(285 days)
The intended use of the Ceragem® Thermal Massager Model CGM-MB-1101 Automatic Thermal Massager is to provide muscle relaxation therapy by delivering heat and soothing massage. Additionally, the product provides topical radiant infrared heat for:
- Temporary relief of minor muscle and joint pain stiffness
- Temporary relief of minor joint pain associated with arthritis
- Temporary increase in local circulation where applied
- Relaxation of muscles
This device is comprised of the main body and optional components. The main body components are the main mat which includes the internal projector and the up/down movement motor, and the lower mat. The optional components are the external projectors (3-sphere). This device is an electrically powered, motorized, multi-functional physical therapy table intended to use for temporary relief of muscle and joint pain and stiffness by applying massage pressure from the vertical and horizontal movements, and heat from the internal and external projectors.
Here's a breakdown of the acceptance criteria and study information for the Ceragem Automatic Thermal Massager, Model CGM-MB-1101, based on the provided FDA 510(k) summary:
This device does not involve AI/ML technology, so many of the requested fields related to AI performance, ground truth establishment, and expert involvement are not applicable and will be marked as such. The study described is primarily a comparison to a predicate device and adherence to industry standards, rather than clinical performance trials with specific disease outcomes.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are mainly demonstrated through substantial equivalence to a predicate device and adherence to recognized safety and performance standards. The "performance" in this context refers to the device's functional specifications being within acceptable limits and similar to the predicate device.
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance (Model CGM-MB-1101) |
|---|---|---|
| Intended Use | Same as predicate: Muscle relaxation therapy by delivering heat and soothing massage. | Same intended use. |
| Indications for Use | Same as predicate: Temporary relief of minor muscle/joint pain/stiffness, arthritis pain, increased local circulation, muscle relaxation. | Same indications for use. |
| Technological Characteristics | Similar emission source (Jade Projectors), infrared emission spectrum (5-20 microns). | Jade Projectors, 5-20 micron infrared emission spectrum. |
| Safety - Electrical Standards | UL 60601-1, CAN/CSA-C22.2 No. 601.1-M90, IEC 60601-1:2005, EN 60601-1:2006. | Tested to and meets these standards. |
| Safety - EMC Standards | IEC 60601-1-2: 2007 (Electromagnetic Compatibility). | Tested to and meets this standard. |
| Safety - Thermal Regulation | Operating Temperature Range similar to predicate, with maximal heat not exceeding predicate. | Internal: 30°C – 65°C; External, main, Auxiliary: 30°C - 60°C. Predicate: 30°C – 60°C. Max temperature does not exceed predicate. |
| Safety - Biocompatibility | ISO 10993-10 (Tests for Irritation and Skin Sensitization). | Tested to and meets this standard. |
| Safety - Risk Management | ISO 14971 (Application of Risk Management). | Tested to and meets this standard. |
| Software Life Cycle (if applicable) | IEC 62304 (Medical device Software Software Life Cycle Processes). | Tested to and meets this standard. |
| Performance - Mechanical Components | Geared DC Motor, Limit Switch, Wire-Chain, Ergonomically Molded Polyethylene Rails. | Geared DC Motor, Limit Switch, Wire-Chain, Ergonomically Molded Polyethylene Rails. (Similar to predicate) |
| Performance - Weight Capacity | Static Weight: 300 pounds (predicate). | 298 pounds (subject device declared substantially equivalent). |
| Maximum Permissible Weight: 300 pounds (predicate). | 298 pounds (subject device declared substantially equivalent). |
Study Details
1. Table of Acceptance Criteria and Reported Device Performance
(See table above)
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not applicable in the context of clinical performance data for efficacy. The "test set" here refers to the device itself being tested for compliance with technical standards and compared against its predicate's specifications. No patient outcome data or imaging data is presented to require a test set sample size.
- Data Provenance: The data primarily originates from the manufacturer's engineering specifications, technical testing reports, and a comparison against the previously cleared predicate device (K040031) by the same manufacturer. It is a retrospective analysis of the device's design and technical specifications relative to a predicate, combined with physical testing for safety standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This is not an AI/ML device that generates diagnoses or interpretations. "Ground truth" in this context would refer to the established engineering standards and the specifications of the predicate device, which are objectively measurable and defined by regulatory bodies and the manufacturer. Experts involved would be engineers and regulatory specialists, but their role is not to establish a "ground truth" for a diagnostic output.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This pertains to diagnostic outcomes and expert consensus, which does not apply to this type of device submission. The "adjudication" is essentially the FDA's review of the manufacturer's claims of substantial equivalence and compliance with 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 is a non-AI therapeutic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a non-AI therapeutic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" implicitly used is the established safety and performance standards for similar electromechanical thermal massage devices (e.g., UL, IEC, ISO standards) and the specifications and regulatory clearance of the predicate device (K040031). There is no diagnostic "ground truth" involved.
8. The sample size for the training set
- Not applicable. This is a non-AI device; there is no training set.
9. How the ground truth for the training set was established
- Not applicable. This is a non-AI device; there is no training set or associated ground truth.
§ 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).