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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 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 Diode Laser System includes 2 types of handpieces with same 1.2 x 1.4 cm spot size:

Single-Wavelength Handpiece

810nm wavelength

The 810nm wavelength handpiece is 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 I-VI), including tanned skin.(HR, and FHR Modes)

Trio-Wavelength Handpiece

The Trio-Wavelength Handpiece combines 3 wavelengths (755+810+1064 mm) into a single handpiece. It is intended for temporary hair reduction in Fast Hair Removal Mode (FHR).

Diode Laser System is a photothermal effect surgical laser device intended for prescription use and is comprised mainly of three components: console, handpieces and water-loop cooling system. There is plenty of melanin in hair follicles and hair shafts. Melanin scatters among hair bulbs and shaft structures (like medullary substance, cortex, and cuticula pili). The laser wavelengths that ST-803 Diode Laser System uses can be well absorbed by melanin, which causes a rapid increase in temperature, destroying surrounding hair follicles, and finally removing hair. The control panel is in the form of an LCD touch screen in front of device and displays for operating and monitoring the laser. The system can automatically identify different handpieces. The product includes 2 types of handpieces that are in the same spot size and 2 combinations of wavelengths.

The diode is exited to emit a high-power therapeutic laser beam intended to reduce unwanted body hair (e.g., armpit, leg, arm, back, chest and bikini line). It is intended to be used by a trained professional to emit a laser of wavelength around 810 nm or 755+810+1064 nm, delivered by a dedicated handpiece, to destroy hair follicles by heat.

This is a premarket notification (510(k)) for a medical device, which seeks to demonstrate substantial equivalence to a predicate device. Therefore, the information provided does not typically include clinical study data in the same way an approval for a novel device would. The "performance data" section focuses on non-clinical testing.

Here's the breakdown based on the provided document:

There is no information regarding acceptance criteria or a study that proves the device meets specific acceptance criteria in terms of clinical performance (e.g., sensitivity, specificity, accuracy). Instead, the document focuses on establishing substantial equivalence for a Class II medical device based on non-clinical performance data and comparison to a predicate device.

The document details the device's technical specifications and compares them to a predicate device, along with outlining various non-clinical tests (electrical safety, EMC, software verification, sterilization, biocompatibility, and bench testing) to demonstrate its safety and performance.

Here's what can be extracted:

• No specific acceptance criteria related to a performance study (e.g., accuracy metrics for an AI device) are mentioned. The “acceptance criteria” for a 510(k) submission primarily revolve around demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is achieved through engineering testing and substantial equivalence arguments rather than a direct clinical performance study with acceptance criteria.

• No study proving the device meets acceptance criteria in the sense of a clinical performance trial is described. The "performance data" section (Section VII) details non-clinical tests.

However, I can extract the information relevant to a 510(k) submission, even if it doesn't directly map to the clinical performance study questions:

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

Since this is a 510(k) submission for a laser device, "acceptance criteria" and "reported device performance" are primarily focused on safety, electrical characteristics, software functionality, and biocompatibility, rather than clinical efficacy metrics typically seen in AI/diagnostic device performance studies. The comparison tables are generally for technical characteristics against the predicate.

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

• No clinical test set is described. The tests are non-clinical (laboratory/bench testing).
• For Biocompatibility:
  • Cytotoxicity: L-929 cell cultures were used (cell lines, not human or animal subjects in the clinical sense).
  • Skin Sensitization: Guinea Pigs were used.
  • Skin Irritation: Rabbits were used.
• Data Provenance: The tests are conducted internally or by a contracted lab and reported by Smedtrum Medical Technology Co., Ltd. (Taiwan).

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

• Not applicable. This information is for clinical performance studies, which were not described. The non-clinical tests rely on established scientific methods and laboratory standards.

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

• Not applicable. This applies to clinical performance studies, particularly for diagnostic devices where subjective interpretation might require adjudication.

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 for hair reduction, 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 is a physical laser system, not an algorithm.

