(83 days)
The Amplaid A311 Series 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 A311 Series 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, Multifrequency, S.I.S.I., A.B.L.B. (Fowler), D.L.I. (Lüscher), M.L.B., and Tone Decay. The A311 Series comes in two models, both using the same internal circuit board: The AM11 which uses a personal computer as the user interface (communicates via RS232), and the A311, with uses a dedicated front panel keyboard with an LCD display.
The provided document [0-3] does not contain specific acceptance criteria or a detailed study proving the device meets said criteria in the way typically expected for a medical device efficacy study (e.g., performance metrics like sensitivity, specificity, accuracy against a gold standard).
Instead, this document is a 510(k) summary for the Amplaid A311 Series audiometer seeking substantial equivalence to predicate devices already on the market. The "acceptance criteria" here are primarily based on demonstrating that the new device performs "as safe and effective as the predicate devices" and conforms to relevant medical device standards.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the comparison to predicate devices and adherence to relevant standards. The "reported device performance" is essentially that it meets these standards and functions similarly to the predicate.
| Characteristic / Acceptance Criteria | Predicate Device Performance (Implied Baseline) | New Device Performance (Amplaid AM11/A311) |
|---|---|---|
| Intended Use (Clinical diagnostic audiometric applications) | Clinical diagnostic audiometric applications | Same as predicate |
| Audiometric Standards (ISO 389, ANSI S3.6, IEC 645) | ISO 389-1975, ANSI S3.6-1969, ANSI S3.13-1972, IEC 645 | ISO 389-1989, ANSI S3.6-1989, IEC 60645 (Updated versions) |
| Electrical Safety Standards (UL, IEC) | UL-544, IEC 601 | UL 2601, IEC 60601-1 (Updated versions) |
| Functional Equivalence (Performance of audiometric tests) | Performs all audiometric tests normally performed in a clinical situation (pure tone, speech, S.I.S.I., A.B.L.B., D.L.I., M.L.B., Tone Decay, etc., as per Predicate Amplaid 309 K880059) | Can perform all audiometric tests normally performed in a clinical situation. Provides testing capability for basic evaluation, cochlear versus retrocochlear dysfunction, central dysfunction and non-organic hearing loss. |
| Safety and Effectiveness (Overall) | Safe and effective (as determined by predicate device's market clearance) | As safe and effective as the predicate devices. |
| Technological Differences (Minor, no new indications) | N/A (point of comparison) | Few technological differences, no new indications for use. |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "The results of bench and user testing indicates that the new device is as safe and effective as the predicate devices." [0] and "After analyzing both bench and user testing data, it is the conclusion of Amplifon S.p.A. that the 'Amplaid A311 Series™' is as safe and effective as the predicate device..." [1] However, the specific sample sizes, the nature of the "test set" (e.g., number of subjects, type of data collected, number of test runs), or the data provenance (country, retrospective/prospective) are not disclosed in this 510(k) summary. It implies testing was done, but details are absent.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not provided in the document. For a 510(k) submission focused on substantial equivalence, the "ground truth" for the device's performance is often established by comparing its output to that of the predicate device, or by confirming its adherence to objective performance standards (e.g., accuracy of dB levels, frequency output). Expert consensus for "ground truth" in terms of clinical diagnosis or outcomes is not explicitly mentioned as a component of this submission type for an audiometer.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of an audiometer, "adjudication" methods like 2+1 or 3+1 consensus, typically used for image or diagnostic interpretation, are not directly applicable. The "user testing" mentioned might involve comparing measurements from the new device against the predicate device or a calibrated standard.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study is not mentioned in the document. This type of study is more relevant for diagnostic devices where human readers interpret outputs (e.g., radiologists reading images) and the AI aims to assist or replace that interpretation. An audiometer directly measures hearing thresholds, and its effectiveness is determined by its measurement accuracy and reproducibility, not by how it improves human reader performance in interpreting its output.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device itself is a standalone clinical diagnostic audiometer. Its primary function is to generate tones and measure responses, guided by a qualified/trained audiologist. The concept of "algorithm only without human-in-the-loop performance" in the context of an audiometer would likely refer to its ability to generate accurate and consistent sounds and register patient responses correctly, independent of operator skill (though an audiologist uses the device). The document broadly implies standalone performance was assessed through "bench and user testing" to confirm it meets audiometric standards, but it doesn't separate an "algorithm-only" performance from the device's operation by a user.
7. The Type of Ground Truth Used
The "ground truth" for an audiometer's performance typically refers to:
- Measurement Accuracy against Calibrated Standards: The device's ability to output precise frequencies and decibel levels, and to accurately record patient responses, as calibrated against known, accepted reference standards (e.g., conforming to ISO and ANSI audiological standards).
