(215 days)
The intended use of the Ceragem Automatic Thermal Massager, Model CGM-MB-1901 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
The Ceragem Automatic Thermal Massager, Model CGM-MB-1901 is an electrically powered, motorized, multi-functional physical therapy table intended to use for temporary relief of muscle/joint pain and stiffness by applying massage pressure from the vertical and horizontal movements, and heat from the internal and external projectors. The main components of the subject device are a main mat, a supporting mat, a 3-Sphere projector, an abdominal vibration projector, and a remote control. The main mat has an internal projector which includes an up/down movement motor for pressure effect with ceramic balls as a medium for thermal massage effect. The internal projector is located in the center of the mat which is mainly for spine and moves up and down as well as vertically. The main mat also has a heating pad. The supporting mat which is mainly for the legs have heating pad only. The 3-sphere projector is an optional accessory which the user can put anywhere needed additionally such as neck and armpit, and it has 3 balls for thermal effect. The abdominal vibration projector is also an optional accessory mainly for abdominal area and offers vibration and thermal effect.
The provided text is a 510(k) summary for the Ceragem Automatic Thermal Massager, Model CGM-MB-1901. This type of document is for medical devices that are deemed substantially equivalent to a legally marketed predicate device. It focuses on demonstrating that the new device is as safe and effective as the predicate, rather than proving efficacy from scratch with extensive clinical trials like a PMA would require.
Therefore, the information regarding acceptance criteria and studies proving the device meets those criteria in the context of efficacy, particularly for AI/Machine Learning devices, is not present in this document. This document details engineering and safety/performance testing relevant to mechanical and thermal devices, not AI performance. Specifically:
- Acceptance Criteria for AI/ML Performance: Not applicable/not defined as this isn't an AI/ML device.
- Study Proving Device Meets Acceptance Criteria: The studies described ("skin temperature study," "usability study," "EMC and electrical safety testing," "cytotoxicity test," "skin irritation & sensitization tests," and "firmware validation tests") are all related to the physical, electrical, and material safety and performance of a thermal massager, not the accuracy or performance of an AI algorithm.
Let's break down what is available in the document related to testing, even though it doesn't fit the typical "acceptance criteria for an AI device" framework:
1. Table of Acceptance Criteria and Reported Device Performance (as inferred for a thermal massager):
| Acceptance Criteria (Inferred for a Thermal Massager) | Reported Device Performance (from "Performance Tests (Non-clinical)") |
|---|---|
| Skin Temperature Control: Maintain skin temperature between 40-45°C during treatment. | "[The] skin temperature study was performed to verify that the subject device maintained skin temperature between 40-45 degree C during the intended treatment." (Conclusion: supported substantial equivalence) |
| Usability: Lay users can operate the device with the provided User Manual. | "The usability study was performed to validate that the lay users can use the subject device only with the User Manual provided." (Conclusion: supported substantial equivalence) |
| Electrical Safety & EMC: Compliance with relevant standards (ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11). | "The EMC and electrical safety testing were conducted on the subject device in accordance with ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-6, and IEC 60601-1-11." (Conclusion: supported substantial equivalence) |
| Biocompatibility (New Materials): Absence of cytotoxicity, skin irritation, and sensitization for patient-contacting materials. | "The cytotoxicity test per ISO 10993-5 and skin irritation & sensitization tests per ISO 10993-10 were performed to evaluate the safety of the new materials which contact the patients." (Conclusion: supported substantial equivalence) |
| Software/Firmware Functionality: Firmware works as intended. (Level of concern: Moderate) | "The level of concern for the subject device SW is moderate and the validation tests were performed to verify that the firmware works as intended." (Conclusion: supported substantial equivalence) |
| Heating Performance (Abdominal Vibration Projector): Able to heat skin to 40-45°C within 15-20 minutes and maintain this temperature. | "Similar to the predicate device, the subject device was able to heat skin to 40-45 degree C within 15-20 minutes. During the intended treatment the subject device maintained skin temperature between 40-45 degree C." |
2. Sample size used for the test set and the data provenance:
- The document does not specify sample sizes for these performance and safety tests (e.g., number of subjects in the skin temperature or usability study, number of material samples for biocompatibility).
- Data Provenance: Not specified (e.g., country of origin). The studies appear to be non-clinical (laboratory/in-house testing) with a potential small human component for skin temperature and usability. They are not referred to as retrospective or prospective clinical studies in the typical sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/not specified. The studies described are engineering, safety, and basic human factor (usability) tests, not diagnostic accuracy studies requiring expert readers to establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is not a study requiring reader adjudication for diagnostic accuracy.
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:
- No, an MRMC study was not done. This device is not an AI/ML diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, this is not an AI/ML device. "Standalone performance" is not relevant here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Ground truth in the typical AI/ML sense (e.g., confirmed disease status) is not relevant. The "ground truth" for the tests performed would be:
- Skin Temperature: Measured temperature readings.
- Usability: Observation of user interaction and completion of tasks using the manual.
- Electrical Safety/EMC: Compliance with standard thresholds and test procedures.
- Biocompatibility: Laboratory results showing absence of toxic or irritating reactions.
- Firmware: Expected functional outputs/behaviors.
8. The sample size for the training set:
- Not applicable. This device is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable.
§ 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).