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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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"Otogram" can perform the functions of:
Pure tone and speech audiometer, 1.
Impedance audiometer (tympanometry, acoustic reflex), and 2.
Distortion product otoacoustic emissions analyzer. 3.
The unit is intended for use by a qualified/trained audiologist on both adult and pediatric subjects for measurement of acoustic impedance.

The Otogram is a computer-controlled, audiometric instrument combining the functions of an Audiometer, a Impedance Instrument, and a DPOAE Instrument. 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. The device performs comprehensive audiometry; tympanometry, acoustic reflex; and otoacoustic emissions. Additional features include manual audiometer and NOAH v.3 compliant (hearing aid fitting software). Available in multiple languages, including English, Spanish, Russian, Mandarin, Vietnamese, and Korean.

The provided text describes the regulatory submission for the Tympany Otogram device and its comparison to predicate devices, focusing on substantial equivalence rather than a study proving the device meets specific acceptance criteria in a clinical performance sense.

Therefore, many of the requested elements (like sample size for test/training sets, number and qualifications of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and type of ground truth) either do not apply directly to this type of submission or are not detailed in the provided information. This document is a 510(k) summary, which focuses on demonstrating equivalence to existing legally marketed devices based on technical characteristics and intended use, often supported by bench and user testing rather than extensive clinical trials with human subjects.

Here's an attempt to answer the questions based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state "acceptance criteria" in the format of specific quantitative thresholds to be met. Instead, it demonstrates "substantial equivalence" to predicate devices by comparing technical characteristics. The "reported device performance" is essentially the detailed technical specifications of the Otogram and its comparison to the predicate devices.

The table below reconstructs the comparison from the provided Substantial Equivalence Chart as effectively serving the role of demonstrating performance relative to established benchmarks (the predicate devices). The implied "acceptance criterion" for each characteristic is that the Otogram's performance/specification is comparable to or within acceptable ranges of the predicate devices.

The study proving the device meets these criteria is described as "bench, user, and laboratory testing" (Section 5. and 7.). These tests indicate that the new device is "as safe and effective as the predicate device," thus demonstrating substantial equivalence.

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified. The document mentions "bench, user, and laboratory testing" but does not quantify the sample size (e.g., number of devices tested, number of users, number of measurements).
• Data Provenance: Not specified. It's internal company testing ("Tympany Inc."). There is no indication of country of origin or whether the testing was retrospective or prospective in detail, although "user testing" implies prospective interaction with the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not specified. This is a technical medical device, and the "ground truth" for its performance is typically established by comparing its physical outputs (e.g., sound frequencies, pressure measurements) against calibrated standards and predicate devices, rather than expert consensus on a diagnosis for a test set. The submission focuses on technical performance and safety.

4. Adjudication method for the test set

Not applicable/Not specified. Adjudication methods like 2+1 or 3+1 are typically used in studies where human readers evaluate cases and their agreement needs to be resolved. This document describes bench and user testing of a medical device's technical specifications and safety, not an evaluation of diagnostic accuracy by human readers.

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

No. This type of study (MRMC, AI assistance) is not mentioned and is typically associated with diagnostic algorithms or imaging interpretation, which is not the primary focus of this device's regulatory submission. The Otogram is a measurement device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable for this device in the context of "algorithm only." The performance of the device itself (its hardware and embedded software) was tested, implying a "standalone" evaluation of its technical capabilities against its specifications and predicate devices. However, this is not in the context of an "AI algorithm." The device's operation is "computer-controlled" (Section 4), but the submission focuses on its measurement functions, not on a standalone diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the device's technical performance would be established by calibrated standards and the specifications of predicate devices. For example, to verify "Probe tone frequency: 226 Hz, +/- 3%", the device's output would be measured against a known, highly accurate frequency standard. For safety, compliance with standards like EN 60601-1 is the ground truth. There's no mention of patient-specific "outcomes data" or "pathology" as ground truth for this type of device submission.

8. The sample size for the training set

Not applicable. The device described (Otogram) is an audiometer, impedance instrument, and DPOAE instrument. It is a measurement device, not an AI/machine learning model that requires a "training set" in the conventional sense.

9. How the ground truth for the training set was established

Not applicable (as established in point 8).

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