(69 days)
The ER35 is intended to be a test instrument that measures otoacoustic emissions and tympanic membrane performance (tympanometry).
The ER35 ERO-SCAN Pro Hearing Test System (ER35) is indicated for testing of cochlear and middle ear function in infants, children, and adults by measuring otoacoustic emissions (OAEs) and tympanometry.
The ER35 is a microprocessor-controlled instrument designed to screen otoacoustic emissions and tympanic membrane performance (tympanometry). Test information is stored in memory, displayed on a graphic LCD, and can be printed by a dot matrix printer or stored on a computer. The product is manufactured and delivered completely assembled to the retailer using materials and techniques widely used by manufacturers of hearing devices
The provided document describes the ER35 ERO-SCAN Pro Hearing Test System, a device intended to measure otoacoustic emissions and tympanic membrane performance. The submission is a Traditional 510(k) Premarket Notification.
Here's an analysis of the provided information regarding acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The document primarily focuses on establishing substantial equivalence to predicate devices and adherence to performance standards rather than defining specific acceptance criteria for a new clinical study. The "performance" discussed is related to compliance with existing standards.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Compliance with ANSI S3.39-1987 (Aural Impedance and Admittance) | The ER35 is in compliance with this standard. |
| Compliance with IEC 60645-5 (Aural Acoustic Impedance / Admittance) | The ER35 is in compliance with this standard. |
| Compliance with ANSI S3.6-2004 (Audiometers) | The ER35 is in compliance with this standard. |
| Substantial Equivalence to Predicate Devices | The ER35 utilizes the same technology and has the same intended use as the cited predicate devices (ERO-SCAN OAE Test System K980533, K010165; Interacoustics AT235 Impedance Audiometer K994254). All device parameters and materials are stated to be the same, with some reduced parameter ranges on the ER35. |
| Intended Use Match | The ER35 is intended to be a test instrument that measures otoacoustic emissions and tympanic membrane performance (tympanometry), matching the intended use of predicate devices. |
| Indications for Use Match | The ER35 is indicated for testing cochlear and middle ear function in infants, children, and adults by measuring OAEs and tympanometry. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not mention any specific sample sizes for a test set or clinical study. The submission relies on demonstrating substantial equivalence to existing devices and compliance with recognized performance standards. Therefore, information on data provenance (country of origin, retrospective/prospective) for a test set is also not provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the document does not describe a clinical study that required expert-established ground truth. The device performance is assessed against recognized standards and equivalence to predicate devices, not through a new ground truth determination of a specific condition.
4. Adjudication Method for the Test Set
This information is not applicable as the document does not describe a clinical study requiring an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. This type of study would typically assess the improvement of human readers with AI assistance, which is not relevant to this device's function or the nature of its 510(k) submission.
6. Standalone Performance Study
The document does not describe a standalone (algorithm only without human-in-the-loop performance) study. The ER35 is described as a "microprocessor-controlled instrument" designed for screening, implying it performs measurements rather than an "algorithm only" function in the AI sense. Its performance is linked to its compliance with established standards for such instruments.
7. Type of Ground Truth Used
The concept of "ground truth" (expert consensus, pathology, outcomes data) as typically understood for diagnostic algorithms is not directly applicable to this 510(k) submission. The "truth" or "performance" is benchmarked against established performance standards for audiometers and immittance meters (ANSI S3.39-1987, IEC 60645-5, ANSI S3.6-2004) and the demonstrated performance and technical specifications of legally marketed predicate devices.
8. Sample Size for the Training Set
The document does not mention a training set sample size. This is expected for a device like the ER35, which is an instrument measuring physiological responses, rather than an AI/Machine Learning model that requires a training set.
9. How Ground Truth for the Training Set Was Established
This information is not applicable as there is no mention of a training set or an AI/Machine Learning model that would require a ground truth for training.
§ 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.