(90 days)
The Arthrex Distal Extremity Plate System is intended for use in stabilization of fresh fractures, revision procedures, osteotomies, joint fusion and reconstruction of small bones and bone fragments of the hand/wrist, foot/ankle, and osteopenic bone.
The Arthrex Distal Extremity Plate System is comprised of a variety of flat and pre-contoured plate geometries. The plates are manufactured from titanium and feature both locking and non-locking holes. The screw ranges from 2.0 mm to 4.0 mm in diameter and in length from 8 mm to 80 mm. The screws are solid and may be either locking or non-locking.
The provided document describes a 510(k) premarket notification for the Arthrex Distal Extremity Plate System. This type of submission relies on demonstrating substantial equivalence to predicate devices already on the market, rather than conducting new clinical trials to establish novel safety and effectiveness. Therefore, the information typically requested in your prompt regarding acceptance criteria, study details, human readers, and ground truth in the context of an AI/algorithm-based device is not fully applicable here.
However, I can extract the relevant information about how "acceptance criteria" (which are framed as demonstration of substantial equivalence through mechanical testing) and "study" (mechanical testing) are addressed in this 510(k) submission.
Here's a breakdown based on the provided text:
1. Acceptance Criteria and Reported Device Performance
For a medical device like the Arthrex Distal Extremity Plate System, "acceptance criteria" are intrinsically linked to demonstrating substantial equivalence to legally marketed predicate devices. This is achieved through comparisons of material, design, intended use, and performance, often relying on mechanical testing.
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance (Summary of Mechanical Testing) |
|---|---|
| Material Equivalence: Composed of titanium that is substantially equivalent to predicate devices. | The proposed devices are composed of titanium that is substantially equivalent to the predicate devices. |
| Bending Strength Equivalence: Bending strength of the plates is substantially equivalent to that of the predicate devices. | The submitted mechanical testing data demonstrated that the bending strength of the plates is substantially equivalent to that of the predicate devices. |
| Torque and Pull-Out Force Equivalence: Torque and pull-out force of the screws are substantially equivalent to that of the predicate devices. | The submitted mechanical testing data demonstrated that the torque and pull-out force of the screws are substantially equivalent to that of the predicate devices. |
| Intended Use & Technological Characteristics Equivalence: Intended use and technological characteristics are consistent with predicate devices. | Based on the indication for use, technological characteristics, and the comparison to the predicate devices, Arthrex, Inc. has determined that the Distal Extremity Plate System is substantially equivalent to currently marketed predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided text for the mechanical testing. For mechanical testing of medical devices, sample sizes are typically determined by engineering standards (e.g., ASTM, ISO) to achieve statistical significance for the property being tested (e.g., fatigue life, bending modulus).
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. Mechanical testing data is typically generated in a laboratory setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable in the context of mechanical testing for substantial equivalence. "Ground truth" in this context refers to established material properties and biomechanical performance standards, not expert clinical interpretation.
4. Adjudication Method for the Test Set
- Not applicable. Mechanical testing results are typically based on objective measurements and calculations, not on human adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the diagnostic performance of imaging devices or algorithms with human readers, which is not the purpose of this 510(k) submission for a bone fixation system.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is a physical bone fixation system, not an algorithm.
7. The Type of Ground Truth Used
- For this 510(k) submission, the "ground truth" for the mechanical testing would be the accepted engineering standards and the established performance characteristics of the predicate devices. The goal is to demonstrate that the new device's performance aligns with these benchmarks.
8. The Sample Size for the Training Set
- Not applicable. This device is not an AI/algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for this type of device.
In summary, this 510(k) submission primarily relies on demonstrating substantial equivalence through mechanical testing and comparison of material properties, design, and intended use to existing predicate devices. It does not involve the types of studies typically associated with AI/algorithmic devices that require human expert input or "ground truth" establishment in a diagnostic context.
