The Acumed Wrist Spanning Plate is intended for fixation of fractures, osteotomies, and nonunions of the radius.
The Acumed Wrist Spanning Plate is indicated for fixation of fractures, osteotomies, and non-unions of the radius.

Device Description

The Acumed Wrist Spanning Plate comprises two anatomically designed dorsal fixation plate and is provided in sterile packaging.

AI/ML Overview

The provided text describes a 510(k) summary for the Acumed Wrist Spanning Plate, a medical device for bone fixation. The information available focuses on the device's technical characteristics and its substantial equivalence to a predicate device based on mechanical performance.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Objective	Acceptance Criteria	Reported Device Performance
Bending Strength Performance	Statistically equivalent to that of the predicate device (Synthes 3.5mm Locking Compression Plate standard bone plate (K082807)).	"The bending strength performance of the Acumed Wrist Spanning Plate was verified to be statistically equivalent to that of the predicate device." (Section 1)

2. Sample Size Used for the Test Set and Data Provenance

The provided summary does not explicitly state the sample size used for the mechanical bending strength performance test. It mentions that "detailed test reports can be found in Section 36," but Section 36 is not included in the provided text.

The data provenance is for a mechanical bench test comparing the new device to a predicate device, not clinical data from patients. Therefore, concepts like country of origin and retrospective/prospective do not apply in the typical sense for this type of study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This question is not applicable to the study described. The study is a mechanical bench test comparing the bending strength of two bone plates. There is no "ground truth" established by human experts in this context. The "ground truth" is determined by direct mechanical testing according to established engineering principles.

4. Adjudication Method for the Test Set

This question is not applicable to the study described. Adjudication methods are relevant for studies involving human interpretation or clinical outcomes, which is not the case for this mechanical bench test.

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 question is not applicable. The study is a mechanical bench test of a bone plate, not a study involving AI, human readers, or medical image interpretation.

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

This question is not applicable. The study is a mechanical bench test of a bone plate, not an algorithm.

7. The Type of Ground Truth Used

For the bending strength performance study, the "ground truth" is established by direct mechanical measurements of the plates' bending strength under controlled experimental conditions, following standardized testing protocols (likely ASTM standards for metallic bone fixation devices). It's an objective physical measurement, not an expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

This question is not applicable. The described study is a mechanical validation of a medical device, not a machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable for the same reason as above.

In summary:

The provided text focuses on the mechanical performance of the Acumed Wrist Spanning Plate, demonstrating its substantial equivalence to a legally marketed predicate device through bench testing. The acceptance criteria were met when the bending strength performance of the new device was statistically equivalent to the predicate. The study type is a mechanical performance validation, not a clinical study or an AI performance study.

Summary

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K131764

Section 4: 510(k) SUMMARY

Device Trade Name:	Acumed Wrist Spanning Plate
Date:	June 14, 2013
Sponsor:	Acumed, LLC5885 NW Cornelius Pass RoadHillsboro, OR 97124Phone: (503) 627-9957Fax: (503) 520-9618
Contact Person:	Nathan Wolf, Regulatory Specialist
Manufacturer:	Acumed, LLC5885 NW Cornelius Pass RoadHillsboro, OR 97124Phone: (503) 207 1502Fax: (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 accessories
Device Regulation Panel:	Orthopedic

HRS

Device Product Code:

Device Description:

The Acumed Wrist Spanning Plate comprises two anatomically designed dorsal fixation plate and is provided in sterile packaging.

Intended Use:

The Acumed Wrist Spanning Plate is intended for fixation of fractures, osteotomies, and nonunions of the radius.

Indications For Use:

The Acumed Wrist Spanning Plate is indicated for fixation of fractures, osteotomies, and nonunions of the radius.

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Materials:

The Acumed Wrist Spanning Plate is manufactured from titanium alloy (Ti-6AI-4V) as described in ASTM F136.

Technological Characteristics:

There are no technological characteristics that raise new issues of safety or effectiveness.

Assessment of performance data:

The bending strength performance of the Acumed Wrist Spanning Plate was verified to be statistically equivalent to that of the predicate device. A summary of the objective, acceptance criteria, results, and conclusions, as well as the detailed test reports can be found in Section 36.

Legally Marketed Predicate Device:

Synthes 3.5mm Locking Compression Plate standard bone plate (K082807)

Predicate Indications for Use:

The Synthes 3.5 mm Locking Compression Plate (LCP) System is indicated for fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olectranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone for adult patients.

Based upon the similarities of the Acumed Wrist Spanning Plate and the predicate devices studied, the safety and effectiveness of the Acumed Wrist Spanning Plate is substantially equivalent to the predicate devices referenced.

Purpose:

The purpose of this Traditional 510(k) submission is to gain clearance for the Acumed Wrist Spanning Plate.

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Image /page/2/Picture/0 description: The image shows a circular seal with text around the perimeter and a stylized eagle in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)". The eagle is depicted with three curved lines forming its body and wings, creating a sense of movement.

DEPARTMENT OF HEALTH & HUMAN SERVICES

September 5, 2013

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

Mr. Nathan Wolf Regulatory Specialist Acumed. LLC 5885 Northwest Cornelius Pass Road Hillsboro. Oregon 97124

Re: K131764

Trade/Device Name: Acumed Wrist Spanning Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: June 14, 2013 Received: June 17, 2013

Dear Mr. Wolf:

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 cnactment date of the Medical Device Amendments. or 10 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 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): medical device reporting (reporting of medical

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Page 2 - Mr. Nathan Wolf

device-related adverse events) (21 CFR 803); 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.

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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic 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): K131764

Device Name: Acumed Wrist Spanning Plate

Indications for Use:

The Acumed Wrist Spanning Plate is indicated for fixation of fractures, osteotomies, and non-unions of the radius.

Prescription Use	X
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AND/OR

Over-the-Counter Use
----------------------	--

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

Concurrence of CDRH, Office of Device Evaluation

Elizabeth L. Frank -S

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.