(73 days)
AccuScreen is a portable instrument used to screen infants for hearing loss. The instrument uses the Distortion Product Otoacoustic Emissions (DPOAE), Transient Evoked Otoacoustic Emissions (TEOAE) and Auditory Brainstem Response (ABR) technologies. The instrument is intended for screening infants from 34 weeks (gestational age) up to 6 months of age that are well enough to be ready for discharge from the hospital. Infants should be asleep or in a quiet state at the time of screening. AccuScreen is intended for use by audiologists, ENTs and other health care professionals.
GN Otometrics Type 1077 AccuScreen is a handheld examination system based on Otoacoustic Emissions (OAE) and/or Auditory Brainstem Response (ABR). The Type 1077 AccuScreen is designed to be easy to use, and employs automated OAE and/or ABR tests. The measurement flow is menu-guided and evaluation is based upon signal statistics. The Type 1077 AccuScreen is designed for trained personnel in a medical or home environment to examine hearing in infants from 34 weeks (gestational age) up to 6 months of age that are well enough to be ready for discharge from the hospital.
The Type 1077 AccuScreen OAE system consists of the AccuScreen handheld device, a Docking Station with mains adapter, OAE probe with disposable probe- and ear-tips, and AccuLink software for installation on a PC. When ABR is included an optional ear coupler cable and disposable ear couplers can be included in the system, as well.
The AccuScreen handheld device comes in two hardware versions; one for OAE screening only and one for both OAE and ABR screening. Both versions are based on a common hardware platform (printed circuit board), but with different configurations.
The measurement application is controlled from a self-contained firmware (software) module installed in the handheld device. The firmware module can be configured to allow different OAE measurement types (DPOAE and/or TEOAE) by a license key stored in the device.
For automated OAE measurements, the handheld device uses an OAE probe, designed and manufactured by PATH Medical GmbH. The OAE probe is fitted with an ear-tip (constructed of biocompatible material) and inserted in the ear canal of the patient. The AccuScreen device plays stimulus sounds in the ear canal via small speakers in the OAE probe. The AccuScreen device measures the patient's response to the stimulus sounds via a microphone in the probe. The measured response is processed by the AccuScreen device using statistics to help determine whether or not a hearing loss may be present.
When the OAE measurement is a DPOAE measurement, the stimulus signal is while and of two pure tone signals, each presented by a speaker in the OAE probe. When the OAE measurement is a TEOAE measurement, the stimulus signal is a series of broadband clicks presented by one speaker in the OAE probe.
For automated ABR measurements, the device uses the OAE probe, or an ABR ear coupler cable for providing the acoustical stimulus for the patient. When the ABR ear coupler cable is used, its speakers are inserted in the ABR Ear Couplers, which are then placed over the patient's ear with a biocompatible adhesive gel on the ear coupler rim. The stimulus signal is a series of broadband clicks and the AccuScreen device measures the patient's response as an electrical signal from three electrodes placed on the head of the patient. The measured response is processed by the AccuScreen device using statistics to help determine whether or not a hearing loss may be present.
The 1077 Docking Station serves as a means of providing power to charge the rechargeable battery in the AccuScreen handheld device. The Docking Station also provides an interface to an optional label printer or to a PC. The label printer is used for printing test results from the AccuScreen handheld device. The PC is used for transferring patient demographical data to the AccuScreen handheld device and for collecting measurement results from the AccuScreen handheld device by using the AccuLink PC software.
The provided text is a 510(k) summary for the GN Otometrics Type 1077 AccuScreen device. It primarily focuses on demonstrating substantial equivalence to a predicate device (Echo-Screen) by comparing design, functionality, and compliance with various medical device standards. Crucially, this document does not contain details about specific acceptance criteria or a dedicated study proving the device meets performance claims through clinical evaluation.
The “performance data” mentioned refers to compliance with safety, EMC, software lifecycle, usability, and biocompatibility standards, rather than clinical performance metrics like sensitivity or specificity for hearing loss detection against a ground truth.
Therefore, many of the requested sections cannot be answered from the provided document.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
Based on the provided document, there are no specific performance-based acceptance criteria (e.g., sensitivity, specificity, accuracy) or reported clinical performance metrics for the device to screen for hearing loss. The document focuses on demonstrating substantial equivalence through:
- Design and principal similarity to the predicate device (Echo-Screen).
- Compliance with recognized electrical, software, and biocompatibility standards.
The "performance data" section in the document refers to compliance with standards, not clinical performance metrics.
| Acceptance Criteria (as implied by the document for substantial equivalence) | Reported Device Performance (as stated in the document) |
|---|---|
| Design and Working Principles: Similar to predicate (Echo-Screen) | * "Design and working principals of Type 1077 AccuScreen are very similar to the Echo-Screen with the technological improvements added to the design." |
| Measurement Methods: Utilizes DPOAE, TEOAE, ABR (same as predicate) | * "Both systems use a battery driven handheld and portable device with attached OAE probe- and ABR electrode cables." |
| * "From a measurement perspective, the two devices utilize the same measurement methods (DPOAE, TEOAE and ABR) and use very similar probes and electrodes." | |
| Signal Processing and Detection: Similar to predicate | * "The signal processing and detection methods within the devices are also very similar, and both devices give a Pass/Refer result as an automated screening result." |
| Compliance with Safety Standards: IEC 60601-1 | * Compliance affirmed: "equivalent results... evaluated to determine compliance with... standards clearly demonstrates the substantial equivalence." |
| Compliance with EMC Standards: IEC 60601-1-2 | * Compliance affirmed. |
| Compliance with Programmable Medical Systems Standards: IEC 60601-1-4 | * Compliance affirmed. |
| Compliance with Medical Device Software Life Cycle Process Standards: IEC 62304 | * Compliance affirmed. |
| Compliance with Usability Engineering Standards: IEC 62366 | * Compliance affirmed. |
| Compliance with Biological Evaluation Standards (Cytotoxicity): ISO 10993-5 | * Compliance affirmed. |
| Compliance with Biological Evaluation Standards (Irritation/Hypersensitivity): ISO 10993-10 | * Compliance affirmed. |
| Compliance with Biological Evaluation Standards (Evaluation/Testing): ISO 10993-1 | * Compliance affirmed. |
| Compliance with Biological Evaluation Standards (Sample Prep/Reference Materials): ISO 10993-12 | * Compliance affirmed. |
The following information cannot be determined from the provided text:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document does not describe a clinical performance study with a test set. It relies on demonstrating substantial equivalence to a predicate device and compliance with standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable, as no clinical performance study with a test set and ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable, as no clinical performance study with a test set 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
- This device is an automated screening tool, not an AI assistance 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
- The document implies standalone performance comparison to the predicate, as both are automated screening devices ("both devices give a Pass/Refer result as an automated screening result"). However, specific performance metrics (sensitivity, specificity) of this standalone operation are not provided beyond the claim of being "very similar" to the predicate. No dedicated standalone validation study with concrete performance data is detailed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable, as no clinical performance study with a ground truth is described.
8. The sample size for the training set
- This document describes a device whose "measurement application is controlled from a self-contained firmware (software) module." There is no mention of a machine learning or AI model that would require a "training set" in the conventional sense. The device's "statistics" for determining hearing loss are likely based on pre-programmed algorithms and thresholds, not a learned model from a large training dataset.
9. How the ground truth for the training set was established
- Not applicable, as no training set for a machine learning model is mentioned.
§ 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).