(118 days)
The Intense Pulsed Light (IPL) Systems (inclusive of the handpiece used to deliver pulsed-light energy) are indicated for use in surgical, aesthetic and cosmetic applications in permanent hair reduction, treatment of pigmented lesions, moderate inflammatory acne vulgaris, ephelides (freckles), and vascular lesions.
The Intense Pulsed Light (IPL) Systems are intense pulsed light system which delivers intense pulsed light at a wavelength ranging from 430nm-1200nm. Intense Pulsed Light (IPL) systems work on the principles of selective thermolysis. That is, causing thermal damage to target chromophores by using light of appropriate wavelength in pulses that exceeds the chromophores' thermal relaxation time but sparing normal skin by limiting the pulse width below the thermal relaxation time for skin. IPL Systems are different from lasers in that they deliver many wavelengths in each pulse of light instead of just one wavelength. Generally, IPL enhances penetration without using excessive energy levels and enables targeting of specific chromophores.
The provided text describes a 510(k) submission for the Intense Pulsed Light (IPL) Systems (K122995), which seeks to demonstrate substantial equivalence to a predicate device (IPULSELIGHT IPL SYSTEM, K093627). However, it does not contain information about a clinical study demonstrating the device's performance against specific acceptance criteria.
The document focuses on non-clinical bench tests to verify that the proposed device met design specifications and standard compliance, and a detailed comparison with the predicate device to establish substantial equivalence.
Therefore, many of the requested sections regarding acceptance criteria, study details, human reader performance, and ground truth establishment cannot be fulfilled from the provided text.
Here's a breakdown of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
Based on the provided text, there are no specific performance acceptance criteria reported for clinical efficacy. The "acceptance criteria" discussed are primarily related to safety and technical specifications, which are implicitly met by complying with the listed standards and demonstrating similarity to the predicate device.
Safety and Technical Performance Criteria (Inferred from compliance and comparison):
| Acceptance Criteria Category | Reported Device Performance (Compliance/Similarity) |
|---|---|
| Electrical Safety | Complies with IEC 60601-1 |
| EMC (Electromagnetic Compatibility) | Complies with IEC 60601-1-2 |
| Biocompatibility - Cytotoxicity | Complies with ISO 10993-5 |
| Biocompatibility - Irritation & Skin Sensitization | Complies with ISO 10993-10 |
| Intended Use | Analogous to predicate device for permanent hair reduction, pigmented lesions, moderate inflammatory acne vulgaris, ephelides (freckles), and vascular lesions. |
| Light Source | Intense pulsed light (Same as predicate) |
| Wavelength Range | 430-1200nm, 530-1200nm, 640-1200nm (Proposed device has similar ranges, with some optional variations compared to predicate) |
| Delivery System | Sapphire (Same as predicate) |
| Energy Density | 10-60J/cm² (Same as predicate) |
| Pulse Sequence | 1-15 pulses (Same as predicate) |
| Pulse Delay | 5-50ms (Same as predicate) |
| Pulse Width | 1-20ms (Similar to predicate's 2-20ms) |
| Spot Size | MED-210: 15mmX50mm, MED-230: 12mmX33mm, 15mmX50mm (Similar, with some variations, to predicate's various sizes) |
| Power Supply | 220V±20V 50Hz or 110V±20V 60Hz (Similar to predicate's 100/110V, 50 |
| Max. Power Consumption | MED-210: 1400 W, MED-230: 2000 W (Higher than predicate's 1200 W, but considered not to affect safety/effectiveness) |
| Therapeutic Parameters (e.g., Energy Range for indications) | Similar ranges for permanent hair reduction, pigmented lesions, acne vulgaris, ephelides, and vascular lesions compared to predicate. Differences are discussed and concluded not to affect effectiveness/safety. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable/Not provided. The document states "Bench tests were conducted to verify that the proposed device met all design specifications," and these appear to be primarily engineering and safety compliance tests, not clinical performance studies involving a "test set" of patients or data in the typical sense of AI/diagnostic device evaluation. No information on data provenance or study type (retrospective/prospective) is available.
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/Not provided. No clinical ground truth establishment is mentioned, as there is no clinical performance study described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not provided. This is relevant for studies involving human assessment of data, which is not described here.
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
No. A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an IPL system for various cosmetic and therapeutic applications, not an AI-assisted diagnostic or interpretation tool. The submission is for a medical device that directly performs a treatment.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical IPL system, not an algorithm, and its performance is inherently human-in-the-loop (operated by a practitioner).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable/Not provided. For a treatment device, "ground truth" would typically refer to clinical outcomes measured against a recognized standard of care or objective physiological changes. No such clinical performance data or ground truth validation is detailed in this 510(k) summary, as the submission relies on substantial equivalence to the predicate device and compliance with safety standards rather than a de novo clinical efficacy study.
8. The sample size for the training set
Not applicable/Not provided. As there is no AI algorithm being developed or evaluated, there is no "training set" in this context.
9. How the ground truth for the training set was established
Not applicable/Not provided. See point 8.
§ 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.