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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.

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.

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Thermal Massage Bed (2D-LX) is a device intended 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
• temporary relief of minor joint pain associated with arthritis
• temporary increase in local circulation where applied
• Relaxation of muscles

Thermal Massage Bed (2D-LX) is a device intended 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
• temporary relief of minor joint pain associated with arthritis
• temporary increase in local circulation where applied
• Relaxation of muscles

The given document is a 510(k) summary for the INAREX Thermal Massage Bed (2D-LX). It mainly focuses on demonstrating substantial equivalence to already marketed predicate devices rather than providing detailed acceptance criteria and specific study performance data for the device itself against those criteria.

Therefore, many of the requested details cannot be extracted from this document, as it describes a clearance based on substantial equivalence, not a direct clinical validation study with specific performance metrics.

Here's a breakdown of what can and cannot be provided based on the input:

1. A table of acceptance criteria and the reported device performance

This information is not provided in the document. The document focuses on demonstrating equivalence to predicate devices (Ceragem-C and Ceragem-RH1) regarding intended use, design, and function, rather than setting specific acceptance criteria for performance metrics (e.g., specific temperatures, massage force, or clinical outcomes) and then reporting the INAREX device's performance against those. The comparison table provided lists technical specifications (Voltage, Power, Frequency, Ambient temperature, Classification) and shows them to be comparable.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided. The document states "Testing was performed according to 'Harmonized Standard'. Software testing and validation were done according to EN 60601-1-4. Test results were reviewed by designated technical professionals before software proceeded to release. Test results support the conclusion that actual device performance satisfies the design intent." This is a general statement about engineering and software validation, not a clinical test set with human subjects.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. No clinical ground truth establishment is described for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided. No clinical test set or adjudication method is described.

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

This information is not applicable/not provided. The device is a "Thermal Massage Bed," not an AI-powered diagnostic or interpretive system that would involve human "readers" or AI assistance in that context.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not applicable/not provided. The device is a physical therapy bed; it does not involve algorithms in a standalone diagnostic or interpretive capacity.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided. No clinical ground truth is mentioned. The testing described pertains to safety and performance according to harmonized standards (e.g., electrical safety, software validation), not clinical outcomes.

8. The sample size for the training set

This information is not applicable/not provided. This device does not appear to involve machine learning or a "training set" in the context of AI development.

9. How the ground truth for the training set was established

This information is not applicable/not provided. As above, no training set or ground truth for it is mentioned.

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