(202 days)
The intended use of the CERAGEM-C Thermal Massager is to provide muscle relaxation therapy by delivering heat and soothing massage. Additionally, the Ceragem-C Thermal Massager provides radiant infrared heat for,
temporary relief of minor muscle and joint pain, and stiffness
the temporary relief of minor joint pain associated with arthritis
the temporary increase in local circulation where applied
relaxation of muscles
The CERAGEM-C Thermal Massager is an electrically powered motorized multi-functional physical therapy table. Its intended use is to provide muscle relaxation therapy by delivering heat and soothing The massage function is delivered by massage rollers mounted on an independent carriage massage. underneath a pad on the table torso section. The heat function is delivered by two components (1) heated jade massage rollers mounted together on the moving carriage and (2) heated Epoxy Carbon Panels. In both cases, the radiant infrared heat is emitted. Together, the massage action and heated pressure points apply light pressure as well as radiant infrared heat to the user.
The Ceragem-C Thermal Massager is not a device that would require AI performance metrics or a clinical study in the traditional sense, as it is a physical therapy device. The provided text is a 510(k) summary for a medical device that aims to demonstrate substantial equivalence to a predicate device, not to prove performance against specific acceptance criteria using a study with AI.
However, I can extract the "acceptance criteria" through the lens of regulatory compliance and the "study" as the comparison made to the predicate device.
Here's an interpretation based on the provided text:
Acceptance Criteria and Device Performance (in the context of regulatory equivalence):
| Acceptance Criteria (Regulatory) | Reported Device Performance (as demonstrated for equivalence) |
|---|---|
| Same intended use | The CERAGEM-C Thermal Massager has the same intended use as the predicate device (Migun HY5000 Thermassage Energy Product). |
| Same indications for use | The CERAGEM-C Thermal Massager has the same indications for use as the predicate device: muscle relaxation therapy, temporary relief of minor muscle/joint pain and stiffness, temporary relief of minor joint pain associated with arthritis, temporary increase in local circulation, and relaxation of muscles. |
| Same intended population | The CERAGEM-C Thermal Massager has the same intended population. |
| Similar functional and performance characteristics | Both devices use massage rollers and heat. The CERAGEM-C emits topical radiant infrared heat (5-20 microns) from jade rollers (heated by light bulbs), similar to the predicate. |
| No new safety or effectiveness issues raised by new components | The addition of three Epoxy Carbon Panels does not raise new safety or effectiveness issues as the temperature never exceeds the maximal temperature of the predicate device. |
| Compliance with established safety standards (e.g., electrical) | The CERAGEM-C and the predicate device both have and meet UL 60601-1:1997, CAN/CSA C22.2 No. 601.1-M90, EN 60601-1 (1990), IEC 60601-1, and IEC 60601-2-38 (1996). |
Since this is a 510(k) submission for a non-AI physical therapy device, the following points are not applicable or do not have direct analogues in the provided text:
- Sample sizes used for the test set and the data provenance: Not applicable. No test set data in the conventional sense was used for performance evaluation of an AI algorithm. Equivalence was established via comparison to a predicate device and adherence to safety standards.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" for a test set was established in this context.
- Adjudication method: Not applicable. There was no need for adjudication as it was not an AI performance study measuring agreement.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study was not done. The device is a physical therapy massager, not an AI diagnostic tool.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
- The type of ground truth used: Not applicable in the context of an AI study. The "ground truth" in this regulatory context is the established safety and effectiveness of the predicate device and compliance with recognized safety standards.
- The sample size for the training set: Not applicable. This is not an AI algorithm.
- How the ground truth for the training set was established: Not applicable. This is not an AI algorithm.
§ 890.5880 Multi-function physical therapy table.
(a)
Identification. A multi-function physical therapy table is a device intended for medical purposes that consists of a motorized table equipped to provide patients with heat, traction, and muscle relaxation therapy.(b)
Classification. Class II (performance standards).