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The HONKON-Slimming I+/HONKON-Slimming III+ are indicated for the relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation, temporary reduction in the appearance of cellulite, and for temporary reduction of thighs circumferences.

The HONKON-Slimming I+ and HONKON-Slimming III+ are the non-invasive body shaping product to combine four different technologies including IR (infrared), Bi-Polar RF (radio-frequency) and mechanical tissue manipulation using pulsed vacuum and massage rollers. The combination of the IR and vacuum coupled RF technologies causes deep heating of the connective tissue including the fibrous septae which in turn promotes an increase in local cellular reduction. The additional mechanical tissue manipulation of the device causes an immediate increase in circulation and lymphatic drainage, both essential components for healthy skin structure.

The HONKON-Slimming I+ and HONKON-Slimming III+ can output infrared light with wavelength 700-2000nm, the infrared light can penetrate whole skin tissue. The infrared light has the effect to expand blood vessels, temporary improvement of local blood circulation; At the same time, this spectrum has a good efficacy for temporary reduction in the appearance of cellulite, and for temporary reduction of thighs circumferences..

The HONKON-Slimming I+ and HONKON-Slimming III+ can output 1MHz frequency, produce RF energy from X, Y and Z directions in the subcutaneous tissue. Temperature of skin tissues becomes higher, Enzyme activity was enhanced so that fat cells can be fully released within the triglyceride; Triglycerides in the fat under the action of enzymes, cracking into fatty acids and glycerol.

Massage rollers has obvious mechanical compression to skin tissues. Meanwhile, deep negative pressure gives skin and muscles full relaxation and rest. Maximum 8kg negative pressure can absorb all skin tissues into the gap between the bipolar RF tips, ensure RF energy can reach fat layers.

Based on this,the HONKON-Slimming I+/HONKON-Slimming III+ are indicated for the relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation, temporary reduction in the appearance of cellulite, and for temporary reduction of thighs circumferences..

This document is a 510(k) Summary for a medical device called the "Slimming Treatment Device" (models HONKON-Slimming I+ and HONKON-Slimming III+). It seeks to demonstrate substantial equivalence to previously cleared predicate devices.

The document does not describe a study that proves the device meets specific acceptance criteria related to its clinical efficacy (e.g., reduction in cellulite or thigh circumference). Instead, it focuses on demonstrating substantial equivalence to predicate devices based on technical specifications, safety, and regulatory compliance.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly defined as pass/fail thresholds for clinical performance but rather as demonstrating substantial equivalence to the predicate devices across various technical and safety parameters. The "Reported Device Performance" in this context refers to the device's technical specifications and the results of non-clinical safety tests.

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 test set sample size or data provenance (country, retrospective/prospective) for clinical effectiveness. The "tests" mentioned are non-clinical (electrical safety, EMC, biocompatibility) and comparisons to existing predicate device specifications.

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

Not applicable, as no clinical study or test set with expert-established ground truth was performed for this submission. The "ground truth" for the substantial equivalence claim relies on regulatory standards and the specifications of the predicate devices.

4. Adjudication method for the test set

Not applicable, as no clinical study or test set requiring adjudication 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 physical therapeutic device, not an AI-assisted diagnostic or interpretive tool that would 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 physical therapeutic device, not an algorithm. Its operation involves human application.

7. The type of ground truth used

For the purpose of this 510(k) submission, the "ground truth" is largely:

• Regulatory Standards: Compliance with established international standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, ISO 10993-5, -10) for safety and performance.
• Predicate Device Specifications: The accepted safety and effectiveness profiles of the legally marketed predicate devices (Reaction™ System K090221 and VelaShape K122579). The proposed device's specifications are compared to these predicates to demonstrate similarity.

8. The sample size for the training set

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

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

Not applicable, as no training set was used or described.