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

• Not applicable for clinical ground truth. For non-clinical tests, "ground truth" is defined by adherence to international standards and validated laboratory methodologies. For example, in biocompatibility, the ground truth for "no cytotoxicity" is a certain cell viability percentage.

8. The sample size for the training set:

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

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

• Not applicable. This is a hardware medical device.

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The Diode Laser System is intended for use in dermatologic and general surgical procedures. The Fast Mode is intended for hair removal of unwanted hair, and permanent hair regrowth. The Free Mode is intended for hair removal of unwanted hair, and permanent hair regrowth. The Diode Laser System is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin.

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

The Diode Laser System is a surgical device intended for use in dermatologic and general surgical procedure. It utilizes a semiconductor diode with invisible infrared radiation as a laser source (810 nm). The laser power is delivered to the treatment area via a laser handpiece. The emission laser is activated by a footswitch.

The proposed Diode Laser System has two models, GP900A8 and GP900Q8. Both GP900A8 and GP900Q8 have the same functions modules, such as the power supply system, central control system, cooling system, laser delivery system and safety feature, and same working mode, such as Fast mode and Free mode.

The GP900A8 is a standard case with wheels to allow easy movement on the floor. The GP90008 is a desktop case.

I am sorry, but the provided text does not contain information about acceptance criteria and device performance for an AI/ML device or a study proving that the device meets those criteria. The document is a 510(k) premarket notification for a Diode Laser System, which is a physical medical device, not an AI/ML software. It primarily focuses on demonstrating substantial equivalence to a predicate device through technical specifications, intended use, and non-clinical safety tests.

Therefore, I cannot provide the requested information, which includes:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. If an MRMC comparative effectiveness study was done and its effect size.
6. If a standalone (algorithm only) performance was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

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The Diode Laser System is intended for hair reduction on all skin types (Fitzpatrick skin type 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 proposed device, Diode Laser System, is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI);

Function module description
a. Control Panel
b. Main Control Module
c. Constant current board module
d. Temperature and humidity control system
e. Handpiece module

The provided document is a 510(k) Summary for a Diode Laser System intended for hair reduction. It does not contain information about specific acceptance criteria for device performance beyond general safety and effectiveness. The document states "No clinical study is included in this submission." Therefore, the requested information regarding acceptance criteria, device performance, study details, expert involvement, and ground truth cannot be fully provided from the text.

However, based on the provided text, here's what can be extracted and inferred:

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

The document does not explicitly state quantitative "acceptance criteria" for hair reduction. Instead, it defines the intended use based on "permanent hair reduction... 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."

Performance is primarily addressed through non-clinical tests comparing the proposed device's specifications and safety compliance to predicate devices.

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: "No clinical study is included in this submission."
Therefore, there is no clinical test set, sample size, or data provenance information. Non-clinical tests were conducted to verify design specifications and compliance with standards.

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

Not applicable, as no clinical study or test set for efficacy was conducted or provided in this submission for hair reduction. Safety and technical compliance were assessed through non-clinical testing against established standards.

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

Not applicable, as no clinical study or test set for efficacy was conducted.

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 for hair reduction, not an AI-assisted diagnostic or imaging device that would involve human readers.

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

This question is not applicable in the context of a physical medical device (Diode Laser System) for hair removal. The "algorithm" in this context refers to the device's control logic, which determines energy output, pulse duration, and frequency. The device operates in a standalone manner in the sense that it mechanically delivers laser energy based on programmed parameters, but its application requires a human operator for treatment and safety.

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

For the primary indication (hair reduction efficacy), no clinical study was presented to establish ground truth from patient outcomes data. The submission relies on substantial equivalence to predicate devices that have established their effectiveness and safety for permanent hair reduction.

For safety (biocompatibility, electrical, EMC, laser safety), the "ground truth" is compliance with recognized international standards (e.g., IEC 60601 series, ISO 10993 series).

8. The sample size for the training set

Not applicable, as no machine learning algorithm requiring a "training set" is mentioned or implied for the intended use and performance assessment described.

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

Not applicable.

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