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Diode Laser Hair Removal Machine (Model: GLD01) is intended for hair removal, permanent 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 Diode Laser Hair Removal Machine (Model: GLD01) consists with the power system, microprocessor controller system, operation and screen system, cooling system, laser module and security alarm system. The microprocessor control the laser power, which can provide the constant current for the laser module. The inner high energy diode, from the laser module, transform the electronic to light energy, which output the constant laser with wavelength.The laser light on the skin by leaded crystal, penetrate into the deep tissue of the skin. The light energy is absorbed and then turned into the thermal energy, which can destroy the hair follicle tissue, make it gone and never grow again.

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The Diode laser device is intended for hair removal, permanent 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.

Diode laser device consists of a main unit, a handheld, a foot switch and a power cord.

Device composition and handle characteristics: The device includes a handle with a single-band 808nm semiconductor laser, and the semiconductor lasers of the handle are powered by the laser power supply in the host to emit the laser of the corresponding wavelength.

Working principle of semiconductor laser: Semiconductor laser uses semiconductor materials of different doping types as laser working substance, uses natural cleavage surface to form resonant cavity for laser oscillation and amplification, and adds forward voltage to PN junction area of semiconductor laser to form particle number inversion of non-equilibrium carrier between conduction band and valence band of semiconductor substance. When a large number of electrons and holes in particle number inversion state are recombined, excess energy will be released, and these energies will be expressed in the form of photons, that is, laser is formed. Due to resonance amplification of cleavage surface resonant cavity, stimulated feedback is realized, so that laser can be directionally emitted and output from semiconductor laser.

This 510(k) clearance letter and summary primarily focus on demonstrating substantial equivalence to a predicate device, which is typical for Class II medical devices. The information provided does not contain a detailed study report with specific acceptance criteria related to a performance study for the device's efficacy (hair removal/reduction). Instead, it relies on comparison to a predicate device and adherence to recognized standards for safety and performance.

Here's an analysis based on the provided text:

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

The document does not explicitly state "acceptance criteria" in the context of a clinical or performance study with numerical targets for efficacy (e.g., a certain percentage of hair reduction). Instead, it relies on demonstrating substantial equivalence to a predicate device that is already legally marketed for the same indication. The "performance" assessment is based on the similarity of technical specifications and the successful completion of non-clinical tests to applicable standards, ensuring safety and basic functionality.

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

The document explicitly states: "No clinical study is included in this submission."

Therefore:

• Sample size for the test set: Not applicable (no clinical test set was used for this submission).
• Data provenance: Not applicable.

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

Not applicable, as no clinical study or test set with expert-established ground truth was part of this submission. The "ground truth" for clearance in this context is established by the FDA's acceptance of substantial equivalence to an already cleared device, which presumably had clinical data at the time of its own clearance.

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, 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 for hair removal, not an AI-assisted diagnostic or imaging device that would typically involve human readers or MRMC studies.

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

Not applicable. This is a physical medical device (diode laser), not a software algorithm.

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

For the purpose of this 510(k) submission, the "ground truth" for the device's indications for use and general safety/effectiveness is implicitly the regulatory clearance and established performance of the predicate devices. The applicant is demonstrating that their device is sufficiently similar to these predicates to be considered equally safe and effective.

8. The sample size for the training set

Not applicable, as no clinical study was conducted. There is no "training set" in the context of this 510(k) submission for efficacy.

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

Not applicable, as no clinical study or training set was used.

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The KALA Therapy Wand (Model: KALA-03) is intended for the treatment of facial wrinkles, and mild to moderate inflammatory acne. The red light is intended for the treatment of wrinkles, and the blue light is intended for the treatment of mild to moderate inflammatory acne.

The KALA Therapy Wand (Model: KALA-03) is indicated for over-the-counter aesthetic use. The red light is intended for the treatment of wrinkles, and the blue light is intended for the treatment of mild to moderate inflammatory acne. The device is vibrating in red light model. The device is powered by a Lithium-Ion rechargeable battery, and it has a charging cable, USB charging stand, protective goggles, storage case and instruction manual.

The wand can be rotated 135 degrees in either direction.

There are two switches of the device: one function is red light to wrinkle removal and vibration for relax, the other function is blue light to treat mild to inflammatory acne.

The device will automatically shut down after 12 minutes of operation. The recommended treatment time is 3 minutes per area. After every three minutes of treatment, the device will vibrate to indicate the time. If you need to continue treatment, simply turn on the device again.

