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The Avologi Gel Primer is intended to be used with Luminice device to improve skin conductivity.

The Avologi 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.

This document describes the Avologi Gel Primer (Model: Av25), an electroconductive gel intended for use with the Luminice device to improve skin conductivity. The submission demonstrates substantial equivalence to the predicate device, NuFACE Gel Primer (K161654), through performance testing.

1. Table of Acceptance Criteria and Reported Device Performance:

Notes from the document:

• Note 1: Differences in pH, viscosity, and packaging do not affect device performance, and packaging compatibility has been tested. Therefore, these differences do not raise issues of safety or effectiveness.
• Note 2: Although predicate impedance and shelf life are not publicly available, the proposed device underwent 3 years of real-time stability testing and impedance testing. The impedance (154 Ω ± 10%) is acceptable, even if different from other reference devices, and does not raise issues of safety or effectiveness.
• Note 3: Conductivity is similar to the predicate and higher (more conductive) than some cleared devices, thus not raising safety or effectiveness issues.
• Note 4: Both the proposed device and predicate conducted microbiological growth tests (per USP61/62) and biocompatibility tests, indicating no adverse reactions.

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

The document describes non-clinical testing for the Avologi Gel Primer but does not specify a "test set" in the context of a clinical study or expert review for a diagnostic algorithm. The tests performed are laboratory-based and relate to the physical, chemical, and biological properties of the gel.

• Biocompatibility Testing:
  • In vitro Cytotoxicity Test: Used L929 cells. (Details on sample size of cells not provided, but standard for in vitro assays).
  • Intracutaneous Reactivity Test: Performed in a rabbit model. (Specific number of rabbits not provided, but "a rabbit" implies at least one).
  • Skin Sensitization Test: Performed in a guinea pig model. (Specific number of guinea pigs not provided, but "the guinea pig" implies at least one).
• Shelf-life testing: Real-time stability testing for 3 years. (Details on number of samples or batches tested not provided).
• Physical property testing: Includes microbiological growth, packaging compatibility, conductivity, and stability testing. (Details on specific sample sizes for these tests are not provided).

Data Provenance: The tests are described as non-clinical testing, implying they were conducted in a laboratory setting by the manufacturer or a contracted lab. The document does not specify the country of origin for these tests. It is retrospective in nature, summarizing completed tests.

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

This information is not applicable (N/A) as the submission is for an electroconductive gel and its substantial equivalence and does not involve an AI device requiring expert-established ground truth for a diagnostic test set. The "ground truth" here is established through scientific laboratory testing results against established standards (e.g., ISO, USP).

4. Adjudication method for the test set:

This information is not applicable (N/A) for the same reasons as above. No expert adjudication method (like 2+1, 3+1) was used as there's no diagnostic output from an AI algorithm being evaluated.

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:

This information is not applicable (N/A). The device is an electroconductive gel, not an AI-powered diagnostic tool. Therefore, no MRMC study or evaluation of human reader improvement with AI assistance was conducted.

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

This information is not applicable (N/A). The device is a physical product (gel), not an algorithm or AI system.

7. The type of ground truth used:

The ground truth for the performance of the Avologi Gel Primer is established through objective laboratory testing against recognized standards (e.g., ISO 10993 standards for biocompatibility, USP 61/62 for microbiological growth, and internal specifications for physical properties like pH, viscosity, impedance, and conductivity). The comparison is primarily against the predicate device's characteristics and general requirements for electroconductive media.

8. The sample size for the training set:

This information is not applicable (N/A). The device is a physical product and does not involve AI model training.

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

This information is not applicable (N/A) for the same reasons as above.

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To be used for temporary relief of pain associated with sore and aching muscles in the back of neck, due to strain from exercise or normal household and work activities.

• Neck Pad is used in back of neck.

