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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 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 Medical Diode Laser Hair Removal System 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.

Medical Diode Laser Hair Removal System adopts 808nm semi-conductor laser, based on selective photothermolysis principle, through specific wavelength, penetrate epidermis into dermis, optical energy was absorbed and translated into heat energy with restraining hair follicle tissues, and produce photothermal effect. It takes laser energy in hair follicle with rich in melanin, surrounding tissues absorb less even no energy, reach to restrained melanin of hair follicles and remove hair. The Medical Diode Laser Hair Removal System utilize a semiconductor diode with invisible infrared radiation as a laser source to emit 808nm wavelength laser which is absorbed by melanin. The laser power is delivered to the treatment area via laser handpiece. The emission laser is activated by a foot-switch.

Based on the provided FDA 510(k) clearance letter for the "Medical Diode Laser Hair Removal System (MNLT-D1)", it is important to note that no in-vivo clinical studies were conducted or presented in this submission to demonstrate device performance against acceptance criteria in a clinical setting. The clearance is based on substantial equivalence to a predicate device, supported by non-clinical (bench) testing and compliance with relevant safety and performance standards.

Therefore, the following answers describe the absence of a study proving the device meets acceptance criteria in a clinical sense, and instead focus on what was presented:

Acceptance Criteria and Device Performance (Non-Clinical)

Since no clinical study was conducted as part of this 510(k) submission to demonstrate device performance in terms of hair removal efficacy or permanent hair reduction against clinical acceptance criteria, a table showing "reported device performance" in that context cannot be generated.

Instead, the acceptance criteria and performance were focused on non-clinical tests to demonstrate compliance with recognized standards and substantial equivalence to a predicate device in terms of safety and technical specifications.

Table: Non-Clinical Acceptance Criteria and Reported Device Performance

Study Details (Relevant to Non-Clinical Testing and Equivalence)

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

   • No clinical test set was used.
   • For the non-clinical tests (e.g., electrical safety, EMC, laser safety, biocompatibility), the device itself (Medical Diode Laser Hair Removal System MNLT-D1) served as the "sample." These tests are typically conducted in a laboratory setting on one or a few units to ensure design compliance.
   • Data provenance is from non-clinical laboratory testing reports conducted by the manufacturer (Shandong Moonlight Electronics Tech Co.,Ltd.) or their designated testing facilities in China. The documentation implicitly indicates these were prospective tests performed for regulatory submission.

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

   • Not applicable. Since no clinical study or test set requiring human assessment of performance (like image interpretation or clinical outcomes) was conducted, there was no need for experts to establish "ground truth" in the typical sense for clinical performance.
   • The "ground truth" for non-clinical tests is established by objective measurements and adherence to international standards (e.g., IEC, ISO). The expertise involved would be that of test engineers, metrologists, and quality assurance personnel performing and verifying the tests.

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

   • Not applicable. No clinical test set requiring human rater adjudication was involved. Non-clinical compliance testing relies on quantitative measurements and pass/fail criteria from international standards.

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 MRMC comparative effectiveness study was done. This device is a laser hair removal system, not an AI-assisted diagnostic tool.

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

   • Not applicable. This is a hardware medical device; it is not an AI algorithm. Its performance is inherent to its physical and functional specifications.

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

   • For the non-clinical tests, the "ground truth" was based on objective, verifiable measurements against the specified requirements of international consensus standards (e.g., maximum allowable leakage current, specific electromagnetic emission limits, defined biocompatibility thresholds).

7. The sample size for the training set:

   • Not applicable. There was no "training set" as this is not an AI/machine learning device.

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

   • Not applicable. As there was no training set, no ground truth needed to be established for it.

