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Relieves minor muscle aches and pains; Relieve muscle spasm; Temporarily Improve local circulation; Temporarily reduces the appearance of cellulite; Relieves minor muscle aches and pains, relieves muscle spasm and improves local circulation during Burn rehabilitation

The LPG devices are intended for practitioners who work in specific fields but all are substantially equivalent devices: ES1 for Endermologie; Cellu M6 for Endermologie and therapeutic applications; S6 sport for sport applications, before, after exercise and rehabilitation after injuries; ES/M60 for therapeutic applications and cosmetic applications on the face or on small area; LPG Equine for animal treatment. These devices are substantially equivalent to the ES1 therapeutic massager because the mode of operation and operating parameters and specifications are basically the same. Each LPG device comprises a main console housing a vacuum pump and a computerized regulation system. All of them contain treatment heads (from 5 to 12), that are designed to accommodate all parts of the body. ES1, Cellu M6, S6, LPG Equine devices have a main motorized head, the other device contain auxiliary heads (non-motorized) only. The equine device head is the largest in order to be able to be applied on the horse's body surface. The suction power of all these machines range from 50mBar to 500mBar which is represented by a scale from 1 to 10; for a specific machine and application, the suction power must be cyclically interrupted to provide vibration to the skin which is another stimulation for the tissues.

The provided text describes a 510(k) summary for the LPG Therapeutic Massager/Vibrator, which details its substantial equivalence to existing devices and its intended uses. However, it does not contain the kind of detailed study information (like acceptance criteria, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC study results) that would be needed to fill out the requested table and answer all questions directly.

The document states, "Our objective is not to substantiate new claims but to prove that the exempt claims are appropriate for the burn victim and that the product is safe and effective for its general uses when used in burn rehabilitation." This indicates that the 510(k) submission primarily relies on demonstrating substantial equivalence to predicates for its claims, rather than presenting a novel clinical study with explicit acceptance criteria for device performance.

One study is mentioned: "Doctor Gavroy compared treatment on burn victim with LPG and rhythmicity and LPG without rhythmicity." However, no details about the study design, sample size, methodology, or results are provided to determine how it would "prove" the device meets specific acceptance criteria.

Therefore, many of the requested fields cannot be filled from the provided document.

Here's an attempt to answer based on the available information, with explanations for what cannot be provided:

Acceptance Criteria and Device Performance Study for LPG Therapeutic Massager/Vibrator

The provided 510(k) summary for the LPG Therapeutic Massager/Vibrator (K990445) does not explicitly define acceptance criteria in terms of specific performance metrics that the device had to meet in a study. The submission relies on demonstrating substantial equivalence to legally marketed predicate devices for its intended uses. The "performance" is implicitly demonstrated through the device's adherence to the established indications for use of the predicate devices and its design and specifications being comparable.

The objective stated is: "Our objective is not to substantiate new claims but to prove that the exempt claims are appropriate for the burn victim and that the product is safe and effective for its general uses when used in burn rehabilitation." This suggests the efficacy for established claims is taken as given based on substantial equivalence, with a specific focus on the applicability of these claims to burn rehabilitation.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not explicitly stated for any formal clinical trial or test set in the document.
• Data Provenance: The general context indicates the company is French (LPG Systems Technoparc de la Plaine, France), and the inventor is Louis Paul Guitay. One study mentions "Doctor Gavroy compared treatment on burn victim with LPG and rhythmicity and LPG without rhythmicity," but the country of origin of this study or its retrospective/prospective nature is not specified. The claim for cellulite reduction is based on observing results in female patients being treated for low back pain, described as part of a "specific methodology based on physiological and pathological data" rather than a formal test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not specified. The document primarily relies on substantial equivalence and a methodology ("Endermologie") with observed "significant" results for the cellulite claim. The "Doctor Gavroy" study details are absent.

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

• Not specified.

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/Not mentioned. The device is a therapeutic massager, not an AI-assisted diagnostic or imaging device where "human readers" or AI assistance in that context would typically apply.

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

• Not applicable. This is a physical therapeutic device, not an algorithm. Its operation is "standalone" in the sense that it performs its physical function, but it is applied by a practitioner ("licensed physician" per caution, or "practitioners" in general).

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

• For claims of relieving pain, muscle spasm, and improving circulation, the ground truth is implied by the established efficacy of the predicate devices and general scientific literature on vibration therapy.
• For the cellulite reduction claim, the ground truth was based on observed outcomes ("noticed that their patients were showing an improvement...Results on the appearance of cellulite were so significant"). This was formulated into a "specific methodology based on physiological and pathological data."
• For burn rehabilitation, the ground truth relies on a comparison study by "Doctor Gavroy," but the specific type of ground truth measured (e.g., pain scales, circulation markers, recovery rates) is not detailed.

8. The sample size for the training set:

• Not applicable/Not specified. This is a physical device, and the "Endermologie" methodology evolved from clinical observations rather than a computational "training set."

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

• Not applicable for a "training set" in the computational sense. The efficacy for the claims is rooted in the perceived effects of the LPG technique and its substantial equivalence to predicate devices. For the cellulite claim, it was established through observation of "significant" improvement in patients over an average of fourteen sessions during development of the "Endermologie" methodology. This seems to be a form of empirical observation from initial clinical use rather than a formally established ground truth for a defined training dataset.

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