Bell Implants (Gold and Titanium): The KURZ Bell implants are intended for partial replacement of the ossicular chain to facilitate conduction of sound energy from the ear drum to the inner ear. The prostheses are implanted into the middle ear during a tympanoplasty procedure and are retained in the middle ear by the design configuration of the devices and the favorable biocompatible characteristics of gold and titanium.
Angular Prosthesis (Plester) (Gold with Titanium Bands): The KURZ Angular Prosthesis is intended to bridge defects at the long incudal process and otherwise intact chain.
Bell Prosthesis (Partial): Ossicle replacement in case of interrupted sound conducting chain and intact, mobile stapes footplate. The Bell Prosthesis is intended for partial replacement of the auditory ossicles.

Device Description

The implant consists of a golden wire rectangle or an extremely thin mesh plate with a structured outer surface and a stem which is available in 1/4mm incremental lengths. It ends in a 'bell' with miniscule slits.
The implant consists of a titanium mesh plate that is textured on the surface that faces the tvmpanum. A bell with four slits and a textured inner side is located at the upper end of the shaft.
The Angular prosthesis (Plester) consists of a slit bell, an angular stem (both Au), and two (2) titanium clamps at its end. The open ends of the titanium clamps are slightly staggered, so that they do not touch each other.
The devices are implants for single patient use. They come in an individual sterile package in a sealed carton.

AI/ML Overview

Unfortunately, the provided documents (510(k) summary and FDA clearance letters) for the Heinz Kurz GmbH Medizintechnik ossicular prostheses do not contain the detailed information necessary to describe acceptance criteria and a study proving device performance in the way you've requested.

Here's why and what information is provided:

What a 510(k) Summary and Clearance Letter Contain:

A 510(k) premarket notification is a regulatory submission to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device. It typically focuses on:

Intended Use: What the device is designed to do.
Technological Characteristics: How it's made and what it's made of (e.g., gold, titanium).
Comparison to Predicate Devices: Showing it's similar in design, materials, and function to devices already on the market.
Biocompatibility (often mentioned implicitly or through material choice): Ensuring materials are safe for implantation.
Sterility: How it's sterilized and packaged.
Labeling: Instructions for use.

What is Typically Not in a 510(k) Summary (especially for devices cleared decades ago):

Formal clinical studies with detailed acceptance criteria, performance metrics, and statistical analysis: For most Class II devices (like these ossicular prostheses), especially those cleared before the mid-2000s, clinical trials demonstrating specific performance metrics against pre-defined acceptance criteria were often not required if substantial equivalence could be shown through design, materials, and intended use. The FDA relied heavily on a comparison to existing, already-cleared devices.
Specific sample sizes, data provenance, expert qualifications for ground truth, or adjudication methods for clinical performance evaluation: These are elements of a formal clinical trial or performance study, which, as noted, were not explicitly presented in this type of submission for this device.
MRMC comparative effectiveness studies: These are highly sophisticated clinical study designs usually associated with diagnostic imaging or AI devices, not typically a mechanical implant like an ossicular prosthesis.
Standalone algorithm performance: This is irrelevant as these are physical implants, not AI algorithms.
Ground truth types for performance studies: Again, not typically applicable to the evidence presented in a 510(k) for this type of device.
Training set sample sizes or ground truth establishment for training: Irrelevant for a non-AI, physical implant.

Based on the provided text, here's what can be extracted and why the rest cannot be filled:

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

Acceptance Criteria	Reported Device Performance
Not provided in the document. The document states the device has the "same intended use as predicate devices" and "no additional characteristics known that should adversely affect the safety and effectiveness." This implies performance is expected to be similar to legally marketed predicate devices, but specific numerical acceptance criteria (e.g., sound transmission in dB loss, implant stability rates) and corresponding clinical performance data are not detailed.

