(13 days)
The BIS Click sensor is applied directly to the patient's skin to enable recordings of electrophysiological (such as EEG) signals.
The BIS Click Sensor is a system comprised of the BIS Click disposable sensor and the reusable cable. This 510(k) is being submitted for the BIS Click which is a minor modification to the BIS SRS (K#050313) to enable the reusable cable to be used for indefinite uses with the disposable sensors and to recognize the smart card on the disposable sensor. The disposable sensor has been modified to add a smart card memory device containing information for lot number, expiration date, and number of connections. This information is used by the monitor for end user messaging, like in the Enhanced Sensor (K#002734).
The provided Special 510(k) summary for the K091854 BIS Click Sensor does not contain the detailed information requested to describe the acceptance criteria and the study that proves the device meets those criteria in the format you've requested.
Here's why and what information is available:
- Type of Submission: This is a Special 510(k) submission. Special 510(k)s are used for changes to a manufacturer's own legally marketed device where the modifications do not require a new intended use or fundamental scientific technology. They typically rely heavily on comparison to the predicate device and verification/validation of the changes, rather than extensive clinical studies with specific performance metrics against a "ground truth" as might be found in a De Novo or traditional 510(k) for a novel device.
- Device Type: The BIS Click Sensor is a cutaneous electrode. Its primary function is to enable the recording of electrophysiological signals (like EEG) by providing a connection between the patient's skin and monitoring equipment. It is not an interpretive AI device; therefore, the types of "acceptance criteria" and "ground truth" associated with diagnostic algorithms (e.g., sensitivity, specificity, AUC compared to expert consensus or pathology) are not applicable here.
- Focus of the Submission: The 510(k) states that the BIS Click is a "minor modification" to a previously cleared device (BIS SRS, K#050313). The modifications primarily involve:
- Enabling a reusable cable for indefinite uses with disposable sensors.
- Adding a smart card memory device to the disposable sensor for information like lot number, expiration date, and number of connections.
- Testing Summary Provided: The document lists generic categories of tests performed: "Mechanical," "Electrical," "Multiple use," "Shelf Life," and "Hazard Analysis." It states that "Results indicate the device meets its performance specifications and validation test requirements, and is safe for its intended use." However, it does not provide specific numerical acceptance criteria for these tests, nor the reported device performance against those criteria. It also does not include details on sample sizes, data provenance, ground truth establishment, or expert involvement as would be relevant for an AI/diagnostic device.
Therefore, I cannot populate the table or provide specific answers to most of your numbered questions because that level of detail is not present in the provided FDA submission document.
Here is a summary of what can be extracted from the provided text, acknowledging the limitations:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Mechanical | Meets performance specifications and validation test requirements. |
| Electrical | Meets performance specifications and validation test requirements. |
| Multiple Use | Meets performance specifications and validation test requirements. |
| Shelf Life | Meets performance specifications and validation test requirements. |
| Hazard Analysis | All identified hazards have been sufficiently mitigated. |
| Specific Numerical Criteria | Not provided in this document. The document only states that the device "meets its performance specifications." |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for any of the tests.
- Data Provenance: Not specified. As an electrode, the testing would likely involve bench testing and possibly some limited in-vivo testing to confirm signal integrity, but no details are provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable for this device and submission type. The device is a cutaneous electrode, not a diagnostic interpretive device requiring expert-established ground truth. Performance is assessed against engineering specifications, safety standards, and functional requirements.
4. Adjudication method for the test set:
- Not applicable as no expert adjudication is described or required for the type of testing performed (mechanical, electrical, etc.).
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-enabled diagnostic tool that would participate in an MRMC study.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a sensor, not an algorithm.
7. The type of ground truth used:
- For this type of device (cutaneous electrode), the "ground truth" for performance would be engineering specifications, industry standards (e.g., for electrical safety, biocompatibility), and functional requirements (e.g., signal quality, adhesive strength, material compatibility).
8. The sample size for the training set:
- Not applicable. This device is a hardware component (electrode), not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable for a hardware device.
In conclusion: The provided documentation focuses on showing substantial equivalence through verification and validation of engineering changes for a Class II cutaneous electrode, rather than providing the detailed clinical study data and performance metrics typically associated with AI/diagnostic devices that require extensive "ground truth" and expert consensus.
§ 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).