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The NuFACE FIX+ Device is intended for facial stimulation and is indicated for over-the-counter cosmetic use.

FIX+ is a portable hand-held microcurrent stimulator for facial skin stimulation indicated for over-the-counter cosmetic use. Main components: Main unit, USB power cable, and NuFACE Line Smoothing FIX Serum conductivity gel. Housing of the device made from Acrylonitrile Butadiene Styrene, with chrome-plated spherical probes. Inclusion of three microcurrent output frequency levels. Integrated rechargeable lithium-ion battery.

The provided text is a 510(k) summary for the NuFACE® FIX+ device, which is a microcurrent stimulator for facial stimulation. It describes the device, its intended use, and how it compares to a predicate device. This document is a regulatory submission to the FDA, demonstrating substantial equivalence to a legally marketed predicate device, rather than a clinical study report proving a device meets specific acceptance criteria for a diagnostic or AI-driven medical device.

Therefore, the information required to answer the prompt (acceptance criteria, study details for an AI/diagnostic device, sample sizes, expert involvement, etc.) is not present in the provided text. The document focuses on electrical safety, EMC, bench testing of output characteristics, and biocompatibility to demonstrate safety and performance equivalence to a similar device already on the market.

Specifically:

• Acceptance Criteria Table and Reported Performance: The document provides "Performance Specifications Comparison" in Table 4, but these are comparisons to the predicate device's specifications, not acceptance criteria for a diagnostic claim, nor are they reported "device performance" in the sense of clinical accuracy or efficacy for a diagnostic output.
• Sample Size for Test Set and Data Provenance: Not applicable. The "testing summaries" refer to bench testing of the device's electrical characteristics and safety, not testing on human subjects for a diagnostic outcome.
• Number of Experts and Qualifications: Not applicable. The testing described is engineering and safety testing.
• Adjudication Method: Not applicable.
• MRMC Comparative Effectiveness Study: Not applicable. The device is a cosmetic facial stimulator, not an AI-assisted diagnostic tool for human readers.
• Standalone Performance: The bench testing addresses the device's standalone electrical performance, but not in the context of a diagnostic algorithm.
• Type of Ground Truth: Not applicable for a diagnostic purpose. Ground truth for the engineering tests would be established by validated measurement equipment.
• Sample Size for Training Set: Not applicable. This device does not appear to employ machine learning that would require a training set in the conventional sense of an AI model for diagnostic imaging.
• Ground Truth for Training Set: Not applicable for the same reason.

In summary, the provided document details the regulatory pathway for a Class II medical device based on substantial equivalence, primarily focusing on engineering and safety characteristics. It is not a report on a study proving the device meets acceptance criteria for a diagnostic or AI-assisted application in the way the prompt implies.

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The Trinity Plus Wrinkle Reducer is an over-the-counter hand-held for reduction of full-face fine lines and wrinkles, and increase in local circulation within the perioral region.

The Trinity Plus Wrinkle Reducer (hereinafter referred to as "TWR Plus") comprises the TWR Plus main body, a TWR Plus light attachment head, a charging cradle, and a wall-mount power adaptor. The device and all its associated components are reusable and provided non-sterile.

The TWR Plus is a hand-held phototherapy device that emits Red and Infrared (IR) light energy in the 605, 630, 645, 660 and 855 nanometer wavelengths via a light attachment head. The light attachment head comprises (34) Light Emitting Diodes (LED's) which are the source of the light energy. The Red and IR light energy is used in the treatment of fine lines and wrinkles around eyes, mouth, and forehead and promotes local blood circulation.

The subject device includes three indicator LED's, one internal speaker and one vibration motor. These features provide visual, audible, and haptic feedback to the user during normal operation. The light attachment head includes a proximity sensor to detect when device is pressed onto the skin.

The subject device is turned on and turned off via a dedicated ON/OFF button. Once the subject device is ON, the user follows the provided Instructions for Use to start the treatment. The ON/OFF button also serves as a multi-function User Interface (UI) button by allowing the User to control other functions while the subject device is in Standby, Treating, Charging or Sleep modes. A long press of approximately one second on the ON/OFF button can stop treatment at any time.

