(322 days)
The intended use of the CHOYANG Thermal Massager (Model: CY-7000) is to provide patients with muscle relaxation therapy by delivering heat and soothing massage.
The CHOYANG Thermal Massager (Model: CY-7000) is an electrically powered, motorized multi-functional physical therapy table. It is intended function and use is to provide patients with muscle relaxation therapy by delivering heat and soothing massage. The massage function is delivered by way of two independent carriages. Each carriage has five infrared lights. During use, these carriages traverse from lower torso to upper torso and apply light pressure as well as heat to the supine user.
The provided document describes the safety and effectiveness of the CHOYANG Thermal Massager (Model: CY-7000) by demonstrating its substantial equivalence to two predicate devices, rather than through a study with specific acceptance criteria and performance metrics for the device itself.
The "study" in this context is a substantial equivalence comparison to legally marketed predicate devices.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify quantitative acceptance criteria. Instead, it asserts that the new device is "as safe and effective as the predicate devices" based on bench and clinical evaluation, and a comparison of technical specifications and intended use. The "reported device performance" is essentially its similarity to the predicates.
| Item | CHOYANG Thermal Massager (New Device) | Predicate Device 1 (HY7000 Thermassage Energy Product) | Predicate Device 2 (CERAGEM-RH1 Automatic Thermal Massager) | Conclusion (Acceptance) |
|---|---|---|---|---|
| Safety Standard Compliance | Complies with EN 60601-1-2 | - | - | |
| Intended Use | To provide patients with muscle relaxation therapy by delivering heat and soothing massage. | To provide patients with muscle relaxation therapy by delivering heat and soothing massage. Additionally, the infrared lamps provide topical heating 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 muscle | -(Implicit in classification as "Multi-function physical therapy table" and "Therapeutic massager" as well as the similarity to Predicate 1's use) | Substantially equivalent in primary intended use (muscle relaxation, heat, massage). Differences in secondary infrared claims for Predicate 1 are noted but do not preclude substantial equivalence for the new device's stated indications. |
| Rated input voltage | 120V a.c | 120V a.c | 120V a.c | Equivalent |
| Supply Frequency | 50-60Hz | 50Hz | 60Hz | Functionally equivalent for typical mains power |
| Rated input power | 250W | 269W | 290W | Comparable range, deemed equivalent |
| Degree of protection | Type BF applied part | Type BF applied part | Type BF applied part | Equivalent |
| Ambient temperature | 40~70℃ | 40~70℃ | 30~60℃ | Overlapping and comparable, deemed equivalent |
| Weight | 64Kg | 74Kg | 87Kg | Comparable range, deemed equivalent |
| Safe working load | Max. 150Kg | Max. 150Kg | Max. 140Kg | Equivalent or exceeds predicate |
| Massage roller | Jade | Geranium Cerramic | Jade | Different material from one predicate but similar to other, deemed equivalent in function |
| Mode Set-Up | Auto Mode, Semi-Auto Mode | Auto Mode, Semi-Auto Mode | Auto Mode, Semi-Auto Mode | Equivalent |
| Remote Buttons | Rubber Pad Type | Rubber Pad Type | Rubber Pad Type | Equivalent |
| Operating time | 36min | 34min | 40min | Comparable range, deemed equivalent |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a "test set" in the sense of a dataset used for performance evaluation of an AI/software device. The evaluation is based on bench testing for safety (EN 60601-1-2) and a comparison of specifications and intended use to predicate devices.
- Sample size: Not applicable for a typical test set using patient data. The "sample" is of the device itself (one unit of CY-7000) for bench testing.
- Data provenance: Bench test reports were performed by SGS Testing Korea. The comparison data for predicate devices is from their respective 510(k) submissions.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. There is no "ground truth" derived from expert consensus on a test set of data for this type of device submission. The substantial equivalence is determined by regulatory review based on engineering, safety, and functional comparisons.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no expert adjudication process for determining ground truth in a test set.
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 physical thermal massager, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical thermal massager.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable in the context of an AI/software device. The "ground truth" for the submission is the documented performance, safety standards compliance, and intended use of the predicate devices, against which the new device is compared. The determination of "safe and effective" for the new device is made through this comparison and adherence to relevant standards.
8. The sample size for the training set
Not applicable. This is a physical thermal massager, not an AI/software 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).