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510(k) Data Aggregation
(119 days)
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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(199 days)
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 (<24h) duration contact. Specific performance metrics are not given, only the conclusion of biocompatibility.
- Safety, Performance and Bench Testing (Optical Safety, Electrical Safety, EMC, Wireless Coexistence): The conclusion is that the device "meets and complies with the safety and performance of the applicable standards and bench testing requirements." No specific quantitative results or acceptance thresholds are provided in this summary.
- Software Verification and Validation: Concluded that the device "meets and complies with the applicable software requirements specifications." No detailed performance metrics are given.
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: No information on a "test set" in the context of clinical performance is provided because no clinical testing was performed or deemed necessary to support substantial equivalence.
- Data Provenance: Not applicable as no clinical data for performance assessment (wrinkle reduction/circulation increase) was collected for this submission. The non-clinical testing data provenance is not specified (e.g., in-house labs, certified external labs).
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. No clinical test set with human "ground truth" establishment was performed or reported for this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical 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 direct-to-consumer medical device for wrinkle reduction and local circulation increase, not an AI-assisted diagnostic or interpretative system that would involve human "readers" or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not relevant to the device described. The device is a physical light therapy device, not an algorithm. Its performance is measured by its physical output and safety, and by comparing its technological characteristics to a predicate device, not by an algorithm's classification performance.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable for clinical performance. For the non-clinical tests (biocompatibility, electrical/optical safety, EMC, software), the "ground truth" is adherence to established industry standards and internal design specifications.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
Summary of Device Performance and 510(k) Claims:
The 510(k) submission for the Trinity Plus Wrinkle Reducer relies on demonstrating substantial equivalence to existing predicate devices (NuFACE® Trinity Wrinkle Remover K120560 and reVive Perioral LED Light Therapy System K172662). This regulatory pathway often does not require new clinical studies if the technological characteristics and indications for use are similar to a predicate device that has already established its safety and effectiveness.
The "study that proves the device meets the acceptance criteria" in this context is the compilation of non-clinical performance data and the comparison to predicate devices:
- Biocompatibility Evaluation: Concluded the materials are biocompatible based on industry standards and prior use in other FDA-cleared devices.
- Safety, Performance and Bench Testing (Optical Safety, Electrical Safety, EMC, Wireless Coexistence): Concluded compliance with applicable standards.
- Software Verification and Validation: Concluded compliance with software requirements.
The core argument for acceptance is presented in Section 8, "Overall Conclusion":
"The documentation and test results provided in this submission and comparison of intended use, principle of operation, performance data, design and the overall technological characteristics, demonstrate that the NuFACE® Trinity Plus Wrinkle Reducer device is substantially equivalent to the predicate device."
Therefore, the "acceptance criteria" here relate to meeting the necessary non-clinical standards and successfully demonstrating equivalence to a predicate, rather than achieving specific performance thresholds in a de novo clinical trial.
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(230 days)
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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(206 days)
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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(113 days)
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.
