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The MF SC GEN2 Facial Toning System is intended to stimulate the face. The device is intended for over the counter cosmetic use.

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The provided document is an FDA 510(k) clearance letter for the "MF SC GEN2 Facial Toning System." It confirms the device's substantial equivalence to legally marketed predicate devices for its stated indications for use.

Crucially, the document does NOT contain any information regarding acceptance criteria or a study proving the device meets these criteria.

This type of FDA letter is primarily a regulatory approval and does not detail the clinical or performance study data that the manufacturer submitted to support their 510(k) application. To provide the requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc.), one would need access to the actual 510(k) submission document itself, which is typically confidential business information and not released publicly by the FDA in detail.

Therefore,Based on the information provided in the FDA 510(k) clearance letter (K252218), it is not possible to describe the acceptance criteria and the study that proves the device meets these criteria.

The clearance letter primarily states that the device, "MF SC GEN2 Facial Toning System," is substantially equivalent to legally marketed predicate devices for its intended use (to stimulate the face, for over-the-counter cosmetic use). It does not contain the detailed performance data, study design, or acceptance criteria that would have been part of the manufacturer's 510(k) submission.

All sections of your request cannot be fulfilled as the necessary information is not present in the provided document.

To provide the requested details, one would need access to the full 510(k) submission document from Micro Current Technology, Inc., which is not publicly available in this correspondence.

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CEC101 and EE0101:
Microcurrent Facial Device is intended for facial stimulation for over-the-counter aesthetic use.

EEI101:
Microcurrent Facial Device is intended for facial, neck and body skin stimulation for over-the-counter aesthetic use.

The Microcurrent Facial Device is a portable, non-sterile, reusable device designed to achieve the aesthetic effect. It consists of main unit, charging cable, membrane cloth, conductive gel and user manual. The device is supplied by internal rechargeable lithium battery, which can be recharged by external charger through the Type-C charging cable. The device is un-usable when charging.

The provided FDA 510(k) clearance letter and summary for the Microcurrent Facial Device (K244004) does not contain information on acceptance criteria for a clinical study or a study proving the device meets performance criteria beyond safety and electrical standards.

This document primarily focuses on establishing substantial equivalence to predicate devices through technical comparisons, safety testing (biocompatibility, electrical safety, EMC), and software verification/validation. It explicitly states that "The following performance data were provided in support of the substantial equivalence determination," and lists the aforementioned safety and software tests.

The listed "Indications for Use" for this device are for "facial stimulation for over-the-counter aesthetic use" and "facial, neck and body skin stimulation for over-the-counter aesthetic use." These are aesthetic claims, not medical claims requiring clinical efficacy studies in the same way a device for diagnosing or treating a disease would.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance for clinical efficacy
• Sample size used for the test set and data provenance related to clinical efficacy
• Number of experts used to establish ground truth or their qualifications for clinical efficacy
• Adjudication method for a clinical test set
• MRMC comparative effectiveness study or effect size
• Standalone algorithm performance
• Type of ground truth used for clinical efficacy
• Sample size for the training set (for clinical efficacy)
• How ground truth for the training set was established (for clinical efficacy)

The document focuses solely on engineering and safety performance to demonstrate substantial equivalence, not clinical efficacy for aesthetic outcomes. The "performance data" section (Page 15) explicitly lists only biocompatibility, electrical safety, EMC, and software verification/validation as the bases for establishing substantial equivalence.

In summary, for K244004, the acceptance criteria and proof of meeting them are primarily related to safety and functional performance, not clinical efficacy for aesthetic outcomes, as it falls under the "Transcutaneous Electrical Nerve Stimulator For Pain Relief" product code (NFO) but is indicated for aesthetic use. The FDA clearance is based on the device being "as safe, as effective and performs as well as the legally marketed predicate devices" for its intended aesthetic stimulatory purpose, which is proven through the technical and safety evaluations outlined.

If this were an AI/ML medical device, the information requested would be crucial. However, for a microcurrent facial device, the regulatory pathway relies on different types of "performance data."

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SmartAppGuided™ MicroCurrent Face-Lift Pen | 6 in 1 is intended for the stimulation of neck and facial skin and is indicated for over-the-counter cosmetic use.