Summary of Reliance for Clearance:

The FDA clearance for the Medical Diode Laser Hair Removal System (MNLT-D1) was based on:

• Demonstration of substantial equivalence to an existing legally marketed predicate device (K221312) in terms of indications for use, fundamental technology (diode laser), and principle of operation.
• Non-clinical testing to prove the device's compliance with electrical safety, EMC, laser safety, and biocompatibility standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1, ISO 10993-5, ISO 10993-10, ISO 10993-23).
• Engineering analysis confirming that any differences in technical specifications (e.g., spot size, fluence, pulse duration) compared to the predicate device did not raise new questions of safety or effectiveness.

The submission explicitly states: "No clinical study is included in this submission." This indicates that the clearance for this specific device relied entirely on non-clinical data and the regulatory pathway of substantial equivalence.

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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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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 System 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.

808nm diode laser using selective light absorption, the Diode 808 laser is preferentially absorbed by the melanin of the hair. The light energy is taken up by the hair follicle and converted to heat energy, and minimal energy is transferred to the skin. This preferentially heats the hair and its DNA, while reducing oxygen organization around hair follicle - reducing the chance of hair regrowth. Special cooling technology is applied simultaneously during treatment to cool the skin and protect skin.

Diode Laser Hair Removal is the safest and fastest at the present. It adopts Gold standard 808nm semi-conductor laser, based on selective photothermolysis principle, through specific wavelength, penetrate epidermis into dermis, optical energy was absorbed and translated into heat energy with restraining hair follicle tissues, and produce photothermal effect. It takes laser energy in hair follicle with rich in melanin, surrounding tissues absorb less even no energy, reach to restrained melanin of hair follicles and remove hair. Meanwhile, don't hurt around tissues and virtually pain-free remove surplus hair; eventually, reach to permanent Hair Removal.

Here's a breakdown of the acceptance criteria and study information based on the provided FDA 510(k) summary:

This device is a Diode Laser Hair Removal System. The provided document is a 510(k) summary for a premarket notification, which focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical trial results for novel devices. Therefore, a clinical study documenting device performance against specific acceptance criteria for efficacy (e.g., hair reduction percentage) is explicitly stated as not included in this submission. The acceptance criteria primarily revolve around demonstrating safety and performance equivalence through non-clinical testing.

Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria

This 510(k) submission explicitly states: "No clinical study is included in this submission."

The "study" or evidence provided to meet the acceptance criteria is primarily a non-clinical testing report demonstrating compliance with recognized safety and performance standards, and a comparison to the predicate device's specifications.

1. Sample size used for the test set and the data provenance: Not applicable for a clinical study, as none was included. For non-clinical tests, the "sample" would refer to the device itself or its components. The provenance of the data is from in-house testing and external laboratory testing for standard compliance.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for non-clinical tests is established by adherence to recognized international standards (e.g., IEC, ISO) and laboratory testing protocols.

3. Adjudication method for the test set: Not applicable. Non-clinical tests typically involve objective measurements against pass/fail criteria defined by the standards.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, not applicable for this type of device and submission (no clinical study was conducted).

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device (laser system), not an AI algorithm.

6. The type of ground truth used:

   • For Safety Criteria: Adherence to established international consensus standards (IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-22 for electrical and laser safety; ISO 10993-5, ISO 10993-10, ISO 10993-23 for biocompatibility). These standards define the test methods and acceptance limits that constitute "ground truth" for safety.
   • For Performance (Functional Equivalence): Engineering rationale comparing the proposed device specifications (Fluence, Pulse Duration, Power Supply) to the predicate device, asserting that minor differences do not impact safety or effectiveness, supported by successful completion of the aforementioned non-clinical safety standards.

7. The sample size for the training set: Not applicable, as no clinical study or machine learning component (requiring a training set) was mentioned or conducted.

8. How the ground truth for the training set was established: Not applicable.

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The Diode Laser Hair Removal System (Model: MBT-Diode Laser) 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 Hair Removal System (Model: MBT-Diode Laser) is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI). The Dermatological Diode Laser Systems utilize a semiconductor diode with invisible infrared radiation as a laser source to emit 808nm wavelength laser which is absorbed by melanin. The laser power is delivered to the treatment area via laser handle. The emission laser is activated by footswitch or handle button.

