This appears to be a 510(k) premarket notification document for a medical device, specifically an ossicular prosthesis. The document states that the device is a "Clip Partial Prosthesis - Titanium "Dresden"" and it is a modification of a previously cleared device made of gold.

Based on the provided text, a conventional study demonstrating clinical acceptance criteria with statistical endpoints like sensitivity, specificity, or AUC for a diagnostic AI device is not applicable or present. This document describes a medical device (an implant) and its physical characteristics, rather than an AI/ML-based diagnostic or prognostic tool.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, ground truth, or MRMC comparative effectiveness studies as these concepts are primarily relevant to AI/ML device evaluations, which this document does not describe.

The document focuses on demonstrating substantial equivalence to an predicate device, primarily through changes in material and design. The "acceptance criteria" here would be demonstrating that the new device is as safe and effective as the predicate device, despite the modifications.

Here's a breakdown of what can be extracted and why other parts cannot:

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

Cannot provide this for AI/ML performance metrics.

However, the document does compare the new device to the predicate device in terms of physical characteristics and safety/effectiveness justifications. This isn't a table of "acceptance criteria" in the AI sense, but rather a comparison for regulatory equivalence.

Characteristic	Clip Partial Prosthesis "Dresden" (New Device)	Dresden Bell Prosthesis (Predicate Device - Gold)
Device	Clip Partial Prosthesis "Dresden"	Dresden Bell Prosthesis
Catalog #	1002 250 - 257	1001 023 - 030
Intended Use	Ossicle replacement in case of interrupted sound conducting chain in patients with intact, mobile stapes	Identical
# of Sizes	8	Identical
Length	1.75 - 3.5 mm (0.25 mm intervals)	Identical
Head Plate Ø	2.6 mm	N/A (Not explicitly specified for gold bell)
Shaft Ø	0.2 mm	N/A (Not explicitly specified for gold bell)
Material	ASTM F67 Titanium	Pure Gold
Weight	4-5 mg	10-12 mg
Single Use	Yes	Identical
Sterile	Yes	Identical
Design Comparison	Clip with seven (7) resilient prongs securely clips around stapes head and upper part of stapes. No manipulation and/or adjustment in situ.	The four (4) gold strips of Bell prosthesis are gently pushed against stapes with wire crimper to achieve mechanically close fit.
Custom Accessories	KURZ Sizer Cat.# 8000 121, KURZ Precise Cat # 8000 101	Identical
Safety & Effectiveness of Material and Design Changes	Titanium is a clinically well-established implant material with excellent biocompatibility. Much lighter weight appears better suited. Clinical evidence suggests excellent sound conduction properties resulting in improved hearing gain. Tensile clip mechanism significantly reduces dislocation risk and improves long-term hearing gains.	N/A (Baseline for comparison)

2. Sample sized used for the test set and the data provenance:

Cannot provide. This is not an AI/ML device tested on a "test set" of data. The device itself is the physical product.

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

Cannot provide. Not applicable to a physical medical implant.

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

Cannot provide. Not applicable.

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:

Cannot provide. This study pertains to human reader performance with AI, which is not relevant to this physical implant device.

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

Cannot provide. Not applicable.

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

Cannot provide. Not applicable. The "ground truth" for a physical implant like this would be its physical properties, biocompatibility, mechanical stability, and clinical performance (which is alluded to as "clinical evidence" but not detailed as a formal study in this document). The document mentions "Testing in a 0.5 Tesla nuclear magnetic resonance (NMR) tomograph has revealed no implant movement and no adverse tissue effects attributable to MRI-generated heating." which is a form of performance testing.

8. The sample size for the training set:

Cannot provide. Not applicable to a physical medical implant.

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

Cannot provide. Not applicable.

In summary, this document is a regulatory submission (510(k)) for a conventional medical device (an implant) and not an AI/ML-driven diagnostic or treatment device. Therefore, most of the requested information, which is specific to AI/ML device evaluations, is not present or applicable.

