(128 days)
The ANTHEM™ Fracture System is indicated for fixation of fractures, arthrodesis and reconstruction of bones for the appropriate size of the device to be used in adult patients, including the clavicle, scapula, humerus, radius, ulpa, small bones (metacarpals, metatarsals, phalanges), wrist, pelvis, fibula, ankle, and foot. Small fragment and distal fibula plates may be used in all pediatric subgroups (except neonates) and small stature adults. Distal radius plates may be used in adolescents (12-21 years of age).
The ANTHEM™ Fracture System is a family of plates and screws designed to be used for internal bone fixation. The implants are available in various sizes and shapes to accommodate patient anatomy, and may be contoured or straight, sterile and non-sterile, with locking and non-locking screws. ANTHEM™ implants are manufactured from medical grade titanium alloy, cobalt chromium molybdenum alloy, or stainless steel. All implants are for single use only.
This document is a 510(k) Summary for the ANTHEM™ Fracture System, a medical device. Based on the provided text, there is no study described that proves the device meets specific acceptance criteria based on AI/algorithm performance, nor is there any mention of an AI device. The document explicitly describes the ANTHEM™ Fracture System as a system of "plates and screws designed to be used for internal bone fixation."
Therefore, I cannot provide the requested information regarding:
- A table of acceptance criteria and reported device performance related to AI/algorithmic accuracy.
- Sample size and data provenance for an AI test set.
- Number of experts and qualifications for AI ground truthing.
- Adjudication method for an AI test set.
- MRMC comparative effectiveness study for AI assistance.
- Standalone AI performance.
- Type of ground truth used for AI.
- Sample size for training set for AI.
- How ground truth for a training set was established for AI.
The document focuses on the mechanical and material performance of bone fixation devices, not on diagnostic or AI-driven performance.
Here's a summary of the performance data that is mentioned in the document, which pertains to the physical device itself:
1. Acceptance Criteria and Reported Device Performance (for the physical device):
- Acceptance Criteria (Implicit Standard Performance): The device's performance was evaluated in accordance with recognized ASTM standards for bone fixation devices. This implies that the device had to meet performance benchmarks defined by these standards to demonstrate substantial equivalence to predicate devices. While specific numerical acceptance criteria are not explicitly stated (e.g., "minimum bending strength of X N-m"), the adherence to these standards serves as the implicit acceptance criteria for mechanical performance.
- Reported Device Performance:
- Tests Conducted: Engineering analysis, bending strength tests (for plates and screws), pullout strength tests (for screws), and insertion/removal torque tests (for screws).
- Outcome: "Performance data demonstrates substantial equivalence to the predicate devices."
- Bacterial Endotoxin Testing (BET): Conducted in accordance with ANSI/AAMI ST-72:2011 to ensure sterility or low endotoxin levels.
2. Sample Size and Data Provenance (for the physical device testing):
- The document does not specify the sample sizes used for the mechanical performance tests (e.g., how many plates or screws were tested for bending strength).
- The data provenance is not mentioned (e.g., where the tests were conducted, whether the materials were from specific batches, etc.).
3. Number of experts used to establish the ground truth... and qualifications of those experts:
- Not applicable. This document is about a physical medical device (bone plates and screws), not an AI algorithm requiring expert review for ground truth.
4. Adjudication method for the test set:
- Not applicable. This document is about a physical medical device (bone plates and screws), not an AI algorithm.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done...:
- Not applicable. This document is about a physical medical device (bone plates and screws), not an AI algorithm.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This document describes a physical medical device, not an algorithm.
7. The type of ground truth used:
- For the physical device, "ground truth" would be the objective measurements obtained from standardized mechanical tests (e.g., actual force at failure, actual torque values) against the requirements of the ASTM standards.
8. The sample size for the training set:
- Not applicable, as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not applicable, as this is not an AI/machine learning device.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 7, 2017
Globus Medical Inc. Kelly Baker Senior Vice President, Regulatory And Clinical Affairs 2560 General Armistead Ave. Audubon, Pennsylvania 19403
Re: K163361 Trade/Device Name: Anthem™ 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: HRS, HWC Dated: March 8, 2017 Received: March 9, 2017
Dear Dr. Baker:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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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" (21 CFR 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,
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
510(k) Number (if known) K163361
Device Name ANTHEM™ Fracture System
Indications for Use (Describe)
The ANTHEM™ Fracture System is indicated for fixation of fractures, arthrodesis and reconstruction of bones for the appropriate size of the device to be used in adult patients, including the clavicle, scapula, humerus, radius, ulpa, small bones (metacarpals, metatarsals, phalanges), wrist, pelvis, fibula, ankle, and foot. Small fragment and distal fibula plates may be used in all pediatric subgroups (except neonates) and small stature adults. Distal radius plates may be used in adolescents (12-21 years of age).
