(133 days)
Thermal Massage Bed (2D-GX) is a device intended to provide patients with muscle relaxation therapy by delivering heat and soothing massage. Additionally, the lamps provide topical heating. -temporary relief of minor muscle and joint pain, and stiffness -temporary relief of minor joint pain associated with arthritis -temporary increase in local circulation where applied -Relaxation of muscles
This device is intended to provide patient with muscle relaxation therapy by delivering heat and soothing massage. This device has auto mode, and four custom modes to massage the back and apply heat to calves and thighs. For the upper mattress, there are germanium ceramic roller controlled left and right by motor. Germanium ceramic roller also can be controlled up and down. The users can choose the auto mode or custom mode by using the remote control and the remote control has the FND screen which shows the temperature and LED which indicates operation condition.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:
Device: Thermal Massage Bed (2D-GX)
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly define specific quantitative acceptance criteria for performance in the same way one might for diagnostic accuracy or detection rates. Instead, the "acceptance criteria" appear to be broadly demonstrating safety and the ability to achieve a therapeutic temperature range.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: Device meets applicable electrical and medical device safety standards. | The device has been tested to and meets the requirements of IEC60601-1, IEC 60601-2-38, and IEC60601-1-2. Risk analysis and mitigation strategies were also discussed (e.g., temperature control by sensor and bimetal, system shutdown if sensors are disconnected, motor initialization on shutdown). |
| Therapeutic Effect (Heat): Ability to elevate skin surface temperature to a therapeutic range (40-45℃). | "The device is able to elevate skin surface temperature from normal baseline temperature to the therapeutic range (40~~45℃) when the device activated by 65℃ setting." (Note: this is only achieved at the maximum setting; 30℃ setting is for comfort warming only). |
| Substantial Equivalence: To the predicate device (2D-LX). | The document states: "The non-clinical testing and clinical study results demonstrate that the 2D-GX, thermal massage bed is safe, accurate. It also demonstrates that the 2D-GX, thermal massage bed is substantially equivalent to the predicate device, 2D-LX, currently sold on the U.S. market." This is supported by direct comparison of features and intended use. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Performance Test (Clinical Test): 5 people (for the temperature elevation study).
- Data Provenance: Not explicitly stated, but given the company's address in Korea, it is highly likely the study was conducted in Korea. The study is described as a "clinical test," suggesting it was conducted prospectively for the purpose of this submission.
- Sample Size for Non-Clinical Tests: Not specified, but these refer to compliance with standards (IEC 60601-1, -1-2, -2-38). These are typically laboratory tests of the device itself, not with human subjects, and involve standardized test configurations rather than "test sets" in the clinical sense.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
For the clinical study on skin surface temperature elevation, the concept of "ground truth" established by experts is not directly applicable. The "ground truth" here is the objective measurement of skin surface temperature. No external experts are mentioned as establishing the truth for these temperature measurements.
4. Adjudication Method for the Test Set
Not applicable, as the clinical study involves direct physiological measurement (skin temperature) rather than subjective assessments requiring adjudication or consensus.
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 device is a thermal massage bed, not a diagnostic imaging or AI-assisted diagnostic tool. Therefore, an MRMC study and AI assistance are outside the scope of this device type.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical therapy device, not an algorithm or AI system.
7. The Type of Ground Truth Used
For the clinical performance test, the ground truth was objective physiological measurement: the skin surface temperature, measured before and after device activation. For the safety tests, the ground truth was compliance with recognized international safety standards.
8. The Sample Size for the Training Set
Not applicable. This is a physical device, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this device.
§ 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).