Upon power up, the three indicator lights turn on and an ascending audible beep is emitted notifying the user that the device is ON. Once the device is ON, the light therapy LEDs are set to a visible, but significantly dimmed non-treatment state. As the device is placed in direct contact with the skin, the proximity sensor will turn the light therapy LEDs on to start the treatment. While in treatment, if the device is moved away from the skin, the device emits three beeps, and the LEDs revert to the significantly dimmed non-treatment state. The device also emits two beeps to inform the user when a treatment interval is complete and that it is time to treat another section of skin. The device automatically Shuts OFF after 24 minutes of use to indicate the treatment is complete.

The device is powered by one internal rechargeable, non-removable battery which is charged via a provided wireless charging cradle. The charging cradle is powered by a pre-approved wall-mount power supply. The light energy output power is zero watts while the device is in the charging cradle or when turned off. All charging circuitry is contained within the handheld unit itself.

The housings of TWR Plus main body, the light attachment head and the charging cradle are made from injection molded thermoplastic resins. The light attachment head, which is intended to come in contact with the skin, is made from a biocompatible polymer material. The TWR Plus, including the light attachment head, measures 5.4" H x 2.6" W x 1.7" D and weighs 7.8 oz. The charging cradle measures 2.3" H x 3.0" W x 2.7" D and weighs 7.30 oz.

The TWR Plus uses Bluetooth Low Energy (BLE) wireless technology to pair to and connect with compatible devices capable of running the NuFACE® App. The NuFACE® App allows the user to select and run pre-programmed treatment profiles stored in the device.

Device component list:

• 1 x TWR Plus Main Body
• 1 x TWR Plus Light Attachment Head
• 1 x Wireless Charging Cradle
• 1 x Pre-approved wall-mount power adaptor

The provided text is a 510(k) Summary for the NuFACE® Trinity Plus Wrinkle Reducer. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving the detailed performance metrics through rigorous clinical studies often associated with novel or high-risk devices. As such, the information typically requested in your prompt (e.g., acceptance criteria for clinical performance, sample sizes for test sets, expert qualifications, MRMC studies, specific ground truth types) is largely absent because it was not required for this type of submission.

Here's an analysis based on the provided document:

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

The document does not provide a specific table of acceptance criteria for clinical performance (e.g., specific percentage reduction of wrinkles, or circulation increase metrics) nor does it report device performance in those terms. Instead, the "acceptance criteria" for a 510(k) are typically met by demonstrating that the new device is as safe and effective as a predicate device.

The reported "performance" is concluded through:

• Biocompatibility Evaluation: The materials (ABS Thermoplastic and a Polymer for the lens) were deemed biocompatible for surface device, intact skin, limited (

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The Trinity ELE Plus and Trinity ELE Plus Pro devices are intended for facial stimulation and are indicated for over-the counter cosmetic use.

The Trinity ELE Plus comprises the Trinity ELE Plus device main body, a Trinity ELE Plus microcurrent attachment head, a charging cradle, and a wall-mount power adaptor. A tube of NuFACE® Gel Primer is provided with the subject device as an accessory. The subject device and all its associated components and accessories are reusable and provided non-sterile.

The Trinity ELE Plus is a hand-held device that produces low levels of microcurrent which is discharged through two dual chrome-plated precise wands for aesthetic purposes. The device provides audible feedback to inform the user to relocate the device to treat a new location on the skin. The device also includes "hum" features to guide the user during the treatment cycle.

The subject device is powered by one internal rechargeable, non-removable battery which is charged via a provided wireless charging cradle. The charging cradle connects to a provided wall-mount power adaptor. Microcurrent output is cut-off while the device is sitting on the charging cradle either charging the battery or when the battery is fully charged.

The enclosures of the subject device main body, the attachment head and the charging cradle are made from injection molded ABS thermoplastic material. The same ABS material is used in other FDA-cleared devices. The dual chrome-plated precise wands on the attachment head use chromium. The same chromium material is used in the predicate device dual chrome-plated precise wands.

The subject device, including the attachment head, measures 6.1" H x 2.4" W x 1.2" D. The charging cradle measures 2.3" H x 3.0" W x 2.7" D.

The device includes an 'ON/OFF' multi-function button to turn the device on and off, start and stop treatment, increase or decrease the microcurrent output level and pair with a smart device. The device also includes a "BOOST" button that temporarily increases the microcurrent output level.

The device includes indicator LED's to provide information to the user on the status of the device and the progress of the treatment.

