Search Results

The SmoothCool HR System is indicated for hair removal (permanent hair reduction).

The SmoothCool HR System is an Intense Pulsed Light (IPL) system used hair removal (Permanent hair reduction) in the area of dermatology. The system consists of a console containing the power unit and control electronics with control and display panel including software. Applicators/hand pieces are connected to the system in order to generate light energy for treatment in the waveband 420-950 nm. Four different hand pieces are attached with the system.

The provided text describes a 510(k) premarket notification for the "SmoothCool HR System," an Intense Pulsed Light (IPL) system for hair removal. However, it does not contain any information regarding acceptance criteria, device performance metrics, or any study involving a test set, expert adjudication, or AI assistance. The document focuses on establishing substantial equivalence to a predicate device based on technical characteristics and modifications (adding more filters).

Therefore, I cannot provide the requested information about acceptance criteria and the study proving the device meets them from the given text. The text only mentions "risk analysis and verification/validation tests" and lists "Energy Output Test" and "Button Operation Test" as performed, but does not provide specific criteria, results, or study details.

Here's what I can extract from the provided text, highlighting the absence of the requested information:

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

   • Information not provided. The document states that "risk analysis and verification/validation tests per modification" were performed, and "the test results support that the modifications do not raise a question in safety and performance." However, no specific acceptance criteria or performance metrics are detailed.

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

   • Information not provided. There is no mention of a test set, sample sizes, or data provenance (e.g., country of origin, retrospective/prospective study design).

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

   • Information not provided. No experts or ground truth establishment for a test set are mentioned.

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

   • Information not provided. No adjudication method is mentioned as a test set or clinical study is not described.

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:

   • Information not provided. This device is an IPL system for hair removal; it is not an AI-assisted diagnostic or imaging device, so an MRMC study with human readers and AI assistance would not be relevant.

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

   • Information not provided. This device is a physical IPL system, not an algorithm.

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

   • Information not provided. Ground truth is not discussed as no clinical study or diagnostic performance evaluation is described.

8. The sample size for the training set:

   • Information not provided. Training sets are not relevant for this type of device and the information provided.

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

   • Information not provided. Ground truth for a training set is not relevant here.

Ask a specific question about this device

The SmoothCool HR System is indicated for hair removal (permanent hair reduction).

SmoothCool HR System is an Intense Pulsed Light (IPL) system used for hair removal (permanent hair reduction) in the area of dermatology. The system consists of a console containing the power unit and control electronics with control and display panel including software. Applicators/hand pieces are connected to the system in order to generate light energy for treatment. Four different hand pieces are offered with the system.

The provided document is a 510(k) summary for the SmoothCool HR System, which is an Intense Pulsed Light (IPL) system for hair removal. It aims to demonstrate substantial equivalence to predicate devices, not to describe the acceptance criteria and study that proves the device meets those criteria in the way typically associated with AI/ML-based medical devices or diagnostic devices involving performance metrics like sensitivity, specificity, or AUC.

Therefore, the specific information requested in the prompt (e.g., acceptance criteria table, sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth type, training set sample size, how ground truth was established for training set) is not present in this document.

This document focuses on regulatory equivalence for a hardware device (IPL system) based on updated components and technical characteristics rather than a software algorithm's performance against clinical endpoints or expert consensus. The "tests" mentioned are for energy output and electrical safety/EMC, which are standard for such physical devices, not performance evaluation against clinical outcomes or a ground truth as would be relevant for devices that interpret data or diagnose conditions.

Ask a specific question about this device

The SmoothCool HR System is indicated for hair removal (permanent hair reduction).

Not Found

This document is a 510(k) clearance letter from the FDA for a device called the "SmoothCool HR System," indicated for hair removal (permanent hair reduction). It does not contain information about acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or details about ground truth establishment.

The letter focuses on the FDA's determination of substantial equivalence to a predicate device, which is a regulatory pathway for market clearance, not a detailed performance study report.

Therefore, I cannot extract the requested information from the provided text.

Ask a specific question about this device