The Acumed Polarus® Connect System includes plates, nails, screws and accessories designed to address fractures, fusions, and osteotomies of the humerus.

Device Description

The Acumed Polarus® Connect System of bone plates, intramedullary nails, screws and accessories are designed to provide fixation for fractures of the humerus while they heal. The Polarus® Connect System also includes instruments to facilitate placement of implants.

AI/ML Overview

This document seems to be a 510(k) summary for a medical device called the "Acumed Polarus® Connect System," which is a humerus intramedullary nail and plate fixation system. This type of submission relies on demonstrating substantial equivalence to predicate devices, rather than conducting new clinical performance studies in the way you might for novel AI/software devices.

Therefore, the provided text does not contain the detailed information required to describe acceptance criteria and a study proving a device meets those criteria for software or AI-driven medical devices.

Specifically, it lacks information about:

Performance metrics like sensitivity, specificity, AUC, etc., which are typical for software/AI.
Test sets in terms of patient data (images, clinical records).
Ground truth establishment by experts.
Human reader studies (MRMC).
Standalone algorithm performance.
Training set details.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to mechanical and material testing standards for orthopedic implants, and the "proof" is that the device met these engineering standards and demonstrated substantial equivalence in design, materials, and intended use to existing cleared devices.

Here's how I can describe what is available in the document, framed against your request, and explicitly stating what is not present:

Analysis of the Provided 510(k) Summary:

The Acumed Polarus® Connect System is a hardware medical device (bone plates, intramedullary nails, screws, and accessories) designed for humerus fracture fixation. The regulatory submission (510(k)) for such a device primarily focuses on demonstrating "substantial equivalence" to predicate devices already on the market, rather than novel clinical performance studies or AI/software evaluations.

Therefore, the "acceptance criteria" and "study" described in this document are related to mechanical performance and material compatibility, not diagnostic accuracy or AI performance.

Acceptance Criteria and Reported Device Performance (Based on Mechanical Testing for Hardware):

Acceptance Criteria (Standards Applied)	Reported Device Performance (Conclusion)
ASTM F382 - Standard Specification and Test Method for Metallic Bone Plates	The results demonstrated that the Polarus Connect System is substantially equivalent to the predicate devices and performs as well as or better than.
ASTM F543 - Standard Specification and Test Methods for Metallic Medical Bone Screws	The results demonstrated that the Polarus Connect System is substantially equivalent to the predicate devices and performs as well as or better than.
ASTM F1264 - Standard Specification and Test Methods for Intramedullary Fixation Devices	The results demonstrated that the Polarus Connect System is substantially equivalent to the predicate devices and performs as well as or better than.

Information Not Applicable or Not Found in This Document (as it pertains to software/AI studies):

This submission is for an orthopedic implant, not an AI/software device. Therefore, the following points in your request are not applicable or details are not provided within this hardware 510(k) summary:

2. Sample size used for the test set and the data provenance: Not applicable. The "test set" here would refer to
- Mechanical test specimens (e.g., number of nails, plates, screws tested). This is not detailed in the summary.
- No patient data/images as it's not a diagnostic AI device.
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 mechanical testing is based on engineering specifications and measurements, not expert consensus on clinical data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 is not an AI-assisted diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For mechanical testing, the "ground truth" is adherence to established engineering standards (ASTM F382, F543, F1264) and the physical properties observed during testing. Not clinical expert consensus or pathology.
8. The sample size for the training set: Not applicable. There is no "training set" as it's not an AI/ML model.
9. How the ground truth for the training set was established: Not applicable.

Conclusion:

The provided 510(k) summary successfully demonstrates substantial equivalence of the Acumed Polarus® Connect System to predicate devices based on design, materials, intended use, and adherence to relevant mechanical testing standards (ASTM F382, F543, F1264). It is important to note that this device is a physical orthopedic implant, and as such, the regulatory evidence focuses on engineering performance and safety, not on the type of clinical performance or AI evaluation metrics you've inquired about.