Summary

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NOV 0 9 2001

2.1

K 013573

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

Heinz Kurz GmbH Medizintechnik

Tübinger Straße 3 D-72144 Dussling

Telefon (0 70 72) 9 Telefax (0 70 72) 9

Internet: http://www.kurzme

E-Mail: info@kurzn

2. 510(k) SUMMARY of Safety and Effectiveness

As required by Section 807.92(c)

Submitter: [807.92 (a)(1)]
Heinz Kurz GmbH Medizintechnik
Tübinger Str. 3	Tel.	+49-7072-91 79 0
D-72144 Dusslingen	Fax	+49-7072-91 79 75
Germany	eMail	info@kurzmed.de

Contact Person: [807.92 (a)(1)]
Dagmar S. Mäser
Business Support International
Amstel 320-I	Tel.	+31-20-428 95 91
1017 AP Amsterdam	Fax	+31-20-428 94 29
The Netherlands	eMail	bsi@xs4all.nl

Date Summary Prepared: [807.92 (a)(1)] 2.3 October 10, 2001
2.4 Device Names: [807.92 (a)(2)] Proprietary Clip Partial Prosthesis - Titanium "Dresden"
- Common Partial Ossicular Replacement Prosthesis Classification Middle Ear Prosthesis, Partial Ossicular Replacement Product Code 77 ETB Regulation # CFR 874.3450

2.5 Reason for Submission:

Change in material and design when compared to previously cleared device

Geschäftsführer: Heinz Kurz Traute Kurz-Butzki USt.-Id. Nr. DE 8115701

Volksbank Steinlach-Wiesaz eG (BLZ 640 618 54) Konto-Nr. 70 150 001 SWIFT: GENODES1STW IBAN DE386406 18540070 150001

2-1

BW Bank AG Tübingen (BLZ 641 200 30) Konto-Nr. 1 201 402 300 SWIFT: BWBKDE6S641 IBAN DF186417 0020 1701 1072 00

Amtsgericht Tübingen

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Image /page/1/Picture/0 description: The image shows a logo with the word "KURZ" inside of a circle. The letters are in a simple, sans-serif font and appear to be slightly distressed or textured. The circle is not fully closed at the top, leaving a small gap above the letter "K". The logo has a vintage or worn appearance, possibly due to the texture and style of the letters and circle.

Heinz Kurz GmbH Medizintechnik

Modification to Existing Device: [807.92 (a)(3)] 2.6

Bell Prosthesis (Partial) K 972492

Heinz Kurz GmbH · Medizintechnik · Postfach 39 · D-72142 Dussfieleared 08/04/97

Device Description: [807.92(a)(4)+(6)] 2.7

Tübinger Straße 3 The all-titanium prosthesis consists of a clip with seven (7-72144 Dussinge resilient prongs, a shaft, and a head plate. Telefon (0 70 72) 91

Reasons for Device Modification: [807.92 (d)] 2.8 Material:

Internet:

http://www.kurzme Titanium provides excellent sound conduction even E-Mail: info@kurzm at higher frequencies
Due to the lower specific weight of titanium, the 2. device is substantially lighter than the gold KURZ Bell "Dresden" prosthesis

Design:

By pushing the elastic clip over the stapes head and upper part of the stapes, a more secure connection is established that not only eliminates the need for device manipulation in situ but also the chance of implant dislocation with a high degree of certainty.

2.9 Intended Use: [807.92 (a)(5)]

Ossicle replacement in case of interrupted sound conducting chain in patients with intact, mobile stapes

Industry Standards: [807.92 (d)] 2.10

KURZ certifies compliance with all appropriate industry standards and the validation of methods and processes covered by these standards.

2.11 MRI Environment: [807.92 (d)]

Testing in a 0.5 Tesla nuclear magnetic resonance (NMR) tomograph has revealed no implant movement and no adverse tissue effects attributable to MRI-generated heating.

Information Bearing on the Safety and Effectiveness: 2.12

[807.92 (b)(3)]

The KURZ Clip Partial Prosthesis -- Titanium "Dresden" has the same intended use as the previously cleared device made of pure gold. With the exception of the described material and design changes, there are no additional characteristics known that should adversely affect the safety and effectiveness of these implants.

The results of design validation raise no new issues of safety and effectiveness.

Geschäftsführer: Heinz Kurz Traute Kurz-Butzki USt .- Id. Nr. DE 8115.

2-2

BW Bank AG Tübingen (BLZ 641 200 30) Konto-Nr. 1 201 402 300 SWIFT: BWBKDE6S641

Telefax (07072) 91 Internet:

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Image /page/2/Picture/0 description: The image is a black and white logo. The logo consists of the word "KURZ" in a stylized font, with the letters arranged in a slightly curved manner. The word is enclosed within a circle that is not fully complete, with gaps at the top and bottom. Below the circle, the letters "ESS" are visible.