SmartAppGuided™ MicroCurrent Face-Lift Pen| 6 in 1 is an over-the-counter stimulation device. Its enclosure is injection-molded thermoplastic resin with silicone embedded in it. The output contacts consist of an electrode composed of chrome-plated or titanium- gold plated sphere. The device is powered by a rechargeable lithium-ion battery and cannot be used while charging. The device produces microcurrent that is discharged through two fixed, smooth spherical electrodes, and it has 3 current intensity levels that can be adjusted by pressing the on/off button on the device. Press the on/off button to turn on the device, and two spherical electrodes provide low-level electrical pulses to the target position of the face, and when the EMS function is turned on, the vibration function is also turned on simultaneously; The device spheres are designed for optimal contact with facial skin. The device delivers microcurrent as a constant biphasic square wave comprised of 10 positive pulses followed by 10 negative pulses. The microcurrent output continuously alternates between the positive and negative spherical electrodes.

The provided FDA 510(k) clearance letter and summary for the SmartAppGuided™ MicroCurrent Face-Lift Pen | 6 in 1 focuses on establishing substantial equivalence to predicate devices through technical comparisons and non-clinical performance testing. It does not contain information about acceptance criteria for performance related to its cosmetic claims, nor does it detail a study that proves the device meets such criteria.

The document confirms that clinical performance data and animal studies were not required for this submission. The assessments conducted were primarily for safety and electrical characteristics to ensure the device is as safe and effective as its predicate devices, rather than measuring the cosmetic effect of the device itself.

Therefore, the following information, based on the provided text, will reflect the absence of specific acceptance criteria or studies related to cosmetic performance, and will focus on the safety and technical compliance criteria.

Acceptance Criteria and Study Proving Device Meets Criteria for SmartAppGuided™ MicroCurrent Face-Lift Pen | 6 in 1

The provided FDA 510(k) submission primarily focuses on establishing the substantial equivalence of the SmartAppGuided™ MicroCurrent Face-Lift Pen | 6 in 1 to predicate devices concerning safety and technical characteristics. The document does not specify acceptance criteria related to its cosmetic effects (e.g., face-lift efficacy) or include a clinical study designed to demonstrate performance against such cosmetic criteria.

The acceptance criteria mentioned are related to electrical and mechanical safety, electromagnetic compatibility, software validation, and biocompatibility, ensuring the device is safe for its intended use as an over-the-counter stimulation device for cosmetic use.

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

Since specific performance acceptance criteria for cosmetic "face-lift" efficacy are not detailed in the provided document, the table below focuses on the reported technical performance and compliance with relevant safety standards. The "Acceptance Criteria" are implied by the standards the device claims compliance with and the comparisons to predicate devices.

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

The document specifies "production-equivalent devices" were used for bench testing. It does not provide a specific sample size (N=?) for these test devices.
The data provenance is based on internal testing conducted by GESKE Beauty Tech GmbH and evaluation by a "third-party accredited laboratory." The country of origin for these tests is not explicitly stated, but the submitter is based in Berlin, Germany. The testing described is prospective in nature, as it involves newly conducted tests on the device.

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

The document does not mention the use of experts to establish a "ground truth" for any performance claims related to cosmetic efficacy. The "ground truth" for the technical and safety performance is established by compliance with international standards (e.g., IEC, ISO) and comparison to legally marketed predicate devices, which are assessed by regulatory bodies. The qualifications of personnel conducting the internal and third-party laboratory tests are implied by their accreditation to perform such standards-based evaluations, but specific expert details are not provided.

4. Adjudication method for the test set

No adjudication method (e.g., 2+1, 3+1) is described, as the testing focuses on objective measurements against engineering specifications and compliance with recognized safety standards, rather than subjective interpretation or consensus-based clinical assessments.

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 MRMC comparative effectiveness study was conducted. The device is a direct-to-consumer electrical stimulation device, not an AI-assisted diagnostic or interpretative tool. Therefore, the concept of "human readers improving with AI assistance" does not apply.

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

A standalone performance study focused on cosmetic efficacy (e.g., "face-lifting" ability) was not conducted or reported. The "standalone" performance here refers to the device's technical specifications and safety compliance, which were evaluated in bench tests and by a third-party laboratory without human interaction for performance claims beyond safety.

