(176 days)
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
The Santamedical Pulse Stimulator, a Transcutaneous Electrical Nerve Stimulator (TENS), is for overthe-counter use and for home use, which is intended to relieve pain associated with sore and aching muscles in the shoulder, waist, neck, back, arm, and leg, due to strain from exercise or normal household and work activities. The portable and microprocessor-controlled Santamedical Pulse Stimulator delivers a gentle electrical pulse through two channels with four attachment pads and shows graphic information about mode style, intensity and time remaining on a LCD based display which is incorporated within the device body.
This is a 510(k) summary for a Transcutaneous Electrical Nerve Stimulator (TENS) device, which does not involve AI or complex diagnostic interpretations. Therefore, many of the requested categories concerning AI performance, expert consensus, and ground truth establishment are not applicable.
Here's the analysis based on the provided text:
Device: Santamedical Pulse Stimulator (Transcutaneous Electrical Nerve Stimulator - TENS)
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria Category | Specific Criteria | Proposed Device Performance (Met/Not Applicable) |
|---|---|---|
| Safety and Electrical | IEC 60601-1 (General basic safety) | Met (Compliance demonstrated through non-clinical tests) |
| IEC 60601-1-2 (EMC requirements) | Met (Compliance demonstrated through non-clinical tests) | |
| Electrode Safety | Safety requirements for electrodes | Met (Electrodes meet safety requirements) |
| Software Verification | FDA Guidance for Software in Medical Devices | Met (Software verification carried out per FDA guidance) |
| Substantial Equivalence | Demonstration of equivalence to predicate device K122744 | Met (Concluded to be substantially equivalent based on comparison) |
2. Sample Size Used for the Test Set and the Data Provenance
This is an OTC TENS device. The performance and safety testing described are primarily non-clinical bench testing to confirm compliance with electrical safety and EMC standards (IEC 60601-1, IEC 60601-1-2) and electrode safety. Software verification was also performed.
- Test Set Sample Size: Not applicable in the context of patient data. The "test set" would refer to the physical device units undergoing non-clinical testing. The document does not specify the number of devices tested, which is typical for such non-clinical regulatory submissions.
- Data Provenance: Not applicable in the context of patient data. The data provenance refers to laboratory testing results, not patient or clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. Ground truth, in the context of this device, refers to the established standards and safety requirements (e.g., electrical parameters, EMC limits). Compliance with these standards is assessed by testing laboratories and engineers, not by clinical experts establishing a "ground truth" for diagnostic or AI performance.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods are typically used for clinical studies involving multiple reviewers for diagnostic agreement or outcome assessment. This submission demonstrates compliance with engineering and safety standards.
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 pain relief stimulator, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical stimulator, not an algorithm, and does not have standalone AI performance in the way a diagnostic AI would.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The "ground truth" implicitly used for this device is compliance with established electrical safety and electromagnetic compatibility (EMC) standards (IEC 60601-1, IEC 60601-1-2) and FDA's guidance for software in medical devices. The device's technological characteristics were also compared directly to a legally marketed predicate device (K122744).
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set for model development.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/ML device.
§ 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).