The subject device is the capable of pairing with compatible smart devices using Bluetooth Low Energy (BLE) wireless communications technology. This technology allows the subject device to communicate with other devices running the NūFACE® App which allows the user to select and run pre-programmed treatment profiles.

The Trinity ELE Plus provides microcurrent output at selected frequencies from 0.3 to 50 Hz.

The Trinity ELE Plus is available in two models, a Standard model and a 'Pro'' model. The Trinity ELE Plus Standard model has a maximum output current without Boost of 170 uA, and the Trinity ELE Plus Pro model has a maximum output current without Boost of 200 uA. All other aspects of the Trinity ELE Plus except those related to maximum output current, are the same between the Standard model and Pro models.

I regret to inform you that the provided text does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

The document is a 510(k) premarket notification for the Trinity ELE Plus and Trinity ELE Plus Pro devices. It focuses on demonstrating substantial equivalence to existing predicate devices, rather than establishing and proving new acceptance criteria for the subject device itself.

Here's a breakdown of what the document does include and why it doesn't answer your specific questions:

• Indications for Use: The devices are intended for "facial stimulation" and are indicated for "over-the-counter cosmetic use."
• Technological Characteristics Comparison: There are tables comparing the subject device's features (Type of Energy Output, Energy Delivery, Energy Flow, Energy Output, Microcurrent Boost, Energy Power Source, Power Accessories, Charging Method, Charging Circuitry, Power Supply Type, Special Requirements, Wireless Technology, Output Frequency) and output specifications (Waveform Type, Shape, Max Output Voltage, Max Output Current, Output Tolerance, Pulse Period, Output Frequency, Beat Frequency, Symmetrical Phases, Phase Duration, Net Charge, Max Phase Charge, Max Current Density, Max Power Density, Burst mode information, ON time, OFF time) to those of a predicate device. Many of these are listed as "Same" or "Different," with explanations for why the "Different" aspects do not affect safety and effectiveness.
• Non-Clinical Performance Data:
  • Biocompatibility Evaluation: This describes the materials used and concludes they are biocompatible based on their use in other FDA-cleared devices or the predicate device.
  • Safety, Performance, and Bench Testing: This section states that EMC, Wireless Coexistence, and bench testing concluded the device "meets and complies with the safety and performance of the applicable standards and bench testing requirements." However, it does not list specific acceptance criteria for these tests or provide detailed results. It also mentions electrical safety tests are "currently being conducted and will be provided to the FDA before the subject device is released to market."
  • Software Verification and Validation: This states the software "meets and complies with the applicable software requirements specifications" but does not detail those specifications or acceptance criteria.
• No Animal Testing or Clinical Testing: The document explicitly states that substantial equivalence is not supported by animal or clinical testing.

Therefore, I cannot provide the requested table or answer the questions because the necessary data (specific acceptance criteria, detailed study results proving these criteria are met, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC study details) is not present in the provided text. The document focuses on demonstrating that the new device is substantially equivalent to a previously cleared device, not on proving its independent performance against new, explicit acceptance criteria.

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The NuFACE® Trinity Plus Device is intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use.

The NuFACE® Trinity Plus comprises the Trinity Plus device main body, a Trinity Plus microcurrent attachment head, a charging cradle and a wall-mount power adaptor. A tube of NuFACE® Gel Primer is provided with the device as an accessory. The device and all associated components are reusable and provided non-sterile. The NuFACE® Trinity Plus is a hand-held device that produces low levels of microcurrent which is discharged through two dual-plated chrome spheres for aesthetic purposes. The device provides audible feedback to inform the user to relocate the device to treat a new location on the skin. The device also includes "hum" features to guide the user during the treatment cycle. The device is powered by one internal rechargeable, non-removable battery which is charged via a provided wireless charging cradle. The charging cradle connects to a provided wall-mount power adaptor. Microcurrent output is cut-off while the device is sitting on the charging cradle either charging the battery or when the battery is fully charged. The enclosures of the device main body, the attachment head and the charging cradle are made from injection molded ABS thermoplastic material. The dual spheres on the attachment head use chromium. The device includes an 'ON/OFF' multifunction button to turn the device on and off, start and stop treatment, increase or decrease the microcurrent output level and pair with a smart device. The device also includes a "BOOST" button that temporarily increases the microcurrent output level. The device includes indicator LED's to provide information to the user on the status of the device and the progress of the treatment. The device is the capable of pairing with compatible smart devices using Bluetooth Low Energy (BLE) wireless communications technology. This technology allows the device to communicate with other devices running the NuFACE® App which allows the user to select and run pre-programmed treatment profiles. The NuFACE® Trinity Plus provides microcurrent output at selected frequencies from 0.3 to 50 Hz.

