(27 days)
The intended use of The CUB®DIS II™ DPOAE Measurement System is to determine the presence of cochlear function.
The CUBEDIS II TM DPOAE Measurement system is designed to provide acoustic stimuli for, and rapid clinical measurement and evaluation of, odd order distortion product tones generated by the cochlea and measured in the ear canal, at the audiometric frequencies (or other frequencies, as desired), between 500 through 8,000 Hz with no known artifacts, a low noise floor system, and a high signal-to-noise ratio.
Here's a summary of the provided text regarding the CUBEDIS II™ DPOAE Measurement System, structured according to your requested categories.
Based on the provided K981460 510(k) Summary, the regulatory submission focuses on demonstrating substantial equivalence to a predicate device (Etymotic Research CUBEDIS™ Otoacoustic Emission). The information provided does not include a formal acceptance criteria table, nor a detailed study that proves the device meets specific performance criteria in a clinical sense. Instead, the document highlights technical comparisons and regulatory compliance.
Here's an attempt to interpret and present the available information in the requested format, with significant limitations due to the nature of the provided document:
Acceptance Criteria and Device Performance (Interpreted from Technical Comparison)
The document doesn't explicitly state "acceptance criteria" but rather provides a technical comparison between the CUBEDIS II™ and its predicate device, the Ariel_DSP16+. The implicit acceptance criterion is that the performance of the CUBEDIS II™ should be comparable or better than the predicate device across critical technical specifications.
| Parameter | Implicit Acceptance Criteria (Comparable/Better than Predicate) | Reported Device Performance (Mimosa DSP) |
|---|---|---|
| Input | ||
| Measurement Bandwidth | 20 kHz | Same (20 kHz) |
| ADC Resolution | 16 bit | Same (16 bit) |
| ADC Differential Nonlinearity | N/A (Predicate not specified) | $\pm0.5$ LSB |
| Instantaneous Dynamic Range - Line Inputs | 88 dB | 85 dB (Slightly lower) |
| Total Harmonic Distortion - Line Inputs | 0.025 | 0.006 (Significantly better) |
| Signal-to-Intermodulation Distortion | N/A (Predicate not specified) | 90 dB (Typ) |
| Full Scale Input Voltage | 20 Vpp | 2.9 Vpp (Significantly lower) |
| Output | ||
| Measurement Bandwidth | 20 kHz | Same (20 kHz) |
| DAC Resolution | 16 bits | Same (16 bits) |
| DAC Differential Nonlinearity | N/A (Predicate not specified) | $\pm0.5$ LSB |
| Total Dynamic Range | 88 dB | 95 dB (Better) |
| Total Harmonic Distortion | 0.025 | 0.01% (Better) |
| Signal-to-Intermodulation Distortion | N/A (Predicate not specified) | 85 dB |
| Full Scale Output Voltage | 20 Vpp | 2.8 Vpp (Significantly lower) |
Note on Interpretation: The discrepancies in "Instantaneous Dynamic Range - Line Inputs" and "Full Scale Input/Output Voltage" between the devices would typically warrant further explanation in a comprehensive submission. However, in the context of a 510(k) for substantial equivalence, the overall functionality and safety are key. The improved "Total Harmonic Distortion" and "Total Dynamic Range" in other areas might offset these differences for the intended use.
Study Details:
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Sample size used for the test set and the data provenance:
- The provided document does not specify a test set sample size or data provenance (e.g., country of origin, retrospective/prospective clinical data). The comparison appears to be purely based on technical specifications and characteristics of the hardware. This is typical for a 510(k) for a device like this, where the focus is on a technical comparison to a predicate, rather than new clinical effectiveness studies.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not mention any experts or a ground truth establishment process related to a clinical test set. The ground truth for the device's technical specifications would be engineering measurements.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- No adjudication method is mentioned as there's no clinical test set described.
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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 MRMC or comparative effectiveness study involving human readers/AI assistance is mentioned. This device is an Otoacoustic Emissions Test Instrument, which directly measures physiological responses, not an AI-assisted diagnostic tool requiring human interpretation improvement studies.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is an instrument to measure physical phenomena, not an "algorithm" in the AI sense. Its primary function is to provide acoustic stimuli and measure responses.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the technical comparison, the "ground truth" implicitly refers to the established technical specifications and performance characteristics of both the predicate device and the new device, measured through standard engineering tests. There's no clinical ground truth (like pathology or outcomes data) mentioned in this submission summary. The intended use "to determine the presence of cochlear function" implies that the device's output is the diagnostic information, which then a clinician interprets.
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The sample size for the training set:
- N/A. This document describes a medical device for physiological measurement, not a machine learning model. Therefore, there is no "training set."
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How the ground truth for the training set was established:
- N/A, as there is no training set.
