(94 days)
Therm-X (Therm-X Pro, Therm-X Pro Athlete, 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 traumatic and post-surgical medical and/or surgical conditions for which localized thermal therapy (hot or cold) are indicated.
Therm-X Pro and Therm-X Pro Athlete systems also provide DVT therapy. Therm-X Pro and Therm-X Pro Athlete 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 Pro, Therm-X Pro Athlete 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 of a licensed healthcare professional. The device is available in three configurations: Therm-X Pro, Therm-X Pro Athlete and Therm-X AT.
Therm-X (Therm-X Pro, Therm-X Pro Athlete and Therm-X AT) features iceless cold therapy, heat therapy, and contrast (alternating heat and cold) therapy. Therm-X Pro and Therm-X Pro Athlete systems also provide DVT prophylaxis therapy.
Therm-X consists of various single-patient use inflatable wraps for thermal treatment of the back, elbow, shoulder, ankle, or knee and DVT prophylactic treatment applied to the foot or calf. 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 Therm-X Pro and Therm-X Pro Athlete systems 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 AT and Therm-X Pro models provide an optional password protection feature that allows for a home user to use a stored cvcle without being able to change it, 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 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 document describes the Therm-X device, which combines cold, heat, contrast, and compression therapy. It includes a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel acceptance criteria or detailing a clinical study to prove device performance against specific, quantifiable metrics.
Therefore, the information required to fully answer the request, particularly regarding specific acceptance criteria values and a dedicated study proving these criteria are met, is not present in the provided text. The document refers to "established performance criteria" and "predetermined specifications" but does not explicitly list them.
Based on the available text, here's what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with specific, quantifiable acceptance criteria and directly reported device performance values against those criteria. Instead, it makes general statements about compliance with standards and equivalence to predicate devices.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified for any performance testing.
- Data Provenance: Not specified. Retrospective or prospective nature is not mentioned for any testing.
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)
This information is not provided. The document details various tests (EMC/Electrical Safety, Biocompatibility, Software Validation, Bench Performance, Skin Temperature Testing, Human Factors/Usability) but does not mention the use of experts to establish a "ground truth" in the context of diagnostic accuracy, which is what "ground truth" typically refers to in medical device validation studies.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided. This concept typically applies to studies where multiple readers assess cases and their disagreements need to be resolved, which isn't described for the Therm-X validation.
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
There is no mention of an MRMC comparative effectiveness study, human readers, AI assistance, or effect size related to AI improvement. The Therm-X is a physical therapy device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This concept is not applicable to the Therm-X device. It is a physical therapy device, not an algorithm, and its performance inherently involves human interaction during application and use.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically understood in diagnostic studies (e.g., expert consensus, pathology) is not applicable here. The device's validation relies on demonstrating compliance with safety standards, proper operation, and equivalence to predicate devices, rather than a diagnostic accuracy evaluation against a reference standard. For the "Clinical Testing" (skin temperature testing), the "ground truth" would implicitly be the actual skin temperature measurements and the absence of thermal damage, but the methodology for establishing this is not detailed as a "ground truth" process.
8. The sample size for the training set
This information is not provided. The term "training set" typically refers to data used to train machine learning algorithms, which is not relevant for this device.
9. How the ground truth for the training set was established
This information is not provided and is not applicable to this device as it does not involve machine learning.
Summary of available information regarding acceptance and studies:
The document focuses on demonstrating substantial equivalence to predicate devices through various verification and validation activities.
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Acceptance Criteria (Implicit/General):
- Conformance with established performance criteria/predetermined specifications.
- Compliance with Electromagnetic Compatibility / Electrical Safety standards (IEC 60601-1, IEC 60601-1-2).
- Biocompatibility of patient contact materials per ISO 10993 series (ISO 10993-1, ISO 10993-5, ISO 10993-10).
- Software meeting performance requirements and specifications, and complying with FDA Guidance documents and Industry Standards for Moderate Level of Concern software.
- Proper operation of the system (bench performance).
- Temperature limits not causing thermal damage to the skin (clinical testing).
- Safe and effective operation by users (human factors/usability).
- Overall safety and effectiveness equivalent to predicate devices.
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Study/Testing Information:
- Electromagnetic Compatibility / Electrical Safety: Performed in accordance with IEC 60601-1 and IEC 60601-1-2.
- Biocompatibility: Testing of patient contact materials per ISO 10993-1, ISO 10993-5, ISO 10993-10.
- Software Validation: Completed according to an established Validation procedure and FDA Guidance documents ("General Principles of Software Validation," "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"). Software is classified as a Moderate Level of Concern.
- Performance (Bench): Tested for proper operation against predetermined specifications.
- Clinical Testing (Skin Temperature): Performed for maximum time limits at highest/lowest temperature settings and for contrast therapy at default settings. Concluded no thermal damage and device is safe and effective as predicate devices. The type of study and sample size are not specified.
- Human Factors / Usability: Assessments performed in a simulated use environment.
In conclusion, the document aims to assert substantial equivalence through demonstrating compliance with relevant standards and successful completion of various tests, rather than detailing a specific clinical study with quantifiable acceptance criteria against which the device's performance is precisely measured and reported.
§ 890.5650 Powered inflatable tube massager.
(a)
Identification. A powered inflatable tube massager is a powered device intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.(b)
Classification. Class II (performance standards).