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The diode laser for hair removal is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI). 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 for hair removal is generally included components such as semiconductor solid-state lasers, switching power supply, laser power, treatment handle, key switch, cooling system and accessories. Its models are 808CL, 808CM, 808CH, 808EH, 808BL, 808BM, 808BH, 808FH, 808HGG and 808DH. Theirs differences are between the size of device which is described in the table below:

The provided text describes a 510(k) premarket notification for a "Diode Laser for Hair Removal" (K131838) and references a predicate device (K112031). However, the document does not contain specific acceptance criteria, a study that proves the device meets those criteria, or any details related to AI performance, sample sizes for test/training sets, expert qualifications, or ground truth establishment.

The document primarily focuses on establishing substantial equivalence to the predicate device based on technical specifications and intended use. The table provided in the input is a comparison of the Honkon device's technical specifications to those of the predicate device (Alma Lasers 810nm Diode Laser System with HR Mode).

Therefore, I cannot fulfill the request for information on acceptance criteria, a proving study, sample sizes, expert details, or ground truth, as none of this information is present in the provided text.

Here's an output reflecting what can be extracted from the provided text:

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

The provided document does not explicitly state "acceptance criteria" in the traditional sense of performance metrics with thresholds. Instead, it compares the technical specifications and intended use of the proposed device to a predicate device to establish substantial equivalence. The "performance" is implied by meeting similar specifications.

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The CO2 Laser (10600nm) is indicated for use in dermatological procedures requiring ablation, resurfacing and coagulation of soft tissue.

The CO2 Laser consists of semiconductor solid-state lasers, switching power supply, laser power, treatment handle, key switch, cooling system and accessories. The CO2 Laser produces a beam of coherent infrared light with 10600nm wavelength. The CO2 laser comprises five models: YILIYA-10600AH, YILIYA-10600AL, YILIYA-10600CH, Aeslight-10600EH, Aeslight-Ultra peel; their technical parameters and functions are the same, the only difference is their appearances and sizes.

The provided 510(k) Premarket Notification Submission (K131837) for the HONKON CO2 Laser focuses on establishing substantial equivalence to a predicate device (K080496). This type of submission generally relies on demonstrating that the new device has the same intended use and similar technological characteristics as a legally marketed predicate device, and that any differences do not raise new questions of safety or effectiveness.

Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context are primarily related to demonstrating substantial equivalence through technical comparison with the predicate device and adherence to relevant safety standards, rather than a clinical performance study with specific metrics like sensitivity, specificity, or reader improvement.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

This is a 510(k) submission for a medical laser device, not an AI or diagnostic device that typically uses "test sets" of data for performance evaluation in the way you might describe for software.

• Sample Size for Test Set: Not applicable in the context of clinical data. The "test set" here refers to the physical device being tested against engineering standards and compared to the predicate device's specifications. The document does not specify a "sample size" of devices tested, but rather refers to conformance of "the CO2 Laser" (implying a representative unit/design) with established standards.
• Data Provenance: The data provenance is primarily from non-clinical testing (bench testing, engineering verification, and compliance with recognized standards) conducted by the manufacturer (Beijing Honkon Technologies Co., Ltd.) to demonstrate safety and performance according to the cited IEC and ISO standards. The country of origin for the manufacturing and testing would be China. This is a prospective evaluation in the sense that the device was manufactured and then tested to meet these criteria.

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

Not applicable. For a laser device like this, "ground truth" is not established by medical experts for diagnostic accuracy. Instead, safety and performance are assessed against predefined engineering specifications, international safety standards (IEC, ISO), and the performance characteristics of the predicate device. The "experts" involved would be engineers, quality control specialists, and regulatory affairs personnel who conducted and reviewed the technical testing.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for diagnostic accuracy to resolve discrepancies between human readers or between human readers and AI. This submission is based on technical specifications and compliance with standards.

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. An MRMC study is relevant for diagnostic devices (often AI-powered) where human readers evaluate cases. This document describes a medical laser, not a diagnostic imaging or AI system.

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

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

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

The "ground truth" for this device's acceptance is based on:

• Engineering Specifications: Conformance to the stated technical parameters (e.g., wavelength, energy output, pulse duration, frequency).
• International Safety and Performance Standards: Compliance with recognized standards like IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-22, ISO 10993-5, and ISO 10993-10. These standards define the acceptable limits and test methods for safety and performance of such devices.
• Predicate Device Equivalence: The key "ground truth" is showing that the device's technical characteristics and intended use are substantially equivalent to a legally marketed predicate device, implying it is as safe and effective.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI model that requires a training set.

