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510(k) Data Aggregation
(149 days)
The DeltaScan Patch is applied directly to the patient's skin to record EEG signals.
The DeltaScan Patch is dedicated and only intended to be used in combination with the DeltaScan Monitor (K222680) through a proprietary connector design.
The DeltaScan Patch is a single use EEG electrode Patch, used exclusively with the DeltaScan Monitor. The DeltaScan Patch is used with the DeltaScan Monitor to enable the acquisition of EEG signals. The DeltaScan Monitor provides signal analysis technology intended for use as an adjunct to clinical judgment.
The DeltaScan Patch is used to collect EEG signals from two electrode locations see Figure 5-1 DeltaScan Patch Electrode Locations.
The provided text describes the DeltaScan Patch, a cutaneous electrode intended to record EEG signals in conjunction with the DeltaScan Monitor. However, the document primarily focuses on the substantial equivalence argument to a predicate device (Covidien BIS Sensors, K143506) and the safety testing (biocompatibility, electrical safety, mechanical testing, and shelf-life).
Crucially, the document explicitly states that "No dedicated clinical study is needed to validate the device performance" for the DeltaScan Patch. Therefore, it does not contain information about acceptance criteria for device performance in terms of signal capture quality or diagnostic accuracy, nor does it describe a study proving the device meets such criteria. The "performance data" section primarily refers to safety and functional verification, not clinical performance for its primary intended use of recording EEG signals (beyond "it transfers the electrical signals as intended").
Given this limitation in the input, I cannot populate all sections of your requested table and study description definitively. I will outline what can be inferred from the provided text, and explicitly state where information is missing due to the nature of the FDA submission for this device.
Acceptance Criteria and Reported Device Performance
As noted, the document explicitly states that "No dedicated clinical study is needed to validate the device performance" for recording EEG signals. The performance data provided relates to safety, materials, and mechanical integrity.
| Acceptance Criteria (from provided text) | Reported Device Performance (from provided text) |
|---|---|
| Biocompatibility: Meet ISO 10993-1:2018 requirements for a surface contacting device (<24 hours each day) | All parts of the DeltaScan Patch R2 with REF 009.000.B that are directly in contact with the patient's skin have passed the acceptance criteria defined per ISO 10993-1:2018 requirements. |
| Electrical Safety: Not Applicable (not Medical Electrical Equipment per EN ISO 60601-1) | The DeltaScan Patch is not considered Medical Electrical Equipment as defined by the EN ISO 60601-1. Its use does not depend on essential performance according to EN ISO 60601-1. |
| Software V&V: Not Applicable (does not contain software) | N/A |
| Mechanical Testing (Labels): Legible, durable, compliant, compatible with packaging | The labels on the packaging were tested to verify be legible, durable, compliant with regulations, and compatible with the packaging. |
| Mechanical Testing (Packaging): Compatible with labeling, can be shipped without damage | The packaging was tested to verify to be compatible with the labeling, and can be shipped without damage. |
| Shelf Life: 9 months | The stated shelf life of 9 months is mainly based on the degradation of the two frontal electrodes. This is verified and documented in the Verification Report based on accelerated aging. (Real time aging in progress, may show longer shelf life in future.) |
| Electrical Signal Transfer: Transfers electrical signals as intended | The Verification Report provides sufficient proof that it transfers the electrical signals as intended. (This is a functional claim, but no specific performance metrics or studies are described for how well or with what fidelity it transfers EEG signals, beyond the implication that it works sufficiently for its intended use in conjunction with the DeltaScan Monitor, which presumably has its own performance validation). The report concludes that it "shows that it performs as intended, is safe and effective for its intended use, and provides similar safety and effectiveness results to the predicate device." |
Study Details (Based on the provided text)
Since the document states "No dedicated clinical study is needed to validate the device performance" for the DeltaScan Patch itself, the following sections will reflect the lack of such clinical performance study data in this submission. The "studies" mentioned are largely engineering verification and validation for safety and functional aspects.
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Sample size used for the test set and the data provenance:
- Biocompatibility: Not specified for the number of samples, but "all parts of the DeltaScan Patch R2" were tested.
- Mechanical Testing (Labels & Packaging): Not specified.
- Shelf Life: Not specified for the number of patches or test duration, but based on accelerated aging.
- Electrical Signal Transfer ("Verification Report"): Not specified.
- Data Provenance: The studies appear to be internal verification and validation studies conducted by the manufacturer (Prolira B.V.). No information on country of origin of data or retrospective/prospective nature is given beyond the type of studies (e.g., accelerated aging).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as no clinical performance study with expert ground truth data is described for the DeltaScan Patch itself. The "ground truth" for the verification activities would be established by industry standards (e.g., ISO 10993-1) and internal engineering specifications.
