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The Zerona®-Z6 is indicated for use as non-invasive dermatological aesthetic treatment as an adjunct for individuals intending to undergo liposuction procedures for the reduction of circumference of hips, waist, and thighs.

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Here's a breakdown of the acceptance criteria and study information for the Zerona®-Z6 device, based on the provided FDA 510(k) clearance letter.

It's important to note that the provided text is an FDA clearance letter, which summarizes the FDA's decision and the device's indications for use. It typically references the underlying study data submitted by the manufacturer but does not contain the full study report itself. Therefore, some details (like specific sample sizes for training sets, detailed expert qualifications, or adjudication methods) may not be explicitly stated in this document but would be found in the manufacturer's 510(k) submission.

Study Context:

The Zerona®-Z6 is indicated for use an adjunct for individuals intending to undergo liposuction procedures for the reduction of circumference of hips, waist, and thighs.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes the indication for use, which implies the clinical effect the device is intended to achieve. However, it does not explicitly state a numerical "acceptance criteria" (e.g., "must reduce circumference by X cm") or specific "reported device performance" metrics. The FDA's 510(k) clearance process focuses on substantial equivalence to a predicate device, meaning the new device is as safe and effective as a legally marketed device. The specific performance data and statistical significance that justified this substantial equivalence would be in the full submission, not typically in the clearance letter.

To fully answer this, one would need access to the full 510(k) submission document (Premarket Notification file K133718), which would contain the clinical trial results.

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

The provided document does not explicitly state the sample size used for the clinical study that supported the 510(k) submission.

Data Provenance: The document does not specify the country of origin or whether the study was retrospective or prospective. Clinical trials for FDA clearance are typically prospective.

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

The provided document does not mention the number or qualifications of experts used to establish ground truth. For a device like this, "ground truth" would likely refer to objective measurements of circumference reduction, potentially taken by trained medical professionals.

4. Adjudication Method for the Test Set

The provided document does not specify an adjudication method.

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

The provided document does not indicate if an MRMC comparative effectiveness study was done. This type of study is more typically associated with imaging diagnostic devices where multiple readers interpret images. For a device like the Zerona®-Z6, which focuses on circumference reduction, the primary outcome would be objective measurements, not reader interpretation.

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

The Zerona®-Z6 is described as a "non-invasive dermatological aesthetic treatment," implying a device that directly applies a treatment. It is not an algorithm, so the concept of "standalone performance" for an algorithm does not apply in this context.

7. The Type of Ground Truth Used

Based on the device's indication for use ("reduction of circumference of hips, waist, and thighs"), the most probable "ground truth" would be objective anthropometric measurements (e.g., tape measurements) of the circumference of the target areas, taken by trained personnel using standardized protocols. These measurements would likely be compared to baseline measurements to determine reduction. Outcomes data relevant to patient satisfaction or changes in body contour could also be considered secondary ground truth.

8. The Sample Size for the Training Set

The concept of a "training set" primarily applies to machine learning algorithms. Since the Zerona®-Z6 is a treatment device, not an AI/ML algorithm, a "training set" in that sense would not be applicable.

If "training set" refers to the cohort used to establish the efficacy and safety parameters of the device during its development prior to the pivotal study, that information is not present in this document.

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

As with point 8, the concept of a "training set" in the AI/ML context is not directly applicable here. If referring to early development data, the ground truth would likely be established through objective circumference measurements, similar to the test set.

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The Erchonia® Zerona™ 2.0 Laser is indicated for use as a noninvasive dermatological aesthetic treatment as an adjunct for individuals intending to undergo liposuction procedures for the reduction of circumference of hips, waist, and thighs.

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The provided document is a 510(k) summary for the Erchonia® Zerona™ 2.0 Laser. It primarily focuses on the FDA's determination of substantial equivalence and regulatory compliance. It does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria, as typically found in clinical study reports or comprehensive device documentation.

Therefore, I cannot provide the requested information from the given text. The document does not include:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set or data provenance.
• Number and qualifications of experts for ground truth.
• Adjudication method.
• Information on a multi-reader, multi-case study or effect size.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for the training set.
• Method for establishing ground truth for the training set.

The document only states the "Indications for Use" for the device, which is "as a non-invasive dermatological aesthetic treatment as an adjunct for individuals intending to undergo liposuction procedures for the reduction of circumference of hips, waist, and thighs." To find the specifics of how this claim was substantiated, one would need to refer to the actual studies conducted by Erchonia Corporation and submitted to the FDA, which are not part of this 510(k) summary letter.

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