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The WinForth is intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation.

The WinForth massage device is intended to provide a temporary reduction in the appearance of cellulite.

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I am sorry, but the provided text from the FDA 510(k) Clearance Letter for the WinForth (LM-E470KA) device does not contain any information regarding acceptance criteria or the details of a study that proves the device meets such criteria.

The document primarily focuses on:

• The FDA's decision of substantial equivalence to predicate devices.
• General regulatory requirements for the device (e.g., quality system, labeling, adverse event reporting, UDI).
• The intended indications for use of the device.

There is no mention of:

• Specific performance metrics (e.g., accuracy, sensitivity, specificity, or technical performance parameters)
• A trial or study design.
• Sample sizes for test or training sets.
• Number or qualifications of experts.
• Ground truth establishment or type.
• MRMC studies or effect sizes.
• Standalone algorithm performance.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. This type of detailed study information is typically found in the applicant's 510(k) submission summary or a separate clinical/performance study report, not in the FDA clearance letter itself.

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Mjolnir Pro. With single-electrode plasma tip is used in the removal and destruction of skin lesions and coagulation of tissue.

Mjolnir Pro. With Multi-electrode plasma tip is intended for use in dermatologic and general surgical procedures for coagulation and hemostasis.

Mjolnir Pro. With single-electrode plasma tip is used in the removal and destruction of skin lesions and coagulation of tissue. With Multi-electrode plasma tip is intended for use in dermatologic and general surgical procedures for coagulation and hemostasis. Under the controllable way, the device utilizes a treatment method called plasma sublimation, which causes controlled skin damage through the generation of an electrical arc. The arc between the electrode tip and the skin is created by a radio frequency generator housed in an electrosurgical unit (handpiece) that ionizes the gas particles in the air. A straight active electrode made of 316 stainless steel is available with the system.

The provided document describes the Mjolnir Pro. (Multi-electrode plasma) device and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of clinical performance or diagnostic accuracy.

The document focuses on demonstrating substantial equivalence based on:

• Intended Use and Technological Characteristics Comparison: Highlighting similarities in indications for use, product code, classification regulation, mode of operation, and maximum output power with predicate devices (pages 6-7).
• Non-Clinical Testing: Including compliance with electrical safety (ANSI/AAMI ES60601-1, IEC 60601-2-2), EMC (IEC 60601-1-2), and biocompatibility (ISO 10993-5, ISO 10993-10, ISO 10993-23) standards.
• Performance Testing for Tissue Thermal Effect: "The tests were conducted on freshly ex vivo pig tissue. Histological evaluation with Hematoxylin-Eosin (H&E) demonstrated the tissue damages by the subject device are less than 0.25mm, which is considered superficial and substantially equivalent to the tissue damages." (page 9)
• Software Verification and Validation Testing: Conducted per FDA guidance, with a moderate level of concern (page 9).

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details on sample sizes for test sets (as no clinical test set for diagnostic accuracy or clinical effectiveness is mentioned), number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, or ground truth types related to a clinical study demonstrating performance against specific clinical acceptance criteria.

The document's scope is primarily a non-clinical evaluation to support substantial equivalence for a 510(k) submission for an electrosurgical device, not a clinical trial with performance metrics like sensitivity, specificity, accuracy, or reader agreement.

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The Planar LED mate is a prescription-use only device intended for removal of unwanted body and/or facial hair.

The Planar LED mate is a prescription-use only device intended for removal of unwanted body and/or facial hair. It utilizes a diode LED as a light source (780-850 nm). lt works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the external power adapter and its emission activation is by finger switch.

The device contains a capacitive sensor to detect appropriate skin contact. If the device is not properly applied to the treatment area (in full contact with the skin), the device cannot emit the treatment light. The device is for single-person use only.

The proposed Planar LED mate is equipped with a light depilation function that is based on the theory of selective photo thermolysis. There is abundant melanin in the hair follicle and hair stem. The melanin is distributed amidst the cells between the hair ball substrate and it can be transferred to the structure of hair stems (such as medulla, cortex, and hair cuticle). The Near infrared light can precisely target the melanin and apply the depilation treatment selectively. After the melanin absorbs Near infrared light energy, the temperature rises, in this way, the surrounding hair follicle tissues are damaged, and the hairs are removed.

The device has 5 level Output Intensity.