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

Not applicable. As there is no training set for an AI model, there is no ground truth established for it in this context.

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1064 nm wavelength: Tattoo Removal (Dark Ink, Black & Blue ) Ota's nevus
532 nm wavelength: Tattoo Removal (Light Ink, Red, Sky Blue and Green) Treatment of Pigmented Lesions Solar Lentiginos Senile Lentiginos

The proposed device includes three models as YILIYA- 1064QCH, YILIYA- 1064QCL and Aeslight-1064QEH, the differences between three models described in the subsection 5 specification. The proposed device is the laser system with modularization and multi-wavelength, includes the waveform as 1064 nm and 532 nm. The proposed device consisted by control system, power supplier, cooling system, laser generator, articulated arm and foot switch.

The provided text is a 510(k) Summary for a Q-Switched ND: YAG Laser Device. This type of submission is for demonstrating substantial equivalence to a predicate device, not typically for a clinical study with acceptance criteria and performance reporting in the same way a new, high-risk device might be.

Therefore, many of the requested categories for a clinical study will not be explicitly present or applicable in this document. The submission focuses on bench tests and technological characteristics comparison to show equivalence.

Here's the information extracted and organized based on your request, with notes on what is not available in this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

Note: This document does not present acceptance criteria and performance in the "acceptance criteria" vs. "reported performance" format typically found in clinical studies validating device effectiveness. Instead, it demonstrates Substantial Equivalence (SE) to a predicate device by comparing technical specifications and ensuring compliance with recognized standards.

The table below summarizes the key technical specifications compared to the predicate device to demonstrate SE. The implicit "acceptance criteria" here is that the proposed device's specifications are within an acceptable range or are equivalent to the predicate device, especially regarding safety and intended use.

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

• Sample Size: Not applicable. This submission relies on non-clinical bench tests and comparison of technical specifications rather than a clinical human subject test set. The "test set" would be the device itself undergoing various engineering and electrical tests.
• Data Provenance: The data comes from bench tests conducted by the manufacturer, Beijing Honkon Technologies Co., Ltd. (P.R.China). This is a prospective evaluation of the newly designed device's physical and electrical characteristics against established standards and the predicate device's specifications.

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

• Not applicable. Ground truth in the context of clinical expert consensus or diagnostic accuracy is not relevant here. The "ground truth" for non-clinical bench tests is defined by international safety and performance standards (e.g., IEC standards) and the specifications of the legally marketed predicate device.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication is a process for resolving discrepancies among expert readers in clinical studies. This document describes non-clinical bench testing.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

• No. This is not an AI-assisted diagnostic device, nor is it a multi-reader, multi-case study. It's a laser device for dermatological and aesthetic procedures.

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

• Not applicable. This device does not involve an algorithm working in standalone mode. Its performance is evaluated through its physical and electrical outputs.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• The "ground truth" for this submission are the international safety and performance standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1) and the established technical specifications and Intended Use of the predicate device (RevLite™ Q-Switched Nd: YAG Laser System, K063834). Compliance with these standards and equivalence to the predicate's technical characteristics serves as the basis for demonstrating safety and effectiveness.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" in the context of machine learning or clinical trials for this type of device submission.

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

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

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The Multifunctional Series device (inclusive of the handpiece used to deliver pulsed-light energy) are indicated for use in surgical, aesthetic and cosmetic applications in hair removal, moderate inflammatory acne vulgaris, and benign cutaneous vascular lesions.

The Multifunctional Series device are intense pulsed light system which delivers intense pulsed light at a wavelength ranging from 530nm-1200nm. Intense Pulsed Light (IPL) systems work on the principles of selective thermolysis. That is, causing thermal damage to target chromophores by using light of appropriate wavelength in pulses that exceeds the chromophores" thermal relaxation time but sparing normal skin by limiting the pulse width below the thermal relaxation time for skin. IPL. Systems are different from lasers in that they deliver many wavelengths in each pulse of light instead of just one wavelength. Generally, IPL enhances penctration without using excessive energy levels and enables targeting of specific chromophores. Based on this, The Multifunctional Series device (inclusive of the handpiece used to deliver pulsed-light energy) are indicated for use in surgical, aesthetic applications in hair removal, acne, and blood vessel lesions. The proposed device includes four models as Aeslight-S3D, HONKON-S3C. HONKON-M40e+ and HONKON-M80e+.

