The Otogram is an auditory diagnostic instrument intended to administer, under supervision by a trained healthcare professional, a battery of diagnostic and screening procedures that include the following:

Pure tone air and bone conduction audiometry with automated masking
Speech recognition threshold with automated masking
Speech discrimination with automated masking
Tympanometry
Acoustic reflex threshold, both ipsilateral and contralateral
Distortion product otoacoustic emissions
Pure tone Stenger
Patient survey

The Otogram is indicated for use by trained healthcare professionals on both adult and pediatric subjects for measurement of audiometric parameters to identify and supply data to help diagnose hearing loss and ear disorders.

Device Description

The Otogram CA3350 is a computer-controlled, audiometric instrument combining the functions of an Audiometer, Distortion Product Otoacoustic Emissions Analyzer and Auditory Acoustic Impedance/Admittance Tester (i.e. Tympanometer). The device is controlled through the use of ASCII commands transmitted over a standard RS-232 communication port. Control software is installed on the supplied PC.

AI/ML Overview

Here's an analysis of the provided 510(k) summary for the Otogram CA3350, focusing on the acceptance criteria and the study that demonstrates its conformity:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (K070118) is a 510(k) premarket notification for a new device, the Otogram CA3350, claiming substantial equivalence to predicate devices. In such submissions, the acceptance criteria are generally established by demonstrating that the new device performs at least as well as, or is equivalent to, the legally marketed predicate devices. The "reported device performance" is primarily based on this comparison and adherence to relevant standards.

Since this is a submission focused on substantial equivalence to existing devices, the "acceptance criteria" are implied to be the performance characteristics of the predicate devices themselves, and the "reported device performance" is the demonstration that the Otogram CA3350 meets or is equivalent to these.

Characteristic	Acceptance Criteria (Predicate Devices' Performance)	Reported Device Performance (Otogram CA3350)
Intended Use	To diagnose various middle ear disorders (tympanometry, acoustic reflex), test cochlear function (otoacoustic emissions), and diagnose hearing/otologic disorders using audiometry. (Based on combined predicate device functions)	Administer diagnostic and screening procedures: pure tone air/bone conduction audiometry with automated masking, speech recognition threshold/discrimination with automated masking, tympanometry, acoustic reflex threshold (ipsilateral/contralateral), distortion product otoacoustic emissions, pure tone Stenger, patient survey. Indicated for trained healthcare professionals, adult/pediatric subjects. (Broader, but encompasses predicate uses)
Computer Interface	RS 232C (Madsen Zodiac 901 & Bio-Logic AuDX)	Computer included, RS 232C
Internal Printer	Thermal (112mm or 59mm) (Madsen Zodiac 901 & Bio-Logic AuDX)	NA (Implies no internal printer, or relies on external printing)
Printer Interface	Parallel port (Madsen Zodiac 901), RS 232C thermal printer (Bio-Logic AuDX)	Parallel port or USB (Utilizes modern computer connectivity)
Display	Graphic supertwist LCD (Madsen Zodiac 901), LCD 1" x 3" (Bio-Logic AuDX)	Color, resistive touchscreen (Improved display technology)
Control Interface	Keyboard (Madsen Zodiac 901), Touchpad (Bio-Logic AuDX)	Keyboard, touchscreen (Combines and improves control)
Size/Weight	Various (e.g., Madsen: 370 x 385 x 120 mm, 7.6 kg; Bio-Logic: 98 x 41 x 197 mm, 0.45 kg)	356 x 348 x 493 mm, 21.1 kg (Within a comparable range for combined devices)
Energy Source	AC 50/60 Hz, 100-240 V (Various)	AC 47-63 Hz, 90-250 VAC (Standard AC power compatibility)
Hardcopy Output	Thermal paper or external printer paper (Madsen Zodiac 901), External thermal printer (Bio-Logic AuDX)	External printer paper (Relies on external computer printing capabilities)
Performance/Calibration Standards	IEC 1027, ANSI S3.39 (Madsen Zodiac 901), NA (Bio-Logic AuDX - implies compliance via general safety)	IEC 1027, ANSI S3.39, IEC 60645-5 (Compliance with relevant audiometric and otoacoustic emissions standards)
Electrical Safety Standards	EN 60601-1, class I, type B (Madsen Zodiac 901), EN 55011: 1991 group 1 Class B (Bio-Logic AuDX)	IEC 60601-1 and 60601-1-1, class I, type B and BF and IEC 60601-1-2 (EMC) (Compliance with comprehensive medical electrical safety standards)
Safety and Effectiveness	As safe and effective as predicate devices.	"The results of bench, user, and laboratory testing indicate that the new device is as safe and effective as the predicate devices." (Conclusion of the submission)

