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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:

1. Pure tone air and bone conduction audiometry with automated masking

2. Speech recognition threshold with automated masking

3. Speech discrimination with automated masking

4. Tympanometry

5. Acoustic reflex threshold, both ipsilateral and contralateral

6. Distortion product otoacoustic emissions

7. Pure tone Stenger

8. 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.

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.

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.

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.

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