Replacement of the distal ulnar head for rheumatoid, degenerative, or post-traumatic arthritis . presenting with the following findings:
Pain and weakness of the wrist joint not improved by non-operative treatment .
Instability of the ulnar head with radiographic evidence of dislocation or erosive changes of . the distal radioulnar joint
Failed ulnar head resection; eg. Darrach resection .
Primary replacement after fracture of the ulnar head or neck. .
Revision following failed ulnar head arthroplasty. .

Device Description

The ulnar head implant like the predicate device includes various sizes of implants and surgical instruments. The implant allows for replacement of the distal ulnar head.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (Wrist joint ulnar (hemi-wrist) prosthesis), which primarily focuses on demonstrating substantial equivalence to a predicate device. It does not contain information about specific acceptance criteria or a study designed to prove the device meets those criteria.

Here's a breakdown of why the requested information cannot be fully provided based solely on the input, and what can be inferred or stated about the nature of this submission:

This 510(k) submission is for an expanded product line (additional stem lengths and diameters) of an already existing, legally marketed predicate device (the Aptis Medical Distal Radio-Ulnar Joint Implant). The focus of such a submission is usually to demonstrate that the new sizes do not introduce new questions of safety or effectiveness compared to the predicate. This often relies on comparative analysis, materials testing, and mechanical testing, rather than clinical efficacy studies with ground truth.

Given this context, here's an attempt to address your points, explaining where information is absent:

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

This information is not present in the provided 510(k) summary. A 510(k) for a device like this, especially for additional sizes of an existing product, typically relies on comparison to a predicate device and engineering/bench testing rather than clinical performance criteria (like sensitivity/specificity or other metrics for diagnostic/AI devices). If any specific performance criteria were used (e.g., maximum stress, fatigue life), they are not disclosed in this summary document.

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

This information is not applicable in the context of a 510(k) for an orthopedic implant and is not present in the document. There is no mention of a "test set" in the sense of patient data for evaluating performance against ground truth. The "test" in this context would likely refer to mechanical or materials testing, for which sample sizes are not provided in this summary.

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)

This is not applicable and not present. Ground truth, expert consensus, or clinical adjudication by experts are typically relevant for diagnostic devices or AI algorithms that interpret medical data. This document describes a surgical implant.

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

This is not applicable and not present for the same reasons as point 3.

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

This is not applicable. An MRMC study is relevant for diagnostic devices, particularly those involving human interpretation of images or data, often in conjunction with AI. This document pertains to a medical implant.

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

This is not applicable. This device is a physical implant, not an algorithm.

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

This is not applicable for this type of device and submission. The "ground truth" for an orthopedic implant is generally its mechanical integrity, biocompatibility, and clinical outcomes over time, which are usually assessed through a combination of engineering tests, pre-clinical studies, and post-market surveillance for established devices. No specific "ground truth" data is detailed in this summary.

8. The sample size for the training set

This is not applicable and not present. There is no "training set" as this is not an AI/ML device.

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

This is not applicable and not present for the same reasons as point 8.

Summary of the Study (as described in the 510(k) summary):

The "study" or justification for substantial equivalence in this 510(k) involves a comparative analysis of the proposed device (Aptis Medical Distal Radio-Ulnar Joint Implant with additional stem lengths and diameters) to its legally marketed predicate device (the original Aptis Medical Distal Radio-Ulnar Joint Implant).

The document states:

"The legally marketed predicate device to which this device is substantially equivalent is the same device, the Aptis Medical Distal Radio-Ulnar Joint Implant"
"Comparison of original Aptis Medical Distal Radioulnar Joint to the new configuration the additional stem lengths and diameters."
The comparison table highlights similarities in product name, use, fixation, constraint, material, and crucially, identical indications for use.
The summary explicitly notes: "Both devices are made of the same industry standard materials. No new materials are introduced in either product; Both devices are comparably sized; Both devices have the identical indications for use."
"The device and the predicate device have the same design characteristics and intended use. The new device is substantially equivalent to the predicate device."

Conclusion:

This 510(k) summary provides a justification for substantial equivalence based on the similarity in design, materials, and intended use between the new device (additional sizes) and its existing predicate. It primarily relies on demonstrating that the changes are minor and do not alter the safety or effectiveness profile as established by the predicate device. It does not describe a clinical performance study with acceptance criteria, ground truth, or expert evaluation typically associated with diagnostic or AI-driven devices.

Summary

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K053119 p1/3

510 (k) Summary

2005 DEC 7

Summary of 510 (k) safety and effectiveness information upon which the substantial equivalence determination is based:

Prepared:	October 27, 2005
Applicant:	Aptis Medical, LLC
	5 River Hill Road
	Louisville, KY 40207
Telephone	502-899-3974
Fax	502-897-9007

Device Name: Device Trade Name: Device Classification: Reviewing Panel: Regulation Number Product Code: Original Predicate Device: Registration Number: Owner Operator Number:

Wrist joint ulnar (hemi-wrist) prosthesis Distal Radio-Ulnar Joint Implant Class II Orthopedic 888.3810 87 KXE Distal Radio-Ulnar Joint Implant 3004521401 9054354

Device Description:

The ulnar head implant like the predicate device includes various sizes of implants and surgical instruments. The implant allows for replacement of the distal ulnar head.

