(183 days)
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:
| Feature | Reported Information / Status |
|---|---|
| Acceptance Criteria | Not explicitly stated in quantitative terms. The general criterion for approval appears to be "safe and effective for the described indications for use" and that "the specific indications for use is met." |
| Reported Device Performance | "Clinical data has been provided to demonstrate that the NLite system is safe and effective." Specific performance metrics (e.g., percentage improvement in acne, side effect rates) are not detailed in this summary document. |
| Test Set Sample Size | Not provided. |
| Test Set Data Provenance | Not provided (e.g., country of origin, retrospective/prospective). |
| Number of Experts for GT | Not provided. |
| Qualifications of Experts for GT | Not provided. |
| Adjudication Method | Not applicable/Not provided. |
| MRMC Comparative Effectiveness Study | Not applicable (device is a laser for treatment, not an AI diagnostic aid). |
| Effect Size of Human Improvement with AI | Not applicable. |
| Standalone Performance Study (Algorithm only) | Not applicable (device is a physical laser system, not an algorithm). |
| Type of Ground Truth Used | Clinical outcomes data (e.g., assessment of acne severity, lesion counts, patient response, adverse event rates from clinical studies). |
| Training Set Sample Size | Not applicable in the ML sense; clinical study sample size not provided. |
| How Training Set GT was established | Not applicable in the ML sense. Efficacy evidence would be established through clinical assessment of treatment outcomes by qualified healthcare professionals during a clinical study. |
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.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.