(132 days)
The OTOflex 100 type 1012 is an auditory impedance tester 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. This device is also used to measure the acoustic reflex threshold and decay testing as well as eustachian tube function testing for intact and perforated tympanic membranes.
The OTOflex system consists of a charger unit, a handheld unit with built-in Bluetooth interface, a probe, a contra earphone, and software for installation on a PC. The probe and contra earphone is connected to the handheld unit. The handheld unit can be operated as a standalone device, as a desktop device when placed in the charger, or as a PC-based system from the software via a Bluetooth radio link. The handheld unit is powered from batteries that are recharged when the unit is placed in the mains powered charger unit and two transducers for contra stimulus presentation are available: Probe and Insert phone.
The provided text is a 510(k) summary for the OTOflex 100 type 1012 auditory impedance tester. This type of document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and device performance metrics in the way a clinical trial report would.
Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes for test/training sets, ground truth establishment, expert qualifications, and MRMC studies is not available within this document. The document primarily highlights safety compliance, technological characteristics compared to a predicate, and adherence to relevant standards.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion/Feature | Acceptance Standard (Implicit or Explicit) | OTOflex 100 Performance |
|---|---|---|
| Safety | Compliance with EN 60601-1, UL 2601-1, CAN/CSA-C22.2 NO 601.1-90, EN 60601-1-1, EN 60601-1-2, EN 60601-1-4, Medical Devices Directive 93/42/EEC | Complies with all listed safety standards. |
| Effectiveness (Product Performance Standards) | Compliance with EN 61027 and ANSI S3.39 (impedance/admittance instruments) | Complies with EN 61027 and ANSI S3.39. |
| Intended Use | To change air pressure in external auditory canal, measure and graph tympanic membrane mobility, evaluate middle ear function, measure acoustic reflex threshold and decay, and perform eustachian tube function testing for intact and perforated tympanic membranes. | Meets the stated Intended Use (explicitly stated in the document). |
| Technological Characteristics (Comparison to Predicate Zodiac 901, K910247) | Equivalent functionality despite differences in construction type, power, and interface. | Handheld, Desktop, PC-based system (vs. Desktop system for Zodiac 901) |
| Batteries recharged from mains powered charger unit (vs. Mains for Zodiac 901) | ||
| Bluetooth radio link (vs. RS232 cable for Zodiac 901) | ||
| NOAH database SW (vs. NOAH and PAX database for Zodiac 901) | ||
| Similarities to Other Predicates | Handheld operation powered by batteries (similar to Handtymp K923072) | |
| Measurement with 1000 Hz probe tone (similar to GSI 2000 Middle Ear Analyzer K000097) | OTOflex exhibits these similar characteristics. |
Missing: Specific performance metrics (e.g., accuracy, precision, sensitivity, specificity) for measuring tympanic membrane mobility, acoustic reflex, or eustachian tube function are not detailed in this 510(k) summary. The acceptance criteria are primarily framed as compliance with recognized standards and similarity to predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the document.
- Data Provenance: Not specified in the document. This is a 510(k) submission, which relies on demonstrating substantial equivalence to existing devices and compliance with standards, rather than presenting new clinical study data with test sets of patients.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Number of Experts: Not applicable/Not specified. This information is typically relevant for studies involving subjective assessments or expert consensus in fields like image interpretation, which is not the primary focus for an auditory impedance tester 510(k).
- Qualifications of Experts: Not applicable/Not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/Not specified. This concept is usually associated with studies where multiple readers or experts make assessments that need to be reconciled for ground truth establishment.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done or reported in this 510(k) summary.
- Effect Size of Human Reader Improvement with AI vs. Without AI Assistance: Not applicable, as this device is a standalone diagnostic instrument, not an AI-assisted interpretation tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, this submission describes the device's standalone performance in terms of its ability to meet performance standards (EN 61027, ANSI S3.39) and its technological characteristics. The OTOflex 100 is an auditory impedance tester, and its "performance" is its intrinsic capability to perform the measurements as specified, rather than an "algorithm" performance in the AI sense.
7. The Type of Ground Truth Used
- For this type of device, "ground truth" is derived from its ability to accurately and reliably perform physical measurements according to specified engineering and performance standards.
- Effectiveness: Compliance with product performance standards for impedance/admittance instruments: EN 61027 and ANSI S3.39. These standards define the expected accuracy and performance characteristics for such devices.
- Safety: Compliance with various electrical and medical device safety standards (e.g., EN 60601-1 series).
- There is no mention of expert consensus, pathology, or outcomes data being used as "ground truth" in the context of this 510(k) submission for this specific device.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable/Not specified. This device is not described as involving machine learning or AI models that would require a "training set" of data in the typical sense. Its design and performance are based on established engineering principles and adherence to recognized standards.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment for Training Set: Not applicable, as no training set for a machine learning model is mentioned or implied.
§ 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.