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The DERMASCULPT is intended for Dermatological procedures requiring incision, excision, coagulation and vaporization of soft tissue. The specific indications using the applicable handpieces are as follows: Skin resurfacing in the treatment of wrinkles and scar revision (including acne scars) with the non-fractionated handpiece. Removal of cutaneous skin lesions with the micron tip handpieces including epidermal nevi, actinic chellitis, keloids, verrucae, skin tags, anal tags, keratosis, scar revision, (including acne scars), benign tumors and cysts, superficial skin lesions and diagnostic biopsies. The DERMASCULPT with the fractionated scanner handpiece is intended/indicated for Dermatological procedures requiring coagulation of soft tissue and skin resurfacing.

The DermaSCULPT Er:YAG Laser System [DermaSCULPT] unit and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. The laser energy produced within the device is delivered to the tissue by means of Fiber Delivery System and specially designed Scanner, Handpieces, Tips and Adaptors. The user activates laser emission by means of a footswitch. The lamp power supply causes the flash lamp to light, causing the emission of an invisible infrared Er:YAG laser beam (2.94 microns). A visible white light pulsed beam from the flashlamp is used as an aiming beam. The laser beam passes through a partially reflecting mirror and then passes through the energy monitor, after which its power is measured. When all the pre-conditions have been satisfied and the READY button is pressed and the foot switch is depressed, the safety shutter opens and the laser beam is allowed into the delivery unit coupler. The electrical system is comprised of the laser power supply, the control unit, calibrator, control panel, key switch, emergency stop switch, and foot switch. The components of the laser power supply include a high voltage power supply and a high voltage trigger control board. The high voltage power supply uses the high voltage to illuminate the flashlamp. The control unit comprises a microprocessor board, accessory board and other components that it controls. The calibrator measures the transmittance of the fiber delivery unit. The handheld scanner module is an attachment to the fiber.

The provided text describes the DermaSCULPT Er:YAG Laser System, its intended use, and its comparison to predicate devices, but it does not contain details about a study that establishes acceptance criteria or proves the device meets those criteria with specific performance metrics.

The document is a 510(k) summary for a medical device which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed performance studies with acceptance criteria in the way you've described for AI/algorithm performance.

Therefore, I cannot provide the information requested in your bullet points as the provided document does not contain it. The "Nonclinical Performance Data" section states: "The review of the technical characteristics, indications for use, mechanism of action, and verification and validation information provided demonstrate that the DermaSculpt is substantially equivalent to its predicate device." and "Clinical Performance Data" states: "HOYA ConBio has established that the DermaSculpt performs as clinically intended and that no new issues of safety and effectiveness are introduced." These statements indicate that performance was reviewed for substantial equivalence, but they do not provide specific acceptance criteria or study results in the format you've requested.

If you have a document that describes specific studies with acceptance criteria for an AI/algorithm-based device, please provide that text.

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Sculpture Plus Nano-Hybrid Composite is an indirect or direct/indirect dental restorative material. It is indicated for use, in cured form, to restore carious lesions or structural defects or lost tooth structure either by itself or in combination of metal/ceramic/polymeric substrates and conditioners such as bonding, luting, etching agents commonly used in tooth restoration. The curing can be processed using photo and/or heat curing devices. The curing can accomplished in air, under vacuum or under pressure without or with inert atmosphere.

Sculpture Plus Nano-Hybrid Composite is an indirect or direct/indirect dental restorative material.

I am sorry, but based on the provided text, there is no information about acceptance criteria, a study proving device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

The document is a 510(k) summary for a dental restorative material, Sculpture Plus Nano-Hybrid Composite, stating its substantial equivalence to a predicate device. It focuses on regulatory approval based on equivalence, not on performance studies with specific acceptance criteria as you've outlined.

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The SCULPTURE is designed for use in fragmentation, emulsification and aspiration of soft ussue in the following Surgical Specialties: plastic and reconstructive surgery, general surgery

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This appears to be a 510(k) clearance letter from the FDA for a device called "Sculpture." The letter confirms that SMEI, Inc. can market the device because it has been determined to be substantially equivalent to devices marketed prior to May 28, 1976.

However, the provided text does not contain any information regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications. This document is a regulatory approval letter, not a clinical study report.

Therefore, I cannot provide the requested information from the given text. To answer your questions, I would need access to the actual 510(k) submission document or a clinical study report for the Sculpture device.

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