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The DioSculpt laser system is intended for non-invasive lipolysis of the abdomen, flanks, back, and thighs in individuals with a Body Mass Index (BMI) of 30 or less.

The DioSculpt laser lipolysis system is a diode laser system, Electrically efficient semiconductor generate optical radiation (1060nm) which is used to deliver laser energy to subcutaneous tissue layers. DioSculpt's cooling and electical systems assist in maintaining safe and comfortable skin surface temperatures.

The provided text describes the 510(k) premarket notification for the DioSculpt laser system, which is intended for non-invasive lipolysis. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of diagnostic performance or clinical outcomes.

The document focuses on demonstrating substantial equivalence to predicate devices through:

• Technological characteristics comparison: Showing similar technology, wavelength, pulse width, cooling, and patient attachment methods.
• Non-clinical testing: Biocompatibility, electrical safety, EMC, and performance testing (specifically temperature testing to ensure safety despite slightly higher energy density/peak power).
• Software verification and validation.

Therefore, I cannot provide the requested information about acceptance criteria, reported device performance, sample sizes for test/training sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, or types of ground truth used for clinical efficacy or diagnostic accuracy. These types of studies are not typically part of a 510(k) submission that relies on demonstrating substantial equivalence to a legally marketed predicate device through technological similarity and non-clinical safety/performance.

The only "performance" discussed is related to safety (temperature testing) and compliance with electrical and laser safety standards.

What can be extracted from the text related to performance/safety criteria are:

1. A table of acceptance criteria and the reported device performance (focused on safety performance):

The remaining requested information is not available in the provided document:

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable for this type of submission which focuses on non-clinical testing and substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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, as this is not an AI/diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the safety tests, the "ground truth" is compliance with established international standards and the measured physical properties (e.g., temperature).
8. The sample size for the training set: Not applicable (no machine learning model for training).
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document details the non-clinical testing performed to demonstrate the safety and performance (in a technical compliance sense, not clinical efficacy) of the DioSculpt device for its 510(k) clearance, asserting substantial equivalence to predicate devices. It does not contain information on clinical studies that establish efficacy acceptance criteria or clinical performance outcomes.

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It is indicated for incision, ablation, vaporization and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology, neurosurgery, orthopaedics, general and thorasic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.

The CO2 System is intended for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery, general surgery.

Dermatology, Plastic Surgery and General Surgery procedures:

• Laser skin resurfacing.
• Treatment of furrows and wrinkles.
• Removal of skin taqs, actinic keratosis, acne scars, keloids, tattoos, telangiectasia, squamous and basal cell carcinoma, warts and uneven pigmentation.
• Treatment of cysts, abscesses, hemorrhoids and other soft tissue applications.
• Blepharoplasty.
• Site preparation for hair transplants.
• The fractional scanner is for skin resurfacing.

The MATRIX LS-40 CO2 Surgical laser System incorporating a permanently articulated arm that delivers CO2 laser power in a wavelength of 10,600nm in its normal operations. The device is activated by means of a footswitch.

The Laser System is designed for use in an office or a clinic, which shall be a clean, dry and well-ventilated room with a door.

This document describes a 510(k) premarket notification for the "Matrix LS-40 CO2 Laser System". This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving independent clinical efficacy or diagnostic accuracy with extensive studies. Therefore, many of the requested elements for a study proving device performance (like acceptance criteria, sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, or standalone algorithm performance) are not typically included or required in this type of submission.

Based on the provided document, here's what can be extracted and what is not applicable:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria and reported device performance in terms of clinical outcomes or diagnostic accuracy. Instead, it focuses on demonstrating technological equivalence to a predicate device and compliance with safety standards.

The technological characteristics comparison between the Matrix LS-40 CO2 Laser System and the predicate device (Cortex Laser System K150587) can be viewed as demonstrating performance parity in key technical specifications:

Differences observed:

• Dimension: Matrix LS-40 (34cm46cm96cm) vs. Cortex Laser System (150cm46cm 31cm)
• Weight: Matrix LS-40 (46.5Kg) vs. Cortex Laser System (60kg)

The document asserts that "the subject device is substantially equivalent to the predicate device K150587" based on "performance testing, indication for use, and technology." The "performance testing" mentioned likely refers to the non-clinical tests described in Section 8.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This is a laser surgical instrument, and the provided document details a 510(k) submission, which focuses on demonstrating substantial equivalence to a predicate device through engineering and safety testing, not a clinical study on human subjects with a "test set" in the context of diagnostic performance. The document only refers to non-clinical tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This type of information is pertinent to diagnostic devices and clinical studies establishing ground truth, which is not the focus of this 510(k) submission for a surgical laser.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, for the same reasons as above.

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 not an AI-powered diagnostic tool, and no MRMC study is mentioned or relevant in this context.

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

Not applicable. The device is a surgical laser system, not a standalone algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable. Ground truth for diagnostic accuracy is not the subject of this 510(k). The "ground truth" here is compliance with established electrical, EMC, and radiation safety standards, and equivalence in technical specifications to the predicate device.

8. The sample size for the training set

Not applicable. This device is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Not applicable.

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