The provided document is a 510(k) summary for the "CliP Piston àWengen" device, which is a modification of an existing middle ear prosthesis. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than performing extensive novel clinical studies with detailed acceptance criteria and standalone performance metrics in the way a PMA (Pre-Market Approval) might.

Therefore, much of the requested information (like specific acceptance criteria for performance, sample sizes for test sets, expert ground truth establishment, MRMC studies, and standalone algorithm performance) is not present in the provided 510(k) summary, as it's not typically required for a 510(k) for a device modification. The "study" here is primarily a comparison to the predicate device and validation of the design changes.

Here's a breakdown of what can be extracted from the document based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: The document implies acceptance criteria by stating the reasons for device modification and the expected improvements:
- Reduce risk of tissue necrosis by improving vascular circulation.
- Standardize and significantly shorten surgical procedure.
- Eliminate need for instruments and crimping and reduce potential risks.
- Improve audiological results.
- No adverse effects attributable to MRI-generated heating.
- No implant movement in MRI environment.
- Maintain safety and effectiveness compared to the predicate device.
- Clinical test results confirm safety and effectiveness.
Reported Device Performance:

Acceptance Criteria (Implied)	Reported Device Performance
Reduce risk of tissue necrosis by improving vascular circulation	"reduces risk of tissue necrosis on incudal process by improving vascular circulation" (Claimed due to design)
Standardize and significantly shorten surgical procedure	"shortens surgical procedure" (Claimed due to 'click-on' mechanism)
Eliminate need for instruments and crimping and reduce risks	"eliminates need for instruments and crimping and to reduce potential risks connected therewith" (Claimed due to 'click-on' mechanism)
Improve audiological results	"potentially improves long-term hearing gain with appropriate physiological conditions." and "expected to result in equal if not better audiological post-operative hearing gain." (Anticipated, not definitively proven as a primary endpoint in this summary)
No adverse effects attributable to MRI-generated heating	"Testing in a 0.5 Tesla nuclear magnetic resonance (NMR) tomograph has revealed no... adverse tissue effects attributable to MRI-generated heating." (Specific testing result)
No implant movement in MRI environment	"Testing in a 0.5 Tesla nuclear magnetic resonance (NMR) tomograph has revealed no implant movement" (Specific testing result)
Maintain safety and effectiveness compared to predicate	"There are no additional characteristics known that should adversely affect the safety and effectiveness of these implants." and "The results of design validation raise no new issues of safety and effectiveness." and "Clinical test results to date confirm the safety and effectiveness of the new design." (General statements of compliance and safety, but no specific comparative metrics are provided in the summary for the clinical test results).

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

Sample Size for Test Set: Not specified in the provided 510(k) summary. The document mentions "Clinical test results to date" but does not give any details on the number of patients or cases.
Data Provenance: Not specified for the clinical test results. The submitter is based in Germany, and the contact person in the Netherlands, but this doesn't tell us where the clinical data, if any, was collected.
Retrospective/Prospective: Not specified.

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 specified. The clinical "test results" mentioned pertain to the device's functional performance in patients, not interpretation of data by experts for ground truth establishment.

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

Not applicable/Not specified.

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

Not applicable. This is a medical device (prosthesis), not an AI/software. No MRMC studies were performed or are relevant to this submission.

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

Not applicable. This is a medical device (prosthesis), not an algorithm.

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

The "ground truth" here would be the actual clinical outcomes following surgical implantation of the device (or predicate device). This falls under "outcomes data." The summary broadly mentions "Clinical test results to date confirm the safety and effectiveness of the new design," implying that patient outcomes were assessed to some extent, but no specifics are provided. For MRI compatibility, the ground truth was direct observation/measurement in a 0.5 Tesla NMR tomograph.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning algorithm that requires a "training set."

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

Not applicable.

Summary

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K021479

MAY 2 1 2002

510(k) SUMMARY of Safety 2. 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 79
Germany	eMail	info@kurzmed.de

2.2 Contact Person: [807.92 (a)(1)] Dagmar S. Mäser Business Support International +31-20-428 95 91 Tel. Amstel 320-l Fax +31-20-428 94 29 1017 AP Amsterdam eMail bsi@xs4all.nl The Netherlands
2.3 Date Summary Prepared: [807.92 (a)(1)] April 30, 2001
2.4 Device Names: [807.92 (a)(2)] CIIP Piston àWengen Proprietary
- Stapedial Piston Common
- Middle Ear Prosthesis, Partial Ossicular Classification Replacement

77 ETB Product Code

CFR 874.3450 Regulation #

2.5 Reason for Submission:
Change in design when compared to previously cleared device

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

K-Piston Titanium Stapedial Prosthesis (Partial) Cleared 08/09/2000

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

K 002221

The all-titanium prosthesis consists of an undulated, selfretaining, two-limbed clip that is laser-welded to a conventional KURZ piston shaft.

