(85 days)
The Amplaid 460 is a two channel clinical diagnostic audiometer which can perform all audiometric tests normally performed in a clinical situation. It is intended for use by a qualified/trained audiologist on both adult and pediatric subjects for measurement and diagnosis of various types of hearing losses.
The Amplaid 460 is a two channel clinical diagnostic audiometer which can perform all audiometric tests normally performed in a clinical situation. It provides testing capability for basic evaluation, cochlear versus retrocochlear dysfunction, central dysfunction and non-organic hearing loss. Other diagnostic audiometric tests are: pure tone, Speech, High Frequency, Multifrequency, Bekesy, S.I.S.I., A.B.L.B. (Fowler), D.L.I. (Lüscher), M.L.B., Tone Decay, and M.L.D.(Masking Level Difference).
The provided text describes the 510(k) submission for the Amplaid 460 Research and Clinical Audiometer. However, it does not contain detailed information about specific acceptance criteria or the study that definitively proves the device meets those criteria. The document is a regulatory submission for substantial equivalence to a predicate device, rather than a detailed scientific study report.
Here's an analysis based on the provided text and what is typically found (or not found) in such 510(k) summaries:
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A table of acceptance criteria and the reported device performance:
The document states: "The results of bench and user testing indicates that the new device is as safe and effective as the predicate devices." No specific acceptance criteria (e.g., accuracy, precision, sensitivity, specificity, or specific tolerances for audiometric measurements) are listed, nor are detailed performance metrics reported. The statement refers to a general equivalence to predicate devices, but without quantification. -
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
No information on sample size, data provenance, or study design (retrospective/prospective) is provided for the "bench and user testing." -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not available in the provided text. The document mentions the intended use by a "qualified/trained audiologist," but does not specify their role in testing or establishing ground truth for the device's performance. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
No information about adjudication methods is provided. -
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:
This device is an audiometer, a diagnostic instrument that measures hearing thresholds. It is not an AI-assisted diagnostic tool that would typically involve human readers interpreting results in a MRMC study. Therefore, an MRMC study with AI assistance is not applicable here, and no such study is mentioned. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device is a standalone diagnostic instrument. Its performance would inherently be evaluated without a human-in-the-loop performance study in the context of interpretation, as it generates raw audiometric data. The "user testing" mentioned likely refers to user interaction and functionality, not diagnostic interpretation. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not explicitly stated. For an audiometer, the "ground truth" would typically refer to the instrument's ability to accurately measure sound levels and hearing thresholds against a known standard, often calibrated using established methods. The "bench testing" would likely cover this. For "user testing," the ground truth might be the expected audiogram from a patient with a known hearing status, but this is speculative given the lack of detail. -
The sample size for the training set:
This device is not described as utilizing a machine learning algorithm that requires a "training set" in the conventional sense. It's a measurement instrument. -
How the ground truth for the training set was established:
As above, the concept of a "training set" and ground truth for it, as typically applied to machine learning, is not relevant to this type of device based on the provided information.
Summary of what is present:
- Predicate Device: Amplaid 309 Clinical Audiometer (K880059)
- Safety and Effectiveness Claim: "The results of bench and user testing indicates that the new device is as safe and effective as the predicate devices." This is a qualitative claim of equivalence, not a detailed report of adherence to specific, quantified acceptance criteria.
- Intended Use: Diagnosis of hearing losses by qualified audiologists on both adult and pediatric subjects.
In conclusion, the provided text from the 510(k) summary focuses on demonstrating substantial equivalence to a predicate device based on design, function, and general safety/effectiveness, rather than detailing a rigorous study with specific acceptance criteria and performance data in the manner typically expected for advanced diagnostic algorithms or AI-driven systems. For a device like an audiometer, "bench testing" would likely involve calibration against known sound pressure levels and electrical signals, and "user testing" would confirm usability and correct functionality in clinical scenarios, but the details are not provided here.
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AUG - 5 1997
EXHIBIT 2 Amplifon S.p.A. Via Ripamonti, 133 20141 Milan, ITALY Tel ++39-2-57472.482 Fax ++39-2-57409427 Contact: Giovanni Rollier, President
April 30, 1997
510(k) Summary of Safety and Effectiveness
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Identification of the Device: -Proprietary-Trade Name: Amplaid 460 Classification Name: Audiometer 77EWO Common/Usual Name: Clinical Diagnostic Audiometer
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Equivalent legally marketed devices This product is similar in design and function 2 to the Amplaid 309 Clinical Audiometer (K880059)
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- Indications for Use (intended use) The Amplaid 460 is a clinical diagnostic audiometer which can perform all audiometric tests normally performed in a clinical situation. It is intended for use by a qualified/trained audiologist on both adult and pediatric subjects for measurement and diagnosis of various types of hearing losses.
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- Description of the Device: The Amplaid 460 is a two channel clinical diagnostic audiometer which can perform all audiometric tests normally performed in a clinical situation. It provides testing capability for basic evaluation, cochlear versus retrocochlear dysfunction, central dysfunction and non-organic hearing loss. Other diagnostic audiometric tests are: pure tone, Speech, High Frequency, Multifrequency, Bekesy, S.I.S.I., A.B.L.B. (Fowler), D.L.I. (Lüscher), M.L.B., Tone Decay, and M.L.D.(Masking Level Difference).
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- Safety and Effectiveness, comparison to predicate device. The results of bench and user testing indicates that the new device is as safe and effective as the predicate devices.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 5 1997
Amplifon S.P.A. Daniel Kamm Regulatory Engineer c/o Kamm & Associates P.O. Box 7007 Deerfield, IL 60015
Re: K971747
Amplaid 460 Research and Clinical Audiometer Dated: April 30, 1997 Received: May 12, 1997 Regulatory class: II 21 CFR 874.1050/Procode: 77 EWO
Dear Mr. Kamm:
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, 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 III (Premarket Approval), it may be subject (c 1 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 requirement, as set forth in the Quality System Regulation (QS) 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 531 through 542 of the Act for devices under 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 question 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/dsmamain.html".
Sincerely yours
hTliau Yi
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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j) Indications for Use
K471747 510(k) Number
Device Name: Amplaid 460 Research and Clinical Audiometer
Indications for Use: The Amplaid 460 is a two channel clinical diagnostic audiometer which can perform all audiometric tests normally performed in a clinical situation. It is which can personn an ualified/trained audiologist on both adult and pediatric subjects for measurement and diagnosis of various types of hearing losses.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use OR Over the Counter Use __
(Per 21 CFR 801.109)
Ra-Pally
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K971747
§ 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.