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Traditional 510(k): Arthrex Distal Extremity Plate System, May 2, 2011
Arthrex 510(K): ARTHREX DISTAL EXTREMITY PLATE SYSTEM
AUG - 2 2011
Summary of Safety and Effectiveness April 22, 2011 Date Summary Prepared Manufacturer/Distributor/Sponsor Arthrex, Inc. 1370 Creekside Boulevard Naples, FL 34108-1945 USA Courtney Smith 510(k) Contact Regulatory Affairs Project Manager Arthrex, Inc. 1370 Creekside Boulevard Naples, FL 34108-1945 USA Telephone: 239/643.5553, ext. 1720 Fax: 239/598.5508 Email: courtney.smith(@arthrex.com Trade Name Distal Extremity Plate System Common Name Plate, fixation, bone Screw, fixation, bone HWC, HRS Product Code -Classification Name 21 CFR 888.3030: Single/multiple component metallic bone CFR fixation appliances and accessories. 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener. K090692: Wright Ortholoc 2.0/2.4 Plate System Predicate Device K063049: Synthes Modular Mini Fragment LCP System K050110: Synthes Modular Foot System K103705: Arthrex Low Profile Screws Purpose of Submission This traditional 510(k) premarket notification is submitted to obtain clearance for the Distal Extremity Plate System. Device Description and Intended The Arthrex Distal Extremity Plate System is comprised of a Use variety of flat and pre-contoured plate geometries. The plates are manufactured from titanium and feature both locking and non-locking holes. The screw ranges from 2.0 mm to 4.0 mm in diameter and in length from 8 mm to 80 mm. The screws are solid and may be either locking or non-locking. The Arthrex Distal Extremity Plate System is intended for use in stabilization of fresh fractures, revision procedures, osteotomies, joint fusion and reconstruction of small bones and bone fragments of the hand/wrist, foot/ankle, and osteopenic bone. The Distal Extremity Plate System is substantially equivalent Substantial Equivalence
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K111253 (pg 2/2)
Traditional 510(k): Arthrex Distal Extremity Plate System, May 2, 2011
| Arthrex 510/KV ARTHREX DISTAL EXTREMITY PLATE SYSTE* |
|---|
| Summary | to the predicate devices, in which the basic features andintended uses are the same. Any differences between theDistal Extremity Plate System and the predicates areconsidered minor and do not raise questions concerning safetyand effectiveness. |
|---|---|
| The proposed devices are composed of titanium that issubstantially equivalent to the predicate devices. | |
| The submitted mechanical testing data demonstrated that thebending strength of the plates and the torque and pull-outforce of the screws are substantially equivalent to that of thepredicate devices. | |
| Based on the indication for use, technological characteristics,and the comparison to the predicate devices, Arthrex, Inc. hasdetermined that the Distal Extremity Plate System issubstantially equivalent to currently marketed predicatedevices. |
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Arthrex, Inc. % Ms. Courtney Smith Regulatory Affairs Project Manager 1370 Creekside Blvd. Naples. FL 34108-1945
AUG - 2 2011
Re: K111253
Trade/Device Name: Arthrex Distal Extremity Plate System Regulation Number: 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: May 2, 2011 Received: May 4, 2011
Dear Ms. Smith:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have deternined 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
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Page 2 - Ms. Courtney Smith
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 Parl 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 McMillan
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Arthrex 510(K): ARTHREX DISTAL EXTREMITY PLATE SYSTEM
Indications for Use Form
Indications for Use
510(k) Number (if known): KU1253 (pa 1/1
Device Name: Arthrex Distal Extremity Plate System
Indications For Use:
The Arthrex Distal Extremity Plate System is intended for use in stabilization of fresh fractures, revision procedures, osteotomies, joint fusion and reconstruction of small bones and bone fragments of the hand/wrist, foot/ankle, and osteopenic bone.
Prescription Use _ V AND/OR Over-The-Counter Use (Per 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
PAGE 1 of 1
for M. Melkerson
(Division/Sign-Off) (Division/Sign-on/Surgical, Orthopedic,
Division of Surgical, Orthopedic, Divisionative Devices
510(k) Number K111253
§ 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.