(50 days)
The Candela Family of Pulse Dye Laser Systems Pigmented Lesion Handpiece Accessory is indicated for the Treatment of Benign Epidermal Pigmented Lesions
The Candela Family of Pulsed Dye Laser Systems are 585, 595nm flash-lamp excited pulse dye medical lasers, indicated for the following uses: The laser output energy is delivered via an optical fiber to a handpiece, which produces circular beams or elliptical beams on the skin.. The Pigmented Lesion Handpiece Accessory attaches to the standard handpiece and replaces the standard distance gauge for the treatment of benign epidermal pigmented lesions The Candela Family of Pulsed Dye Laser Systems is equipped with safety interlock systems to protect patients and operators. Users of the device make selections from an onboard control panel to regulate operation during treatment. The pigmented lesion handpiece accessory is designed for use with the Candela Pulsed Dye Laser handpiece, for the treatment of Benign Epidermal pigmented Lesions
The provided text is a 510(k) Summary for a medical device (Candela Family of Pulsed Dye Lasers Pigmented Lesion Handpiece Accessory) and does not contain detailed information about specific acceptance criteria or an in-depth study proving the device meets those criteria. The document primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance.
However, based on the information provided, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide a specific table of acceptance criteria for a clinical study measuring device performance (e.g., lesion clearance rates, skin reaction scores). Instead, it refers to regulatory compliance and safety standards.
| Acceptance Criteria Category | Reported Device Performance/Compliance |
|---|---|
| CDRH Laser Performance Standard (21 CFR 1040) | The Candela Family of Pulsed Dye Laser Systems conforms to this standard. |
| Electrical Safety Standard (IEC 60601-1) | The Candela Family of Pulsed Dye Laser Systems conforms to this standard. |
| Biocompatibility (ISO 10993-1) | All materials contacting the patient conform to the requirements of this standard for biocompatibility. |
| Substantial Equivalence to Predicate Devices | The device is deemed substantially equivalent to K043251, K040200, and K001746 based on "similarities in key design aspects, intended uses and materials." |
| Indication for Use | "Treatment of Benign Epidermal Pigmented Lesions." No specific performance metrics for this indication are provided in this summary. |
2. Sample Size for Test Set and Data Provenance:
The document does not provide information on a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective) for evaluating the clinical performance of the pigmented lesion handpiece accessory. The "Testing" section focuses on regulatory compliance for laser and electrical safety, and biocompatibility, rather than clinical efficacy/safety studies for the accessory's intended use.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not provided in the document. As there's no mention of a clinical study with a test set that required ground truth establishment, these details are absent.
4. Adjudication Method for the Test Set:
This information is not provided in the document, as there is no mention of a clinical test set that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC study was not conducted or reported in this document. The focus is on regulatory clearance through substantial equivalence, not on comparing human reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study:
A standalone performance study was not conducted or reported. This device is a laser accessory, not an AI algorithm.
7. Type of Ground Truth Used:
This information is not provided as no specific clinical study data requiring ground truth for efficacy assessment is presented. The "ground truth" for regulatory clearance is based on adherence to established safety and performance standards for laser products and materials, and comparison to predicate devices.
8. Sample Size for the Training Set:
This information is not applicable/not provided. The device is a physical laser accessory, not an AI model that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable/not provided for the same reason as above.
§ 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.