(25 days)
The Amplaid A756 Screening Admittance Meter can
- 1 . Evaluate middle ear functions such as otitis media, glue ear, eardrum scar tissues, perform myringotomy status, ossicular chain discontinuity ear canal volume, otosclerosis, stapes fixation.
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- Perform Acoustic reflex test.
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- Determine acoustic reflex threshold
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- Perform reflex decay test.
The unit is intended for use by a qualified/trained audiologist on both adult and pediatric subjects for measurement of acoustic impedance.
The Amplaid A756 Screening ADMITTANCE METER performs plane and compensated tympanometry; Programmed and manual stimuli for ipsilateral and contralateral acoustic reflex; Automatic reflex threshold; and Decay measurements.
The Amplaid A756 Screening Admittance Meter was determined to be substantially equivalent to the predicate device (Amplaid A724 – A728 ADMITTANCE METERS, K992370) based on bench and user testing. The provided document does not contain explicit acceptance criteria thresholds or detailed study results beyond a general statement of safety and effectiveness.
Here's the information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the A756 device is "as safe and effective as the predicate device" after analyzing "bench and user testing data." No specific quantitative acceptance criteria or detailed performance metrics are given in the provided text. The comparison focuses on technical and safety characteristics.
| Characteristic | Acceptance Criteria (Implicit: Equivalence to Predicate) | Reported Device Performance (Amplaid A756) |
|---|---|---|
| Intended Use | Similar to predicate: Clinical auditory impedance testing applications | Screening audiometry impedance testing applications (subset of predicate's use) |
| Computer Interface | RS232 Bi-directional | SAME (RS232 Bi-directional) |
| Display | Built-in liquid crystal | SAME (Built-in liquid crystal) |
| Control Interface | Built-in keyboard | SAME (Built-in keyboard) |
| Hardcopy Output | Built-in Thermal printer | SAME (Built-in Thermal printer) |
| Audiometric Standards | Compliance with IEC 61027, ANSI S3.39, IEC 60645-1, ANSI S3.6, EN ISO 389 | SAME (Compliance with listed standards) |
| Electrical Safety Standards | Compliance with EN 60601-1 Class I Type BF (1990) and amendments, EMC: EN 60601-1-2 (1993) | EN 60601-1 Class I Type B (1990) and amendments, EMC: EN 60601-1-2 (1993) (Note: Type B vs Type BF, but considered substantially equivalent) |
| Overall Safety & Effectiveness | As safe and effective as predicate | "as safe and effective as the predicate device" |
2. Sample size used for the test set and the data provenance
The document mentions "bench and user testing" but does not specify the sample size for the test set. It also does not detail the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document.
4. Adjudication method for the test set
This information is not provided in the document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC study was not conducted as this device is an Auditory Impedance Tester, not an AI-powered diagnostic tool. The comparison is between two medical devices, not AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is an Auditory Impedance Tester, which is a physical medical device and not an algorithm or AI system. Therefore, a "standalone algorithm-only" performance study is not applicable. The device's performance is inherently standalone in its function, but results are interpreted by a "qualified/trained audiologist."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not specify the type of ground truth used for validating the "user testing" or "bench testing." It can be inferred that for an auditory impedance tester, validation would typically involve comparing measurements against established audiometric standards or clinical diagnoses, but this is not explicitly stated.
8. The sample size for the training set
This information is not applicable as the device is not an AI/machine learning model that typically requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as the device is not an AI/machine learning model.
§ 874.1090 Auditory impedance tester.
(a)
Identification. An auditory impedance tester is a device that is intended to change the air pressure in the external auditory canal and measure and graph the mobility characteristics of the tympanic membrane to evaluate the functional condition of the middle ear. The device is used to determine abnormalities in the mobility of the tympanic membrane due to stiffness, flaccidity, or the presence of fluid in the middle ear cavity. The device is also used to measure the acoustic reflex threshold from contractions of the stapedial muscle, to monitor healing of tympanic membrane grafts or stapedectomies, or to monitor followup treatment for inflammation of the middle ear.(b)
Classification. Class II (special controls). The device, when it is a tympanometer or auditory impedance tester that complies with FDA-recognized consensus standard ANSI S3.39, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.