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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

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."

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The BIS Quatro sensor is applied directly to the patient's skin to enable recordings of electrophysiological (such as EEG) signals.

This 510(k) is being submitted for the BIS Quatro which is a minor modification to the 510(k) cleared Enhanced Sensor (K#002734). The formulation of the aqueous hydrogel is being changed.

This 510(k) submission (K093183) is for the BIS Quatro Sensor, a cutaneous electrode intended to enable recordings of electrophysiological signals (such as EEG) from the patient's skin. The submission primarily focuses on a minor modification to the predicate device, the Enhanced BIS Sensor (K002734), specifically a change in the formulation of the aqueous hydrogel.

Given the nature of the device (a minor modification to an existing electrode design) and the information provided, the "acceptance criteria" and "device performance" are centered around demonstrating that the modified device remains safe and effective for its intended use, and performs equivalently to the predicate device, particularly regarding its electrical and mechanical properties, shelf life, and biocompatibility.

Absence of a Traditional Clinical Study (MRMC or Standalone AI Performance):
It is crucial to note that this submission does not involve a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm-only performance study because the device is a simple medical electrode, not an AI-powered diagnostic or therapeutic tool. The "performance" here refers to physical and material properties rather than diagnostic accuracy or algorithmic output. Therefore, sections related to expert ground truth, adjudication, training sets, and AI-specific metrics are not applicable and will be marked as "N/A" (Not Applicable).

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implicitly tied to demonstrating that the modified BIS Quatro Sensor is substantially equivalent to the predicate device and meets its specified performance requirements after the hydrogel formulation change. The device performance is reported as meeting these specifications.

2. Sample Size Used for the Test Set and Data Provenance

The submission does not detail specific sample sizes for tests such as electrical, mechanical, shelf life, or biocompatibility. Given it's a materials-based modification, these tests would typically involve a statistically relevant number of manufactured units or samples of the modified hydrogel and assembled sensors.

• Sample Size for Test Set: Not specified in the provided summary. These would be laboratory tests on a representative sample of devices.
• Data Provenance: Not specified, but likely from internal laboratory testing conducted by Aspect Medical Systems, Inc. (USA-based company). The origin would be prospective manufacturing and testing of the modified device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Number of Experts: N/A (Not Applicable). This is a physical device and material testing, not a diagnostic interpretation task requiring expert consensus for ground truth.
• Qualifications of Experts: N/A

4. Adjudication Method for the Test Set

• Adjudication Method: N/A. Ground truth establishment through adjudication by experts is not applicable for this type of device submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No. This is a medical device, specifically an electrode, not a diagnostic imaging or AI system that would typically undergo an MRMC study.
• Effect Size of Human Readers Improvement with AI vs. without AI assistance: N/A, as no AI component is involved.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

• Standalone Study: No. This is a physical medical device; there is no standalone algorithm to evaluate.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the various tests (electrical, mechanical, shelf life, biocompatibility), the "ground truth" would be the established engineering specifications, industry standards (e.g., for biocompatibility), and performance benchmarks set by the predicate device. These are objective, rather than subjective, data points (e.g., resistance values, tensile strength, sterility, non-cytotoxicity).

8. The Sample Size for the Training Set

• Sample Size for Training Set: N/A. There is no AI model or "training set" in the context of this device.

9. How the Ground Truth for the Training Set Was Established

• How Ground Truth for Training Set Was Established: N/A.

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