The KAPP Custom Radial Elbow Implant is intended to be used for: replacement of the proximal end of the radius: Replacement of the radial head for degenerative, or post-traumatic disabilities presenting pain, crepitation and decreased motion at the radio-humeral and or proximal radio-ulnar joint with either joint destruction or subluxation visible on x-ray and or resistance to conservative treatment; primary replacement after fracture of the radial head; symptomatic sequelae after radial head resection; revision following failed radial head arthroplasty. It is intended for custom single use with bone cement.

Device Description

The Kapp Custom Radial Head Elbow Implant includes various sizes of implants and accessories including sizers. The implant allows for replacement of the proximal radial head.

AI/ML Overview

This submission describes the Kapp Custom Radial Head Elbow Implant, a medical device designed to replace the proximal radial head. The document is a 510(k) summary, which indicates that the manufacturer is seeking to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness or safety through extensive clinical trials.

Therefore, the typical acceptance criteria and study designs associated with novel AI/software applications are not applicable here. This device is an orthopedic implant, where "performance" is assessed through material properties, mechanical testing, and comparison to existing implants, rather than through accuracy, sensitivity, or specificity metrics of a diagnostic algorithm.

Here's a breakdown of why many of your requested points cannot be directly addressed from this document and what information can be inferred or is typically involved in such device submissions:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: For orthopedic implants like this, acceptance criteria typically revolve around substantial equivalence to predicate devices in terms of:
- Indications for Use: Must be the same or very similar.
- Technological Characteristics: Materials, design, fixation, constraint must be similar or demonstrate equivalent performance.
- Safety and Effectiveness: Demonstrated through comparison to predicate devices, material testing, mechanical testing (e.g., fatigue, static strength), and biocompatibility.
Reported Device Performance: The document primarily focuses on demonstrating equivalence to predicate devices, rather than establishing new performance metrics. Performance here means the implant's ability to mechanically function as intended and integrate into the body safely.

Attribute	Acceptance Criteria (Implied by 510(k) Equivalence)	Reported Device Performance (as stated or implied)
Indications for Use	Functionally identical to predicate devices.	"Replacement of the proximal end of the radius: Replacement of the radial head for degenerative, or post-traumatic disabilities…primary replacement after fracture of the radial head; symptomatic sequelae after radial head resection; revision following failed radial head arthroplasty." (Matches predicate devices)
Fixation Method	Similar to predicate devices (Intermedullary Canal Stem).	"Intermedullary Canal Stem" (Matches predicate devices)
Constraint	Non-constrained, similar to predicate devices.	"Non-constrained" (Matches predicate devices)
Material	Biocompatible and mechanically suitable; comparison to predicate.	"316L Stainless Steel" (Different from Co-Cr/CpTi or Ti/Ti6Al4V/Co-Cr of predicates, but implied to be equivalent in performance/biocompatibility via other undisclosed data, e.g., established use of 316L for implants, mechanical testing, biocompatibility testing.) This difference would typically require specific data (e.g., mechanical testing, biocompatibility) to justify equivalence.
Sizes	Offer a range similar to or sufficiently covering patient needs.	"6 custom sizes – 2, 2.5, 3, 4, 5, and 6." (More sizes than one predicate, fewer than another, but demonstrates a range of available options.)
Use	Single Use, similar to predicate devices.	"Single Use" (Matches predicate devices)

Study that Proves the Device Meets the Acceptance Criteria:

The "study" in a 510(k) for a device like this is not a clinical trial in the sense of comparing outcomes in patients directly. Instead, it relies on:

Comparison to Predicate Devices: This is the primary "study" presented in the document (see the "Comparison to the Predicate Devices" table). The manufacturer argues that their device is substantially equivalent to the Avanta Radial Head Implant and Wright Medical Metallic Radial Head Implants based on shared attributes like indications for use, fixation, constraint, and general purpose.
Bench Testing / Mechanical Testing (Implicit): While not detailed in this summary, a 510(k) for an orthopedic implant always includes data from in-vitro mechanical testing to demonstrate that the device meets appropriate strength, fatigue, and wear resistance standards. This would be crucial, especially since the material (316L Stainless Steel) of the candidate device differs from the predicates, requiring evidence that it performs equivalently in a simulated physiological environment. These tests would have their own acceptance criteria (e.g., withstand X load for Y cycles without failure).
Material Biocompatibility (Implicit): Data showing the 316L Stainless Steel is biocompatible and suitable for implantation would also be part of the submission, typically adhering to ISO 10993 standards.

The following points are not applicable or cannot be answered from the provided 510(k) summary, as they relate to AI/Software studies, which this device is not:

Sample size used for the test set and the data provenance: Not applicable. There's no "test set" of data in the AI sense for an orthopedic implant. Mechanical testing would involve a sample size of physical implants.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There's no "ground truth" established by experts for a diagnostic output.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 not an AI-assisted diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for a mechanical implant is its performance in specific mechanical tests and comparison to established, safe materials and designs.
The sample size for the training set: Not applicable. There is no AI training set. The "training" in a sense comes from the established history of materials science and orthopedic implant design.
How the ground truth for the training set was established: Not applicable.

In summary: The provided document is a 510(k) summary for an orthopedic implant. Its "acceptance criteria" and "proof" primarily hinge on demonstrating substantial equivalence to already cleared predicate devices through direct comparison of indications and technological characteristics, supported by (undisclosed in this brief sumamry) mechanical testing and biocompatibility data. It does not involve the types of studies or performance metrics associated with AI/software medical devices.

Summary

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Kapp Surgical Instrument, Inc.

AUG 2 9 2003

K030237 PG 142

Attachment 1 - 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92, upon which the substantial equivalence determination is based.