This submission for the Planar LED mate (K230362) does not include a study that proves the device meets specific acceptance criteria related to its performance for hair removal. Instead, it relies on non-clinical tests to demonstrate substantial equivalence to predicate devices and adherence to safety and performance standards.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria for hair removal efficacy and corresponding device performance. The focus is on demonstrating that the device's technical characteristics and safety comply with relevant standards and are similar to predicate devices.

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

• For hair removal efficacy: Not applicable. No clinical test set involving human subjects for hair removal efficacy was conducted or reported in this submission.
• For non-clinical tests (biocompatibility, electrical safety, EMC, laser safety, software, usability, energy output): The document does not specify the sample sizes for these tests (e.g., number of units tested, number of participants in usability study). The tests were likely performed in a laboratory setting, but the provenance of the data itself (e.g., from which specific test labs) is not detailed beyond adherence to international standards.

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

• Not applicable for hair removal efficacy. As no clinical study was performed, there was no ground truth for this purpose established by medical experts for a test set.
• For non-clinical safety and performance: Ground truth for these aspects is generally established by adherence to recognized international standards (e.g., ISO, IEC, ANSI/AAMI) for testing methodologies and acceptable limits, rather than by individual expert consensus on a test set. The experts involved would be those who performed the standard-compliant testing and validated the results. Their specific qualifications are not detailed in this summary.

4. Adjudication method for the test set

• Not applicable for hair removal efficacy. No clinical test set was performed.

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 hair removal system, not an AI-assisted diagnostic or therapeutic 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 device is a hardware-based light energy device for hair removal, not an algorithm.

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

• For hair removal efficacy: Not applicable. No clinical study was performed, so no "ground truth" for efficacy (e.g., based on clinical outcomes or hair counts) was established.
• For device safety and technical performance: The "ground truth" is based on established engineering and biocompatibility standards (e.g., IEC 60601-1, ISO 10993, IEC 62471) which define acceptable limits and performance criteria for medical devices. Compliance with these standards serves as the benchmark.

8. The sample size for the training set

• Not applicable. This device is a hair removal system and does not appear to involve machine learning algorithms that would require a "training set."

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

• Not applicable. As no training set is mentioned, this question is not relevant.

In summary: The provided 510(k) summary for the Planar LED mate (K230362) focuses on demonstrating substantial equivalence through a comparison of technological characteristics with predicate devices and comprehensive non-clinical testing against established safety and performance standards. Crucially, it explicitly states, "No clinical study is included in this submission," meaning there is no direct clinical data or study to demonstrate the device's hair removal efficacy against specific acceptance criteria.

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The LED Therapy Device is intended for hair removal, permanent hair reduction on all 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 LED Therapy Device is a surgical device intended for use in dermatologic and general surgical procedure. It utilizes a diode LED as a light source (780-850 nm). The LED light power is delivered to the treatment area via a LED hand piece. The emission LED is activated by a foot switch and a hand piece.

The proposed LED Therapy Device is equipped with a light depilation function that is based on the theory of selective photo thermolysis. There is abundant melanin in the hair follicle and hair stem. The melanin is distributed amidst the cells between the hair ball substrate and it can be transferred to the structure of hair stems (such as medulla, cortex, and hair cuticle). The Near infrared light can precisely target the melanin and apply the depilation treatment selectively. After the melanin absorbs Near infrared light energy, the temperature rises, in this way, the surrounding hair follicle tissues are damaged, and the hairs are removed.

The provided text is a 510(k) summary for the Shenzhen Leaflife Technology Co., Ltd's LED Therapy Device. It details the device's characteristics and compares them to predicate devices, but it explicitly states that "No clinical study is included in this submission."

Therefore, I cannot provide information regarding acceptance criteria and a study proving the device meets those criteria, as no such study is presented in the document.

Here's what I can extract based on the provided text, primarily about the technical specifications and comparison:

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

Since no clinical study with acceptance criteria is provided, I cannot create such a table for performance against clinical endpoints. However, the document does compare technical characteristics to predicate devices. Here's a table focusing on the technical characteristics comparison, noting where they are "Same," "Similar," or "Discussion" (implying a difference that the manufacturer argues does not impact substantial equivalence):

2. Sample sized used for the test set and the data provenance:
Not applicable as no clinical study or test set for performance evaluation is mentioned. The non-clinical tests mentioned are for safety and technical standards compliance.