The subject device is intended to use on back of neck and it designed accord with human body cervical physiological curvature of streamlined ring design. It is a body-worn and home-use device. It uses low-frequency electronic therapy and designed to temporary relief of pain associated with sore and aching muscles in the back of neck. It only has one model: ST-304.
The trade name of the subject device is Transcutaneous electrical nerve stimulator.
The Transcutaneous electrical nerve stimulator (model: ST-304) consists of a main unit and Type C-USB charging cable. The main unit consists of shell, lithium battery (only 1pcs), neck electrodes pads (a pair of fixed neck electrodes pads), lower shell connector and control buttons and silicone pads. There are two fixed neck electrodes pads on the main unit. The material of neck electrodes pads is titanium material (Gr.2). There are only 1 pcs lithium battery in-build in main unit. The model of lithium battery is KRL 103040.
The neck electrodes pads (a pair of fixed neck electrodes pads) are a kind of Titanium material, and the detail content as following description and as the classify of ASTM F67 2017 it is under Gr2.
The Transcutaneous electrical nerve stimulator (model: ST-304) power supply is 3.7V DC using built-in lithium battery(1200mAh). The built-in lithium battery can be recharged. But the power adapter (Input: 100-240V~, 50/60Hz,0.7A, Output: 5V== 1000mA) is not the parts of the subject device so it shall be supplied by the user. There are two fixed neck electrodes pads on the main unit. The material of neck electrodes pads is Titanium material (Gr.2).
The Transcutaneous electrical nerve stimulator (model: ST-304) totally has 3 modes. The stimulation has 2 modes for stimulating and 15 output Intensity Levels for each mode, so the device can give certain electrical pulse through the neck electrodes pads on the intact skin of back neck to help users to temporary relief of pain. The heating only has 1 mode for heating and it can also provide a constant temperature of 32℃ to 38℃ to provide a warming sensation. The stimulation function and heating function can be used separately or simultaneously. The neck electrodes pads provide users with back of neck stimulation and heat to warm and comfort the muscles of the back of neck.
The main unit provides access to adjust the intensity up or down and adjust stimulating mode, put ON/OFF the main unit and heating function.
The Intensity level of electrical stimulation and heating function are easily controlled by the end user using manual, push-button controls. The push-button controls are consisted of four button which are Switch on/off button/mode switch button, heating button, Intensity increase button and Intensity decrease button.
The default stimulation time is 10 minutes, and the user cannot adjust but could turn off the device during working condition.
Transcutaneous electrical nerve stimulator (model: ST-304) has 2 types stimulation modes: Mode 1, Mode 2.
Before use the device to wipe the Electro Therapy Conductive Gel on the Neck Electrode Pads. But the Electro Therapy Conductive Gel is not the part of subject device so it shall be supplied by the user.
Principle of operation:
The Transcutaneous electrical nerve stimulator (model: ST-304) sends low-voltage electrical pulses to specific nerves via two fixed neck electrodes pads applied on the intact skin of back of neck and powered by rechargeable lithium battery. The purpose is to temporarily relieve pain. By adjusting the output voltage and frequency to produce the low-voltage electrical pulses and achieve the effect of electrotherapy. Voltage regulation is realized by the Boost Converter circuit, which controls the voltage amplitude by modifying the PWM control circuit. After that, the voltage is released to the electrode through the analog circuit, and the time change of the output voltage is controlled by modifying the PWM frequency to achieve the specific electrotherapy effect.

The provided text is a 510(k) summary for a Transcutaneous Electrical Nerve Stimulator (TENS) device. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study.

Therefore, the document does not contain the information requested regarding:

• Acceptance criteria in the context of a clinical study or specific performance metrics for the device's intended use.
• A study that proves the device meets acceptance criteria. No clinical performance study is described.
• Sample size for test sets or training sets.
• Data provenance (country of origin, retrospective/prospective).
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
• Standalone algorithm performance.
• Type of ground truth used.
• How ground truth for the training set was established.

Instead, the document details non-clinical testing performed to demonstrate that the device is as safe and effective as its predicate devices, based on compliance with recognized consensus standards.

However, I can extract information related to the device's technical specifications and how they compare to predicate devices, which implicitly serves as the "acceptance criteria" and "device performance" for the substantial equivalence claim.

1. Table of Acceptance Criteria (Implicit for Substantial Equivalence) and Reported Device Performance:

The "acceptance criteria" for this 510(k) submission are implicitly defined by the technical specifications of the predicate devices. The "reported device performance" refers to the subject device's technical specifications. The discussion of differences (D1-D17) explains why these differences do not raise new questions of safety or effectiveness.

Since this is a 510(k) submission, the device's acceptance is based on demonstrating "substantial equivalence" to predicate devices, primarily through non-clinical testing and comparison of technical characteristics, not through clinical trials demonstrating specific performance criteria against a disease outcome.

Summary of Missing Information (as per your request, not present in the document):

2. Sample size for the test set and the data provenance: Not applicable, as no clinical test set is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
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 is not an AI/imaging diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no clinical ground truth is established for efficacy.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The "study that proves the device meets the acceptance criteria" in this context refers to the non-clinical testing for electrical safety, EMC, biocompatibility, and software verification, as listed in Section 7. This testing demonstrates that despite minor technical differences, the device is as safe and effective as the predicate devices for its intended use.

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