This document is a 510(k) summary for the NuFACE® Trinity Plus Device. It is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. The document focuses on demonstrating that the new device is as safe and effective as the predicate, not on proving new clinical efficacy or superiority through rigorous clinical trials.

Therefore, the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/Machine Learning (ML) device, which typically involves performance metrics like sensitivity, specificity, accuracy, and detailed clinical study designs with human readers and ground truth, is not applicable to this document.

This FDA submission is for a physical medical device (Transcutaneous Electrical Nerve Stimulator for Pain Relief, used for cosmetic facial and neck stimulation) and primarily relies on a comparison of technological characteristics, safety data (biocompatibility, electrical safety, EMC), and software verification and validation to demonstrate substantial equivalence to a predicate device.

Here's why the AI/ML-centric questions are not applicable:

• No AI/ML Component: The document describes a device that "produces low levels of microcurrent" and has "indicator LED's," a "multifunction button," and Bluetooth Low Energy for app connectivity to select pre-programmed treatment profiles. There is no mention of an AI or ML algorithm making diagnostic or therapeutic decisions, interpreting data, or providing automated recommendations.
• Safety and Substantial Equivalence, Not Efficacy Proof: The core purpose of a 510(k) is to demonstrate that a new device is "substantially equivalent" to a predicate device. This typically involves showing that its indications for use, technological characteristics, and safety and effectiveness profiles are similar enough that it doesn't raise new questions of safety or effectiveness. It's not a P-value seeking clinical trial to prove a new mechanism or superior efficacy.
• "Clinical Testing" was not performed: The document explicitly states under section 9, "Clinical Testing: The substantial equivalence for the subject device will not be demonstrated by results of clinical testing. Therefore, no clinical testing was performed." This clearly indicates that no human-subject efficacy study was conducted for this submission.

In summary, this document does not describe the kind of study (e.g., MRMC, standalone performance) that would be conducted for an AI/ML device requiring rigorous clinical performance validation against acceptance criteria based on metrics like sensitivity or specificity. The "acceptance criteria" here implicitly relate to demonstrating safety and similar performance to the predicate device through non-clinical testing.

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The NuFACE Mini Device is intended for facial and neck stimulation and is indicated for over-the-counter use.

The NuFACE® Mini Device is an over- the- counter facial and neck toning device. The chrome plated dual spheres of the NuFACE® Mini are designed to gently glide over the skin to deliver low-level electrical impulses to strategic locations on the face and neck. The NuFACE® Mini electrodes are designed for optimal contact with the face.

The NuFACE® Mini microcurrent continually alternates between the positive electrodes and allows the user to adjust settings.

The NuFACE® Mini Device measures approximately 2.5" W x 4.2" D. Its outer case is injection mold thermoplastic resin. The device comes with an external Power Supply to recharge the lithium ion battery of the device when not in use. The external Power Supply is a pre- approved wall adapter. All charging circuitry is contained within the device itself.

This document is a 510(k) Premarket Notification for the NuFACE Mini Device. It aims to demonstrate substantial equivalence to a predicate device, the NuFACE Trinity Device, rather than proving the device meets specific performance acceptance criteria through clinical studies. Therefore, much of the requested information regarding study design, sample sizes, expert ground truth establishment, and comparative effectiveness studies is not present in this type of submission.

However, based on the provided text, here's what can be extracted and inferred:

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

Since this filing is for substantial equivalence, the "acceptance criteria" are primarily established by the characteristics and performance of the predicate device (NuFACE Trinity). The reported device performance for the NuFACE Mini is presented as a comparison to the predicate.

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The NuFACE FIX™ Device is intended for facial stimulation and is indicated for over-the-counter cosmetic use.

NuFACE FIX Skin Toning Device is intended for facial stimulation and is indicated for over-the-counter cosmetic use. Two (2) spherical electrodes, fixed on the NuFACE FIX device main face, deliver low level electrical impulses (aka. microcurrent) to targeted locations on the face.

