(90 days)
The Intense Pulsed Light Treatment System (Model: LK-PT) is indicated for use in surgical and aesthetic applications in permanent hair removal, reduction of benign pigmented lesions and benign vascular lesions.
Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.
The LK-PT device is an intense pulsed light system which delivers intense pulsed light at wavelengths ranging from 560mm ~ 1200nm. Intense Pulsed Light(IPL) system 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 does not contain any information about acceptance criteria or a study that proves the device meets those criteria, as typically seen for AI/ML-enabled devices.
Instead, this document is a 510(k) Premarket Notification from the U.S. FDA, indicating that the device, an Intense Pulsed Light Treatment System (Model: LK-PT), has been reviewed and determined to be substantially equivalent to a legally marketed predicate device (Intense Pulsed Light Treatment System, Model: HM-IPL-B8, K192521).
The type of analysis performed here is a comparison to a predicate device to show substantial equivalence, not a performance study against predefined acceptance criteria for an AI/ML algorithm.
Here's why the requested information cannot be extracted and what the document does discuss:
- No AI/ML Component: The device described is an "Intense Pulsed Light Treatment System." The description focuses on its physical parameters (wavelength, energy density, pulse width, spot size, power) and its working principle (selective thermolysis). There is no mention of any AI or machine learning component in the device. Therefore, questions 1, 3, 4, 5, 6, and 7, which relate to AI/ML study design, ground truth, and reader studies, are not applicable.
- No Acceptance Criteria for Performance: The document doesn't define acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy) because it's not demonstrating de novo performance; it's demonstrating equivalence to an already cleared device.
- No Specific Performance Study: Section 10 explicitly states: "No clinical study is included in this submission." This means there was no clinical performance study conducted to prove the device meets specific acceptance criteria.
- Basis for Equivalence: The determination of substantial equivalence (SE) is based on:
- Same intended use: Permanent hair removal, reduction of benign pigmented lesions, and benign vascular lesions.
- Similar technological characteristics: Both are Intense Pulsed Light (IPL) systems.
- Non-clinical performance tests: These tests are for safety and essential performance (e.g., electrical safety, electromagnetic compatibility, photobiological safety, biocompatibility), not for clinical efficacy or diagnostic accuracy.
- Comparison of technical parameters: Wavelength, energy density, pulse delay, pulse width, spot size, and max power are compared to the predicate, with minor differences deemed not to negatively affect safety and effectiveness.
Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, AI performance studies, sample sizes for AI, ground truth establishment, or expert adjudication, as this information is not present in the provided 510(k) document for this non-AI/ML device.
§ 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.