(210 days)
The intended use of the current Scout Otoacoustic Emissions Test Instrument is to measure or determine cochlear function either by measuring and recording transient (click evoked) otoacoustic emissions or by measuring and recording distortion product otoacoustic emissions utilizing continuous pure tones. The intended use of this new software feature is essentially the same as that of the predicate device. It provides for an additional test methodology which measures DPOAE threshold instead of the more-routine DPOAE amplitude test. The threshold test (also called the Input/Output (1/0) function) involves varying the stimulus intensity levels while keeping the frequencies constant. Both test methods can be effectively used to differentiate normal and hearing- impaired subjects, but the amplitude test is usually preferred because it usually requires a shorter testing time. However, in cases where the amplitude test results in a DP-gram with a low DP response (close to the noise floor) at specific frequencies, the I/O function test can be used to determine if there is an improved response at other stimulus frequencies. Therefore, the I/O function test offers the potential to improve the identification of patients with normal hearing.
Addition to the Scout Otoacoustic Emissions (OAE) Test Instrument. Modification and Software Feature. The system still uses the Etymotic ER-10C probe.
The provided text describes a modification to the Bio-logic Scout Otoacoustic Emissions (OAE) Test Instrument, specifically the addition of a new software feature for measuring DPOAE threshold (Input/Output or I/O function). The document focuses on regulatory compliance and demonstrating that the new feature does not negatively impact safety or effectiveness. As such, it does not contain the typical performance metrics (sensitivity, specificity, AUC, etc.) and study design details usually found for AI/ML device evaluations.
Here's an analysis based on the information provided, highlighting what is present and what is absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety: Device presents no new safety issues compared to predicate. | Verified. No changes to hardware or software controlling hardware. Only changes are to test sequence generation, which does not affect safety. No direct electrical connection to the patient. |
| Effectiveness (General): Performs in accordance with specifications. | Verified. System was validated in accordance with IEEE Standards for Software Engineering and Bio-logic's internal development policies. Found to perform in accordance with specifications. |
| Effectiveness (Intended Use): Effectively differentiate normal and hearing-impaired subjects; potential to improve identification of patients with normal hearing. | This claim is made for both the original DPOAE amplitude test and the new I/O function. The I/O function offers additional information when the amplitude test results in a low DP response, potentially improving identification of normal hearing. Specific performance metrics (e.g., sensitivity, specificity, accuracy) for this new feature are not provided. |
| Performance (Time): | The time to perform a DPOAE I/O (threshold) test is somewhat longer than the DPOAE amplitude test. No specific duration or acceptable range is provided. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided. The document describes software validation and verification, implying internal testing, but no details on clinical test sets (e.g., number of patients, their demographics, country of origin) are given for the new I/O feature's performance effectiveness.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided. Given that the validation focuses on software functionality rather than a clinical performance study with human interpretation, external experts for ground truth establishment are not mentioned for the new feature. The "ground truth" here seems to be the system's ability to correctly generate the specified test sequences and display results.
4. Adjudication Method for the Test Set
This information is not provided. There is no mention of a clinical test set requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is not an AI/ML algorithm that assists human readers in interpretation. It's a re-sequencing of a medical test.
6. Standalone Performance Study
A standalone performance study in the context of an AI/ML algorithm (i.e., algorithm only without human-in-the-loop performance) was not done. This device is a test instrument. The "standalone" performance here refers to the software performing its intended function (generating test sequences and displaying data), which was verified through internal validation.
7. Type of Ground Truth Used
For the software validation, the "ground truth" seems to be:
- Adherence to IEEE Standards for Software Engineering.
- Adherence to Bio-logic internal software development policies and procedures.
- Performance in accordance with specifications (implicitly referring to design requirements for test sequence generation and data presentation).
There is no mention of a ground truth established by clinical outcomes, pathology, or expert consensus regarding the diagnostic performance of the new DPOAE threshold feature itself in differentiating normal from hearing-impaired subjects.
8. Sample Size for the Training Set
This information is not applicable / not provided. This is not an AI/ML device that requires a training set. The validation described is for software engineering and functionality.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable / not provided. This is not an AI/ML device with a training set.
§ 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.