The Acumed Pelvic Bone Plate System includes plates, screws, and accessories designed to provide fixation during fractures, fusions, and osteotomies for the acetabulum, sacrum, ilium, and entire pelvic ring, as well as treatment of sacroiliac joint dislocations and symphysis pubis disruptions.

Device Description

The Acumed Pelvic Bone Plate System consists of plates, screws and accessories intended to provide fixation during fractures, fusions, and osteotomies of the acetabulum, sacrum, ilium, and entire pelvic ring, as well as treatment of sacroiliac joint dislocations and symphysis pubis disruptions. Plates are available in a variety of shapes and sizes which can be used "as is" or additionally contoured and/or trimmed intraoperatively to accommodate varying injury patterns and/or patient anatomy. All plates are made of titanium per ASTM F67 and are designed to accommodate the 3.5mm screws included in the system. Plates range in length from 30mm to 250mm, have a width of 4mm to 17mm, and a thickness of 1.5mm to 4mm. The system includes 3 families of screws with different diameters: 2.7mm, 3.5mm, and 4.3mm. All screw families can be used for fixation independent of the plates. Screws are made of titanium alloy per ASTM F136. All implants are provided sterile and non-sterile.

AI/ML Overview

The provided document is a 510(k) summary for the Acumed Pelvic Bone Plate System. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing acceptance criteria and proving performance through a clinical study in the way a new drug or novel high-risk device might.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, ground truth, and training sets is not applicable to this specific type of regulatory submission (510(k) for a Class II metallic bone fixation appliance).

Here's why and what information is available in the document:

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

Not Applicable. The 510(k) process for this device type typically relies on demonstrating substantial equivalence to predicate devices based on design, materials, manufacturing, and performance through non-clinical bench testing, rather than setting and meeting specific clinical performance acceptance criteria. The document does not define such criteria or report on device performance against them.

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

Not Applicable. No clinical "test set" and associated data provenance are mentioned because clinical studies are generally not required for this type of 510(k) submission.

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):

Not Applicable. As no clinical test set requiring ground truth establishment is described, this information is not relevant.

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

Not Applicable. No clinical test set to adjudicate is mentioned.

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. The device is a physical bone plate system, not an AI-assisted diagnostic tool. Therefore, MRMC studies and AI effect sizes are irrelevant.

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

Not Applicable. The device is a physical bone plate system, not an algorithm.

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

Not Applicable. No clinical ground truth is established for this type of submission.

8. The sample size for the training set:

Not Applicable. The device is a physical bone plate system, not a machine learning model that requires a training set.

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

Not Applicable. Not a machine learning model.

What the document does provide regarding device performance and equivalence:

The document states:

"The non-clinical testing included in this submission includes testing to ASTM F382 and F543." These are industry standards for:
- ASTM F382: Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400) (While the F382 mentioned in the document is likely referring to a test method, the common ASTM standards for implant materials are F67 for commercially pure titanium and F136 for titanium alloy, both of which are listed in the material comparison table.)
- ASTM F543: Standard Specification for Metallic Medical Bone Screws (This standard specifies requirements for metallic bone screws, including mechanical properties and test methods.)
The purpose of this testing is to demonstrate that the Acumed Pelvic Bone Plate System performs mechanically similarly to the legally marketed predicate devices. The conclusion in the 510(k) summary is: "There are some differences, but none of them raise new issues of safety or effectiveness. The Acumed Pelvic Bone Plate System is substantially equivalent to the predicate devices."

In summary, for a traditional 510(k) for a Class II orthopedic implant, the "acceptance criteria" are typically the demonstration of substantial equivalence through design comparisons, material compliance to ASTM standards, and non-clinical mechanical testing that shows the device meets the performance characteristics expected of such devices and is comparable to predicate devices. Clinical performance studies with detailed acceptance criteria and expert reviews are generally not required at this stage unless there are significant differences in technology or intended use that raise new questions of safety or effectiveness.

