(77 days)
The Oro-Facial Myographic Measurement Instrument is intended as a diagnostic aid for the quantitative evaluation of oro-facial muscle strength. It is indicated for use in the oro-facial cavity.
The Oro-Facial Myographic Measurement Instrument (OMMI™) is a myographic measurement method for direct strength measurement of the oro-facial muscles.
The provided text describes the 510(k) submission for the Oro-Facial Myographic Measurement Instrument (OMMI™) and focuses on demonstrating substantial equivalence to a predicate device. It does not contain information about specific acceptance criteria, a detailed study proving performance against those criteria, or the methodology typically associated with evaluating AI/algorithm-based medical devices (such as sample sizes for test/training sets, ground truth establishment, or expert adjudication).
Therefore, many of the requested fields cannot be directly extracted or inferred from the provided document.
Here's a breakdown based on the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document. The submission focuses on demonstrating substantial equivalence to a predicate device rather than meeting pre-defined performance metrics for the OMMI™ itself. | Bench testing (Pressure Validation) and biocompatibility evaluation were performed. The results are reported to "support the substantial equivalence claims" and "effectively demonstrate the OMMI's substantial equivalence to the predicate device." Specific performance values (e.g., accuracy, precision) are not provided. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document mentions "bench testing (Pressure Validation)" but does not provide details on the number of samples or measurements taken.
- Data Provenance: Not specified. The nature of "bench testing" suggests laboratory-based data, but geographical origin or whether it was retrospective/prospective is not mentioned.
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. The "ground truth" for a myographic measurement instrument's bench testing would typically involve calibrated instruments for pressure validation, not expert interpretation of outputs. No human experts are mentioned for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are relevant for subjective interpretations, often in image analysis. For bench testing of a measurement device, the comparison would be against a known standard or calibrated reference, not through expert adjudication.
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. An MRMC study is not mentioned. This type of study is relevant for AI-assisted diagnostic tools and involves human readers evaluating cases. The OMMI™ is described as a direct measurement instrument, not an AI-based diagnostic aid that would assist human readers in interpreting complex data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The OMMI™ is a physical myographic measurement instrument. It is not an algorithm or AI product. Its performance would inherently be "standalone" in the sense that it provides measurements directly, without necessarily a human-in-the-loop interpreting algorithm output. However, this question as phrased is typically for software-as-a-medical-device (SaMD) or AI devices. The device's performance was evaluated through "bench testing (Pressure Validation)."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For "Pressure Validation" bench testing, the ground truth would likely be established using calibrated reference instruments or known physical standards for pressure. This is an objective, instrumental ground truth, not based on expert consensus, pathology, or outcomes data.
8. The sample size for the training set
- Not applicable. The OMMI™ is a physical measurement device and does not involve a "training set" in the context of machine learning or AI models.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set for this type of device, ground truth establishment for a training set is irrelevant.
§ 888.1240 AC-powered dynamometer.
(a)
Identification. An AC-powered dynamometer is an AC-powered device intended for medical purposes to assess neuromuscular function or degree of neuromuscular blockage by measuring, with a force transducer (a device that translates force into electrical impulses), the grip-strength of a patient's hand.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.