(90 days)
The Amplaid AM50 is a Programmable Admittance Meter which can:
- 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.
- Perform Acoustic reflex test. ●
- Determine acoustic reflex threshold .
- . Perform reflex decay test.
It is intended for use by a qualified/trained audiologist on both adult and pediatric subjects for measurement and diagnosis of various types of hearing losses.
The Amplaid AM50 ADMITTANCE METER performs plan and compensated tympanometry; Programmed and manual stimuli for ipsilateral and contralateral acoustic reflex; Automatic reflex threshold; and Decay measurements.
The provided documentation describes the Amplaid AM50 Clinical Automatic Programmable Admittance Meter and its substantial equivalence to a predicate device, the Amplaid 770 Admittance Meter, rather than outlining specific acceptance criteria or an in-depth study proving its performance against such criteria.
The submission is a 510(k) Summary of Safety and Effectiveness, which typically focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This process often relies on comparisons of intended use, technological characteristics, and performance data to show that the new device is as safe and effective. It explicitly states, "The results of bench and user testing indicates that the new device is as safe and effective as the predicate device." and "After analyzing both bench and user testing data, it is the conclusion of Amplifon S.p.A. that the Amplaid AM50 is as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate Device."
Given this, I cannot provide a table of acceptance criteria and reported device performance in the typical format of a clinical trial or performance study, because the document does not present such criteria or detailed results. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate device, which itself would have undergone performance validation.
However, I can extract the information that is present and frame it in response to your request as best as possible given the limitations of the provided text.
1. Table of Acceptance Criteria and the Reported Device Performance
As specific, quantitative acceptance criteria are not explicitly defined in the provided 510(k) summary, the "acceptance" is understood to be the demonstration of substantial equivalence to the predicate device, the Amplaid 770. The "performance" is implicitly deemed equivalent to the predicate.
| Acceptance Criteria (Implicit from Substantial Equivalence) | Reported Device Performance (as stated in the 510(k) Summary) |
|---|---|
| Intended Use: Device must perform clinical auditory impedance testing for evaluation of middle ear functions, acoustic reflex tests, thresholds, and decay. | Amplaid AM50 Performance: "The Amplaid AM50 is a Programmable Admittance Meter which can: |
- 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.
- Perform Acoustic reflex test.
- Determine acoustic reflex threshold.
- Perform reflex decay test."
(Stated as "Same" as predicate in the comparison chart, implying equivalent performance for these functions). |
| Technical Characteristics: Device must perform plain and compensated tympanometry; Programmed and manual stimuli for ipsilateral and contralateral acoustic reflex; Automatic reflex threshold; and Decay measurements. | Amplaid AM50 Performance: "The Amplaid AM50 ADMITTANCE METER performs plan and compensated tympanometry; Programmed and manual stimuli for ipsilateral and contralateral acoustic reflex; Automatic reflex threshold; and Decay measurements."
(Stated as "Same" as predicate in the comparison chart, implying equivalent performance for these functions). |
| Safety and Effectiveness: Device must be as safe and effective as the predicate device (Amplaid 770). | Amplaid AM50 Performance: "The results of bench and user testing indicates that the new device is as safe and effective as the predicate device. The same circuit technology is used in both devices."
"After analyzing both bench and user testing data, it is the conclusion of Amplifon S.p.A. that the Amplaid AM50 is as safe and effective as the predicate device..." |
| Standards Compliance: Compliance with relevant audiometric and electrical safety standards (e.g., ANSI 1969, ISO 1975, IEC 61027, UL-544, IEC 601). | Amplaid AM50 Performance: "Audiometric: (Same) [as predicate, which is] ANSI 1969, ISO 1975 for contralateral, 2 cm³ cavity for ipsilateral, IEC 61027"
"Electrical safety: (Same) [as predicate, which is] UL-544, IEC 601" |
| Technological Differences: Differences should not raise new questions of safety or effectiveness. | Amplaid AM50 Performance: The only changes noted are "packaging and control software," where "all keyboard, display, and control functions have been moved to the attached (via RS232) personal computer."
"few technological differences, and has no new indications for use." |
The "study" that proves the device meets (or rather, is substantially equivalent to) these criteria is referred to as "bench and user testing." No specific details on the methodology, sample sizes, or results of these tests are provided in this summary.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document only mentions "bench and user testing."
- Data Provenance: Not specified. The manufacturer is Amplifon S.p.A. in Milan, ITALY. It is plausible the "bench and user testing" was conducted in Italy or a region accessible to the manufacturer, but this is not confirmed. The data appears to be retrospective in the sense that it supports a regulatory submission rather than a prospective clinical trial for public dissemination.
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. The "user testing" would likely involve qualified audiologists as the device is intended for use by a "qualified/trained audiologist," but the number and specific qualifications are not detailed.
4. Adjudication method for the test set
- Not specified.
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
- This device is not an AI-powered diagnostic tool, but rather an acoustic admittance meter. Therefore, an MRMC comparative effectiveness study involving "AI vs without AI assistance" is not applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This device is a medical instrument and requires human operation ("intended for use by a qualified/trained audiologist"). Therefore, a standalone (algorithm only) performance study is not applicable and was not performed. The performance evaluated was of the device in a user-testing context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The concept of "ground truth" as typically applied to diagnostic AI models is not directly applicable here. For an admittance meter, "ground truth" would likely refer to the accuracy and reliability of its physical measurements against known standards or against the established performance of the predicate device. This would involve calibrated equipment and possibly clinical comparisons, but the specifics are not detailed.
8. The sample size for the training set
- This device does not utilize a "training set" in the context of machine learning or AI. Its functionality is based on established physical principles and circuit technology, not on learned patterns from a dataset.
9. How the ground truth for the training set was established
- As there is no training set for this type of device, this question is not applicable.
§ 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.