The Amplaid MK12 Multi-channel system for electrodiagnosis consists of a two or four channel signal acquisition system coupled to a microcomputer which can perform signal averaging, storage and display, along with microcomputer controlled multiple mode evoked potential stimulators: auditory, visual, and electrical. A thermal printer is built in, and laser printer connection is supported.

AI/ML Overview

The provided text describes the Amplaid MK12, an evoked potential electrodiagnostic system, and its substantial equivalence to a predicate device, the Amplaid MK15. However, the document does not contain details about specific acceptance criteria, a dedicated study proving device performance against those criteria, or the methodology typically used for such studies in the context of AI/ML or a new, novel medical device.

The submission is a 510(k) for a device that is stated to be "similar in design and function" to a previously cleared device (K861014). The primary focus of the 510(k) summary is to demonstrate substantial equivalence, rather than to present a de novo performance study against explicit acceptance criteria.

Therefore, many sections of your request cannot be fulfilled by the provided text.

Here is an attempt to address your request based on the available information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it relies on demonstrating that the new device is "as safe and effective as the predicate device" through a comparison of characteristics.

Characteristic	Acceptance Criteria (Implied)	Reported Device Performance (Amplaid MK12)
Intended Use	Same as predicate device	Electronystagmography, Visual Evoked Potentials, Auditory Evoked Potentials, Electrical (Somatosensory) Evoked Potentials (Same as MK15)
Physical Characteristics (Size/Weight)	Comparable to predicate device	21.25"H x 19.7"D x 7.9"H, 28.6 lbs (Different from MK15, but acceptable)
Energy Source	Same as predicate device	115/230 Vac, ± 10%, 50-60 Hz (Same as MK15)
Hardcopy Output	Equivalent or improved functionality to predicate device	Built-in via 640 point thermal printer or laser printer connection (Improved/added functionality compared to MK15's computer interface output)
Electrical Safety	Compliance with UL-544, IEC 601	UL-544, IEC 601 (Same as MK15)
Safety and Effectiveness	As safe and effective as predicate device	Reported as "as safe and effective as the predicate devices" based on "bench and user testing."
Technological Differences	Few and do not raise new questions of safety or effectiveness	Has "few technological differences" compared to the predicate.
New Indications for Use	None	No new indications for use.

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

The document mentions "bench and user testing" but does not provide details on:

The specific sample size (number of cases, subjects, or data points) used for this testing.
The data provenance (e.g., country of origin, retrospective or prospective nature).

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

This information is not provided in the document. Given that the testing mainly aimed to establish substantial equivalence based on safety and effectiveness comparable to a predicate, it's unlikely a formal "ground truth" establishment by multiple experts, as understood in an AI/ML context, was performed or detailed.

4. Adjudication method for the test set

This information is not provided in the document.

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

An MRMC study is not mentioned. The device is an evoked potential electrodiagnostic system and does not appear to be an AI-assisted diagnostic tool for human readers in the way an AI-powered image analysis system would be.

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

This concept is not applicable to the device described. The Amplaid MK12 is a multi-channel system for electrodiagnosis, implying human operation and interpretation of the evoked potentials. It's not a standalone algorithm in the sense of AI/ML.

7. The type of ground truth used

The document does not specify the type of ground truth used. For an evoked potential system, "ground truth" would generally relate to the accuracy, reliability, and precision of the physiological signal acquisition and processing compared to established medical benchmarks or the performance of the predicate device.

8. The sample size for the training set

The concept of a "training set" in the context of machine learning is not applicable here, as the device is not described as using AI/ML algorithms that require training data.

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

Not applicable for the same reason as point 8.

Summary

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K971740

MAR 1 6 1998

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

March 12, 1997

510(k) Summary of Safety and Effectiveness

Identification of the Device: 1.

Proprietary-Trade Name: Amplaid MK22 Common/Usual Name: Evoked potential electrodiagnostic system Classification Names/ Device class: The electrodiagnostic system is a combination of devices which are Class II per regulations 882.1835, 882.1845, 882.1870. 882.1890. and 882.1900

Equivalent legally marketed devices This product is similar in design and 2. function to the Amplaid USA. Inc. Evoked Potentials System MK15 (K861014)

Indications for Use (intended use) Electronystagmography (for identification of middle ear conditions), Visual evoked notentials, Auditory evoked potentials, and Electrical (somatosensory) evoked potentials.
Description of the Device: The Amplaid MK12 Multi-channel system for electrodiagnosis consists of a two or four channel signal acquisition system coupled to a microcomputer which can perform signal averaging, storage and display, along with microcomputer controlled multiple mode evoked potential stimulators: auditory, visual, and clectrical. A thermal printer is built in, and laser printer connection is supported.

Safety and Effectiveness, comparison to predicate device. The results of hench న్. and user testing indicates that the new device is as safe and effective as the predicate devices.

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Substantial Equivalence Chart હ.

Characteristic	Predicate device: TheAmplaid MK15	New device: "AmplaidMK12TM"
Intended Use:	Electronystagmography,Visual Evoked Potentials,Auditory Evoked Potentials,Electrical (Somatosensory)Evoked Potentials	(Same)
Physical characteristics:
Size/weight	20.8"W x 18.9"D x 13.4"H,44 Ibs.	21.25"H x 19.7"D x 7.9"H28.6 lbs.
Energy Source:	115/230 Vac, ± 10%, 50-60Hz.	(Same)
Hardcopy Output:	Possible via computerinterface	Built in via 640 pointthermal printer or laserprinter connection
Standards and Safetycharacteristics:
Electrical safety:	UL-544, IEC 601	(Same)

7. Conclusion

After analyzing both bench and user testing data, it is the conclusion of Amplifon S.p.A. that the "Amplaid MK12™" 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Daniel Kamm ·c/o Kamm & Associates P.O. Box 7007 Deerfield, Illinois 60015

K971740 Re: Amplaid MK12 Trade Name: Regulatory Class: II GWF Product Code: March 2, 1998 Dated: March 4, 1998 Received:

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, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 requlations 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 (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. 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 requlations.

MAR 1 6 1998

Image /page/2/Picture/9 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle with three human profiles incorporated into its design.

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Page 2 - Mr. Kamm

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) 594-4595. 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/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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j) Indications for Use

510(k) Number K971740

Device Name: Amplaid MK12

Indications for Use: The Amplaid MK12 is a multi-channel system for electrodiagnosis capable of performing multisensory evoked potential tests including:

Electronystagmography ﻨﺴ
1. Visual evoked potentials,
1. Auditory evoked potentials, and
1. Electrical (somatosensory) evoked potentials.

Concurrence of CDRH, Office of Device Evaluation (ODE)

	(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	K971740

Prescription Use		OR	Over the Counter Use
			(Per 21 CFR 801.109)

Regulation Number and Section

§ 882.1870 Evoked response electrical stimulator.

(a)
Identification. An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.(b)
Classification. Class II (performance standards).