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The PMT SPHENOIDAL Electrode is indicated for Intraoperative recording of electrical signals for Epilepsy monitoring at the surface and subsurface levels of the brain. It is not intended for long term monitoring.

Device Description

The PMT Sphenoidal electrode consists of an insulated Platinum/lridum or Stainless Steel wire with an exposed distal portion used to record EEG activity. The proximal end of the wire terminates in a connector. The connector attaches to an Interconnection cable external to the patient and connected to the EEG equipment.

The PMT Sphenoidal electrode is introduced to the recording site via an introducer. Once in place, the introducer is removed leaving the electrode available for recording EEG patterns from the inferior mesial temporal lobe.

The PMT Sphenoidal Electrode is provided sterile for single use and for Intraoperative use only.

AI/ML Overview

The provided text describes a Premarket Notification [510(k)] for the PMT Sphenoidal Electrode. This is a medical device submission to demonstrate substantial equivalence to a predicate device, not a study focused on establishing specific performance metrics against pre-defined acceptance criteria in the way a clinical trial or a machine learning algorithm validation would.

Therefore, many of the requested categories in the prompt regarding acceptance criteria, study design, sample sizes, expert ground truth, and AI performance are not applicable to this type of regulatory submission. The goal of a 510(k) is to prove equivalence, not to quantify specific performance beyond what is required for safety and effectiveness, often relying on existing standards and predicate device performance.

Here's a breakdown of the information that is available, and why other categories are not applicable:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance
Substantial Equivalence	Equivalence to Wyler Sphenoidal Electrode (K861031) manufactured by AD-Tech Medical	Confirmed: "The PMT Sphenoidal Electrode is substantially equivalent, for the purpose of this 510(K), to the Wyler Sphenoidal Electrode (K861031) manufactured by AD-Tech Medical."
Mechanical Biocompatibility	Compliance with ASTM, ANSI/AAMI standards	Confirmed: "The Mechanical biocompatibility testing will comply with ASTM, ANSI/AAMI standards." (Implies compliance was achieved and demonstrated as part of the submission, though specific results aren't detailed in the summary.)
Sterility	Sterility Assurance Level (SAL) of 10⁻⁶	Achieved: Sterilized by ethylene oxide method to provide a SAL of 10⁻⁶. Products are manufactured in a clean room environment and double bagged.
Pyrogen-Free	Pyrogen-free status	Achieved: Provided pyrogen-free. Method of determination: Limulus Amebocyte Lysate Test.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. This 510(k) summary does not describe a clinical study with a "test set" in the context of performance evaluation (e.g., for an AI algorithm). The testing mentioned refers to engineering and biocompatibility tests designed to meet standards, not a specific patient data set for performance metrics.

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. There is no "ground truth" establishment in the context of expert review of data for performance evaluation described in this 510(k) summary. The ground truth for sterility and biocompatibility is established by accepted laboratory methods and standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. No human adjudication of a "test set" is described for this device.

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 a Sphenoidal Electrode for recording electrical signals, not an AI-powered diagnostic tool. There is no mention or relevance of an MRMC study or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This device is a physical electrode, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" in this context refers to established scientific and regulatory standards for device characteristics:
- Substantial Equivalence: Features and performance of the predicate device (Wyler Sphenoidal Electrode).
- Mechanical Biocompatibility: ASTM, ANSI/AAMI standards.
- Sterility: Sterility Assurance Level (SAL) of 10⁻⁶, confirmed by validated sterilization processes (ethylene oxide).
- Pyrogen-Free: Limulus Amebocyte Lysate Test (LAL test) results.

8. The sample size for the training set

Not Applicable. This is a physical medical device, not an AI model requiring a training set.

9. How the ground truth for the training set was established

Not Applicable. As above, no training set for an AI model.

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