(291 days)
The Eclipse 2000™ is intended for use in general surgery, including thoracic and abdominal surgeries. This includes the incision, excision, vaporization or coagulation of soft tissue and firm cartilage:
- . cholecystectomy
- lysis of adhesions .
- herniorrhaphy .
- sessile polyps of the intestine and colon .
- hemorrhoidectomy .
- condyloma .
- appendectomy ●
The Eclipse Model 2000™ laser system is designed to be easy to operate and userfriendly. It features a security keyswitch and simple one-button start-up. Energy output is controlled by the Power thumbwheel adjustment. Energy is delivered through the Eclipse delivery system only when:
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- the laser is in Ready mode,
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- the Foot Pedal is depressed, and
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- the delivery system is properly installed in the laser aperture.
A variety of disposable fiber optic delivery systems in a range of sizes, designs and configurations is available from Eclipse. A fiber optic delivery system must be used to delivery laser energy to the treatment site.
The provided text describes a medical device, the Eclipse Model 2000™ laser system, and its intended use and safety information. However, it does not contain any information about acceptance criteria, device performance, a study conducted to prove performance, sample sizes, ground truth establishment, or any of the other specific details requested in your prompt regarding a study.
Therefore, I cannot fulfill your request for a table of acceptance criteria, study details, or information about MRMC studies, standalone performance, or training set specifics based on the provided text.
The document is a "Summary of Safety and Effectiveness" which typically focuses on the device's design, how it works, and safety precautions, rather than detailed study results for performance metrics against pre-defined acceptance criteria.
§ 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.