AVANTA CARPAL FUSION PLATING SYSTEM by AVANTA ORTHOPAEDICS, INC.

The Avanta carpal fusion plate is designed for fusion of the carpal bones of the hand including; capitate, hamate, lunate, and triquetrum. The fusion plate is intended for use in patients suffering from pain and/or loss of function due to osteoarthritis, post-traumatic arthritis, fractures, revision of failed partial wrist fusions, carpal instability, or rheumatoid arthritis. The fusion plate is used in conjunction with screws that fix the plate to the carpal bones of the hand.

Device Description

The Avanta carpal fusion plate is a low profile single piece construct designed to fit over the dorsal aspect of the carpal bones in the hand. The plate has spherical holes or slots that accommodate screws for fixation. The plate and screws are fabricated from implantable grade stainless steel.

AI/ML Overview

The provided document describes a 510(k) premarket notification for a medical device: the Avanta Carpal Fusion Plating System. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving device performance through clinical studies with acceptance criteria in the same way a Premarket Approval (PMA) application would.

Therefore, the requested information regarding acceptance criteria, study sizes, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth for training and testing is not available in this document.

Here's why and what can be extracted:

510(k) Mechanism: A 510(k) submission establishes substantial equivalence to a legally marketed predicate device. This typically involves comparing design, materials, indications for use, and technological characteristics. Clinical performance data (like sensitivity, specificity, accuracy) based on specific acceptance criteria is generally not required unless special controls apply or substantial equivalence cannot be established through non-clinical means.
Device Type: The Avanta Carpal Fusion Plating System is a metallic bone fixation appliance. Its safety and effectiveness are primarily demonstrated through material testing, mechanical testing, and comparison of design features to existing, cleared devices. It's not an AI/software device that would have performance metrics like those typically requested (e.g., sensitivity, specificity, AUROC).

Information Available from the Document:

A table of acceptance criteria and the reported device performance:

Not applicable. The document does not define specific performance acceptance criteria (e.g., for accuracy, sensitivity, etc.) because it is a 510(k) for a physical implant, not a diagnostic or AI device. The "performance" is implicitly deemed acceptable if it's substantially equivalent to the predicate devices.

Item	Avanta	KMI	Acumed
ProductName	Carpal Fusion Plate	KMI WristFusion System	Acumed WristFusion Plate
Use	Single use	Single use	Single use
Fixation	Bone screw	Bone screw	Bone screw
Material	Stainless steel	Stainless steel	Titanium
Indicationsfor use	Intended for use in patients suffering from pain and/or loss of function due to osteoarthritis, post-traumatic arthritis, fractures, revision of failed partial wrist fusions, carpal instability, or rheumatoid arthritis.	Same indications	Same indications

Reported Device Performance (Implicit): "The Avanta device and the predicate devices studied have similar design characteristics and intended use. The safety and effectiveness of the Avanta Carpal Fusion Plate is substantially equivalent to the predicate devices mentioned above."

Sample sized used for the test set and the data provenance:
- Not applicable. This document pertains to a physical implant and its substantial equivalence. There is no "test set" of data or patient cases in the context of diagnostic accuracy. Clinical studies involving patient data with specific sample sizes for performance evaluation are not described.
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. No such information is present as this is not a diagnostic device requiring expert interpretation for ground truth.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Not a diagnostic device.
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 or imaging device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an algorithm-based device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. No ground truth in the context of diagnostic accuracy is relevant here. The "truth" for this device relates to its mechanical integrity, biocompatibility, and functional equivalence to similar implants already on the market.
The sample size for the training set:
- Not applicable. No "training set" in the context of machine learning or diagnostic algorithm development is used for this type of device.
How the ground truth for the training set was established:
- Not applicable. No training set ground truth to establish.

In summary, the provided K030881 document is a 510(k) premarket notification for a physical medical implant (carpal fusion plate). Its clearance is based on substantial equivalence to predicate devices, not on clinical performance studies that would generate the kind of data on acceptance criteria, reader studies, or algorithmic performance as typically seen for diagnostic devices or AI/ML-based products.

Summary

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K030881
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510 (k) Summary

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

Prepared: March 19, 2003

Applicant: Avanta Orthopaedics, Inc. 9369 Carroll Park Drive, Suite A San Diego, CA 92121

H. Doug Plunkett Contact: Avanta Orthopaedics, Inc. 8600 Evergreen Blvd. Minneapolis, MN 55433
Telephone: 763-783-5017 Fax: 763-783-5073 Email dplunkett@machine.com

Device Name:	Single/Multiple Component MetallicBone Fixation Appliance andAccessories
Device Trade Name:	Avanta Carpal Fusion Plating System
Device Classification:	Class II
Reviewing Panel:	Orthopaedic
Regulation Number	888.3030
Product Code:	HRS
Predicate Device:	KMI Wrist Fusion System (K991873)Acumed Wrist Fusion Plate (K021321)

Device Description:

Intended Use:

The Avanta carpal fusion plate is designed for fusion of the carpal bones of the hand including; capitate, hamate, and triquetrum. The fusion plate is intended for use in patients suffering from pain and/or loss of function due to osteoarthritis, post-traumatic

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K030881
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arthritis, fractures, revision of failed partial wrist fusions, carpal instability, or rheumatoid arthritis. The fusion plate is used in conjunction with screws that fix the plate to the carpal bones of the hand.

Comparison to Predicate Device: (Appendix 4 contains predicate device literature.)

The table below summarizes similarities and differences between the Avanta, KMI, and Acumed plates.

Item	Avanta	KMI	Acumed
ProductName	Carpal Fusion Plate	KMI WristFusion System	Acumed WristFusion Plate
Use	Single use	Single use	Single use
Fixation	Bone screw	Bone screw	Bone screw
Material	Stainless steel	Stainless steel	Titanium
Indicationsfor use	Intended for use in patients suffering from pain and/or loss of function due to osteoarthritis, post-traumatic arthritis, fractures, revision of failed partial wrist fusions, carpal instability, or rheumatoid arthritis.	Same indications	Same indications

Summary:

The Avanta device and the predicate devices studied have similar design characteristics and intended use. The safety and effectiveness of the Avanta Carpal Fusion Plate is substantially equivalent to the predicate devices mentioned above.

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three wavy lines above a shape that resembles a caduceus, a symbol often associated with medicine and healthcare.

Public Health Service

Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 0 2003

Mr. H. Doug Plunkett Director Avanta Orthopaedics, Inc. 8600 Evergreen Boulevard Minneapolis, Minnesota 55433

Re: K030881

Trade Name: Avanta Carpal Fusion Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliance and Accessories Regulatory Class: II Product Code: HRS Dated: March 19, 2003 Received: March 20, 2003

Dear Mr. Plunkett:

We have reviewed your Section 510(k) premarket 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) 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. H. Doug Plunkett

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) 594-4659. 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 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,

for Mark N. Milkman

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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510 (k) Number (If Known): K030881 Device Name: Carpal Fusion Plating System

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
OR
Over the Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)

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

510(k) Number
K030881

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.