(63 days)
The MEDSTAR 100 Interferential Stimulator should only be used under the supervision for adjunctive therapy in the treatment of medical diseases and conditions to relive pain. When used for pain relief, the standard indications for use are:
- symptomatic relief and management of chronic pain and/or .
- an adjunctive treatment in the management of post surgical and posttraumatic acute . pain.
The MEDSTAR 100 is a DC battery powered device that generates small pulses of electric current. These small pulses of electrical current are delivered through leads cables to electrodes placed on the skin. These electrical pulses pass through the skin and activate underlying nerves.
The provided text does not contain information about acceptance criteria for a device's performance, nor does it describe a study to prove the device meets such criteria in the context of clinical or diagnostic efficacy. Instead, the document is a 510(k) summary and FDA clearance letter for a medical device called the MEDSTAR 100 Interferential Stimulator.
The "study" mentioned relates to functional and safety testing to demonstrate substantial equivalence to a predicate device, not clinical performance or diagnostic accuracy.
Here's an analysis based on the provided text, addressing the points where information is available:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria for clinical performance or diagnostic accuracy. It states:
- Functional & Safety Testing: "Was performed with a signal generator voltmeter, 420 ohm resistor, and alligator clip wires. The signal generator was set to 1000 Hz and V1 was set at approximately 2 volts. The voltage drop across the electrodes (V7) was measured and the impedance of the electrodes calculation is as follows: Impedance (Z) = V7/V1 x R"
- Reported Performance: No specific numerical performance results from this testing are reported in the provided text. The document only describes the methodology.
- Conclusion regarding performance: "The MEDSTAR™ 100 Interferential Stimulator is substantially equivalent to the HMP 4000 Interferential Stimulator for intended use, design, and electrical performance." This is an overall conclusion based on the testing, but no specific performance values are listed against explicit acceptance criteria beyond the general statement of electrical performance equivalence.
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not applicable in the context of a clinical or diagnostic test set. The functional and safety testing described would typically involve a small number of devices, often a single unit or a few units, to confirm manufacturing specifications and basic electrical safety. The text does not specify the number of devices tested.
- Data provenance: Not applicable. The testing is described as "performed" by the submitter, MedNet Services, Inc. It is functional and safety testing, not human subject data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. The "ground truth" here is the expected electrical behavior of the device and its safety, which is assessed through engineering measurements against established standards or predicate device specifications, not by expert interpretation of clinical data.
4. Adjudication method for the test set
- Not applicable. There is no "adjudication" in the clinical sense mentioned. The functional and safety testing relies on direct electrical measurements.
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
- No. This is not an AI device or a diagnostic device that would involve human readers interpreting cases. It is an Interferential Stimulator for pain relief.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an algorithm-based device. It's a physical medical device.
7. The type of ground truth used
- For the functional and safety testing, the "ground truth" would be the engineering specifications and established electrical safety standards for medical devices of this type, potentially derived from the predicate device's characteristics. There's no clinical ground truth (pathology, expert consensus, outcomes data) as this is not a diagnostic device.
8. The sample size for the training set
- Not applicable. This device does not use machine learning or AI, so there is no training set.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set.
§ 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).