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The SurgiLight 1470 Diode Laser System (Model: Halo) 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 SurgiLight 1470 Diode Laser System (model: Halo) incorporates a 1470nm wavelength Gallium Arsenide (GaAs) 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, footswitch, a power cord and remote interlock components. 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 optical fibers with SMA905 connectors.

This document is a 510(k) clearance letter for the SurgiLight 1470 Diode Laser System (Model:Halo). It states that the device is substantially equivalent to legally marketed predicate devices.

Important Note: The provided document is a 510(k) clearance letter for a laser surgical instrument. These types of devices typically demonstrate substantial equivalence through performance testing against recognized consensus standards and comparison of technological characteristics to predicate devices. They do not involve AI-based image analysis or diagnostic capabilities that would require the kind of complex study design (e.g., MRMC studies, human reader improvement metrics, expert consensus ground truth for image data) described in your request.

Therefore, many of the specific criteria related to AI performance studies (e.g., sample size for test sets, number of experts for ground truth, MRMC studies, standalone AI performance) are not applicable to this type of medical device clearance.

Here's an analysis based on the information provided in the 510(k) document, addressing your questions where applicable and noting when information is not pertinent to this device type:

Acceptance Criteria and Device Performance for SurgiLight 1470 Diode Laser System (Model:Halo)

Based on the 510(k) summary, the "acceptance criteria" are primarily demonstrated through compliance with recognized international standards for medical electrical equipment and a comparison of technical specifications to legally marketed predicate devices. The "study" proving the device meets these criteria is the non-clinical testing performed.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the compliance with the listed standards and the demonstrated substantial equivalence to predicate devices in key technical specifications.

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The Medical Diode Laser Systems, include model: VELASⅡ-30A, GBOX-15AB, GBOX-20B, CHEESEⅡ-10B are intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with minor arthritis, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation.

The Medical Diode Laser Systems, model: VELASⅡ-30B is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with minor arthritis, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation.

The Medical Diode Laser Systems, model: VELASⅡ-30B is also indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).

The "Medical Diode Laser Systems", include model: VELASⅡ-30B, VELASⅡ-30A, GBOX-15AB, GBOX-20B, CHEESEⅡ-10B which consist of three main components: Main device; Foot switch; Accessories.

Diode laser is a kind of laser with semiconductor as working material. It consists of working material, cavity resonator and power source.

The diode laser for this unit is GaAlAs diode bar, and the wavelength is 810nm and/or 980nm+/-10nm (pilot beam: 650nm+/-10nm). It features impact structure, high efficiency and long lifetime. Generally, the beam shall be emitted as the big beam divergence of the laser from the diode. With the unique fiber-coupling technology, the laser beam can be coupled efficiently into the fiber.

MCU (Micro Controller Unit) is the control center of system. MCU controls the drive board and temperature system by changing operating current. The operating power supply is the power source of the whole system. It supplies power for MCU, diode laser module by DC-DC conversion module and temp system by temp-control circuit. MCU controls the drive current of diode laser module by adjusting the DC-DC module and current-control circuit. The MCU has three external input sources: footswitch, remote interlock connector and information input from the touch units, it has one external output unit: display terminal. The diode laser module provides laser power output by fiber with optical fiber coupling system.

The provided FDA 510(k) clearance letter for the Gigaalaser Medical Diode Laser Systems does not contain a study that proves the device meets specific acceptance criteria related to its clinical efficacy. Instead, it demonstrates substantial equivalence to legally marketed predicate devices based on technological characteristics and safety standards.

The document focuses on non-clinical performance data (electrical safety, EMC, software V&V, mechanical/acoustic, animal, and clinical studies are noted as "not applicable" for this submission type) to argue that the proposed device is as safe and effective as its predicates.

Therefore, I cannot directly provide a table of acceptance criteria and reported device performance in the context of a clinical efficacy study, as such a study is explicitly stated as "not applicable" in this 510(k) submission. Similarly, details about sample size, expert ground truth, adjudication methods, MRMC studies, or standalone performance are not present because clinical efficacy testing was not required for this type of submission.

