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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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The Fraxel IV SR Laser System and accessories is intended for use in:

Dermatological procedures requiring the coagulation of soft tissue;

Treatment of periorbital wrinkles;

Treatment of acne scars and surgical scars;

Photocoagulation of pigmented lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), melasma and dyschromia;

Skin resurfacing procedures.

The Fraxel IV SR Laser System consists of a fiber laser, controlled by an embedded processor, to be used in dermatology. The laser system uses scanning and focusing optics to deliver a pattern of thermal energy to the skin.

The provided text for K063808 is a 510(k) summary of safety and effectiveness for a medical device (Fraxel IV SR Laser System and Accessories). This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the new device meets specific, novel acceptance criteria through a dedicated study.

Therefore, the document does not contain the information requested for a detailed breakdown of acceptance criteria and a study proving the device meets them.

Here's why and what information is contained:

• No Acceptance Criteria or Device Performance Table: The document does not define specific performance metrics or acceptance criteria for the Fraxel IV SR Laser System. Instead, it relies on demonstrating that its indications for use and technological characteristics are substantially equivalent to already approved predicate devices.
• No Dedicated Study to Prove Criteria: Because no new, specific acceptance criteria are presented for this device, there is no study described that aims to prove the device meets such criteria. The "Clinical Performance Data" section merely states, "Sufficient safety data has been gathered to determine that the Fraxel IV Laser System and Accessories performs as clinically intended and that no new issues of safety and effectiveness are introduced." This is a general statement, not a detailed study report.
• No Information on Sample Sizes, Data Provenance, Expert Ground Truth, or Adjudication: Since there isn't a detailed study described for this device, there is no information about sample sizes for test sets, data provenance, the number or qualifications of experts, or adjudication methods.
• No MRMC or Standalone Study Information: The document does not mention any Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance studies. The Fraxel IV SR is a physical laser system, not an AI or imaging diagnostic tool.
• No Ground Truth Type or Training Set Information: As there's no diagnostic or analytical algorithm being evaluated, the concepts of ground truth (expert consensus, pathology, outcomes data) and training sets are not applicable or discussed in this context.

In summary, the provided 510(k) pertains to demonstrating substantial equivalence, not to presenting a study proving a device meets specific quantitative acceptance criteria.

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