Acceptance Criteria

Reported Device Performance

Not provided in the document. The document states the device has the "same intended use as predicate devices" and "no additional characteristics known that should adversely affect the safety and effectiveness." This implies performance is expected to be similar to legally marketed predicate devices, but specific numerical acceptance criteria (e.g., sound transmission in dB loss, implant stability rates) and corresponding clinical performance data are not detailed.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not provided. No "test set" in the context of a performance study is described. The submission focuses on substantial equivalence to existing devices.

3. 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)

Not applicable/Not provided. This information pertains to a formal performance study, which is not described. The ground truth for this device's regulatory clearance is its similarity to already-cleared devices that are considered safe and effective in clinical use by the medical community.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not provided.

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 is completely irrelevant for a mechanical ossicular implant. It's designed for diagnostic tools, often involving interpretation by human "readers" (e.g., radiologists) with or without AI assistance.

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

No. This is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Implicit "Ground Truth": The "ground truth" for this 510(k) submission is the established safety and effectiveness of the legally marketed predicate devices (Smith & Nephew Richards and Xomed ossicular devices). The submission argues that the Kurz devices are so similar in design, materials, and intended use that they can be expected to perform equivalently. There isn't a separate, explicit "ground truth" established for this specific device's performance in the document.

8. The sample size for the training set

Not applicable/Not provided. This is not an AI device with a training set.

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

Not applicable/Not provided.

In summary, the provided documents represent a 510(k) submission, which relies on demonstrating "substantial equivalence" to existing legally marketed devices, rather than presenting a de novo clinical study with specific acceptance criteria and performance data for the device itself. Therefore, much of the information you've requested is not typically part of such a submission.

Summary

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Image /page/0/Picture/2 description: The image shows the word "KURZ" inside of a circle. The word is written in a simple, sans-serif font, and the letters are slightly spaced apart. The circle is not a solid line, but rather a series of small dots or dashes, giving it a slightly rough or textured appearance. The overall impression is simple and slightly distressed.

Heinz Kurz GmbH Medizintechnik Hausanschrift: Tübinger Straße 3 D-72144 Dußlingen

Telefon (0 70 72) 91 79-

Telefax (0 70 72) 91 79-

AUG - 4 1997

Heinz Kurz GmbH · Medizintechnik · Postfach 39 · D-72142 Dußlingen

510(k) SUMMARY

As required by Section 807.92(c)

Submitter | {807.92(a)(1)} (1) Dagmar S. Mäser Business Support International Tel. 011 - 31 - 20 - 428 9591 Amstel 320-1 Fax -428 9429 Amsterdam, 1017AP The Netherlands BusinessSupportInternational@compuserve.com e-mail
(2) Identification of Devices [807.92(a)(2)] Bell Prostheses (Various Models) Trade Names a. Angular Prosthesis (Plester) b. Common Name Partial Ossicular Replacement Prosthesis (PORP) Middle-Ear, Prosthesis, Partial Ossicular Replacement Classification Name Product Code 77 ETB Class 【 Regulatory Number 874 3450

Identification of Predicate Devices [807.92(a)(3)] (3)

The KURZ Bell ossicular implants are substantially equivalent to partial ossicular devices of Smith & Nephew Richards, Bartlett, TN, USA and Xomed, Jacksonville, FL, USA (which also markets Ionos devices); the Angular (Plester) is substantially equivalent to S&N Richards Applebaum Prosthesis. These devices have been found substantially equivalent through the 510(k) premarket notification process.

(4) Description of Device [807.92(a)(4)]

The implant consists of a golden wire rectangle or an Gold (Bell) extremely thin mesh plate with a structured outer surface and a stem which is available in 1/4mm incremental lengths. It ends in a 'bell' with miniscule slits.
The implant consists of a titanium mesh plate that is b. Titanium (Bell) textured on the surface that faces the tvmpanum. A bell with four slits and a textured inner side is located at the upper end of the shaft.

6-1

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Heinz Kurz GmbH Medizintechnik

510(k) Summary (Cont'd)

The Angular prosthesis (Plester) consists of a slit bell, Angular C. an angular stem (both Au), and two (2) titanium clamps at its end. The open ends of the titanium clamps are slightly staggered, so that they do not touch each other.
The devices are implants for single patient use. They come in an individual sterile package in a sealed carton.