Summary Information:

Applicant:	Kapp Surgical Instrument Co., Inc.4919 Warrensville Center RoadWarrensville Heights, Ohio 44128Tel: (216) 587-4400Fax: (216) 587-0411
Contact :	Albert Santilli, President
Prepared:	January 22, 2003

Device Identification:

Proprietary Name:	Kapp Custom Radial Head Elbow Implant
Common Name:	Radial Head Implant
Classification Nameand Regulation:	Prosthesis, Elbow, Hemi-radial, polymer,21 CFR 888.3170, 87KWI
Predicate Device(s):	Avanta Radial Head Implant andWright Medical Metallic Radial Head Implants

Device Description:

The Kapp Custom Radial Head Elbow Implant includes various sizes of implants and accessories including sizers. The implant allows for replacement of the proximal radial head.

Indications for use:

The KAPP Custom Radial Elbow Implant is intended to be used for: replacement of the proximal end of the radius: Replacement of the radial head for degenerative, or posttraumatic disabilities presenting pain, crepitation and decreased motion at the radiohumeral and or proximal radio-ulnar joint with either joint destruction or subluxation visible on x-ray and or resistance to conservative treatment; primary replacement after fracture of the radial head; symptomatic sequelae after radial head resection; revision following failed radial head arthroplasty. It is intended for custom single use with bone cement.

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Comparison to the Predicate Devices:

page 2 of 2

The legally marketed predicate devices to which this device is substantially equivalent is the Avanta Radial Head Implant and Wright Medical Technologies Metallic Radial Head Implants.

Attribute	Candidate Device	Predicate Devices
Product Name	Kapp Custom RadialHead Elbow Implant	Advanta Radial HeadImplant	WMT Metallic RadialHead Implants
Use	Single Use	Single Use	Single Use
Fixation	Intermedullary CanalStem	Intermedullary CanalStem	Intermedullary CanalStem
Constraint	Non-constrained	Non-constrained	Non-constrained
Material	316L Stainless Steel	Co-Cr/CpTi	Ti, Ti6Al4V, Co-Cr
Sizes	6 custom sizes – 2, 2.5,3, 4, 5, and 6	3 sizes: 1, 2, 3	7 sizes: 0, 1, 1.5, 2, 2.5,3, 4
Indications for use:	The KAPP CustomRadial Elbow Implant isintended to be used for:replacement of theproximal end of theradius: Replacement ofthe radial head fordegenerative, or post-traumatic disabilitiespresenting pain,crepitation anddecreased motion at theradio-humeral and orproximal radio-ulnarjoint with either jointdestruction orsubluxation visible onx-ray and or resistanceto conservativetreatment; primaryreplacement afterfracture of the radialhead; symptomaticsequelae after radialhead resection; revisionfollowing failed radialhead arthroplasty. It isintended for customsingle use with bonecement.	The Advanta RadialHead Implant isintended for:replacement of theproximal end of theradius: Replacement ofthe radial head fordegenerative, or post-traumatic disabilitiespresenting pain,crepitation anddecreased motion at theradio-humeral and orproximal radio-ulnarjoint with either jointdestruction orsubluxation visible onx-ray and or resistanceto conservativetreatment; primaryreplacement afterfracture of the radialhead; symptomaticsequelae after radialhead resection; revisionfollowing failed radialhead arthroplasty.	The WMT MetallicRadial Head Implantsare intended for:replacement of theradial head fordegenerative, or post-traumatic disabilitiespresenting pain,crepitation anddecreased motion at theradio-humeral and orproximal radio-ulnarjoint with: jointdestruction and orsubluxation visible onx-ray and or resistanceto conservativetreatment; primaryreplacement afterfracture of the radialhead; symptomaticsequelae after radialhead resection; revisionfollowing failed radialhead arthroplasty.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three stylized wing shapes.

Public Health Service

AUG 2 9 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Albert N. Santilli President KAPP Surgical Instrument Company, Inc. 4919 Warrensville Center Rd. Warrensville Heights, Ohio 44128

K030237 Re:

Trade/Device Name: KAPP Custom Radial Head Elbow Implant Regulation Number: 21 CFR 888. 3170 Regulation Name: Elbow joint radial (hemi-elbow) polymer prosthesis Regulatory Class: II Product Code: KWI Dated: June 6, 2003 Received: June 11, 2003

Dear Mr. Santilli:

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 - Mr. Albert N. Santilli

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), 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) you may obtain. 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,

Mach n Millerson

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

Enclosure

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Attachment 3 - Statement of Indications for Use

510(k) Number:

Device Name: KAPP Surgical Instrument, Inc. Radial Head Elbow Implant

Intended Use / Indications for Use:

The KAPP Radial Elbow Implant is intended to be used for: replacement of the proximal end of the radius:

Replacement of the radial head for degenerative, or post-traumatic disabilities presenting pain, crepitation and decreased motion at the radio-humeral and or proximal radio-ulnar joint with either joint destruction or subluxation visible on xray and or resistance to conservative treatment;

Primary replace nent after fracture of the radial head;

Symptomatic sequelae after radial head resection;

Revision following failed radial head arthroplasty

The device is inlended for custom single use with bone cement

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

()

for Mark N. Millham

Division of General, Festorative and Neurological De

510(k) Number __ K03023t

Prescription Use
(per 21 CFR 801.109)

Over the Counter Use
Optional Format 1-2-96

A3-1

Regulation Number and Section

§ 888.3170 Elbow joint radial (hemi-elbow) polymer prosthesis.

(a)
Identification. An elbow joint radial (hemi-elbow) polymer prosthesis is a device intended to be implanted made of medical grade silicone elastomer used to replace the proximal end of the radius.(b)
Classification. Class II.