| Characteristic | Acceptance Criteria (Predicate: NuFACE Trinity) | Reported Device Performance (NuFACE Mini) | Met/Comparable |
|---|---|---|---|
| Regulatory | |||
| Regulation Number | 21 C.F.R. § 882.5890 | 21 C.F.R. § 882.5890 | Met (Same) |
| Regulation Name | Transcutaneous electrical nerve stimulator for pain relief | Transcutaneous electrical nerve stimulator for pain relief | Met (Same) |
| Regulatory Class | Class II | Class II | Met (Same) |
| Product Code | NFO | NFO | Met (Same) |
| Intended Use | Facial and neck stimulation for over-the-counter cosmetic use | Facial and neck stimulation for over-the-counter cosmetic use | Met (Same) |
| Indications for Use | Over-the-Counter Cosmetic Use | Over-the-Counter Cosmetic Use | Met (Same) |
| Anatomic Sites | Face and Neck | Face and Neck | Met (Same) |
| Technological Characteristics | |||
| Form Factor (General) | Handheld, dual spherical electrodes, microcurrent | Handheld, dual spherical electrodes, microcurrent | Comparable (Same general design principles) |
| Waveform | Pulsed Biphasic | Pulsed Biphasic | Met (Same) |
| Shape | Modulated Square | Modulated Square | Met (Same) |
| Max Output Voltage | 28 VDC | 28 VDC | Met (Same) |
| Max Output Current | $400 \mu A$ at 500 Ω | $348 \mu A$ at 500 Ω | Comparable (Slightly lower, but within expected range for similar devices/intended use, and not clinically significant for this type of equivalence claim) |
| Max Output Current Density | 0.419 mA/cm² | 0.452 mA/cm² | Comparable (Slightly higher, but within expected range for similar devices/intended use, and not clinically significant for this type of equivalence claim) |
| Output Current (not stimulating) | < 1 μΑ | < 1 μΑ | Met (Same) |
| Output Tolerance | +/- 10% | +/- 5% | Met (Improved) |
| Pulse Width | 60 msec | 60 msec | Met (Same) |
| Frequency (Hz) | Approximately 8.3 Hz | Approximately 8.3 Hz | Met (Same) |
| Beat Frequency | No Beat Frequency | No Beat Frequency | Met (Same) |
| Burst Mode - Pulses per burst | 20 | 20 | Met (Same) |
| Burst Mode - Pulses per second | 8.3 | 8.3 | Met (Same) |
| Burst Mode - Burst duration | 2.4 s | 2.4 s | Met (Same) |
| Burst Mode - Duty Cycle | 50% | 50% | Met (Same) |
| ON Time | 60 msec | 60 msec | Met (Same) |
| OFF Time | 60 msec | 60 msec | Met (Same) |
| Power Source | Internal rechargeable Lithium ion battery | Internal rechargeable Lithium ion battery | Met (Same) |
| Line Current Isolation | Type BF | Type BF | Met (Same) |
| Patient Leakage Current | N/A - Battery operated | N/A - Battery operated | Met (Same) |
| External Power Adapter | NuFACE 7-volt power adapter | NuFACE 5-volt power adapter | Comparable (Different voltage, but functionality and safety verified through standards compliance) |
| Number of Output Channels | 1 | 1 | Met (Same) |
| Regulated Current or Voltage | Both | Both | Met (Same) |
| Software/Firmware/Microprocessor | Yes | Yes | Met (Same) |
| Automatic Overload Trip | Not required due to circuit design | Not required due to circuit design | Met (Same) |
| Automatic No-Load Trip | Yes | Yes | Met (Same) |
| Automatic Shut Off | Yes (20 minutes) | Yes (5 minutes) | Comparable (Difference in timing, but both include shut-off for safety/usage. Not a critical difference for equivalence) |
| Patient Override Control | Yes | Yes | Met (Same) |
| Indicator Display | On/Off, Low Battery, Voltage/Current Level | On/Off, Low Battery, Voltage/Current Level | Met (Same) |
| Compliance with Voluntary Standards | IEC 60601-1, IEC 60601-1-2 | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-11 | Met (Same, with additional relevant standards cited for the proposed device) |
| Compliance with 21 CFR 898 | Yes | Yes | Met (Same) |
| Weight | 9 oz. without charging base | 6 oz. | Comparable (Different, but lighter weight for a 'mini' version is expected and not adverse to safety/effectiveness for intended use) |
| Dimensions | 2.8" x 5.1" x 1.3" | 2.5" x 4.2" x 1.2" | Comparable (Different, 'mini' implies smaller, not adverse) |
| Housing Materials | Thermoplastic | Thermoplastic | Met (Same) |
| Biocompatibility | User contacting materials tested and shown biocompatible | User contacting materials identical to predicate, previously tested and shown biocompatible | Met (Same) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document does not describe a clinical "test set" in the context of efficacy or clinical performance. The comparison provided is a technical comparison to a predicate device. Performance testing was conducted for safety and EMC standards compliance, but details on sample size for these engineering tests are not provided and typically not part of the 510(k) summary for such devices. There is no information on data provenance related to clinical outcomes.
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. No "ground truth" establishment by medical experts is described, as this is a technical equivalence review against a predicate device and relevant safety standards, not a clinical efficacy study requiring interpretation of outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication method is described as there is no clinical test set requiring expert consensus.
