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The Avazzia OTC TENS for aesthetics, model BEST-AV1™: EZZI-LIFT™ Device is indicated for over-the-counter aesthetic use including facial and neck stimulation or body skin stimulation.

Candidate device is a handheld, AA battery-operated portable device for use in the home or clinic. It has pre-set modes and is for over-the-counter use in the home or a clinical setting. The candidate device uses transcutaneous electrical stimulation (TENS) for aesthetic use for facial, neck, and body stimulation. The EZZI-LIFT device has built-in electrodes. Accessories, listed below, are also available to be used with the device.

The Avazzia OTC TENS for Aesthetics, model BEST-AV1: EZZI-LIFT Device did not have a clinical study that proves the device meets acceptance criteria for a specific clinical outcome. Instead, the device's substantial equivalence was established through non-clinical bench testing, performance testing, and a comparison of its technical characteristics to predicate devices.

Here's the breakdown based on the provided text:

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

The document does not present a formal "acceptance criteria" table with specific quantitative thresholds for clinical performance. Instead, it demonstrates substantial equivalence by comparing the technical specifications of the candidate device (EZZI-LIFT) to its predicate devices (NuFACE Trinity and NuBODY Skin Toning Device) and by confirming compliance with relevant safety standards.

The comparison table provided in the document highlights the following characteristics:

The acceptance criterion, though not explicitly stated as a pass/fail threshold, is implied to be that the device's technical characteristics, particularly regarding stimulation output and safety features, fall within the range of equivalence to predicate devices and comply with accepted safety standards (e.g., ANSI/AAMI NS4:2013/(R)2017). The document explicitly states: "The candidate devices fall within the same range of equivalence for performance and energy output for meeting the ANSI/AAMI NS4:2013/(R)2017 standard requirements for safety; and therefore, they do not raise new questions of safety."

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 primarily describes non-clinical bench testing and usability studies, not traditional clinical trials with patient test sets. Therefore, terms like "sample size for the test set" (in a clinical context) and "data provenance" (country of origin, retrospective/prospective) are not directly applicable.

• Test Set (Non-clinical): The "test set" for performance testing consisted of "a production equivalent of the candidate device." The specific number of devices tested is not mentioned.
• Usability Study: A usability study was performed, but the number of participants or their demographics are not provided.

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 information is not applicable as the clearance was based on substantial equivalence to predicate devices and non-clinical testing, rather than a study requiring expert consensus on clinical ground truth.

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

This information is not applicable as the clearance was based on non-clinical testing and comparison to predicate devices, which do not involve adjudication by multiple experts on a clinical test set.

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

There was no MRMC comparative effectiveness study done. This device is a Transcutaneous Electrical Nerve Stimulator (TENS) for aesthetic use, not an AI-assisted diagnostic or imaging device that would typically involve human readers or MRMC studies.

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

This information is not applicable as the device is not an algorithm or AI-based system. It's a hardware device (TENS stimulator). Its "standalone performance" refers to its electrical output, safety, and functionality as evaluated in non-clinical bench tests.

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

For this type of device and submission, the "ground truth" is primarily established by compliance with recognized electrical and medical device safety standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 14971, IEC 62366, ANSI/AAMI NS4:2013/(R)2017) and the established safety and effectiveness of the legally marketed predicate devices for their intended uses. The document states that "The Avazzia device technological specifications are similar; therefore, they do not pose new questions regarding safety and effectiveness." The usability study also confirmed that the device and instructions "met requirements for usability factors for over-the-counter use."

8. The sample size for the training set

This information is not applicable as the device is a hardware TENS stimulator and does not involve AI/machine learning models with training sets.

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

This information is not applicable as there is no training set for this device.

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Transcutaneous Electrical Nerve Stimulation (TENS) for the temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back of the neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.

Avazzia OTC TENS electronic pulse massage devices are electrically powered device intended for overthe-counter use and used to apply a microcurrent electrical pulses to electrodes on a user's skin to relieve pain. They are easy-to-use, handheld, AA battery-operated portable devices for use in the home or clinic. The candidate devices have pre-set modes. The devices are portable, battery operated microcurrent electrical stimulation device that applies charge and power to the tissue through electrodes where maximum power delivered to the load is controlled and limited, and an automatic shut off is implemented. The user can apply the built-in onboard electrodes or place self-adhesive conductive electrodes where indicated and apply stimulation for a period of time. The user controls the output by selecting the mode and power setting.

This document is a 510(k) premarket notification for the Avazzia OTC TENS Model Best-AV1™ family of devices. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a full clinical trial with acceptance criteria for device performance. Therefore, directly answering all your questions about acceptance criteria and a study proving the device meets them, in the typical sense of a diagnostic or therapeutic study, is not applicable to this document.