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 ground truth for performance evaluation is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable as no clinical study or test set for performance evaluation 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:
Not applicable as no clinical study, MRMC study, or AI component is mentioned. This is a physical LED therapy device, not an AI-powered diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable as this is a physical LED therapy device, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
Not applicable as no clinical study or ground truth for performance evaluation is mentioned. Non-clinical tests were conducted to verify compliance with safety and electrical standards.

8. The sample size for the training set:
Not applicable as no clinical study or AI model requiring a training set is mentioned.

9. How the ground truth for the training set was established:
Not applicable as no clinical study or AI model requiring a training set is mentioned.

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The Leaf Smooth is an over-the-counter device intended for removal of unwanted body and/or facial hair.

The Leaf Smooth (LH-LIPLB) is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user. The device provides hair reduction using Intense Pulsed Light (IPL) technology. It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the external power adapter and its IPL emission activation is by finger switch. The device contains a Xenon Arc Flashlamp, capacitive sensor to detect appropriate skin contact and a skin sensor to detect appropriate skin color. If the device is not properly applied to the treatment area (in full contact with the skin), the device cannot emit the treatment light pulses. The device is for single-person use only. The Leaf Smooth has 6 levels output intensity.

This document is a 510(k) Premarket Notification for the "Leaf Smooth" hair removal device. It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a de novo study with specific performance metrics defined by acceptance criteria in the way an AI/ML device would.

Therefore, many of the requested criteria for an AI/ML device (e.g., sample size for AI test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this submission, as it's for a non-AI hardware device (Intense Pulsed Light hair removal device).

However, I can extract the relevant "acceptance criteria" (which are more akin to design specifications and regulatory compliance) and the "study" (non-clinical testing) that proves the device meets these.

Here's the information based on the provided document:

Acceptance Criteria and Device Performance for Leaf Smooth (LH-LIPLB)

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (IPL hair removal), "acceptance criteria" are derived from recognized consensus standards and comparisons to predicate devices. The "reported device performance" indicates compliance or similarity.

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

• Sample Size: Not explicitly stated as a number of "samples" in the context of a typical AI/ML test set. The testing conducted was primarily non-clinical (bench testing, electrical, light, EMC, biocompatibility).
• Data Provenance: The tests are likely performed in a laboratory setting by the manufacturer (Shenzhen Leaflife Technology Co., Ltd) or a contract testing organization. The document does not specify a country of origin for data, but the manufacturer is based in Shenzhen, China.
• Retrospective/Prospective: Not applicable to this type of non-clinical device testing.

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

• Not applicable. Ground truth for non-clinical tests (e.g., electrical safety, light output) is established by adherence to recognized international standards (e.g., IEC, ISO, ANSI/AAMI) and the results are measurements from calibrated equipment, not expert consensus (as would be for image interpretation).

4. Adjudication Method for the Test Set

• Not applicable. This is not a study assessing diagnostic performance where adjudication of ambiguous cases is required.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. This is a hardware device submission, not an AI/ML device requiring an MRMC study to assess human reader improvement.
• Effect Size: Not applicable.

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

• Yes, in a sense. The "non-clinical tests" represent the standalone performance of the device against its design specifications and relevant safety standards. The device is intended for over-the-counter use by lay users, so there isn't a "human-in-the-loop" professional interpretation component that would differentiate from a "standalone algorithm." The device itself is the "algorithm" that produces the hair reduction effect.

7. The Type of Ground Truth Used

• The "ground truth" for the non-clinical tests are the requirements set by the consensus standards (e.g., IEC 60601-1, ISO 10993 series) for electrical safety, biocompatibility, light safety, EMC, and the device's own design specifications for output (fluence, wavelength, spot size accuracy). These are objective, measurable criteria.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/ML device that requires a training set. The device's "knowledge" is embedded in its hardware design and manufacturing processes based on engineering principles and regulatory standards.

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

• Not applicable (see #8).

In summary, the "study" proving the device meets its "acceptance criteria" for the Leaf Smooth (LH-LIPLB) device consists of a series of non-clinical bench tests (e.g., electrical safety, EMC, light safety, biocompatibility, performance accuracy) that confirm the device adheres to recognized international standards and its own design specifications, thereby demonstrating substantial equivalence to predicate devices and ensuring safety and effectiveness for its intended use. Clinical studies were explicitly stated as not included in this submission.

