(388 days)
The IPL System - KDT750 is intended for use in aesthetic applications requiring selective photothermolysis (photocoagulation or coagulation) of soft tissue in the medical specialties of general and plastic surgery, and dermatology.
Indications for use for IPL System with 515-980nm IPL Handpiece (SR Handpiece).
- · Benign pigmented epidermal and cutaneous lesions including warts, melasma, epithelides (freckles) and lentigines.
- · Benign cutaneous vascular lesions, including port wine stains, facial and truncal telangiectasias, rosacea, erythema of rosacea and poikiloderma of Civatte.
- · For use on skin types(I-V)
Indications for use for IPL System with 640-950nm IPL Handpiece (HR Handpiece).
- · The removal of unwanted hair to effect stable long-term or permanent hair reduction.
- · For use on Fitzpatrick skin types (I-V)
- 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 regime.
The IPL System - KDT750 is a multi-wavelength non-invasive system for IPL skin treatments, treatment of vascular and pigmented lesions, and hair removal using two wavelength ranges: 530-950nm and 640-950nm. The IPL System consists of a system console, electronics and software, cooling system, and two hand pieces with different wavelength.
The provided text is a 510(k) summary for the IPL System - KDT750, a non-AI medical device (an IPL system for aesthetic applications). Therefore, the information requested about acceptance criteria and studies that prove the device meets these criteria, specifically in the context of an AI/ML device, is not applicable.
The document discusses the substantial equivalence of the IPL System - KDT750 to a predicate device (Alma Harmony XL Multi-Application Platform) based on general device performance characteristics, safety, and non-clinical tests. It explicitly states that clinical testing was not performed for this submission.
Here's why the requested information cannot be extracted from this document:
- No AI Component: The device is an "IPL System," which is a light-based medical device. There is no mention of an AI/ML component.
- No Acceptance Criteria for AI Performance: Since it's not an AI device, there are no acceptance criteria related to AI performance metrics like sensitivity, specificity, accuracy, etc.
- No Clinical Study for Performance Proof: The document clearly states: "Clinical testing was not performed for the subject device as part of the submission." This means there is no study described here to "prove the device meets the acceptance criteria" in a clinical performance sense.
- No Ground Truth Establishment: Without clinical performance testing, there's no need for ground truth establishment, expert consensus, or adjudication methods as typically required for AI/ML device validation.
- No Training/Test Sets: The concepts of training and test sets are specific to AI/ML model development and validation, which are not relevant to this device.
- No MRMC Study: A Multi-Reader Multi-Case (MRMC) study is used to assess the impact of an AI system on human reader performance, which again is irrelevant for a non-AI device.
In summary, the provided document is a regulatory submission for a traditional medical device (IPL system) demonstrating substantial equivalence based on technological characteristics and non-clinical safety testing, not an AI/ML device demonstrating performance through clinical studies with specific acceptance criteria.
If you have a document pertaining to an AI/ML medical device, I would be happy to analyze it for the requested information.
§ 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.