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510(k) Data Aggregation
(175 days)
The VEEGix EEG System, is intended to be used for measuring and recording the electrical activity of a patient's brain, obtained by placing electrodes on the forehead and wirelessly transmitting the electroencephalographic (EEG) signals for storage and display.
The VEEGix EEG System, is intended for use in the acquisition of EEG signals, displaying them in real time and storing them for later review and analysis.
The VEEGix EEG System, is intended for use in a hospital Operating Room. Post Anesthesia Care Unit, Intensive Care Unit, Emergency Department, or in other medical facilities such as inpatient and outpatient (ambulatory) surgery settings.
The VEEGix EEG System is indicated for use on patients 18 years of age or older and is to be used by licensed medical professionals who have been adequately trained in the use and interpretation of EEG data for determination of brain state.
The VEEGix EEG System does not provide any diagnostic conclusion about the patient's condition.
The VEEGix EEG System is not to be used as a stand-alone in the evaluation or diagnosis of a disease or other condition.
The VEEGix EEG System is not intended for use in life support systems.
The VEEGix™ EEG system (subject device) is a Electrocochleographic (EEG) device to allow healthcare practitioners, nurses, neurologists and qualified technicians working in hospital Operating Room, Post Anesthesia Care Unit, Intensive Care Unit, Emergency Department, or in other medical facilities such as inpatient and outpatient (ambulatory) surgery settings to observe a patient's EEG signals and its derivatives.
The use of the subject device is a straight-forward procedure of applying the VEEGix Electrode, which is a lightweight band, onto the patient's scalp in which the electrodes acquire the patient's EEG signals. Those signals are transmitted via the VEEGix EEG module) to the VEEGix iOS app (application) which display the patient's EEG measurements in real-time to allow healthcare practitioners, nurses, neurologists and qualified technicians to monitor and record those EEG measurements.
Here's a breakdown of the acceptance criteria and study details for the VEEGix EEG System, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly list a table of quantitative acceptance criteria with corresponding performance values for the software component of the device. Instead, the "Technology Comparison" table highlights specific technical characteristics where the VEEGix EEG System aligns with or exceeds its predicates, implying these are the implicit acceptance criteria for technical equivalence. The clinical performance section describes the methodology used to demonstrate comparable EEG signal quality to a conventional clinical EEG system, which serves as the overarching performance goal.
Implicit Acceptance Criteria and Reported Device Performance (based on "Technology Comparison" and "Clinical Performance Testing" sections):
| Acceptance Criteria (Implied) | Reported Device Performance (VEEGix EEG System) | Reference/Context |
|---|---|---|
| Technical Equivalence | ||
| Classification Regulation | Class II per 882.1400 | Same as primary predicate |
| Product Code(s) | OLT, OMC, ORT, GXY | Same as primary predicate |
| Indications for Use | Subset of primary, same as secondary predicate | No new safety/effectiveness questions |
| Modalities | EEG | Same as predicates |
| Environment of Use | Hospital OR, PACU, ICU, ED, inpatient/outpatient surgery settings | Same as primary predicate, included in secondary |
| Number of EEG Channels | 1 bipolar | Same as secondary predicate, substantially equivalent to primary |
| Number of Electrodes | 3 (Fp1, Fpz, Fp2) | Same as secondary predicate, substantially equivalent to primary |
| Sensing Electrodes | Silver, disposable | Substantially equivalent |
| Power Source | Battery | Same as predicates |
| System Components | Electrode Array, Sensor module, acquisition, Tablet for memory and data viewing | Same as primary predicate, similar to secondary |
| Screen Display Details | Raw EEG Waveforms; Signal Quality (Channel Connection, Artifact, Noise, Interference); Spectral Parameters (EEG power spectrum, SEF 95%, DSA, α, Β, δ, θ, γ) | Substantially equivalent to primary (missing 10/20 Hz markers, B band division not raising new questions), secondary display capabilities included |
| Storage for offline recording | Yes, in the tablet display | Same as primary predicate |
| Electrode Impedance | Yes | Same as primary predicate |
| Detection for Leads Off | Yes | Same as predicates |
| File output capability | Yes | Same as predicates |
| Real-time EEG Display | Yes, wireless to tablet | Same as predicates |
| Processed EEG Bandwidth | 0.5 Hz to 80 Hz | Substantially equivalent as primary predicate (0.5 Hz to 45 Hz) |
| Automatic Artifact Identification | Yes | Same as primary predicate |
