(133 days)
The Contours Lapidus Plating System is intended for revision procedures and joint fusion in the small bones of the foot.
The Contours Lapidus Plating System consists of bone plates, screws and manual, orthopedic, surgical instruments. The plates (left and right versions) are low-profile and anatomically contoured for the 1st metatarsal and cuneiform. Each plate has a trapezoidal screw hole geometry with three angled, threaded holes at both the distal and proximal ends as well as a compression hole for intraoperative compression across the joint. The Contours Lapidus plate and bone screws are made from titanium alloy conforming to ASTM F136.
The provided text describes a 510(k) summary for the "Contours Lapidus Plating System," a bone plate device. The information details the device's technical characteristics, indications for use, and a statement about biomechanical testing and substantial equivalence to a predicate device.
However, the document does NOT contain specific acceptance criteria or the detailed study results that prove the device meets those criteria in a format applicable to evaluating AI/ML-based medical devices. The document focuses on demonstrating substantial equivalence to a predicate device through material characterization and biomechanical testing of mechanical properties, not performance in terms of diagnostic accuracy or clinical outcomes in a statistical sense that would involve sample sizes for testing, expert ground truth, or comparative effectiveness studies.
The provided information is for a conventional medical device (bone plate), not an AI/ML device. Therefore, many of the requested categories (like sample size for test/training sets, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, etc.) are not applicable to this type of submission.
Here's a breakdown of the relevant information provided, and where the requested AI/ML specific information is absent:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" in terms of performance metrics like sensitivity, specificity, or accuracy that would be typical for an AI/ML device. Instead, it speaks to meeting "testing requirements" and performing "as well as the predicate device" through biomechanical testing.
| Acceptance Criteria (Implied from text) | Reported Device Performance |
|---|---|
| Mechanical properties (bending strength, bending stiffness, fatigue life, screw torque) sufficient for intended use. | The results of the testing demonstrated the Contours Lapidus Plating System to meet or exceed all testing requirements. |
| Perform as well as the predicate device (Darco Locking Plate System). | The results of the testing demonstrated the Contours Lapidus Plating System to perform as well as the predicate device. Substantial equivalence is based upon design, dimension, material characterization, and biomechanical testing of the device in comparison to the predicate. |
Regarding the Study:
The study referenced is "Biomechanical Testing" which included:
- Bending strength
- Bending stiffness
- Fatigue life
- Screw torque
- Cadaveric functional testing
The purpose of this testing was to demonstrate:
- The Contours Lapidus Plating System has the mechanical properties necessary to perform its intended use.
- The device performs as well as the predicate device (Darco® Locking Plate System: K061808).
The following information is NOT available or NOT APPLICABLE from the provided text, as it pertains to AI/ML device evaluations:
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not Applicable. This device is a bone plate, and the "testing" refers to mechanical and cadaveric biomechanical tests, not the statistical evaluation of an algorithm's performance on a dataset 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)
- Not Applicable. Ground truth for mechanical testing is based on physical measurements and engineering specifications, not expert interpretation of medical images or clinical data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. See point 3.
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 image-reading AI device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. There is no algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For biomechanical testing, the "ground truth" would be the measured physical properties and performance against established engineering standards or direct comparison to the predicate device under specific test conditions.
8. The sample size for the training set
- Not Applicable. There is no training set as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not Applicable. There is no training set.
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510(k) SUMMARY
DEC 1 5 2010
| Summary Date: | December 4, 2010 |
|---|---|
| Submitter Data: | Orthofix Inc.1720 Bray Central DriveMcKinney, TX 75609214-937-2000214-937-2736 (fax) |
| Primary Contact: | Darla Chewdarlachew@orthofix.com |
| Device Trade Name: | Contours Lapidus Plating System |
| Common Name: | bone plate |
| Classification Name: | Single/multiple component metallic bone fixation appliances andaccessories. (21 CFR Parts 888.3030 |
| Product Code: | HRS |
| Legally MarketedPredicate Device: | Darco ® Locking Plate System: K061808 / August 17, 2006 |
| Device Description: | The Contours Lapidus Plating System consists of bone plates,screws and manual, orthopedic, surgical instruments. The plates(left and right versions) are low-profile and anatomically contouredfor the 1st metatarsal and cuneiform. Each plate has a trapezoidalscrew hole geometry with three angled, threaded holes at both thedistal and proximal ends as well as a compression hole forintraoperative compression across the joint. The Contours Lapidusplate and bone screws are made from titanium alloy conforming toASTM F136. |
| Indications for Use: | The Contours Lapidus Plating System is intended for revisionprocedures and joint fusion in the small bones of the foot. |
| BiomechanicalTesting: | In order to demonstrate that the Contours Lapidus Plating Systemhas the mechanical properties necessary to perform its intendeduse and to perform as well as the predicate device, Orthofix hasconducted mechanical and functional testing of the ContoursLapidus Plating System. This testing includes bending strength,bending stiffness, fatigue life, screw torque and cadavericfunctional testing. The results of the testing demonstrated theContours Lapidus Plating System to meet or exceed all testingrequirements and to perform as well as the predicate device. |
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Technological Characteristics:
The Contours Lapidus Plating System is considered to be substantially equivalent in design, intended use and material to the predicate device. However, there are certain design differences, but these do not raise new questions regarding safety and effectiveness. Refer to the Table of Technological Characteristics for a summary.
| Features | Contours Lapidus Plating System |
|---|---|
| Indications for Use | The Contours Lapidus Plating System is indicated for revisionprocedures and joint fusion in the small bones of the foot. |
| Plate/Screw Material | Implant grade Titanium (Ti6A14V ELI) |
| Plate Size | 50mm x 16mm x 2mm(left and right versions) |
| Plate Geometry | Low-profile, anatomically shaped for 1st metatarsal and cuneiformbones. |
| Fixation Method,Screw Holes | Trapezoidal screw hole placement. Three in proximal end, three indistal end plus compression hole. |
| Screw Type | Low profile, locking, non-locking and compression |
| Screw Length | Locking and non-locking screws: 12mm to 32mm lengths (in 2mmincrements); compression screws are offered in sizes ranging from16mm to 20mm lengths (in 2mm increments), 25mm to 40mm lengthsin 5mm increments, and 42mm to 50mm lengths (in 2 mm increments) |
Sterilization:
The Contours Lapidus Plating System components are supplied NON-STERILE and require sterilization prior to use.
Substantial Equivalence:
Substantial equivalence is based upon design, dimension, material characterization, and biomechanical testing of thre device in companson to the predicate. The Contours Lapidus Plating System is substantially equivalent in design and function to the Darco Locking Plate System which was cleared under K061808 / August 17, 2006.
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Image /page/2/Picture/1 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 logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DEC 1 5 2010
Orthofix, Inc. % Ms. Mary E. Biggers, RAC Regulatory Affairs Consultant 1720 Bray Central Drive McKinney, Texas 75069
Re: K102201
Trade/Device Name: Contours Lapidus Plating System (bone plate) Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: December 4, 2010 Received: December 8, 2010
Dear Ms. Biggers:
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. Mary E. Biggers, RAC
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/ucm11.5809.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 yours,
Ais B. Rto
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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Indication for Use Statement
Page ___ of
510(k) Number (if known):
Device Name:
Contours Lapidus Plating System (bone plate)
Indications for Use:
The Contours Lapidus Plating System is intended for revision procedures and joint fusion in the small bones of the foot.
Prescription Use: (Per 21 CFR 801.109)
Over-The-Counter (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Or
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) for M. Mellekson
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K102201
§ 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.