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The ProLite™ Pulsed Light System, equipped with the HR handpiece and 600 nanometer filter, is intended for the removal of unwanted hair in all Fitzpatrick skin types.

The ProLite™ Pulsed Light System, equipped with the SR handpiece and 550 or 580 nanometer filters, is intended for the treatment of benign pigmented lesions and the removal of tattoos, the treatment of vascular lesions, and the treatment of shallow facial veins, telangiectasia, facial hemangiomas, and rosacea vascular lesions

The 550 nanometer filter may be more efficient for Types I and II skin. The 580 nanometer filter may be more efficient for Types III and IV skin.

The ProLite™ Pulsed Light System uses a Xenon Flash Lamp which is filtered to specified wavelengths for its intended uses. The System consists of a cabinet with power supply, a distilled water cooling system, the microcontroller, an umbilical which attaches to a handpiece which houses the selected filter.

The provided text explicitly states, "Performance Data: None required." It clarifies that "The claim of substantial equivalence is based the fact that the ProLite™ Pulsed Light System described in this premarket notification is the same as described in several previous premarket notifications. No changes in specifications, performance characteristics, or indications for use are proposed."

Therefore, based on the input text:

1. A table of acceptance criteria and the reported device performance: Not provided. The submission claims no performance data was required because the device is "substantially equivalent to itself."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as no performance data or test set was reported.

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): Not applicable, as no ground truth was established for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no test set or adjudication was performed.

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: Not applicable. The device is a pulsed light system, not an AI-assisted diagnostic tool, and no comparative effectiveness study was reported.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a physical system, not an algorithm, and no standalone performance study was reported.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no ground truth was established or used for performance evaluation.

8. The sample size for the training set: Not applicable, as no training set was mentioned or used for device development or evaluation.

9. How the ground truth for the training set was established: Not applicable, as no training set or its ground truth was established.

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The ProLite Pulsed Light System is indicated for use to remove unwanted hair in all skin types according to the Fitzpatrick Scale.

The ProLite Pulsed Light System delivers pulsed light at a wavelength beginning at a wavelength of 600 nm. The device consists of three interconnected sections: The cabinet which houses the internal cooling system, power sypply and microcontroller, the umbilical to the handpiece, and the handpiece, which houses the waveguide

This document describes the ProLite Pulsed Light System for hair removal. However, it does not contain acceptance criteria in the typical sense for a medical device study leading to performance metrics for the device itself. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

Here's an analysis of the provided text in relation to your request:

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

The document does not provide specific quantitative acceptance criteria (e.g., "90% hair reduction after X treatments") or detailed device performance metrics (e.g., "average hair reduction of Y%").

Instead, the "Performance Data" section states: "Clinical studies were conducted to provide assurance that difference in the specifications of the ProLite Pulsed Light System and the predicate device for hair removal did not result in different performance during use." And the "Results of Clinical Study" section states: "Observation in the clinical study were recorded prior to Results of Clinical Study: treatment and at 3-6 months after treatment. There was no scarring in any subject. The study demonstrated that selective photothermolysis targeting melanin in the human hair follicle is an effective tool for hair removal."

The "Conclusion" then states: "The ProLite Pulsed Light System is substantially equivalent to other existing pulsed light systems in commercial distribution for removal of hair in Dermatology and Plastic Surgery."

Therefore, the implicit acceptance criterion is that the ProLite Pulsed Light System performs similarly to the legally marketed predicate device (EpiLight/Photoderm HR System, K974536) in terms of efficacy for hair removal and safety (no scarring). The documented performance is that the study "demonstrated that selective photothermolysis targeting melanin in the human hair follicle is an effective tool for hair removal" and that there was "no scarring in any subject."

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: The document does not explicitly state the sample size of subjects in the clinical study. It only refers to "any subject" in the results, implying a group of individuals participated.
• Data Provenance: Not specified. The applicant is from Sweden, but the location of the clinical study is not mentioned.
• Retrospective or Prospective: Not specified, but clinical studies are generally prospective.