However, I can interpret the acceptance criteria in the context of a 510(k) submission as the requirements for demonstrating substantial equivalence to predicates, particularly regarding safety and technological characteristics. The "performance" reported is the demonstration that these criteria are met through compliance with recognized standards.

Here's an interpretation based on the provided document:

Overview of "Acceptance Criteria" for Substantial Equivalence and Device Performance (as demonstrated in the 510(k))

Within the context of a 510(k) submission, "acceptance criteria" are primarily established through demonstrating compliance with recognized performance standards and substantial equivalence to legally marketed predicate devices. The "study" proving this involves a comprehensive technical comparison and non-clinical testing.

The document explicitly states that clinical studies are "not applicable" for this 510(k) submission, meaning the acceptance criteria are focused on non-clinical performance and technological equivalence rather than empirical clinical efficacy data from a human trial.

1. Table of "Acceptance Criteria" (Substantial Equivalence) and "Reported Device Performance" (Demonstrated Compliance)

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

This document does not describe a "test set" in the context of clinical data for efficacy. The "testing" referred to is primarily bench testing and compliance validation with international safety and performance standards. Therefore, concepts like sample size for a patient test set and data provenance (country of origin, retrospective/prospective) are not applicable as no clinical study for efficacy was performed or presented.

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

Not applicable. As no clinical efficacy test set was used, there was no need for experts to establish ground truth on patient outcomes/diagnoses. The "ground truth" for the substantial equivalence argument relies on comparison to the published specifications and regulatory clearances of the predicate devices.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring adjudication was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document explicitly states "Clinical Studies: It is not applicable." Therefore, no MRMC study for human reader improvement with AI assistance was conducted or reported.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. This device is a laser system hardware, not an AI algorithm. Its performance is inherent to its physical output characteristics, not an algorithm's classification or detection performance.

7. The Type of Ground Truth Used

The "ground truth" for this 510(k) submission is primarily:

• Predicate Device Specifications: The established technical parameters and indications for use of the legally marketed predicate devices (K142078, K150138, K121363, K230047).
• Industry Standards: The requirements laid out in the cited IEC and other international standards for medical electrical equipment and laser safety.

8. The Sample Size for the Training Set

Not applicable. This is a hardware device, not a machine learning model that requires a training set of data.

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

Not applicable, as there is no training set for this type of device.

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Diode laser system is used for hair removal, HR mode is for professional hair removal, and FHR is for rapid hair removal. The indications for use for the 810nm Diode Laser Module include: The HR mode and FHR mode are intended for hair removal and permanent hair reduction. Use on all skin types (Fitzpatrick I-VI) including tanned skin.

Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

The product is intended for the removal of unwanted body hair. It is suitable for all skin types, including tanned skin. The Diode laser system consists of the following main components:

1. The main unit, including the CPU main board, power supply module, control panel, service panel and cooling system.
2. Handlpiece, including the diode laser, TEC, handle switch, signal, cable and plug.
3. Foot switch.

The provided FDA 510(k) clearance letter (K250206) for the "Diode laser system (Night Universe; Predator)" does not contain information typically associated with AI/ML device performance studies, specifically regarding acceptance criteria, test set details (sample size, provenance, expert adjudication), MRMC studies, standalone algorithm performance, or ground truth establishment for training and test sets.

The information primarily focuses on the device's technical specifications, non-clinical test results, and substantial equivalence to predicate devices for its intended use (hair removal and permanent hair reduction). The testing described relates to electrical safety, electromagnetic compatibility, laser safety, and biological evaluation (biocompatibility) under various IEC and ISO standards.

Therefore, I cannot populate the requested table or answer the specific questions about the study that proves the device meets acceptance criteria in the context of an AI/ML-driven medical device.

Here's why the requested information is not present in the document:

• Device Type: The "Diode laser system" is a hardware medical device (laser surgical instrument) used for a physical intervention (hair removal). It is not an AI/ML-driven diagnostic or prognostic device that would require performance metrics like sensitivity, specificity, AUC, or studies involving interpretation of medical images by experts.
• Acceptance Criteria Mentioned: The acceptance criteria mentioned in the document are related to compliance with safety and performance standards for laser devices (e.g., IEC 60601-1, IEC 60601-2-22, IEC 60825-1) and biocompatibility (ISO 10993). The "reported device performance" in this context would be that the device successfully passes these standard-based tests (e.g., emits laser at specified wavelengths and power, is electrically safe, compatible with human tissue).
• No AI/ML Component: There is no indication or mention of any artificial intelligence or machine learning component in the device's description, function, or the studies performed to support its clearance.

