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.

Device Description

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.

AI/ML Overview

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.

Summary

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MAR 3 1 2004

K033645

510(k) Summary of Safety and Effectiveness

Submitter

Name and address:	GN Otometrics A/S
	Dybendalsvaenget 2
	DK-2630 Taastrup
	Denmark
Phone:	+45 7211 1555
Fax:	+45 7211 1548
Contact person:	Per Pape Thomsen

November 14, 2003 Summary prepared:

Device name

Common/Usual name: Trade/Proprietary name: Classification name;

AudioDiagnostic Testing System OTOflex 100 type 1012 Auditory Impedance Tester

Predicate devices

OTOflex is similar to the product Zodiac 901 Middle-Ear Analyzer (K910247) but differs in three ways: handheld operation powered by batteries, measurement with 1000 Hz probe tone and wireless computer interface.

Handheld operation powered by batteries is currently performed by Handtymp (K923072) and measurement with 1000 Hz probe tone is currently performed by GSI 2000 Middle Ear Analyzer (K000097).

Description

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.

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Intended Use

Technological Characteristics

Device Specifications	OTOflex	Zodiac 901
Safety compliance	EN 60601-1	EN 60601-1
Construction type	Handheld, Desktop, PC-based system	Desktop system
Power source	Batteries recharged frommains powered charger unit	Mains
Computer interface	Bluetooth radio link	RS232 cable connection
Supporting software	NOAH database SW	NOAH and PAX database

Safety

OTOflex is designed to provide safety to the patient as well as the user and complies with:

EN 60601-1, UL 2601-1, CAN/CSA-C22.2 NO 601.1-90: Medical Electrica1 . Equipment. Part 1: Generel requirements for safety
EN 60601-1-1: Medical Electrical Equipment. Part 1: Generel requirements . ● for safety. 1. Collateral standard: Safety requirements for medical electrical systems
EN 60601-1-2: Medical Electrical Equipment. Part 1-2: Generel requirements � for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
EN 60601-1-4: Medical Electrical Equipment. Part 1: Generel requirements . for safety. 4. Collateral standard: Programmable electrical medical systems
Medical devices Directive 93/42/EEC

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OTOflex is designed, developed and manufactured according to:

ISO 9001: Quality Management Systems Requirements .
.
ISO13485: Quality Systems Medical devices Particular requirements for . the application of ISO 9001

Effectiveness

The OTOflex is an Auditory Impedance Tester for replacement of an existing product of a technology type that is available and accepted in the market. OTOflex complies with product performance standards for impedance/admitance instruments: EN 61027 and ANSI S3.39. :

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle image.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 3 1 2004

GN Otometrics A/S c/o Per Pape Thomsen 2 Dybendalsvænget P.O. Box 119 DK-2630 Taastrup Denmark

Re: K033645

Trade/Device Name: OTOflex 100 Type 1012 Regulation Number: 21 CFR 874.1090 Regulation Name: Auditory impedance tester Regulatory Class: Class II Product Code: ETY Dated: February 25, 2004 Received: March 2, 2004

Dear Mr. Thomsen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Per Pape Thomsen

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Statement of Indications for Use

Prescription Use
(Per 21 CFR 801.109)

(Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises

(033645) 510(k) Number

Regulation Number and Section

§ 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.