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Adjudication method for the test set:
- Not applicable as no clinical performance study requiring expert adjudication is described.
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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:
- No MRMC study was done. The DeltaScan Patch is an EEG electrode, not an AI-powered diagnostic device, and thus this type of study is not relevant to its primary submission. The document explicitly states "No dedicated clinical study is needed to validate the device performance" and that the patch does not contain software.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The DeltaScan Patch is a hardware component (an electrode); it is not an algorithm. Its function is to acquire signals for a separate device (DeltaScan Monitor, K222680).
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The type of ground truth used:
- For Biocompatibility: Established by adherence to ISO 10993-1:2018 standards and their defined acceptance criteria.
- For Mechanical Testing (Labels & Packaging): Established by internal specifications for legibility, durability, compliance, and shipping integrity.
- For Shelf Life: Established by accelerated aging protocols and internal specifications for electrode degradation.
- For Electrical Signal Transfer: Established by internal verification that the patch "transfers the electrical signals as intended." Specific metrics or objective "ground truth" (e.g., comparison to a gold-standard EEG recording) for signal fidelity are not detailed in this summary.
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The sample size for the training set:
- Not applicable. The DeltaScan Patch is a hardware device; it does not involve machine learning algorithms requiring a training set.
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How the ground truth for the training set was established:
- Not applicable (no training set as it's a hardware device).
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(149 days)
The DeltaScan Monitor provides the binary DeltaScan Output based on a technical index of polymorphic delta (PMD) waveshape detections made in the EEG from the bipolar Fp2 and Pz channel on adult patients (over 60 years of age) to aid in the diagnosis of acute encephalopathy.
DeltaScan should only be used by a healthcare provider as a component of a complete clinical evaluation or as support for the clinician's decision to pursue further testing. The device is NOT to be used as a stand-alone method in the evaluation or diagnosis of acute encephalopathy.
The intended patient is a hospitalized, awake adult, who is at risk of acute encephalopathy and delirium as decided by the responsible licensed healthcare physician or a medical professional working under the responsibility of a licensed healthcare physician.
The use environment is in hospitals:
· non-sterile environments;
· ICUs, wards, and other patient evaluation locations;
The DeltaScan Monitor is intended to be used in combination with the DeltaScan Patch (K222671) through a proprietary connector design.
The DeltaScan Monitor provides EEG signal acquisition and analysis technology intended for use as an adjunct to clinical judgment. The DeltaScan Monitor provides support in clinical decision-making by providing an assessment for a patient having acute encephalopathy or not, based on a measure of the detected polymorphic delta (PMD) waves in the EEG.
The DeltaScan Monitor consists of a Monitor and a Patch connector. The Patch connector contains the EEG amplifier hardware. The Monitor contains electronics for galvanic isolation to the EEG cable with Patch connector, storage of EEG recording and log files (eMMC memory chip), processing capacity to run software (DeltaScan Monitor Application, or DMA), user interface elements (e.g., screen, keys, recording button), battery (FEY PA-IEC-LNB162Q.R001), and the charging circuitry. EEG data is collected by the DeltaScan Monitor using a DeltaScan Patch. Collected EEG signals are amplified, digitized, and then processed by the software algorithms to provide the user with the DeltaScan Output. The DeltaScan Monitor Application is stand-alone software running on an Embedded Linux OS.