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

To reduce risk of tissue necrosis by improving 1. vascular circulation;
To standardize and significantly shorten surgical 2. procedure by 'click-on' mechanism for attachment to long incudal process;
To eliminate need for instruments and crimping and 3. to reduce potential risks connected therewith;
To improve audiological results by the unique 4. attachment to incudal process

2.9 Intended Use: 1807.92 (a)(5)]

Bridging the stapes in cases of otosclerosis

2.10 Industry Standards: [807.92 (d)]

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.

2.12 Information Bearing on the Safety and Effectiveness:

[807.92 (b)(3)]

Like the K-Piston Titanium Stapedial Prosthesis, the KURZ CliP àWengen is used for bridging the stapes in cases of otosclerosis. The click-on mechanism and the self-retaining design shorten the procedure, minimize the risks connected with instrument manipulation and, by improving vascular circulation, reduce the risk of tissue necrosis. The gentle attachment to the incudal process along the axis of mechanical sound transmission is expected to result in equal if not better audiological post-operative hearing gain. 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.

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2.13 COMPARISON of DESIGN ・SAFETY and EFFECTIVENESS

	CliP àWengen	Titanium K-PistonK 002221
DeviceCatalog #	1006 805 - 1006 861	1006 103 - 1006 170
Intended Use	Bridging the stapes in cases ofotosclerosis	1. Bridging the stapes in cases ofotosclerosis2. Bridging defects of the ossicularchain between manubriummallei and vestibulum(malleovestibulopexy)
# of Sizes	12 (6 for each Ø)	28 (14 for each Ø)
Device Lengths	4.00 - 5.00 mm (0.25 mm intervals)5.00 - 5.50 mm (0.50 mm interval)	3.50 - 6.00 mm (0.25 mm intervals)6.00 - 10.00 mm (1.00 mm intervals
Piston Ø	0.4 + 0.6 mm	Identical
Material	ASTM F67 Titanium	Identical
Single Use	Yes	Identical
Sterile	Yes	Identical
DesignComparison	An open clip is attached to a 0.2 mmshaft that is seamlessly laserweldedto the piston stem (0.4 + 0.6 mm)	A laterally displaced band loop isattached to a 0.2 mm shaft that isseamlessly laserwelded to the pistonstem (0.4 + 0.6 mm)
CustomAccessories	KURZ Measuring RodCat. # 8000 106(to determine proper device length)	Identical
Safety &Effectiveness ofMaterial andDesignChanges[807.92 (b)(1)]	The tensile clip-on mechanismshortens surgical procedure,reduces risk of tissue necrosis onincudal process by improvingvascular circulation, reduces riskof implant dislocation with highdegree of certainty, andpotentially improves long-termhearing gain with appropriatephysiological conditions. Clinicaltest results to date confirm thesafety and effectiveness of thenew design.There are no knowncharacteristics that wouldintroduce adverse effects

. . . . . . . .

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 21 2002

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

Re: K021479

Trade/Device Name: CliP Piston à Wengen Regulation Number: 21 CFR 874.3450 Regulation Name: Middle Ear Prosthesis, Partial Ossicular Replacement Regulatory Class: Class II Product Code: ETB Dated: May 6, 2002 Received: May 8, 2002

Dear Ms. Mäser:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Dagmar S. Mäser

This letter will allow you to begin marketing your device as described in your Section 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 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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Heinz Kurz GmbH Medizintechnik

Special 510(k): Device Modification - 77 ETB

510(k) Number

KO21479

Device Name

CliP Piston à Wengen

INDICATIONS FOR USE

For bridging the stapes in case of otosclerosis;

Description of Implant and Intended Situs

The titanium prosthesis consists of a piston with an open undulated clip at its end. Contrary to convential prostheses, the CliP requires no crimping. After positioning it on the long incudal process, slightly above the incudostapedial joint, it is permanently attached with a slight push of a microhook instrument. The CliP is self-retaining and stays securely in place due to the elasticity of material and design

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

✓

Prescription Use
(Per CFR) 801 109)

Over-The-Counter Use

Optional Format 1-2-

(Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises

510(k) Number K02179

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.