The NuFACE FIX Skin Toning Device is intended for facial stimulation for over-the-counter cosmetic use. The 510(k) summary provided indicates substantial equivalence to the predicate device, NuFACE Trinity ELE (K131251), rather than presenting specific performance criteria and a study demonstrating the device meets those criteria.

However, since a direct study proving the device meets individual acceptance criteria is not provided, the following outlines the acceptance criteria established by the manufacturer and the reported performance as demonstrated through a substantial equivalence comparison to a predicate device, rather than a standalone performance study with specific device performance metrics against predefined acceptance thresholds.

1. Table of Acceptance Criteria and Reported Device Performance

As this submission establishes substantial equivalence, the "acceptance criteria" for the new device are implicitly that its technological characteristics, intended use, indications for use, and performance data are either the same as or demonstrate equivalence to the predicate device.

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

The primary evidence presented is a comparison against a predicate device's specifications and compliance with recognized standards. There isn't a "test set" in the traditional sense of a clinical trial or performance study with a specific sample size of patients or images for which direct performance metrics against acceptance criteria are measured.

Instead, the "test set" for this substantial equivalence submission comprises:

• Engineering and Bench Testing Data: This includes measurements of electrical output specifications (voltage, current, pulse width, frequency), mechanical integrity, and software functionality.
• Safety Standard Compliance Reports: Documentation demonstrating that the device meets the requirements of various international and national safety and performance standards (e.g., IEC 60601 series, ISO 14971, IEC 62366).
• Usability Study: A prospective usability study was conducted. Details on sample size or provenance are not provided in this summary.

Data Provenance: The data originates from the manufacturer's internal testing and evaluations, conducted according to recognized industry standards. No external clinical data or specific geographic provenance (e.g., country of origin) for a clinical "test set" is explicitly mentioned for the substantial equivalence claim. The usability study is described as "prospective" but no further detail on its sample size or provenance is provided within this document.

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

Given that this is a 510(k) submission based on substantial equivalence to a predicate device and compliance with engineering and safety standards, the concept of "ground truth" derived from expert consensus on a clinical test set is not directly applicable in the same way as it would be for a diagnostic AI device.

• Engineering/Safety Standards: The "ground truth" here is established by the specifications and performance requirements outlined in the international and national standards themselves (e.g., IEC 60601 series). Compliance is typically assessed by engineers and technicians who are qualified in the relevant testing methodologies and regulatory requirements.
• Usability Study: If the usability study involved expert feedback, the qualifications of those experts (e.g., human factors engineers, ergonomists, clinicians who would use such a device) would be relevant. However, this detail is not provided in the summary.

4. Adjudication method for the test set

Not applicable in the context of this 510(k) submission. Adjudication methods like 2+1 or 3+1 are typically used in clinical trials or reader studies where multiple experts independently review cases and then resolve disagreements to establish a consensus ground truth. This type of clinical adjudication is not described or implied for the non-clinical and technical testing presented for substantial equivalence.

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 NuFACE FIX Device is a direct-to-consumer cosmetic device, not an AI-assisted diagnostic or therapeutic tool that would involve "human readers" or "AI assistance" in the clinical decision-making process. Therefore, an MRMC comparative effectiveness study involving AI assistance was not performed.

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

This refers to an "algorithm-only" performance, which is not applicable here as the device is a physical, microcurrent stimulation device for cosmetic use, not a software algorithm. The device does have software (as confirmed by IEC 62304 compliance), but it's embedded control software, not a standalone AI algorithm with a distinct performance metric for a specific clinical task.

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

The "ground truth" for demonstrating substantial equivalence and safety/performance in this context is predominantly:

• Engineering Specifications and Measurements: The measured electrical output values (voltage, current, pulse width, frequency) are compared directly against the specified values and the predicate device's values.
• Compliance with Recognized Standards: The successful completion of tests required by established international and national safety and performance standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60529). These standards themselves define what constitutes acceptable performance and safety.
• Predicate Device Comparison: The "ground truth" for the equivalence claim is the established safety and effectiveness profile of the legally marketed predicate device (NuFACE Trinity ELE, K131251). The new device is deemed safe and effective if its differences from the predicate device do not raise new questions of safety or effectiveness.

