(455 days)
Radionics Epidural Peg, Sphenoidal and Foramen Ovale Depth Electrodes are indicated for intraoperative recording of electrical signals for epilepsy monitoring at the surface levels of the brain.
The Epidural Peg, Sphenoidal, and Foramen Ovale Depth Electrodes addressed in this PMN have similar intended uses, materials, technological characteristics, sterilization procedures, and packaging as the commercially available Radionics Cortical Surface and Depth Electrodes (K926424). These electrodes are used for intraoperative recording of electrical signals for epilepsy monitoring at the surface and subsurface levels of the brain.
The provided text is related to a 510(k) submission for Radionics Epidural Peg, Sphenoidal, and Foramen Ovale Depth Electrodes for epilepsy monitoring. However, the document does not contain the detailed study information required to fill out the table and answer the specific questions about acceptance criteria and device performance as requested.
The document states that the device is "substantially equivalent" to a predicate device (Radionics Cortical Surface & Depth Electrodes K926424) based on similar intended uses, materials, technological characteristics, sterilization procedures, and packaging. This means that the regulatory submission primarily relies on demonstrating similarity to an already approved device rather than presenting new performance data against pre-defined acceptance criteria from a specific study.
Therefore, most of the requested information cannot be extracted from the provided text.
Here is what can be inferred or explicitly stated from the document, and what cannot:
Acceptance Criteria and Device Performance Study Information from K961942:
-
Table of Acceptance Criteria and Reported Device Performance: This information is not provided in the document. The submission focuses on substantial equivalence to a predicate device rather than establishing and testing against specific performance acceptance criteria.
-
Sample size used for the test set and the data provenance: This information is not provided. No specific test set or study data is mentioned beyond the comparison to the predicate device's characteristics.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided. No test set requiring expert ground truth is described.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set: This information is not provided.
-
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: This information is not provided. This device is an electrode for electrical signal recording, not an AI-assisted diagnostic tool for human readers.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This information is not applicable/not provided. This is a physical medical device (electrodes) for direct signal recording, not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc): This information is not provided.
-
The sample size for the training set: This information is not provided. No training set data is referenced.
-
How the ground truth for the training set was established: This information is not provided.
Summary of what is available from the document:
- Device Name: Radionics Epidural Peg, Sphenoidal, and Foramen Ovale Depth Electrodes
- Intended Use: For intraoperative recording of electrical signals for epilepsy monitoring at the surface and subsurface levels of the brain.
- Predicate Device: Radionics Cortical Surface & Depth Electrodes (K926424)
- Basis for Substantial Equivalence: Similar intended uses, materials, technological characteristics, sterilization procedures, and packaging as the predicate device. The submission asserts that the labeling contains instructions ensuring safe and effective use when followed by a physician.
The provided text only constitutes a "Summary of Safety and Effectiveness" that outlines the general information and the basis for substantial equivalence for a 510(k) submission. It does not include the detailed performance study data that would be found in a full submission, especially for novel devices or those requiring specific performance claims.
§ 882.1310 Cortical electrode.
(a)
Identification. A cortical electrode is an electrode which is temporarily placed on the surface of the brain for stimulating the brain or recording the brain's electrical activity.(b)
Classification. Class II (performance standards).