Indications for Use:

Aptis Medical Distal Radio Ulnar Head implant is intended for replacement of the distal radioulnar joint following ulnar head resection arthroplasty:

Replacement of the distal ulnar head for rheumatoid, degenerative, or post-traumatic arthritis . presenting with the following findings:
Pain and weakness of the wrist joint not improved by non-operative treatment .
Instability of the ulnar head with radiographic evidence of dislocation or erosive changes of . the distal radioulnar joint

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K053119 p2/3

Failed ulnar head resection; eg. Darrach resection .
Primary replacement after fracture of the ulnar head or neck. .
Revision following failed ulnar head arthroplasty. .

Comparison to the Original Predicate Device:

The legally marketed predicate device to which this device is substantially equivalent is the same device, the Aptis Medical Distal Radio-Ulnar Joint Implant

II Regulatory Class: 87 KXE Product Code:

Comparison of original Aptis Medical Distal Radioulnar Joint to the new configuration the additional stem lengths and diameters.

Item	Original Aptis Product	Proposed additional size
Product Name	Distal Radioulnar Joint	Distal Radioulnar Joint
	Implant	Implant
Use	Single use	Single use
Fixation	stem in intramedulary canal,	stem in intramedulary canal,
	screw fixation to the distal	screw fixation to the distal
	radius	radius
Constraint	Semi constrained	Semi constrained
Material	Co-Cr, UHMWPe, CPTi	Co-Cr, UHMWPe, CPTi
Sizes	2 sizes, 20, 30 body and	2 sizes, 20, 30, body
	stem	25 size stems
Indications for use	Aptis Medical Distal Radio UlnarHead implant is intended forreplacement of the distal radioulnarjoint following ulnar headresection arthroplasty:	Aptis Medical Distal Radio UlnarHead implant is intended forreplacement of the distal radioulnarjoint following ulnar headresection arthroplasty:
	Replacement of the distal ulnarhead for rheumatoid, degenerative,or post-traumatic arthritispresenting with the followingfindings:	Replacement of the distal ulnarhead for rheumatoid, degenerative,or post-traumatic arthritispresenting with the followingfindings:
	Pain and weakness of the wristjoint not improved by non-operative treatment	Pain and weakness of the wristjoint not improved by non-operative treatment
	Instability of the ulnar head withradiographic evidence ofdislocation or erosive changes ofthe distal radioulnar joint	Instability of the ulnar head withradiographic evidence ofdislocation or erosive changes ofthe distal radioulnar joint
	Failed ulnar head resection; eg.Darrach resection	Failed ulnar head resection; eg.Darrach resection
	Primary replacement after fractureof the ulnar head or neck.	Primary replacement after fractureof the ulnar head or neck.

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K053119 p³/₃

Revision following failed ulnar head arthroplasty.

Similarities of the Aptis Medical DRUJ and the Aptis Medical DRUJ additional length and diameter stems include;

Both devices are intended for single use only; Both devices are intended for surgical implantation longer than 30 days; Both devices are placed into the intramedullary canal of the distal ulna; Both devices are made of the same industry standard materials. No new materials are introduced in either product; Both devices are comparably sized; Both devices have the identical indications for use.

Summary:

The device and the predicate device have the same design characteristics and intended use. The new device is substantially equivalent to the predicate device.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines forming the shape of a bird. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

DEC 7 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Bryan Babb Aptis Medical, LLC. 5 River Hill Road Louisville, Kentucky 40207

Re: K053119

Trade/Device Name: Distal Radio-Ulnar Joint Implant (DRUJ) Regulation Number: 21 CFR 888.3810 Regulation Name: Wrist joint ulnar (hemi-wrist) polymer prosthesis Regulatory Class: II Product Code: KXE Dated: October 27, 2005 Received: November 7, 2005

Dear Mr. Babb:

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 Cossmetic 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 elcctronic product radiation control provisions (Scctions 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Bryan Babb

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to oogh manieting your and equivalence of your device to a legally premarket notheation: "The PDA maing of castion 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 If you desire specific at not 10-1 at (240) 276-0120. Also, please note the regulation entitled, Contact the Oriece of Commarket notification" (21CFR Part 807.97). You may obtain Misoranung Uy releveloe to premanton on your responsibilities under the Act from the Division of Small other general information of your copsumer Assistance at its toll-free number (800) 638-2041 or 1011) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,
Mark A. Millman

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): Device Name: Distal Radio Ulnar Head Implant Indications for Use:

Aptis Medical Distal Radio Ulnar Head implant is intended for replacement of the distal radioulnar joint following ulnar head resection arthroplasty:

Replacement of the distal ulnar head for rheumatoid, degenerative, or post-traumatic arthritis . presenting with the following findings:
Pain and weakness of the wrist joint not improved by non-operative treatment .
Instability of the ulnar head with radiographic evidence of dislocation or erosive changes of . the distal radioulnar joint
Failed ulnar head resection; eg. Darrach resection .
Primary replacement after fracture of the ulnar head or neck. .
Revision following failed ulnar head arthroplasty. .

Over-The-Counter Use Prescription Use X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Mark A. Milliken

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number

Regulation Number and Section

§ 888.3810 Wrist joint ulnar (hemi-wrist) polymer prosthesis.

(a)
Identification. A wrist joint ulnar (hemi-wrist) polymer prosthesis is a mushroom-shaped device made of a medical grade silicone elastomer or ultra-high molecular weight polyethylene intended to be implanted into the intramedullary canal of the bone and held in place by a suture. Its purpose is to cover the resected end of the distal ulna to control bone overgrowth and to provide an articular surface for the radius and carpus.(b)
Classification. Class II.