8. The sample size for the training set

Not applicable. As this device is not an AI/ML algorithm requiring a training set, this concept does not apply.

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

Not applicable, as no training set for an AI/ML algorithm was used.

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The NuFACE Trinity is intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use.

The NuFACE Trinity Device(proposed) is intended for facial and neck skin stimulation and is indicated for over-the-counter cosmetic use. It is identical to that of its NuFACE Plus (predicate) and its technological characteristics remain unchanged. It produces microcurrent discharged through the two spherical probes.

Here's an analysis of the provided text regarding the acceptance criteria and study for the NuFACE Trinity Device:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary for the NuFACE Trinity Device does not present typical "acceptance criteria" in the sense of performance metrics with specific thresholds (e.g., sensitivity > X%, specificity > Y%). Instead, it establishes substantial equivalence to a predicate device (NuFACE Plus). The primary "acceptance criteria" appear to be that the proposed device (NuFACE Trinity) is identical in technological characteristics and performance standards to the predicate device, with an expanded intended use to include the neck.

The table presented is a "Substantial Equivalence Comparison Table" which compares the proposed NuFACE Trinity Device to its predicate, the NuFACE Plus. The performance is "reported" by asserting that the devices are critically similar or identical in most technical specifications.

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

The document states: "Literature provided and usability studies conducted demonstrate that the device is substantially equivalent to the predicate given the new indications." This implies that some form of usability study was performed for the new indications (neck stimulation). However, the document does not specify the sample size for any test set, nor does it provide details on the data provenance (e.g., country of origin, retrospective or prospective nature). The primary reliance is on the device being identical to the predicate from a technical standpoint.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention any experts being used to establish ground truth for a test set in the traditional sense of clinical performance evaluation. The "ground truth" for substantial equivalence rests on the comparison of specifications and the assumption that the predicate device (NuFACE Plus) already established its safety and effectiveness.

4. Adjudication Method

There is no mention of an adjudication method for a test set. This type of method is typically used in studies where human readers evaluate cases and their discrepancies are resolved. Since this submission relies on substantial equivalence through technical and functional identicality, such a method does not apply here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done as described. The submission focuses on substantial equivalence of a new device (NuFACE Trinity) to an existing one (NuFACE Plus), not on improving human reader performance with AI assistance. The device itself is an electrical stimulator, not an AI-powered diagnostic tool.

6. Standalone Performance Study

A standalone performance study (algorithm only performance without human-in-the-loop) was not explicitly done or reported in the traditional sense. The "performance" assessment focuses on the identical nature of the NuFACE Trinity to the NuFACE Plus in terms of electrical output, safety, and EMC. The non-clinical testing for electrical safety, EMC, and biocompatibility, as well as the usability studies, implicitly serve as a standalone performance assessment to demonstrate that the expanded use (neck) is safe and effective when delivered by an identical device.

7. Type of Ground Truth Used

The "ground truth" in this context is the established safety and effectiveness of the predicate device (NuFACE Plus), as accepted by the FDA when it was cleared (K103472). The submission's argument for the NuFACE Trinity is that its identical technological characteristics and performance standards mean it also meets those same safety and effectiveness criteria, even with the expanded anatomical site (neck), which was further supported by usability studies.

8. Sample Size for the Training Set

The document does not mention a training set sample size. This is because the device is not an AI/machine learning device that requires a training set for model development. The approval pathway is an equivalence pathway, not one that requires de novo clinical validation with training and test sets for an algorithm.

9. How Ground Truth for the Training Set Was Established

As there is no training set for an AI/ML algorithm for this device, there is no ground truth established for a training set. The entire premise is based on the previously cleared predicate device.

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NuBODY Skin Toning Device is intended for body skin stimulation and is indicated for over-the-counter cosmetic use.

NuBODY Skin Toning Device is intended for body skin stimulation and is indicated for over-the-counter cosmetic use. Four (4) spherical electrodes, fixed on the NuBODY device main body, deliver low level electrical impulses (microcurrent) to targeted locations on the body.

This document describes a 510(k) premarket notification for the NuBODY Skin Toning Device, claiming substantial equivalence to the NuFACE Plus device. As such, the study focuses on characterizing the new device's technical specifications and safety standards rather than a clinical efficacy trial.

