(89 days)
The Synthes Variable Angle LCP Ankle Trauma System is intended for fixation of the ankle in adults and adolescents (12-21) in which the growth plates have fused, and particularly in osteopenic bone. Specifically, Medial and Anteromedial Distal Tibia Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia Distal Tibia T Plates and Distal Tibia L Plates are intended to buttress partial articular fractures and bone fragments of the distal tibia, and Lateral Distal Fibula Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal fibula.
The Synthes Variable Angle LCP Ankle Trauma System contains plates that are intended to treat fractures of the ankle, and includes multiple plate types to accommodate different fracture patterns and patient anatomy. Two new screw configurations are included in the Synthes Variable Angle LCP Ankle Trauma System; 2.7mm metaphyseal screws and 3.5mm VA Locking Screws. Specifically, the following plates and screws are included in the Synthes Variable Angle LCP Ankle Trauma System: • Medial and Anteromedial Distal Tibia Plates • Distal Tibia T Plates and Distal Tibia L Plates • Lateral Distal Fibula plate • 2.7mm Metaphyseal Screws • 3.5mm VA Locking Screws All of the plates will be offered in both stainless steel and titanium alloy (TAN), and in both sterile and non-sterile configurations. All of the plate configurations (with the exception of the Distal Tibia T plate, which is symmetrical), will be offered in left and right designs. The system accepts existing cortical and locking screws (i.e. K000684 and K043185) as well as new 3.5mm VA Locking Screws and 2.7mm Metaphyseal Screws, and allows for both dynamic compression and locking through Combi holes.
The provided text describes Synthes Variable Angle LCP Ankle Trauma System. This is a medical device and not an AI/ML algorithm. Therefore, many of the requested categories related to AI/ML performance and study design are not applicable.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance
For a medical implant like the Synthes Variable Angle LCP Ankle Trauma System, "acceptance criteria" are generally related to demonstrating substantial equivalence to predicate devices in terms of mechanical properties and biocompatibility. The summary details these as:
| Acceptance Criteria Category | Reported Device Performance (Synthes Variable Angle LCP Ankle Trauma System) |
|---|---|
| Mechanical Strength | - Shown to be at least as strong as predicate systems through engineering analysis, static strength, and fatigue strength testing. - New screws shown to be substantially equivalent to existing screws. |
| Biocompatibility/Materials | - Plates offered in stainless steel and titanium alloy (materials commonly used and accepted for bone fixation). |
| Design Characteristics | - Similar design characteristics to predicate Synthes Systems. |
| Indications for Use | - Similar indications for use to predicate Synthes Systems (fixation of ankle fractures, osteotomies, nonunions, malunions, and replantations in adults and adolescents with fused growth plates, particularly 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)
The information provided does not detail specific "test sets" in the context of clinical studies with human subjects for performance evaluation as would be done for an AI/ML device. The testing mentioned ("engineering analysis, static strength, and fatigue strength testing") refers to mechanical testing of the device components. The sample size for such mechanical tests would be the number of physical samples tested, but this is not provided in the 510(k) summary. The provenance would be the laboratory where the testing was conducted, but this is also not specified.
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 as there is no "ground truth" derived from human experts for this type of mechanical device submission. The substantial equivalence is based on engineering and material science principles.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no clinical adjudication mentioned.
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 is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this device, the "ground truth" for substantial equivalence is derived from:
- Established engineering principles (e.g., calculations of stress, strain).
- Material properties data for stainless steel and titanium alloys.
- Mechanical testing standards for orthopedic implants, which dictate how strength and fatigue are measured.
