(48 days)
The system is intended for use in adult and pediatric (subpopulation: transitional adolescent B (18 years to <21 years) cases requiring stabilizations of mal-unions, non-unions, and osteotomies of long bones, as well as repair of closed and open fractures. The system is indicated for the fixation of long bone fractures including but not limited to fractures of the humerus, tibia, and femur, particularly in osteopenic bone.
The G3 ™ Active Plate ® Large Fragment System is a straight plate and locking screw system comprised of a variety of sizes to accommodate various patient anatomy and pathology. The plates and screws are intended to be used for long bone fracture fixation. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI) and silicone elastomer in the subject device. The screws are 5.0 mm diameter and come in lengths ranging from 14 to 145 mm. The plates range in size from 6 holes to 14 holes. The plates incorporate sliding elements, which are constrained within the plate and embedded in a silicone elastomer sheath that is bonded to both the plate and sliding element. Once locking screws are inserted, the active elements allow for independent controlled axial translation of the screws. All instruments are made from stainless steel.
The provided text describes a 510(k) premarket notification for the G3™ Active Plate® Large Fragment System, a medical device for bone fixation. However, it does not contain the specific detailed information typically found in a study proving the device meets particular acceptance criteria, especially for AI/ML device performance.
The document primarily focuses on establishing substantial equivalence to predicate devices based on intended use, material, geometry, and mechanical testing (stiffness, fatigue, pullout, torsion, torque, construct fatigue, and wear) according to ASTM F543 and ASTM F382. It also notes biocompatibility evaluation per ISO 10993-1.
Therefore, many of the requested elements for an AI/ML device's acceptance criteria and study cannot be extracted from this document, as it outlines a submission for a traditional mechanical medical device, not an AI/ML product.
I will fill in the table and address the questions to the best of my ability based on the provided text, indicating where information is not present.
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document describes mechanical performance testing to demonstrate substantial equivalence, rather than traditional "acceptance criteria" with specific thresholds for sensitivity, specificity, or other AI/ML metrics. The performance is assessed against predicate devices.
| Acceptance Criterion (implicitly by substantial equivalence) | Reported Device Performance |
|---|---|
| Mechanical Performance: | |
| Stiffness (per ASTM F543 & F382) | "demonstrated to be substantially equivalent in terms of construct stiffness performance when compared to the previously cleared Zimmer MotionLoc™ Screws for NCB® Locking Plate System" |
| Fatigue (per ASTM F543 & F382) | "G3™ Active Plate® Large Fragment System has demonstrated to be substantially equivalent to the Synthes LCP Plate (K05186; S.E. 9/8/2005) in construct fatigue testing." |
| Pullout (per ASTM F543) | "Mechanical testing, including... pullout... have been performed per ASTM F543 and ASTM F382 on the subject G3™ Active Plate® Large Fragment System, as well as the G3™ locking screws used within the system and the results have shown them to be substantially equivalent to the predicate plate and screw systems." (Specific quantitative equivalence not provided, only statement of substantial equivalence). |
| Torsion (per ASTM F543) | "Mechanical testing, including... torsion... have been performed per ASTM F543 and ASTM F382 on the subject G3™ Active Plate® Large Fragment System, as well as the G3™ locking screws used within the system and the results have shown them to be substantially equivalent to the predicate plate and screw systems." (Specific quantitative equivalence not provided, only statement of substantial equivalence). |
| Torque (per ASTM F543) | "Mechanical testing, including... torque... have been performed per ASTM F543 and ASTM F382 on the subject G3™ Active Plate® Large Fragment System, as well as the G3™ locking screws used within the system and the results have shown them to be substantially equivalent to the predicate plate and screw systems." (Specific quantitative equivalence not provided, only statement of substantial equivalence). |
| Construct Fatigue (per ASTM F382) | Covered under "Fatigue" above. |
| Wear (per applicable standards) | "Mechanical testing, including... wear have been performed... and the results have shown them to be substantially equivalent to the predicate plate and screw systems." (Specific quantitative equivalence not provided, only statement of substantial equivalence). |
| Biocompatibility (per ISO 10993-1) | "Biocompatibility of the G3™ Active Plate® Large Fragment System was evaluated per ISO 10993-1." (No specific results or acceptance criteria are detailed, only that it was evaluated). |
| Locking Screw Performance | "The subject G3™ Locking Screws have also demonstrated to be substantially equivalent to those in the previously cleared Zimmer Periarticular Locking Plate System (K040593; S.E. 04/12/2004) in terms of performance." |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document mentions "mechanical testing" and "construct fatigue testing" per ASTM standards, but does not provide details on the number of samples or specimens used for these tests.
- Data Provenance: Not applicable in the context of clinical data. The tests are in vitro mechanical tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This device is a mechanical implant, not an AI/ML diagnostic or image analysis device that would require expert-established ground truth from clinical data. The "ground truth" for mechanical testing is derived from standardized test methods and measurement equipment.
4. Adjudication method for the test set
- Not applicable. Adjudication methods are relevant for expert review of clinical data, not for in vitro 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
- No, an MRMC study was not done. This is a mechanical device, not an AI/ML diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a mechanical device, not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the performance testing is based on standardized mechanical testing methodologies (e.g., ASTM F543, ASTM F382) which provide quantitative measurements of properties like stiffness, fatigue life, pullout strength, etc. The performance is then compared against established predicate devices.
8. The sample size for the training set
- Not applicable. This document is for a mechanical device, not an AI/ML device that requires a training set of data.