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

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

The document does not explicitly state "acceptance criteria" in a separate section. Instead, the performance is demonstrated by comparing the new device (NuBODY) to a legally marketed predicate device (NuFACE Plus) based on their technological characteristics, basic unit characteristics, and output specifications. The assertion is that NuBODY meets the predicate's performance by being "the same, or similar," and that "differences do not alter the clinical utility."

Therefore, the "acceptance criteria" are implied to be that the NuBODY device should have comparable performance characteristics and meet the same safety standards as the NuFACE Plus predicate device.

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The NuFACE Gel Primer is intended to be used with NuFACE microcurrent devices to improve skin conductivity.

The NuFACE Gel Primer is a clear, viscous and chloride-free formulation. The gel is to be applied to the area under an electrode to reduce the impedance of the contact interface between the electrode surface and the skin.

The provided text is a 510(k) summary for the NuFACE Gel Primer, a medical device. This type of document is a premarket submission made to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. While it contains information about testing and compliance, it does not describe a study that uses human experts to establish ground truth or compare AI performance, as typically found in studies for AI/ML-based medical devices.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this document.

However, I can extract information related to the device's acceptance criteria and the performed performance testing.

Acceptance Criteria and Reported Device Performance

Study Details (based on available information):

• Sample sized used for the test set and the data provenance: Not applicable. The document discusses device characteristics and performance testing internally, not on a "test set" of patient data for AI evaluation.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI algorithm is not relevant for this device.
• Adjudication method for the test set: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This is not an AI/ML device, so such a study is not relevant.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML algorithm.
• The type of ground truth used: For the physical, chemical, and biological characteristics, the "ground truth" or reference is established specifications and industry standards. For biocompatibility, the ground truth is compliance with ISO 10993 standards and negative results for cytotoxicity, irritation, and sensitization. These are not 'ground truth' in the context of an AI study (e.g., pathology report, clinical outcome).
• The sample size for the training set: Not applicable. This device does not involve a training set as it is not an AI/ML product.
• How the ground truth for the training set was established: Not applicable.

Summary of the device proving it meets the acceptance criteria:

The NuFACE Gel Primer's acceptance criteria are primarily based on its physical, chemical, and biological characteristics, its performance in improving skin conductivity, and its biocompatibility. The study that proves the device meets these criteria involved a series of performance tests:

1. Physical, chemical and biological characteristics: The gel was tested for color, odor, appearance, pH, microbiological growth, specific gravity, and viscosity. The document states that "The test results demonstrate that the NuFACE Gel Primer meets the established specifications."
2. Conductivity: The gel's ability to improve skin conductivity was tested. "The test results demonstrate that the NuFACE Gel Primer meets the established specifications."
3. Biocompatibility: This was a critical aspect, evaluated according to ISO 10993-1. Specific tests included:
   • In vitro Cytotoxicity: ISO 10993-5
   • Skin Sensitization: ISO 10993-10
   • Skin Irritation: ISO 10993-10
     All biocompatibility testing was performed in accordance with CFR 21 Part 58 Good Laboratory Practice (GLP) and "The test results demonstrate the NuFACE Gel Primer is biocompatible when used as intended."
4. Packaging compatibility: Tested to ensure the gel remains stable and effective within its packaging. "The test results demonstrate that the NuFACE Gel Primer meets the established specifications."
5. Stability: Tested to confirm the product's integrity and performance over time. "The test results demonstrate that the NuFACE Gel Primer meets the established specifications."

The conclusion explicitly states: "Based on the results of the performance tests and the biocompatibility evaluation, NuFACE Gel Primer is substantially equivalent to the predicate device in safety." This indicates that meeting these established specifications and demonstrating biocompatibility are the primary means by which the device proves it meets its acceptance criteria for safety and effectiveness, especially in comparison to its predicate device.

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The NuFACE® Mini Device is intended for facial stimulation and is indicated for overthe-counter cosmetic use. (21 CFR 801 Subpart C).

The NuFACE® Mini Device is a non-invasive at home, over-the-counter facial toning device. The dual spheres of the NuFACE® Mini Device are designed for optimal contact with the face and are identical in size to the predicate device. The NuFACE® Mini Device is extremely responsive as it delivers soft wave micro-current in the millionths of an ampere and has the ability to increase facial contour and firm the skin and muscles.