In summary, the provided document does not describe the kind of acceptance criteria or performance study typically associated with AI/ML medical devices.

If the question implicitly assumes an AI/ML component based on the general prompt, then the provided text does not support that assumption.

However, if we strictly interpret "acceptance criteria" and "study" as presented in the document for this specific device, here's what can be inferred:

Acceptance Criteria and Study for Diode Laser System (Night Universe; Predator)

The acceptance criteria for this device are primarily based on its compliance with established international safety and performance standards for medical electrical equipment and laser products. The study proving these criteria are met consists of non-clinical bench testing to demonstrate adherence to these standards and substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not applicable in the context of clinical trial-like "test sets" for diagnostic performance. The "test" consists of a single device (or representative samples) undergoing bench testing against regulatory standards.
• Data Provenance: Not applicable in the sense of patient data. The "data" comes from engineering and laboratory test results on the device itself.

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

• Not applicable. "Ground truth" in this context refers to the defined parameters and safety requirements of the standards themselves, not a medical "diagnosis" by experts. Compliance is assessed by accredited testing laboratories and regulatory bodies.

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

• Not applicable. This concept pertains to expert review for diagnostic devices, not hardware safety testing.

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. This device is not an AI-assisted diagnostic tool.

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

• Not applicable. This device does not have a standalone algorithm for performance evaluation. Its "standalone performance" is its adherence to physical and electrical safety standards.

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

• The "ground truth" for this device's acceptance is based on engineering and biophysical principles codified in international consensus standards (IEC, ISO). For example, a "safe" laser emission level is determined by these standards. "Performance" is meeting the specified output parameters safely.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device that requires training data.

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

• Not applicable.

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The THEIA808 is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type 1-VI), including tanned skin.

Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

The Diode laser is a kind of laser with semiconductor as working material. It consists of working material, cavity resonator and power source.

The diode laser for this unit is GaAlAs diode bar, and the wavelength is 808nm. It features impact structure, high efficiency and long lifetime. Generally the beam shall be emitted as the big beam divergence of the laser from the diode. With the unique fiber-coupling technology, the laser beam can be coupled efficiently into the handpiece.

When the THEIA808 works, the thermoelectric cooler cools the light outlet, and the main device measures the working temperature of the light outlet through the NTC temperature measuring resistor.

When the temperature reaches the minimum temperature, the TEC is controlled to stop working. The heat generated by thermoelectric cooler is conducted away by the water flow in the cooling module.

The energy of the laser is preferentially absorbed by the melanin in the hair, so that the hair follicle produces high heat. Thereby destroying the structure of the hair follicle, making the hair lose the ability to regenerate, and achieving the purpose of hair removal. The light outlet (treatment head) adopts a uniquely designed dynamic cooling device.

During the hair removal process, it can ensure that the epidermis will not be burned, so that the laser heat is limited to damage the hair follicles, while allowing the heat to diffuse from the epidermis, so that the epidermis can be anesthetized in a short time. The skin will not reach the damage threshold and can be protected from heat damage, thus ensuring a painless, fast and permanent hair removal effect.

This document is a 510(k) clearance letter for the Medical Diode Laser Systems (THEIA808). It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria related to AI or algorithm performance.

The document specifically states:

• "No clinical study is included in this submission." This means there are no clinical trials proving efficacy or performance based on patient outcomes related to hair removal or reduction using this specific device.
• The clearance is based on "Substantial Equivalence" to a predicate device (K162659 Diode Laser Hair Removal System). This means the FDA determined the new device is as safe and effective as a legally marketed predicate device, primarily through non-clinical testing and comparison of specifications (e.g., wavelength, power, cooling methods).
• The non-clinical tests conducted verified compliance with electrical safety, EMC, laser safety, and biocompatibility standards. These are not performance metrics for hair removal efficacy or AI assistance.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details for AI or algorithm performance because the provided text does not contain any such details. The device itself is a laser system, not an AI or algorithmic diagnostic/assistive device.