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "Comparison testing with predicate devices was performed by a Hearing Instrument Specialist Intern," and that "Test reports are contained in Exhibit 12 of the 510(k) submission." However, the specific sample size for the test set is not provided in the publicly available summary. There is no information on the number of subjects or tests performed for this comparison.

The data provenance is implied to be prospective testing conducted specifically for this 510(k) submission. The country of origin of the data is not explicitly stated but would presumably be the United States, given Tympany, Inc.'s location.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The summary does not explicitly describe the establishment of a "ground truth" through expert consensus for the test set. Instead, the testing likely involved comparing the results generated by the Otogram CA3350 directly against the results of the predicate devices. The performance of the predicate devices is considered to be the "truth" against which the new device is measured.

The testing for the Otogram CA3350 was performed by a "Hearing Instrument Specialist Intern." While this individual is trained on equipment use, their specific qualifications are not detailed beyond "Intern," and they are explicitly stated not to be an audiologist. This suggests the testing focused on operational equivalence and consistency with established devices rather than independent expert clinical diagnosis for ground truth.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set. Since the evaluation appears to be a direct comparison of the new device's output against predicate device outputs (rather than independent diagnostic assessments with potential disagreements), an adjudication process would not be necessary in the conventional sense. The "ground truth" is considered to be the established performance of the predicate devices.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned or implied. The submission focuses on device equivalence, not on the impact of AI or assisted reading on human performance. The device is an audiometric instrument, not an AI-powered diagnostic imaging tool that typically involves MRMC studies to evaluate reader improvement.

6. Standalone Performance Study

Yes, a form of standalone performance was likely done. The "comparison testing with predicate devices" and "bench, user, and laboratory testing" evaluate the Otogram CA3350's performance as a standalone device against the established performance of the predicate devices. The device is intended to perform its functions independently, similar to how the predicate devices operate. The "algorithm only" aspect isn't directly applicable as it's a hardware/software system, but its output is evaluated independently.

7. Type of Ground Truth Used

The primary "ground truth" used for this submission is the established performance and specifications of the legally marketed predicate devices (Madsen Zodiac 901 and Bio-Logic AuDX). The Otogram CA3350 claims substantial equivalence by demonstrating that its technical characteristics, performance, and intended use are as safe and effective as these predicates, or improve upon them without raising new questions of safety or effectiveness.

8. Sample Size for the Training Set

The document does not mention a training set sample size. This type of device (audiometer, otoacoustic emissions analyzer, tympanometer) does not typically rely on complex machine learning models that require large labeled training sets in the same way an AI-powered image analysis system would. The device's functionality is based on established acoustic and electrical engineering principles, standardized measurement techniques, and calibrated hardware. Any "training" would be in the sense of calibrating the device to known standards, rather than training a machine learning algorithm.

9. How the Ground Truth for the Training Set Was Established

Since there's no mention of a traditional machine learning "training set" for the device, the concept of establishing ground truth for it is not applicable in that context. If the question implicitly refers to the accuracy and calibration of the device's measurements, then the ground truth would be established through:

Adherence to recognized national and international standards: IEC 1027, ANSI S3.39, IEC 60645-5 for performance and calibration, and IEC 60601 series for electrical safety. These standards define the expected accurate behavior and output of such devices.
Calibration with certified reference equipment: During manufacturing and maintenance, the device would be calibrated against instruments that meet primary metrological standards to ensure its measurements are accurate.