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 in the document. The evaluation of hair removal and scarring would typically involve medical professionals, but their number and qualifications are not mentioned.

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

This information is not provided.

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

This document describes a medical device, not an AI software. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned.

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

This is a physical pulsed light system, not an algorithm. Therefore, "standalone" performance in the context of an algorithm is not applicable and not mentioned. The device's performance is inherently "standalone" in that it performs the therapeutic action.

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

The "ground truth" or primary endpoints for this type of device would typically be observed hair reduction and absence of adverse events (like scarring). The document states "Observations in the clinical study were recorded prior to treatment and at 3-6 months after treatment." This implies clinical observation and outcomes data were used.

8. The sample size for the training set

This is a physical device, not a machine learning model, so there is no training set in the context of AI.

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

As there is no training set for an AI model, this is not applicable.

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The ProLite Pulsed Light System is indicated the treatment of benign pigmented lesions and the removal of tattoos.

The ProLite Pulsed Light System delivers pulsed light at a wavelength of 550 nanometers. The device consists of three interconnected sections: The cabinet which houses the power supply, the cooling system and the microcontroller, the umbilical to the handpiece, and the handpiece, which houses the waveguide.

The provided text is a 510(k) summary for the ProLite Pulsed Light System, and it primarily focuses on establishing substantial equivalence to a predicate device rather than presenting detailed data from a specific study designed to meet pre-defined acceptance criteria for the new device.

Therefore, much of the requested information regarding acceptance criteria, specific study design, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not available in the provided document.

Here's what can be extracted based on the input:

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

The document does not specify quantitative acceptance criteria or provide detailed performance data from a specific study. Instead, it makes a general statement of substantial equivalence to an existing predicate device.

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

The document does not provide information on a specific test set sample size or data provenance. Since it establishes substantial equivalence, it likely refers to the performance of the predicate device.

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

The document does not provide information on experts used to establish ground truth.

4. Adjudication method for the test set

The document does not provide information on any adjudication method.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. This device is a pulsed light system, not an AI-driven diagnostic tool, so such a study would likely not be applicable.

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

The document does not describe a standalone algorithm performance study. This device is a medical instrument used by practitioners.

7. The type of ground truth used

The document does not explicitly state the type of ground truth used as it doesn't describe a specific performance study. Given the intended use (treatment of benign pigmented lesions and tattoo removal), ground truth in relevant studies for such devices typically involves clinical assessment of treatment efficacy and safety, potentially supported by photographic evidence or patient reported outcomes.

8. The sample size for the training set

The document does not provide information on a training set sample size.

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

The document does not provide information on how ground truth for a training set was established.

Summary of what is available from the document regarding "acceptance" and "proof":

The document's central claim is:

• Conclusion: "The ProLite Pulsed Light System is substantially equivalent to other existing pulsed light systems in commercial distribution for treatment of benign pigmented lesions and the removal of tattoos in Dermatology and Plastic Surgery."

The "proof" for this "acceptance" of substantial equivalence is based on:

• Predicate Device Comparison: The ProLite Pulsed Light System is compared to the Photoderm PL System (K60772).
• Device Description: Both devices deliver pulsed light. The ProLite system delivers pulsed light at a wavelength of 550 nanometers. The document implies that the operating principles and intended use are similar enough to the predicate device to establish equivalence, rather than presenting de novo performance data.
• Intended Use: "The ProLite Pulsed Light System is indicated the treatment of benign pigmented lesions and the removal of tattoos." This matches the general scope of use for similar pulsed light systems according to the 510(k) process for substantial equivalence.

In essence, the "acceptance criteria" here implicitly refer to the FDA's criteria for substantial equivalence, and the "study that proves the device meets the acceptance criteria" is the 510(k) submission process itself, where the manufacturer demonstrates that the new device is as safe and effective as a legally marketed predicate device. The document provided is the FDA's response confirming this substantial equivalence, not a detailed clinical study report comparing performance against specific metrics.

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