(26 days)
The ALGO® 3i Newborn Hearing Screener is a portable, noninvasive instrument used to screen infants for hearing loss. The screener uses Natus AABR® technology. The screener is intended for babies between the ages of 34 weeks (gestational age) and 6 months. Babies should be well enough to be ready for discharge from the hospital, and should be asleep or in a quiet state at the time of screening.
The ALGO® 3i Newborn Hearing Screener is a portable, noninvasive instrument used to screen infants for hearing loss. The screener uses Natus AABR® technology. The ALGO 3i Newborn Hearing Screener is a modification of the ALGO 3 Newborn Hearing Screener. The ALGO 3i and the ALGO 3 Newborn Hearing Screeners have the same intended use and use the same operating principle. The new device performs and is specified within all performance parameters of the predicate device.
The provided 510(k) summary for the ALGO® 3i Newborn Hearing Screener (K030823) explicitly states "Nonclinical Performance Data: None" and "Clinical Performance Data: None."
Therefore, based on the provided document, the device did not undergo a study to demonstrate its performance against specific acceptance criteria. The submission indicates that the device is a modification of the ALGO 3 Newborn Hearing Screener (K013137) and that it "performs and is specified within all performance parameters of the predicate device." This implies that its acceptance was based on its substantial equivalence to the predicate, rather than new performance data.
Therefore, the following information cannot be extracted from the provided document:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method for the test set
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
§ 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).