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The Pulsaderm Wrinkle Mask 28 and 72 are intended for the use in the treatment of facial wrinkles and for people with Fitzpatrick Skin Types I,II and/or III.

The Pulsaderm Wrinkle Mask 28 and Wrinkle Mask 72 are over the counter devices and consist of a collection of red and infrared diodes for the treatment of facial wrinkles. Pulsadern Wrinkle Masks 28 and 72 are powered rechargeable Ni-MH batteries. To receive treatment, the user simply places the mask over the face for a specific period to receive treatment.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies for the Pulsaderm Wrinkle Mask 28 and 72.

It's important to note that this document is a 510(k) Summary, not a full study report. Therefore, it provides a high-level overview and justifications for substantial equivalence rather than detailed experimental results. The FDA's issuance of a substantial equivalence determination means they agreed the device is as safe and effective as a legally marketed predicate, not necessarily that new, extensive clinical trials proving efficacy outright were conducted for this specific device.

Acceptance Criteria and Study Details for Pulsaderm Wrinkle Mask 28 & 72

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" for clinical efficacy in the way one might expect for a new drug or novel medical device. Instead, the performance is primarily evaluated against predicate devices to demonstrate substantial equivalence, focusing on similar technological characteristics and the ability of lay users to understand product labeling and use the device.

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

A "lay-user study and self-selection study" was conducted.

• Sample Size: Not explicitly stated. The document only mentions "the majority of lay users."
• Data Provenance: This was a prospective study described as a "lay-user study and self-selection study." The country of origin is not specified, but the submission is to the U.S. FDA.

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

• Number of Experts: Not applicable/not stated in the context of the lay-user study. The ground truth for this usability study was based on the ability of lay users to comprehend instructions and self-select, rather than expert judgment on clinical outcomes.
• Qualifications of Experts: No experts were directly used to establish "ground truth" for the lay-user study's primary outcomes (comprehension and self-selection).

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The lay-user study focused on user comprehension and self-selection, which doesn't typically involve an adjudication process between multiple expert readers. The results were likely binary (understood/didn't understand, self-selected correctly/incorrectly) or rated on a simple scale.

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

• Was it done? No, an MRMC comparative effectiveness study was not done. This document focuses on demonstrating substantial equivalence to predicate devices, not on proving a specific clinical improvement or comparing performance with and without AI assistance (which is not relevant for this device type).

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

• Was it done? This question is not directly applicable to the Pulsaderm Wrinkle Mask, as it is a physical light therapy device, not an AI algorithm. Its performance is inherent in its design and operation, not an "algorithm only" component. The "performance data" refers to its physical characteristics and safety compliance, as well as the lay-user study.

7. The Type of Ground Truth Used

• Ground Truth for Lay-User Study: For the usability aspects of the lay-user study, the "ground truth" was likely established by pre-defined criteria for correct understanding of labeling and ability to follow instructions, assessed against an objective standard of "correct use" and "correct self-selection" based on the product's intended use and contraindications.
• Ground Truth for Clinical Efficacy: For the clinical efficacy aspect (reduction of wrinkles), the submission relies on the established efficacy of the predicate devices and the documented similarity of the Pulsaderm device's technological characteristics. No new clinical efficacy ground truth was established specifically for the Pulsaderm device within this 510(k) summary.

8. The Sample Size for the Training Set

• Sample Size: Not applicable. This device is a hardware product, not a machine learning model, so there is no "training set."

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

• How Established? Not applicable. As there is no training set for an algorithm, there is no ground truth established for it.

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