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(1) The Medical Diode Laser Systems, model: GBOX-6H, VELAS II-6H is indicated for use in surgical applications requiring the vaporization, excision, ablation, cutting and hemostasis, or coaqulation 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. The output wavelength of model GBOX-6H and VELAS II -6H is 1940nm.

(2) The Medical Diode Laser Systems, model: GBOX-10D, GBOX-12D is indicated for use in surgical applications requiring the vaporization, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endloscopic 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. The output wavelength of model GBOX-10D and GBOX-12D is 1470nm.

(3) The Medical Diode Laser Systems, model: GBOX-15D, VELAS II -15D is indicated for use in endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The GBOX-15D, VELAS II - 15D is further indicated for laser assisted lipolysis. The output wavelength of model GBOX-15D and VELAS II -15D is 1470nm.

(4) The Medical Diode Laser Systems, model: VELAS Pro-30B15D is indicated for use in surgical applications requiring the vaporization, incision, 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. Medical Diode Laser Systems, model: VELAS Pro-30B15D is further indicated for laser assisted lipolysis. The output wavelength of model VELAS Pro-30B15D is 980nm or 1470nm.

The "Medical Diode Laser Systems", include model: GBOX-6H, VELAS II -6H, GBOX-10D, GBOX-12D, GBOX-15D, VELAS II-15D, VELAS Pro-30B15D which consist of three main components: Main device; Foot switch; Accessories. Diode laser is a kind of laser with semiconductor as working material. It consists of working material, cavity resonator and power source. The diode laser for this unit is GaAlAs diode bar, and the wavelength is 1940nm for GBOX-6H, VELAS II -6H; 1470nm for GBOX-10D, GBOX-12D, GBOX-15D, VELAS III-15D; 980nm or 1470nm for VELAS Pro-30B15D. It features impact structure, high efficiency and long lifetime. Generally, the beam shall be emitted as the big beam divergence of the laser from the diode. With the unique fiber-coupling technology, the laser beam can be coupled efficiently into the fiber. MCU (Micro Controller Unit) is the control center of system. MCU controls the drive board and temperature system by changing operating current. The operating power supply is the power source of the whole system. It supplies power for MCU, diode laser module by DC-DC conversion module and temp system by temp-control circuit. MCU controls the drive current of diode laser module by adjusting the DC-DC module and current-control circuit. The MCU has three external input sources: footswitch, remote interlock connector and information input from the touch units, it has one external output unit: display terminal. The diode laser module provides laser power output by fiber with optical fiber coupling system.

The provided document is a 510(k) summary for Medical Diode Laser Systems. It focuses on establishing substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study demonstrating the device meets those criteria in terms of clinical performance. The document primarily discusses the similarity of the proposed device to predicate devices. Therefore, much of the requested information cannot be extracted directly from this type of regulatory submission.

Here's a breakdown of what can be inferred or explicitly stated:

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

The document does not present explicit acceptance criteria for clinical performance (e.g., specific efficacy rates or safety profiles) for the proposed device, nor does it report its performance against such criteria. Instead, it compares the technological characteristics of the proposed device to predicate devices. The "acceptance criteria" here are implicitly meeting the performance characteristics of the predicate devices to prove substantial equivalence.

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

The document explicitly states: "Animal Study - It is not applicable." and "Clinical Studies - It is not applicable." This indicates that no clinical "test set" (i.e., patient data for direct performance evaluation) was used for this 510(k) submission. The data provenance is therefore not relevant in this context.

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)

Since no clinical studies or test sets with patient data were conducted for this submission, there were no experts used to establish ground truth for such a test set. The submission relies on establishing equivalence to legally marketed predicate devices, implying their established safety and efficacy.

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

Not applicable, as no clinical test set 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. This device is a laser system, not an AI-powered diagnostic tool, and no MRMC studies were mentioned.

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

Not applicable. This is a hardware medical device, not an algorithm.

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

Not applicable, as no clinical studies requiring a ground truth for performance evaluation were conducted. The "ground truth" in this context is the safety and efficacy profiles of the predicate devices as legally marketed.

