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The ProLite / Plasmalite MPX Pulsed Light System is indicated to permanently reduce unwanted hair.
The ProLite / Plasmalite MPX is intended to be used for the permanent reduction of unwanted hair.

The ProLite / PlasmaliteMPX 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 supply and microcontroller, the umbilical to the handpiece, and the handpiece, which houses the waveguide

Below is an analysis of the provided text regarding the ProLite / Plasmalite MPX Pulsed Light System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (510(K) Summary for ProLite / Plasmalite MPX Pulsed Light System) focuses on demonstrating "substantial equivalence" to a predicate device rather than setting explicit, quantifiable "acceptance criteria" in the typical sense of a clinical trial's primary endpoint. The primary outcome discussed relates to the intended use of the device, which is "to permanently reduce unwanted hair."

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

• Sample Size: The document does not specify the exact number of subjects in the clinical study. It generically states "Clinical studies were conducted" and "Observation in the clinical study were recorded prior to treatment and at 3-6 months after treatment."
• Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).

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

The document does not provide information on the number or qualifications of experts used to establish a ground truth for the test set. The efficacy is described as being observed (e.g., reduction of hair, absence of scarring), but the method of assessment for this observation (e.g., expert clinical assessment, objective measurement) is not detailed.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method for the test set results.

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 section is not applicable. The device is a pulsed light system for hair removal, not an AI-powered diagnostic or assistive technology for human readers. Therefore, an MRMC study related to human reader improvement with AI is irrelevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This section is not applicable. The device is a physical medical device (pulsed light system) and does not involve an algorithm working in a "standalone" capacity in the sense of AI performance. Its performance is directly tied to its physical application by a human operator.

7. The Type of Ground Truth Used

The "ground truth" for the efficacy of the hair removal system appears to be clinical observation/outcomes data. The document states:

• "Observation in the clinical study were recorded prior to treatment and at 3-6 months after treatment."
• "The study demonstrated that selective photothermolysis targeting melanin in the human hair follicle is an effective tool for hair removal."
• "There was no scarring in any subject."

This indicates that the effectiveness and safety were assessed directly from the patients' responses to the treatment.

8. The Sample Size for the Training Set

This section is not applicable. The device is a physical pulsed light system and does not involve a "training set" in the context of machine learning or AI algorithms. The "clinical studies" mentioned are for validation/testing, not for training.

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

This section is not applicable for the same reasons as point 8.

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

The Plasmalite 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 supply and microcontroller, the umbilical to the handpiece, and the handpiece, which houses the waveguide

The provided text describes the Plasmalite Pulsed Light System and its substantial equivalence to a predicate device, the ProLite Pulsed Light System. However, it explicitly states that no clinical studies were specifically conducted for the Plasmalite device. Instead, it relies on the clinical studies performed for its predicate, the ProLite.

Therefore, many of the requested details about acceptance criteria, study design, and ground truth for the Plasmalite device cannot be provided directly from this document. The information below reflects what is available or inferred from the provided text, primarily referencing the predicate device's studies when mentioned.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for the Plasmalite Pulsed Light System. It asserts substantial equivalence to the ProLite Pulsed Light System, which was previously cleared. The "performance data" section only states that the Plasmalite is technically the exact device as the ProLite.

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

The document states: "No Clinical studies were specifically conducted using the Plasmalite. The Plasmalite is technically the exact device as the predicate device, the ProLite. Results from the clinical studies for the ProLite were submitted in 510(K) number 013366."

Therefore, the sample size and data provenance information refers to the studies conducted for the predicate device, ProLite, and this specific document does not provide those details.

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

This information is not available in the provided document, as no specific clinical studies for the Plasmalite device are detailed, and the details of the predicate's studies (K013366) are not included here.

4. Adjudication method for the test set

This information is not available in the provided document, as no specific clinical studies for the Plasmalite device are detailed, and the details of the predicate's studies (K013366) are not included here.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done

This information is not available in the provided document. The device is a pulsed light system for hair removal, not an imaging or diagnostic device that would typically involve a multi-reader study.

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

This question is not applicable as the device is a medical device for hair removal, not an AI algorithm.

7. The type of ground truth used

For the predicate device (ProLite), the ground truth for hair removal studies would typically involve objective measurements of hair count reduction or clinical assessment of hair regrowth over a period. However, the specific type of ground truth used for the ProLite studies is not described in this 510(k) summary.

8. The sample size for the training set

This question is not applicable as the device is a medical device, not an AI algorithm requiring a training set in the conventional sense.

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

This question is not applicable as the device is a medical device, not an AI algorithm.

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

The ProLite / Plasmalite MPX 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 supply and microcontroller, the umbilical to the handpiece, and the handpiece, which houses the waveguide

The provided text does not contain any information regarding acceptance criteria or a study proving device performance.

The document is a 510(k) summary for the ProLite / Plasmalite MPX Pulsed Light System. It states that "Performance Data: None" and concludes that the device is "substantially equivalent to other existing pulsed light systems in commercial distribution for removal of unwanted hair in all skin types according to the Fitzpatrick Scale."

Therefore, I cannot provide the requested information.

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The ProLite Pulsed Light System is intended to be used in the treatment of vascular lesions.

The Prolite / Plasmalite MPX 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 document (K022569/A) states under "Performance Data:" that there is "None". Therefore, the remaining requested information regarding acceptance criteria and study details cannot be extracted from this submission.

Here is the table that can be created based on the available information:

Table of Acceptance Criteria and Reported Device Performance

Further information regarding the study:

1. Sample size used for the test set and the data provenance: Not applicable, as no performance data or study details are provided.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
3. Adjudication method for the test set: Not applicable.
4. 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.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a pulsed light system, not an AI algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
7. The sample size for the training set: Not applicable.
8. How the ground truth for the training set was established: Not applicable.

The submission focuses solely on demonstrating substantial equivalence to a predicate device (ProLite Pulsed Light System, K number 010928) based on its design, intended use (treatment of vascular lesions), and technical specifications (delivers pulsed light at 550 nanometers). It does not include any clinical performance data or studies.

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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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