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510(k) Data Aggregation
(146 days)
The Interacoustics EP15 ABR Stand Alone Unit is a diagnostic tool for computer-based testing. Data is collected in a Windows 95,98 database format that allows for easy inspection of results. The EP15 Stand Alone Unit produces a sound stimuly is for use in evoked response measurements or electroencephalogram activation.
The Interacoustics EP15 ABR Stand Alone Unit is a diagnostic tool for computerbased testing. Data is collected in a Windows 95,98 database format that allows for easy inspection of results. The EP15 Stand Alone Unit produces a sound stimuly is for use in evoked response measurements or electroencephalogram activation.
The provided 510(k) summary (K991853) is for the Interacoustics Model EP15 ABR Stand Alone Unit. Based on the document, this is a comparison study against a predicate device, not a study proving device performance against specific acceptance criteria in the typical sense of a new technology. The summary mainly outlines the technical specifications and functional equivalency to the predicate device, not empirical performance data from clinical trials.
Therefore, many of the requested fields regarding acceptance criteria, study sample sizes, expert involvement, and ground truth are not applicable or cannot be extracted from this type of regulatory submission. The 510(k) process for this device focuses on demonstrating substantial equivalence to a legally marketed predicate device.
However, I can extract the comparative "acceptance criteria" through the lens of technical specifications between the proposed device and its predicate.
1. Table of Acceptance Criteria (as inferred from comparison to predicate) and Reported Device Performance
For this 510(k) submission, "acceptance criteria" are implicitly met by demonstrating that the proposed device, Interacoustics Model EP15 ABR, is either identical to or has equivalent or superior specifications compared to the predicate device, ICS Medical Corp. Chartr EP System, for key functional and safety aspects. The reported device performance is presented as its technical specifications.
| Feature / Acceptance Criteria Category | Predicate Device (Chartr EP) | Proposed Device (EP15 ABR) | Substantial Equivalence Justification / Performance |
|---|---|---|---|
| Indications for Use | Same | Same | Identical |
| Display Description | 15" SVGA Monitor | 12.1" Wide Angle Industrial TFT | Different size/type, but both provide necessary display. |
| Software Features | Windows 95/98 Operating System | Windows 95/98 Operating System | Same operating system implies similar user interface and functionality. |
| Amplifier Channels | 2 (optionally up to 8) | 2 | Equivalent baseline channels. |
| Amplifier Gain | X50 - X5000000 | 80 dB | Expressed differently, but assumed to meet diagnostic needs. (Specific dB gain needs to be evaluated against voltage gain range for direct comparison, but for 510k, it's considered functionally equivalent if appropriate for ABR). |
| Preamplifier Frequency Response | Same (as EP15) | 100 to 8000 Hz | Identical. |
| Preamplifier CMR Ratio | >100dB at 50/60 Hz | >120dB at 50/60 Hz | EP15 ABR is superior in Common Mode Rejection. |
| Preamplifier Noise | <1.5 µV RMS (0.1 Hz – 5 kHz) | 0.3µV RMS (0-3 kHz); 0.5µV RMS (100-8000 Hz) | EP15 ABR claims lower noise, indicating potentially better signal quality. |
| Points Per Trace | 600 | 450 (30 kHz sample) | Different, but 450 points at 30kHz sample often sufficient for ABR. |
| Low Pass Filter | 15 Hz to 25 kHz, 12 dB/octave | 1000, 1500, 2000, 3000, 5000 Hz, none (12000Hz). 33 taps FIR filter. | Different ranges/types, both provide filtering for ABR. |
| High Pass Filter | DC, 0.002 – 1 kHz, 6 dB/octave | None (5 Hz), 50, 100, 150, 300 500 Hz. 6dB/octave. | Different ranges/types, both provide filtering for ABR. |
| Stimuli Types | Click, Tone Burst | Click, Tone Burst, Blackman, Gaussian, Hanning, Hamming, Bartlett, Rectangle, Manual | EP15 ABR offers a broader range of stimuli, indicating potentially greater flexibility. |
| Stimulus Rate | Programmable 0.1 - 100/sec | 7.1, 13.1, 21.1, 23.1, 29.1, 31.1, 35.1, 41.1, 45.1, 49.1 Hz, ext. trigger input | Both programmable, EP15 lists specific rates. Functionally equivalent. |
| Intensity Range | -12 dB to +128 dB SPL | 20 dB to 130 dB peSPL; 10 dB to 100 dB HL | Both offer a wide and clinically relevant intensity range. |
| Masking | White noise, programmable intensity | White noise; masking ear is opposite side of stimulus | Both offer white noise masking. |
| Transducers | TDH-49 earphones, insert earphones, bone conduction transducer | EAR 3A Insert Phones-ABR | Different specific types, but both provide appropriate transducers for ABR. |
| Optical Isolation | Yes | Yes | Identical for safety. |
| Built-in Isolation Transformer | Yes | Yes | Identical for safety. |
| Controlled Parameters (Examples) | Stimulated Ear, Masked Ear, Stimulus Intensity, etc. | Stimuli Rate; Number of Stimuli; Stimulus Polarity; Click; Tone Burst (frequency, etc.); Stimulus Intensity; etc. | Both offer comprehensive control over testing parameters appropriate for an evoked response stimulator. |
| Data Collection Features | Tests Impedance, Display Waveform Buffers, Displays EEG, Stores Waveforms | Impedance Test, Waveform Buffer, Show Online EEG, Store Waveforms in unlimited Storage database | Both offer essential data collection and display features. |
| Power Supply Safety | 200 Watts, 50/60 Hz, 120 or 240 volts | Input volts: 90 to 250 VAC Universal Input Switch Mode; Safety: VDE750, EN60601-1, IEC601, IEC1010, UL544, CSA 22.2 | EP15 specifies compliance with multiple international safety standards. |
2. Sample size used for the test set and the data provenance:
- Not Applicable. This 510(k) relies on a comparison of technical specifications and safety standards, not a clinical test set with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. No ground truth for a test set was established as per this document. The assessment is based on technical specifications and compliance with recognized standards.
4. Adjudication method for the test set:
- Not Applicable. No test set requiring adjudication was used.
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 stimulator, not an AI-powered diagnostic tool requiring human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a hardware device for generating stimuli and collecting data for evoked responses, not an algorithm.
7. The type of ground truth used:
- Not Applicable. No explicit "ground truth" was established for a performance study. Equivalence is based on adherence to technical specifications and safety standards, and functional similarity to the predicate.
8. The sample size for the training set:
- Not Applicable. This is a hardware device, not an AI/machine learning algorithm requiring a training set.
9. How the ground truth for the training set was established:
- Not Applicable. No training set or associated ground truth.
Summary of the Study (510(k) Submission Approach):
The "study" presented in this 510(k) is a comparison study demonstrating substantial equivalence to a predicate device, the ICS Medical Corp. Chartr EP System. The manufacturer establishes this equivalence by detailing the technical specifications of the Interacoustics Model EP15 ABR Stand Alone Unit and comparing them point-by-point with those of the predicate device. The claim is that the device shares the same indications for use and has similar technological characteristics, and any differences either do not raise new questions of safety and effectiveness or are demonstrated to be as safe and effective as the predicate. The compliance with various performance and safety standards (e.g., VDE750, EN 60601 series, EN 60645-3) is also cited to support safety and effectiveness. This is a common approach for Class II medical devices seeking 510(k) clearance, where demonstrating equivalence to an already legally marketed device is the primary pathway to market.
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