The provided 510(k) summary (K131859) describes a Substantial Equivalence (SE) determination for the Multifunctional Series IPL device. This type of submission relies on comparing the new device to existing legally marketed predicate devices rather than conducting new clinical studies to prove efficacy and safety from scratch.

Here's an analysis of the provided information concerning acceptance criteria and supporting evidence:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this 510(k) submission are based on demonstrating "substantial equivalence" to predicate devices. This means that the proposed device must be as safe and effective as the predicate device(s) and have similar technological characteristics and intended use. The "acceptance criteria" are therefore represented by the characteristics of the predicate devices. The "reported device performance" is the specification of the proposed device, which is considered acceptable if it falls within a similar range or has slight differences that do not affect safety or effectiveness.

Below is a combined table summarizing the key performance parameters of the proposed device (Multifunctional Series) and its two primary predicate devices (Intense Pulsed Light (IPL) Systems (K122995) and IPULSELIGHT IPL SYSTEM (K093627)). The "Remark" column indicates if the characteristic is considered "Substantially Equivalent" (SE) or subject to "Analysis," which then details why the difference is deemed acceptable.

Table 1: Multifunctional Series Device Performance vs. Predicate Devices

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

This is a 510(k) submission based on substantial equivalence, not a de novo clinical study for device performance validation. Therefore, there is no specific "test set sample size" as would be associated with a typical clinical trial evaluating a new device's performance. The study described is a "Bench Test" outlined in item 7: "Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device."

• Sample Size: Not applicable in the context of a clinical test set. The "samples" would be the device itself and its components tested against design specifications and international standards.
• Data Provenance: The bench tests were conducted by the manufacturer, Beijing Honkon Technologies Co., Ltd., which is based in Beijing, P.R. China. The data would be considered retrospective in the sense that it's a comparison to already approved predicate devices and adherence to established standards rather than data from a prospective clinical trial.

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

Since there was no clinical "test set" in the traditional sense as part of this 510(k) submission, no experts were explicitly used to establish ground truth for a test set. The "ground truth" for proving substantial equivalence lies in the established safety and effectiveness profiles of the legally marketed predicate devices and the international standards (IEC 60601-1, IEC 60601-1-2) that the proposed device complies with.

4. Adjudication Method for the Test Set

Not applicable. As noted above, there was no clinical test set requiring expert adjudication for establishing ground truth. The "adjudication" in a 510(k) process is the review by the FDA to determine if substantial equivalence has been demonstrated.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices or those requiring human interpretation of results, and it's not a standard requirement for IPL devices seeking 510(k) clearance based on substantial equivalence to existing devices for aesthetic applications. Therefore, there is no reported effect size for how much human readers improve with AI vs without AI assistance.

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

No, a standalone (algorithm only) performance study was not done. This device is an Intense Pulsed Light system, a physical medical device, not a software algorithm. Therefore, "algorithm only" performance is not relevant.

7. The Type of Ground Truth Used

The "ground truth" for this 510(k) submission is established by:

• Predicate Device Equivalence: The safety and effectiveness established for the legally marketed predicate devices (K122995 and K093627). The proposed device is deemed substantially equivalent because its technological characteristics and intended use are highly similar, and any minor differences are argued not to affect safety or effectiveness.
• Compliance with International Standards: Adherence to recognized consensus standards for medical electrical equipment (IEC 60601-1 and IEC 60601-1-2). These standards provide a benchmark for fundamental safety and essential performance.

In essence, the "ground truth" is that the predicate devices are safe and effective, and the new device is sufficiently similar to share that "truth."

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a training set. The submission is for a physical IPL device based on established technology.

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

Not applicable. As there is no training set, there is no ground truth established for one.

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