(162 days)
The intended use of the Ceragem Automatic Thermal Massager, Model CGM MB-2401 is designed to provide muscle relaxation therapy by delivering heat and soothing massage to affected areas.
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
The aircell leg massager is designed to provide temporary relief of minor muscle aches and pains and a temporary increase in blood circulation to the treated areas. The aircell leg massager stimulates kneading and stroking of tissues by using an inflatable garment.
Not Found
The FDA 510(k) Clearance Letter for the Ceragem Automatic Thermal Massager (CGM MB-2401) does not contain information regarding detailed acceptance criteria and a study that proves the device meets specific performance metrics beyond its stated indications for use.
The letter primarily focuses on the regulatory determination of substantial equivalence to predicate devices, allowing the manufacturer to market the device. It outlines the device's intended use and general regulatory requirements but does not include clinical study data, statistical performance metrics, or details about the validation process typically associated with detailed acceptance criteria of an AI/algorithm-driven device.
Therefore, the requested information cannot be extracted from the provided document.
Information NOT available in the provided document:
- Table of acceptance criteria and the reported device performance: This information is not present. The letter does not specify quantitative performance metrics or acceptance thresholds.
- Sample size used for the test set and the data provenance: Not provided. There is no mention of a test set, its size, or where any data used for validation (if any) originated.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no test set or ground truth establishment process is described.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable. The device is a physical therapy massager, not an AI-assisted diagnostic tool for which MRMC studies are typically performed.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical device, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable, as this is not an AI/ML device requiring a training set in the conventional sense.
- How the ground truth for the training set was established: Not applicable.
The FDA 510(k) clearance process for a Multi-Function Physical Therapy Table (like the Ceragem Automatic Thermal Massager) typically relies on demonstrating substantial equivalence to a legally marketed predicate device, often through engineering performance tests and adherence to recognized standards, rather than complex clinical effectiveness studies with explicit performance metrics like those for diagnostic AI tools. The provided document is a regulatory clearance letter, not a full submission document that would detail all validation studies.
§ 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).