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The TherMassager is indicated for use in:

• Relief of minor muscle aches and pains
• Relief of muscle spasm
• Temporary improvement of local circulation (i.e., blood circulation)
• Temporary improvement in the appearance of cellulite

The TherMassager is a self-contained, 9.0 VIDC electrically powered therapeutic massager. The basic configuration is that of an ergonomically rounded hand-held box-like unit. Weight is approximately 4 pounds. The housing is made from medical grade plastic and contains a suction pump, a massage motor and skin rollers. The outside of the unit is affixed with a strap which may be secured over the operators hand to provide additional grip during treatment application. Three treatment rollers are supplied with each unit. The TherMassager unit has I spiral roller, 1 ribbed roller and 1 lobed (contoured) roller. The rollers are made from medical grade silicone elastomer meeting ISO 10993 biocompatibility standards.

The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner requested. This document is a 510(k) premarket notification for a therapeutic massager, the TherMassager.

Instead, the document details the device's substantial equivalence to a predicate device (UPC Therapeutic Massager, K990445) based on a comparison of device characteristics and intended use. The core of this submission is to demonstrate that the new device is as safe and effective as a legally marketed device, not to present novel performance data from a specific study against predefined acceptance criteria.

Therefore, I cannot provide the requested table, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, or ground truth information because this type of data is not present in the provided 510(k) summary.

The closest information available related to "acceptance criteria" is the comparison of device characteristics to the predicate device to establish substantial equivalence.

Here's a breakdown of what can be extracted or inferred based on the document's content, acknowledging the limitations for your specific request:

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

This information is not provided in a format of "acceptance criteria" versus "reported performance." Instead, the document presents a side-by-side comparison of features between the TherMassager and the predicate device (LPG). Substantial equivalence is the "acceptance criteria" here, meaning the device's characteristics and performance are similar enough to the predicate to be considered safe and effective for the same indications.

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The intended use of the Migun Model HY-7000 Thermassage Energy Product is to provide thermassage 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 o
• the temporary relief of minor joint pain associated with arthritis o
• the temporary increase in local circulation where applied o
• relaxation of muscles O

Not Found

The provided document is a 510(k) clearance letter from the FDA to Migun Medical Instrument Co. Ltd. for their HY7000 Thermassage Energy Product. This document does not contain information about acceptance criteria or a study proving the device meets those criteria.

FDA 510(k) clearances are based on demonstrating substantial equivalence to a predicate device, not necessarily on new studies proving specific performance criteria against predefined thresholds. The letter states: "We have reviewed your Section 510(k) premarket notification of intent to market the device... and have determined the device is substantially equivalent (for the indications referenced above and as described in the enclosure) to legally marketed predicate devices."

Therefore, I cannot extract the requested information (table of acceptance criteria, study details, sample sizes, expert qualifications, etc.) from this document because it is not present. The document focuses on regulatory clearance based on substantial equivalence, not on a detailed performance study with explicit acceptance criteria for the new device.

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The intended use of the Migun Model HY5000 Thermassage Energy Product is 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 o
• the temporary relief of minor joint pain associated with arthritis o
• the temporary increase in local circulation where applied O
• relaxation of muscles o

The Migun Model HY5000 Thermassage Energy Product is an electrically powered, motorized, multifunctional physical therapy table. It's 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 (2) independent carriages, which are mounted under a pad of the table torso section. The heat function is delivered by use of ten (10) infrared lights, which are mounted directly to the traversing carriages. Each carriage has five (5) 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.

This 510(k) premarket notification (K032449) is for a physical therapy table, not an AI/ML powered device. As such, information regarding AI/ML specific acceptance criteria, study designs, sample sizes for test and training sets, expert qualifications, adjudication methods, or MRMC studies for AI performance is not present in the provided document.

The "Performance Data" section of the document describes the device's compliance with safety and electrical standards, which serve as its acceptance criteria.

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

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 applicable and is not provided in the document. The performance data is based on compliance with electrical and safety standards, not on clinical testing with a patient sample set.

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 applicable and is not provided in the document. "Ground truth" in the context of expert consensus is relevant for diagnostic or AI/ML performance studies, not for the safety and electrical compliance of a physical therapy table. The "experts" in this context would be the testing laboratories and engineers who verify compliance with the specified standards.

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

This information is not applicable and is not provided in the document. Adjudication methods are typically used in clinical studies or for establishing ground truth in AI/ML performance evaluations.

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. This information is not applicable as the device is a physical therapy table, not an AI-powered diagnostic or assistive tool.

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

No. This information is not applicable as the device is a physical therapy table and does not involve an algorithm or AI.

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

This information is not applicable in the context of the provided document. The "ground truth" for this device's performance is its conformity to established international safety and electrical standards, as demonstrated through testing by accredited bodies (e.g., Underwriters Laboratories).

8. The sample size for the training set

This information is not applicable as the device is a physical therapy table and does not involve AI or machine learning that would require a training set.

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

This information is not applicable as the device is a physical therapy table and does not involve AI or machine learning that would require a training set or its associated ground truth establishment.

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