However, I can extract the information related to safety and performance from the perspective of substantial equivalence.

Here's an analysis based on the provided document:

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

Since this is a 510(k) submission for a TENS device, the "acceptance criteria" are primarily established by demonstrating that the new device (candidate) has similar technological characteristics and performance specifications to a predicate device that has already been cleared by the FDA, and that it does not raise new questions of safety or effectiveness. The reported device performance is presented as a comparison to the predicate.

Study Proving Acceptance Criteria:

The document states: "Verification and validation tests as well as certificates and test reports contained in this submission demonstrate that the submitted models are substantially equivalent to the safety and effectiveness as that of the cleared devices."

Specifically, it mentions:

• "The software verification is conducted according to the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices – Guidance for Industry and FDA Staff – May 11, 2005."
• "The candidates devices and accessories meet general safety requirements IEC 60601-1 and requirements EMC: IEC 60601-1-2."

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 trial or performance study with a "test set" of human subjects or patient data in the typical sense of evaluating a diagnostic or therapeutic performance. The "test set" here refers to the device itself undergoing engineering and safety testing. The provenance of this engineering test data is not explicitly stated beyond being part of the submission by Avazzia, Inc. in Dallas, Texas, USA. These tests are typically conducted in a laboratory setting.

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

Not applicable. This is not a study that involved human experts establishing ground truth for a diagnostic or clinical outcome. The "ground truth" for the engineering performance and safety tests would be the established international standards (IEC 60601-1, IEC 60601-1-2) and the technical specifications of the predicate device.

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

Not applicable. This is not a study involving expert adjudication of clinical findings.

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 (TENS) for pain relief, not an AI-assisted diagnostic or imaging device used by human "readers."

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

Not applicable. This is a medical device, not a standalone algorithm in the AI sense. The device's performance is inherently "standalone" in that its electrical output is measured without human intervention in the primary performance tests, but it is used by a human.

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

The "ground truth" for this 510(k) submission is based on:

• Engineering Standards: Compliance with international safety and electromagnetic compatibility standards (IEC 60601-1, IEC 60601-1-2).
• Predicate Device Specifications: The technical and performance characteristics of the previously cleared predicate device (Prospera OTC TENS Electronic Pulse Massager, Models PL009, PL009A, and PL029, K122744). The new device is deemed substantially equivalent if its performance is similar or better, and it doesn't introduce new safety concerns.
• Software Verification: Adherence to FDA guidance for software in medical devices.

8. The sample size for the training set

Not applicable. This device does not employ a machine learning algorithm that requires a "training set" of data.

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

Not applicable. As there is no training set for a machine learning algorithm, there is no ground truth established for it.

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Pro-Sport™ is indicated for:

• . symptomatic relief and management of chronic, intractable pain
• adjunctive treatment in the management of post-surgical and post-traumatic pain .

The candidate Pro-Sport Avazzia device is a micro-current transcutaneous electro-stimulation device. It is an easy-to-use, handheld, AA battery-operated portable device for use in the home or clinic.
The device is a portable, battery operated microcurrent electrical stimulation device that applies charge and power to the tissue through electrodes where maximum power delivered to the load is controlled and limited, and an automatic shut off is implemented.
The user can passively place the electrodes where indicated and apply stimulation for a period of time.
The user controls the output by selecting the preset mode and power setting. The device's controls and visual indicators are located on the upper side of the case and on the upper cover.
The Pro-Sport™ device incorporates a more sophisticated digital liquid crystal display user interface to help the user select the mode and see parameters like the power level, time, and other information and has one mode that allows practitioners to set up their own therapy signals.

The provided document is a 510(k) summary for the Avazzia Pro-Sport™ device, which is a microcurrent transcutaneous electro-stimulation device. The purpose of a 510(k) submission is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device, meaning it has the same intended use and similar technological characteristics, and does not raise new questions of safety or effectiveness.

This submission focuses on comparing the new device, Avazzia Pro-Sport™, to its predicate devices (Body-Stim™, Biomodulator™, Best-RSI™, Best-Pro 1™, Model BEST -- AV1™, K062641). The acceptance criteria for such a device are primarily based on demonstrating substantial equivalence to the predicate, rather than meeting specific performance metrics from a clinical study for a novel device.

Here's an analysis based on the provided text, addressing your specific points:

1. Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for K123099 are essentially the characteristics of the predicate device, as the goal is to show substantial equivalence. The document doesn't provide specific quantitative performance metrics like sensitivity/specificity for a diagnostic device, but rather technical specifications and shared indications for use.

