(60 days)
The Lite Saber™ 2000 indications for use are for the cleared indications for the laser system to which it is attached. For example, dermatological, ENT, general surgery, GYN surgery, oral/dental, maxillofacial, orthopaedic and podiatric procedures for the incision, excision, ablation, vaporization and hemostasis of soft tissue.
The Licesaber™ 2000 is an "after-market" accessory for use with an existing surgical laser system. The device may be used as a complete system (handpiece and tips) or just the tips may be used with an existing handpiece of the ultradent style. The LiceSaber™ 2000 is used as a direct replacement for the laser handpiece supplied as original equipment or the original equipment laser handpiece tip. The Licesaber™ 2000 is designed address the need to direct the beam in a direction other than straight through the handpiece. Further, it does so without the need for refractive or reflective contact tips. The Licesaber 2000 gently and effectively clasps the clad fiber while bending the distal bare fiber into a smooth radius. Pre-curved disposable tips channel the fiber. Precurved tips are available. The directional tips may be rotated 360 degrees. This allows the laser fiber to be directed laterally, up, down or any angle or radius in between. The tips are disposable and the handpiece is reusable.
I'm sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets them. The document is a 510(k) premarket notification for the "LiteSaber™ 2000" laser accessory, primarily focusing on its substantial equivalence to a predicate device.
The document discusses:
- Device trade name, common name, and classification.
- Equivalent/comparison device.
- Device description and intended use.
- Sterilization information.
- The FDA's 510(k) clearance letter.
It does not include:
- A table of acceptance criteria or reported device performance metrics.
- Details on sample sizes for test sets, data provenance, or study design.
- Information on experts, ground truth establishment, or adjudication methods for test sets.
- Mention of any Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
- Details of a standalone (algorithm only) performance study.
- The type of ground truth used in any study.
- Sample size or ground truth establishment for a training set.
Therefore, I cannot fulfill your request for this specific information 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.