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510(k) Data Aggregation
(14 days)
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.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Electrical Performance: Equivalent to predicate device. | "Results indicate the device meets its performance specifications." |
| Mechanical Performance: Equivalent to predicate device. | "Results indicate the device meets its performance specifications." |
| Shelf Life: Maintained or equivalent to predicate device. | "Results indicate the device meets its performance specifications." |
| Biocompatibility: Safe for patient contact. | "Results indicate the device meets its performance specifications." |
| Hazard Analysis: All identified hazards sufficiently mitigated. | "All identified hazards have been sufficiently mitigated." |
| Intended Use: Consistent with predicate device. | "The BIS Quatro has the same intended use... as the predicate device." |
| Fundamental Scientific Technology: Consistent with predicate device. | "The BIS Quatro has the same... fundamental scientific technology as the predicate device." |
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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