The Diode Laser Hair Removal System consists of the following major components

• The main console unit that incorporates the main CPU board, power supply modules, laser power supply, laser device, cooling system and switching module
• Handpiece
• Footswitch

The provided text is a 510(k) Summary for a Diode Laser Hair Removal System (MBT-Diode Laser). It describes the device, its intended use, and a comparison to a predicate device to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not outline specific, quantified acceptance criteria for the new device as would be seen in a clinical study. Instead, it demonstrates substantial equivalence to a predicate device by comparing technical specifications and adherence to recognized standards.

The table below summarizes the technical comparison provided, where "acceptance criteria" can be interpreted as demonstrating equivalence or justification for differences compared to the predicate/reference devices:

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

The document explicitly states: "No clinical study is included in this submission."
Therefore, there is no "test set" in the context of clinical performance data. The evaluation relies on non-clinical (bench) testing and comparison to predicate devices, not human subject data.

Since no clinical study was conducted, there is no data provenance (country of origin, retrospective/prospective) for a test set.

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

Not applicable. As no clinical study was conducted and no clinical test set was used, there was no ground truth for a test set established by experts.

4. Adjudication Method for the Test Set

Not applicable. As no clinical study was conducted and no clinical test set was used, there was no adjudication method.

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

No. The document explicitly states: "No clinical study is included in this submission." Therefore, no MRMC study was conducted.

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

The device is a hardware product (Diode Laser Hair Removal System), not an algorithm or software-only device. Therefore, the concept of "standalone algorithm performance" as typically applied to AI/software as a medical device (SaMD) is not applicable here. The performance is evaluated based on its physical/electrical characteristics and safety standards.

7. The Type of Ground Truth Used

For the non-clinical tests regarding electrical safety, EMC, laser safety, and biocompatibility, the "ground truth" is defined by compliance with internationally recognized standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-22, ISO 10993 series). The device's performance is measured against the requirements of these standards.

8. The Sample Size for the Training Set

Not applicable. This is a hardware device submission, not an AI/ML algorithm requiring a training set.

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

Not applicable. No training set was used.

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

The Trio-Wavelength Handpiece combines 3 wavelengths (755+810+1064 nm) into a single handpiece, which intended for temporary hair reduction in Fast Hair Removal Mode(FHR). It consists of a main unit, a foot switch and a handle-piece. The foot switch and the handle switch are activated to start emitting light pulses. The hand-piece has a cooled light outlet. The laser parameters and other system functions are controlled by a control panel on the main unit.

I am sorry, but the provided text does not contain the specific information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as per your detailed request.

The document is an FDA 510(k) clearance letter and a 510(k) summary for a laser hair removal system. It addresses general regulatory compliance, device characteristics, and substantial equivalence to predicate devices, but it does not include a detailed report of performance testing against specific acceptance criteria, nor does it describe a study involving human readers or expert consensus as would be typical for an AI/ML medical device.

Specifically, the text states:

• "No clinical study is included in this submission." (Page 5)
• The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section on Page 5 only lists compliance with various IEC and ISO standards related to electrical safety, EMC, laser safety, and biocompatibility. It does not provide performance metrics like sensitivity, specificity, or accuracy, which would typically be associated with acceptance criteria for a diagnostic or AI-powered device.

Therefore, I cannot provide:

• A table of acceptance criteria and reported device performance.
• Sample size used for a test set or data provenance.
• Number of experts or their qualifications for ground truth.
• Adjudication methods.
• Information on MRMC studies or effect sizes.
• Standalone performance data.
• Type of ground truth used (other than references to standards compliance).
• Sample size for the training set.
• How ground truth for the training set was established.

This document pertains to a hardware device (laser system) and its safety and performance based on engineering and biocompatibility standards, not an AI/ML software device that typically involves the kind of performance metrics and study designs you are asking about.

