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The MED Sculpt Computerized Body Massager and M-Sonic Ultrasound Diathermy is indicated for:
a. Therapeutic Massager:
i. Provides temporary relief of minor muscle aches and pains . -
ii . Relieves muscle spasms
iii. Temporarily improves local blood circulation
iv. Temporarily reduces the appearance of cellulite
b. Ultrasonic Diathermy:
i. Relief of pain
ii. Muscle spasms
III. Joint contractures
iv. NOT for the treatment of malignancies

The MED SCULPT Computerized Body Massager and M-Sonic Ultrasound Diathermy system has massage and ultrasound diathermy components. The massage portion of the device uses a specially designed membrane, made up of elastomeric material. This membrane, fastened onto the handbiece, moves in an alternate way due to changeable depression created by a vacuum pump; such movement is due to the opening and closing of two electronically controlled electrovalves. The unit also includes an ultrasonic handpiece that can be used to perform ultrasound diathermy. Ultrasound is a particular form of mechanical energy which leads to an increase in the molecular vibration of the tissue resulting in heat generation and according to this principle the ultrasonic handpiece of the unit, using an ultrasound wave at the fixed frequency of 3 MHz, produces thermal changes in the areas of the body where it is applied.

Here's an analysis of the provided 510(k) summary regarding the MED Sculpt Computerized Body Massager and M-Sonic Ultrasound Diathermy, focusing on acceptance criteria and study information:

Based on the provided document, there is no performance data or clinical study detailed. The 510(k) summary explicitly states under "6. Performance Data": "None presented."

This type of 510(k) submission typically relies on substantial equivalence to a predicate device without requiring new clinical performance data if the new device's technology and intended use are similar enough to an already legally marketed device. In this instance, the MED Sculpt device is deemed substantially equivalent to the Dermosonic manufactured by Sybaritic, Inc. (K024307).

Therefore, most of the questions regarding acceptance criteria, study design, and performance metrics cannot be answered from the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The document explicitly states "None presented" for performance data. There are no acceptance criteria or reported device performance metrics provided in this 510(k) summary. The submission relies on substantial equivalence to a predicate device.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. No test set was used to generate performance data for this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable. No test set requiring ground truth establishment was conducted or reported.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring adjudication was conducted or reported.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or reported in this 510(k) summary.

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

Not applicable. This device is a physical medical device (massager and ultrasound diathermy), not an algorithm or AI system, so the concept of standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

Not applicable. No ground truth data was used, as no performance study was conducted or reported.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device, not an AI or algorithm-based system that uses a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. As a physical device, there is no training set or ground truth establishment relevant to an algorithm's training.

In summary: The provided 510(k) submission for the MED Sculpt Computerized Body Massager and M-Sonic Ultrasound Diathermy relies on the concept of substantial equivalence to a predicate device (Dermosonic, K024307) rather than presenting new performance data or clinical studies for the device itself. Therefore, the document does not contain information about acceptance criteria, study design, sample sizes, expert involvement, or ground truth establishment for performance data.

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