(210 days)
The SABRe Compac Auditory Brainstem Response Screener is a device that produces a sound stimulus for use in evoked response measurements. It is intended to be used by trained professionals in the determination of hearing disorders.
The SABRe Compac ABR Screener is an evoked potential device to be used in the diagnosis of hearing disorders.
Unfortunately, the provided text does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets them. The document is a 510(k) summary for the SABRe Compac Auditory Brainstem Response Screener, which primarily focuses on establishing substantial equivalence to a predicate device.
Specifically, the text is missing:
- A table of acceptance criteria and reported device performance: There are no specific performance metrics or thresholds mentioned for the device.
- Sample size used for the test set and data provenance: The document does not describe any specific test set or the characteristics of the data used for testing.
- Number of experts used to establish ground truth and their qualifications: This information is not present.
- Adjudication method: Not mentioned.
- Multi-reader multi-case (MRMC) comparative effectiveness study information: There is no indication of such a study being conducted or its results.
- Standalone (algorithm-only) performance: The device is described as an "evoked potential device" and "Screener" for use by "trained professionals," suggesting it's generally a diagnostic tool, but no standalone algorithmic performance is detailed.
- Type of ground truth used: Not specified.
- Sample size for the training set: Not mentioned as there's no description of an AI/ML algorithm being "trained" in the typical sense.
- How ground truth for the training set was established: Not applicable given the lack of training set information.
The core of the provided text is about the device's intended use and its substantial equivalence to a previously cleared device (SLE SABRE ABR Screener, K993177). This type of submission relies on demonstrating that the new device has similar technological characteristics and performs comparably to an already approved device, rather than presenting a full de novo study with detailed performance metrics against specific acceptance criteria.
§ 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).