(63 days)
The DYmedix Inc. Chin Electrode is a cutaneous electromyography (EMG) electrode. The Chin Electrode supports EMG monitoring of muscles in the chin and other surface EMG monitoring locations as directed by a physician during sleep studies.
The Chin Electrode is provided as a convenience to the sleep clinician. The Chin Electrode consists of three cutaneous electrodes within one assembly. In clinical application, the Chin Electrode is placed on the subject's chin. The lead wires are connected to the user's sleep recording instrumentation. The user's sleep recording instrument provides the electrical isolation for patient safety.
The provided text describes a 510(k) submission for the DYmedix, Inc. Chin Electrode. It focuses on demonstrating substantial equivalence to a predicate device rather than providing specific performance metrics against defined acceptance criteria from a study. Therefore, most of the requested information regarding acceptance criteria, study details, expert involvement, and ground truth cannot be extracted directly from this document.
Here's a breakdown of what can and cannot be provided based on the given text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy, signal-to-noise ratio) for the Chin Electrode. Instead, it focuses on demonstrating technological equivalence and compliance with safety standards.
Therefore, a table of acceptance criteria and reported device performance cannot be created from this text. The "Data Summary" section vaguely mentions "Laboratory data are presented to demonstrate performance," but no specific performance results are provided.
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 does not mention any formal clinical study or test set with a specified sample size. The "Laboratory data" mentioned are likely related to engineering testing for compliance with standards rather than clinical performance evaluation on patient data.
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 no clinical test set or ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set or adjudication process is described.
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. The Chin Electrode is a physical medical device (electrode) for EMG monitoring, not an AI or software-as-a-medical-device (SaMD) product. Therefore, an MRMC study or AI-assistance evaluation is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no clinical ground truth establishment is described. The "ground truth" in this context would likely be the accurate measurement of EMG signals, which would be assessed through electrical performance testing, not clinical consensus or pathology.
8. The sample size for the training set
Not applicable, as this is a physical device, not an algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as this is a physical device, not an algorithm that requires a training set.
Summary of Information from the Document:
While the document doesn't provide the requested AI/algorithm-specific details, it does state the following relevant information regarding the device's acceptance and supporting data:
-
Acceptance Criteria (Implied / Compliance-based):
- Technological Equivalence: The Chin Electrode must be technologically equivalent to existing cutaneous electrodes.
- Biocompatibility: Skin contact materials must be qualified by ISO 10993 or have a history of safe use.
- Lead Wire Safety: Lead wires must comply with FDA requirement 21 CFR Part 898.
- Functional Performance: Must be able to conduct EMG signals. (No specific performance metrics are given, but "Laboratory data are presented to demonstrate performance.")
- Safety and Effectiveness: The overall conclusion of the submission is to support the safety and effectiveness.
-
Study That Proves the Device Meets Acceptance Criteria (as described):
- Type of Study: The submission primarily relies on "Laboratory data" and "Certification of Conformance" to relevant standards. This indicates engineering testing and compliance documentation rather than a clinical trial.
- Specific Tests/Certifications Mentioned:
- Certification of Conformance to the FDA Performance Standard for Lead Wires and Patient Cables, 21 CFR Part 898.
- Compliance with ISO 10993 for biocompatibility.
- Nature of "Data Summary": The document states that "Laboratory data are presented to demonstrate performance," but does not elaborate on the specific tests conducted or their results in a quantitative manner. The FDA's decision is based on a review of the provided 510(k) submission, confirming "substantial equivalence" to the predicate device.
§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).