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The Diode Laser Hair Removal System 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.

808nm diode laser using selective light absorption, the Diode 808 laser is preferentially absorbed by the melanin of the hair. The light energy is taken up by the hair follicle and converted to heat energy, and minimal energy is transferred to the skin. This preferentially heats the hair and its DNA, while reducing oxygen organization around hair follicle - reducing the chance of hair regrowth. Special cooling technology is applied simultaneously during treatment to cool the skin and protect skin.

Diode Laser Hair Removal is the safest and fastest at the present. It adopts Gold standard 808nm semi-conductor laser, based on selective photothermolysis principle, through specific wavelength, penetrate epidermis into dermis, optical energy was absorbed and translated into heat energy with restraining hair follicle tissues, and produce photothermal effect. It takes laser energy in hair follicle with rich in melanin, surrounding tissues absorb less even no energy, reach to restrained melanin of hair follicles and remove hair. Meanwhile, don't hurt around tissues and virtually pain-free remove surplus hair; eventually, reach to permanent Hair Removal.

The provided document is a 510(k) summary for the Diode Laser Hair Removal System (SH-VD910). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove the device meets specific acceptance criteria for performance in terms of hair removal. The document explicitly states: "No clinical study is included in this submission." Therefore, it does not contain information about:

• A table of acceptance criteria and reported device performance (in terms of hair removal efficacy).
• Sample size used for a test set for clinical performance.
• Data provenance for a clinical test set.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for a clinical test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone (algorithm only) performance.
• Type of ground truth used for performance validation.
• Sample size for a training set.
• How ground truth for a training set was established.

Instead, the document details non-clinical tests to demonstrate that the new device meets safety and performance standards equivalent to a predicate device, focusing on technical specifications and compliance with recognized standards.

Here's the relevant information that is provided:

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

The document doesn't provide specific quantitative acceptance criteria for hair removal efficacy and corresponding reported performance metrics (e.g., percentage hair reduction). Instead, it compares technical specifications of the proposed device to a predicate device and states that the proposed device complies with various safety and electrical standards.

2. Sample size used for the test set and the data provenance: Not applicable, as no clinical study was conducted.

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 was conducted.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as no clinical study 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, as this device is a laser hair removal system, not an AI-assisted diagnostic tool. No clinical study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this device is a laser hair removal system, not an algorithm. No clinical study was conducted.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no clinical study was conducted. The ground truth for the non-clinical tests is based on compliance with established international standards (e.g., IEC, ISO).

8. The sample size for the training set: Not applicable, as this is a laser device, not a machine learning algorithm.

9. How the ground truth for the training set was established: Not applicable, as this is a laser device, not a machine learning algorithm.

Non-Clinical Test Conclusions:
The manufacturer performed non-clinical tests to verify that the proposed device met design specifications and was substantially equivalent to the predicate device. These tests demonstrated compliance with the following standards:

• IEC 60601-1 Edition 3.2 2020-08 (Medical electrical equipment - General requirements for basic safety and essential performance)
• IEC 60601-1-2 Edition 4.1 2020-09 (Medical Equipment - Collateral Standard: Electromagnetic Compatibility-Requirements And Tests)
• IEC 60825-1:2014 (Safety of laser products - Part 1: Equipment classification, and requirements)
• IEC 60601-2-22: 2012 (Medical electrical equipment - Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment)
• ISO 10993-5: 2009 (Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity)
• ISO 10993-10 Fourth edition 2021 (Biological evaluation of medical devices - Part 10: Tests for skin sensitization)
• ISO 10993-23 First edition 2021-01 (Biological evaluation of medical devices - Part 23: Tests for irritation)

The conclusion is that the device is as safe, as effective, and performs as well as or better than the legally marketed predicate device (K162659) based on these non-clinical tests.

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Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064) is intended for hair removal, permanent hair reduction.

