(121 days)
The Inventis Middle Ear Analyzers, Flute and Viola, are intended for use by trained operators in hospitals, nurseries, ENT clinics and audiology offices in conducting diagnostic hearing evaluations and assisting in diagnosis of possible otologic disorders. The Inventis Middle Ear Analyzers are intended for use on individuals six months of age or older. Flute is a tympanometer. Viola is a combination of audiometer and tympanometer, which reduces the amount of necessary equipment.
Flute is stand-alone tympanometry / reflex diagnostic device. Viola is a stand-alone combined unit, integrating a screening middle ear analyzer and a diagnostic audiometer capable of performing air and bone conduction threshold and speech exams. Flute and Viola are available with or without the integrated thermal printer.
Here's an analysis of the acceptance criteria and supporting study for the Inventis Middle Ear Analyzers, based on the provided 510(k) summary:
The document indicates that the Inventis Middle Ear Analyzers (Flute and Viola) underwent bench testing to demonstrate substantial equivalence to a predicate device, the Interacoustics Audiotraveller, Model AA222 (K022728). The acceptance criteria are largely implicitly defined by compliance with established electrical, mechanical, electromagnetic compatibility, and performance standards for auditory impedance testers and audiometers.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Standard/Requirement | Reported Device Performance (Inventis Middle Ear Analyzers) |
|---|---|---|
| Electrical and Mechanical Safety | IEC 60601-1 (Class I, Type B for predicate; Class II, Type BF for new device) | Compliance with IEC 60601-1:2005. "The results demonstrate that the Inventis Middle Ear Analyzer is in compliance with...IEC 60601-1:2005 and is safe as the predicate device." |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2 | Compliance with IEC 60601-1-2:2007. "The results demonstrate that the Inventis Middle Ear Analyzer is in compliance with...IEC 60601-1-2:2007." |
| Impedance Measurement Performance | ANSI S3.39 / IEC 60645-5 (Type 2 for both predicate and new device) | "All the necessary performance tests in support of substantial equivalence determination were conducted... The tests demonstrate that the Inventis Middle Ear Analyzer is effective and performs as well as the predicate device." Specific impedance features match, with minor differences: Probe Tone Frequency: 226 Hz, 1kHz (Flute HF); 226 Hz (Viola) vs. 226 Hz, 678 Hz, 800 Hz, 1 kHz (predicate). Compliance Range: up to 8.0 ml (Same as predicate). Pressure Range: -600 to +400 daPa vs. -600 to +300 daPa (predicate). |
| Audiometer Performance (Viola only) | ANSI S3.6 / IEC 60645-1 (Type 3 Pure-tone Audiometer for new device; Type 2 Tone Audiometer for predicate) | "All the necessary performance tests in support of substantial equivalence determination were conducted... The tests demonstrate that the Inventis Middle Ear Analyzer is effective and performs as well as the predicate device." Specific audiometry features match, e.g., Available Frequencies, Outputs, Inputs. Note: Viola is a Type 3, predicate was a Type 2. |
| Substantial Equivalence to Predicate Device | Overall design, function, safety, technological and performance characteristics, intended use. | "Inventis Middle Ear Analyzers (Flute and Viola) are substantially equivalent to the predicate device with regard to design, function, safety and technological and performance characteristic, intended use. Any differences in the technological characteristics between the devices do not raise any new issues of safety or effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes bench testing, which typically does not involve human subjects or a "test set" in the sense of clinical data. It refers to testing on the device itself against engineering and performance standards. Therefore, specific sample sizes for a "test set" or data provenance (country of origin, retrospective/prospective) are not applicable in the context of this 510(k) submission, as it focuses on demonstrating technical equivalence rather than clinical performance from patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. Ground truth for bench testing is established by the specifications defined in the relevant engineering and performance standards (e.g., ANSI S3.39, IEC 60601-1). There is no "test set" requiring expert adjudication for diagnosis, as would be the case in a clinical study for an AI-powered diagnostic device.
4. Adjudication Method for the Test Set:
Not applicable, as there is no clinical "test set" in this context that would require adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No. An MRMC comparative effectiveness study was not done. This 510(k) submission is for a traditional medical device (auditory impedance tester and audiometer), not an AI-assisted diagnostic tool.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
Not applicable. The device described is a medical instrument for conducting diagnostic evaluations, not an algorithm, and its performance is inherently mechanical/electronic, not based on an independent algorithm's output.
7. The type of ground truth used:
The ground truth for the "tests" performed (bench testing) is defined by the specifications and criteria outlined in the referenced international and national standards (e.g., ANSI S3.39, IEC 60645-5, IEC 60601-1, IEC 60601-1-2, ANSI S3.6, IEC 60645-1). These standards set the benchmarks for electrical safety, EMC, and the accuracy/performance parameters of impedance and audiometry measurements.
8. The sample size for the training set:
Not applicable. This device is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. As no training set is used, no ground truth needed to be established for it.
§ 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.