(568 days)
This device is intended for muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction.
This device is a dual channel battery operated electrical stimulator for use with skin surface electrodes. The output current in each channel can be adjusted from 0-25 ma in 1 ma increments. The pulse repetition rate is fixed at 80 Hz. The output waveform is bipolar symmetrical constant current.
The provided text describes the eSWALLOW™ Dysphagia Therapy Unit, an electrical stimulator intended for muscle re-education for pharyngeal contraction. However, the document is a 510(k) summary for a medical device regulatory submission, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance metrics for a novel technology.
Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, study design (sample size, ground truth, expert qualifications, adjudication, MRMC, standalone performance, training set details) is not present in the provided text.
Here's what can be extracted based on the information given:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Comparability to predicate device (Vital Stim, K023347) | "Tests were performed on the device which demonstrated that the device performs comparably to and is substantially equivalent to the predicate device." |
| Electrode resistance within acceptable limits | "Tests include: Electrode resistance..." |
| Output accuracy within acceptable limits | "...output accuracy..." |
| Software Validation completed successfully | "...Software Validation..." |
| EMC compatibility testing completed successfully | "...and EMC compatibility testing." |
| Technological characteristics similar to predicate (pulse type, rate, output) | "Because the technological characteristics and intended use are nearly identical to the predicate device (including pulse type, rate, and output) we have determined that the eSWALLOW™ device is substantially equivalent to the predicate device." |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified (no clinical data is presented, only engineering tests).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. The document does not describe a clinical study with a "ground truth" established by experts. The "tests" mentioned are engineering/technical tests.
4. Adjudication method for the test set:
- Not applicable/Not specified.
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 MRMC comparative effectiveness study was done. This device is an electrical stimulator, not an AI-driven diagnostic or assistive device for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable/Not specified. This is a therapeutic electrical stimulator, not an algorithm. The "Software Validation" mentioned refers to validating the device's internal software, not an AI algorithm's standalone performance.
7. The type of ground truth used:
- Not applicable. The tests performed are engineering/technical tests (e.g., measuring electrode resistance, output accuracy) against established technical specifications, not against clinical ground truth from human patients.
8. The sample size for the training set:
- Not applicable. This device is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable. This device is not an AI algorithm requiring a training set.
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).