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 transcutaneous electrical nerve stimulator for cosmetic use (facial and neck toning), not an AI-powered diagnostic or interpretive device. Therefore, MRMC studies and AI assistance comparisons are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a hardware product for direct user application, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this submission is effectively the established safety and performance characteristics of the legally marketed predicate device (NuFACE Trinity) and compliance with recognized safety and EMC standards. The proposed device is demonstrating that its technical specifications and safety parameters are either identical or acceptably similar and safe compared to the predicate.
8. The sample size for the training set
Not applicable. This document does not describe a machine learning or AI algorithm that would require a training set.
9. How the ground truth for the training set was established
Not applicable.
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(103 days)
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.
| Category | Acceptance Criteria (Based on Predicate Device K131251) | Reported Device Performance (NuFACE FIX) | Justification / (Same/Different) |
|---|---|---|---|
| Intended Use | Intended for facial stimulation and indicated for over-the-counter cosmetic use. | Intended for facial stimulation and indicated for over-the-counter cosmetic use. | Same |
| Indications for Use | Over-the-Counter Cosmetic Use | Over-the-Counter Cosmetic Use | Same |
| Regulation Number | 21 C.F.R. § 882.5890 (Transcutaneous electrical nerve stimulator for pain relief) | 21 C.F.R. § 882.5890 (Transcutaneous electrical nerve stimulator for pain relief) | Same |
| Regulatory Class | Class II | Class II | Same |
| Product Code | NFO | NFO | Same |
| Waveform | Pulsed Biphasic | Pulsed Biphasic | Same |
| Shape | Modulated Square | Modulated Square | Same |
| Maximum Output Voltage | 28 VDC | 28 VDC | Same |
| Maximum Output Current | 208 μΑ @ 500Ω | 200 μΑ @ 500Ω | Same (within acceptable limits) |
| Maximum Output Current Density | 0.800 μΑ/cm² | 0.418 μΑ/cm² | Same (though value is lower, it's considered within safe/effective range for equivalence) |
| Output Tolerance | +/- 10% | +/- 10% | Same |
| Pulse Width | 60 ms | 60 ms | Same |
| Frequency (Hz) | Approximately 8.3 Hz | Approximately 8.3 Hz | Same |
| Power Source | Internal rechargeable Lithium Ion battery | Internal rechargeable Lithium Ion battery | Same |
| External Power Adapter | NuFACE 7-volt power adapter | User supplied standard 5-volt USB port | Different (but considered equivalent in functionality) |
| Automatic Shut-Off | 20 minutes | 3 minutes | Different (justified as not impacting safety/effectiveness) |
| Weight | 9 oz. without charging base | Approximately 2 oz. | Different (justified as not impacting safety/effectiveness) |
| Dimensions | 2.8" x 5.1" x 1.3" | Approximately 5.7" x 0.82" | Different (justified as not impacting safety/effectiveness) |
| Housing Materials | Thermoplastic | Thermoplastic | Same |
| Safety Standards | Compliance with various IEC/ANSI/CAN/CSA standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 14971, IEC 62366, IEC 60601-1-11, IEC 62133, ANSI/AMI ES60601-1, CAN/CSA-C22.2 No. 60601-1, IEC 60529 (Ingress Protection), IEC 62304 (Software)) | Compliance with identical set of IEC/ANSI/CAN/CSA standards. (Specific testing performed and passed for electrical safety, EMC, usability engineering, battery testing, software V&V, ingress protection). | Same conformance |
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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(177 days)
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.
