(81 days)
Earscan 3 is a peripheral used with a computer that creates an air conduction, bone conduction and speech audiometer, as defined by the standards shown in the labeling of the About Screen and the Splash Screen of the Earscan 3 software.
The Earscan 3 is similar to and predicated upon the Micro Audiometrics Corp. Earscan and Earscan II, and Decibel Instruments, Inc. ProDigit 2000. Earscan 3 is a computer peripheral whose purpose is to test the condition of the auditory pathway through manual and automatic air conduction audiometry, bone conduction audiometry and speech audiometry. Earscan 3 is a lower level of concern device and is intended to be used by trained personnel in the industrial, school and medical environment.
The provided text is a 510(k) summary for the Micro Audiometrics Corp. Earscan 3, an audiometer. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a dedicated study with a test set, ground truth, or statistical analysis that are typically found in more recent, high-risk device submissions, especially those involving AI/ML.
Here's an analysis based on the provided text, addressing your points where possible and noting where information is absent:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not present a formal table of acceptance criteria with corresponding performance results in the way typically seen for AI/ML devices or novel high-risk medical devices. Instead, it relies on demonstrating substantial equivalence to existing predicate audiometers by meeting established electrical and mechanical standards.
| Acceptance Criteria (Inferred from Text) | Reported Device Performance (Inferred from Text) |
|---|---|
| Functional Equivalence: Performs manual and automatic air conduction audiometry, bone conduction audiometry, and speech audiometry. | The Earscan 3 is described as a "combination of three predicate audiometer devices into one computer interfaced audiometer equivalent or superior in effectiveness to its predicates in testing the auditory pathway." Its purpose is "to test the condition of the auditory pathway through manual and automatic air conduction audiometry, bone conduction audiometry and speech audiometry." |
| Electrical Safety Standards: Meets IEC 601-1.1992 and UL2601. | "The design of Earscan 3 provides electrical safety to the patient and the user. Earscan 3 intends to meet electrical standards IEC 601-1.1992 and UL2601. The wall cube will comply with UL2601-1." This phrasing implies it either meets or is designed to meet, but doesn't explicitly state the results of such testing if performed. |
| Prevention of Excessive Sound Exposure: Limits maximum duration of continuous tones. | "To prevent the unlikely possibility of excessive exposure to high-level sounds, a firmware check was implemented which limits the maximum duration of continuous tones." |
| Hearing Level Compliance: Prevents generation of hearing levels greater than specified by ANSI S3.6-1996 Type 3C and IEC 60645 Type 3. | "The software also prevents the generation of a hearing level greater than specified by ANSI S3.6-1996 Type 3C audiometer and IEC 60645 Type 3 audiometer." |
| USB Compliance: Complies with USB Spec. 1.0 (to prevent interference). | "In complying with USB Spec. 1.0, Earscan 3 will not interfere with other devices in its computer environment." |
| Mechanical Safety (Headbands): Air conduction headband complies with ANSI S3.6; bone conduction vibrator and headband comply with ANSI S3.6. | "With respect to mechanical safety, the air conduction headband comply with ANSI S3.6, and the bone conduction vibrator and headband comply with ANSI S3.6." |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not describe a specific test set, sample size, or data provenance in the context of an accuracy or performance study. The submission relies on demonstrating substantial equivalence to its predicate devices by showing it meets recognized industry standards and performs the same functions. There is no mention of a clinical or technical study using a specific dataset to prove its effectiveness in the way one would for an AI/ML device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Given that no specific test set or performance study is described, there is no information provided regarding experts used to establish ground truth.
4. Adjudication Method for the Test Set
As no specific test set or performance study is described, there is no adjudication method provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.
No MRMC study was performed or mentioned in the provided document. The device is an audiometer, which typically measures auditory responses directly, rather than interpreting complex medical images or data that would necessitate human reader interaction for diagnostic interpretation. The submission is focused on the device's technical specifications and functional equivalence.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done.
The Earscan 3 is a medical device, specifically an audiometer. While it uses "firmware check" and "software" to prevent certain conditions, these are internal device functions to ensure safety and compliance, not an "algorithm" in the sense of an AI/ML prediction model. Therefore, the concept of a "standalone" or "human-in-the-loop" performance study for an algorithm as you might find for AI/ML devices is not applicable to this type of traditional audiometer submission and is not mentioned.
7. The Type of Ground Truth Used
No explicit "ground truth" is used in the context of a performance study as described in your question. The "ground truth" in this context is implicitly the compliance with established industry standards (ANSI S3.6, IEC 601-1.1992, UL2601, USB Spec. 1.0) and the functional equivalence to predicate audiometers. The device's "correctness" is determined by its adherence to these standards and its ability to perform audiometry as expected, not by comparing its outputs against a diagnostically confirmed truth derived from a patient dataset.
8. The Sample Size for the Training Set
Since the Earscan 3 is a traditional medical device (an audiometer) and not an AI/ML system, the concept of a "training set" is not applicable and therefore no sample size for a training set is mentioned.
9. How the Ground Truth for the Training Set Was Established
As there is no training set, there is no description of how any ground truth for a training set was established.
In Summary:
The provided 510(k) summary for the Earscan 3 focuses on demonstrating substantial equivalence to predicate devices by asserting compliance with relevant electrical, mechanical, and performance standards. It does not contain the detailed performance study information (test sets, ground truth, expert adjudication, MRMC studies) typically associated with more complex diagnostic devices or AI/ML systems where objective performance metrics against a defined ground truth are required for clearance. The "effectiveness" is primarily described in terms of its ability to perform similar functions to its predicates and meet safety standards.
§ 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.