(114 days)
The Med4 Elite™ combines cold, heat, contrast and compression therapies. It 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/or surgical medical and/or surgical conditions for which localized thermal therapy (hot or cold or contrast) are indicated. It is intended to be used by, or on the order of, licensed healthcare professionals in rehabilitation facilities, outpatient clinics, and athletic training settings.
The Med4 Elite™ (Model Number 650550) is an AC powered, software-controlled multimodality device, designed to be used in a clinical setting, and under the direction and supervision of a licensed healthcare professional in rehabilitation facilities, outpatient clinics and athletic training settings. The device features iceless cold therapy, heat therapy, contrast (alternating heat and cold) therapy, and intermittent pneumatic compression therapy for one or two patients at a time. The device is designed to be compatible with the pre-existing portfolio of ergonomic Game Ready Wraps made for specific body parts (e.g., shoulder, elbow, knee, ankle, back, etc.). The Wraps are flexible water circulating garments that apply to the body to deliver cold, heat, or rapid contrast temperature and/or compression therapy. The wrap is comprised of an inner ATX Series Heat Exchanger and an Outer Sleeve. The Med4 Elite™ allows for treatment of one or two patients, or two anatomical locations simultaneously. The device 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. The physical description of the Med4 Elite™ is a compact unit with four caster wheels and a built-in handle. It has two separate, covered reservoirs - one for holding cold water and the other for holding hot water. The water reservoirs, pumps, cold engine, valves, power supplies and any other electronics are inside a covered enclosure made out of both plastic and sheet metal that can only be accessed with a tool.
The provided document is a 510(k) premarket notification for a medical device called "Med4 Elite™" by Cool Systems, Inc. (dba Game Ready). This document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and detailed study results for a new device's performance against specific metrics, particularly in the context of an AI/ML diagnostic device.
Therefore, the information required to fully answer the request, especially regarding acceptance criteria for an AI device (like sensitivity, specificity, AUC), sample size, ground truth establishment for AI training/test sets, expert adjudication, or MRMC studies, is not present in this document. This device is a physical therapy device (a powered inflatable tube massager combining cold, heat, contrast, and compression therapies) and not an AI-powered diagnostic tool.
However, I can extract the information relevant to the performance testing and safety assessment of this specific device as presented in the document.
Here's what can be extracted from the provided text regarding the device's validation:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list "acceptance criteria" in the typical sense of quantitative performance metrics (like accuracy, sensitivity) that would be common for diagnostic AI devices. Instead, it describes various performance tests and their outcomes, primarily to demonstrate safety and functional equivalency to predicate devices. The "performance" is more about adherence to safety standards and functional operation within specified ranges.
| Acceptance Criteria (Implied from tests/standards) | Reported Device Performance (Summary of Study Results) |
|---|---|
| Electrical Safety Standards Compliance | Complies with ANSI/AAMI ES60601-1:2005/(R) 2012 and CAN/CSA C22.2 No. 60601-1:2014. |
| Electromagnetic Compatibility (EMC) | Complies with all EMC requirements of IEC 60601 3rd edition standards, including ANSI/AAMI/ES60601 and collateral standard for EMC. |
| Biocompatibility of Patient-Contacting Components | Wraps and outside of connector hoses tested successfully for cytotoxicity, skin irritation, and skin sensitization according to ISO 10993-1, -5, and -10. Found to be biocompatible for intended patient contact duration (limited: ≤ 24 hrs or prolonged: >24 hrs to 30 days). |
| Software Validation (Moderate Level of Concern) | Software (custom-developed and OTS) validated and demonstrated to be safe and effective for its intended use. All required items related to software as required by FDA guidance included. |
| Safety of Thermal Therapies (Skin Temperature) | Maximum Temp: Skin temperature measured as high as 111 °F (44 °C) when set to maximum Heat Reservoir set point. (Supported by reference to Table 3 and finding "no thermal damage to the skin"). |
| Safety of Thermal Therapies (Skin Temperature) | Minimum Temp: Skin temperature measured as low as 44 °F (7 °C) when set to minimum Cold Reservoir set point. (Supported by reference to Table 3 and finding "no thermal damage to the skin"). |
| Cleaning and Disinfection Effectiveness | Cleaning and disinfection instructions for non-patient contacting components (Control Unit, connector hoses, drain hoses) have been validated, including impact of repeated use over expected life. |
| Functional Performance (System/Bench Testing) | Device subjected to design verification and validation testing for system/bench. Tests verified and validated proper operation of the system. |
| Storage and Transport Performance | Device subjected to design verification and validation testing for storage and transport performance. |
| Labeling Clarity | Labeling materials found to be easy to use and understandable to the intended users. |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: The document mentions "healthy volunteers" for the clinical study measuring skin temperatures (Table 3), but it does not specify the number of volunteers (sample size).
- Data Provenance: The study was a "clinical study" on "healthy volunteers" which implies it was prospectively collected. The country of origin is not explicitly stated, but as it's an FDA submission for a US company, it's highly likely to be US-based data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This question is not applicable to the Med4 Elite™ device. The device is a therapy device, not a diagnostic device requiring expert interpretation of images or other data to establish "ground truth" in the AI sense. The "ground truth" for the skin temperature study was direct measurement of skin temperature. No experts are mentioned in this context for establishing "ground truth."
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:
Not applicable. There was no expert "adjudication" in the sense of reconciling divergent interpretations for a diagnostic test set. The validation involved direct physical measurements and compliance with engineering/safety standards.
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. This device is not an AI-assisted diagnostic tool, so an MRMC study comparing human readers with and without AI assistance was not performed and is irrelevant to this device type.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is not an algorithm/software-only device. Its "performance" is based on its physical operation and thermal/compression outputs. The software component is described as a "Moderate Level of Concern" for control, not for independent diagnostic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the clinical study was direct physical measurement of skin temperature on healthy volunteers using sensors, as well as adherence to established engineering and biocompatibility standards.
8. The sample size for the Training Set:
Not applicable. This device did not involve an AI model requiring a "training set" in the machine learning sense. The device's "training" would be its design and manufacturing process, and its "validation" is through engineering tests and a small clinical safety study.
9. How the ground truth for the Training Set was established:
Not applicable, as there was no AI model training set.
§ 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).