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The iPulse SmoothSkin Hair Removal System is an intense pulsed light (IPL) system composed of a base unit housing the electrical and electronic sub-assembly and an umbilical cord which is connected to the applicator, located in which is the source of optical radiation, namely a Xenon flashlamp. The system is powered from AC power via an external power converter.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the iPulse SmoothSkin Hair Removal System, a light-based over-the-counter hair removal system. The information is primarily focused on demonstrating substantial equivalence to predicate devices, rather than establishing specific acceptance criteria for performance against a defined standard.

Therefore, the requested information elements related to acceptance criteria, specific performance metrics, sample sizes for test/training sets, ground truth establishment, expert involvement, and comparative effectiveness studies as typically found in AI/algorithm device submissions are not detailed in this document.

However, based on the information provided, here's what can be extracted and inferred:

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

The document doesn't explicitly state "acceptance criteria" in a table format with specific quantifiable thresholds for device performance. Instead, it reports the outcome of a clinical study aimed at demonstrating hair reduction efficacy.

Performance Metric	Reported Device Performance
Hair Reduction	Mean hair count reduction of 54.7% at six months
Subjects experiencing hair reduction	83.3% of subjects

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample size for the test set: 29 subjects for clinical testing.
Data provenance: Not explicitly stated, but clinical testing is generally prospective. The country of origin for the data is also not stated, but the company is based in the UK.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not provided. The study design described focuses on quantifiable hair count reduction, which would be measured directly rather than requiring expert ground truth in the same way an AI diagnostic device would.

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

This information is not provided. Hair count reduction measurements typically involve direct observation and measurement by study personnel rather than an adjudication process between experts.

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 MRMC comparative effectiveness study was done. This device is a direct-to-consumer hair removal system, not an AI diagnostic algorithm that assists human readers.

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

This concept is not applicable as this is not an algorithm-only device. It's a physical hair removal system.

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

The "ground truth" for efficacy was based on quantitative hair count reduction observed at specified follow-up intervals (six months after the last treatment). This is an objective clinical outcome.

8. The sample size for the training set

This information is not applicable. The device is a physical system, not an AI model that requires a training set.

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

This information is not applicable for the reasons stated above.

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