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510(k) Data Aggregation
(294 days)
The Background Pattern Classification algorithm is intended for:
· Neonatal patients, defined as from birth to 28 days post-delivery, and corresponding to a post-conceptual age of 37 to 46 weeks, in clinical environments such as the intensive care unit, operating room, and for clinical research.
• To analyze and identify background patterns in aEG, including continuous and discontinuous activity, burst suppression, low voltage, and inactive patterns. The aEEG must be obtained from a pair of parietal electrodes located at positions corresponding with P3 and P4 of the International 10/20 System. The background pattern classification algorithm must be reviewed and interpreted by qualified clinical practitioners.
The device does not provide any diagnostic conclusion about the patient's condition.
BPc™ is a software only product that identifies background patterns seen on aEEG signal recorded from a pair of parietal electrodes (P3-P4) in neonates, defined as from birth to 28 days post-delivery, and corresponding to a post-conceptual age of 37 to 46 weeks. The classification of aEEG background pattern into one of five different classes is done in accordance with the scoring scheme described in the following table:
- Continuous (C): Continuous activity with lower (minimum) amplitude around (5 to) 7 to 10 µV and maximum amplitude of 10 to 25 (to 50) µV.
- Discontinuous (DC): Discontinuous background with minimum amplitude variable, but below 5 µV, and maximum amplitude above 10 µV.
- Burst-suppression (BSA): Discontinuous background with minimum amplitude without variability at 0 to 1 (2) µV and bursts with amplitude >25 µV. BS+ denotes burst density >100 bursts/h, and BS- means burst density
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Implicit) | Reported Device Performance (BPc™ Algorithm) |
|---|---|---|
| Positive Percent Agreement (PPA) | Not explicitly stated but inferred from comparison to inter-rater performance | Overall PPA: 77% (95% CI: 72 – 82) |
| False Detection Rate (FDR) | Not explicitly stated but inferred from comparison to inter-rater performance | Overall FDR: 2.5 FD/hr (95% CI: 1.6 – 3.5) |
Detailed PPA and FDR by Pattern:
| Pattern | Reported PPA (%) (95% CI) | Reported FDR (FD/hr) (95% CI) |
|---|---|---|
| Continuous (C) | 86 (77 - 94) | 0.3 (0.1 - 0.7) |
| Discontinuous (D) | 64 (51 - 77) | 0.1 (0.1 - 0.3) |
| Burst-suppression (BS) | 89 (78 - 99) | 4.4 (1.5 - 5.0) |
| Low Voltage (LV) | 66 (50 - 83) | 4.2 (2.3 - 4.8) |
| Inactive, flat (FT) | 80 (63 - 96) | 4.2 (1.2 - 4.8) |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: Not explicitly stated but derived from the information on "EEG studies" for the clinical validation. Given the gender distribution (36 female/28 male), the test set involved 64 patients/EEG studies.
- Data Provenance: Not explicitly stated, but the study was conducted by Natus Medical Incorporated in Canada, suggesting the data may be from Canada or a similar clinical environment. The study is retrospective, as it uses de-identified, randomized EEG studies that were provided to experts.
3. Number of Experts and Qualifications
- Number of Experts: 3
- Qualifications of Experts: "board certified neurophysiologists"
4. Adjudication Method for the Test Set
The adjudication method was not explicitly a "2+1" or "3+1" approach. Instead, it seems to have used a "consensus-based" ground truth methodology. The "panel of 3 EEG board certified medical professionals" independently, blindly, and manually marked background pattern states. The "Gold standard" for comparison was defined as "background pattern as classified by a panel of 3 EEG board certified medical professionals." While the exact mechanism for how the three independent markings were combined to form the "gold standard" is not detailed (e.g., majority vote, discussion to consensus), it implies a form of expert consensus without a clear formal adjudication rule like 2+1. The results report "Inter Rater Performance" for each reviewer against a collective "gold standard" (likely the consensus or majority of the other two, though not explicitly stated for this table).
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done involving human readers with and without AI assistance. The study focuses purely on comparing the standalone performance of the AI algorithm against a "gold standard" established by human experts. It also includes inter-rater variability among human experts.
6. Standalone (Algorithm Only) Performance
Yes, a standalone performance study was done. The "Algorithm Performance Comparison" table directly reports the diagnostic performance (PPA and FDR) of the BPc™ algorithm when compared to the "gold standard" established by the panel of experts.
7. Type of Ground Truth Used
The type of ground truth used was expert consensus. It was established by "a panel of 3 EEG board certified medical professionals" who independently, blindly, and manually marked background pattern states.
8. Sample Size for the Training Set
The sample size for the training set is not provided in the document. The document describes the clinical validation dataset (test set) but no information regarding the dataset used to train the algorithm.
9. How the Ground Truth for the Training Set Was Established
As the sample size and nature of the training set are not provided, how the ground truth for the training set was established is also not detailed in the document.
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