In summary, the K070118 submission demonstrates substantial equivalence by comparing the Otogram CA3350's features, intended use, technical specifications, and general performance against legally marketed predicate devices. The "ground truth" for this process is primarily derived from the well-established safety and effectiveness of those predicate devices and compliance with relevant industry standards.

Summary

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510(k) Supplementary Information K070118

Submitters Name and Address: Tympany, Inc.

	2795 East Cottonwood Parkway, Suite 660Salt Lake City, UT 84121Phone: (801) 365-2800FAX: (801) 365-3000
2. Contact Person & Phone:	Mr. Lex J. PearcePhone: (801) 365-2868FAX: (801) 365-3005lex@sonici.com
3. Date Prepared:	26 January 2007
4. Device Name / Classification:	Audiometer, Otoacoustic Emissions Analyzer (21CFR 874.1050, Product Code EWO)Auditory Impedance Tester, Tympanometer (21CFR 874.1090, Product Codes ETY, NAS)
5. Proprietary / Trade Name:	Otogram CA3350

6. Device Description:

7. Intended Use:

Pure tone air and bone conduction audiometry with automated masking

1. Speech recognition threshold with automated masking
1. Speech discrimination with automated masking

Tympanometry

1. Acoustic reflex threshold, both ipsilateral and contralateral
1. Distortion product otoacoustic emissions
1. Pure tone Stenger
1. Patient survey

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	The previous version of this chart appears in Exhibits 5, 10, and 12.
	Characteristic	PredicateImpedance AudiometerMadsen Zodiac 901K910247	PredicateOtoacoustic EmissionsBio-Logic AuDXK974076	PredicateTympany OtogramCombined DeviceImpedance AudiometerOtoacoustic EmissionsK041853	PredicateTympany OtogramCA3350Combined DeviceImpedance AudiometerOtoacoustic EmissionsK070118
	Intended Use:	To diagnose a variety ofmiddle ear disorders usingimpedance and staticpressure measurements(i.e., tympanometry andacoustic reflex) in the earcanal.	To test cochlear functionby measuring otoacousticemissions.	To diagnose hearing andotologic disorders in themiddle-ear and total earsystem, using audiometry,Tympanometry, andacoustic reflex. To testcochlear function andpresence of otoacousticemissions.	To administer, undersupervision by a trainedhealthcare professional, abattery of diagnostic andscreening procedures thatinclude pure tone air andbone conductionaudiometry with automatedmasking, speechrecognition threshold withautomated masking, speechdiscrimination withautomated masking,tympanometry, acousticreflex threshold (bothipsilateral andcontralateral), distortionproduct emissions, puretone Stenger and patientsurvey.
Characteristic	PredicateImpedance AudiometerMadsen Zodiac 901K910247	PredicateOtoacoustic EmissionsBio-Logic AuDXK974076	PredicateTympany OtogramCombined DeviceImpedance AudiometerOtoacoustic EmissionsK041853	Tympany OtogramCA3350Combined DeviceImpedance AudiometerOtoacoustic EmissionsK070118
Physicalcharacteristics:
Computerinterface:	RS 232C	RS 232C	Computer included, RS232C	Computer included, RS232C
Internal printer	Thermal 112 mm, 4.5"	Thermal 59 mm,2 1/4"	Thermal 58 mm,2 1/4"	NA
Printer interface	Parallel port	RS 232C thermal printer	Parallel port or USBComputer LCD 1024 x 768	Parallel port or USBComputer LCD 1024 x 768
Display	Graphic supertwist LCDbacklight, 256 lines x 128dotsWhite text/graphics onblue background	LCD 1" x 3"Black and white	Color, resistivetouchscreen	Color, resistivetouchscreen
Control interface	Keyboard	Touchpad	Keyboard, touchscreen	Keyboard, touchscreen
Size/weight-metric	370 x 385 x 120 mm(W x D x H), 7.6 kg	98 x 41 x 197 mm(W x D x H), 0.45 kg	410 x 300 x 480 mm(W x D x H), 20.4 kg	356 x 348 x 493 mm(W x D x H), 21.1 kg
Size/weight-American	14.8" x 15.4" x 4.8", 16.8lbs	3 7/8" x 1 5/8" x 7 3/4", 1lb	16" x 19", x 12", 45 lbs	14.0" x 13.7" x 19.4", 46.5lbs
Energy source	AC 50/60 Hz, 100-240 V	AC 50/60 Hz, 100-240 V	AC 50/60 Hz, 100-120 V	AC 47-63 Hz. 90-250VAC
Hardcopy output	Thermal paper or externalprinter paper	External thermal printer	Thermal paper or externalprinter paper	External printer paper
Standard andsafetycharacteristics:
Performance andcalibration	IEC 1027, ANSI S3.39	NA	IEC 1027, ANSI S3.39	IEC 1027, ANSI S3.39,IEC 60645-5
Electrical safety	EN 60601-1, class I,type B	EN 55011: 1991 group 1Class B	EN 60601-1, class I,type B	IEC 60601-1 and 60601-1-1, class I, type B and BFand IEC 60601-1-2 (EMC)

