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The EON (1064nm laser) is intended for non-invasive lipolysis of the abdomen, flanks, back, and thighs to achieve disruption of adipocyte cells intended for non-invasive aesthetic use to achieve a desired aesthetic effect. It is intended for individuals with a Body Mass Index of 30 or less.

EON aesthetic laser system is 1064nm diode laser device that is intended for non-invasive lipolysis of the abdomen, flanks, back, and thighs in individuals with a Body Mass Index (BMI) of 30 or less. This wavelength is used to affect the appearance of visible fat bulges in the abdomen and flanks.

Both laser energy and cooling air are delivered concurrently through the same treatment head that is positioned and moved over the skin at a fixed height by a robotic arm. The treatment head is never in contact with the skin.

During treatment, the desired area will be defined by the physician and will be treated with the 1064nm laser over a 20-minute timeframe. The mechanism of action is to preferentially heat the adipose tissue to temperatures that will induce apoptosis (>42°C). The cooling system will maintain the skin at comfortable temperature (<43°C).

The provided text describes a 510(k) premarket notification for the EON aesthetic laser system. The submission, K222226, seeks to expand the indications for use of the EON device to include the thighs and back, in addition to the previously cleared abdomen and flanks.

The documentation focuses on demonstrating substantial equivalence to a predicate device (K211681), which is also the EON system but with a more limited indication for use.

Based on the provided text, the information regarding acceptance criteria and the study proving the device meets these criteria is very limited and primarily relies on literature support rather than a de novo clinical study with specific acceptance criteria.

Here's an attempt to extract the requested information, highlighting what is provided and what is not provided:

Acceptance Criteria and Study for EON (K222226)

The EON device is a low-level laser system intended for non-invasive lipolysis. The current submission (K222226) is an update to a previously cleared device (K211681 and K180511), seeking to expand its indications to include the thighs and back.

The primary method used to demonstrate device performance and substantial equivalence for the expanded indications is via literature review and justification, rather than a new, dedicated clinical study with pre-defined acceptance criteria for the new treatment areas. Therefore, explicit "acceptance criteria" in the traditional sense of a clinical trial (e.g., statistical thresholds for efficacy endpoints) are not presented for this specific submission for the new treatment areas. Instead, the "acceptance" is based on inferring equivalent safety and effectiveness from existing data and the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

As specific numerical acceptance criteria for clinical efficacy for the new indications (thighs and back) are not provided in this document, the table reflects the regulatory claim of substantial equivalence and relies on the performance of the predicate.

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

• Sample Size for Test Set: Not applicable. No new specific clinical test set was used for the expanded indications. The FDA submission relies on "Literature" to support the addition of thighs and back. The sample size for the original studies that supported the predicate device (K211681, K180511) is not detailed in this document.
• Data Provenance: "Literature was used to support the addition of the two proposed areas (thighs and back)." The specific origin (country, retrospective/prospective) of this literature is not specified in the provided document.

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

Not applicable. No new specific test set requiring expert ground truth establishment for the expanded indications (thighs and back) is described in this document. The reliance is on existing literature and the established performance of the predicate device.

4. Adjudication Method for the Test Set

Not applicable. No new specific test set is described.

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

No. An MRMC comparative effectiveness study is not mentioned or described in this document. The submission relies on demonstrating substantial equivalence based on technical specifications and existing literature/predicate performance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

Not applicable. The EON is a physical laser device, not an AI algorithm. Its performance is directly tied to its physical operation rather than an independent algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the expanded indications (thighs and back) is implicitly established through published literature regarding the efficacy and safety of similar laser lipolysis technologies and the known performance of the EON device in previously cleared indications (abdomen and flanks). It is not based on pathology or specific outcomes data from a new trial for these expanded areas within this submission document.

8. The Sample Size for the Training Set

Not applicable. This device is a physical laser system, not an AI/ML algorithm that requires a "training set" in the computational sense.

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

Not applicable.

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