(127 days)
The BIS Sensor is applied directly to the patient's skin to enable recordings of electrophysiological (such as EEG) signals.
The BIS Sensor, generally speaking with regard to the four variations of the sensor, is a rectangular shaped, pre-gelled array of four zipprep electrodes that is applied to the patient's skin to record electrophysiological signals, such as EEG signals.
It is a low impedance, single patient use, disposable electrode sensor designed for application to the frontal/temporal area. The sensor is designed to provide ease of use and electrode placement accuracy. It is in conjunction with Covidien BIS Monitors.
The body of the sensor houses three (3) electrodes which are placed on the forehead, and a fourth electrode placed over the temple area. The sensor collects EEG signals from these areas, and the differential signals from the temple and above the eye relative to the center of the forehead are used to calculate the Bispectral Index (BIS) value.
The "zipprep" design is constructed using flexible tine disks placed in pockets on a polyethylene basepad. A polyurethane foam disk and hydrogel is placed over the tines. The basepad has a medical grade pressure sensitive adhesive for adhering to the skin. A mylar substrate with conductive silver / silver chloride ink circuit is adhered to the other side of the basepad. The flexible tines, surrounded by hydrogel, are used to part the outermost layer of skin. While the flexible tines part the skin, hydrogel flows around the tines and forms a conductive bridge with the skin. The silver / silver chloride circuit provides signal continuity from each electrode (gel/tine/foam) to the monitor. A polyester insulation is used to restrict electrical contact to the electrode area.
The sensor connects to the monitor at a single point (paddle tab) that is low profile and easy to insert and remove. The tab has an electronic smart card memory device that contains identification information (date of manufacture, number of connections, lot number).
Each sensor is presented on a silicone liner tray and packed in individual heat-sealed pouches. Twenty-five (25) sealed pouches are packed into a cardboard box.
The provided text describes a 510(k) premarket notification for a reformulation of the gel in Covidien BIS Sensors. The document focuses on demonstrating substantial equivalence to previously cleared devices rather than reporting on a study demonstrating clinical performance against acceptance criteria for an AI-based device.
Therefore, many of the requested categories for AI device evaluation (such as sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, effect size, standalone performance, training set sample size, and ground truth for training set) are not applicable or not provided in this document, as it concerns a change in a physical component (gel) of a medical device, not an AI algorithm.
However, I can extract the relevant information regarding acceptance criteria and reported device performance from the provided text, specifically related to the gel reformulation, even though it's not in the context of an AI study.
Here's a summary based on the provided text, adapted to the context of a physical device component change:
Acceptance Criteria and Study for Covidien BIS Sensor Gel Reformulation
The provided document describes a Traditional 510(k) submission (K143506) for a reformulation of the gel used in Covidien BIS Sensors (BIS Quatro Sensor, BIS Extend, BIS Pediatric Sensor, BIS Bilateral Sensor). The study aims to demonstrate that the new gel formulation does not change the device's fundamental safety and effectiveness and that the device remains substantially equivalent to its predicate devices.
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Implied/Explicit) | Reported Device Performance (with new gel formulation) |
|---|---|---|
| Electrical Performance | Meets AAMI standard EC12:2000 (standard for disposable ECG electrodes) | "All testing results are considered acceptable." The electrical testing results demonstrated compliance with the AAMI standard EC12:2000. |
| Shelf Life | Maintains performance over its intended shelf life. | "All testing results are considered acceptable." Shelf life testing was performed, and results were acceptable. |
| Biocompatibility - Cytotoxicity | Non-cytotoxic. | "All testing results are considered acceptable." Biocompatibility tests for Cytotoxicity were performed and passed. |
| Biocompatibility - Irritation | Non-irritating. | "All testing results are considered acceptable." Biocompatibility tests for Irritation were performed and passed. |
| Biocompatibility - Sensitization | Non-sensitizing. | "All testing results are considered acceptable." Biocompatibility tests for Sensitization were performed and passed. |
| Hazard Analysis | No new hazards introduced. | "This change does not result in any changes to the hazard analysis." |
| Substantial Equivalence | Remains safe and effective and substantially equivalent to predicate devices. | "Covidien has concluded that the device is substantially equivalent to the predicate devices, with specific regard to the gel, and is safe and effective for its intended use." |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated in the provided text. The document refers to "test results" and "testing" without specifying the number of units or patients involved in each test category (electrical, shelf life, biocompatibility).
- Data Provenance: Not explicitly stated. The manufacturer is Covidien (Boulder, CO, USA), and a contract manufacturer is Celestica Electronics PTE LTD. (Singapore). The testing would presumably have been conducted in facilities associated with these entities or their designated testing laboratories. The data is retrospective in the sense that it's reported after the completion of tests for submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable: This information is not relevant to the evaluation of a gel reformulation for a cutaneous electrode. The "ground truth" for the tests (e.g., cytotoxicity, electrical performance) would be determined by standard laboratory methods and equipment, not by human expert consensus or interpretation of complex medical data.
4. Adjudication method for the test set
- Not Applicable: Adjudication methods (like 2+1, 3+1) are typically used for interpreting subjective medical data or resolving disagreements among human readers in diagnostic studies. This is not reported for the technical and biological tests performed on a material reformulation.
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 document describes changes to a physical medical device (electrode gel), not an AI-powered diagnostic system. Therefore, an MRMC study related to AI assistance is not relevant or reported here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This document is not about an algorithm or AI.
7. The type of ground truth used
- For electrical testing: Compliance with AAMI standard EC12:2000, which has defined objective electrical performance parameters.
- For shelf life testing: Stability and performance of the device over time, likely assessed against engineering specifications.
- For biocompatibility testing: Compliance with ISO 10993 standards (implied by "biocompatibility tests for Cytotoxicity, Irritation, and Sensitization" mentioned). These standards define objective criteria for biological safety.
8. The sample size for the training set
- Not Applicable: This is not an AI device, so there is no "training set."
9. How the ground truth for the training set was established
- Not Applicable: This is not an AI device, so there is no "training set."
§ 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).