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The Shaser Skin Beauty SkinREJUV Intense Pulsed Light System Family is a prescription home use device intended to provide phototherapeutic light to the body. It is specifically intended for:
The treatment of benign pigmented lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles);
The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosecea, erythema of rosacea, angiomas, poikiloderma of Civate, leg veins and venous malformations.

Shaser Skin Beauty SkinREJUV Intense Pulsed Light System Family devices are prescription home use, light-based skin care systems. The family includes an AC mains powered and battery powered version of the same device. The Principle of Operation is selective photothermolysis and the Mechanism of Action is to lighten or resolve lesions using light for preferentially heating. Emission activation is by finger switch. Device includes a limited life treatment head. Electrical requirement is 115 VAC, 15A, 50-60 Hz, single phase.

The provided text describes the Shaser Skin Beauty SkinREJUV Intense Pulsed Light System Family, a prescription home-use device for treating benign pigmented and vascular lesions. The document focuses on regulatory approval (510(k)) and demonstrates substantial equivalence to predicate devices.

However, the document does not contain the detailed information needed to construct a table of "acceptance criteria and reported device performance" as typically understood in a medical device study (e.g., sensitivity, specificity, accuracy, or specific clinical outcomes for lesion treatment). The acceptance criteria described are primarily related to label comprehension and safe usability in a simulated home-use environment, rather than the clinical efficacy of treating lesions.

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

Here's an attempt to answer based on the available information:

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

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

• Label Comprehension Test Set Sample Size: 150 subjects
• Usability Test Set Sample Size: 123 subjects
• Data Provenance: The study was a "label comprehension and usability test of consumers" and was conducted in a "simulated home-use environment." The country of origin is not specified, but the submission is to the U.S. FDA. It would be considered a prospective study for regulatory purposes. The text explicitly mentions "Both test populations included low literacy subjects."

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

This information is not provided in the document. The ground truth for label comprehension and usability would typically be established by defining correct understanding and safe operation, likely assessed by trained observers or evaluators, but no details on their number or qualifications are given.

4. Adjudication method for the test set

This information is not provided in the document. For label comprehension and usability tests, an adjudication method (like 2+1 or 3+1) is not typically used as it would for clinical diagnostic endpoints. Assessments are usually made based on objective criteria or observer ratings.

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, an MRMC comparative effectiveness study was NOT done. This device is an Intense Pulsed Light System for direct treatment, not an AI-assisted diagnostic tool for "human readers." The document describes a usability and label comprehension study for a direct treatment device, not a diagnostic aid.

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

• This question is not applicable as the device described is a direct treatment device (Intense Pulsed Light System), not an algorithm or AI system. Its performance inherently involves human interaction for operation as a home-use device. The "standalone" performance here refers to its physical operation and energy output, which was subject to "Bench testing for performance verification."

7. The type of ground truth used

• For the label comprehension test: "Ground truth" was established by pre-defined correct answers/interpretations of the Instructions For Use (IFU) and safety warnings.
• For the usability test: "Ground truth" was established by pre-defined safe and appropriate operational steps and procedures for using the device.

8. The sample size for the training set

• This information is not provided. The document describes a usability and label comprehension study, which are typically evaluation studies, not "training set" development for machine learning models. The device's underlying technology (Intense Pulsed Light) relies on established principles of photothermolysis, not a machine learning model that requires a training set.

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

• This information is not applicable as there is no "training set" in the context of this device and study. The device's operation is based on physical principles, not a machine learning model.

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