(76 days)
The use of the Model CMU Cortical Mapping Unit is indicated where intraoperative, short-term recording of cortical surface EEG activity is required.
AD-TECH's Model CMU Cortical Mapping Unit has similar intended uses, materials and technological characteristics as the predicate device. There are only three differences of note:
(1) Our electrode plates are made of clear Lexan plastic while theirs are stainless steel. We maintain that the clear plates are a marketing feature.
(2) Our electrodes are made of stainless steel; theirs use cotton wicks.
(3) Our device is sterilized via EtO: theirs may be autoclaved.
This 510(k) summary describes a device called the "Model CMU Cortical Mapping Unit" and compares it to a predicate device, the "Model CE-1 Cortical Electrode" (Grass Instruments). The summary explicitly states that the new device is an "enhanced version of a pre-amendment device" and has "similar intended uses, materials and technological characteristics as the predicate device." Crucially, it then states: "None of these difference are material to the safety & effectiveness of the device."
The document does not include a study with acceptance criteria and reported device performance in the traditional sense for demonstrating a new algorithm's efficacy. Instead, it relies on demonstrating substantial equivalence to a legally marketed pre-amendment device. Therefore, many of the requested fields about study design and performance metrics are not applicable in this context.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable. This submission hinges on demonstrating substantial equivalence to a predicate device, not on meeting specific, quantified performance acceptance criteria through a new study. The "performance" is implicitly deemed equivalent to the predicate device.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. No new performance study on a test set (with a specific sample size) was conducted or reported.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. No new test set with ground truth established by experts was used.
4. Adjudication Method for the Test Set
Not applicable.
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. This device is not an AI-assisted diagnostic tool and no MRMC study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a hardware unit for recording EEG potentials, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The basis for approval is substantial equivalence to a pre-amendment device, not a new ground truth study.
8. The sample size for the training set
Not applicable. This device is a hardware unit, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
Summary of Device Equivalence (as detailed in the 510(k) Summary):
The submission argues for substantial equivalence based on the following:
| Feature | Model CMU Cortical Mapping Unit (New Device) | Model CE-1 Cortical Electrode (Predicate Device) | Statement of Equivalence |
|---|---|---|---|
| Intended Use | To facilitate the recording of EEG potentials from the surface of the exposed human brain during surgery. | To facilitate the recording of EEG potentials from the surface of the exposed human brain during surgery. | Equivalent: "Both devices have received indications for use, namely to facilitate the recording of EEG potentials from the surface of the exposed human brain during surgery." |
| Materials - Electrode Plates | Clear Lexan plastic | Stainless steel | Not Materially Different: Stated as a "marketing feature" and not impacting safety/effectiveness. |
| Materials - Electrodes | Stainless steel | Cotton wicks | Not Materially Different: Stated as not material to safety/effectiveness. |
| Sterilization Method | EtO | Autoclaved (may be) | Not Materially Different: Stated as not material to safety/effectiveness. |
| Technological Characteristics | Similar to predicate device | Equivalent: "AD-TECH's Model CMU Cortical Mapping Unit has similar intended uses, materials and technological characteristics as the predicate device." |
Key Takeaway from the FDA Letter:
The FDA's letter (K992194) confirms their agreement with AD-TECH's assessment of substantial equivalence to the predicate device. It states, "We have reviewed your Section 510(k) notification... and we have determined the device is substantially equivalent... You may, therefore, market the device, subject to the general controls provisions of the Act." This indicates that the regulatory pathway chosen (510(k)) relies on demonstrating similarity to an already approved device rather than presenting a novel performance study against defined acceptance criteria.
§ 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).