(89 days)
The PhotoMedex LaserPro 810, 940 and 980 Surgical Diode Laser Systems, (and the fiber delivery systems and accessories used to deliver laser energy), are intended for delivery of laser light in the contact or non-contact mode during surgical procedures, including via endoscopes, introducers, or catheters. The PhotoMedex LaserPro 810, 940 and 980 Surgical Diode Laser Systems, (and the fiber delivery systems and accessories used to deliver laser energy), are generally indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, hemostasis or coagulation of soft tissue in surgical procedures in medical specialties including: dermatology, gastroenterology, general surgery (including specific treatment of varicose veins and varicosities associated with superficial reflux of the greater saphenous vein), genitourinary surgery (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT), orthopedics, ophthalmology, pulmonology, and thoracic surgery.
The PhotoMedex LaserPro 810. 940 and 980 Diode Laser Systems are designed to provide laser power at wavelengths of 810nm, 940nm, and 980mm, depending on model, which can be used for the procedures indicated in the next section of this summary . The system is comprised of the following main components:
- A laser console/cabinet with fiber port to accept SMA-905 connectors. .
- Display panel with soft-touch keypad control and separate Emergency Off . button.
- Laser system microprocessor control electronics with operating software .
- A detachable covered footswitch. .
The provided text is a 510(k) summary for the PhotoMedex LaserPro 810, 940, and 980 Diode Laser Systems. It describes the device, its intended use, and its substantial equivalence to predicate devices but does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in performance studies for AI/ML devices.
This document is a regulatory submission for a traditional medical device (a surgical laser system), not an AI/ML powered medical device. Therefore, the questions related to AI/ML device performance metrics (such as "sample size used for the test set," "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," and "sample size for the training set") are not applicable to the content provided.
The "Safety and Effectiveness" section (Section 7) states: "The PhotoMedex LaserPro 810. 940 and 980 Diode Laser Systems are designed, tested and manufactured in accordance with both mandatory and voluntary Standards ensuring when used with marketed cleared delivery systems identified to be compatible, they are considered both safe and effective for the medical applications indicated. No new clinical indications are to be provided by the introduction of LaserPro Diode Surgical Lasers as compared to the identified predicates, which have previously demonstrated clinical effectiveness."
This indicates that safety and effectiveness are established through adherence to standards and by demonstrating substantial equivalence to predicate devices that have already proven clinical effectiveness, rather than through a new, specific clinical performance study for this device with "acceptance criteria" in the context of AI/ML performance metrics.
Therefore, I cannot populate the table or answer most of the requested questions based on the provided text.
§ 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.