(106 days)
The Titan Impedance System is an electroacoustic test instrument that produces controlled levels of test tones and signals intended for use in conduction diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders. It features tympanometry and acoustics reflex.
Titan IMP440 consists of a handheld unit named Titan, Titan Cradle and PC software (Titan Suite and Titan IMP440 module). The measurements are controlled by the handheld unit. Titan IMP440 is going to be offered as 3 configurations that will support screening, diagnostic and clinic users. A license system makes it possible within each configuration to select which functionality the user wants to be incorporated in the system. Titan IMP440 is an impedance product based on a hardware platform named Titan Platform. It uses a cabinet named Titan but may use any other cabinets as long as it meets the requirement of the platform. Other products will in the future be developed to the Titan platform and submitted as required and thereby become a part of the Titan System Family as Titan IMP440. A connection box named Titan Shoulder Box enables different types of accessories to the hardware platform.
The provided text is a 510(k) summary for the Interacoustics Titan IMP440 device, which is an auditory impedance tester. This type of document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. As such, it focuses on comparing the new device's technological characteristics and performance to an existing, cleared device, rather than conducting a full clinical study with acceptance criteria, sample sizes, and expert validation in the way a novel AI/ML device might.
Therefore, many of the requested categories (e.g., sample size for training/test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, specific acceptance criteria with reported performance, ground truth types) are NOT applicable to this type of regulatory submission as it appears from the provided text.
Based on the information given, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
The document states: "The performance data indicated that the Titan Impedance System meets all specified requirements, and is substantially equivalent to the predicate device." However, the specific acceptance criteria (e.g., accuracy thresholds, precision ranges) are not detailed in this summary. The "specified requirements" likely refer to internal design specifications and relevant industry standards for auditory impedance testers, but these are not enumerated here.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in this document. | "meets all specified requirements" and "is substantially equivalent to the predicate device." |
2. Sample size used for the test set and the data provenance
Not applicable. This 510(k) summary does not describe a clinical study with a specific test set, sample size, or data provenance in the context of an AI/ML device. The "performance data" likely refers to engineering tests and comparisons against the predicate device's specifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not a clinical study involving expert-established ground truth for a test set.
4. Adjudication method for the test set
Not applicable.
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
Not applicable. The Titan IMP440 is an electroacoustic test instrument, not an AI-assisted diagnostic tool that would involve human readers interpreting results with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a diagnostic instrument, not an algorithm, and its performance is inherently standalone in generating measurement data for a clinician to interpret.
7. The type of ground truth used
Not applicable in the typical sense of a clinical study or AI/ML validation. For an impedance system, "ground truth" would be the physically accurate measurement of the auditory system's impedance. The document implies that the device's measurements are accurate enough to be considered substantially equivalent to the predicate device, which is already an accepted method for obtaining such "ground truth" in routine clinical use.
8. The sample size for the training set
Not applicable. This device does not use machine learning, so there is no training set.
9. How the ground truth for the training set was established
Not applicable.
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Ko8 3861
Titan System 510k Notification :
.
APR 0 9 2009
Author Hanne Nielsen "
Image /page/0/Picture/4 description: The image shows the Interacoustics logo. The logo consists of the word "Interacoustics" in a bold, sans-serif font, enclosed within an oval shape. The oval shape is stylized to resemble a globe, with curved lines representing lines of latitude and longitude. The logo is black and white.
; }); Revision 1
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
Titan
SUBMITTER INFORMATION
| A | Company Name: | Interacoustics A/S |
|---|---|---|
| B | Company Address: | Drejervaenget 8 |
| Assens, DK-5610, Denmark | ||
| C | Company Phone: | +45 6371 3555 |
| C | Company Fax: | +45 6371 3522 |
| D | Contact Person: | Hanne Nielsen |
| Quality Manager | ||
| Interacoustics A/S | ||
| E | Date Summary Prepared: | 04/11/2008 |
DEVICE IDENTIFICATION
| A | Generic Device Name: | Tester, Auditory Impedance |
|---|---|---|
| B | Trade/proprietaryName: | Titan, Titan Shoulder Box, Titan Cradle, Titan Printer, Titan IMP440,Titan IMP440 Module, Titan Suite |
| C | Classification: | Class II | |
|---|---|---|---|
| D | Product Code: | ETY |
Date 11/12/2008
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Titan System 510k Notification
Author Hanne Nielser
Image /page/1/Picture/2 description: The image shows the Interacoustics logo. The logo consists of the word "Interacoustics" in a bold, sans-serif font, enclosed within an oval shape. The oval shape is formed by lines resembling the longitudes and latitudes of a globe. The logo is simple and clean, with a focus on the company name and a subtle representation of global reach.
Revision 1
SUBSTANTIAL EQUIVALENCE
| Predicate Device | Manufacture | 510(k) No. | Date Cleared |
|---|---|---|---|
| AT235 | Interacoustics | K994254 | 14/03/2000 |
DEVICE DESCRIPTION
Product name: Titan IMP440
Titan IMP440 consists of a handheld unit named Titan, Titan Cradle and PC software (Titan Suite and Titan IMP440 module). The measurements are controlled by the handheld unit. Titan IMP440 is going to be offered as 3 configurations that will support screening, diagnostic and clinic users. A license system makes it possible within each configuration to select which functionality the user wants to be incorporated in the system.
Titan IMP440 is an impedance product based on a hardware platform named Titan Platform. It uses a cabinet named Titan but may use any other cabinets as long as it meets the requirement of the platform. Other products will in the future be developed to the Titan platform and submitted as required and thereby become a part of the Titan System Family as Titan IMP440.
A connection box named Titan Shoulder Box enables different types of accessories to the hardware platform.
INTENDED USE
The Titan Impedance System is an electroacoustic test instrument that produces controlled levels of test tones and signals intended for use in conduction diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders. It features tympanometry and acoustics reflex.
TECHNOLOGICAL CHARACTERISTICS
A comparison of the technological characteristics of the Titan Impedance System and the predicate device has been performed. The results of this comparison demonstrate that the Titan Impedance System is equivalent to the marketed predicate device.
PERFORMANCE DATA
The performance data indicated that the Titan Impedance System meets all specified requirements, and is substantially equivalent to the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the perimeter of the circle. In the center of the seal is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 0 9 2009
Interacoustics A/S Ms. Hanne Nielsen Quality manager Drejervaenget 8 Assens, DK-5610. Denmark
Re: K083861 Trade/Device Name: Titan IMP440 Regulation Number: 21 CFR 874.1090 Regulatory Class: Class II Product Code: ETY Dated: March 5, 2009 Received: March 9, 2009
Dear Ms. Nielson:
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.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97).
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For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
M.B. Egelston, MD
Malvina B. Eydelman, 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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Indications for Use
510(k) Number (if known): K083861
Device Name: Interacoustics A/S Titan IMP440
Indications for Use:
The Titan Impedance System is an electroacoustic test instrument that produces controlled levels of test tones and signals intended for use in conduction diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders. It features tympanometry and acoustics reflex.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
AZ
(Division, Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices
KOR SAL 510(k) Number
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§ 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.