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The Laser Therapy 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.

The Laser Therapy Device is a surgical device intended for use in dermatologic and general surgical procedure. It utilizes a diode laser source (808 nm). The laser power is delivered to the treatment area via a laser hand piece. The emission laser is activated by a foot switch and a hand piece. The components of the Laser Therapy Device are mainly including main unit, hand piece, watered cup, overflow tube, foot switch, key, interlock, power cord, fuse, glasses and blindfold, etc.

The proposed Laser Therapy Device is equipped with laser depilation function that is based on the theory of selective photo thermolysis. There is abundant melanin in hair follicle and hair stem. The melanin is distributed amidst the cells between the hair ball substrate and it can be transferred to the structure of hair stems (such as medulla, cortex and hair cuticle). The laser can precisely target at the melanin and apply the depilation treatment selectively. After the melanin absorbs laser energy, the temperature rises, in this way, the surrounding hair follicle tissues are damaged, and the hairs are removed.

This document is a 510(k) premarket notification for a Laser Therapy Device. It does not contain information about a study that proves the device meets specific acceptance criteria in the way typically found for algorithms or AI-driven diagnostic devices (e.g., sensitivity, specificity, AUC). Instead, it demonstrates substantial equivalence to predicate devices through technical comparisons and non-clinical testing against recognized standards.

Therefore, many of the requested fields regarding acceptance criteria and performance studies are not applicable or cannot be extracted from this type of regulatory submission.

Here's a breakdown of the information that can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance

Generally, for a 510(k) for a physical medical device like a laser, acceptance criteria often revolve around meeting recognized safety and performance standards, and demonstrating substantial equivalence to a predicate device in terms of intended use and technological characteristics. The "performance" reported is adherence to these standards and similarity to predicates.

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

• Not applicable / Not explicitly stated. This document describes non-clinical testing (electrical safety, EMC, laser safety, biocompatibility, and performance testing for accuracy), not a clinical trial with a "test set" of patient data. The "test set" in this context refers to hardware tests.

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

• Not applicable / Not explicitly stated. This document covers regulatory compliance for a physical medical device, not a diagnostic algorithm requiring expert "ground truth" labeling of data.

4. Adjudication method for the test set

• Not applicable. This concept primarily applies to clinical studies or algorithm performance evaluations where expert consensus confirms labels.

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 document is for a laser therapy device, not an AI or diagnostic imaging device that would typically undergo an MRMC study.

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

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

7. The type of ground truth used

• For the non-clinical tests (e.g., electrical safety, EMC, laser safety, biocompatibility), the "ground truth" is adherence to established regulatory standards (e.g., IEC, ISO) and internal design specifications.
• For the claim of "permanent hair reduction," this definition serves as the clinical outcome benchmark, but no clinical study was included in this submission to demonstrate the proposed device meets this definition. Instead, it relies on substantial equivalence to predicates that are already cleared for this indication.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device.

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

• Not applicable. This is not an AI/machine learning device.

Summary of the Study:

The "study" described in the 510(k) submission for the Shenzhen Leaflife Technology Co., Ltd Laser Therapy Device primarily consists of non-clinical testing to demonstrate compliance with recognized medical device safety and performance standards, and a comparison of technological characteristics to legally marketed predicate devices.

• Non-Clinical Tests: These included Electrical Safety (ANSI/AAMI ES60601-1, IEC 60601-2-22), EMC (IEC 60601-1-2), Laser Safety (IEC 60601-2-22, IEC 60825-1), Biocompatibility (ISO 10993-5 for Cytotoxicity, ISO 10993-10 for Irritation and Sensitization), and Performance Testing for Spot Size Accuracy and Energy Output Accuracy.
• Software Verification and Validation: Conducted for the device's software, determining a "Moderate" level of concern.
• Substantial Equivalence Comparison: The document extensively compares the proposed device's intended use, principle of operation, laser type, wavelength, spot size, irradiance, fluence, frequency, and pulse duration to those of two predicate devices (K162659 and K180353).

Conclusion drawn from the study:
The non-clinical tests verified that the proposed device met all design specifications and complied with the listed standards. Based on the comparison and analysis, the proposed device was determined to be "as safe, as effective, and performs as well as the legally marketed predicate devices," thereby establishing substantial equivalence. No clinical studies were included in this submission.

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