| Common Mode Rejection | > 100 dB | Substantially equivalent as primary predicate (> 90 dB) |
| Amplifier Input Impedance | 200 GΩ | Substantially equivalent as primary predicate (> 500 M Ohm) |
| Electrode Impedance Test | Yes | Same as primary predicate |
| Patient Contains Isolation | Reinforced Insulation (2 MOPP), battery powered | Substantially equivalent as primary predicate |
| Event Markers | Yes, artifact detection | Same as primary predicate |
| Burst Suppression Display | Yes, Suppression Ratio (%) | Substantially equivalent as primary predicate (Burst Suppression Probability) |
| Display Interface | Tablet display indicates connection and operation | Same as primary predicate |
| Biocompatibility | Tested per ISO 10993 (cytotoxicity, irritation, sensitization) | Substantially equivalent |
| Clinical Performance | ||
| Comparable EEG signal quality to conventional clinical EEG systems | Pearson's correlation coefficient (r=0.84, p<0.0001) between time-aligned NS and N1 waveforms. Substantial overlap visually. | Bench testing in ICU setting |
2. Sample size used for the test set and the data provenance
The document states: "Bench testing was performed in hospital to compare the quality and medical EEG feature similarity of electroencephalography (EEG) signals obtained by the NeuroServo (NS) device and those recorded with a conventional clinical EEG system (N1) (NicoletOne, Natus Medical Inc., Pleasanton, CA) in an ICU setting."
- Sample Size for Test Set: Not explicitly stated as a number of patients or recordings. The description focuses on signal processing and comparison, implying data was collected from one or more patients, but a specific count is missing.
- Data Provenance:
- Country of Origin: Not explicitly stated, but the study was performed "in hospital" in an "ICU setting," suggesting prospective data collection.
- Retrospective or Prospective: Prospective, as the testing was described as being "performed in hospital" to compare signals.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document mentions "experts" in the context of "10-second epochs as this is a common temporal range used by experts for the offline or online visualization of data." However, it does not state the number of experts used to establish the ground truth for the test set, nor their specific qualifications. The comparison was primarily quantitative (Pearson's correlation) and visual ("substantial overlap between the waveforms").
4. Adjudication method for the test set (e.g., 2+1, 3+1, none)
No explicit adjudication method (e.g., 2+1 or 3+1 for clinical consensus on ground truth) is mentioned for the test set. The comparison relies on a quantitative statistical measure (Pearson's correlation coefficient) and visual assessment of waveform overlap against a predicate device.
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
No multi-reader multi-case (MRMC) comparative effectiveness study involving human readers or AI assistance effect size is reported. The VEEGix EEG System "does not provide any diagnostic conclusion about the patient's condition" and "is not to be used as a stand-alone in the evaluation or diagnosis of a disease or other condition." Its purpose is to measure, record, and display EEG signals for interpretation by licensed medical professionals.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The clinical performance test described is a standalone (algorithm only) performance evaluation, although it's comparing the VEEGix system's signal acquisition and processing directly against a predicate system. The study quantified the similarity of EEG signals obtained by the VEEGix system with a conventional clinical EEG system (NicoletOne, N1) using Pearson's correlation coefficient. The output of the VEEGix system (processed EEG signals) was directly compared to the output of the N1 system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the clinical performance testing was the EEG signals obtained from a "conventional clinical EEG system (NicoletOne, Natus Medical Inc., Pleasanton, CA)". This predicate device's output served as the reference standard against which the VEEGix device's signal quality was compared.
8. The sample size for the training set
The document does not provide any information regarding a training set sample size. The VEEGix EEG System appears to be a signal acquisition and display system without explicit mention of deep learning or AI models that would require a dedicated training set in the conventional sense. The "Automatic Artifact Identification" feature might implicitly involve some learned algorithms, but no details on training data are provided.
9. How the ground truth for the training set was established
As no training set is mentioned or detailed, there is no information provided on how ground truth for a training set was established.
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