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The Medical Diode Laser Hair Removal Device (PZ-606VI, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04) 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 proposed device, Medical Diode Laser Hair Removal Device (PZ-606VI、PZ-BDT68-01、PZ-BDT68-02、PZ-BDT68-03、PZ-BDT68-04), is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI);

The device incorporates a diode laser that emits invisible infrared laser radiation centered on a wavelength of 808 nm. According to the selective light absorption theory, the laser can be preferentially absorbed by the melanin in the hair follicle, thus achieving the purpose of permanent hair removal. 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. Hair growth must remain stable for a certain amount of time and must exceed the entire growth cycle of the hair follicle. Permanent hair removal does not mean that all hair in the treated area is completely lost. Special cooling technology is applied simultaneously during treatment to cool the skin and protect skin.

There are 5 models included, PZ-606VI, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03 and PZ-BDT68-04, the five models have the same intended use, mechanism of action and principle, only the minimum values of energy density and pulse duration are different.

The provided FDA 510(k) clearance letter and synopsis are for a Medical Diode Laser Hair Removal Device. This document is a regulatory submission for a physical medical device, not an AI/software as a medical device (SaMD). Therefore, the information requested in your prompt regarding acceptance criteria and studies for AI/SaMD (e.g., sample size for test/training sets, data provenance, expert adjudication, MRMC studies, standalone performance, ground truth establishment) is not applicable to this device submission.

The document describes the device, its intended use, a comparison to a predicate device, and the non-clinical tests performed to demonstrate substantial equivalence for a hardware device. It explicitly states: "No clinical study is included in this submission."

Therefore, I cannot provide a table of AI acceptance criteria or details about AI-specific studies as requested, because this information is not present in the provided document and is not relevant to the type of device being cleared.

However, I can extract the acceptance criteria and performance information that is relevant to this type of physical device, based on the non-clinical testing mentioned:

Acceptance Criteria and Reported Device Performance (Non-Clinical for a Physical Device)

Regarding the AI/SaMD specific questions from your prompt:

1. Sample size used for the test set and the data provenance: Not applicable. No AI/SaMD test set described.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No AI/SaMD ground truth described.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
7. The sample size for the training set: Not applicable.
8. 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 Hair Removal Device (Model: EVOLUTION MEDICAL, M-I-X MEDICAL) 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 two models included, EVOLUTION MEDICAL, M-I-X MEDICAL, the two 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/cm²), M-I-X MEDICAL (1-70 J/cm²).

The provided text describes a 510(k) premarket notification for a Diode Laser Hair Removal Device, which means the submission is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device rather than proving novel effectiveness. Therefore, the information typically associated with complex clinical studies and detailed acceptance criteria for AI/Software as a Medical Device (SaMD) is not present in this document.

However, I can extract the non-clinical acceptance criteria and the studies that verify them, as outlined in the document. The device in question is a physical laser device, not an AI-driven one, so many of the requested categories (like MRMC studies, ground truth for training data, etc.) are not applicable here.

Here's a breakdown of the available information regarding acceptance criteria and the studies that prove the device meets them:

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

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

This information is not applicable as the document describes a physical laser device, not a diagnostic or AI device with a "test set" in the typical sense of evaluating performance on a dataset of images or clinical cases. The "tests" mentioned are primarily engineering safety and performance tests on the device itself and its components.

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

This information is not applicable. Ground truth establishment by clinical experts is relevant for diagnostic or AI systems; for this physical device, compliance is measured against engineering and biocompatibility standards.

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

This information is not applicable. Adjudication methods are used in clinical studies or AI evaluations to establish a consensus ground truth from multiple readers/experts. This is not reported for the non-clinical tests of this device.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. This describes a physical laser hair removal device, not an AI software intended to assist human readers. No MRMC study was performed or is relevant to this type of device.

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

This information is not applicable. The device is a physical laser system, not a standalone algorithm. Its performance is evaluated through its physical output and safety features.

