(85 days)
The Bio-logic OAE Ear Probe is used as an accessory to the Bio-logic SCOUT Sport and AuDX Otoacoustic Emissions Test Instruments. These instruments are identical to each other in purpose, and are indicated for use when it is necessary for a trained health care professional (for example, an Audiologist) to measure or determine cochlear function. This test consists of either measuring transient (click-evoked) otoacoustic emissions (TEOAE) or by measuring and recording distorion product otoacoustic emissions (DPOAE) utilizing continuous pure tones. The same Ear Probe is used with both instruments for both types of test.
It can be used for patients of all ages, from newborn infants through adults, to and including geriatric patients. The otoacoustic emissions test is especially indicated for use in testing individuals for whom behavioral audiometric results are deemed unreliable, such as infants, young children, and cognitively impaired or uncooperative adults.
The Scout Sport/AuDX OAE Test Instrument with Bio-logic Ear Probe is a battery-operated device which connects to the patient's ear using the new Bio-logic Ear Probe. There are no metallic parts which touch the patient in the normal use of this device. The power supply / battery charger supplies 12 volts DC to the Sport OAE box when it is connected, and this charger is UL and CSA listed with a leakage current of less than 100 microamps. During normal OAE testing, the Scout Sport is connected to the computer running the Scout software through a standard RS-232 serial data communications link. The AuDX is not connected to the computer in normal operation, but may be connected as the Sport during setup and data downloading.
The provided text does not contain specific acceptance criteria or a detailed study description with performance metrics for the Sport/AuDX OAE Test Instrument with Bio-logic Ear Probe.
The document is a 510(k) premarket notification clearance letter from the FDA, along with a Safety and Effectiveness Summary and an Indications for Use statement. These documents confirm that the device is substantially equivalent to a predicate device and outline its intended use, but they do not provide the detailed study results that would typically include acceptance criteria and reported device performance.
Therefore, I cannot populate the table or answer most of your specific questions based on the provided text.
Here's what can be inferred/extracted:
- Device Name: Sport/AuDX OAE Test Instrument with Bio-logic Ear Probe
- Intended Use: Determining cochlear function by measuring and recording transient (click-evoked) otoacoustic emissions (TEOAE) or distortion product otoacoustic emissions (DPOAE) utilizing continuous pure tones.
- Target Population: Patients of all ages, from newborn infants through adults, and geriatric patients, especially those for whom behavioral audiometric results are deemed unreliable.
- User: Trained healthcare professional (e.g., Audiologist).
Regarding the device's validation:
The Safety and Effectiveness Summary states: "To establish the safety and effectiveness of the software which controls the Scout Sport/AuDX OAE Test Instrument with Bio-logic Ear Probe, the system was validated in accordance with the Bio-logic internal software development policies and procedures modeled after the IEEE Standards. The programs in the Scout Sport/AuDX were developed and tested as specified in these procedures. The system, for which this application is submitted, was verified and validated; it was found to perform in accordance with specifications."
This statement indicates that internal validation was performed to establish safety and effectiveness, and that the device "was found to perform in accordance with specifications." However, it does not detail what those specifications (acceptance criteria) were or the specific performance metrics achieved. It also doesn't describe the studies (sample size, data provenance, ground truth, etc.) that would typically be included in a regulatory submission to demonstrate performance against those criteria.
Therefore, I cannot complete the requested information, as the necessary details are not present in the provided submission.
§ 874.1050 Audiometer.
(a)
Identification. An audiometer or automated audiometer is an electroacoustic device that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.(b)
Classification. Class II. Except for the otoacoustic emission device, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, if it is in compliance with American National Standard Institute S3.6-1996, “Specification for Audiometers,” and subject to the limitations in § 874.9.