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Dermatology, Plastic & General Surgery

The CO2 laser, model MedArt 620, is intended to be used by physicians in the performance of the following specialties:

The ablation and coagulation of soft tissue in dermatology, plastic and general surgery in the performance of:

• Skin resurfacing I
• Treatment of wrinkles and rhytids .
• Treatment of furrows I
• Soft tissue ablation .

Not Found

I am sorry, but the provided text from the FDA 510(k) summary for the MedArt 620 Laser System does not contain the specific information required to address your comprehensive request regarding acceptance criteria and a study proving the device meets those criteria.

The 510(k) summary primarily focuses on:

• Substantial Equivalence Determination: This document confirms that the FDA has reviewed the device and determined it to be "substantially equivalent" to legally marketed predicate devices, based on its indications for use.
• Regulatory Information: It details the device's regulation number, name, class, product code, and relevant FDA regulations.
• General Controls: It reminds the applicant of obligations under general controls provisions (registration, labeling, GMP, etc.).
• Indications for Use: It clearly outlines the intended medical applications for the CO2 laser system in dermatology, plastic, and general surgery (skin resurfacing, treatment of wrinkles, furrows, soft tissue ablation).
• Contraindications: It specifies conditions for which the device should not be used (hard tissue dental applications, not evaluated as a fractionated scanner).

Missing Information:

The document does not include details about:

• Specific performance acceptance criteria for the device (e.g., specific thresholds for ablation depth, coagulation effectiveness, wrinkle reduction percentages).
• Any performance study, clinical trial, or validation report that would describe:
  • A table of acceptance criteria and reported device performance.
  • Sample sizes, data provenance (e.g., country of origin, retrospective/prospective).
  • Number and qualifications of experts for ground truth.
  • Adjudication methods.
  • Multi-reader multi-case (MRMC) comparative effectiveness studies.
  • Standalone algorithm performance (not applicable for this type of laser device).
  • Type of ground truth used (e.g., pathology, outcomes data).
  • Training set sample size (not applicable for a physical laser device).
  • How ground truth for the training set was established.

This is typical for a 510(k) clearance for a device like a surgical laser, where substantial equivalence is often demonstrated through adherence to recognized performance standards, engineering testing, and a comparison of features, materials, and intended use against a legally marketed predicate device, rather than a clinical study proving specific objective performance metrics with human readers or AI.

To obtain the kind of detailed study information you're asking for, you would typically need to review:

• PMA (Premarket Approval) applications: For novel, high-risk devices, which require extensive clinical data.
• Clinical Study Reports: Published literature, or data submitted as part of a 510(k) if the device presents new technological characteristics or different indications that warrant clinical data.
• Specific performance data submitted to the FDA: This is usually summarized in the 510(k) Decision Summary if available publicly, but not embedded in the initial clearance letter itself.

Therefore,Based on the provided text, I cannot answer your specific questions about the device's acceptance criteria and the study proving it meets those criteria.

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The MedArt 720 Diode Laser System & Accessories is a prescription only device intended for delivery of laser light to soft tissue in the contact or non-contact mode during surgical procedures, including via endoscopes, introducers, or catheters.

The MedArt 720 Diode Laser System & Accessories is generally indicated for incision, excision, vaporization, ablation, hemostasis, or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery, and cardiothoracic surgery and ophthalmology.

The MedArt 720 Diode Laser System & Accessories is specifically indicated for laser assisted lipolysis

The MedArt® 720 laser unit is a Class 4 laser that emits invisible laser radiation. The unit is fed by a diode laser module providing continuous or pulsed wave laser beam operating at a wavelength of 980 nm that is primarily absorbed in melanin, haemoglobin and dark tissue. A limited amount of light is absorbed by water enabling fast increase in irradiated areas leading to effective heating of tissue at low power outputs.

The provided text doesn't contain information about acceptance criteria or a study proving the device meets them. The document is a 510(k) summary for the MedArt® 720 Diode Laser System & Accessories, outlining its intended use, technological characteristics compared to a predicate device, and the FDA's clearance letter.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth and their qualifications
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human reader improvement with AI assistance
6. If a standalone performance study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

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Dermatology, Plastic & General Surgery

The CO2 laser, model MedArt 610, is intended to be used by physicians in the performatice of the following specialities:

The ablation and coagulation of soft tissue in dermatology, plastic and general surgery in the performance of:

• Skin Resurfacing .
• . Treatment of wrinkles and rhytids
• Treatment of furrows .
• Soft tissuc ablation .

The MedArt 610 system comprises the following major parts:

• A laser console containing a CO2 laser module capable of providing a laser beam having a wave-. length of 10,600 nm.
• A scanner that is intended to manipulate and place a pulsed beam received from the laser console in . a pre-specified pattern on the skin being treated.
• An optical fiber providing a beam path from the laser to the scanner. .

The MedArt 610 Laser system is identified as substantially equivalent to the Uni-Laser 450P (K991297) manufactured by ASAH Medico A/S. The submission demonstrates substantial equivalence through a side-by-side comparison of device specifications and indications for use, rather than a primary clinical study with predefined acceptance criteria. Therefore, the information provided focuses on the comparative data rather than a direct performance study against specific acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly met by demonstrating substantial equivalence to the predicate device, Uni-Laser 450P. This implies that the MedArt 610 is expected to perform at least as safely and effectively as the predicate device for its stated indications. The document does not provide explicit numerical acceptance criteria, but rather a direct comparison of features and performance parameters.

2. Sample Size Used for the Test Set and Data Provenance

No specific test set or clinical data is provided for the MedArt 610 within this 510(k) summary. The submission relies on a comparison to a legally marketed predicate device (Uni-Laser 450P) to demonstrate substantial equivalence. Therefore, there is no sample size for a test set or data provenance from a new study provided for the MedArt 610.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The submission does not involve a test set requiring expert ground truth establishment for the MedArt 610. The equivalence is based on engineering specifications and comparison to the predicate device's cleared indications and performance characteristics.

4. Adjudication Method for the Test Set

Not applicable. There was no test set or clinical study requiring an adjudication method presented in this 510(k) summary.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a laser system for surgical and dermatological procedures, not an AI-assisted diagnostic or interpretative tool. Therefore, an MRMC study and
effect size related to AI assistance for human readers is not relevant.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a medical laser system operated by physicians, not a standalone algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the MedArt 610's substantial equivalence determination is the previously cleared performance and indications for use of the predicate device, the Uni-Laser 450P. This is based on the regulatory clearance of a similar device with known safety and effectiveness.

8. The Sample Size for the Training Set

Not applicable. This submission does not involve training data for an algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This submission does not involve a training set or ground truth establishment for an algorithm.

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