8. The sample size for the training set

Not applicable, as this is a hardware medical device, not an AI/ML algorithm requiring a training set.

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

Not applicable, as this is a hardware medical device.

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The intended use of the "CHARISMA" is:
-Dermatological procedures requiring coagulation of soft tissue and skin resurfacing procedures. further indicated for treatment of benign pigmented lesions, such as, but not limited to lentigines (age spots), solar lentigos (sun spots), melasma, dyschromia, and for treatment of facial wrinkles and fine lines.
-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
-Further indicated for laser assisted lipolysis.

The intended use of the "REGAL" is:
-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
-Further indicated for laser assisted lipolysis.

Diode laser is a kind of laser with semiconductor as working material. It consists of working material, cavity resonator and power source. The diode laser for this unit is GaAlAs diode bar, and the wavelength is 1470nm. It features impact structure, high efficiency and long lifetime. Generally, the beam shall be emitted as the big beam divergence of the laser from the diode. With the GIGAA'S unique fiber-coupling technology, the laser beam can be coupled efficiently into the fiber. MCU (Micro Controller Unit) is the control center of system. MCU controls the drive board and temperature system by changing operating current. The operating power supply is the power source of the whole system, it supplies power for MCU, diode laser module by DC-DC conversion module and temp-control circuit. MCU controls the drive current of diode laser module by adjusting the DC-DC module and current-control circuit. The MCU has three external input sources: footswitch, remote interlock connector and information input from the touch units, it has one external output unit: display terminal. The diode laser module provides laser power output by fiber with optical fiber coupling system.

The document provided is a 510(k) premarket notification for two medical diode laser systems, CHARISMA and REGAL. It aims to demonstrate substantial equivalence to legally marketed predicate devices, not to prove the device meets specific acceptance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth cannot be extracted from this document in the typical sense of a clinical performance study for an AI/software device.

However, I can provide information on the non-clinical tests performed to demonstrate safety and performance equivalence, as these serve as the "acceptance criteria" for this type of submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k) submission, the "acceptance criteria" are compliance with established electrical safety, EMC, and laser safety standards, as well as satisfactory software verification and validation. The "reported device performance" is the demonstration of compliance through non-clinical testing.

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

• Sample Size: Not applicable. The testing described is non-clinical, involving the physical device and its software being tested against engineering and safety standards, rather than a "test set" of patient data or samples.
• Data Provenance: Not applicable. The testing involves the device itself and its components, not patient data.

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

Not applicable. This is a non-clinical submission. Ground truth, in the context of clinical studies for AI/software, refers to definitive diagnoses or measurements. Here, the "ground truth" is compliance with international safety and performance standards. The "experts" involved would be the engineers and quality assurance personnel conducting and verifying the tests, but their specific number and qualifications are not detailed in this document.

4. Adjudication Method for the Test Set

Not applicable. There is no "adjudication method" in the sense of resolving discrepancies in expert opinions on patient data. Compliance with standards is typically determined by objective measurements and verification protocols.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states under "VIII Clinical Testing" that it "is not applicable." This type of study is usually performed for diagnostic AI devices where human performance with and without AI assistance is being compared.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone performance study in the context of AI/software algorithm only was not done. The device is a physical medical laser system, and the non-clinical tests assess the safety and performance of the hardware and integrated software, not a standalone algorithm.

7. The Type of Ground Truth Used

As this is a non-clinical submission, the "ground truth" is compliance with recognized international safety and performance standards (IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-22) and FDA guidance for software. These standards define the acceptable limits and behaviors for medical electrical equipment, laser products, and software.

8. The Sample Size for the Training Set

Not applicable. This document describes a medical device's safety and performance testing for regulatory clearance, not the development or training of an AI algorithm. Therefore, there is no "training set" in the context of machine learning.

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

Not applicable, as there is no training set mentioned or implied in this regulatory submission.

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The Diode Laser System model Dawn-S is indicated for incision, ablation, vaporization, and coagulation of body soft tissues in surgical application.

The 980mm diode laser is generally indicated for use in surgical applications requiring the vaporization, incision, ablation, cutting and hemostasis, or coagulation of soft tissue, including: general surgery, ENT (ear, nose, and throat) and oral surgery (otolaryngoloty), dental procedures, dermatology, plastic surgery, podiatry, urology, gastroenterology, and gynecology. The laser is further indicated for laser assisted lipolysis.

