(112 days)
The Otoport can perform Transient Evoked (TE) and Distortion Product (DP) Oto-Acoustic Emission (OAE) measurements on ears via an ear piece or "probe" fitted into the ear canal.
The Otoport is a compact, sclf-contained, handheld Otoacoustic emission analyzer which has integral. rechargeable batteries for use. The Otoport can screen for cochlear function using either Transicnt Evoked or Distortion Product Otacoustic Emissions (TE or DPOAEs). It uses state-of-the-art technology and high performance signal analysis to provide robust indications of cochlear function and high immunity to extraneous noise. The Otoport has a high degree of connectivity, being capable of immediate connection to any IBM compatible PC via either USB port or Bluctooth wireless technology. The instrument will acccpt probes that are already in use with other products in the Otodynamics range of otoacoustic emission analyzer instruments. There is 100% compatibility between data recorded on the Otoport and data recorded on other Otodynamics OAE products.
The provided text is a 510(k) summary for the Otodynamics Otoport, an Otoacoustic emission analyzer. This document focuses on demonstrating substantial equivalence to a predicate device and lacks specific information regarding acceptance criteria and the detailed study results that would typically be presented in a clinical trial report.
Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert qualifications, and study methodologies are not available in the provided document.
Here's what can be extracted and what is missing:
Description of the Acceptance Criteria and Device Performance
The document does not explicitly state "acceptance criteria" in the traditional sense of numerical thresholds for a new study. Instead, it presents a comparison table showing the specifications of the new device (Otodynamics Otoport) against two predicate devices (Otodynamics ILO2088 Echocheck and Otodynamics ILO292 DP EchoportPlus). The implication is that the Otodynamics Otoport is acceptable because its specifications are comparable to or exceed those of the legally marketed predicate devices.
1. A table of acceptance criteria and the reported device performance
| Parameter | Acceptance Criteria (from Predicate Devices) | Reported Device Performance (Otodynamics Otoport) |
|---|---|---|
| Signal output: | ||
| Frequency range: TEOAE | 1,500 to 3,200Hz (ILO2088) / 500 to 6,000Hz (ILO292) | 500 to 6,000Hz |
| Frequency range: DPOAE | N/A (ILO2088) / 500 to 8,000Hz (ILO292) | 500 to 10,000Hz |
| Level range: TEOAE | 94 to 44dB SPL (Both Predicates) | 94 to 44dB SPL |
| Level range: DPOAE | N/A (ILO2088) / 35 to 75dB SPL (ILO292) | 35 to 75dB SPL |
| Level increments: TEOAE | 1.5dB steps +/-0.5 (Both Predicates) | 1dB steps +/-0.5 (Improved resolution compared to ILO2088) |
| Level increments: DPOAE | N/A (ILO2088) / 1dB steps +/-0.5 (ILO292) | 1dB steps +/-0.5 |
| Signal to noise ratio | >85dB (Both Predicates) | >85dB |
| Harmonic distortion: DPOAE | N/A (ILO2088) / |
§ 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.