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450 nm, 635 nm and 980 nm Diode Laser:
· Intended for intra- and extra-oral surgery including incision, hemostasis, coagulation and vaporization of soft tissue including marginal and inter-dental and epithelial lining of free gingiva and are indicated for: frenectomy; frenotomy; biopsy; operculectomy; implant recovery; gingivoplasty; gingival troughing; crown lengthening; hemostasis of donor site; removal of granulation tıssue; laser assisted flap surgery; debridement of diseased epithelial lining; incisions and draining of abscesses; tissue retraction for impressions; papillectomy; vestibuloplasty; excision of lesions; exposure of unerupted/partially erupted teeth; removal of hyperplastic tissues; treatment of aphthous ulcers; leukoplakia; laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket; sulcular debridement (removal of diseased, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival bleeding index, probe depth, attachment loss and tooth inability); pulpotomy; pulpotomy as adjunct to root canal therapy; fibroma removal; gingival incision; treatment of canker sores; herpetic ulcers of the oral mucosa; laser soft tissue curettage; reduction of gingival hypertrophy.

Whitening:
• Indicated for light activation for bleaching materials for teeth whitening and for laser-assisted whitening/bleaching of teeth.

Low Level Laser Therapy:
· Intended to emit energy in the red and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, and for the temporary increase in local blood circulation and/or temporary relaxation of muscles.

810 nm Diode Laser in dentistry:
· Surgical applications requiring the ablation, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, otolaryngology, ophthalmology, and pulmonology
· Oral/Maxillofacial Indications; Incision, excision, vaporization, ablation and/or coagulation of soft tissue

• · Gingival troughing for crown impression
• · Gingivectomy
• · Gingivoplasty
• · Gingival incision and excision
• · Hemostasis and coagulation
• · Excisional and incisional biopsies
• · Fibroma removal
• · Frenectomy and frenotomy
• · Oral papillectomies
• · Soft tissue crown lengthening
• · Treatment of aphthous ulcers
• · Treatment of herpetic lesions
• · Periodontology;
• · Laser soft tissue curettage
• · Laser soft tissue curettage
• · Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket
• · Cosmetic Dentistry;
• · Laser-assisted bleaching/whitening of the teeth
• · Light activation for bleaching materials for teeth whitening
• · Implant recovery

810 nm Diode Laser in therapy:
· Temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and strains, and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle.

1064 nm Diode Laser in dentistry:

• · Excisional and incisional biopsies;
• · Excision and vaporization of herpes simplex I and II;
• · Frenectomy and frenotomy;
• · Gingivectomy;
• · Gingivoplasty;
• · Gingival incision and excision;
• · Hemostasis;
• · Implant recovery;
• · Operculectomy;
• · Pulpotomy and pulpotomy as an adjunct to root canal therapy;
• · Removal of filling material such as gutta percha or resin as adjunct treatment during root canal therapy;
  · Sulcular debridement or soft tissue curettage (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss, and tooth mobility):
  · Treatment of aphthous ulcers and herpetic lesions

The Dawn Diode Laser System manufactured by SWOT LASERS is a surgical device at the cutting edge of technology, designed for a wide variety of soft tissue procedures. The Dawn Diode Laser System utilizes a solid state diode as laser energy source. The energy is delivered to the operating area by means of a delivery system consisting of a flexible fiber connecting the laser source and the handpiece. The device is activated by means of footswitch.
This laser instrument consists of fiber connecting diode laser system, power supply system and microcomputer control system.
The Dawn Diode Laser System employs the diodes with wavelengths of 450nm, 635nm, 810nm, 980nm and 1064nm, and the device emits laser output energy in blue (450nm), red (635nm), orange (980nm) spectra respectively.

The provided text is a 510(k) summary for the "Dawn Diode Laser System." It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a dedicated study.

Therefore, most of the requested information regarding acceptance criteria, device performance tables, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies is not available in these documents. This is typical for a 510(k) submission where the primary goal is to show that a new device is as safe and effective as a legally marketed predicate device, often by demonstrating similar technological characteristics and performance through non-clinical testing.

Here's a breakdown of what can be extracted and what cannot:

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

This information is not provided in the format requested. The document focuses on comparing the proposed device's technological characteristics to predicate devices. It states that "non-clinical tests" were performed to "verify the performance requirements" and that "the testing results do support substantial equivalence." However, it does not specify what those performance requirements (acceptance criteria) were or numerically report the device's performance against them.

The tables provided (Table 1 and Table 2) are comparison tables of technological characteristics between the proposed device and predicate devices, not performance against acceptance criteria.

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/Not provided. The document explicitly states: "No human clinical data is needed for Dawn Diode Laser System." The non-clinical tests mentioned are likely laboratory-based and do not involve human subjects or data provenance in the clinical sense.