The provided FDA 510(k) clearance letter and summary for the KALA Therapy Wand (Model: KALA-03) primarily focus on demonstrating substantial equivalence to predicate devices through non-clinical testing. This type of clearance generally does not require extensive clinical performance studies with detailed acceptance criteria and human reader studies as would be seen for a new or complex AI/ML-driven diagnostic device.

Based on the provided information, the device is a light-based therapy device for over-the-counter use, intended for aesthetic purposes (facial wrinkles and mild to moderate inflammatory acne). The "study" proving the device meets acceptance criteria is a non-clinical performance testing approach demonstrating compliance with relevant electrical safety, electromagnetic compatibility, photobiological safety, battery safety, and biocompatibility standards. Software verification and validation, and usability validation were also performed.

Here's the breakdown of the information requested, as extractable from the provided document:

Acceptance Criteria and Device Performance

Since this is a non-clinical submission, the "acceptance criteria" are compliance with established safety and performance standards. There isn't a table of statistical performance metrics, but rather successful adherence to defined technical and safety requirements.

Table of Acceptance Criteria and Reported Device Performance (Non-Clinical Compliance)

Study Details (as applicable for a non-clinical submission):

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

   • Test Set (Device Testing): The "test set" here refers to the device prototypes/units that underwent the non-clinical tests. The document does not specify the number of units tested for electrical safety, EMC, etc., which is typical for such submissions.
   • Data Provenance: The testing was conducted by or for the manufacturer (Shenzhen Kaiyan Medical Equipment Co., Ltd) in China, as indicated by the submitter's information. It's inherently "prospective" in the sense that the tests were performed on the device designed for submission.

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

   • This is a non-clinical submission for a device used for aesthetic purposes. The concept of "ground truth" established by medical experts (like radiologists for image analysis) is not applicable here. The "ground truth" for these tests is defined by the passing criteria of the international standards themselves (e.g., specific thresholds for electrical leakage, EMC emissions, irradiance, etc.). Compliance is assessed by qualified test engineers and labs.

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

   • Not applicable. Adjudication methods are typically used in clinical studies, especially those involving subjective assessments or disagreements among human readers. Non-clinical testing against objective standards does not involve expert adjudication in this manner.

4. 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. An MRMC study is not relevant for this type of aesthetic, light-based therapy device where the claim is not for assisting human readers in diagnosis. The clearance is based on safety and functional equivalence.

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

   • Not applicable. This device is not an algorithm for diagnosis or image analysis. It is a physical device providing light therapy. Its "standalone" performance refers to its ability to meet the specified technical parameters and safety standards.

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

   • The "ground truth" for demonstrating substantial equivalence and safety in this context is compliance with recognized international consensus standards (e.g., IEC, ISO). The performance is measured against these technical specifications, not against clinical outcomes or expert consensus on medical conditions.

7. The sample size for the training set:

   • Not applicable. This device does not involve a machine learning algorithm that requires a "training set" in the traditional sense of AI/ML software. The software component, as described, is for controlling device functions ("Basic Documentation Level software"), not for learning from data.

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

   • Not applicable, as there is no training set for an AI/ML algorithm.

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The Diode laser device is intended for use in dermatology procedures requiring coagulation. The indications for use for the Trio-Wavelength Handpiece include: The Fast Hair Removal (FHR) Mode is intended for temporary hair reduction. The HR mode is intended for use in dermatology procedures requiring coagulation. The indications for use for the HR mode include: Benign vascular and vascular dependent lesions.

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).

The Diode Laser device includes two handles with different laser band characteristics. One handle contains a single-band 808nm semiconductor laser, and the other handle contains a three-band (755nm/808nm/1064nm) semiconductor laser. The semiconductor lasers of the two handles are powered by the laser power supply in the host to emit laser of corresponding wavelength.

Working principle of semiconductor laser
Semiconductor laser uses semiconductor materials of different doping types as laser working substance, uses natural cleavage surface to form resonant cavity for laser oscillation and amplification, and adds forward voltage to PN junction area of semiconductor laser to form particle number inversion of non-equilibrium carrier between conduction band and valence band of semiconductor substance. When a large number of electrons and holes in particle number inversion state are recombined, excess energy will be released, and these energies will be expressed in the form of photons, that is, laser is formed. Due to resonance amplification of cleavage surface resonant cavity, the stimulated feedback is amplified, so that laser can be directionally emitted and output from semiconductor laser.

The Diode laser device consists of a main unit, a handheld, a foot switch and a power cord.

Mode Description

1. Trio FHR Mode
   The Diode Laser device Trio-Wavelength module with FHR mode is intended for temporary hair reduction.
   In this mode, there is a set of parameter setting ranges. The specific parameter ranges are as follows: Frequency is 10 Hz and energy fluence is 2-8J/cm2. The operator can adjust the parameters within this range according to the actual situation.