| Characteristic | Acceptance Criteria (based on Predicate) | Reported Device Performance (NuFACE Trinity) | Result/Comment |
|---|---|---|---|
| Intended Use | Facial stimulation for cosmetic use. | Facial and neck stimulation for cosmetic use. | Different (expanded to include neck), but deemed substantially equivalent. |
| Anatomic Sites | Face | Face and Neck | Different (expanded to include neck), but deemed substantially equivalent. |
| Technological Characteristics | Microcurrent, materials (injection molded thermoplastic resin, chrome-plated spheres), lithium-ion battery, biphasic square wave, 10 positive/10 negative pulses, alternating microcurrent, adjustable output, conductive gel requirement, 5-second usage cue. | Identical to predicate. | Same |
| Product Safety (IEC 60601-1) | Compliance with IEC 60601-1. | Compliance with IEC 60601-1. | Same (Based on non-clinical testing and assertion of identity to predicate). |
| EMC (IEC 60601-1-2) | Compliance with IEC 60601-1-2. | Compliance with IEC 60601-1-2. | Same (Based on non-clinical testing and assertion of identity to predicate). |
| FDA Performance Standards (21 CFR 898) | Compliance with 21 CFR 898. | Compliance with 21 CFR 898. | Same (Based on non-clinical testing and assertion of identity to predicate). |
| Power Source | Internal rechargeable Lithium ion battery. | Internal rechargeable Lithium ion battery. | Same |
| Output Waveform | Pulsed Biphasic, Modulated Square. | Pulsed Biphasic, Modulated Square. | Same |
| Maximum Output Voltage | 28 VDC. | 28 VDC. | Same |
| Maximum Output Current | 400 μA @ 500Ω. | 400 μA @ 500Ω. | Same |
| Maximum Output Current Density | 0.419 mA/cm². | 0.419 mA/cm². | Same |
| Pulse Width | 60 msec. | 60 msec. | Same |
| Frequency | Approximately 8.3 Hz. | Approximately 8.3 Hz. | Same |
| Other Output Specs (Burst Mode, ON/OFF Time, etc.) | Identical to those of the predicate. | Identical to predicate specifications. | Same (Specifically: Pulses per burst 20, Pulses per second 8.3, Burst duration 2.4s, Duty Cycle 20.2s, ON Time 60msec, OFF Time 60msec). |
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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(61 days)
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.
| Acceptance Criteria (Implied: Comparable to NuFACE Plus Predicate) | Reported NuBODY Device Performance |
|---|---|
| Technological Characteristics: | |
| - Power Source | Rechargeable, non-replaceable, lithium-ion battery (Same as predicate) |
| - Microcurrent Delivery | Four (4) smooth, chrome-plated, spherical electrodes (Predicate has two spheres, but both deliver microcurrent) |
| - Waveform | Continuous alternating microcurrent delivered in a burst of positive pulses followed by a burst of negative pulses (Same as predicate) |
| Basic Unit Characteristics: | |
| - Power Source | Internal rechargeable Lithium ion battery (Same as predicate) |
| - Method of Line Current Isolation | Type BF (Same as predicate) |
| - Patient Leakage Current | N/A - Battery operated (Same as predicate) |
| - Number of Output Channels | 1 (Same as predicate) |
| - Regulated Current or Voltage | Both (Same as predicate) |
| - Software/Firmware/Microprocessor Control | Yes (Same as predicate) |
| - Automatic Overload Trip | Not required due to circuit design (Same as predicate) |
| - Automatic No-Load Trip | Yes (Same as predicate) |
| - Automatic Shut Off | Yes (Same as predicate) |
| - Patient Override Control | Yes (Same as predicate) |
| - Indicator Display (On/Off, Low Battery, Voltage/Current Level) | All Yes (Same as predicate) |
| - Automatic Shut-Off (minutes) | Yes (5 minutes) (Predicate is 20 minutes; this difference is presented without an explicit "acceptance criterion" but is deemed not to alter clinical utility from the overall conclusion) |
| - Compliance with Voluntary Standards | IEC 60601-1, IEC 60601-1-2, IEC 60529, IEC 60601-2-10, ISO 14971, IEC 60601-1-6, IEC 62366 (More comprehensive than predicate which listed IEC 60601-1, IEC 60601-1-2, demonstrating compliance with relevant standards.) |
| - Compliance with 21 CFR 898 | Yes (Same as predicate) |
| - Housing Materials and Construction | Thermoplastic (Same as predicate) |
| Output Specifications: | |
| - Waveform (e.g., pulsed monophasic, biphasic) | Monophasic waveform that is delivered in a burst of pulses (Same as predicate) |
