(270 days)
To be used in adults only for temporary relief of pain associated with sore and aching muscles in the upper extremities (arms), lower extremities (legs), and lower back due to strain from exercise or normal household and work activities.
TANYX® is based on TENS medical technology. The product is to reduce or eliminate pain through the emission of controlled and focused electrical signals. It is a disposable device, designed to be sold directly to consumers for the temporary relief of pain. TANYX® adheres to a person's skin and emits either a fixed or modulated electrical signal through a grid of integrated electrodes. It is a product which is characterized as portable, inexpensive, disposable, and (compared to other TENS-based products) easy to handle and operate. No medical supervision is required.
Here's an analysis of the provided 510(k) summary for the Tanyx device, focusing on acceptance criteria and the study proving it meets those criteria, based only on the provided text:
Important Note: The provided document is a 510(k) summary for a Transcutaneous Electrical Nerve Stimulator (TENS) device. These submissions typically focus on demonstrating substantial equivalence to a predicate device, rather than proving novel clinical efficacy against specific, quantitative acceptance criteria through a full clinical trial. The "study" mentioned here is primarily non-clinical testing for safety parameters and a usability study. There is no information about a clinical trial or performance metrics like accuracy, sensitivity, or specificity that would typically be found in an AI/Software as a Medical Device (SaMD) submission.
Acceptance Criteria and Device Performance for Tanyx®
1. Table of Acceptance Criteria (Safety Parameters) and Reported Device Performance
The acceptance criteria are generally understood to be compliance with established safety standards for TENS devices, as demonstrated by comparison to a legally marketed predicate device and adherence to relevant ISO and IEC standards. The "performance" here refers to the device's electrical characteristics and its ability to pass specific safety tests.
| Characteristic | Acceptance Criteria (Predicate / Industry Standard) | Tanyx® Reported Performance |
|---|---|---|
| Non-Clinical Performance | ||
| Biocompatibility (ISO 10993-1) | Passed | Passed |
| Biocompatibility (ISO 10993-5:2009) | Not specified (for predicate) | Passed |
| Biocompatibility (ISO 10993-10:2010) | Not specified (for predicate) | Passed |
| Device Safety (IEC 60601-1) | Passed | Passed |
| Device Safety (IEC 60601-2-10) | Passed | Passed |
| Hazard Analysis (ISO 14971:2007) | Not specified (for predicate) | Passed |
| Electrical Parameters (Safety & Efficacy Range) | In range for indicated use, under established limits | In range for indicated use, under established limits |
| Maximum Output Voltage (500 ohm) | 35.4 V (Predicate) | 47.6 Vpp |
| Maximum Output Voltage (2k ohm) | 46.7 V (Predicate) | 64.0 Vpp |
| Maximum Output Voltage (10k ohm) | 50.8 V (Predicate) | 72.8 Vpp |
| Frequency (Hz) | 0-100 Hz (Predicate) | 55 Hz (± 3%) |
| Maximum Output Current (500 ohm) | 4.4 mA (Predicate) | 95.2 mApp |
| Maximum Output Current (2k ohm) | 1.7 mA (Predicate) | 29.1 mApp |
| Maximum Output Current (10k ohm) | 0.4 mA (Predicate) | 7.9 mApp |
| Maximum Average Current | 3.5mA (Predicate) ; under established limits | 6.02mA |
| Maximum Current Density | 0.095mA/Cm² (Predicate) ; under maximum limits | 0.12mA/Cm² |
| Maximum Average Power Density | 89mW/Cm² (Predicate) ; under maximum limits | 98mW/Cm² |
| Maximum Phase Charge (500 ohm) | 1.33 µC (Predicate) ; under established limits | 0.19 µC |
| Usability | Users able to use device correctly and safely | Users able to use device correctly and safely |
2. Sample Size Used for the Test Set and Data Provenance
- Non-Clinical Performance Data (Safety Standards Compliance): The sample size refers to the number of devices or components tested to ISO and IEC standards. This information is not explicitly stated in the provided text. It's typically part of detailed test reports referenced by the submission but not included in summary. The provenance is likely lab testing conducted by the manufacturer or a certified testing facility.
- Usability Study: The sample size for the usability study is not explicitly stated. The provenance is a "usability study was conducted," implying it was conducted by or for Medecell.
- Electrical Parameters: These are measurements of the device's electrical output. The sample size is not stated, but typically involves testing multiple units to ensure consistency. The data provenance is from a company named "No Risk" from Brazil, resulting in the report R120331 - Medecell - Stimulator - Tanyx - parameters - 12042710.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information (experts, ground truth for a test set) is generally applicable to AI/SaMD devices where expert annotation or pathology defines the "truth" for evaluating algorithmic performance. For this TENS device, the "ground truth" for non-clinical testing is adherence to established engineering, electrical, and safety standards (e.g., ISO, IEC). The experts would be the engineers and technicians involved in performing and verifying these tests, but their specific number and qualifications are not mentioned in the summary. For the usability study, there's no mention of experts establishing ground truth; the ground truth is simply whether users could operate the device correctly and safely.
4. Adjudication Method for the Test Set
Again, this is highly relevant for AI/SaMD. For the non-clinical tests described, adjudication methods typically refer to peer review of test plans, results, and adherence to standard protocols within the testing facility. This information is not provided in the summary. For the usability study, no adjudication method is described beyond the conclusion that "users were able to use the device correctly and safely."
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
No. An MRMC study is not mentioned. This type of study assesses how human interpretation (e.g., of images) changes with or without AI assistance, which is not applicable to a TENS device. The Tanyx device itself is the therapy, not an aid to interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No. This question is also highly relevant for AI/SaMD. Tanyx is a hardware device (TENS) that delivers electrical stimulation for pain relief; it does not have a standalone algorithm in the sense of a diagnostic or interpretive AI. Its "performance" is its electrical output and safe operation.
7. The Type of Ground Truth Used
- Non-Clinical Performance (Safety): The ground truth for electrical parameters and safety tests (biocompatibility, electrical safety, hazard analysis) is defined by compliance with internationally recognized standards (ISO 10993, IEC 60601, ISO 14971) and comparison to the electrical output ranges of a legally marketed predicate device (Model PM3030).
- Usability: The ground truth for the usability study is whether users could operate the device as intended and safely, as observed during the study.
8. The Sample Size for the Training Set
This question is applicable to machine learning algorithms. Since Tanyx is a TENS device and not an AI/ML algorithm, there is no training set in this context. The device's 'design' is based on established TENS medical technology and engineering principles, not on learning from a data set.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for this type of device, this question is not applicable.
§ 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).