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The Sharplan Model 4020 Erbium:YAG Surgical Laser System is intended for incision/excision, ablation, vaporization, and/or coagulation of soft-tissue in-Plastion-Surgery/Dermatology.

The Sharplan Model 4020 Erbium YAG Surgical Laser is a medical device which capable of emitting an invisible pulsed treatment laser beam at a wavelength of 2.94 u under the guidance of an visible aiming beam. This laser can be utilized in either the continuous or timed exposure modes of operation

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific performance metrics. The document is a 510(k) summary for the Sharplan Model 4020 Erbium YAG Laser System, focusing on establishing substantial equivalence to predicate devices for regulatory approval.

Here's what the document does state, which is relevant to your request but doesn't fulfill it:

• No new indications were sought. This implies the device is intended for the same uses as its predicate devices.
• No clinical data was presented. This is the most crucial point. Without clinical data, there's no study described that would establish device performance against acceptance criteria.
• Substantial Equivalence: The approval is based on the device being "substantially equivalent" to existing predicate devices (SEO Medical Model 2940 Erbium YAG Laser, Candela (Fotona) SkinLight Er:YAG Laser, Con Bio Erbium/2.94 Laser, ESC Derma 20 Erbium: YAG Laser, and Asculap MCL 29 Erbium: YAG Laser). This means its safety and effectiveness are inferred from the predicate devices, rather than through a new, independent performance study against specific acceptance criteria.

Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, ground truth, expert involvement, or MRMC studies because the provided document explicitly states that "no clinical data was presented" for the Sharplan Model 4020.

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