(237 days)
The foramen ovale electrode is designed for monitoring brain electrical activity (eeg) or defining the location of epileptogenic foci in patients with intractable epilepsy. The foramen ovale electrode is intended for "Surgical Use Only" and "Not Intended for Implantation" This product should only be used by a physician/surgeon trained in the use of foramen ovate electrodes.
Ad-Tech's Foramen Ovale Electrode has similar intended uses, naterials, technological characteristics, sterilization procedures, and packaging as the commercially available Ad-Tech Depth Electrode (K 891920B). The Foramen Ovale Electrodes are used for intraoperative monitoring ( for surgical use only / not for implantation) and recording of electrical brain signals for epilepsy monitoring on the surface and sub-surface of the brain.
The provided text is a Summary of Safety and Effectiveness for the Ad-Tech's Foramen Ovale Electrode, submitted as part of a 510(k) premarket notification to the FDA.
Based on the provided document, the device did NOT undergo a study to demonstrate performance against specific acceptance criteria.
This document describes a "substantial equivalence" determination, which is a regulatory pathway where a new device is compared to a legally marketed predicate device rather than undergoing a de novo clinical study to establish its own performance metrics.
Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not present in this type of regulatory submission. The information provided focuses on demonstrating that the new device is essentially the same as an existing, approved device.
Here's an attempt to answer the questions based only on the provided text, highlighting what is missing or not applicable:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated or defined. The basis for acceptance is "substantial equivalence" to a predicate device.
- Reported Device Performance: No specific performance metrics (e.g., sensitivity, specificity, accuracy, signal-to-noise ratio, impedance) are reported for this specific device. The document states that the device has "similar intended uses, materials, technological characteristics, sterilization procedures, and packaging" as the predicate device.
| Acceptance Criteria (Not explicitly stated in document) | Reported Device Performance (Not explicitly stated as measured performance for this device) |
|---|---|
| Implicit: Substantial equivalence to predicate | Implicit: Similar intended uses, materials, technological characteristics, etc. to predicate |
2. Sample size 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 applicable / Not provided. No test set was used for a performance study.
- Data Provenance: Not applicable. No new data from a performance study is described.
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)
- Number of Experts: Not applicable / Not provided. No ground truth was established for a test set for performance evaluation.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable / None 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
- MRMC Study: No. This device is an electrode for recording brain signals, not an AI-powered diagnostic tool, and no such study is mentioned or relevant to this type of device.
- Effect Size of AI Improvement: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: No. This device is an electrode, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not applicable. No ground truth for performance evaluation was established for this device.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable / Not provided. This document describes a medical device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
- How Ground Truth was Established for Training Set: Not applicable.
§ 882.1330 Depth electrode.
(a)
Identification. A depth electrode is an electrode used for temporary stimulation of, or recording electrical signals at, subsurface levels of the brain.(b)
Classification. Class II (performance standards).