The Conventus DRSTM is an intramedullary device intended to treat distal radius fractures. The device remains flexible during placement, but is made rigid at the completion of the surgical implant procedure. The implant is made from titanium alloy (Ti-6Al-4V) and Nitinol.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the Conventus DRS™ device, which is an intramedullary device for fixing distal radius fractures. The document is a regulatory submission and focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than a clinical study evaluating the performance of an AI algorithm or diagnostic tool.

Therefore, many of the requested elements are not applicable to this type of submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (from the study)	Reported Device Performance
Radiographic success	95% at 12 weeks post-operatively
DASH score assessment	Substantially equivalent to predicates at 12 weeks, 6 months, and 1 year post-operatively
Adverse events monitoring	Surgical instrument failure (4), nerve irritation and pain not requiring intervention (4), and one revision due to a fragment not properly secured

Note: The document does not explicitly state "acceptance criteria" for radiographic success or DASH scores in quantitative terms (e.g., "X% of subjects must achieve radiographic success"). Instead, it reports the "demonstrated" performance. For adverse events, the reporting of specific numbers implies a monitoring and reporting requirement rather than a pass/fail criterion.

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

Sample Size (Test Set): Not explicitly stated as a separate "test set" from a larger training set. The clinical evaluation refers to "study subjects," implying this cohort serves as the primary evaluation set for substantial equivalence. The exact number of subjects is not provided.
Data Provenance: Clinical evaluation was conducted "outside the United States in Tier 1 countries."
Retrospective or Prospective: Not explicitly stated, but the mention of "collection of radiographic outcomes, functional outcomes (DASH), and adverse event information" suggests a prospective clinical trial or observation period following implantation of the device.

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

This information is not provided in the document. The document refers to "radiographic outcomes" being collected, but it does not specify how these outcomes were interpreted or if expert consensus was used to establish ground truth for the fracture classification or healing assessment.

4. Adjudication method for the test set:

This information is not provided in the document.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

An MRMC study was not conducted. This document describes a medical device (intramedullary fixator), not an AI algorithm or diagnostic tool that assists human readers.

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

A standalone performance assessment was not done. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

The "ground truth" for the device's performance is implicitly based on clinical outcomes data, including:
- Radiographic outcomes: Assessment of fracture reduction and healing.
- Functional outcomes: Measured by the DASH (Disabilities of the Arm, Shoulder and Hand) score.
- Adverse event information: Documented complications.

8. The sample size for the training set:

The concept of a "training set" in the context of an AI algorithm is not applicable here. This document describes a physical medical device. The "clinical evaluation" described would be the primary data for demonstrating safety and effectiveness relative to predicates.

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

As mentioned above, the concept of a "training set" for an AI algorithm is not applicable. The ground truth for the clinical evaluation was established through direct clinical observation, radiographic assessment, and patient-reported outcomes.

In summary:

This 510(k) summary focuses on demonstrating the substantial equivalence of a bone fixation device to existing predicate devices. It relies on a clinical evaluation (implicitly a prospective study) to gather data on radiographic and functional outcomes, as well as adverse events. The submission does not involve AI, diagnostic image interpretation, or the associated methodologies for establishing ground truth for algorithms.

Summary

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K102689 Page 1 of 2

510(k) Summary

JAN 1 7 2013

Company:	Conventus Orthopaedics, Inc.10200 73rd Avenue North, Suite 122Maple Grove, MN 55369
Device Trade Name:	Conventus DRSTM
Contact:	Kent R. LindVice President, Quality and RegulatoryPhone: (763) 515-5000Fax: (763) 315-4980
Prepared By:	Musculoskeletal Clinical Regulatory Advisers, LLC1331 H Street, NW, 12th FloorWashington, DC 20005Phone: (202) 552-5800Fax: (202) 552-5798
Date Prepared:	December 7, 2012
Classification:	21 CFR 888.3030, Single/multiple component metallic bonefixation appliances and accessories
Class:	II
Product Codes:	HRS and HSB
Indications for Use:	The Conventus DRSTM is intended for use in the fixation offractures of the distal radius.
Device Description:	The Conventus DRSTM is an intramedullary device intendedto treat distal radius fractures. The device remains flexibleduring placement, but is made rigid at the completion of thesurgical implant procedure. The implant is made fromtitanium alloy (Ti-6Al-4V) and Nitinol.

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Substantial Equivalence:

This 510(k) supports the substantial equivalence of the Conventus DRS™ to legally marketed devices with respect to indications for use, design, materials, and function. Specifically, this 510(k) demonstrates substantial equivalence of the Conventus DRS™ to the following predicate devices: Synthes T-Plate (Pre-amendment device), Sonoma Orthopedic Products EnsplintRxTM Intramedullary Distal Radius Fixation Device (K071809), Wright Radial Nail System (MICRONAIL®) (K040938). Like the identified predicates, the Conventus DRS™M can capture distal radius bone fragments at various angles.

Clinical evaluation, animal testing, analysis of the static and fatigue axial and bending characteristics of the device in a fracture model, biocompatibility testing, nickel release testing, and corrosion testing performed by the company demonstrate that the Conventus DRS™ is substantially equivalent to legally marketed predicate devices.

Clinical evaluation of the Conventus DRS™ was conducted outside the United States in Tier 1 countries for clinical subjects that experienced distal radius fracture due to high impact conditions (falls, sports, etc.). The clinical evaluation included collection of radiographic outcomes, functional outcomes (DASH), and adverse event information.

Radiographic success of 95% was demonstrated for study subjects 12 weeks post-operatively. The DRSTM performs substantially equivalently to the predicates at 12 weeks, 6 months, and 1 year post-operatively as assessed by DASH score. Adverse events included surgical instrument failure (4), nerve irritation and pain not requiring intervention (4), and one revision due to a fragment that was not properly secured at time of implantation.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

January 17, 2013

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

Re: K102689

Trade/Device Name: Conventus DRSTM 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: December 17, 2012 Received: December 17, 2012

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 (21

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Page 2 - Mr. Kent Lind

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 (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 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.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,

Image /page/3/Picture/6 description: The image shows the name "Erin Keith" in a stylized font. The letters "E", "r", "i", "n", "i", "t", and "h" are in a simple, bold font. The letters "K", "e" are in a more complex, geometric font, with lines and shapes filling the interior of the letters.

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

Enclosure

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Indications for Use

510(k) Number: K102689

Device Name: Conventus DRSTM

The Conventus DRS™ is intended for the fixation of distal radius fractures.

Prescription Use V (Part 29 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (29 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)

Anton E. Dmitriev, PhD Division of Orthopedic Devices / 205'00' 11

2013.01.17 14:05:41

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.