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Therm-X (Therm-X Home and Therm-X AT) combines cold, heat, contrast, and compression therapy. Therm-X 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-surgical medical and/or surgical conditions for which localized thermal therapy (hot or cold) are indicated.

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.

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 consists of various reusable inflatable wraps for thermal treatment of the back, elbow, shoulder, ankle, hip, or knee and DVT prophylactic treatment applied to the foot or calf. Multipatient 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 shoulder, 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 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 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 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.

Here's an analysis of the provided text to extract information related to acceptance criteria and the study proving the device meets them, presented in the requested format.

It's important to note that the provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving a device's performance against specific, quantitative clinical acceptance criteria. Therefore, some of the requested information (like specific target performance metrics for a novel technology or a detailed MRMC study with effect sizes) is not present because this type of submission is not designed to provide that. The "acceptance criteria" here are primarily about meeting safety and performance standards equivalent to existing devices and fulfilling regulatory requirements.

Device Name: Therm-X

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission for substantial equivalence, the "acceptance criteria" are primarily defined by the performance characteristics of the predicate devices and general safety/performance standards for medical devices. The performance data presented isn't against pre-defined numerical thresholds for novel claims, but rather to show the new device operates similarly to cleared predicates.

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

• Sample Size:
  • Clinical Testing (Skin Temperature): Not explicitly stated how many healthy volunteer human subjects were included, only "healthy volunteer human subjects who provided informed consent."
  • Biocompatibility, EMC/Electrical, Software, Bench, Cleaning/Disinfection, Human Factors: These involve device-specific testing or material testing, not human subject sample sizes in the clinical sense.
• Data Provenance:
  • Clinical Testing: Stated as "healthy volunteer human subjects who provided informed consent." No country of origin is specified.
  • Retrospective/Prospective: The clinical testing for skin temperature measurement appears to be prospective ("IRB approved studies have been performed to measure the lowest skin temperature... Therm-X was tested for worst case conditions on healthy volunteer human subjects"). Other testing (bench, software, etc.) are standard verification and validation activities.

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

• Clinical Testing (Skin Temperature): The "ground truth" here is the measured skin temperature. This is a direct physical measurement from the device's application. Experts would be involved in designing and overseeing the study, but the "ground truth" itself is objective physical data rather than expert consensus on, say, an image interpretation. No specific number or qualifications of experts establishing ground truth are mentioned beyond the implication of an "IRB approved study."
• Other Testing (Bench, Software, etc.): Ground truth for these studies is typically defined by engineering specifications, regulatory standards, and established test protocols. The "experts" would be the engineers and quality assurance personnel conducting and reviewing the tests, but not in the sense of independent clinical experts adjudicating medical findings.

4. Adjudication Method for the Test Set

• Clinical Testing (Skin Temperature): Not applicable. The "ground truth" is a direct measurement of skin temperature. This is not an interpretive task requiring an adjudication process.
• Other Testing: Not applicable. These are engineering and performance compliance tests.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done.
  • This type of study is typically used for diagnostic devices (e.g., AI for image interpretation) to compare the performance of human readers with and without AI assistance.
  • The Therm-X is a therapeutic device (powered inflatable tube massager). The clinical testing focused on physical performance metrics (skin temperature) and safety, not on human interpretive tasks.
• Effect size of how human readers improve with AI vs without AI assistance: Not applicable, as no MRMC study was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• No, not directly applicable in the typical sense for AI/diagnostic algorithms.
  • The Therm-X does contain software, and "Software Validation" was performed, which is akin to testing the "algorithm" or software functionality in isolation from human interaction, to ensure it meets its specifications. This is a component of the device's overall performance.
  • However, the term "standalone" performance usually refers to an AI's diagnostic accuracy without human input for tasks like image classification. As this is not an AI diagnostic device, this concept doesn't directly apply in that context. The device's primary function is physical therapy, controlled by software.

7. The Type of Ground Truth Used

• Clinical Testing (Skin Temperature): Objective physical measurements (measured skin temperature).
• Biocompatibility: Laboratory test results against recognized standards (ISO 10993).
• Electrical Safety & EMC: Laboratory test results against recognized standards (IEC 60601 series).
• Software Validation: Conformance to pre-defined software requirements and specifications, and compliance with FDA guidance documents.
• Bench Performance: Conformance to engineering specifications for proper system operation and safety limits.
• Human Factors/Usability: Data from simulated use environments to assess safe and effective operation by intended users, typically observed directly or through surveys/interviews.
• Cleaning, Disinfection & Shelf Life: Laboratory validation of cleaning protocols and durability testing.

8. The Sample Size for the Training Set

• Not applicable. The Therm-X is presented as a physical therapy device with software control, not a machine learning/AI device that undergoes a "training" phase on a dataset of patient information (e.g., images for diagnostic AI). The software validation process ensures its functionality, but it's not "trained" on a dataset in the AI sense.

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

• Not applicable, as there is no "training set" in the context of an AI/machine learning model for this device.

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