2. Trio HR Mode
   The Diode Laser device Trio-Wavelength module with HR mode is intended for use in dermatology procedures requiring coagulation. The indications for use for the HR mode include: Benign vascular and vascular dependent lesions.
   In this mode, there is a set of parameter setting ranges. The specific parameter ranges are as follows: Frequency is 1-10 Hz and energy fluence is 2-60J/cm2. The operator can adjust the parameters within this range according to the actual situation.

3. 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 12months after the completion of a treatment regimen. Use on all skin types (Fitzpatrick I-VI)including tanned skin. (HR, and FHR Modes)
   HR Mode: In this mode, there is a set of parameter setting ranges. The specific parameter ranges are as follows: Frequency is 1-10 Hz and energy fluence is 2-60J/cm2. The operator can adjust the parameters within this range according to the actual situation.
   FHR Mode: In this mode, there is a set of parameter setting ranges. The specific parameter ranges are as follows: Frequency is 10 Hz and energy fluence is 2-8J/cm2. The operator can adjust the parameters within this range according to the actual situation.

The FHR Mode of the two handpiece (810nm& Trio-Wavelength) is the fast hair removal mode. This mode means a quick option for pulse frequency. In the FHR mode, the frequency is fixed at 10Hz and cannot be adjusted. The FHR mode of the 810nm handpiece is used for permanent reduction in hair regrowth defined as a long term, while the FHR mode of the Trio -wavelength handpiece is used for temporary hair reduction.

The HR mode of the two handpiece (810nm& Trio-Wavelength) is designed to differentiate from the FHR mode in terms of parameters. The HR mode covers all pulse frequency ranges (frequency: 1 - 10 Hz), and the pulse frequency can be adjusted. The HR mode of the 810 nm handpiece is used for permanent reduction in hair regrowth defined as a long term, while the FHR mode of the Trio -wavelength handpiece is used for benign vascular and vascular dependent lesions.

4. Operation Differences:
   In terms of user operation, the software has two operation modes: HR mode and FHR mode. After startup, there will be a selection interface for these two modes. Users can select different devices to enter different interfaces. In the HR mode interface, can adjust the frequency and energy fluence through the up and down buttons. In the FHR mode interface, the frequency cannot be adjusted, and only the energy fluence can be adjusted through the up and down buttons. Other operations are the same for both modes.

The provided FDA 510(k) clearance letter for the Diode laser device (RF3120-BI) does not contain information about a study proving the device meets acceptance criteria related to AI or algorithm performance.

The document details the device's technical specifications, its intended use (dermatology procedures, hair reduction, benign vascular/vascular-dependent lesions), and comparisons to predicate devices in terms of technical parameters like spot size, energy fluence, and pulse frequency. It also lists several non-clinical tests the device has undergone to ensure electrical safety, laser safety, and biological compatibility (skin sensitization, irritation, cytotoxicity).

Crucially, the clearance letter explicitly states: "The clinical study is not applicable." This indicates that the regulatory pathway for this specific device did not require a clinical study demonstrating its performance in treating patients, nor does it mention any AI or algorithmic components that would necessitate such a study or associated performance metrics like sensitivity, specificity, or AUC.

Therefore, I cannot fulfill your request for information related to "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI or algorithmic performance, as the provided document does not disclose any such study or AI component.

Based on the provided text, the device's acceptance criteria are based on demonstrating substantial equivalence to predicate devices through technical comparisons and compliance with relevant safety and performance standards (non-clinical tests), rather than clinical efficacy studies or AI performance metrics.

If the device did incorporate AI, the FDA clearance letter would typically describe a study to validate its performance according to specific acceptance criteria. Since that information is absent, it suggests the device does not rely on AI for its claimed indications.

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The Diode Laser Hair Removal Machine is intended for hair removal permanent 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 semiconductor laser therapeutic device is mainly composed of a host, the treatment handle, foot switch, power cord, and accessories. The host consists of a control panel, cooling system, circuit control system, semiconductor laser power supply, etc.

The provided document is a 510(k) clearance letter for a Diode Laser Hair Removal Machine (QDTM-02), not a study report. It states that "No clinical study is included in this submission," and therefore, it does not contain the detailed information requested regarding acceptance criteria and a study proving device performance against those criteria.

However, based on the information available in the 510(k) summary, I can infer some aspects related to the intent of testing and acceptance criteria for demonstrating "substantial equivalence."