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

For the non-clinical tests, the "ground truth" is defined by the established international standards (e.g., IEC 60601-1, ISO 10993-5) and the design specifications for parameters like energy output accuracy. For biocompatibility, the ground truth is the chemical and biological response observed in standardized tests on the material.

8. The sample size for the training set

This information is not applicable. This is not an AI/machine learning device that involves a "training set."

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

This information is not applicable. There is no "training set" for this physical device.

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The Diode Laser Hair Removal device 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 Hair Removal device, 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
The module uses the microcontroller as the heart, utilizes the LCD screen to display all prompt information and the system state information to complete the human-machine interaction function, and realizes the device parameters settings and accurate control of the output laser energy by the operator.
b. Main Control Module
The module uses the microcontroller as the heart, receives the laser energy parameters and work instructions from the control panel and detects the footswitch state; Utilizes the sensors of temperature, humidity, liquid level and flow to detect the parameters such as temperature, humidity and water flow during system working, and according to the detected values to calculate the dew point temperature; Controls and detects the work state of constant current board module as well as the temperature and humidity control system; Uploads the state data and alarm information of water circulation system, cooling system, handpiece module and constant current board module during system working.
c. Constant current board module
The module uses the high-power MOS as the heart, receives the laser energy parameters from the main control module, supplies the semiconductor laser with constant drive current which corresponding to the received laser energy parameters to drive the semiconductor laser to emit light. The module also has the detection function of over-current, overvoltage, over-temperature and handpiece state, and uploads the detected data to the control module.
d. Temperature and humidity control system
The system mainly includes the condenser, cold plate, water circulation subsystem and fans. The microcontroller of main control module according to the temperature, humidity parameter detected by the sensors to control the working state of the condenser, cold plate and cooling fan to meet the temperature and humidity requirements during the semiconductor laser working.
e. Handpiece module
Handpiece module is the heart of the device, which is the execution unit of the device and completes the laser emission function. The module is mainly composed of semiconductor laser, sapphire, temperature and humidity sensor, data storage chips, cooling components and water flow path. The semiconductor laser emits light to output energy, temperature and humidity sensors detects the temperature and humidity parameters during handpiece working, the cooling components and water flow path take away the heat of the semiconductor laser to prevent it from being damaged caused by over-temperature, so prolongs the service life of the semiconductor laser.

The provided document is a 510(k) summary for a Diode Laser Hair Removal device. It does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an AI-powered device. This summary is focused on demonstrating substantial equivalence to a predicate device, which is a different regulatory pathway than demonstrating the performance of a novel AI/ML-based device.

Specifically, the document states: "No clinical study is included in this submission." This means there is no study described that would involve test sets, ground truth, expert adjudication, or MRMC studies that are typically associated with evaluating AI-powered devices.

However, I can extract the information provided about the device's performance based on non-clinical testing for substantial equivalence:

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

The document doesn't explicitly state "acceptance criteria" in the sense of predefined thresholds for a novel AI device's performance. Instead, it presents a comparison to a predicate device to demonstrate "substantial equivalence." The "acceptance criteria" here are implicitly that the proposed device performs comparably or within acceptable deviations from the predicate device based on non-clinical tests and safety standards.

2. Sample size used for the test set and the data provenance:
Not applicable. The document states "No clinical study is included in this submission." The testing described is non-clinical performance and safety testing directly on the device components or system, not on patient data or clinical samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. See point 2.

4. Adjudication method for the test set:
Not applicable. See point 2.

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-assisted diagnostic or imaging device. 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 not an AI algorithm. Its performance is evaluated through non-clinical testing against established safety and performance standards relevant to a laser surgical instrument, and by comparison to a predicate device.

7. The type of ground truth used:
For non-clinical tests, the "ground truth" would be the established engineering specifications for the device and compliance with recognized international standards (e.g., IEC standards for electrical, laser, and EMC safety, ISO standards for biocompatibility). For performance aspects like spot size and energy output accuracy, the ground truth is derived from validated measurement techniques.

8. The sample size for the training set:
Not applicable. This is not an AI/ML device. There is no training set mentioned.

9. How the ground truth for the training set was established:
Not applicable. This is not an AI/ML device.

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