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510(k) Summary
MAY 20 1998
PREPARED BY:
Mimosa Acoustics, Inc. 382 Forest Hill Way Mountainside, NJ 07092
Patricia S. Jeng, President
TELEPHONE:
CONTACT PERSON:
DATE ON WHICH THE SUMMARY WAS PREPARED
NAME OF DEVICE:
COMMON NAME:
April 22, 1998
acoustic Emission
(908) 518 0711
CUBEDIS II TM DPOAE Measurement System
Etymotic Research CUBEDIS TM Oto-
Otoacoustic Emissions Test Instrument
PREDICATE DEVICE:
FUNCTION OF DEVICE:
The CUBEDIS II TM DPOAE Measurement system is designed to provide acoustic stimuli for, and rapid clinical measurement and evaluation of, odd order distortion product tones generated by the cochlea and measured in the ear canal, at the audiometric frequencies (or other frequencies, as desired), between 500 through 8,000 Hz with no known artifacts, a low noise floor system, and a high signal-to-noise ratio.
SAFETY:
The Mimosa Acoustic CUBEDIS II TM DPOAE Measurement System is in compliance with the following standards:
EN 55011B Emissions Test EN 60601-1-2 Immunity Test IEC 801-2 Electrostatic Discharge Test IEC 801-3 RF Electromagnetic Field Test IEC 801-4 Fast Transients Test IEC 801-5 Surge Test Standard for Medical Electrical Equipment, Part 1:
General Requirements for Safety - UL 2601-1, Second Edition
1
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Medical Electrical Equipment, Part 1: ical Electrical Equipment, Part 1.
General Requirements for Safety - CAN/CSA - C22.2 No. 601.1-M90.
COMPARISON of the Mimosa CUB®DIS II TM device to the Etymfic Research CUB®DIS TM unit:
Identical for both products INDICATION FOR USE:
ﻟﺴﻢ
Comaprision between Ariel_ DSP16+ and Mimosa DSP Boards
| ComputerSoftware | ComputerHardware | DSP Board | Probe Driver&MicrophonePre-Amplifier | Acoustic Probe&Ear-tips | ||
|---|---|---|---|---|---|---|
| CUBDIS | Data Collections:DOS in FortranGraphic displaysDOS Fortran PackageSignal Processing:Fortran routines | DSP portUses ISA full-sizeplug-in slot | Ariel DSP16 PlusEtymotic ResearchER-10C DPOAEProbe Driver-Preamp | Etymotic ResearchER-10C DPOAELow Noise Probe&ER10C14 series ear-tips | ||
| CUBDIS II | Data Collections:Window95 Visual C++Graphic displaysWindow95 Visual C++Window95 Visual BasicSignal Processing:Same routines as theFortran routines inCUBDIS system. | Uses PCMCIA cardplug-in slot | MA DSP PC Card(PCMCIA Card) | Mimosa AcousticsProbe InterfaceCable (PIC)designed afterER-10C DPOAEProbe Driver-Preampwith Etymotic's help. | Same as above. |
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| Parameters | Ariel DSP16+ | Mimosa DSP |
|---|---|---|
| Size (Type) | ISA full-size DSP board | PC (PCMCIA) Type II DSP card |
| INPUT | ||
| Measurement Bandwidth | 20 kHz | Same |
| ADC Resolution | 16 bit | Same |
| ADC Differential Nonlinearity | - | $ \pm0.5 $ LSB |
| Instantaneous Dynamic Range -Line Inputs | 88 dB | 85 dB |
| Total Harmonic distortion - LineInputs | 0.025 | 0.006 |
| Signal-to-Intermodulation distor-tion | - | 90 dB (Typ) |
| Full Scale Input Voltage: | 20 Vpp | 2.9 Vpp |
| OUTPUT | ||
| Measurement Bandwidth | 20 kHz | Same |
| DAC Resolution | 16 bits | Same |
| DAC Differential Nonlinearity | - | $ \pm0.5 $ LSB |
| Total Dynamic Range | 88 dB | 95 dB |
| Total Harmonic Distortion | 0.025 | 0.01% |
| Signal-to-Intermodulation Distor-tion | - | 85 dB |
| Full Scale Output Voltage | 20 Vpp | 2.8 Vpp |
Comaprision between Ariel_ DSP16+ and Mimosa DSP Boards
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 0 1998
Patricia S. Jeng President Mimosa Acoustics, Inc. P.O. Box 1111 Mountainside, New Jersey 07092 Re:
The CUB® DIS II ™ DPOAE Measurement System Dated: April 22, 1998 Received: April 23, 1998 Regulatory class: II 21 CFR 874.1050/Procode: 77 EWO
Dear Ms. Jeng:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.
If your device is classified (see above) into either class II (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".
Sincerely yours,
Kiliaith
Lillian Yin, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): $9814 6.6 The CUB®DIS II™ DPOAE Measurement System Device Name:
Indications For Use:
1
The intended use of The CUB®DIS II™ DPOAE Measurement System is to determine the presence of cochlear function.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ehrich A. Reppert
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devic
Radiological Devices
510(k) Number K981460
Prescription Use (Pcr 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Formal 1-2-96)
§ 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.