Inferred Acceptance Criteria and Device Performance (Based on Substantial Equivalence Claim)

The submission aims to demonstrate substantial equivalence to predicate devices, meaning the acceptance criteria are implicitly tied to matching or falling within acceptable ranges of the predicate devices' specifications and performance, and complying with recognized safety standards.

1. Table of Acceptance Criteria and Reported Device Performance (Inferred)

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

• The document explicitly states: "No clinical study is included in this submission."
• Therefore, there is no information on a "test set" in the context of clinical performance data for hair removal.
• The testing mentioned (biocompatibility, electrical safety, EMC, laser safety) would involve samples of the device components or the entire device, tested in a laboratory setting. This is not performance data on patients.

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

• Not applicable, as no clinical test set for performance evaluation is reported.
• For the non-clinical tests (biocompatibility, safety standards), the "ground truth" is defined by the requirements of the standards themselves, not by expert consensus on clinical outcomes.

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

• Not applicable, as no clinical test set for performance evaluation requiring expert adjudication is reported.

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 hair removal machine, not an imaging diagnostic device or AI software that would involve human readers or AI assistance in interpretation.

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

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

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

• For the non-clinical tests conducted, the "ground truth" is compliance with established international standards (IEC for electrical and laser safety, ISO for biocompatibility). There is no "outcomes data" or "pathology" cited in the context of device performance on patients.

8. The sample size for the training set:

• Not applicable, as "training set" typically refers to data used to train an algorithm or AI model. This is a physical laser device.

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

• Not applicable for the same reason as above.

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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 Hair Removal Device (Model: EVOLUTION MEDICAL, M-I-X MEDICAL, GENESIS, Lotus and Ultimate) is intended for hair removal, permanent 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 Diode Laser Hair Removal Device is a surgical device intended for use in dermatologic and general surgical procedure. It utilizes a diode laser as a laser source (808 nm). The laser power is delivered to the treatment area via a laser handpiece. The emission laser is activated by a foot switch and a laser handpiece. There are five models included, EVOLUTION MEDICAL, M-I-X MEDICAL, GENESIS, Lotus, and Ultimate, the five models have same mechanism of action, principle and specification, with only one difference: the adjustable range of Energy density is different, EVOLUTION MEDICAL (1-77 J/cm^2), M-I-X MEDICAL (1-70 J/cm^2), GENESIS (1-74 J/cm^2), Lotus(1-67 J/cm^2), and Ultimate(1-65 J/ cm^2).

Changes to the device include the addition of a remote link to the device to obtain and back up the device's usage data, a remote upgrade function, and the ability to provide a URL for users to download the device's usage data, as compared to previously listed devices.

The provided text describes a 510(k) premarket notification for a Diode Laser Hair Removal Device. This document focuses on establishing substantial equivalence to a predicate device rather than detailing a clinical study with acceptance criteria for a new device's performance.

Therefore, the sections below requiring information about acceptance criteria and a study proving the device meets them cannot be fully populated as they would for a de novo or PMA submission. The document primarily discusses non-clinical tests to verify design specifications and compliance with standards.

Here's the information that can be extracted or inferred from the provided text, with clarifications where details are not present:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not contain a table of explicit acceptance criteria with corresponding device performance metrics for efficacy (e.g., specific hair reduction percentages) as would be found in a clinical study report for a new device.

Instead, the document focuses on demonstrating that the device meets safety and performance standards and is technologically equivalent to its predicate. The "performance" discussed primarily relates to meeting design specifications and regulatory standards.

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

The document primarily refers to non-clinical tests for compliance with standards and design specifications. It does not describe a clinical test set with human subjects.

• Test Set Sample Size: Not applicable as a clinical test set is not described. The tests are for device components and system performance.
• Data Provenance: The tests are non-clinical, related to device manufacturing and engineering compliance. No country of origin for clinical data is applicable. The tests are prospective in the sense that they are conducted on the new device to demonstrate compliance.

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 document describes non-clinical engineering and compliance testing, not a clinical study requiring expert ground truth assessment.

4. Adjudication Method for the Test Set

Not applicable, as this refers to a clinical study with human observers or interpreters, which is not described here.

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 hair removal system, not an AI-powered diagnostic or interpretive tool that would involve human readers or AI assistance in a diagnostic context.

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, and the concept of "standalone performance" for an algorithm is not relevant here.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" is defined by the requirements outlined in the cited international and national standards (e.g., IEC 60601-1, ISO 10993) and the device's design specifications. These standards provide benchmarks and methodologies against which the device's performance is measured.

8. The Sample Size for the Training Set

Not applicable. As this document details hardware medical devices, there is no "training set" in the context of machine learning or AI.

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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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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