(37 days)
The Synthes LCP Proximal Tibia System is intended for treatment of nonunions, malunions, osteopenic bone, tibial osteotomies (4.5mm plate only), and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic, and fractures with associated shaft fractures.
The LCP Proximal Tibia Plates are contoured to match the anatomy of the proximal tibia with a limited contact low profile design. These are plates designed for either the right or left tibia in a variety of shaft lengths. The plates have overall lengths ranging from 298 mm to 370 mm and shaft holes ranging from 16 to 20 holes.
The provided document is a 510(k) summary for the Synthes LCP Proximal Tibia Plates Line Extension, followed by the FDA's clearance letter and indications for use. This document describes a medical device related to bone fixation, specifically plates for the proximal tibia.
The request asks for information typically found in studies evaluating AI/ML-driven medical devices or diagnostic tools. This document, however, is for a traditional, non-software medical device (bone plates). Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI/ML evaluation as requested are not directly applicable here.
For a traditional device like this, "acceptance criteria" are usually based on mechanical and material properties, biocompatibility, and sterilization effectiveness, which are typically demonstrated through engineering testing, material characterization, and sometimes animal or cadaver studies, rather than clinical efficacy studies with human experts establishing ground truth or MRMC studies.
Here's a breakdown of why this document does not contain the requested information in the AI/ML context:
- AI/ML Concepts are Irrelevant: The device (Synthes LCP Proximal Tibia Plates Line Extension) is a physical, metallic bone fixation plate. It does not involve any algorithms, software, or AI/ML components for diagnosis, prediction, or image analysis.
- No Performance Metrics like Sensitivity/Specificity: The document describes the device's physical characteristics (contoured to anatomy, limited contact, low profile, various lengths and hole counts) and its intended use (treatment of nonunions, malunions, osteotomies, and various fractures). There are no "performance metrics" in the sense of accuracy, sensitivity, specificity, or AUC that would be generated by an AI/ML model.
- No "Ground Truth" or "Experts": Since there's no diagnostic or predictive output, there's no need for experts to establish a "ground truth" for a test set. The efficacy of bone plates is determined by surgical outcomes, bone healing, and mechanical stability, not by expert interpretation of AI output.
- No Training or Test Sets: As there's no AI/ML model, there are no training or test datasets, no sample sizes for these sets, and no data provenance in that context.
- No MRMC or Standalone Studies: Multi-Reader Multi-Case (MRMC) comparative effectiveness studies are used for evaluating diagnostic performance with human readers. Standalone performance is for evaluating an AI algorithm's performance without human intervention. Neither is applicable to a bone plate.
Therefore, I cannot provide the requested information because the provided document does not describe an AI/ML medical device and thus does not contain the types of acceptance criteria or study methodologies pertinent to AI/ML evaluation.
The "study" that proves this device meets its "acceptance criteria" is implicitly the battery of engineering tests (e.g., fatigue testing, static strength testing), material analyses, biocompatibility assessments, and potentially cadaveric or animal studies that would have been conducted by Synthes to demonstrate that the plates are safe, effective, and perform as intended for their indicated uses. These studies are typically referenced in the full 510(k) submission but are not detailed in this summary document. The FDA's clearance (K052390) indicates that Synthes successfully demonstrated substantial equivalence to a predicate device, implying these foundational tests were satisfactory.
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OCT 7 - 2005
3.0 510(k) Summary
Page _________ of ______ of __________________________________________________________________________________________________________________________________________________
| Sponsor: | Synthes (USA)1302 Wrights Lane EastWest Chester, PA 19380(610) 719-5000 |
|---|---|
| Device Name: | Synthes LCP Proximal Tibia Plates Line Extension |
| Classification: | 21 CFR 888.3030: Plate, Fixation, Bone, Non-spinal, metallic |
| Predicate Devices: | Synthes LCP Proximal Tibia Plates |
| Device Description: | The LCP Proximal Tibia Plates are contoured to match theanatomy of the proximal tibia with a limited contact low profiledesign. These are plates designed for either the right or left tibia ina variety of shaft lengths. The plates have overall lengths rangingfrom 298 mm to 370 mm and shaft holes ranging from 16 to 20holes. |
| Intended Use: | The Synthes LCP Proximal Tibia System is intended for treatmentof nonunions, malunions, osteopenic bone, tibial osteotomies(4.5mm plate only), and fractures of the proximal tibia, includingsimple, comminuted, lateral wedge, depression, medial wedge,bicondylar combination of lateral wedge and depression,periprosthetic, and fractures with associated shaft fractures. |
| SubstantialEquivalence: | Information presented supports substantial equivalence. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features an eagle-like emblem with three stylized, curved lines representing the department's mission. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the emblem.
Public Health Service
OCT 7 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lisa M. Boyle Regulatory Specialist Synthes (USA) 1302 Wrights Lane East West Chester, Pennsylvania 19380
Re: K052390
Trade/Device Name: Synthes (USA) Proximal Tibia Plate Line Extension Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: August 29, 2005 Received: August 30, 2005
Dear Ms. Boyle:
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 such 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); 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.
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
2
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological 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:
2.0
Synthes (USA) Proximal Tibia Plate Line Extension
Indications for Use:
The Synthes LCP Proximal Tibia System is intended for treatment of nonunions, malunions, The Bylittes DOF Tronimal Ticli o (4.5mm plate only), and fractures of the proximal tibia, ostcopcure one, tronal ostoconnes ( "151122 p.depression, medial wedge, bicondylar combination moluding simple, comminuted, laterial bstractic, and fractures with associated shaft fractures.
X 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-OII)
Division of General, Restorative, and Neurological Devices
510(k) Number_Ko 5 23919
§ 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.