The NuFACE® Mini device measures 2.5" W x 4.2" L x 1.2" D. Its outer case is injection molded of thermoplastic resin. The device comes with an external Power Supply to charge the internal batteries of the device when not in use. The external Power Supply provides DC power from a pre-approved wall adapter. All charging circuitry is contained within the device itself. The microcurrent output is disabled when the device is connected to the external Power Supply.

An ascending sequence of beeps informs the customer the NuFACE® Mini is ready for use. When the user turns the device OFF, a descending tone is emitted. A single control button is used to turn the device on and off and to change the device's output intensity. A long press of the control button toggles the device between on and off.

To promote proper use, a single audio beep informs the user to relocate the device to treat a new location on the skin. The user can also adjust the output intensity by briefly pressing the control button to step between multiple micro-current output level selections. When the device is set to the maximum output and the control button is pressed, the device sequences to the minimum output.

The NuFACE® Mini Device's acceptance criteria and the study proving it meets these criteria are described below.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the NuFACE® Mini Device are based on demonstrating substantial equivalence to its predicate device, the NuFACE® Trinity device (cleared as NuFACE® Plus, K103472). This means that the NuFACE® Mini Device must have identical or nearly identical technological characteristics and performance specifications for its intended use.

Here's a comparison table summarizing the core electrical output specifications which form the primary acceptance criteria for demonstrating functional equivalence:

Note on "Identical" Claims vs. Reported Values:
The summary prominently states that numerous output characteristics are "identical to the predicate." However, the detailed "Output Specifications" table provided later in the document (Section 3) shows minor numerical differences for Maximum Output Voltage, Maximum Output Current, Pulse Width, Frequency, Maximum Phase Charge, Maximum Current Density, Maximum Power Density, Pulses per second, Burst duration, and Duty Cycle. Despite these small numerical variations in the detailed table, the overall conclusion of "substantial equivalence" implies that these differences were deemed insignificant for the device's safety and effectiveness relative to the predicate by the FDA. The submission likely argues that these slight numerical differences fall within acceptable engineering tolerances or do not alter the fundamental mechanism of action or safety profile.

Additional acceptance criteria based on compliance standards are:

• Compliance with FDA's performance Standards set forth in 21 CFR §898.
• Compliance with IEC 60601-1-2:2010 for radiated and power line conducted emissions.
• Compliance with IEC 60601-1:2005 (3rd edition) for Electrical Safety.

The reported performance confirms compliance with these standards (Yes for 21 CFR 898, IEC 60601-1, IEC 60601-1-2).

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

The study to prove the device meets acceptance criteria was based on non-clinical performance assessment. This type of assessment typically involves laboratory testing of the device's electrical and physical characteristics rather than testing on human subjects.

• No specific "test set" in the sense of patient data is mentioned.
• The provenance is laboratory testing of the device itself. Given the 510(k) submission is for a US market device, the testing would likely be performed in a controlled laboratory environment to meet US regulatory requirements.
• This was a non-clinical evaluation, not a clinical study with a test set of human subjects.

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

• This information is not applicable as the study was a non-clinical performance assessment focusing on device specifications and compliance with standards, not on clinical outcomes requiring expert consensus or ground truth from patient data.
• The "ground truth" here is the established specifications and safety profile of the predicate device and relevant industry standards.

4. Adjudication Method for the Test Set

• Not applicable, as there was no test set of patient cases requiring adjudication. The assessment was based on direct measurement and comparison of device specifications.

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. The submission relies on demonstrating substantial equivalence through comparison of technical specifications and safety standards, not through a clinical evaluation involving human readers or assessment of improved human performance with AI assistance. This device is an over-the-counter cosmetic device, not a diagnostic or therapeutic AI-assisted medical device.

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

• Not applicable. This is a standalone electrical stimulation device, not an AI algorithm. The device performance was assessed in a standalone capacity (i.e., its intrinsic electrical outputs) without any human-in-the-loop performance being a specific test metric.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical performance assessment was based on:

• Predicate Device Specifications: The established electrical output and technological characteristics of the NuFACE® Trinity device (NuFACE® Plus), which was previously cleared.
• Industry and Regulatory Standards: Compliance with relevant electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and FDA performance standards (21 CFR §898).

8. The Sample Size for the Training Set

• Not applicable. This device is an electrical stimulation device, not an AI or machine learning model that requires a training set.

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

• Not applicable. There was no training set for this device.

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