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

The "ground truth" for this submission is primarily defined by:

• Compliance with international standards: (e.g., IEC 60601 series, ISO 10993 series, ISO 14971, IEC 60529, IEC 62366, etc.) for electrical safety, EMC, biocompatibility, usability, and risk management.
• Technical specifications: Measurements of output characteristics (voltage, current, density, waveform) against design tolerances.
• Substantial equivalence to predicate devices: Comparing its technical characteristics and safety profile to legally marketed devices.

There is no mention of ground truth established by expert consensus, pathology, or cosmetic outcomes data for the device's "face-lift" claims in this 510(k) summary.

8. The sample size for the training set

This device is not an AI/machine learning device that requires a "training set." Therefore, this information is not applicable.

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

This information is not applicable as the device does not utilize a training set in the context of AI/machine learning.

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The Préime DermaFacial with MicroT Applicator is intended to stimulate facial tissues for aesthetic purposes in the face.

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I apologize, but the provided FDA 510(k) clearance letter for the Préime DermaFacial (MicroT) device does not contain the information requested regarding acceptance criteria and the study proving the device meets those criteria.

This type of FDA clearance letter primarily states that the device has been found substantially equivalent to a predicate device and outlines regulatory obligations. It does not typically detail the specific performance studies, acceptance criteria, or expert qualifications that were submitted as part of the 510(k) application.

To answer your questions, I would need to access the full 510(k) submission document or a summary of safety and effectiveness, which is not included in the provided text.

Therefore, I cannot provide the requested table and detailed information based solely on this document.

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PureLift GLOW is intended for facial and neck stimulation, treatment of wrinkles, treatment of mild to moderate inflammatory acne, and indicated for over-the-counter cosmetic use.

PureLift GLOW is a hand-held device intended to apply electrical impulses to strategic locations on the face and Light Emitting Diode (LED) technology that is intended for the treatment of wrinkles and mild to moderate inflammatory acne. The PureLift GLOW probes are designed for optimal contact with the LED technology is not intended to come into contact with the user. The device continually alternates between the positive probes and allows the user to adjust the settings for personalized comfort level by pressing the intensity starts at (1) and continues to (10). The LED treatment area is approximately 36.3cm2 and available five levels of blue (465nm) and red (634nm) wavelengths. The device housing is injection molded of biocompatible thermoplastic resin and the probes consist of chrome-plated spheres. The device, powered by a 3.7-volt rechargeable battery, produces low-level current that is transmitted through the two fixed, smooth spherical probes. To turn the device on, the power button is pressed, and a green light illuminates to indicate that the unit is ready for use. Users then follow the instructions for use. The two probes gently glide over the skin to deliver low-level to strategic locations on the face and neck with the use of a conductive gel and the LED light is directed to the treatment area.

The document does not contain information regarding acceptance criteria or a study proving the device meets acceptance criteria. The document is an FDA 510(k) clearance letter for the PureLift GLOW device, which primarily discusses its substantial equivalence to predicate devices based on technological characteristics and intended use.

While the document states that "Clinical testing was not required to support a substantial equivalence determination" (page 6), it does not describe any specific acceptance criteria for performance metrics (such as sensitivity, specificity, or accuracy for medical devices often associated with AI/ML solutions) nor does it provide details of a study demonstrating the device meets such criteria.

The information provided pertains to bench performance testing to ensure safety and electrical performance, and a comparison table highlighting technological aspects with predicate devices. None of these describe acceptance criteria or a study in the context you've requested.

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The device is indicated for aesthetic use, including facial and neck stimulation or body skin stimulation.

The subject device, the MyoLight Microcurrent Handpieces are intended to be used together with a main control unit that is equipped with a color touch screen that significantly facilitates the use of the device. There are two MyoLight Microcurrent Handpieces that connect to the main unit. The small handpiece (diameter: 3.9 cm, Length: 14 cm) is generally used on the face and the large handpiece (diameter: 6.2 cm, Length: 15 cm) is generally used on the body. The handpieces are different in dimensions but not function. The handpieces contain the electrodes that deliver microcurrent for aesthetic use. The subject device is intended to be used together with a main control unit that is equipped with a color touch screen that significantly facilitates the use of the handpieces. The on-screen information guides the user step-by-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen of the device. During the therapy the device displays information about therapy type, remaining therapy time and main therapy parameters on the screen.

The provided context does not offer information about the acceptance criteria or a study proving that the device meets specific acceptance criteria in the typical format of a clinical or performance study with metrics like sensitivity, specificity, or AUC.