The 1470mm diode laser is indicated for use in surgical applications requiring the vaporization, 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 laser is further indicated for laser assisted lipolysis.

The Diode Laser System model Dawn-S is intended for delivery of dual wavelength laser beam to soft tissue. The Diode Laser System model Dawn-S generates a 1470nm wavelength laser and 980nm wavelength laser.

The laser is controlled via a high-resolution color touch screen display includes a user interface allowing selection of CW and Pulse mode as well as duty cycle and frequency of operation, laser power level and Stand-by/Ready selection.

The laser system consists of an optical block with contains the laser diode, mirrors, lens, and aiming beam diode, an air cooling system, and the laser power system, as well as an external footswitch for laser activation.

This FDA 510(k) summary provides information on the Diode Laser System model Dawn-S. The information focuses on demonstrating substantial equivalence to predicate devices, rather than a clinical study establishing new acceptance criteria or specific performance metrics with detailed statistical analysis.

Based on the provided document, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in terms of specific performance endpoints (e.g., accuracy, sensitivity, specificity) with numerical targets. Instead, it relies on comparison to predicate devices and compliance with recognized standards.

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

The document explicitly states: "No human clinical data is need for Diode Laser System model Dawn-S". Therefore, there was no "test set" of patient data for a clinical study as would be understood for an AI/diagnostic device.

The "test set" for this device appears to be the physical device itself undergoing non-clinical (bench) testing to demonstrate compliance with various IEC standards. No information is provided regarding the specific number of units tested, the origin of these units, or if any particular "data provenance" (e.g., country of origin) applies to non-clinical bench testing.

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

Not applicable. As no human clinical data was used and the device's performance was evaluated through non-clinical testing against recognized standards, there was no "ground truth" to be established by experts in the context of evaluating diagnostic accuracy or clinical outcomes. The "ground truth" here is the adherence to engineering and safety standards.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring expert adjudication of results. The non-clinical testing involved engineers and technicians performing standardized tests.

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 is a laser surgical instrument, not a diagnostic AI device requiring human reader interpretation, and no MRMC study was performed.

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

Not applicable. This is a hardware medical device (laser system), not an AI algorithm. Its performance is inherent in its operation, not derived from an algorithm producing an output for a human to interpret.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For this device, the "ground truth" for demonstrating its safety and effectiveness is primarily established by:

• Compliance with Recognized Standards: The primary "ground truth" is that the device meets the specifications and safety requirements outlined in the cited IEC standards (IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-22).
• Substantial Equivalence to Predicate Devices: The comparison to legally marketed predicate devices (K212734, K240747, K240644) serves as a form of "ground truth" by demonstrating that the new device shares fundamental technological characteristics and indications for use with devices already deemed safe and effective.

No pathology, expert consensus on images, or patient outcome data from a clinical trial were used to establish ground truth for this 510(k) submission.

8. The Sample Size for the Training Set

Not applicable. This is a hardware medical device, not an AI algorithm that requires a training set.

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

Not applicable, as there is no training set for this type of device.

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Diode Laser System, (and the fiber delivery systems and accessories used to deliver laser energy), are indicated for use in surgical applications requiring the hemostasis, ablation, vaporization, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), gastroenterology, general surgery, gentourinary surgery (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT), ophthalmology, podiatry, pulmonology, and thoracic surgery; and Laser Assisted Lipolysis (980 nm only). Diode Laser System, (and the fiber delivery systems and accessories used to deliver laser energy), are in surgical applications requiring the ablation, vaporization, excision, and coagulation of soft tissue in medical specialties including: orthopedics.

The Aurolance AM diode laser system consists of a unit, footswitch, power cord assembly, unit key, and protective eyewear. The Aurolance 980 diode laser system consists of a main unit, footswitch, power cord assembly, unit key and protective eyewear. The Aurolance 810 diode laser system consists of a unit, footswtich, power cord assembly, unit key and protective eyewear. The LaserPro D980 diode laser system consists of a main unit, footswtich, power cord assembly, unit key, and protective eyewear. The LaserPro D810 diode laser system consists of a main unit, footswitch, power cord assembly, unit key and protective eyewear.

