(30 days)
The ALGO 5 Newborn Hearing Screener is a mobile, noninvasive instrument used to screen infants for hearing loss. The screener uses AABR® technology. The screener is intended for babies between the ages of 34 weeks (gestation 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 5 detects the auditory brainstem response (ABR) to a series of stimulus clicks ('clicks'), which screens the entire hearing pathway from the outer ear to the brainstem. The ABR is not affected by the status of the middle ear, and evaluation of middle ear status is not required prior to ABR detection. The ALGO 5 generates soft clicks at 35 dB nHL or at 40 dB nHL ('normal hearing level' scale) which are delivered to the infant's ears through an Acoustic Transducer Assembly cable (ATA) to disposable earphones (Flexicouplers™ Disposable Earphones).
Each click evokes a series of identifiable brain waves from the auditory brainstem area of the infant's brain. Sensors (Jelly Tab™ Sensors) applied to the infant's skin pick up the brain wave response and transmit the signals to the screener via the Patient Cable Attachment (PCA) and Preamplifier (Preamp) assemblies. The ALGO 5 uses advanced signal processing technology to separate the ABR from background noise and from other brain activity.
The ALGO 5 uses a statistical algorithm to determine if there is a response to the stimulus, and if a response is detected, whether the response is consistent with a template of ABRs derived from normal hearing infants (automated auditory brainstem response technology, AABR).
The provided text is a 510(k) summary for the Natus Medical ALGO 5 Newborn Hearing Screener, which is a modification of a predicate device (ALGO 3). The submission specifically states that no clinical performance data is included and that the substantial equivalence is based on non-clinical performance data (design verification and validation) showing the ALGO 5 performs equivalently to the ALGO 3.
Therefore, the requested information regarding acceptance criteria, reported device performance, sample size, ground truth, expert qualifications, adjudication methods, MRMC studies, and standalone performance for a clinical study cannot be extracted from this document. The document explicitly states "No clinical performance data are included."
However, I can provide the limited information available regarding the comparison with the predicate device and the type of performance data used for substantial equivalence.
Here's what can be inferred from the provided text about the device's performance given the context of a 510(k) submission for a device modification:
1. Table of Acceptance Criteria and Reported Device Performance:
Since no clinical performance data is included, there's no specific table of clinical acceptance criteria or reported clinical device performance in this document. The equivalence is based on non-clinical data.
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable, as no clinical test set data is provided.
- Data Provenance: Not applicable, as no clinical test set data is provided.
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 and thus no ground truth established by experts is discussed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no clinical test set is discussed.
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. The document states "No clinical performance data are included." Also, this device is an automated hearing screener that does not involve human readers interpreting results in the way an MRMC study typically assesses. It uses an "automated auditory brainstem response technology (AABR)".
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device is an automated screener, meaning its operation is essentially "standalone" in its assessment. However, the document doesn't present a standalone study as typically requested for AI/ML devices. Instead, it relies on demonstrating equivalence to the predicate device through non-clinical means. The "ALGO 5 uses a statistical algorithm to determine if there is a response to the stimulus, and if a response is detected, whether the response is consistent with a template of ABRs derived from normal hearing infants (automated auditory brainstem response technology, AABR)." This implies standalone algorithmic performance is inherent to its function, but a specific standalone performance study report is not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable, as no clinical performance data or ground truth for a clinical study is discussed. The device's algorithm uses a "template of ABRs derived from normal hearing infants," which serves as an internal reference for its automated determination.
8. The sample size for the training set:
Not applicable. The document does not describe a new training set. The ALGO 5 is a modification of the ALGO 3 and relies on "advanced signal processing technology to separate the ABR from background noise and from other brain activity" and a "statistical algorithm." The "template of ABRs derived from normal hearing infants" likely refers to data used in the development of the original algorithm (ALGO 3) or the modification, but specific training set details are not provided in this 510(k) summary.
9. How the ground truth for the training set was established:
Not applicable. As no training set details are provided, the method for establishing its ground truth is also not mentioned. The document only references a "template of ABRs derived from normal hearing infants."
§ 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).