The document is a 510(k) summary for a medical device (MyoLight Microcurrent Handpiece) and focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed performance study with acceptance criteria.

However, based on the non-clinical testing section, we can infer some "acceptance criteria" through compliance with recognized standards.

Here's the breakdown of the information that can be extracted, and where the requested information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for substantial equivalence, the "acceptance criteria" are implicitly met by demonstrating compliance with recognized standards and similarity to predicate devices. The "reported device performance" is essentially the device's conformance to these standards and its specifications aligning with the predicate devices.

2. Sample size used for the test set and the data provenance
The document does not describe a clinical test set in terms of patient samples. The testing described is non-clinical (bench testing, software V&V, and compliance with electrical safety and EMC standards). Therefore, there is no information on sample size or data provenance in the context of a clinical test set.

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 using expert-established ground truth is described.

4. Adjudication method for the test set
Not applicable, as no clinical test set with adjudication is described.

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. The device is a microcurrent handpiece, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as the device is not an algorithm for diagnostic or prognostic purposes. It is a physical device delivering electrical stimulation, with software controls for operation.

7. The type of ground truth used
For non-clinical testing:

• Electrical Safety, EMC, and Nerve/Muscle Stimulator Standards: Compliance is based on objective measurements against defined limits in the respective IEC standards.
• Biocompatibility: Likely based on laboratory assays and tests according to ISO 10993 standards.
• Software Validation & Verification: Based on predefined software requirements specification and test protocols.
• Bench Testing: Based on objective measurements of physical and electrical parameters against design specifications.

8. The sample size for the training set
Not applicable, as this is not an AI/machine learning device. The "training set" concept doesn't apply.

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

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JMOON NouvelleSkin facial toning device is intended for facial stimulation and indicated for overthe-counter cosmetic use.
JMOON NouvelleSkin facial toning device is an over-the-counter device that emits energy in the red and near-infrared spectrum, designed for the treatment of facial wrinkles.

Jmoon NouvelleSkin Facial Toning device is an at-home handled device that provides an advanced, easy-to-use and efficient solution for better facial wellness. This device includes microcurrent, red and infra-red light LED, which allow you to customize your treatments according to your face skin. The device provides indicator lights and beeps feedback to guide the user during the treatment cycle.
The microcurrent therapy will deliver 3 different low-level electrical microcurrent impulses on face within a few minutes to complete facial stimulation. The red light and infra-red therapy is a treatment that uses red light to reportedly improve your skin's appearance, like reducing wrinkles.

The provided text describes a 510(k) premarket notification for the JMOON NouvelleSkin Facial Toning Device. The submission aims to demonstrate substantial equivalence to predicate devices, rather than proving performance against specific acceptance criteria through a clinical study with real-world data and expert adjudication. Therefore, much of the requested information (like sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, and ground truth for training set) is not applicable or not present in the provided document.

However, the document does contain "acceptance criteria" in the form of conformance to various safety and performance standards for non-clinical testing.

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

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

The acceptance criteria for this device are its conformance to recognized safety and performance standards. The reported performance is that the device "Conforms" to these standards.

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

The document explicitly states: "No clinical test data was used to support the decision of substantial equivalence."
The testing performed was non-clinical (lab bench testing). Therefore, there is no "sample size for the test set" in the context of human subjects or clinical data, nor is there data provenance in terms of country of origin or retrospective/prospective studies.

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)

Not applicable. As no clinical test data was used, no experts were needed to establish ground truth for a test set based on human subjects. The acceptance criteria were based on adherence to international technical standards, which are established by expert consensus in regulatory and technical bodies.

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

Not applicable. No clinical test set with human subject data requiring adjudication was used.

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

Not applicable. No MRMC study was conducted, as the device is not an AI-assisted diagnostic or interpretive tool, and no clinical studies were performed.

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

This concept is not directly applicable to this device, which is a physical facial toning device. However, the non-clinical testing evaluates the device's standalone physical, electrical, and biocompatibility performance against specified standards. The results indicate that the device "Conforms" to these standards in a standalone capacity.

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

The "ground truth" for the non-clinical testing is compliance with the specified international standards (e.g., IEC 60601-1, ISO 10993 series). These standards represent an expert consensus on safety and performance requirements for medical devices.

