(57 days)
"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.
| Characteristic | Acceptance Criterion (Predicate Devices) | Reported Device Performance (Tympany Otogram) |
|---|---|---|
| Probe tone: | ||
| Probe tone frequency | Madsen Zodiac 901: 226 Hz | 226 Hz, +/- 3% |
| Probe tone level | Madsen Zodiac 901: 85 dB SPL | 70 dB SPL, +/- 3 dB |
| Admittance measurement: | ||
| Total range | Madsen Zodiac 901: 0.1 ml to 8.0 ml | 0.2 ml to 6.0 ml |
| Reflex range | Madsen Zodiac 901: 0 ul to 375 ul | 0 ul to 375 ul |
| Calibration | Madsen Zodiac 901: 2 cc cavity | 0.5, 2, 5 cc cavity |
| Pressure system: | ||
| Pump system | Madsen Zodiac 901: Plunger type; stepper motor, digitally controlled | Peristaltic pump; stepper motor, digitally controlled |
| Pressure range - normal | Madsen Zodiac 901: +200 to -400 daPa | +200 to -400 daPa |
| Pressure range - extended | Madsen Zodiac 901: +400 to -600 daPa | NA |
| Accuracy | Madsen Zodiac 901: +/- 10% or +/- 10 daPa (whichever is greater) | +/- 15% or +/- 10 daPa (whichever is greater) |
| Pump speed | Madsen Zodiac 901: As fast as possible: 400 daPa/sec, 200 daPa/sec, 100 daPa/sec, 50 daPa/sec | 50 daPa/sec to 150 daPa/sec |
| Air release | Madsen Zodiac 901: Mechanical safety release valve set to +600 and -800 daPa. Manual & automatic air release | Mechanical safety release valve set to +600 and -800 daPa. Manual & automatic air release |
| Ipsi/contralateral stimuli: | ||
| Pure tone | Madsen Zodiac 901: 0.5, 1, 2, 4 kHz | 0.5, 1, 2, 4 kHz |
| Step size | Madsen Zodiac 901: 1, 2, 5, 10 dB | 1 to 10 dB |
| Attenuator range, ipsi lateral stimulus | Madsen Zodiac 901: 0.5, 1.0, 2.0, kHz 50-115 dB HL, 4.0 kHz 50-90 dB HL | 0.5, 1.0, 2.0, 4.0 kHz 80-105 dB HL |
| Attenuator range, contra lateral stimulus | Madsen Zodiac 901: 0.5, 1.0, 2.0, 4.0 kHz 50-100 dB HL, white noise | 0.5, 1.0, 2.0, 4.0 kHz 80-100 dB HL |
| Frequency accuracy | Madsen Zodiac 901: +/- 0.5% (also Bio-Logic AuDX: +/- 0.5%) | +/-0.5% |
| Distortion Product Otoacoustic Emissions: | ||
| F2 test frequency | Bio-Logic AuDX: 2.0, 3.0, 4.0, 5.0 kHz | 1.0, 1.5, 2.0, 3.0, 4.0 kHz |
| Stimulus level range | Bio-Logic AuDX: 55 dB SPL and 65 dB SPL | 45-70 dB SPL |
| Standard and safety characteristics: | ||
| Performance and calibration | IEC 1027, ANSI S3.39 (for Madsen Zodiac 901) | IEC 1027, ANSI S3.39 |
| Electrical safety | EN 60601-1, class I, type B (for Madsen Zodiac 901); EN 55011: 1991 Group 1 Class B (for Bio-Logic AuDX) | EN 60601-1, class I, type B |
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).
§ 874.3310 Hearing aid calibrator and analysis system.
(a)
Identification. A hearing aid calibrator and analysis system is an electronic reference device intended to calibrate and assess the electroacoustic frequency and sound intensity characteristics emanating from a hearing aid, master hearing aid, group hearing aid or group auditory trainer. The device consists of an acoustic complex of known cavity volume, a sound level meter, a microphone, oscillators, frequency counters, microphone amplifiers, a distoration analyzer, a chart recorder, and a hearing aid test box.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.