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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: MZ-GK) is indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/neck/ENT and Radiology, Oral Surgery and Dental procedures, Endovascular coagulation and endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The Medical Diode Laser (Model: MZ-GK) is further indicated for laser assisted lipolysis.

The Medical Diode Laser (Model: MZ-K20) is indicated for:

• Incision, excision, ablation, vaporization, hemostasis and/or coagulation of soft tissue.
• Endovascular coagulation and endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux.

The Medical Diode Laser (Model: MZ-N75) is intended to incision, excision, ablation, vaporization, hemostasis and/or coagulation of soft tissue.

The Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75) incorporates a solid state diode as laser energy source for producing its therapeutic effects, it is designed to deliver continuous or pulsed, infrared laser energy at wavelengths of 980nm and 1470nm respectively for MZ-GK, 1470nm for MZ-K20 and 1940nm for MZ-N75. The device also incorporates a red (650nm) or green(532nm) aiming beam diode to indicate the area to be irradiated by the laser beam. The device is composed of the main unit, foot switch, power cord, and protective goggles. The device incorporates an LCD touchscreen for the device user to set output parameters and for control of the device. The device transmits the laser output via third-party optical fibers with SMA905 connectors and with single cores of 200μm, 300μm, 400μm, 600μm, 800μm and 1000μm diameter respectively.

The provided FDA 510(k) clearance letter is for a Medical Diode Laser and does not contain information about AI/ML device performance, acceptance criteria, or a comparative effectiveness study involving human readers and AI.

The document primarily focuses on demonstrating substantial equivalence of the new laser device to existing predicate devices based on technical specifications and safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1). It explicitly states "Clinical data: Not applicable" and details only non-clinical bench testing and software verification/validation for the laser's operational performance, not diagnostic or therapeutic accuracy in an AI context.

Therefore, I cannot provide the requested information as it is not present in the provided text. The questions asked are typically relevant for AI/ML-enabled medical devices that involve image analysis, diagnostic assistance, or other functions where performance metrics like sensitivity, specificity, accuracy, and human reader studies are crucial.

To answer your questions, I would need a different type of FDA clearance document, specifically one for an AI/ML-enabled medical device.

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The Medical Diode Laser (Model: M2-GK) is indicated for use in surgical applications requiring the vaporization. incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Thoracic Surgery and Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/neck/ENT and Radiology, Oral Surgery and Dental procedures, Endovascular coagulation and endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The Medical Diode Laser (Model: M2-GK) is further indicated for laser assisted lipolysis.

The Medical Diode Laser device incorporates a dual wavelength Gallium Aluminum Arsenide (GaAlAs) diode laser for producing its therapeutic effects, it is designed to deliver continuous or pulsed, infrared laser energy at wavelengths of 980mm and 1470nm respectively. The device also incorporates a red (650mm) aiming beam diode to indicate the area to be irradiated by the laser beam. The device is composed of the main unit, foot switch, power cord, and protective goggles. The device incorporates an LCD touchscreen for the device user to set output parameters and for control of the device. The device transmits the laser output via third-party optical fibers with SMA905 connectors and with single cores of 200um, 400μm, 600μm, 800μm and 1000um diameter respectively.

This document is a 510(k) Premarket Notification for a Medical Diode Laser, and as such, it focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a dedicated study for a novel device. The information provided is primarily related to non-clinical bench testing and software verification, not clinical performance or impact on human readers.

Therefore, many of the requested categories for a study proving acceptance criteria will either be "Not Applicable" or the information cannot be found in the provided text.

Here is an analysis based on the provided text:

Acceptance Criteria and Device Performance (Not applicable in this context)

The document does not specify quantitative acceptance criteria for clinical device performance in the way one might expect for a diagnostic or AI-powered device. Instead, the "performance" demonstrated is adherence to electrical safety and performance standards for laser products.