8. The sample size for the training set

Not applicable. The device is not based on a machine learning algorithm; therefore, there is no "training set" in the conventional sense of AI/ML development.

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

Not applicable. There is no training set for this device.

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The Medi Lift Mask is intended for facial stimulation and indicated for over-the-counter cosmetic use.

The Medi Lift Mask is composed of a mask made of silicone rubber which is worn on the lower part of the user's face, and covers the user's cheeks and nose. The mask contains two controllers with electrodes, which are attached to the mask. These controllers and electrodes deliver electrical pulses to stimulate facial muscles. The controllers are operated independently by pressing buttons on each controller. The controllers attached to the mask contain two charging pins which allows for the built-in Lithium-ion battery that powers the device to be charged using a USB charging cable and an adapter that is provided as part of the device is not operated during charging.

This document is a 510(k) Summary for the Medi Lift Mask, a medical device. The information provided heavily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria and performance data for a new AI/software-driven device.

Therefore, many of the requested categories for a study proving device performance against acceptance criteria for an AI-driven device cannot be extracted from this document, as the device is not an AI/software device and the clearance is based on substantial equivalence and minor material change, not a performance study of AI.

However, I will extract what is available and note what is not applicable or not provided.

Here's the breakdown based on the provided text:

Device Type: Transcutaneous Electrical Nerve Stimulator For Pain Relief (Aesthetic Purposes) – This is a hardware device, not an AI/software device.

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

The document does not present acceptance criteria for a performance study in the way an AI/software device submission would. Instead, it demonstrates equivalence to a predicate device. The "performance" described is in the context of safety and effectiveness, shown by:

• Risk Analysis: Per ISO 14971:2019 (determined no new risks compared to predicate).
• Biocompatibility Evaluation: Per ISO 10993-1:2018, with testing for Cytotoxicity (ISO 10993-5:2009), Sensitization (ISO 10993-10:2021), and Intracutaneous reactivity (ISO 10993-23:2021).
• Prior Tests (Applicable to predicate, deemed still applicable to new device due to no relevant changes): Tensile strength, polycyclic aromatic hydrocarbons, software verification and validation, electrical stimulation outputs, electrical safety, and electromagnetic compatibility.

• Cytotoxicity per ISO 10993-5:2009
• Sensitization per ISO 10993-10:2021
• Intracutaneous reactivity per ISO 10993-23:2021 |
  | Effectiveness (Equivalence) | "The Medi Lift Mask has the same intended use and indications for use as the predicate device... Thus, the Medi Lift Mask is substantially equivalent." |
  | Material Change Impact | The new UV varnish on the controller housing "does not raise different types of safety and effectiveness questions." |

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

• Sample Size for Test Set: Not applicable in the context of a clinical performance study for an AI algorithm. The testing described is primarily material and electrical safety/biocompatibility testing, which typically uses defined sample sizes for specific component tests as per standards, but a "test set" of patient data is not relevant here.
• Data Provenance: Not applicable for patient data. The provenance of the testing conducted would be controlled laboratory conditions in Japan (where YA-MAN Ltd. is located).

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

• Not applicable. This is not an AI diagnostic/prognostic device requiring expert-established ground truth from medical images or patient data.

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

• Not applicable. No clinical test set requiring adjudication was used.

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

• No. This is not an AI-assisted diagnostic device.

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

• No. This is not an AI device.

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

• Not applicable. The "ground truth" for this device revolves around established safety standards (ISO for biocompatibility, electrical safety) and the functional equivalence to the cleared predicate device.

8. The sample size for the training set

• Not applicable. This device does not use a training set for machine learning.

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

• Not applicable. This device does not use a training set for machine learning.

Summary of the K244048 Submission:

The provided text is an FDA 510(k) summary for a Transcutaneous Electrical Nerve Stimulator (Medi Lift Mask). The submission seeks clearance based on substantial equivalence to a previously cleared predicate device (Medi Lift PLUS, K220198). The primary "change" is a different UV varnish material on the controller housing.

The testing performed and documented focuses on confirming that this minor material change does not introduce new safety or effectiveness concerns. This is demonstrated through:

• Risk analysis (confirming no new risks).
• Biocompatibility testing of the new material.
• Reliance on prior testing of the predicate for aspects not affected by the material change (electrical safety, software, etc.).