2.13 COMPARISON of DESIGN + SAFETY and EFFECTIVENESS

	Heinz Kurz GmbH · Medizintechnik · Postfach 39 · D-721	GoldHeinz Kurz GmbHMedizintechnik
Device	Clip Partial Prosthesis"Dresden"	Dresden Bell ProsthesisTübinger StraßeD-72144 Dusslingen
Catalog #	1002 250 - 257	1001 023 - 030
Intended Use	Ossicle replacement in case ofinterrupted sound conductingchain in patients with intact,mobile stapes	Telefon (0 70 72)IdenticalTelefax (0 70 72)
# of Sizes	8	Identical
Dimensions
Length	1.75 - 3.5 mm (0.25 mm intervals)	Identical
Head Plate Ø	2.6 mm
Shaft Ø	0.2 mm
Material	ASTM F67 Titanium	Pure Gold
Weight	4-5 mg	10-12 mg
Single Use	Yes	Identical
Sterile	Yes	Identical
DesignComparison	Clip with seven (7) resilientprongs securely clips aroundstapes head and upper part ofstapes. No manipulation and/oradjustment in situ.	The four (4) gold strips of Bellprosthesis are gently pushedagainst stapes with wire crimperto achieve mechanically close fit.
CustomAccessories	KURZ Sizer Cat.# 8000 121KURZ Precise Cat # 8000 101	Identical
Safety &Effectiveness ofMaterial andDesignChanges[807.92 (b)(1)]	Titanium is a clinically well-established implant material withexcellent biocompatibility. Themuch lighter weight appears tobe better suited for implantationin the middle ear. Clinicalevidence suggests that titaniumhas excellent sound conductionproperties resulting in improvedhearing gain.The tensile clip mechanismsignificantly reduces the risk ofimplant implant dislocation whilethe secure but vibrant connectionto the stapes head is expected toimprove long-term hearing gainswith appropriate physiologicalconditions.Careful attention must be paid toKURZ operating guidelines

Signature

A. Mihaes M

Uwe Steinhardt Technical Director

Date

October 22, 2001

Geschäftsführer: Heinz Kurz Traute Kurz-Butzki USt.-Id. Nr. DE 81157

A ﺳﻪ ۵۰ -- ۱۰: ۱۰ -- ۳ : ۱ : ۱ --

Volksbank Steinlach-Wiesaz eG
(BLZ 640618 54) Konto-Nr. 70 150001 SWIFT. CENIONES 1 STAI

BW Bank AG Tübingen (BLZ 641 200 30) Konto-Nr. 1 201 402 300
รังกรรม ค.ศ. 1 201 402 300
ราคมีความคร ทรรรคร

2-3

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Image /page/3/Picture/1 description: The image contains the text "Public Health Service" in a bold, sans-serif font. The text is arranged vertically, with "Public Health" on the first line and "Service" on the second line. The text is black against a white background.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 0 9 2001

Heinz Kurz GmbH Medizintechnik c/o Dagmar S. Mäser Business Support International Amstel 320-I 1017 AP Amsterdan The Netherlands

Re: K013573

Trade/Device Name: Clip Partial Prosthesis-Titanium Dresden, Model 1002 Regulation Number: 21 CFR 874.3450 Regulation Name: Partial Ossicular Replacement Prosthesis Regulatory Class: Class II Product Code: ETB Dated: October 24, 2001 Received: October 29, 2001

Dear Ms. Mäser:

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 (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 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 the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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This letter will allow you to begin marketing your device as described in your Section 510(k) rms lotes with and my of the FDA finding of substantial equivalence of your device to a legally premailed notification of the sification 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,

A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Number

Device Name

Clip Partial Prosthesis – Titanium "Dresden"

NOV 0 9 2001

INDICATION FOR USE

Ossicle replacement in case of interrupted sound conducting chain in patients with intact, mobile stapes.

Kolz573

Description of Implant and Intended Situs

The prosthesis consists of a clip consisting of seven (7) resilient prongs, a shaft, and a head plate.

Holding the device vertically to the stapes axis, the clip is gently pushed over the stapes head so that the titanium prongs with their built-in tension securely grasp the stapes head and upper part of the stapes and the two somewhat shorter rear prongs are positioned on either side of the stapedial tendon. The head plate is covered with a thinned cartilage slice and placed under the manubrium mallei or under the tympanic membrane.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

( )[ર

Prescription Use

(Per CFR 801 109)

(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K0/3573

()ver-The-Counter Use

(Optiona) Format 1-2-96)

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.