(259 days)
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.
| Characteristic | Acceptance Criteria (Predicate Device K122744) | Reported Device Performance (Avazzia OTC TENS) |
|---|---|---|
| Power Source | Four 1.5 V AAA batteries | Two 1.5 V AA batteries |
| Patient Leakage Current (Normal Condition) | 1.8 µA | 13.7 µA |
| Patient Leakage Current (Single Fault Condition) | 3.3 µA | 27 µA |
| Avg DC current through electrodes (no pulses) | 0 µA | 0 µA |
| Number of output modes | 3 | 2, 4 |
| Number of output channels | Synchronous | 1 (Synchronous/Alternating = n/a) |
| Regulated Current or Voltage | Voltage control | Voltage control |
| Software control | Yes | Yes |
| Automatic Overload Trip? | No | No |
| Automatic No-Load Trip? | No | Yes |
| Automatic Shut Off? | Yes | Yes |
| User Override Control? | Yes | Yes |
| Indicator Display: On/Off Status? | Yes | Yes |
| Indicator Display: Low Battery? | No | Yes |
| Indicator Display: Voltage/Current intensity? | No | Yes |
| Timer Range | 5, 10, or 15 minutes | 60 minutes |
| Compliance with Voluntary Standards? | Yes | Yes |
| Compliance with 21 CFR 898 | Yes | Yes |
| Weight | 8 OZ | 7 OZ |
| Dimensions | 2.2 x 7.8 x 0.9 In | 4.6 x 2.5 x 1.3 In |
| Housing materials and construction | Enclosure: ABS | Enclosure: ABS |
| Waveform | Monophasic | Biphasic (positive square wave followed by a damped sinusoidal waveform) |
| Shape | Regular | Positive square wave followed by a damped sinusoidal waveform of variable duration depending on damping and body loading |
| Max output voltage at 500 Ω | 12.8 V | -42 V |
| Max output voltage at 2,000 Ω | 51 V | -122 V |
| Max output voltage at 10,000 Ω | 368 V | -348 V |
| Max output current at 500 Ω | 15,000 µA | 3080 µA |
| Max output current at 2,000 Ω | 3,200 µA | 451 µA |
| Max output current at 10,000 Ω | 600 µA | 535 µA |
| Duration of primary (depolarizing phase) | 0.040 µSec | 506 µSec |
| Pulse Duration | 120 to 6800 µSec | 1100 µSec |
| Frequency | 1 to 100 Hz | 20 to 185 Hz |
| Net Charge per pulse at 500 Ω | 18,000 µC | 4.0 µC |
| Max Charge per pulse at 500 Ω | 23 µC | 10.12 µC |
| Max current density at 500 Ω | 1.4 mA/cm² | 1.6 mA/cm² |
| Max average power density at 500 Ω | 230 mW/cm² | 2.445 mW/cm² |
| Burst mode: pulses per burst | 1 | Up to 8 |
| Burst mode: burst per second | 0-25 | Up to 77 |
| Burst mode: burst duration | 1 sec | Up to 6 mSec |
| Burst mode: Duty Cycle | 5 | 46% |
| On Time | Potentiometer switch | 0.46 Sec |
| Off time | Potentiometer switch | 0.54 Sec |
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.
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).