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/Not provided. As no human clinical data was used, there was no "test set" requiring expert ground truth establishment in this context.

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

Not applicable/Not provided. Given the absence of a human clinical test set, no adjudication method was used.

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/Not provided. This device is a laser system, not an AI diagnostic tool.

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

Not applicable/Not provided. This is a hardware device; the concept of "standalone performance" for an algorithm doesn't apply directly. The non-clinical tests assess the device's physical and functional properties.

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

Not applicable/Not provided. For non-clinical tests, "ground truth" would typically refer to established engineering standards or physical measurements, not clinical outcomes or expert consensus on patient data.

8. The sample size for the training set:

Not applicable/Not provided. There is no mention of a "training set," as this isn't an AI/machine learning device.

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

Not applicable/Not provided. No training set was used.

Summary of what is available regarding "acceptance criteria" and "study":

The document lists several non-clinical tests that were performed to demonstrate substantial equivalence and meet "performance requirements":

• Study Type: Non-clinical (laboratory/engineering) tests.
• Proof of Meeting Acceptance Criteria: The document states, "It shows that the testing results do support substantial equivalence." and "Demonstrated by the safety and performance tests, the characteristics of Dawn Diode Laser System are respectively equivalent to those of the predicate devices."
• Specific Standards/Tests Mentioned:
  • IEC 60601-1 Edition 3.2 2020-08: Medical electrical equipment - General requirements for basic safety and essential performance.
  • IEC 60601-1-2 Edition 4.1 2020-09: Electromagnetic disturbances.
  • IEC 60825-1 Edition 2.0 2007-03: Safety of laser products - Equipment classification, and requirements.
  • IEC 60601-2-22 Edition 3.1 2012-10: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment.
  • IEC 62366-1 Edition 1.1 2020-06: Application of usability engineering to medical devices.
  • IEC 62304 Edition 1.1 2015-06: Medical device software - Software life cycle processes.
  • ISO 10993-1 Fifth edition 2018-08: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
  • ISO 10993-5 Third edition 2009-06-01: Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.
  • ISO 10993-10 Fourth edition 2021-11: Biological evaluation of medical devices - Part 10: Tests for skin sensitization.
  • ISO 10993-23 First edition 2021-01: Biological evaluation of medical devices - Part 23: Tests for irritation.
  • ISO 14971 Third Edition 2019-12: Medical devices - Application of risk management to medical devices.
  • IEC 60601-1-6 Edition 3.2 2020-07: Usability.
  • IEC 60601-1-9: Requirements for environmentally conscious design.
  • ISO 17664-1 First edition 2021-07: Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices.

The "acceptance criteria" can be inferred to be compliance with these international standards for safety, performance, EMC, biological compatibility, usability, and software. The "study" is the collection of tests performed according to these standards, which are stated to support substantial equivalence. No specific numeric performance results against these standards are detailed in this summary.

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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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The Cheveux Diode Laser System is indicated for:

• Hair Removal
• Permanent hair reduction
• Treatment of benign vascular lesions
• . Treatment of benign pigmented lesions
• Treatment of Leg Veins
• . Treatment for pseudofolliculitis barbae

The Cheveux Laser System is intended for use on all skin types (Fitzpatrick Skin types I-VI) including tanned Skin.

The 810nm Diode Laser System consists of a console that houses the power supply, control electronics and user interface and a diode laser handpiece. The device is activated by means of a footswitch and a handswitch.

The Laser System is designed for use in a clinic, which shall be a clean, dry and wellventilated room with a door.

The provided text is a 510(k) summary for a medical device called "810nm Diode Laser System." It details the device's characteristics, intended use, and a comparison to a predicate device to demonstrate substantial equivalence.

However, the document does not contain any information regarding acceptance criteria or a study proving the device meets performance claims through clinical studies or AI algorithm performance. The "tests" mentioned are non-clinical and relate to electrical safety, EMC, and radiation safety, which are regulatory compliance tests, not performance studies as would be conducted for an AI/ML device or a device requiring clinical evidence.

Therefore, I cannot provide the requested information for acceptance criteria and a study that proves the device meets them, as this information is not present in the provided text. The document explicitly states:

• "The 810nm Diode Laser System has been conducted related non-clinical tests to identify the substantial equivalence from the predicate device."
• "The tests include the concerning of electrical safety, EMC and the requirements of radiation safety, test data and report information are included in this submission. IEC 60601-1, EN 60601-1-2 : 2015 (EN 55011: 2009+ A1: 2010), EN 60601-1-2 : 2015, EN 61000-3-3, EN 61000-3-2."

These are standards for basic safety and essential performance, not clinical performance or efficacy studies. The substantial equivalence is based on similar technological characteristics and non-clinical safety/EMC standards, not on a study proving specific performance metrics like those for an AI/ML device (e.g., sensitivity, specificity, or improvement in human reader performance).

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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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