- Comparison to a Predicate Device: Demonstrating that the new device produces equivalent results to an already legally marketed and accepted predicate audiometer.
The document emphasizes adherence to:
- Audiometric Standards: ISO 389-1989, ANSI S3.6-1989, IEC 60645.
- Electrical Safety Standards: UL 2601, IEC 60601-1.
This suggests the ground truth was established by verifying the device's technical specifications and performance against these published standards and against the established performance of the predicate device.
8. The Sample Size for the Training Set
This information is not applicable/provided. Audiometers are not typically "trained" in the way AI algorithms are. Their function is based on established physics and electronics to generate and measure sound. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/provided for the reasons stated above.
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JAN | 2 | 1999
EXHIBIT 2 Amplifon S.p.A. Via Ripamonti, 133 20141 Milan, ITALY Tel ++39-02-57472.482 Fax ++39-02-57409427 Contact: Giovanni Rollier, President
October 17, 1998
510(k) Summary of Safety and Effectiveness
- Identification of the Device: 1. Proprietary-Trade Name: "Amplaid A311 Series™ "(AM 11, A311) Classification Name: Audiometer 77EWO Common/Usual Name: Clinical Audiometer
- Equivalent legally marketed devices This product is similar in design and function 2. to the Amplaid 309 Clinical Audiometer (K880059), Amplaid 308 Clinical Audiometer (K891988), and Amplaid A460 (K971747)
- Indications for Use (intended use) The Amplaid A311 Series is a clinical diagnostic 3. 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.
- Description of the Device: The Amplaid A311 Series is a two channel clinical 4. 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, Multifrequency, S.I.S.I., A.B.L.B. (Fowler), D.L.I. (Lüscher), M.L.B., and Tone Decay. The A311 Series comes in two models, both using the same internal circuit board: The AM11 which uses a personal computer as the user interface (communicates via RS232), and the A311, with uses a dedicated front panel keyboard with an LCD display.
- Safety and Effectiveness, comparison to predicate device. The results of bench ર and user testing indicates that the new device is as safe and effective as the predicate devices.
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6. Substantial Equivalence Chart
| Characteristic | Predicate device:The Amplaid 309K880059 | New device:"Amplaid AM11TM" | New device:"Amplaid A311TM" |
|---|---|---|---|
| Intended Use: | Clinical diagnosticaudiometric applications | (Same) | (Same) |
| Physical characteristics: | |||
| Size/weight | 17.3" W x 19.3" D x 7"H, 28 lbs. | 12" W x 9.5" D x 2.75"H, 3 kg =6.6 lbs. | 12.9" W x 15.7" D x6.9" H, 6.8 kg =15 lbs |
| Energy Source: | 115/230 Vac, ± 10%,50-60 Hz | (Same) | (Same) |
| User Interface | LCD/DedicatedKeyboard | Via attached personalcomputer | LCD/DedicatedKeyboard |
| HardcopyOutput: | Possible via computerinterface | Via attached personalcomputer. | Via attached personalcomputer. (Futuresoftware release) |
| Standards and Safetycharacteristics: | |||
| Audiometric: | ISO 389-1975, ANSIS3.6-1969, ANSI S3.13-1972, IEC 645 | ISO 389-1989, ANSIS3.6-1989, IEC 60645 | ISO 389-1989, ANSIS3.6-1989, IEC 60645 |
| Electricalsafety: | UL-544, IEC 601 | UL 2601, IEC 60601-1 | UL 2601, IEC 60601-1 |
7. Conclusion
After analyzing both bench and user testing data, it is the conclusion of Amplifon S.p.A. that the "Amplaid A311 Series™" is as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate Device.
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Re:
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 12 1999
Daniel Kamm, P.E. Kamm & Associates PO Box 7007 Deerfield, IL 60015
K983712 Amplaid A311 Series Clinical Audiometers (AM11 and A311) Dated: October 17, 1998 Received: October 21, 1998 Regulatory class: II 21 CFR 874.1050/Procode: 77 EWO : 12.1 12.1
Dear Mr. Kamm:
We have reviewed vour 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 legally marketed predicate 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 (Special Controls) or class III (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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory 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 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/dsma/dsmamain.html".
Sincerely yours,
Capt. Daniel G. Schultz, M.D. Acting 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
510(k) Number = 9
Device Name: Amplaid A311 Series Clinical Audiometers (AH // +A31/
Indications for Use: The Amplaid A311 Series 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.
Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological D 510(k) Number Prescription Use_ V OR Over the Counter Use (Per 21 CFR 801.109)
§ 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.