9. How the ground truth for the training set was established
- Not applicable. This document is for a mechanical device, not an AI/ML device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's seal, which includes an abstract image of an eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the seal.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 26, 2014
Genesis Fracture Care, Incorporated % Ms. Christine Scifert Memphis Regulatory Consulting, LLC 3416 Roxee Run Cove Bartlett, Tennessee 38133
Re: K142938
Trade/Device Name: G3TM Active Plate® Large Fragment 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: October 8, 2014 Received: October 9, 2014
Dear Ms. Scifert:
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. Christine Scifert
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 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/Resourcesfor You/Industry/default.htm. 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 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 yours.
Vincent J. Devlin -S for Mark N. Melkerson Director Division of Orthopedic 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
G3TM Active Plate® Large Fragment System
Indications for Use (Describe)
The system is intended for use in adult and pediation: transitional adolescent B (18 years to <21 years) requiring stabilizations of mal-unions, and osteotomies of long bones, as well as repair of closed and open fractures. The system is indicated for the fixation of long bone fractures includes of the humerus, thia, and femur, particularly in osteopenic bone.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summary
G3™ Active Plate® Large Fragment System November 21, 2014
| Company: | Genesis Fracture Care, Inc.13568 SE 97th AveSuite 202Clackamas, OR 97015503-528-4048503-413-5216 (fax) |
|---|---|
| Primary Contact: | Christine Scifert |
| Company Contact: | Michael Bottlang |
| Trade Name: | G3 ™ Active Plate ® Large Fragment System |
| Common Name: | Plate, Fixation, BoneScrew, Fixation, Bone |
| Classification: | II |
| Regulation Number: | 888.3030 - Single/multiple component metallic bone fixation appliances and accessories888.3040 - Smooth or threaded metallic bone fixation fastener |
| Panel: | 87-Orthopedic |
| Product Code(s): | HRS, HWC |
| Device Description: | The G3 ™ Active Plate ® Large Fragment System is a straight plate and locking screw system comprised of a variety of sizes to accommodate various patient anatomy and pathology. The plates and screws are intended to be used for long bone fracture fixation. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI) and silicone elastomer in the subject device. The screws are 5.0 mm diameter and come in lengths ranging from 14 to 145 mm. The plates range in size from 6 holes to 14 holes. The plates incorporate sliding elements, which are constrained within the plate and |
embedded in a silicone elastomer sheath that is bonded to both the plate and
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sliding element. Once locking screws are inserted, the active elements allow for independent controlled axial translation of the screws. All instruments are made from stainless steel.
Indications for Use: The system is intended for use in adult and pediatric (subpopulation: transitional adolescent B (18 years to <21 years) cases requiring stabilizations of mal-unions, non-unions, and osteotomies of long bones, as well as repair of closed and open fractures. The system is indicated for the fixation of long bone fractures including but not limited to fractures of the humerus, tibia, and femur, particularly in osteopenic bone.
Substantial Equivalence: The subject components were demonstrated to be substantially
equivalent to the following plate and screw systems previously cleared by the FDA:
- Synthes 4.5mm LCP Reconstruction Plates (K051986, S.E. 09/08/2005)
- Smith & Nephew PERI-LOC Bone Plating and Screw System (K033669, S.E. 12/10/2003 and K083032, S.E. 01/07/2009)
- Zimmer MotionLoc™ Screws for NCB® Locking Plate system (K042695; S.E.10/29/2004 and K101696; S.E. 09/10/2010)
- Zimmer Periarticular Locking Plate System (K040593; S.E. 04/12/2004)
Additionally, Medisil Silicone Sheeting (K040042; S.E. 4/1/2004) was provided as a reference device for the silicone elastomer.
In addition to being substantially equivalent in terms of intended use, material, and geometry, the subject G3™ Active Plate® Large Fragment System has also demonstrated to be substantially equivalent in terms of construct stiffness performance when compared to the previously cleared Zimmer MotionLoc™ Screws for NCB® Locking Plate System (K042695; S.E.10/29/2004) with (K101696; S.E. 09/10/2010). The subject G3™ Locking Screws have also demonstrated to be substantially equivalent to those in the previously cleared Zimmer Periarticular Locking Plate System (K040593; S.E. 04/12/2004) in terms of performance. Finally, the G3™ Active Plate® Large Fragment System has demonstrated to be substantially equivalent to the Synthes LCP Plate (K05186; S.E. 9/8/2005) in construct fatigue testing.
| Subject of Present 510(k): | Predicate Devices | |
|---|---|---|
| G3™ Active Plate™ | ||
| Intended Use/ Indicationsfor Use | The G3™ Active Plate® LargeFragment System isintended for use in adult and | Inclusive |
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| pediatric cases requiringstabilizations od mal-unions,non-unions, andosteotomies of long bones,as well as repair of closedand open fractures, Thesystem is indicated for thefixation of long bonefractures including, but notlimited to, fractures of thehumerus, tibia, and femur,particularly in osteopenicbone. | ||
|---|---|---|
| Primary Material | Titanium | Titanium or Stainless Steel |
| Geometry and Dimensions | Plates: 6 - 14 holes; Lengths:145 mm - 305 mm | Plates: 2 - 24 holes; Lengths:56 mm – 444 mm |
| Locking Screws: Diameter:5.0 mm | Locking Screws: Diameter:4.0mm – 6.5 mm | |
| Lengths: 14 mm - 145 mm | Lengths: 10 mm - 130 mm | |
| Active feature (ifapplicable) | Sliding elements | Flexible screw (K101696) |
- Biocompatibility of the G3™ Active Plate® Large Fragment System was evaluated Performance Testing: per ISO 10993-1. Mechanical testing, including stiffness, fatigue, pullout, torsion, torque, construct fatigue and wear have been performed per ASTM F543 and ASTM F382 on the subject G3™ Active Plate® Large Fragment System, as well as the G3™ locking screws used within the system and the results have shown them to be substantially equivalent to the predicate plate and screw systems.
§ 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.