(ട) Intended Use of Device [807.92(a)(5)]

a. Bell Implants (Gold and Titanium)
The KURZ Bell implants are intended for partial replacement of the ossicular chain to facilitate conduction of sound energy from the ear drum to the inner ear. The prostheses are implanted into the middle ear during a tympanoplasty procedure and are retained in the middle ear by the design configuration of the devices and the favorable biocompatible characteristics of gold and titanium.
b. Angular Prosthesis (Plester) (Gold with Titanium Bands) The KURZ Angular Prosthesis is intended to bridge defects at the long incudal process and otherwise intact chain.
The devices can be used on adults and children.

Technological Characteristics (6)

The implants can be bent and easily shaped to the individual conditions in the middle ear, yet hold their shape after placement.

Information Bearing on the Safety and Effectiveness (7)

The KURZ Bell and Angular partial ossicular replacement prostheses have the same intended use as predicate devices. There are no additional characteristics known that should adversely affect the safety and effectiveness of these implants.

Signature

Do161 1010	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Company Company College of Art	1COMPA	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------And Income of each and and any and any
	t

Dagmar S. Mäser

Date

111/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/11

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510(k) Number

Device Name

INDICATIONS FOR USE:

For bridging defects at the long incudal process in patients with otherwise intact mobile chain.

The Angular prosthesis (Plester) consists of two titanium bands which are connected by a gold wire to the bell with its cross-shaped slits.

The bands function as clamps and are positioned on the long incudal process. In cases of arrosion at the distal end of the long incudal process, the prosthesis allows the reconstruction of the continuity of the auditory ossicular chain. By slight lateral displacement of one end of the bands overclosure is possible. Titanium ensures a firm connection with the bone.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,and Radiological Devices
510(k) Number	K912492

Prescription Use		OR	Over-The-Counter Use
(Per CFR 801 109)

(Optional Formal 1-2-96)

్లు వ

KRZ-ang.ind

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized representation of a human figure in profile, with three overlapping heads suggesting a sense of community and support. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 4 1997

Dagmar S. Maser Business Support International Amstel 320-1················· 1017 AP Amsterdam The Netherlands

Re: K972492 Partial Ossicular Replacement Prosthesis ... Dated: June 20, 1997 ..... ... Received: July 2, 1997 Regulatory class: II 21 CFR 874.3450/Procode: 77 ETB

Dear Mr. Maser:

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 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, Tile 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 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 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 (30) 443-6597 or at its Internet address http://www.fda.gov/cdrk/dsmamain.huml".

Sincercly yours,

h.T.Liau Yin
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	K972492
Device Name	Bell Prosthesis (Partial)

INDICATIONS FOR USE:

Ossicle replacement in case of interrupted sound conducting chain and intact, mobile stapes footplate. --------

The Bell Prosthesis is intended for partial replacement of the auditory ossicles.

The bell is mounted on the head of the stapes, i.e. interposed between stapes and ear drum or stapes and manubrium mallei. Should stapes head no longer exist, bell is placed on intact arch of crus.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

R. Shep

(Division Sign-Off) and Redictive, Abdominal, ENT, and Radiological De

510(k) Number K972492

Prescription Use (Per CFR 801 109)

ાર

Over-The-Counter Use _____________

(Optional Formal 1-2-96)

KRZ-USE.IND

Regulation Number and Section

§ 874.3450 Partial ossicular replacement prosthesis.

(a)
Identification. A partial ossicular replacement prosthesis is a device intended to be implanted for the functional reconstruction of segments of the ossicular chain and facilitates the conduction of sound wave from the tympanic membrane to the inner ear. The device is made of materials such as stainless steel, tantalum, polytetrafluoroethylene, polyethylene, polytetrafluoroethylene with carbon fibers composite, absorbable gelatin material, porous polyethylene, or from a combination of these materials.(b)
Classification. Class II.