Therefore, the document does not contain the information typically found in an FDA submission for an AI/software device that requires extensive clinical performance studies with defined acceptance criteria for AI model performance (e.g., sensitivity, specificity, accuracy against human readers or pathology).

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Micro-current Facial Beauty Device is intended for the treatment of facial wrinkles, and mild to moderate inflammatory acne. (cleared under K241718)

Micro-current Facial Beauty Device is a handheld portable device for over the counter aesthetic use including facial and neck stimulation.

The Micro-current Facial Beauty Device is a portable, non-sterile, reusable device designed to achieve the aesthetic effect. It consists of main unit, charging cable, cleaning flannelette, storage bag, instrument base and user manual. The device is supplied by internal rechargeable lithium battery, which can be recharged by external charger through the Type-C charging cable. The device is un-usable when charging.

The device is only home environment use, which has two massage heads, and three LED light mode (Amber/ Red/ Blue lights are output independently) to provides following functions:

a. Amber, Red and Blue LED irradiation function. The device outputs amber light with the wavelength of 605±10nm, and red light with the wavelength of 630±10mm. It is used to illuminate facial skin with narrow spectral bandwidth light and treat facial wrinkles. Also, it outputs blue light with the wavelength of 415±10nm and is used to illuminate facial skin with narrow spectral bandwidth light and treat mild to moderate inflammatory acne. (Cleared under K241718)
b. Hot compress and vibration function. The device generates different intensity of vibration by a builtin motor to relax the facial skin, and also, the massage head is heated to 40±1℃, making the facial skin feel warm to relax and soothe the facial skin. (The vibration is classified as class I and not need for 510K, and the hot compress is not for medical purpose). (Cleared under K241718)
c. MS-Micro current stimulation function. The device has two electrode massage heads to do facial stimulation.

The provided text is a 510(k) Summary for a Micro-current Facial Beauty Device. It focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and safety standards. It does not describe the acceptance criteria and a study proving the device meets those acceptance criteria for efficacy or performance in terms of its intended medical use (treatment of facial wrinkles and mild to moderate inflammatory acne).

The "Performance Data" section primarily addresses safety and electrical compliance, not clinical efficacy or diagnostic accuracy. This is typical for Class II devices seeking 510(k) clearance, where substantial equivalence often relies on demonstrating similar safety and performance characteristics to previously cleared devices rather than new clinical trials demonstrating efficacy against specific metrics for the stated indications.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those acceptance criteria for its intended clinical use from the given document.

The document states:

• Intended Use: "Micro-current Facial Beauty Device is intended for the treatment of facial wrinkles, and mild to moderate inflammatory acne."
• Performance Data provided: Biocompatibility Testing, Electrical Safety, and Software Verification and Validation.

There is no mention of a study involving human subjects or data related to the actual treatment of wrinkles or acne using this device. The document focuses on demonstrating that the device is similar enough to existing cleared devices in terms of its technical specifications and general safety.

Here's why the requested information cannot be extracted from this document:

1. Acceptance Criteria for Efficacy/Performance: The document does not define specific clinical acceptance criteria (e.g., percentage reduction in wrinkles, improvement score for acne) that the device must meet to demonstrate efficacy for its intended use.
2. Study Proving Efficacy/Performance: There is no description of a clinical study or performance study that measures the device's ability to treat facial wrinkles or mild to moderate inflammatory acne.
3. Specifics of a Clinical Study (Sample Size, Ground Truth, Experts, MRMC): Since no such study is described, all related points (sample size, data provenance, number/qualifications of experts, adjudication method, MRMC study details, standalone performance, type of ground truth, training set details) are absent.

What the document does provide in terms of "acceptance criteria" is largely related to safety and regulatory compliance:

• Biocompatibility: Adherence to ISO 10993 standards (e.g., passing tests for in vitro cytotoxicity, skin sensitization, irritation).
• Electrical Safety: Compliance with various IEC 60601 series standards for medical electrical equipment (general safety, electromagnetic disturbances, home healthcare environment, nerve/muscle stimulators, battery safety).
• Software Verification and Validation: Meeting software requirement specifications and mitigating hazards to acceptable risk levels (consistent with a "Basic Documentation Level of concern").

In conclusion, this 510(k) submission relies on demonstrating substantial equivalence to predicate devices, supported by engineering, electrical, and biocompatibility testing, rather than new clinical efficacy data for the treating indications.

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