The "study" that proves the device meets the acceptance criteria is primarily the comparison to the predicate device and verification and validation tests (e.g., safety and EMC compliance), as stated in the "Conclusions" section: "Verification and validation tests as well as certificates and test reports contained in this submission demonstrate that the submitted models are substantially equivalent to the safety and effectiveness as that of the cleared devices." The document explicitly states that the new device has the same technological characteristics as the predicate for all listed electrical parameters. The differences are in the user interface (LCD vs. LED, more modes, user-programmable mode), which the submission argues "do not pose new questions regarding safety and effectiveness."

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

This document does not describe a clinical study with a "test set" of patients or data in the way one might for a diagnostic or therapeutic AI device. The "test set" here refers to the device itself and its components undergoing engineering and electrical safety testing. The submission confirms "Verification and validation tests" were performed, but does not provide details on the sample size for these tests (e.g., how many devices were tested, how many cycles of operation).

The data provenance is internal testing performed by Avazzia, Inc. There is no mention of external data or country of origin for such data. This appears to be a prospective set of engineering tests conducted on the new device model.

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

Not applicable. This is not a study requiring expert clinical ground truth. The "ground truth" for electrical and mechanical specifications is established by engineering standards and functional requirements.

4. Adjudication method for the test set

Not applicable. No expert adjudication process is described as this is an engineering compliance summary, not a clinical study.

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 or imaging device, and no MRMC study involving human readers is mentioned or relevant.

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

Not applicable. This device is not an algorithm or AI system. It is a physical electro-stimulation device. Its performance is evaluated based on its electrical output characteristics and user interface functionality, not algorithmic performance.

7. The type of ground truth used

The ground truth used for this submission is:

• Predicate Device Specifications: The established, cleared specifications and performance of the previous (predicate) TENS devices.
• Voluntary Standards: International Electro-technical Commission (IEC) standards for medical electrical equipment (IEC 60601-1 for safety and IEC 60601-1-2 for EMC).
• Regulatory Requirements: 21 CFR 898 for device compliance.
• Engineering Specifications: Internal design requirements for the device's electrical output (pulse duration, frequency, voltage, current, waveform) and physical characteristics (weight, dimensions, materials).

8. The sample size for the training set

Not applicable. There is no machine learning or AI component to this device, therefore 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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For symptomatic relief and management of chronic, intractable pain, and adjunctive treatment in the management of post-surgical and posttraumatic pain.

The four Avazzia Biofeedback Electro-Stimulation Technology (BEST) devices are biofeedback, micro-current transcutaneous electro-stimulation devices for symptomatic relief and management of chronic, intractable pain, and adjunctive treatment in the management of post-surgical and post-traumatic pain. They are easy-to-use, handheld, AA battery-operated portable devices for use in the home or clinic.

The provided text is a 510(k) Summary for TENS devices (Body-Stim™, Biomodulator™, BEST-RSI™, BEST-Pro1TM). It states that the technological characteristics of these devices are the same as their predicate device, InterX5000 (K042912). The summary highlights software verification according to FDA guidance and conformity with IEC 60601-1 and EMC:IEC 60601-1-2 international safety standards. It also mentions a CE Mark for the devices.

However, the 510(k) summary does not contain the specific information requested about acceptance criteria and a study proving the device meets those criteria.

Here's why and what's missing:

• Acceptance Criteria and Reported Device Performance: This type of document, a 510(k) Summary, primarily focuses on demonstrating substantial equivalence to a predicate device. It typically does not include a table of detailed performance acceptance criteria and their corresponding reported values from a specific clinical or technical study. Instead, it relies on demonstrating that the new device's technological characteristics are equivalent to the predicate, and safety standards are met.
• Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set): The document refers to "verification and validation tests" but provides no details about them. It does not describe:
  • The sample size of any test set.
  • The provenance of any data (e.g., country of origin, retrospective/prospective).
  • The number or qualifications of experts used for ground truth.
  • Any adjudication methods.
  • Whether an MRMC or standalone study was performed, or any effect sizes.
  • The type of ground truth used (e.g., pathology, outcomes data).
  • The sample size of a training set or how its ground truth was established.

Conclusion:

Based on the provided 510(k) summary, it is not possible to complete the requested table or answer the specific questions regarding acceptance criteria and the details of a study proving the device meets those criteria. The document states that "verification and validation tests contained in this submission demonstrate that the submitted models are equivalent to the safety and effectiveness as that of the cleared devices," but it does not present the data or methodology of those tests in this summary.

To obtain this information, one would typically need to review the full 510(k) submission, not just the summary.

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