The Acumed Wrist Arthrodesis Plate System is intended for wrist arthrodesis and fractures of other small bones. Specific indications include post traumatic arthritis of the wrist, rheumatoid wrist deformities requiring restoration, complex carpal instability, post-septic arthritis of the wrist, severe unremitting wrist pain related to motion, brachial plexus nerve palsies, tumor resection, and spastic deformities.

Device Description

The Acumed Total Wrist Fusion Plating System contains plates which are pre-contoured with an anatomic design. The plates have a combination of distal and proximal holes which utilize 2.3 mm and 3.5 mm cortical locking screws and non-locking screws. The purpose of the Special 510(k) submission is to gain marketing clearance for modifications to the previously cleared Acumed Wrist Arthrodesis Plate System including modifications to existing plates, the addition of the Neutral plate and the modified 2.3 mm screw.

AI/ML Overview

The Acumed Wrist Arthrodesis Plate System is a medical device, and its regulatory clearance process, as described in the provided 510(k) summary, does not involve the types of acceptance criteria and studies typically associated with AI/ML-driven devices. Therefore, many of the requested categories (such as sample size for test set, number of experts, adjudication method, MRMC comparative effectiveness, standalone performance, training set size, and how training ground truth was established) are not applicable to this submission.

Instead, the acceptance criteria and study for this device are based on demonstrating substantial equivalence to previously cleared predicate devices through engineering rationales and bench testing.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance
Material Equivalence	Components manufactured from titanium alloy (Ti-6Al-4V) as described in ASTM F136.	Acumed Total Wrist Fusion Plating System components are manufactured from titanium alloy (Ti-6Al-4V) as described in ASTM F136.
Technological Equivalence	No technological characteristics that raise new issues of safety or effectiveness compared to predicate devices.	The plates and screws are made of titanium alloy (Ti-6Al-4V) per ASTM F136. The predicate devices share these dimensional and material characteristics. No technological characteristics that raise new issues of safety or effectiveness.
Mechanical Performance (Rationales)	Engineering rationales (e.g., calculations of moments of inertia and cross-sectional area) to prove substantial equivalence to predicate plates and screws.	Engineering rationales, including calculations of moments of inertia and cross-sectional area, were conducted. These proved that the subject plates and screws are substantially equivalent to the predicate plates and screws.
Mechanical Performance (Bench Testing)	Distal screw construct pull-out strength demonstrating substantial equivalence to the distal predicate screw-plate construct.	Distal screw construct pull-out bench testing was performed. This proved that the distal subject screw-plate construct is substantially equivalent to the distal predicate screw-plate construct.

2. Sample size used for the test set and the data provenance

Not applicable for this type of medical device submission. The evaluation was primarily based on engineering rationales and bench testing of physical components, not on a "test set" of clinical data or images.

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

Not applicable. Ground truth for AI/ML models is not relevant to this submission. The "ground truth" here is the established safety and effectiveness of the predicate devices and the physical properties and performance characteristics of the materials and designs.

4. Adjudication method for the test set

Not applicable. No "test set" in the context of AI/ML models was used.

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 device is a bone fixation system, not an AI-assisted diagnostic or therapeutic tool.

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

Not applicable. This device is a bone fixation system, not a standalone algorithm.

7. The type of ground truth used

The "ground truth" or basis for comparison used in this submission is the established safety and effectiveness of the legally marketed predicate devices, combined with adherence to recognized material standards (ASTM F136) and biomechanical principles verified through engineering rationales and bench testing.

8. The sample size for the training set

Not applicable. This device is not an AI/ML system that requires a "training set."

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

Not applicable. No training set or associated ground truth was established for this device.

Summary

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K131380

Section 4: 510(k) SUMMARY

Device Trade Name:	Acumed Wrist Arthrodesis Plate System: Acumed Total WristFusion Plating System
Date:	May 10, 2013
Sponsor:	Acumed, LLC5885 NW Cornelius Pass RoadHillsboro, OR 97124Phone: (503) 627-9957Fax: (503) 520-9618
Contact Person:	Brittany Cunningham, Regulatory Specialist 2
Manufacturer:	Acumed, LLC5885 NW Cornelius Pass RoadHillsboro, OR 97124Phone: (503) 207-1467Fax: (503) 520-9618
Common Name:	Plate, Fixation, Bone
Device Classification:	Class II
Classification Name:	Plate, Fixation, Bone
Regulation:	21 CFR 888.3030, Single/multiple component metallic bonefixation appliances and accessories21 CFR 888.3040 Smooth or threaded metallic bone fixationfastener
Device Regulation Panel:	Orthopedic
Device Product Code:	HRS, HWC

Device Description:

Intended Use:

Wrist arthrodesis and fractures of other small bones

Indications For Use:

JUN 1 0 2013

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K131380

arthritis of the wrist, severe unremitting wrist pain related to motion, brachial plexus nerve palsies, tumor resection, and spastic deformities.

Materials:

The Acumed Total Wrist Fusion Plating System components are manufactured from titanium alloy (Ti-6Al-4V) as described in ASTM F136.

Technological Characteristics:

The plates and screws are made of titanium alloy (Ti-6AI-4V) per ASTM F136. The predicate devices share these dimensional and material characteristics. There are no technological characteristics that raise new issues of safety or effectiveness.

Performance Data:

Engineering rationales including calculations of moments of inertia and cross-sectional area were conducted to prove that the subject plates and screws are substantially equivalent to the predicate plates and screws.

Distal screw construct pull-out bench testing was also performed to prove that the distal subject screw-plate construct is substantially equivalent to the distal predicate screw-plate construct.

A discussion of clinical tests is not applicable.

Predicate Device: (modified to subject device) Acumed Wrist Arthrodesis Plate System - K100123

Previous Predicates: (For modified device)

Synthes LCP Wrist Fusion Plate - K042355 Synthes Small Titanium Wrist Fusion Plate - K023870 Synthes Straight Wrist Fusion Plate - K011458 Synthes Wrist Fusion Plate K000558 DVO Wrist Fusion Plate - K052754 KMI Wrist Fusion System - K991873

Based upon the similarities of the Acumed Total Wrist Fusion Plating Device and the predicate devices studied, the safety and effectiveness of the Acumed Total Wrist Fusion Plating System is substantially equivalent to the predicate devices referenced.

The term "substantial equivalence" as used in this Special 510(k) notification is limited to the definition of substantial equivalence found in the Federal Food, Drug, and Cosmetic Act, as amended and applied under 21 CFR 807, Subpart E, under which a device can be marketed without the pre-approval or classification.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 10, 2013

Acumed. LLC % Ms. Brittany Cunningham Regulatory Specialist II 5885 Northwest Cornelius Pass Road Hillsboro, Oregon 97124

Re: K131380

Trade/Device Name: Acumed Wrist Arthrodesis Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: May 10, 2013 Received: May 14, 2013

Dear Ms. Cunningham:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 mav 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Brittany Cunningham

forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note

the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

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For

Mark Melkerson Director Division of Orthonedic Devices Office of-Device Evaluation-Center for Devices and

Radiological Health

Enclosure

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Section 3: INDICATIONS FOR USE

510(k) Number (if known): K131380

Device Name: Acumed Wrist Arthrodesis Plate System

Indications for Use:

Prescription Use	X
------------------	---

AND/OR

Over-the-Counter Use
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(21 CFR 801 Subpart D)
Subpart C)
(21 CFR 807(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation

Elizabeth L. Frank -S

Division of Orthopedic Devices

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.