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 Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064) is intended for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin.

The Diode Laser Hair Removal device models LHR-V6S-1064 and LHR-V6S/B-1064 emit pulses of invisible infrared laser light of 1064nm wavelength that penetrates into the skin and is selectively absorbed by melanin in the hair follicles. This creates a localized thermal effect that disrupts hair growth from the hair follicles. The device contains a sensor that detects contact with the skin so that the device will only emit the infrared laser pulses when the sensor is in contact with the skin. The device also includes a skin cooling feature and the device is powered by an external AC/DC power adaptor.

Here's an analysis of the provided text regarding acceptance criteria and studies demonstrating device performance:

Unfortunately, the provided document does not contain information about acceptance criteria for a specific performance metric (like accuracy, sensitivity, or specificity) of a diagnostic or AI-driven device, nor does it describe a study proving the device meets such criteria.

The document details a 510(k) premarket notification for a Diode Laser Hair Removal device (LHR-V6S-1064, LHR-V6S/B-1064). The focus of this submission is on demonstrating substantial equivalence to existing predicate devices based on technical characteristics, indications for use, and non-clinical safety testing.

Here's a breakdown of why the requested information isn't present and what information is provided:

Key Takeaways from the Document:

• Device Type: It's a physical medical device (laser for hair removal), not a diagnostic or AI-powered software device.
• Regulatory Pathway: 510(k) premarket notification, which relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel clinical effectiveness through extensive performance studies against specific acceptance criteria.
• No Clinical Study: The document explicitly states: "No clinical testing has been performed." This directly indicates that there aren't clinical performance metrics or studies to assess against acceptance criteria.
• Focus on Substantial Equivalence: The primary goal of the submission is to show that the proposed device is "as safe, as effective, and performs as well as or better than the predicate device" based on design, specifications, and non-clinical tests.

Response to your specific questions based on the provided document:

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

   • N/A. The document does not define specific performance acceptance criteria for a diagnostic or AI algorithm, nor does it report performance metrics against such criteria. The "performance testing" mentioned (Appearance, Function, Safety, Label, Shelf Life, Cleaning and Disinfection) are general bench tests for a physical device, not performance metrics like sensitivity or accuracy for a diagnostic.

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

   • N/A. No clinical test set or data for performance evaluation (e.g., diagnostic accuracy) is mentioned because "No clinical testing has been performed."

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

   • N/A. No clinical test set requiring ground truth established by experts is mentioned.

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

   • N/A. No clinical test set requiring adjudication is mentioned.

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

   • N/A. This device is for hair removal, not a diagnostic tool with AI assistance for human readers. No MRMC study was conducted.

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

   • N/A. This is a physical laser device, not an algorithm.

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

   • N/A. No clinical ground truth is established as no clinical studies were performed.

8. The sample size for the training set:

   • N/A. This refers to a dataset for training an algorithm. This device is not an AI algorithm.

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

   • N/A. As above, this is not an AI algorithm.

Information that is available about device equivalence and non-clinical testing:

• Non-Clinical Tests Submitted:
  • Biocompatibility Testing: According to ISO 10993-1:2018, including in vitro cytotoxicity (ISO 10993-5:2009), skin sensitization (ISO 10993-10:2021), and irritation (ISO 10993-23:2021). These tests were performed for parts contacting intact skin.
  • Electrical Safety and Electromagnetic Compatibility Testing: Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-22, and IEC 60825-1.
  • Software Verification and Validation: Performed according to FDA guidance for software in medical devices.
• Concise summary for performance testing (Bench Tests):
  • Appearance, Function, Safety, Label.
  • Shelf Life Test (accelerated aging).
  • Cleaning and Disinfection Verification.

In summary, the provided document is a 510(k) clearance for a laser hair removal device, focusing on demonstrating substantial equivalence through technical specifications and non-clinical safety tests, not clinical performance against specific acceptance criteria for a diagnostic or AI device.

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