(119 days)
The Arthrex Fracture System is intended to be used for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur and fibula. The Arthrex Fracture Plates are to be used with the 2.7mm-4.0mm Arthrex Low Profile Screws.
The Clavicle Plate Button is intended for use with the clavicle plates for clavicle indications such as for the treatment of syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruption, and this button may not be used alone. The button is intended to be used with #5 Fiber Wire or FiberTape.
The Arthrex Fracture System is a family of stainless steel plates, screws, and buttons. The plates may be contoured or straight and may be available in left and right configurations. The plates are to be used with the 2.7mm-4.0mm Low Profile Screws. The screws are solid and fully threaded and may be locking or non-locking. The button is stainless steel and designed to fit securely in the holes of the fracture plates. The button is intended to be used with the previously cleared suture, which is provided separately.
This document describes the Arthrex Fracture System, a device for internal bone fixation. Given the provided text, there is no information available regarding specific acceptance criteria, a study proving the device meets these criteria, or details about artificial intelligence (AI) in this context.
The document is a 510(k) summary for a medical device, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance data against specific, defined acceptance criteria. It primarily addresses the device's description, intended use, and a comparison to existing devices.
Therefore, many of the requested sections regarding acceptance criteria, study details, ground truth, and AI performance cannot be extracted from this text.
Here's a breakdown of what can be inferred or stated based on the provided information, and what cannot:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as pass/fail criteria with numerical thresholds. The "acceptance" for this 510(k) submission is based on demonstrating substantial equivalence to predicate devices.
- Reported Device Performance:
"The submitted mechanical testing data demonstrated that the bending and pull-out strength of the proposed devices are substantially equivalent to the bending and pull-out strength of the predicate devices."- Comment: The document doesn't provide specific numerical values for bending and pull-out strength or detailed comparison data. It only states that the data demonstrated "substantial equivalence."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified.
- Data Provenance: Not specified, but the context implies laboratory mechanical testing rather than clinical data from a specific country. This would be prospective testing on manufactured devices to compare against predicates.
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. This device is a bone fixation system, and the "ground truth" in this context would be physical/mechanical properties, not expert-interpreted diagnostic images or outcomes. The review of the 510(k) submission itself would involve regulatory experts (FDA staff).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is a physical device being evaluated for mechanical equivalence, not a diagnostic algorithm or image interpretation task requiring adjudication of expert opinions.
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
- No, an MRMC study was NOT done. This document is for a physical medical device (fracture system) and does not involve AI or human readers for diagnostic interpretation.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
- No, a standalone algorithm performance study was NOT done. This document is for a physical medical device and does not involve any algorithm or AI component.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Mechanical properties of predicate devices. The "ground truth" for demonstrating substantial equivalence appears to be the established mechanical performance (bending and pull-out strength) of the predicate devices. The new device's performance is compared against these benchmarks.
8. The sample size for the training set
- Not applicable. This document describes a physical medical device. There is no mention of a "training set" in the context of an algorithm. If referring to the manufacturing process, quality control samples would be used, but not a "training set" as understood in AI/ML.
9. How the ground truth for the training set was established
- Not applicable. As above, there is no "training set" in the AI/ML sense for this device.
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2 510(k) Summary of Safety and Effectiveness
K112437 (pg.1 of 2)
| Date Summary Prepared | November 29, 2011 |
|---|---|
| Manufacturer/Distributor/Sponsor | Arthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USA |
| 510(k) Contact | Courtney SmithManager, Regulatory AffairsArthrex, Inc.1370 Creekside Boulevard Naples,FL 34108-1945 USA Telephone:239/643.5553, ext. 1720Fax: 239/598.5508Email: csmith@arthrex.com |
| Trade Name | Arthrex Fracture System |
| Common Name | Plate, fixation, bone |
| Product Code -Classification Name | HWC, HRS, HTN |
| CFR | 21 CFR 888.3030: Single/multiple component metallic bonefixation appliances and accessories21 CFR 888.3040: Smooth or threaded metallic bone fixationfastener. |
| Predicate Device | K011335: Synthes One-Third Tubular PlatesK102998: Acumed Congruent Bone Plate SystemK043248 / K052776: Arthrex TightRope Syndesmosis andAcromioclavicular (AC) DevicesK103705 / K111253: Arthrex Low Profile Screws |
| Device Description andIntended Use | The Arthrex Fracture System is a family of stainless steel plates,screws, and buttons. The plates may be contoured or straight andmay be available in left and right configurations. The plates are tobe used with the 2.7mm-4.0mm Low Profile Screws. The screwsare solid and fully threaded and may be locking or non-locking.The button is stainless steel and designed to fit securely in theholes of the fracture plates. The button is intended to be used withthe previously cleared suture, which is provided separately.The Arthrex Fracture System is intended to be used for internalbone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon,humerus, radius, ulna, tibia, calcaneous, femur and fibula. TheArthrex Fracture Plates are to be used with the 2.7mm-4.0mmArthrex Low Profile Screws. |
| plates for clavicle indications such as for the treatment ofsyndesmotic trauma, such as fixation of acromioclavicularseparations due to coracoclavicular ligament disruption, and thisbutton may not be used alone. The button is intended to be usedwith #5 FiberWire or FiberTape. | |
| Substantial EquivalenceSummary | The Arthrex Fracture System is substantially equivalent to thepredicate Synthes One-Third Tubular Plates (K011335), AcumedCongruent Bone Plate System (K102998), Arthrex TightRopeSyndesmosis and Acromioclavicular (AC) Devices (K043248 /K052776), and the cleared Arthrex Low Profile Screws(K103705, K111253) in which the basic features and intendeduses are the same. Any differences between the Fracture Systemand the predicates are considered minor and do not raise questionsconcerning safety and effectiveness. |
| The proposed devices are composed of Stainless Steel which issubstantially equivalent to the predicate devices. | |
| The submitted mechanical testing data demonstrated that thebending and pull-out strength of the proposed devices aresubstantially equivalent to the bending and pull-out strength of thepredicate devices. | |
| Based on the indication for use, technological characteristics, andthe comparison to the predicate devices, Arthrex, Inc. hasdetermined that the Fracture System is substantially equivalent tocurrently marketed predicate devices. |
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KI12437 (pg. 2 of z)
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Arthrex, Incorporated % Ms. Courtney Smith Manager, Regulatory Affairs 1370 Creekside Boulevard Naples, Florida 34108
DEC 2 1 2011
Re: K112437
Trade/Device Name: Arthrex Fracture System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HTN, HWC, HRS Dated: December 12, 2011 Received: December 14, 2011
Dear Ms. Smith:
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.
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 – Ms. Courtney Smith
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,
Mark N. Melleman
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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1 Indications for Use Form
Indications for Use
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: Arthrex Fracture System
Indications For Use:
The Arthrex Fracture System is intended to be used for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur and fibula. The Arthrex Fracture Plates are to be used with the 2.7mm-4.0mm Arthrex Low Profile Screws.
The Clavicle Plate Button is intended for use with the clavicle plates for clavicle indications such as for the treatment of syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruption, and this button may not be used alone. The button is intended to be used with #5 Fiber Wire or FiberTape.
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
Muthal Mheen
(Division Sign-Off) (Division Sign-On)
Division of Surgical, Orthopedic, DIVIsion of Suices
510(k) Number K112437
§ 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.