This document describes the acceptance criteria and the study that proves the device (DeltaScan Monitor R2) meets these criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Pre-specified Criteria) | Reported Device Performance (Study Result) | Pass/Fail | Discussion and Sensitivity Analysis | Rationale for Safety and Effectiveness |
|---|---|---|---|---|
| ICU | ||||
| Null hypothesis: NPV < 0.80 (lower bound of CI ≥ 0.8) | NPV = 0.85 CI = [0.77, 0.92] | Fail | The reasons why the end-point for NPV was missed is clear: 1) due to COVID-19 restriction, the number of patients on ICUs is less than aimed for, resulting in larger confidence intervals, and 2) the prevalence estimates were too low in the power calculation, resulting in too high pre-specified criteria. A sensitivity analysis that adjusts the prevalence to the study protocol estimate for prevalence (35%) shows that: NPV = 0.89 [0.85, 0.94]. Under these conditions, the end-points would have been met. | We conclude that reasons for the missed end-point on NPV are clear and understood. Overall, NPV values are reasonably high, while NPV+PPV values exceed the pre-specified criterium. Both NPV and PPV results are robust for some variation in study assumptions (sensitivity analysis). When considering both NPV and PPV, the performance shows safety and effectiveness. |
| NPV + PPV ≥ 1 | NPV + PPV = 1.62 CI = [1.50, 1.72] | Pass | ||
| Ward | ||||
| Null hypothesis: NPV < 0.85 (lower bound of CI ≥ 0.85) | NPV = 0.83 CI = [0.76, 0.89] | Fail | The reason why the end-point for NPV was missed is clear: the prevalence estimates were too low in the power calculation, resulting in too high pre-specified criteria. A sensitivity analysis that adjusts the prevalence to the study protocol estimate for prevalence (25%) shows that: NPV = 0.90 [0.87, 0.93]. Under these conditions, the end-points would have been met. | We conclude that reason for the missed end-point on NPV are clear and understood. Overall, NPV values are reasonably high, while NPV+PPV values exceed the pre-specified criterium. Both NPV and PPV results are robust for some variation in study assumptions (sensitivity analysis). When considering both NPV and PPV, the performance shows safety and effectiveness. |
| NPV + PPV ≥ 1 | NPV + PPV = 1.66 CI = [1.55, 1.75] | Pass | ||
| ICU + Ward (pooled) | ||||
| Null hypothesis: NPV < 0.80 (lower bound of CI ≥ 0.8) | NPV = 0.84 CI = [0.79, 0.88] | Fail | The reason why the end-point for NPV was missed is clear: the prevalence estimates were too low in the power calculation, resulting in too high pre-specified criteria. A sensitivity analysis that adjusts the prevalence to the study protocol estimate for prevalence on the ICU (35%) shows that: NPV = 0.87 [0.84, 0.90]. Under these conditions, the end-points would have been met. | We conclude that reason for the missed end-point on NPV are clear and understood. Overall, NPV values are reasonably high, while NPV+PPV values exceed the pre-specified criterium. Both NPV and PPV results are robust for some variation in study assumptions (sensitivity analysis). When considering both NPV and PPV, the performance shows safety and effectiveness. |
| NPV + PPV ≥ 1 | NPV + PPV = 1.63 CI = [1.55, 1.71] | Pass |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 434 patients (195 on ICUs and 239 on wards) fulfilled inclusion, but not exclusion, criteria.
- Data Provenance:
- Country of Origin: The Netherlands (geographically distinct clinics: 6 ICUs and 15 wards).
- Retrospective or Prospective: Prospective. The study "DeltaStudy" was designed to evaluate diagnostic performance and repeatability, involving the collection of EEGs with DeltaScan and clinical data on ICUs and wards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Acute Encephalopathy (EEG reference standard): 3 separate EEG experts. Qualifications are not explicitly detailed beyond being "EEG experts." They visually assessed 4-minutes of EEG data for the presence of polymorphic delta activity.
- Delirium (clinical reference standard): 3 clinical delirium experts. Qualifications are not explicitly detailed beyond being "clinical delirium experts." They assessed clinical data including researcher's interview based on DSM-5 criteria A-C, Electronic Health Record data, and description of patient behavior.
4. Adjudication Method for the Test Set
The ground truth for both acute encephalopathy and delirium was established using consensus (majority vote) among the experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study comparing human readers with and without AI assistance was reported. The study focused on the standalone diagnostic performance of the DeltaScan Monitor in comparison to expert consensus (ground truth).
6. Standalone (Algorithm Only) Performance
Yes, a standalone performance study was conducted. The "DeltaScan Output" (binary positive/negative for acute encephalopathy) was determined by the DeltaScan Monitor from EEG recordings, and these outputs were compared against the expert committee's estimated diagnoses for acute encephalopathy and delirium.
7. Type of Ground Truth Used
- Acute Encephalopathy: Expert consensus from 3 EEG experts visually assessing EEG data for polymorphic delta activity.
- Delirium: Expert consensus from 3 clinical delirium experts assessing clinical data and DSM-5 criteria.
8. Sample Size for the Training Set
The document mentions that the DeltaScan was calibrated based on a "previous clinical calibration dataset" from Numan et al., 2019, BJA. This dataset contained 321 EEG recordings. This is the sample size for the calibration dataset, which effectively serves as a training or development set for the algorithm's scoring and thresholding.
9. How the Ground Truth for the Training Set Was Established
For the calibration dataset (Numan et al., 2019, BJA), the ground truth for acute encephalopathy and delirium was established through expert labels. The document states that the calibration dataset contained "321 EEG recordings with expert labels for acute encephalopathy and delirium." This suggests a similar expert review process to the test set, where experts provided their diagnoses to create the ground truth.
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