rs in Ev 8. Updated Substantial Equivalence Chart:
The previous version of this chart appea

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and the comments of the comments of

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9. Significant changes from predicate Tympany Otogram combination device:

Expansion of intended use to include use by "trained healthcare professional" vs. "qualified/trained audiologist"
- The indications for use stated in the 501(k) submission for the Bio-Logic AuDX device (K974076) indicates use by a "trained health care professional (for example an Audiologist)"
- Training for the Otogram CA3350 includes a thorough review and training using the User Instruction Guide included in Exhibit 13 of the 510(k) submission.
- Comparison testing with predicate devices was performed by a Hearing Instrument Specialist Intern - someone who has been trained on the use of the equipment, but is not an audiologist. Test reports are contained in Exhibit 12 of the 510(k) submission.
Different computer and improved design on various components and assemblies.
- Computer specifications and design specifications are contained in Exhibit 11 of the 510(k) submission.

10. Safety and Effectiveness comparison to predicate devices:

The results of bench, user, and laboratory testing indicate that the new device is as safe and effective as the predicate devices.

11. Conclusion:

After analyzing both bench and user testing data, it is the conclusion of Tympany Inc. that the Tympany Otogram CA3350 is safe and effective as the predicate devices, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate devices.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.

MAR 0 7 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Tympany, Inc. c/o Lex J. Pearce 2795 East Cottonwood Parkway, Suite 660 Salt Lake City, UT 84121

Re: K070118

Trade/Device Name: Otogram CA3350 Regulation Number: 21 CFR 874.1050 Regulation Name: Audiometer Regulatory Class: Class II Product Code: EWO, NAS, ETY Dated: January 11, 2007 Received: January 12, 2007

Dear Mr. Pearce:

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. Iisting 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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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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.

Sincerely yours,

M.B. Egelman Si MD

Malvina B. Evdelman. 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): K070118

Device Name: Otogram CA3350

Indications for Use:

The Otogram is a computer-controlled, audiometric instrument combining the functions of an Audiometer, Distortion Product Otoacoustic Emissions Analyzer and Auditory Acoustic Impedance/Admittance Tester (i.e. Tympanometer) The Otogram is indicated for use by trained healthcare professionals on both adult and pediatric subjects for measurement of audiometric parameters to identify and supply data to help diagnose hearing loss and ear disorders.

Pure tone air and bone conduction audiometry with automated masking
Speech recognition threshold with automated masking
Speech discrimination with automated masking
Tympanometry
Acoustic reflex threshold, both ipsilateral and contralateral
Distortion product otoacoustic emissions
Pure tone Stenger
Patient survey

Prescription Use __ X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use ___________ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number	K070118
---------------	---------

	Prescription Use(Per 21 CFR 801.109)
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Regulation Number and Section

§ 874.1050 Audiometer.

(a)
Identification. An audiometer or automated audiometer is an electroacoustic device that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.(b)
Classification. Class II. Except for the otoacoustic emission device, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, if it is in compliance with American National Standard Institute S3.6-1996, “Specification for Audiometers,” and subject to the limitations in § 874.9.