The Conventus PRSTM System is indicated for treatment of proximal radial fractures when internal fixation is desired, and fracture fragments are not too numerous and/or too small to be stabilized with the use of the device.

Device Description

The Conventus PRSTM is an intramedullary device intended for proximal radius fractures. The PRSTM System is a self-expanding implant which is deployed into the medullary canal and provides a scaffold to which bone fragments are attached using fragment screws. The implant is made from titanium alloy (Ti-6Al-4V ELI) and Nitinol.

AI/ML Overview

This document is a 510(k) premarket notification decision letter from the FDA to Conventus Orthopaedics, Inc. It concerns the Conventus PRSTM System, an intramedullary device for proximal radial fractures. The letter confirms substantial equivalence to predicate devices based on pre-clinical testing mentioned in the 510(k) Summary.

Here's an analysis of the provided information, focusing on acceptance criteria and study details:

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

The provided document does not explicitly state specific acceptance criteria (e.g., pass/fail thresholds) for the pre-clinical tests. It lists the types of tests performed and concludes that "The results demonstrate that the PRSTM System is substantially equivalent to the legally marketed predicate devices." This implies that the device performance met the criteria necessary to demonstrate equivalency to the predicate devices, whatever those inherent criteria were for each test.

Acceptance Criteria Type (Implicit)	Reported Device Performance (Summary)
Static and cyclic axial/bend testing	Met performance equivalent to predicate devices.
Static and cyclic torsional testing	Met performance equivalent to predicate devices.
Screw pullout testing	Met performance equivalent to predicate devices.
Corrosion testing	Met performance equivalent to predicate devices.
Wear testing	Met performance equivalent to predicate devices.
Nickel ion release testing	Met performance equivalent to predicate devices.
Surface analysis testing	Met performance equivalent to predicate devices.
Nitinol phase composition	Met performance equivalent to predicate devices.
Nitinol transition temperature (Af)	Met performance equivalent to predicate devices.
Biocompatibility testing	Met performance equivalent to predicate devices.
Animal Testing	Met performance equivalent to predicate devices.
MRI Testing	Met performance equivalent to predicate devices.

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

The document does not provide specific sample sizes for any of the listed pre-clinical tests. It also does not specify the data provenance in terms of country of origin or whether the studies were retrospective or prospective. Given these are pre-clinical (laboratory and animal) tests, the concept of retrospective/prospective human data provenance does not apply.

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)

This section is not applicable to the type of pre-clinical studies described. These studies involve material science, mechanical engineering, and animal models, not human diagnostic interpretation requiring expert consensus on ground truth.

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

This section is not applicable as the studies are physical/mechanical/biological tests, not diagnostic interpretations requiring adjudication.

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

An MRMC comparative effectiveness study was not conducted. This is a pre-clinical evaluation of a surgical implant, not an AI-assisted diagnostic tool.

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

This refers to AI algorithm performance and is not applicable to the pre-clinical evaluation of a medical device implant.

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

For these pre-clinical studies, "ground truth" refers to the established scientific and engineering principles, material properties, and biological responses measured by validated test methods. For example:

Mechanical tests: Ground truth is derived from engineering standards, material specifications, and the established performance characteristics of the predicate devices.
Corrosion, wear, nickel ion release, surface analysis, Nitinol properties: Ground truth is based on established material science standards and acceptable ranges for medical implant materials.
Biocompatibility: Ground truth is established by ISO standards and recognized biological response criteria (e.g., cytotoxicity, sensitization, irritation).
Animal Testing: Ground truth involves histological analysis, imaging, and functional assessment to determine biological response and healing in comparison to expected outcomes or predicate device performance.

8. The sample size for the training set

This refers to AI model training and is not applicable to the pre-clinical evaluation of a medical device implant.

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

This refers to AI model training and is not applicable to the pre-clinical evaluation of a medical device implant.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol representing the human form, depicted as three stylized profiles facing to the right. The profiles are connected and flow together, creating a sense of unity and collaboration.

August 13, 2015

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

Conventus Orthopaedics. Incorporated Mr. Kent R. Lind Vice President Quality, Regulatory, Clinical 10200 73td Avenue North, Suite 122 Maple Grove, Minnesota 55369

Re: K151379 Trade/Device Name: Conventus PRSTM 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, HSB Dated: May 21, 2015 Received: May 22, 2015

Dear Mr. Lind:

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

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Page 2 - Mr. Kent R. Lind

(21 CFR Part 807); labeling (21 CFR Part 801); medical device 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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

Device Name Conventus PRSTM System

Indications for Use (Describe)

The Conventus PRS™ System is indicated for treatment of proximal radial fractures when internal fixation is desired, and fracture fragments are not too numerous and/or too small to be stabilized with the use of the device.

Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary

Company:	Conventus Orthopaedics, Inc.10200 73rd Avenue North, Suite 122Maple Grove, MN 55369
Device Trade Name:	Conventus PRSTM System
Device Common Name:	Proximal radius fracture system
Contact:	Kent R. LindVice President, Quality, Regulatory, ClinicalPhone: (763) 515-5003Fax: (763) 315-4980
Date Prepared:	July 27, 2015
Classification:	21 CFR 888.3030, Single/multiple component metallic bonefixation appliances and accessories21 CFR 888.3020: Intramedullary fixation rod
Class:	II
Product Codes:	HRS and HSB
Indications for Use:	The Conventus PRSTM System is indicated for treatment ofproximal radial fractures when internal fixation is desired, andfracture fragments are not too numerous and/or too small to bestabilized with the use of the device.
Device Description:	The Conventus PRSTM is an intramedullary device intended forproximal radius fractures. The PRSTM System is a self-expandingimplant which is deployed into the medullary canal and provides ascaffold to which bone fragments are attached using fragmentscrews. The implant is made from titanium alloy (Ti-6Al-4V ELI)and Nitinol.

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Substantial Equivalence: Conventus Orthopaedics has demonstrated that, for purposes of FDA's regulation of medical devices, the Conventus PRS™ System is substantially equivalent to the following devices that have been previously cleared by the FDA:

· Primary predicate: Synthes T-Plate (Pre-Amendment)
· Synthes Elastic Intramedullary Nail System (K042135)
· Conventus DRS™ System (K102689 and K131552)

This finding is supported by the following pre-clinical tests that have been performed:

Static and cyclic axial/bend testing
· Static and cyclic torsional testing
· Screw pullout testing
· Corrosion testing
· Wear testing
· Nickel ion release testing
Surface analysis testing
Nitinol phase composition
Nitinol transition temperature (Af)
· Biocompatibility testing
· Animal Testing
· MRI Testing

The results demonstrate that the PRS™ System is substantially equivalent to the legally marketed predicate 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.