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The NLite System is indicated for use in the specialties of Dermatology and Plastic Surgery, and in particular for the treatment of Inflammatory Acne Vulgaris`.
The NLite System is indicated for use in Dermatological and Plastic Surgery applications and this device is intended for use in the treatment of Inflammatory Acne Vulgaris.

The NLite System is a flashlamp pumped, pulsed dye laser consisting of the following:

• Main laser console incorporating the laser resonator and external optics, high . voltage delivery system, internal cooler, fluid circulation system, control unit and user interface;
• Flexible fibre optic delivery device and optical handpiece; ●
• Footswitch for pulsing control. ●

The provided text for the K024189 submission about the ICN Photonics NLite System does not contain the detailed information necessary to fully address all aspects of the request regarding acceptance criteria and the study proving the device meets them. The submission primarily focuses on establishing substantial equivalence to a predicate device and confirming safety and efficacy for its stated indications for use (treatment of Inflammatory Acne Vulgaris).

Here's a breakdown of what can and cannot be extracted from the provided documents:

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

The document does not explicitly state quantitative acceptance criteria (e.g., a specific percentage reduction in lesions, or a particular success rate) or present a table of device performance against such criteria. It generally states that "Clinical data has been provided to demonstrate that the NLite system is safe and effective for the described indications for use" and "The clinical data provided has demonstrated that the specific indications for use is met and the safety and efficacy of the system has been proved."

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

This information is not provided in the submission. There is no mention of the number of subjects in any clinical study.

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 submission.

4. Adjudication method for the test set

This information is not provided in the submission.

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 NLite System is a laser-based medical device for treating acne, not an AI-assisted diagnostic or imaging device. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study with 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 question is not applicable as the NLite System is a therapeutic device, not an algorithm, and intrinsically involves human-in-the-loop operation (a practitioner using the laser).

7. The type of ground truth used

While not explicitly stated as "ground truth," the studies for demonstrating safety and efficacy for a therapeutic device like this would typically rely on clinical outcomes data. This would involve pre- and post-treatment assessment of acne severity (e.g., lesion counts, grading scales), patient satisfaction, and adverse event reporting.

8. The sample size for the training set

This information is not provided. For a therapeutic device, there isn't a "training set" in the machine learning sense. The clinical studies (which would serve as the basis for evidence) are referred to globally without specific numbers.

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

As with point 8, the concept of a "training set" with established ground truth in the machine learning context does not directly apply to this type of device. The evidence for efficacy would be established through a clinical trial where clinical endpoints (e.g., reduction in acne lesions) are measured and assessed by clinicians.

Summary of available information as per the request:

In conclusion, this 510(k) submission summary for the NLite System focuses on demonstrating substantial equivalence to a predicate device and confirming general safety and effectiveness through clinical data, rather than providing the detailed technical and statistical information typically found for AI/ML-based diagnostic devices. The details requested are not present in this regulatory document.

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The NLite System laser system is indicated for use in Dermatological and Plastic Surgery applications and this device is intended for use in the treatment of Vascular lesions, such as : Port Wine Stains, Telangiectasia, Leg Veins, Spider Veins, Spider Naevus, Poikiloderma of civatte, Hemangiomas, Angiomas, Rosacea

And benign cutaneous lesion, such as: Scars, Straie, Psoriasis, Verrucae Vulgaris and Warts.

The NLite System is a flashlamp pumped, pulsed dye laser consisting of the following:

• Main laser console incorporating the laser resonator and external optics, high . voltage delivery system, internal cooler, fluid circulation system, control unit and user interface;
• Flexible fibre optic delivery device and optical handpiece; .
• Footswitch for pulsing control. .

The provided text is a 510(k) summary for the ICN Photonics Ltd., Nlite System, a laser device. It specifically states that no additional efficacy information was required because the device was found to be substantially equivalent to predicate devices. This means a direct study demonstrating clinical acceptance criteria for the Nlite System itself was not performed or provided within this document.

Therefore, many of the requested sections regarding a specific study proving device performance against acceptance criteria cannot be directly answered from the given text.

Here's a breakdown based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable: The substantial equivalence determination negated the need for an independent clinical study with a test set for the Nlite System's efficacy. The "test" was a comparison against the specifications and performance of the predicate devices.

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

• Not Applicable: No clinical test set requiring expert-established ground truth was part of this 510(k) submission for efficacy. The ground truth was based on the established safety and efficacy of the predicate devices.

4. Adjudication Method for the Test Set

• Not Applicable: No clinical test set requiring adjudication was performed as part of this 510(k) submission for efficacy.

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: This device is a laser system for medical treatment, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI assistance are not relevant to this submission.

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

• Not Applicable: This device is a laser system, not an algorithm. Its performance is directly tied to the physical output of the laser and its application by a human operator in a clinical setting.

7. The Type of Ground Truth Used

• Predicate Device Performance (Established Safety and Efficacy): The primary "ground truth" used for this submission was the established safety and efficacy of the legally marketed predicate devices. The NLite System demonstrated that its parameters and indications for use were equivalent to these already-approved devices, implying similar performance and outcomes.

8. The Sample Size for the Training Set

• Not Applicable: There is no mention of a "training set" in the context of this 510(k) submission, as it relates to a physical device rather than a machine learning algorithm.

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

• Not Applicable: See point 8.

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The NLite System is indicated for use in the specialties of Dermatology and Plastic Surgery, and in particular for the treatment of wrinkles.

The NLite System is indicated for use in Dermatological and Plastic Surgery applications and this device is intended for use in the treatment of wrinkles.

The NLite System is a flashlamp pumped, pulsed dye laser consisting of the following:

• Main laser console incorporating the laser resonator and external optics, high voltage delivery system, internal cooler, fluid circulation system, control unit and user interface;
• Flexible fibre optic delivery device and optical handpiece;
• Footswitch for pulsing control.

The provided text details a 510(k) submission for the ICN Photonics NLite System, specifically for an expansion of its claims to include the treatment of wrinkles. However, it does not contain the detailed acceptance criteria for a study, nor the reported device performance against such criteria. The document is primarily a regulatory submission for substantial equivalence.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them with the provided input. The document mentions that "Clinical data has been provided to demonstrate that the NLite system is safe and effective for the described indications for use," and "The clinical data provided has demonstrated that the specific indications for use is met and the safety and efficacy of the system has been proved," but it does not include the details of this clinical data.

To answer your request, information on the specific study design, acceptance criteria, and detailed results would be needed.

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The NLite System is indicated for use in Dermatological and Plastic Sur ery applications and this device is intended for use in the trea ment of periocular wrinkles.

NLite System

I apologize, but the provided text from the FDA 510(k) clearance letter for the "NLite System" does not contain the detailed information required to answer your request about acceptance criteria and study particulars.

The letter is the clearance itself, stating that the device is "substantially equivalent" to predicate devices, but it does not describe the specific performance studies, acceptance criteria, sample sizes, or ground truth methodologies that were submitted to or reviewed by the FDA as part of the premarket notification.

This type of information is typically found within the 510(k) submission document itself, which is often not publicly available in its entirety without a Freedom of Information Act (FOIA) request.

Therefore, I cannot provide the requested table or answer the specific questions about the study from the given text.

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Ask a specific question about this device