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The UTU series Medical Diode Laser are intended for intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue including marginal and interdental and epithelial lining of free gingiva and are indicated for: frenectomy; frenotomy; biopsy; operculectomy; implant recovery; gingivectomy; gingivoplasty; gingival troughing; crown lengthening; hemostasis of donor site; removal of granulation tissue; 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, infected, inflamed and necrosed soft tissue within the periodontal pocket; sulcular debridement (removal of diseased, infected, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index,gingival bleeding index, probe depth, attachment loss and tooth inability); pulpotomy; pulpotomy as adjunct to root canal therapy; fibroma removal; gingival incision and excision; treatment of canker sores; herpetic ulcers of the oral mucosa; laser soft tissue curettage; reduction of gingival hypertrophy.

Whitening: The UTU series Medical Diode Laser are indicated for light activation for bleaching materials for teeth whitening and for laser-assisted whitening/bleaching of teeth.

Low Level Laser Therapy: The UTU series Medical Diode Laser are 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.

The UTU series Medical Diode Laser (UTU3-F7B, UTU3-F7W, UTU3-G7B, UTU3-G7W, UTU-G20B and UTU-G20W) is a surgical and therapeutic device designated for a wide variety of oral soft tissue procedures and dental whitening as well as for use in providing a temporary relief of minor pain. The device 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 a footswitch.

It is a portable medical device composed of a main unit, a laser delivery system, a footswitch, a power adapter and protective goggles. The main unit incorporates an LCD touchscreen for the device user to set output parameters and for control of the device, and a built-in large-capacity rechargeable lithium battery with longer time of endurance. The laser delivery system includes a fiber optic cable, handpiece and tips (disposable fiber tips, whitening tip, biostimulation tip or therapy tip) designed and optimized for different applications.

The UTU3-F7B and UTU3-F7W employ the diodes with wavelengths of 810nm, 650nm and 450nm, they only different in enclosure color, the enclosure color of UTU3-F7B is black and the enclosure color of UTU3-F7W is white. The UTU3-G7B and UTU3-G7W employ the diodes with wavelengths of 980nm, 650nm and 450nm, they only different in enclosure color, the enclosure color of UTU3-G7B is black and the enclosure color of UTU3-G7W is white. The UTU-G20B and UTU-G20W employ the diode with wavelength of 980nm, they only different in enclosure color, the enclosure color of UTU-G20B is black and the enclosure color of UTU-G20W is white. The device emits laser output energy in the infrared, red and blue spectra respectively.

The provided FDA 510(k) clearance letter and its associated 510(k) Summary for the Medical Diode Laser (K243764) indicate that this device is a laser surgical instrument. The document details the device's indications for use, technological characteristics, and a comparison to predicate devices, primarily focusing on non-clinical performance data such as biocompatibility, electrical safety, and general performance testing (bench testing).

Crucially, this document does not contain information about a study proving the device meets acceptance criteria related to a specific AI/algorithm performance evaluation that would involve concepts like sensitivity, specificity, or human reader improvement with AI assistance. The "Performance Data" section explicitly states "Clinical data: Not applicable" and then lists non-clinical data. The document does mention "Software Verification and Validation Testing," which is a standard requirement for devices with software, and the documentation level was assessed as "Basic Documentation Level," meaning it likely doesn't involve complex AI algorithms requiring deep learning performance evaluations against clinical ground truth.

Therefore, I cannot extract the information required for an AI-specific acceptance criteria table or study description from this document. The device in question is a physical medical device (laser) and its clearance is based on demonstrating substantial equivalence to existing laser devices, rather than on the performance of a diagnostic AI algorithm.

**Based on the provided document, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance related to AI/algorithm output (e.g., sensitivity, specificity).
2. Sample sizes for test sets involving AI/algorithm performance.
3. Number and qualifications of experts for AI ground truth.
4. Adjudication methods for AI test sets.
5. MRMC comparative effectiveness study results or effect sizes for AI assistance.
6. Standalone algorithm performance.
7. Type of ground truth for AI performance.
8. Training set sample size for AI.
9. How ground truth for AI training was established.**

This document describes the regulatory clearance of a hardware device (a medical diode laser), not a software-based AI diagnostic device. The performance data presented are for the physical properties and safety of the laser, not for an AI's ability to interpret medical images or data.

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The Medical Diode Laser (Model: L2) is indicated for:
-Incision, excision, ablation, vaporization, hemostasis and/or coagulation of soft tissue
-Endovascular coagulation and endovenous occlusion of the greatest saphenous vein in patients with superficial vein reflux

The Medical Diode Laser use a wavelength 1470nm Galium Aluminum Arsenide (GaAlAs) diode laser as the beam source. The laser utilizes a red (650nm) aiming beam diode to indicate the area to be irradiated by the laser beam. The Medical Diode Laser (model: L2) is a compact diode laser with a LCD touchscreen for user control. The device is composed of main unit, foot switch, power cord and protective goggles. The fiber delivery system is not included in this device. The device accepts a fiber with single core of 400um and 600um in diameter and with SMA905 connectors.

