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510(k) Data Aggregation
(260 days)
The Tyece OTC TENS Device, Model SEM44 is to be used for temporary relief of pain associated with sore and aching muscles in the lower back, arms, or legs due to strain from exercise or normal household activities.
The Tyece OTC TENS Device, Model SEM44 is a dual channel TENS device operated by DC 4.5V (3 AAA batteries). It is made up of one main unit, two electrode cables, and two pairs of electrode pads. There are 12 selectable, pre-programmed output waveforms (modes) to choose from, blus 3 programmable modes. The two channels can be individually adjusted for intensity from 0 to 50. Running time can be selected from 5 to 100 minutes. All parameters (Menu, Program Number, Impulse intensity for channels, Jow battery, key-lock, frequency, pulse width and timer) are displayed on a full screen display. The only patient contacting components are the Electrode Pads. The patient contacting materials are FDA cleared under K132588.
This is a premarket notification (510(k)) for a Transcutaneous Electrical Nerve Stimulator (TENS) 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 is as safe and effective. In this context, the "acceptance criteria" and "device performance" usually refer to the equivalence demonstrated through engineering and non-clinical testing against recognized standards and comparison to the predicate device. Clinical studies for proving effectiveness in terms of pain relief are typically not required for 510(k) submissions of TENS devices if substantial equivalence can be shown through non-clinical means.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k) submission of a TENS device, the acceptance criteria are generally defined by compliance with recognized consensus standards for electrical safety, electromagnetic compatibility, and performance, as well as demonstrating comparable technical characteristics to the predicate device. The "device performance" reported is its compliance with these standards and its specified output characteristics.
| Acceptance Criteria (Set by Recognized Standards & Predicate Comparison) | Reported Device Performance (Tyece OTC TENS Device, Model SEM44) |
|---|---|
| Electrical Safety Standards: | Complies with IEC 60601-1:2005+Corr.1(2006)+Corr.2(2007)+AM1(2012), EN 60601-1:2006/A1:2013 |
| Basic Safety & Essential Performance of Nerve & Muscle Stimulators: | Complies with IEC 60601-2-10 Edition 2.0 2012-08 |
| Electromagnetic Disturbances Requirements & Tests (EMC): | Complies with IEC 60601-1-2 Edition 2007-03 |
| Home Healthcare Environment Requirements: | Complies with IEC 60601-1-11 First Edition: 2010 |
| Biocompatibility of Patient Contacting Parts: | Electrode pads FDA cleared under K132588; comply with ISO 10993 (Class A ≤ 24 hrs contact) |
| Software Performance: | Software performs within specifications, is safe for intended use, permanent hazard analysis implemented, clear software architecture. Level of concern: Moderate. |
| Cleaning Effectiveness: | Cleaning instructions in Instruction Manual tested and found sufficient. |
| Maximum Output Voltage (Vp-p): | 70Vp-p@500 Ω, 110Vp-p@2K Ω, 190Vp-p@10K Ω (Predicate: 69.2Vp-p@500 Ω, 86.4Vp-p@2K Ω, 88.8Vp-p@10K Ω) |
| Maximum Output Current (mA): | 86mA@500 Ω, 23.3mA@2K Ω, 3.75mA@10K Ω (Predicate: 69.2mA@500 Ω, 21.6mA@2K Ω, 4.4mA@10K Ω) |
| Pulse Duration (μS): | 50-360μS (Predicate: 200μS) |
| Frequency (Hz): | 1-150Hz (Predicate: 1-136Hz) |
| Net Charge (micro coulombs μC) per pulse: | 0.001μC@500 Ω (Predicate: 0.0013μC@500 Ω) |
| Maximum Phase Charge (mC): | 0.0454mC@500 Ω (Predicate: 0.0135mC@500 Ω) |
| Maximum Current Density (mA/cm2, r.m.s): | 0.790mA/cm2@500 Ω (Predicate: 3.270mA/cm2@500 Ω) |
| Maximum Average Current (average absolute value), mA: | 16.0mA (Predicate: 2.218mA) |
| Maximum Average Power Density (W/cm2): | 0.00632W/cm2@500 Ω 1.0S (Predicate: 0.00116W/cm2@500 Ω 1.0S) |
| Number of Output Modes: | 15 Modes (01-15) (Predicate: 7 modes) |
| Intensity Levels: | 0 to 50 (Predicate: 0 to 16, but stated maximum intensity settings of both units produce similar outputs) |
| Timer Range: | 5-100min (Predicate: 20-40 min) |
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 states: "Savia did not conduct, nor rely upon, clinical tests to determine substantial equivalence of the SEM44 vs. the predicate." Therefore, there is no test set of clinical data from human subjects in the traditional sense. The testing performed was non-clinical bench testing to validate design and ensure conformance with voluntary design standards. This means there is no data provenance related to human subjects (country of origin, retrospective/prospective).
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. As noted above, no clinical test set was used for determining substantial equivalence, hence no experts were involved in establishing ground truth for such a set. The "ground truth" was established by the requirements of the recognized consensus standards and direct comparison of technical specifications to the predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set involving human subjects requiring adjudication was used.
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 TENS unit, not an AI-assisted diagnostic or therapeutic 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
Not applicable. The device is a Transcutaneous Electrical Nerve Stimulator; it's a physical device that delivers electrical impulses, not an algorithm in the context of AI or imaging. Performance was evaluated as a standalone product against technical specifications and standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this 510(k) submission is primarily established by:
- Recognized consensus standards: Electrical safety, EMC, performance standards (e.g., IEC 60601 series).
- Technical specifications of the predicate device: The Tyece device's technical characteristics are compared directly to the cleared predicate device to ensure substantial equivalence.
- Design requirements: Internal company design requirements for the device.
There is no "expert consensus," "pathology," or "outcomes data" ground truth in the clinical sense, as clinical studies were not performed for this submission.
8. The sample size for the training set
Not applicable. Since no clinical studies were performed and the device is not an AI/machine learning model, there is no concept of a "training set" of data.
9. How the ground truth for the training set was established
Not applicable, as no training set was used.
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