(88 days)
The NCB Periprosthetic Femur Polyaxial Locking Plate System is indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones, including:
- · Periprosthetic fractures
- · Comminuted fractures
- · Supracondylar fractures
- · Fractures in osteopenic bone
- · Nonunions
- · Malunions
The NCB (Non-Contact Bridging) Periprosthetic Femur Polyaxial Locking Plate System is a line of polyaxial locking plates for the treatment of femur fractures, particularly of periprosthetic femur factures. It consists primarily of Proximal Femur Plates, Distal Femur Plates, and Curved Shaft Plates. The NCB technology allows for polyaxial screw placement (30° cone) with screw locking achieved with the use of locking caps that are threaded into the plate holes. In the locked mode the NCB Periprosthetic plate acts as an internal fixator without contact between the plate and the bone surface, reducing the risk of periosteal blood supply impairment. This Non-Contact Bridging concept can be specifically controlled through the use of 1, 2, or 3mm spacers, which are threaded into the plate holes prior to plate insertion. Plates, screws, blind screw inserts, spacers and locking caps are made of titanium alloy.
The provided document is a 510(k) summary for a medical device called the "NCB® Periprosthetic Femur Polyaxial Locking Plate System." It details the device's description, intended use, and a comparison to predicate devices, but does not describe a study involving acceptance criteria and device performance in the way typically associated with AI/software-as-a-medical-device (SaMD) clearances.
This document focuses on the mechanical and biocompatibility aspects of an implantable medical device, rather than a diagnostic or therapeutic AI algorithm. Therefore, many of the requested elements (like sample size for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable or not present in this type of submission.
Here's an attempt to address the request based on the available information, noting where information is not relevant or unavailable:
Acceptance Criteria and Study for NCB® Periprosthetic Femur Polyaxial Locking Plate System
The acceptance criteria for this device are demonstrated through mechanical performance testing and equivalency to previously cleared predicate devices. The study conducted is non-clinical performance testing.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria/Outcome Expectation | Reported Device Performance (as described) |
|---|---|---|
| Mechanical Strength/Performance | Device is safe and effective and substantially equivalent to predicate devices for intended use. | Plate testing/analysis performed included:- Construct fatigue - Proximal Femur Plate- Distal Femur Plate strength- Shaft Plate strength- NCB screw/Shaft Plate compression slot interface evaluation- Construct fatigue - Proximal Femur Plate with Cable and Cable ButtonSystem screws were tested to determine:- Starting load- Driving torque- Torque to failureThe "results of non-clinical (lab) performance testing demonstrate that the devices are safe and effective and substantially equivalent to the predicate devices." |
| Material Biocompatibility | Made of materials demonstrated to be safe for implantation. | Plates, screws, blind screw inserts, spacers and locking caps are made of titanium alloy. This is implicitly accepted as safe based on widespread use of titanium alloys in predicate devices and medical implants. |
| Intended Use Equivalence | Comparable to predicate devices in intended use. | "The NCB Periprosthetic Femur Polyaxial Locking Plate System is similar in intended use... to the predicate devices." |
| Sterility | Comparable to predicate devices in sterility. | "The NCB Periprosthetic Femur Polyaxial Locking Plate System is similar in... sterility... to the predicate devices." |
| Literature Support (Osteopenic Bone) | Use in osteopenic bone is substantiated. | "A literature review was conducted to substantiate the use of the proposed device in osteopenic bone." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the summary. For mechanical testing, the "sample size" would refer to the number of devices or components tested. The data provenance would be a lab setting, likely in the US or Switzerland (where the sponsor has offices). These would be prospective lab tests.
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 information is not applicable/provided. The "ground truth" for this device comes from engineering standards, mechanical testing results, and established material science. There isn't a human expert "ground truth" establishment in the context of diagnostic interpretation for this type of device. The expertise lies with the engineers and material scientists conducting and interpreting the lab tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. Adjudication methods are typically for subjective assessments (e.g., medical image interpretation). Mechanical testing results are objective measurements.
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 comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic tools, not for a bone fixation implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is a physical implantable device, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is based on engineering standards, mechanical material property data, fatigue testing, strength testing, and torque specifications. For the "use in osteopenic bone," a literature review served as the basis for substantiation. Substantial equivalence to predicate devices is also a key component of the "ground truth" for regulatory clearance.