The provided text is an FDA 510(k) clearance letter and summary for a Medical Diode Laser. It outlines the characteristics of the device and its comparison to a predicate device to establish substantial equivalence.

Crucially, this document does not describe a study involving an AI/Machine Learning device or a diagnostic device. The device described is a Medical Diode Laser, a surgical instrument. The performance data presented refers to bench testing for electrical safety, functional performance, and compliance with laser safety standards, not to the assessment of an algorithm's performance against ground truth in a clinical setting.

Therefore, many of the requested criteria related to AI/ML device performance (like sample size for test/training sets, expert consensus, MRMC studies, standalone performance, ground truth establishment, etc.) are not applicable to this type of device and are not found in the provided text.

Here's how the information that is applicable can be extracted:

Acceptance Criteria and Device Performance (as far as applicable to a surgical laser):

Here's an analysis of the requested information based only on the provided text:

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

   • See table above. The "acceptance criteria" for this device are primarily compliance with international safety and performance standards for medical electrical equipment and lasers, and demonstrating comparable performance characteristics to the predicate device.

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

   • N/A. This information pertains to studies of diagnostic algorithms or clinical trials. For a surgical laser, performance is assessed through bench testing and compliance with engineering standards. No clinical 'test set' in the diagnostic sense is mentioned. The data provenance is related to the testing done by "Pioon" (Wuhan Pioon Technology Co., Ltd.) in China.

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):

   • N/A. Ground truth for diagnostic accuracy is not relevant for this device. Its "performance" is based on physical output (e.g., laser power, wavelength) and safety compliance.

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

   • N/A. Not relevant for a surgical laser's technical performance assessment.

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:

   • N/A. This is a surgical laser, not an AI-assisted diagnostic tool. No human readers or MRMC studies were conducted or are applicable.

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

   • N/A. Not an AI algorithm. Its performance is inherent to its physical operation.

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

   • N/A. The "ground truth" for a laser would be its measured physical properties (e.g., power output, wavelength), electrical safety parameters, and software functionality, validated against engineering standards.

8. The sample size for the training set:

   • N/A. No training set is involved as this is not a machine learning device.

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

   • N/A. No training set is involved.

In summary, the provided document describes the FDA clearance process for a common medical device (a surgical laser) by demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical bench testing and compliance with relevant safety and performance standards. It does not provide information relevant to the assessment of an AI/ML diagnostic algorithm.

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The Medical Diode Laser ,Model S1Pro is indicated for the treatment of the saphenous veins associated with varicose veins and varicosities.

The Medical Diode Laser use a wavelength 1470nm Galium Aluminum Arsenide (GaAlAs) diode laser as the beam source. The laser utilizes a red (650nm) aiming beam diode to indicate the area to be irradiated by the laser beam. The Medical Diode Laser (model: S1Pro) is a compact diode laser with a LCD touchscreen for user control. The device is composed of main unit, foot switch, power cord and protective goggles. The fiber delivery system is not include in this device. The device accepts a fiber with single core of 400μm and 600um in diameter and with SMA905 connectors.

Here's a breakdown of the acceptance criteria and study information for the Medical Diode Laser, Model S1Pro, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the demonstration of substantial equivalence to the predicate device and compliance with relevant safety and performance standards. The "reported device performance" refers to the successful verification against these standards.

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

• Sample Size: Not explicitly stated for specific tests (e.g., how many units were tested for functional performance).
• Data Provenance: The studies are non-clinical bench tests and software verification and validation testing. There is no mention of human subject data, therefore, no country of origin is applicable in the usual sense for clinical trials. The tests were conducted by Wuhan Pioon Technology Co., Ltd.

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

This information is not applicable as the studies are non-clinical (bench testing, software V&V). Ground truth, in this context, would be defined by the technical specifications and standards (e.g., a laser's output power must be within a certain tolerance as per its design specification and relevant IEC standards).

4. Adjudication Method for the Test Set

This information is not applicable as the studies are non-clinical benchmarks against predetermined technical specifications and international standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done. The submission explicitly states "Clinical data: Not applicable." This is a non-clinical submission for a medical device.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

• Yes, the performance data detailed are primarily standalone in nature. This refers to the device itself performing according to its design specifications and relevant safety/performance standards (electrical safety, EMC, laser safety, functional performance, and software V&V). There is no "algorithm" in the sense of AI/image analysis being evaluated, but rather the functional performance of the laser device.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical studies described is:

• Technical Specifications: The device's own design specifications for parameters like wavelength, output power, pulse width, aiming beam power, dimensions, etc.
• International Consensus Standards: Compliance with standards such as IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, and IEC 60825-1.
• FDA Guidance: For software verification and validation, compliance with FDA's guidance for software in medical devices.

8. Sample Size for the Training Set

• This information is not applicable. There is no mention of a "training set" as this is not an AI/machine learning device that requires training data. The "training" of the device is its design and manufacturing to meet specifications.

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

• This information is not applicable for the same reason as point 8.

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