(324 days)
The intended use of the SmartEP-ASSR product is for the recording of auditory steadystate evoked potential data. The product is intended to be used as a diagnostic aid in auditory and hearing related disorders and as an adjunctive tool in the estimation of behavioral hearing thresholds.
SmartEP-ASSR is a auditory evoked potential testing device that is capable of measuring auditory steady state responses (ASSR).
The provided text is a 510(k) summary for the SmartEP-ASSR device, which is an auditory evoked potential testing device. The summary primarily focuses on demonstrating substantial equivalence to a predicate device (Bio-logic MASTER Evoked Response System, K021895) through a comparison of technical specifications.
Based on the provided information, there is no detailed study described that establishes explicit acceptance criteria and proves the device meets those criteria in a quantitative performance study. The submission relies on demonstrating substantial equivalence by comparing technical parameters to a legally marketed predicate device. This type of submission usually implies that if the technical specifications are comparable or superior, and there are no new questions of safety or effectiveness, then the device is considered to meet the requirements for marketing.
Here’s a breakdown of the requested information, indicating where the text provides details and where it does not:
1. Table of Acceptance Criteria and Reported Device Performance
As noted above, no explicit acceptance criteria for diagnostic accuracy or performance metrics (like sensitivity, specificity, or agreement rates) are stated, nor is there a study detailing such performance. The provided table focuses on technical specifications for comparing the SmartEP-ASSR to its predicate device. This comparison is the primary method used to argue for "substantial equivalence."
| Parameter | Predicate Device (Bio-Logic Master, K021895) | SmartEP-ASSR (Device Under Review) | Acceptance Criterion/Performance (Implied) |
|---|---|---|---|
| Data Acquisition | |||
| A/D Resolution | 16 bit | 16 bit | At least 16 bit |
| Artifact Rejection | Programmable | Programmable | Programmable |
| Amplifiers | |||
| Channels | 1 Channel Optically Isolated | 1-4 Channels Optically Isolated | At least 1 channel optically isolated |
| Gain | 10k | Variable (30k-300k) | Comparable or improved range of gain |
| Filters | |||
| Slope | 12 dB/octave | 6 dB/octave | Specified filter slope |
| LP (Low Pass) | 1.5k, 3k, 10k, 20k Hz | 30, 100, 300, 500, 1k, 1.5k, 3k, 5k Hz | Comparable or wider range of LP filters |
| HP (High Pass) | 0.1, 0.3, 1, 3, 10, 30, 100, 300Hz | 1, 10, 30, 50, 100, 150, 300, 500 Hz | Comparable or wider range of HP filters |
| Notch | 50/60Hz | 50/60Hz | 50/60Hz |
| Digital Filters | 1-200Hz | User Selectable (1 -5k Hz) | Comparable or wider range of digital filters |
| Noise Level | 0.45 μV RMS (10-3k Hz) | 0.33 μV RMS (1-3k Hz) | Noise level ≤ 0.45 μV RMS (or better) |
| Input Impedance | 100M Ohms | 5M Ohms | Specified input impedance |
| CMR Ratio | 110 dB at 50/60 Hz | 117 dB at 60 Hz and 110 dB at 1k Hz | CMR Ratio ≥ 110 dB |
| Impedance Test | |||
| Signal | 20 Hz Sinewave | 1k Hz Sinewave | Specified impedance test signal |
| Auditory Stimuli | |||
| Presentation | Monaural or Binaural | Monaural or Binaural | Monaural or Binaural |
| Number of Frequencies | 1-4 | 1-8 | At least 1-4 frequencies |
| Test Frequencies | 500, 750, 1k, 1.5k, 2k, 3k, 4k, 6k, 8k Hz | User Selectable: Clicks, Pure Tones and Multifrequency Stimuli (500Hz-8k Hz) | Comparable range of test frequencies |
| Types | Sinewave | Sinewave, Tone Burst | At least Sinewave |
| Envelopes | Linear, Blackman, Gaussian, Hanning Envelopes | Linear, Blackman, Gaussian, Hanning, Rectangular, Triangular, Trapezoidal, Exact Blackman, Cosine, Cosine Squared, Cosine Cubed | Comparable or wider range of envelopes |
| Intensity | 0-125 dB SPL (132 dB Optional) | 0-125 dB SPL | 0-125 dB SPL |
| Masking | White Noise Programmable | White Noise Programmable | White Noise Programmable |
| Transducers | TDH Earphones, Insert Earphones, Bone Conduction, Sound Field | TDH Earphones, Insert Earphones, Bone Conduction, Sound Field, OAE Probe | Comparable range of transducers |
| Computer Requirements | |||
| Computer Type | Personal Computer | Personal Computer | Personal Computer |
| Operating System | Microsoft Windows | Microsoft Windows 98SE, ME, 2000, XP | Microsoft Windows (compatible) |
| Interface Connection | Serial | USB (Universal Serial Bus) | Specified interface connection |
The "acceptance criteria" can be inferred as the SmartEP-ASSR meeting or exceeding the technical specifications of the predicate device, thereby demonstrating substantial equivalence for its intended use. For instance, the noise level being 0.33 μV RMS is "better" than the predicate's 0.45 μV RMS, which would contribute to showing equivalence or improvement.
2. Sample size used for the test set and the data provenance
The document does not describe any clinical test set or data derived from study participants for performance evaluation. The submission relies solely on comparing technical specifications to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical test set with ground truth established by experts is described.
4. Adjudication method for the test set
Not applicable, as no clinical test set requiring adjudication is described.
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 an auditory evoked potential testing device, not an AI-assisted diagnostic imaging or interpretation tool for human readers. No MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The SmartEP-ASSR is a medical device for measuring physiological responses, not an algorithm being tested for standalone diagnostic performance in the absence of human interpretation. Its function is to acquire and process evoked potential data for trained personnel to interpret.
7. The type of ground truth used
Not applicable, as no clinical performance study requiring ground truth is described. The "ground truth" equivalent for this type of submission is the established safety and effectiveness of the predicate device and the technical measurements demonstrating the new device performs similarly.
8. The sample size for the training set
Not applicable, as this device does not utilize a machine learning algorithm that requires a training set in the context of the provided document.
9. How the ground truth for the training set was established
Not applicable, as no training set for a machine learning algorithm is discussed.
§ 882.1900 Evoked response auditory stimulator.
(a)
Identification. An evoked response auditory stimulator is a device that produces a sound stimulus for use in evoked response measurements or electroencephalogram activation.(b)
Classification. Class II (performance standards).