| - Shape (e.g., rectangular, spike, rectified sinusoidal) | Voltage Modulated Square (Same as predicate) |
| - Maximum Output Voltage | 28 VDC (Same as predicate) |
| - Output Current when not stimulating | < 1 µA (Same as predicate) |
| - Output Tolerance | +/- 10% (Same as predicate) |
| - Pulse Width | 60 ms (Same as predicate) |
| - Frequency (Hz) | Approximately 8.3 Hz (Same as predicate) |
| - For interferential modes | No Beat Frequency (Same as predicate) |
| - For multiphasic waveforms | Not Multiphasic (Same as predicate) |
| - Pulses per burst | 20 (Same as predicate) |
| - Pulses per second | 8.3 (Same as predicate) |
| - Burst duration (seconds) | 2.4 s (Same as predicate) |
| - Duty Cycle [Line (b) x Line (c)] (on time per burst) | 20.2 s (Same as predicate) |
| - ON Time (seconds) | 60 msec (Same as predicate) |
| - OFF Time (seconds) | 60 msec (Same as predicate) |
| Differences noted but deemed acceptable: | |
| - Anatomic Sites (Intended Use) | Body (NuBODY) vs. Face (NuFACE Plus) - This is the primary intended use difference for which equivalence is sought. |
| - Number of Electrodes | 4 Spheres (NuBODY) vs. 2 Spheres (NuFACE Plus) |
| - External Power Adapter | NuFACE 5-volt power adapter (NuBODY) vs. NuFACE 7-volt power adapter (NuFACE Plus) |
| - Maximum Output Current | 900 µA @ 500Ω (NuBODY) vs. 400 µA @ 500Ω (NuFACE Plus) |
| - Maximum Output Current Density | 0.468 mA/cm² (NuBODY) vs. 0.419 mA/cm² (NuFACE Plus) |
| - Net Charge (µC per pulse) | 54 µC (NuBODY) vs. 24 µC (NuFACE Plus) |
| - Maximum Average Power Density (mW/cm²) | 4.18 (NuBODY) vs. 1.12 (NuFACE Plus) |
| - Maximum Phase Charge (µC/Burst) | 1.08 (NuBODY) vs. 0.48 (NuFACE Plus) |
| - Automatic Shut-Off | 5 minutes (NuBODY) vs. 20 minutes (NuFACE Plus) |
| - Weight | Approximately 10-14 oz. (NuBODY) vs. 9 oz. (NuFACE Plus) |
| - Dimensions | Approximately 2.75" x 6.5" x 6.0" (NuBODY) vs. 2.8" x 5.1" x 1.3" (NuFACE Plus) |
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 describes bench testing for nonclinical performance and safety. It tests "a production equivalent of the NuBODY, and a commercial unit of the predicate."
- Sample Size for Test Set: One "production equivalent" NuBODY device and one "commercial unit" of the NuFACE Plus predicate device were used for the performance testing.
- Data Provenance: Not explicitly stated, but the testing would have been conducted by or for the manufacturer (Carol Cole Company/NuFACE) in the USA (Vista, CA is the address). This is non-clinical, prospective bench testing.
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)
This product is a microcurrent stimulator for cosmetic use, and the submission is a 510(k) based on substantial equivalence demonstrated through bench testing and compliance with recognized standards. There is no mention of clinical studies using human subjects or expert clinical panels to establish "ground truth" for the performance criteria in this document. The "ground truth" for this type of submission is typically derived from established engineering and safety standards and comparison to a predicate device's specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As described above, there was no clinical study involving human readers or assessment that would require an adjudication method. The evaluation was based on non-clinical bench testing against engineering specifications and predicate device characteristics.
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 transcutaneous electrical nerve stimulator for cosmetic purposes, not an AI-powered diagnostic device or a system designed to assist human readers. Therefore, an MRMC comparative effectiveness study or AI-related performance metrics are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical electronic device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this 510(k) submission is primarily the technical specifications and safety standards as defined by regulatory bodies (e.g., FDA regulations, IEC standards) and demonstrated by the performance of the predicate device (NuFACE Plus). The "study" (bench testing) aims to confirm that the new device's technical output and safety parameters are comparable and compliant.
8. The sample size for the training set
Not applicable. This device does not involve machine learning or AI, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set.
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