A review of the provided PDF reveals that it describes the FDA's decision to clear several Diode Laser Systems for marketing based on their substantial equivalence to previously marketed predicate devices. It does not contain information about acceptance criteria, the specific studies performed, sample sizes, expert qualifications, or ground truth establishment relevant to AI/ML device performance. The document focuses on regulatory approval rather than detailed performance evaluations of an AI/ML algorithm.

Therefore, I cannot provide the requested information because the provided text does not contain the details about acceptance criteria and studies for an AI/ML device. The document is an FDA 510(k) clearance letter for a physical medical device (Diode Laser System), not an AI/ML software device.

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The indications for use for the TL-S20S-TWC include: The Super Hair Removal (SHR) Mode are intended for temporary hair reduction. The indications for use for the TL-S20S-755A include: The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re- growing when measured at 6,9 and 12 months after the completion of a treatment regimen. Use on all skin types (Fitzpatrick L-VI), including tanned skin. (HR. SHR Modes) The indications for use for the TL-S20S-810B include: The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a long term. stable reduction in the number of airs re- growing when measured at 6,9 and 12 months after the completion of a treatment regimen. Use on all skin types (Fitzpatrick I-VI), including tanned skin. (HR, and SHR Modes).

Not Found

This document is an FDA 510(k) clearance letter for the Luna Diode Laser System. It does not contain any information about the acceptance criteria, device performance, study details (sample sizes, data provenance, expert qualifications, adjudication methods), MRMC studies, standalone performance, or ground truth establishment relevant to an AI/ML medical device.

The letter is a regulatory document confirming that the device is substantially equivalent to legally marketed predicate devices. It discusses general controls, regulations, and manufacturing practices, but not the technical validation of an AI algorithm.

Therefore, I cannot provide the requested information based on the provided text.

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Medical Diode Laser Systems are intended for intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue including marginal and epithelial lining of free gingiva and are indicated for: frenectomy; frenotomy; biopsy; operculectomy; implant recovery; gingivoplasty; 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;papillectorny; 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 and excision; treatment of canker sores; herpetic ulcers of the oral mucosa; laser soft tissue curettage; reduction of gingival hypertrophy.

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

Low Level Laser Therapy: Medical Diode Laser Systems are intended to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffins pain, or muscle spasm, and for the temporary increase in local blood circulation and/or temporary relaxation of muscles.

The Medical Diode Laser System is a compact, air-cooled unit. It is a complete self-contained instrument, which includes a high efficiency power supply, a microprocessor controlled, adjustable light output with automatic power stabilization, (fan cooled), as well as a switch panel and LCD screen display panel designed to be user friendly. The system includes high power lasers, safety features and an SMA fiber output connector. The system includes a Lithium battery, it can work 1hour when not external power input at maximum power output in pulse or CW but intermittent mode. The diodes are made from GaAlAs semiconductor material for high output and superior reliability. The diode lasers are enclosed in a rugged, factory-aligned, replaceable, environmentally protective module. High-capacity fans eliminate the need for water-cooling, and assure low maintenance and reliable laser operation. The diodes convert electric energy into coherent laser radiation with a wavelength of 810nm or 980nm+/-10nm (pilot beam: 650nm+/-10nm).

This document is a 510(k) premarket notification for a medical device (Medical Diode Laser Systems) and explicitly states that no clinical testing was performed. Therefore, the request for "acceptance criteria and the study that proves the device meets the acceptance criteria" cannot be fully answered as it pertains to clinical performance and AI integration.

The provided document focuses on demonstrating substantial equivalence to predicate devices primarily through non-clinical testing (electrical safety, EMC, laser safety standards, and software verification). There is no mention of AI/ML, human-in-the-loop performance studies, or ground truth establishment based on expert consensus, pathology, or outcomes data, which are typical requirements for AI/ML device clearances.

Based on the provided text, here's what can be inferred/extracted and what cannot be answered:

1. Table of acceptance criteria and the reported device performance:

Since no clinical or AI performance study was presented, the "acceptance criteria" here refer to conformance with established safety and performance standards for laser medical devices.

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