Study Information (Based on the document):

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

   • See table above. As explained, these are technical and regulatory performance criteria rather than typical clinical acceptance criteria for an AI or diagnostic device.

2. Sample sizes used for the test set and the data provenance:

   • Not applicable. The document states "Clinical data: Not applicable." The "Performance Testing - Bench" refers to laboratory bench testing of the laser's physical parameters and safety, not a test set of patient data. The provenance of such bench testing data would typically be the manufacturer's internal testing facilities, but this detail is not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. Not a clinical study. Ground truth in this context would be the calibrated measurement instruments used for technical performance testing.

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

   • Not applicable. Not a clinical study.

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:

   • No. The document explicitly states "Clinical data: Not applicable." This device is a surgical laser, not an AI-assisted diagnostic tool.

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

   • Yes, implicitly. The "Performance Testing - Bench" and "Software Verification and Validation Testing" are essentially standalone tests of the device's technical functionality and software, without human users interacting in a clinical evaluation sense. The device itself (Medical Diode Laser) operates as a standalone piece of equipment for surgical procedures.

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

   • The "ground truth" for the non-clinical performance and safety testing is established by international consensus standards (IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-22) and the accuracy specifications defined by the manufacturer for the device's output parameters. For software, the ground truth is adherence to the validated software requirements.

8. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device that requires a training set in the conventional sense.

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

   • Not applicable. See #8.

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The Medical Diode Laser (Model: S1Pro) is indicated for use in surgical applications requiring the vaporization, incision. excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Headineck/ENT and Radiology, Oral Surgery and Dental procedures, Endovascular coagulation and endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The Medical Diode Laser (Model: S1Pro) is further indicated for laser assisted lipolysis.

The Medical Diode Laser device incorporates a 1470nm wavelength Gallium Aluminum Arsenide (GaAlAs) diode laser for producing its therapeutic effects. The device also incorporates a red (650nm) aiming beam diode to indicate the area to be irradiated by the laser beam. The device is composed of the main unit, foot switch, power cord, and protective goggles. The device incorporates an LCD touchscreen for the device user to set output parameters and for control of the device transmits the laser output via third-party optical fibers with SMA905 connectors and with single cores of 400um and 600um diameter respectively.

The provided text is a 510(k) premarket notification for a medical device called "Medical Diode Laser (S1Pro)". It describes the device, its intended use, comparison to predicate devices, and performance data from non-clinical testing.

However, the document does not contain information about a study that proves the device meets specific acceptance criteria related to AI/algorithm performance (e.g., sensitivity, specificity, accuracy) using a test set with ground truth established by experts, as implied by your detailed request. The device in question is a physical medical laser, not an AI software/algorithm.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance related to AI/algorithm metrics.
2. Sample size and provenance for an AI test set.
3. Number and qualifications of experts for AI ground truth.
4. Adjudication method for an AI test set.
5. MRMC comparative effectiveness study results for AI.
6. Standalone performance of an AI algorithm.
7. Type of ground truth for an AI test set.
8. Sample size for an AI training set.
9. How an AI training set's ground truth was established.

The document focuses on demonstrating substantial equivalence of the laser device to existing predicate devices based on:

• Similar Indications for Use: The uses of the S1Pro laser (e.g., vaporization, incision, coagulation of soft tissue in various surgical specialties, and laser-assisted lipolysis) are compared to those of the predicate devices.
• Similar Technology: It uses a 1470nm diode laser, similar to the predicate devices.
• Similar Output Parameters: While there are minor differences (e.g., Max Output Power, Pulse Duration, Repetition Rate), the document states these differences "do not raise new types of questions regarding the safety and effectiveness."
• Non-Clinical Performance Data: This primarily consists of compliance with recognized electrical safety and performance standards for medical electrical equipment and laser products (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-22).
• Software Verification and Validation: This confirms the software (likely controlling the laser's operation) performs as intended, following FDA guidance for device software.