Summary

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510(k) Summary

Contact Details

Applicant Name: Acumed LLC 5885 NW Cornelius Pass Road, Hillsboro, OR 97124-9432

Kara Budor, Regulatory Specialist 503-207-1412

Date Prepared: August 20, 2012

Device Name

Trade Name: Acumed Pelvic Bone Plate System

Common Name: Pelvic System

Classification: 21 CFR 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

Class: II

Product Code: HRS

Legally Marketed Predicate Device(s)

There are two predicate devices. The comparison is to the Stryker Trauma Pelvic Set and the I.T.S. Pelvic Reconstruction System.

510(k) Number	Product Code	Trade Name	Applicant
K001614	KTW888.3030	Stryker Trauma Pelvic Set	Howmedica OsteonicsCorp.
K063166	HRS888.3030	I.T.S. Pelvic ReconstructionSystem	I.T.S. Implantat-Technologie-SystemeGmbH

Device Description

The Acumed Pelvic Bone Plate System consists of plates, screws and accessories intended to provide fixation during fractures, fusions, and osteotomies of the acetabulum, sacrum, ilium,

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and entire pelvic ring, as well as treatment of sacroiliac joint dislocations and symphysis pubis disruptions.

Plates are available in a variety of shapes and sizes which can be used "as is" or additionally contoured and/or trimmed intraoperatively to accommodate varying injury patterns and/or patient anatomy. All plates are made of titanium per ASTM F67 and are designed to accommodate the 3.5mm screws included in the system. Plates range in length from 30mm to 250mm, have a width of 4mm to 17mm, and a thickness of 1.5mm to 4mm.

The system includes 3 families of screws with different diameters: 2.7mm, 3.5mm, and 4.3mm. All screw families can be used for fixation independent of the plates. Screws are made of titanium alloy per ASTM F136.

All implants are provided sterile and non-sterile.

Intended Use/Indications for use

Substantial Equivalence Comparison

The basic comparison between the Acumed Pelvic Bone Plate System and the predicate devices is given in the table below.

Category	Acumed PelvicBone Plate System	I.T.S. Pelvic Reconstruc-tion System K063166	Stryker Trauma Pelvic SetK001614
Material	Titanium per ASTM F67and Titanium alloy perASTM F136	Commercially puretitanium and 6-4 alloyedtitanium	Stainless Steel per ASTMF138
Plate Shape	Straight platesCurved platesPlates for anatomy specificsites	Straight platesCurved platesPlates for anatomy specificsites	Straight platesCurved platesPlates for anatomy specificsites
Plate FixationMethod	Screw fixation	Screw fixation	Screw fixation
Screw Type	Non-locking	Non-locking and Locking	Non-locking
Provided sterileand/or non-sterile	Provided sterile and non-sterile	Unknown	Provided sterile and non-sterile
Implants areused withgeneral surgicalinstrumentation	Yes	Yes	Yes

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Acumed Pelvic Bone Plate System 510(k) Notification

The Acumed Pelvic Bone Plate System, the I.T.S. PRS Low Profile – Multiple Type – Pelvic Plating System, and the Stryker Trauma Pelvic Set are all systems of plates, screws, and instruments which are used to achieve fixation. There are some differences, but none of them raise new issues of safety or effectiveness. The Acumed Pelvic Bone Plate System is substantially equivalent to the predicate devices.

Non-clinical Testing

The non-clinical testing included in this submission includes testing to ASTM F382 and F543.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a bird-like figure with three wing-like shapes.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Letter Dated: November 19, 2012

Acumed, LLC % Ms. Kara Budor Regulatory Specialist 5885 Northwest Cornelius Pass Road Hillsboro, Oregon 97124

Re: K122538

Trade/Device Name: Acumed Pelvic Bone 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 Dated: August 20, 2012 Received: August 21, 2012

Dear Ms. Budor: .

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 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

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Page 2- Ms. Kara Budor

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.htmfor 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 vours. Erin I. Keith

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation · Center for Devices and Radiological Health

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Acumed Pelvic Bone Plate System 510(k) Notification

Indications for Use

510(k) Number (if known): K122538

Device Name: Acumed Pelvic Bone Plate System

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21. CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE) .

K. Ath

(Division Sign-Off) Division of Orthopedic Device 510(k) Number K12253

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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.