- Comparison to existing predicate devices and their known performance and safety profiles.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
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K12.0854
JUN 1 8 2012
| 510K Summary | |
|---|---|
| Sponsor: | SynthesAngela F. Lassandro1301 Goshen ParkwayWest Chester, PA 19380(610) 719-6854 |
| Device Name: | Synthes Variable Angle LCP Ankle Trauma System |
| Classification: | Classification: Class II, §888.3030, Single/multiple component metallic bonefixation appliances and accessories.Product Code: HRS, HWC |
| Predicate Device: | Synthes 4.5/3.5 LCP Metaphyseal Plates (K033805)Synthes 2.7/3.5 LCP Lateral Distal Fibula Plates (K083213 & K073460)Synthes One-Third Tubular Plates (K011335)3.5mm Cortex Screws (K112583)3.5 mm Locking Screws (K000684)Synthes 2.7mm VA Locking Screws (K100776)4.5mm VA Curved Condylar Plate Set (K110354)2.7/3.5mm VA-LCP Elbow System (K120070 and K120717) |
| DeviceDescription: | The Synthes Variable Angle LCP Ankle Trauma System contains plates that areintended to treat fractures of the ankle, and includes multiple plate types toaccommodate different fracture patterns and patient anatomy. Two new screwconfigurations are included in the Synthes Variable Angle LCP Ankle TraumaSystem; 2.7mm metaphyseal screws and 3.5mm VA Locking Screws.Specifically, the following plates and screws are included in the SynthesVariable Angle LCP Ankle Trauma System:• Medial and Anteromedial Distal Tibia Plates• Distal Tibia T Plates and Distal Tibia L Plates• Lateral Distal Fibula plate• 2.7mm Metaphyseal Screws• 3.5mm VA Locking ScrewsAll of the plates will be offered in both stainless steel and titanium alloy (TAN),and in both sterile and non-sterile configurations. All of the plate configurations(with the exception of the Distal Tibia T plate, which is symmetrical), will beoffered in left and right designs.The system accepts existing cortical and locking screws (i.e. K000684 andK043185) as well as new 3.5mm VA Locking Screws and 2.7mm MetaphysealScrews, and allows for both dynamic compression and locking through Combiholes. |
Page 112
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Date Prepared: May 23, 2012
与10k Summary
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K 120 854
| Intended Use: | The Synthes Variable Angle LCP Ankle Trauma System is intended for fixationof the ankle in adults and adolescents (12-21) in which the growth plates havefused, and particularly in osteopenic bone. Specifically, Medial and Anteromedial Distal Tibia Plates are intended for fixationof osteotomies, fractures, nonunions, malunions, and replantations ofbones and bone fragments of the diaphyseal and metaphyseal regionsof the distal tibia Distal Tibia T Plates and Distal Tibia L Plates are intended to buttresspartial articular fractures and bone fragments of the distal tibia, and Lateral Distal Fibula Plates are intended for fixation of osteotomies,fractures, nonunions, malunions, and replantations of bones and bonefragments of the diaphyseal and metaphyseal regions of the distalfibula. |
|---|---|
| SubstantialEquivalence: | Both the subject Synthes VA-LCP Ankle Trauma System and predicate SynthesSystems have similar indications, design characteristics, materials, andperformance characteristics. The subject system has been shown to be at least asstrong as the predicate systems through engineering analysis, static strength, andfatigue strength testing. Similarly, the new screws have been shown to besubstantially equivalent to existing screws. |
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Image /page/2/Picture/15 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular fashion around the symbol. The caduceus is depicted in black, and the text is also in black.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 1 8 2012
Synthes % Ms. Angela F. Lassandro 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K120854
Trade/Device Name: Synthes Variable Angle LCP Ankle Trauma 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: May 23, 2012 Received: May 25, 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
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Page 2 – Ms. Angela F. Lassandro
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.
ho mp
pto Rump Dr
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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Image /page/4/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a logo that appears to be a stylized representation of a person inside of a circle. The logo is also in black. There is a registered trademark symbol to the right of the word "SYNTHES".
4.0 - Indications for Use Statement
510(k) Number (if known):
120854
Device Name:
Synthes Variable Angle LCP Ankle Trauma System
Indications for Use:
The Synthes Variable Angle LCP Ankle Trauma System is intended for fixation of the ankle in adults and adolescents (12-21) in which the growth plates have fused, and particularly in osteopenic bone. Specifically,
- · Medial and Anteromedial Distal Tibia Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia,
- · Distal Tibia T Plates and Distal Tibia L Plates are intended to buttress partial articular fractures and bone fragments of the distal tibia, and
- · Lateral Distal Fibula Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal fibula.
Prescription Use (Per 21 CFR 801.109) 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)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K120854
§ 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.