In summary, the provided text describes a medical laser device, not an AI-powered diagnostic or assistive tool. Thus, it does not contain the information required to answer your specific questions related to AI/algorithm acceptance criteria and studies.

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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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Medical Diode Laser is intended to incision, ablation, vaporization, hemostasis and/or coagulation of soft tissue.

The Medical Diode Laser use a wavelength 1940nm 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: M2) 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 400um and 600um in diameter and with SMA905 connectors.

This document is about the 510(k) premarket notification for a Medical Diode Laser (M2) by Wuhan Pioon Technology Co., Ltd. The document does not describe a study involving acceptance criteria and device performance in the way typically associated with AI/algorithm-based medical devices.

Instead, this submission is for a physical medical device (a laser surgical instrument) and focuses on demonstrating substantial equivalence to a predicate device (Fotona SkyPulse Laser Platform) based on technical characteristics and compliance with recognized performance standards.

Here's an analysis based on the provided text, addressing the requested points where applicable, and noting when information is not present:

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

   • The document does not present acceptance criteria and device performance in terms of specific clinical or algorithmic metrics (like sensitivity, specificity, or AUC) as would be typical for an AI/CADe device.
   • Instead, the "performance data" for this laser device refers to compliance with established electrical safety, electromagnetic compatibility (EMC), and software standards. The acceptance criterion is implicitly successful demonstration of compliance with these standards.

   Table: Performance Data and Compliance

   Performance Area	Acceptance Criteria (Standards)	Reported Device Performance (Compliance)
   Electrical safety	IEC 60601-1:2005+AMD1:2012+AMD2:2020

IEC 60601-2-22:2019 | Complies |
| Electromagnetic compatibility (EMC) | IEC 60601-1-2:2014+A1:2020 | Complies |
| Laser product safety | IEC 60825-1:2014 | Complies |
| Software Verification and Validation | FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (Moderate level of concern) | Documentation provided and testing conducted; software considered verified and validated |

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

   • This information is not applicable and not provided as this is not an AI/CADe device that uses a test set of patient data for performance evaluation. The "tests" here refer to engineering and quality assurance tests on the physical device and its software.

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)

   • This information is not applicable and not provided as this is not an AI/CADe device requiring expert ground truth for a test set.

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

   • This information is not applicable and not provided.

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

   • This information is not applicable and not provided. The device is a surgical laser, not an AI diagnostic or assistance tool for human readers.

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

   • This information is not applicable and not provided. The device is a physical laser for surgical use, not an algorithm.

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

   • This information is not applicable and not provided in the context of clinical "ground truth" for patient data analysis. The ground truth, in the context of this device, refers to the established standards and specifications that the device must meet (e.g., electrical safety tolerances, EMC emissions limits, software functional requirements).

8. The sample size for the training set

   • This information is not applicable and not provided as this is not an AI/machine learning device.

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

   • This information is not applicable and not provided.

Summary of the Study (as described in the document):

The "study" refers to the engineering and regulatory testing performed to demonstrate the safety and effectiveness of the Medical Diode Laser (M2) by showing its compliance with recognized national and international standards.

• Type of Study: This is a premarket notification (510(k)) submission for a physical medical device. The "studies" involve compliance testing against recognized standards for electrical safety, electromagnetic compatibility, and laser product safety, as well as software verification and validation.
• Performance Data Provided:
  • Electrical safety and EMC: The device complies with IEC 60601-1, IEC 60601-2-22, IEC 60825-1, and IEC 60601-1-2 standards.
  • Software Verification and Validation: Conducted according to FDA guidance for "moderate" level of concern software.
• Conclusion: Based on these technical characteristics and performance data, the Medical Diode Laser was found to have a safety and effectiveness profile "same as the predicate device."
• Animal or clinical studies: The document explicitly states "None," indicating that no animal or clinical studies were performed or required for this 510(k) submission to demonstrate substantial equivalence.

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