8. The sample size for the training set
This information is not applicable/provided. This device does not involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
This information is not applicable. There is no "training set" for this device.
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K100111 (1/2)
Image /page/0/Picture/1 description: The image shows the logo for Zimmer. The logo consists of a large, bold letter "Z" inside of a circle. Below the circle is the word "zimmer" in a smaller, sans-serif font.
APR 1 2 2010
P.O. Box 708 Warsaw, IN 46581-0708 574 267-6131
Summary of Safety and Effectiveness
Sponsors: Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581-0708 Zimmer, GmbH SulzerAllee 8 Winterthur, Switzerland CH-8404 Contact Person: Anthony Francalancia RAC Senior Associate, Regulatory Affairs Telephone: (574) 372-4570 Fax: (574) 372-4605 Date: April 12, 2010 NCB® Periprosthetic Femur Polyaxial Locking Plate Trade Name: System Common Name: Locking Plate System Classification Name Plate, Fixation, Bone: Screw, Fixation, Bone and Reference: 21 CFR § 888.3030 and 888.3040 Predicate Devices: 4.5mm Locking Compression Plate (LCP) System with Expanded Indications, manufactured by Synthes, K082807, cleared January 13, 2009, and NCB® Plating System, K042695, cleared October 29, 2004. Device Description: The NCB (Non-Contact Bridging) Periprosthetic Femur Polyaxial Locking Plate System is a line of polyaxial locking plates for the treatment of femur fractures, particularly of periprosthetic femur factures. It consists primarily of Proximal Femur
Plates, Distal Femur Plates, and Curved Shaft Plates. The NCB technology allows for polyaxial screw placement (30° cone) with screw locking achieved with the use of locking caps that are
threaded into the plate holes. In the locked mode the NCB Periprosthetic plate acts as an internal fixator without contact between the plate and the bone
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K100111(2/2)
Page 2
Intended Use:
Comparison to Predicate Devices:
Performance Data (Nonclinical and/or Clinical):
surface, reducing the risk of periosteal blood supply impairment. This Non-Contact Bridging concept can be specifically controlled through the use of 1, 2, or 3mm spacers, which are threaded into the plate holes prior to plate insertion. Plates, screws, blind screw inserts, spacers and locking caps are made of titanium alloy.
The NCB Periprosthetic Femur Polyaxial Locking Plate System is indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones, including: Periprosthetic fractures, Comminuted fractures, Supracondylar fractures. Fractures in osteopenic bone, Nonunions, Malunions
The NCB Periprosthetic Femur Polyaxial Locking Plate System is similar in intended use, materials, sterility, and performance characteristics to the predicate devices.
Non-Clinical Performance and Conclusions:
The results of non-clinical (lab) performance testing demonstrate that the devices are safe and effective and substantially equivalent to the predicate devices. Plate testing/analysis performed included: construct fatigue-Proximal Femur Plate, Distal Femur Plate strength, Shaft Plate strength, NCB screw/Shaft Plate compression slot interface evaluation, and construct fatigue - Proximal Femur Plate with Cable and Cable Button. System screws were tested to determine starting load, driving torque and torque to failure.
A literature review was conducted to substantiate the use of the proposed device in osteopenic bone.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Zimmer, Inc. % Mr. Anthony Francalancia Senior Associate, Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708
APR 1 2 2010
Re: K100111
Trade/Device Name: NCB® Periprosthetic Femur Polyaxial Locking Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS, HWC Dated: January 12, 2010 Received: January 14, 2010
Dear Mr. Francalancia:
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. Iisting 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.
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Page 2 - Mr. Anthony Francalancia
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
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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Sincerely yours,
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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Indications for Use
510(k) Number (if known):
Device Name:
NCB® Periprosthetic Femur Polyaxial Locking Plate System
Indications for Use:
The NCB Periprosthetic Femur Polyaxial Locking Plate System is indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones, including:
- · Periprosthetic fractures
- · Comminuted fractures
- · Supracondylar fractures
- · Fractures in osteopenic bone
- · Nonunions
- · Malunions
Prescription Use _X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Smita for MXS
(Division Sign-Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K100111
Page 1 of 1
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§ 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.