(135 days)
The PMT® TruScan® Surface Electrodes are indicated for cutaneous use in the general recording and monitoring of the Electroencephalograph (EEG) and Evoked Potential (EP).
The PMT® TruScan® Surface Electrodes are CT compatible and MR Conditional under the following conditions:
- Static magnetic field strength of 1.5-T only
- Maximum spatial gradient magnetic field of 5,000 Gauss/cm (50T/m) or less
- The connector hub must be placed near the center MR system's bore, and must be at least 20-cm from the wall of the MR system's bore at all times.
- The extension cable must be disconnected from the PMT TruScan Surface Electrode before scanning and MUST remain disconnected throughout the entire MR scan.
- Normal Operating Mode of operation for the MR system with a maximum whole body averaged specific absorption rate (SAR) of 2.0-W/kg for 15 minutes of scanning (i.e., per pulse sequence)
The PMT® TruScan® Surface Electrodes are non-invasive, cutaneous devices used in the acquisition of signals for the purpose of monitoring and recording Electroencephalograph (EEG) and Evoked Potentials (EP).
The reusable TruScan® Surface Electrodes have a disc with a diameter of 10 mm coated with silver / silver chloride (Ag/AgCl). Each disc is permanently adhered to an insulated lead wire. An extension cable is required to connect the Truscan® Surface Electrodes to the recording equipment. The extension cable is electrically insulated and terminated by a molded touch proof connector that is compliant to the safety requirements outlined in IEC 60601-1 subclause 56.3(c).
During a MRI examination, the extension cable must be disconnected from the TruScan® Surface Electrodes.
Numbered and color coated lead wires are provided to facilitate identification.
The electrodes are provided non-sterile and can be reused.
This 510(k) summary (K122376) describes the PMT TruScan® Surface Electrodes. The document primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the device's characteristics and MR compatibility conditions.
Here's an analysis of the provided information concerning acceptance criteria and supporting studies, formatted as requested:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state quantitative acceptance criteria in the typical sense (e.g., a specific sensitivity or specificity threshold for a diagnostic device). Instead, the performance is detailed through technical specifications, material characteristics, and compliance with MR conditional guidelines. The "acceptance criteria" here are implied by the conformity to these specifications and the statement of MR conditions.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Intended Use: Cutaneous EEG/EP recording and monitoring. | Indicated for cutaneous use in general recording/monitoring of EEG and EP. |
| CT Compatibility: Compatible with CT scans. | Stated as CT compatible. |
| MR Conditional: Safe under specified MRI conditions. | MR Conditional under the following specified conditions: |
- Static magnetic field strength of 1.5-T only.
- Maximum spatial gradient magnetic field of 5,000 Gauss/cm (50T/m) or less.
- Connector hub near center MR bore, >= 20-cm from MR system's bore wall.
- Extension cable must be disconnected before and during MR scan.
- Normal Operating Mode of MR system with max whole body averaged SAR of 2.0-W/kg for 15 minutes of scanning. |
| Material Composition (Sensor Cup): Silver/silver chloride. | Silver/silver chloride. |
| Cup Diameter: 10 mm. | 10 mm. |
| Assembly to Cup Material: ABS/Carbon fiber composite. | ABS/Carbon fiber composite. |
| Lead Wire Core Material: Nichrome. | Nichrome. |
| Lead Wire Insulation Material: PVC. | PVC. |
| Electrode + Cable Length: 60". | 60". |
| Lead Wire Connection Compliance: IEC 60601-1 subclause 56.3(c).| 1.5 mm Brass/Polypropylene IEC 60601-1 subclause 56.3(c) compliant. |
| Packaging: Non-sterile, sealed in PE pouch or equivalent. | Non-sterile, sealed in PE pouch or equivalent. |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not contain information about a test set with a specific sample size or data provenance (e.g., country of origin, retrospective/prospective). This device is a surface electrode for physiological signal acquisition, not a diagnostic algorithm. The "testing" referred to in the document involves adherence to material specifications and MR compatibility standards, likely through engineering tests and simulations rather than patient-based clinical studies with specific sample sizes.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable and not present in the document. As mentioned above, this filing pertains to a medical device (electrode), not an AI/ML diagnostic system that would require expert-established ground truth from clinical cases. The "ground truth" for this device relates to its physical and electrical properties, and its safe use under MR conditions, which are typically verified through technical testing by engineers and physicists.
4. Adjudication Method for the Test Set
This information is not applicable and not present in the document for the reasons explained in point 3. Clinical adjudication methods (e.g., 2+1, 3+1) are relevant to the evaluation of diagnostic performance where expert disagreement needs resolution, which is not the case for this type of medical device filing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done and is not mentioned. This type of study is specifically designed for evaluating the performance of diagnostic algorithms or imaging interpretations, often comparing human readers with and without AI assistance. The TruScan® Surface Electrodes are hardware devices for signal acquisition, not an interpretation tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone performance study (algorithm only) was not done and is not mentioned. This concept is relevant for AI/ML diagnostic algorithms, not for physical medical devices like electrodes.
7. The Type of Ground Truth Used
The "ground truth" for the PMT TruScan® Surface Electrodes relies on physical measurement, engineering testing, and compliance with recognized standards (e.g., IEC 60601-1) and MR conditional safety guidelines. This is primarily focused on:
- Material properties and composition: Verification of specified materials (e.g., silver/silver chloride, Nichrome, PVC, ABS/Carbon fiber composite).
- Dimensional accuracy: Verification of cup diameter and electrode/cable length.
- Electrical safety and performance: Adherence to standards like IEC 60601-1.
- MR compatibility and safety: Demonstration that the device meets the specified MR conditional criteria through testing following guidelines relevant to MR safety (e.g., heating, artifact generation).
8. The Sample Size for the Training Set
This information is not applicable and not present in the document. The concept of a "training set" is relevant for machine learning algorithms, which is not what this device is.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not present in the document for the reasons explained in point 8.
§ 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).