Summary

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510(k) Summary

Manufacturer:

Acumed 5885 NW Cornelius Pass Road Hillsboro, OR 97124

Date:

Submitted by:

Company Contact

5885 NW Cornelius Pass Road
Hillsboro, OR 97124

June 1, 2013

Orgenix LLC

111 Hill Road

+1-646-460-2984

Acumed 5885 NW Cornelius Pass Road Hillsboro, OR 97124

Brittany Cunningham Regulatory Specialist 2 Phone: (503) 207-1467 Fax: (503) 520-9618

Mr. Donald W. Guthner

Douglassville, PA 19518

+1-484-363-5879 (FAX)

component, metal composite

Acumed Polarus® Connect System

F382, ASTM F543 and ASTM F1264

OCT 1 0 2013

Secondary Contact:

Classification Name:

Common/Usual Name:

Proprietary Name:

Performance standards:

Classification no .:

21 CFR 888.3030 LXT, HRS, HSB - Humerus Intramedullary Nail and Plate System Class II

The Acumed Polarus Connect System components and constructs were mechanically tested to the following standards - ASTM

Appliance, fixation, nail/blade/plate combination, multiple

Humerus Intramedullary Nail and Plate Fixation System

Substantial Equivalence:

Substantial equivalence for the Acumed Polarus Connect System is based on its similarities in indications for use, design features, operational principles and material composition when compared to the predicate devices cleared under the following submissions:

. K051735 Smith & Nephew PERI-LOC Locking Bone Plates and Locking Bone Screws for the upper extremity
K091425 NMB Medical Applications. Ltd Quantum IM . Composite Nailing System

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K131636

	K012655 Acumed Congruent Bone Plate System K951740 Acumed Intramedullary Fixation Rod
Predicate Devices:	The subject device is substantially equivalent to previously cleared devices listed above.
Device Description:	The Acumed Polarus® Connect System of bone plates, intramedullary nails, screws and accessories are designed to provide fixation for fractures of the humerus while they heal.
	The Polarus® Connect System also includes instruments to facilitate placement of implants.
Intended Use:	The Acumed Polarus® Connect System includes plates, nails, screws and accessories designed to address fractures, fusions, and osteotomies of the humerus.
Summary ofTechnologicalCharacteristics	The Acumed Polarus® Connect System is manufactured from Titanium alloy complying with ASTM F136 and PEEK complying with ASTM F2026. The devices provide stabilization of humerus fractures.
Non-Clinical Testing	The Acumed Polarus® Connect System was tested according to the following standards:ASTM F382 - Standard Specification and Test Method for Metallic Bone PlatesASTM F543 - Standard Specification and Test Methods for Metallic Medical Bone ScrewsASTM F1264 - Standard Specification and Test Methods for Intramedullary Fixation DevicesThe results demonstrated that the Polarus Connect System is substantially equivalent to the predicate devices.
Conclusion	The information discussed above demonstrates that the Acumed Polarus® Connect System devices are effective and perform as well as or better than the predicate devices. Based upon the similarities of the Polarus® Connect System and the predicate devices studies, the safety and the effectiveness of the Polarus® Connect System is substantially equivalent to the predicate devices referenced.

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Public Health Service

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

October 10, 2013

Acumed. LLC Ms. Brittany Cunningham Regulatory Specialist 2 5885 North West Cornelius Pass Road Hillsboro, Oregon 97124

Re: K131636

Trade/Device Name: Polarus * Connect Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: LXT. HRS. HSB Dated: September 26, 2013 Received: September 30, 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 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

Image /page/2/Picture/11 description: The image shows a circular logo with text around the perimeter and a symbol in the center. The text around the perimeter appears to be the name of a government organization, possibly related to health or human services. The symbol in the center consists of three curved lines that resemble a stylized representation of a person or a flame. The logo is in black and white and has a simple, clean design.

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Page 2 - Ms. Brittany Cunningham

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/MedicalDcvices/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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Erin | Keith

for

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

Enclosure

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K131636

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page

510(k) Number (if known) K131636

Device Name Polarus® Connect

Indications for Use (Describe)

The Acumed Polarus® Connect System includes plates, nails, screws and accessories designed to address fractures, fusions, and osteotomies of the humerus.

Type of Use (Select one or both, as applicable)

区 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

FORM FDA 3881 (9/13)

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.