to the regulatory requirements for demonstrating substantial equivalence to a predicate device, which largely involves comparing design, intended use, technological characteristics, and safety/performance data.

Therefore, many of the specific questions about "acceptance criteria" and "study that proves the device meets acceptance criteria" as they relate to AI/ML performance metrics (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone performance) are not directly applicable to this type of device and submission.

However, I can extract the relevant information regarding the device's performance claims and the testing undertaken to support its substantial equivalence, particularly concerning the newly added indications for use.

Here's an interpretation based on the provided document:

Acceptance Criteria and Device Performance (in the context of a 510(k) submission)

The primary "acceptance criteria" for this 510(k) submission is to demonstrate substantial equivalence to predicate devices for the specified indications for use, and to show the device is safe and effective. This is not about meeting specific numerical performance targets for an AI algorithm's diagnostic accuracy, but rather demonstrating that the device functions as intended and does not raise new questions of safety or effectiveness compared to existing devices.

The "device performance" reported is largely in the form of conformance to established standards and the outcome of testing, rather than specific quantitative metrics of clinical efficacy.

Table of "Acceptance Criteria" (Regulatory Requirements for Substantial Equivalence) and Reported Device Performance:

Study Details (as applicable to this type of device submission):

1. Sample size used for the test set and the data provenance:

   • Test Set (for clinical testing): The document mentions "healthy volunteer human subjects" for the skin temperature measurement. The exact sample size is not specified in the provided text.
   • Data Provenance: Not explicitly stated, but clinical testing typically occurs in supervised settings. The nature of the device (physical therapy equipment) suggests this is likely prospective data collection for specific safety parameters. There is no indication of retrospective data from any specific country.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This is not applicable in the context of this device and submission. "Ground truth" in AI/ML typically refers to expert labels for diagnostic tasks. For Therm-X, "ground truth" for physical characteristics would be instrument measurements (e.g., temperature gauges, pressure sensors) or established clinical endpoints (e.g., absence of skin damage). The experts involved would be medical and engineering professionals conducting the tests, not labeling data for an algorithm.

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

   • Not applicable. This is a method used for resolving discrepancies in expert labeling of data for AI/ML validation. The testing described for Therm-X is direct physical performance validation and human factors assessment.

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:

   • Not applicable. This is a framework for evaluating the diagnostic performance of AI-assisted human readers. Therm-X is a physical therapy device, not an AI for diagnosis or interpretation.

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

   • Not applicable, as Therm-X is not an AI/ML algorithm. However, the device itself has "software validation" which assesses its performance independently of direct human control over its internal functions, ensuring it meets its "performance requirements and specifications."

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

   • For the skin temperature testing: The ground truth was direct physiological measurement (skin temperature) obtained from human subjects under controlled, worst-case conditions. The "ground truth" for other tests (e.g., electrical safety, biocompatibility, cleaning validation) would be adherence to scientific standards and specifications, confirmed through various laboratory and bench tests.

7. The sample size for the training set:

   • Not applicable. Therm-X is not an AI/ML device that requires a "training set" in the machine learning sense. The device's operation is based on pre-programmed parameters and physical principles, not learned from data.

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

   • Not applicable, as there is no "training set."

Important Note: The document explicitly states: "No additional testing has been performed for the additional indications for use." This means the demonstration of substantial equivalence for the new indications (lymphedema and CVI) relies primarily on the comparison to the predicate device (VascuTherm™ K061866) which already has these indications, and on the existing testing data for the Therm-X device from its previous 510(k) clearance (K231912) and general safety and performance testing.

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