(72 days)
The Synthes Variable Angle LCP Elbow System is intended for fixation of fractures of the distal humerus, olecranon and ulna in adults and adolescents (12-21) in which the growth plates have fused. Specifically,
- Distal humerus plates are indicated for intra-articular fractures, comminuted supracondylar fractures, osteotomies, malunions and non-unions of the distal humerus.
- Olecranon and Proximal ulna plates are indicated for fractures, osteotomies, malunions and non-unions of the olecranon and proximal ulna.
The Synthes Variable Angle LCP Elbow System contains plates intended to treat fractures of the distal humerus and proximal ulna. A variety of plate configurations are included in the system to allow for fixation of multiple fracture patterns. Specifically, the system includes several plate configurations for fixation of the distal humerus which are intended to be used in a two-plate construct where plates are positioned medially and laterally. Additionally, the system includes plates for fixation of the olecranon and proximal ulna. In its entirety, the following plate types are included in the system:
• Medial Distal Humerus Plate
• Lateral Distal Humerus Plate
• Olecranon Plate
• Proximal Olecranon Plate
• Extra-articular Proximal Ulna Plate
The system accepts existing cortical and locking screws as well as new metaphyseal screws, and allows for both dynamic compression and locking through Combi holes. The plates are universally designed for both left and right use and will be offered in both stainless steel and titanium.
This document describes the Synthes Variable Angle LCP Elbow System, a medical device for fixing elbow and ulna fractures. The information provided is a 510(k) summary and an FDA clearance letter. It is not a study demonstrating the device meets acceptance criteria related to software or AI.
Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth for an AI/software device cannot be extracted from this document. This submission pertains to a traditional medical device (bone fixation plates and screws) and primarily relies on mechanical performance testing and substantial equivalence to predicate devices.
However, I can provide what information is available based on the document's content:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantified acceptance criteria (e.g., specific thresholds for strength or fatigue life) nor does it report detailed performance results in the way an AI/software study would. Instead, it states:
| Criterion | Reported Device Performance |
|---|---|
| Material & Design | "Both the subject Synthes VA Elbow System and predicate Synthes 3.5mm LCP Elbow System and Small Fragment System have similar indications, design characteristics, materials..." |
| Mechanical Performance | "Static and fatigue strength testing, as well as engineering strength analyses, were completed for the plates included in the Synthes Variable Angle LCP Elbow System, demonstrating equal to or greater strength in comparison to the predicate devices and constructs." (This implies the acceptance criterion was "equal to or greater strength" than the predicate devices, but no specific values are given.) |
| Intended Use Equivalence | "similar indications" to predicate devices. |
| Classification Equivalence | Class II, §888.3030, Single/multiple component metallic bone fixation appliances and accessories. Product Code: HRS, HWC (This confirms it fits the same regulatory classification as the predicate). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable and not provided in the document, as it describes mechanical testing of physical implants, not a data-driven AI/software study. "Test set" in this context would refer to the physical samples of the device tested, but their number is not specified, nor is the origin of "data" in the sense of patient data.
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 is not applicable. The "ground truth" for this type of device is established through engineering and biomechanical principles, material science, and testing standards, not through expert consensus on medical images or clinical outcomes in the same way as an AI diagnostic tool.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept is for clinical or image-based ground truth establishment, not mechanical testing.
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
Not applicable. This document is for a bone fixation system and does not involve AI or human "readers" or diagnostic tasks.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is based on biomechanical engineering principles and testing standards. The company performed "static and fatigue strength testing, as well as engineering strength analyses," comparing the results to predicate devices. This implies that the 'truth' is defined by established mechanical thresholds and the performance of previously cleared devices.
8. The sample size for the training set
Not applicable. This is not an AI/software device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/software device that requires a training set.
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MAR 2 1 2012
510(k) Summary
Date Prepared: March 19, 2012
| Sponsor: | SynthesAngela F. Lassandro.1301 Goshen ParkwayWest Chester, PA19380(610) 719-6854 |
|---|---|
| Device Name: | Synthes Variable Angle LCP Elbow System |
| Classification: | Classification:Class II, §888.3030, Single/multiple component metallic bonefixation appliances and accessories. |
| Predicate Device: | Product Code: HRS, HWCSynthes 3.5mm LCP Elbow System (K033995)Synthes Small Fragment System (K000684, K011335)Synthes 2.4 mm / 2.7 mm VA-LCP Forefoot /Midfoot System (K100776) |
| DeviceDescription: | The Synthes Variable Angle LCP Elbow System contains plates intended to treatfractures of the distal humerus and proximal ulna. A variety of plateconfigurations are included in the system to allow for fixation of multiplefracture patterns. Specifically, the system includes several plate configurationsfor fixation of the distal humerus which are intended to be used in a two-plateconstruct where plates are positioned medially and laterally. Additionally, thesystem includes plates for fixation of the olecranon and proximal ulna. In itsentirety, the following plate types are included in the system:• Medial Distal Humerus Plate• Lateral Distal Humerus Plate• Olecranon Plate• Proximal Olecranon Plate• Extra-articular Proximal Ulna PlateThe system accepts existing cortical and locking screws as well as newmetaphyseal screws, and allows for both dynamic compression and lockingthrough Combi holes. The plates are universally designed for both left and rightuse and will be offered in both stainless steel and titanium. |
| Intended Use: | The Synthes Variable Angle LCP Elbow System is intended for fixation offractures of the distal humerus, olecranon and ulna in adults and adolescents (12-21) in which the growth plates have fused. Specifically,• Distal humerus plates are indicated for intra-articular fractures,comminuted supracondylar fractures, osteotomies, malunions andnon-unions of the distal humerus.• Olecranon and Proximal ulna plates are indicated for fractures,osteotomies, malunions and non-unions of the olecranon and proximalulna. |
| SubstantialEquivalence: | Both the subject Synthes VA Elbow System and predicate Synthes3.5mm LCPElbow System and Small Fragment System have similar indications, designcharacteristics, materials, and performance characteristics. Static and fatiguestrength testing, as well as engineering strength analyses, were completed for theplates included in the Synthes Variable Angle LCP Elbow System,demonstrating equal to or greater strength in comparison to the predicate devicesand constructs |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image contains the words "Public Health Service" in a simple, sans-serif font. The text is arranged vertically, with "Public Health" on the first line and "Service" on the second line. The words are in a dark color, likely black or a dark shade of gray, against a light background.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR 2 1 2012
Synthes · % Ms. Angela F. Lassandro 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K120070
Trade/Device Name: Synthes Variable Angle LCP Elbow System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Product Code: HRS, HWC Dated: January 6, 2012 Received: January 10, 2012
Dear Ms. Lassandro:
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 - Ms. Angela F. Lassandro
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/ResourcesforYou/Industry/default.htm.
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 Statement
510(k) Number (if known):
/20070
Device Name:
Synthes Variable Angle LCP Elbow System
Indications for Use:
The Synthes Variable Angle LCP Elbow System is intended for fixation of fractures of the distal humerus, olecranon and ulna in adults and adolescents (12-21) in which the growth plates have fused. Specifically,
- · Distal humerus plates are indicated for intra-articular fractures, comminuted supracondylar fractures, osteotomies, malunions and non-unions of the distal humerus.
- · Olecranon and Proximal ulna plates are indicated for fractures, osteotomies, malunions and non-unions of the olecranon and proximal ulna.
X Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Signature
Dirision Sien-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K120070
§ 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.