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summary: ANTHEM™ Fracture System
- Company: Globus Medical Inc. 2560 General Armistead Ave. Audubon, PA 19403 610-930-1800
- Contact: Kelly J. Baker, Ph.D. Senior Vice President, Regulatory and Clinical Affairs
- April 6, 2017 Date Prepared:
- Device Name: ANTHEM™ Fracture System
- Common Name: Bone plate & screws
Classification: Per 21 CFR as follows: §888.3030 Single/multiple component metallic bone fixation appliance and accessories §888.3040 Smooth or threaded metallic bone fixation fastener Product Code: HRS, HWC Regulatory Class: II
Predicates: Synthes 2.7mm/3.5mm LCP Distal Fibula Plates (K073460) Arthrex Fracture System (K112437) Synthes Volar Distal Radius Plate (K092556, K982732) Stryker Anatomic Volar Plate (K133974) Skeletal Dynamics Geminus Volar Distal Radius Plate System (K111620) Trimed Bearing Bridge Plate (K040112) Medartis Hook Plate (K142906) Synthes LCP Distal Radius System (K102694) Synthes LCP Proximal Humerus Plates (K011815, K041860) Arthrex Humeral Fracture Plate (K041965) Synthes 3.5mm LCP Periarticular Proximal Humerus Plates (K082625) Biomet Proximal Humerus Plating System (K143697) Synthes Small Fragment DCL System (K000684) Stryker Plating System (K060514) PERI-LOC Plating and Screw System (K083032) Arthrex Fracture System (K112437) OrthoPediatrics PediLoc Locking Plate System (K083286) Synthes Modular Mini Fragment LCP (K063049) GPC BRAND Locking Bone Plates and Screws (K153716)
Synthes Large Fragment DCL System (K000682)
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EVOS Mini-Fragment Plating System (K140814) TriMed Volar Buttress Pin (K951303) AFT GTF System (K133668) Modified Shoulder Fixation System (K060290) Synthes LCP Dia-Meta Volar Distal Radius Plates (K070946)
Purpose:
The purpose of this submission is to request clearance for the ANTHEM™ Fracture System.
Device Description:
The ANTHEM™ Fracture System is a family of plates and screws designed to be used for internal bone fixation. The implants are available in various sizes and shapes to accommodate patient anatomy, and may be contoured or straight, sterile and non-sterile, with locking and non-locking screws. ANTHEM™ implants are manufactured from medical grade titanium alloy, cobalt chromium molybdenum alloy, or stainless steel. All implants are for single use only.
Indications for Use:
The ANTHEM™ Fracture System is indicated for fixation of fractures, osteotomies, arthrodesis and reconstruction of bones for the appropriate size of the device to be used in adult patients, including the clavicle, scapula, humerus, radius, ulna, small bones (metacarpals, metatarsals, phalanges), wrist, pelvis, femur, tibia, fibula, ankle, and foot. Small fragment and distal fibula plates may be used in all pediatric subgroups (except neonates) and small stature adults. Distal radius plates may be used in adolescents (12-21 years of age).
Performance Data:
Performance of the ANTHEM™ Fracture System plates and screws were evaluated in accordance with ASTM F543, F382, and F2193. Engineering analysis and bending strength tests were conducted for the plates and screws, and pullout strength and insertion/removal torque tests were conducted for the screws. Performance data demonstrates substantial equivalence to the predicate devices. Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011.
Technological Characteristics:
ANTHEM™ implants have the same technological characteristics as the predicate devices including design, intended use, material composition, function, and range of sizes.
Basis of Substantial Equivalence:
The subject ANTHEM™ Fracture System has been found to be substantially equivalent to the predicate devices with respect to technical characteristics, performance, and intended use. The information provided within this premarket notification supports substantial equivalence to the predicate devices.
§ 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.