(29 days)
The Synthes TomoFix™ Osteotomy System is intended for open and closed wedge osteotomies of the medial proximal tibia, lateral proximal tibia, medial and lateral distal femur, treatment of bone and joint deformities, fractures, and malalignment caused by injury or disease such as osteoarthritis.
The Synthes (USA) TomoFix™ Medial High Tibia Plate is a part of the Synthes TomoFix™ Osteotomy System which is a system consisting of titanium plates with locking and combination holes designed to provide stable fixation close to the knee.
The provided text is a 510(k) summary for the Synthes (USA) TomoFix™ Medial High Tibia Plate, Small. It describes a medical device, its classification, indications for use, and a statement of substantial equivalence to a predicate device. It explicitly states that preclinical testing was performed, but does not describe a clinical study or performance data of the device in a clinical setting against acceptance criteria.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment as these details are not present in the provided text.
Based on the information provided in the 510(k) summary:
- A table of acceptance criteria and the reported device performance: Not available. The document states "preclinical testing - including dynamic fatigue and static 3-point bend testing was performed comparing the proposed plate to the predicate plate and the results support substantial equivalence." It does not provide the specific acceptance criteria or the numerical results of these tests, nor does it describe clinical performance.
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for a clinical test set. The document refers to preclinical testing.
- 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, as no clinical test set or human-based ground truth establishment is described.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 device is a bone fixation plate, not an AI diagnostic tool that would involve human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a bone fixation plate, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable for a clinical test. Preclinical testing would use established engineering standards or comparisons to the predicate device to establish "ground truth" for mechanical properties.
- The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
- How the ground truth for the training set was established: Not applicable.
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K100676(pg 1/1)
3.0 510(k) Summary Page Synthes (USA) Sponsor: 1301 Goshen Parkway West Chester, PA 19380 APR - 8 2010 (610) 719-6604 Karl J. Nittinger Contact: Synthes (USA) 1301 Goshen Parkway West Chester, PA 19380 (610) 719-6941 Synthes (USA) TomoFix™ Medial High Tibia Plate, Small Device Name: Classification: Class II, §888.3030 - Single / multiple component metallic bone fixation appliance and accessories. HRS (Plate, Fixation, Bone) Classification Product Code: Synthes (USA) TomoFixTM Osteotomy System Predicate Devices: The Synthes (USA) TomoFix™ Medial High Tibia Plate is a part of Device the Synthes TomoFix™ Osteotomy System which is a system Description: consisting of titanium plates with locking and combination holes designed to provide stable fixation close to the knee. The Synthes (USA) TomoFix™ Osteotomy System is intended for Indications for open and closed wedge osteotomies of the medial proximal tibia, Use: lateral proximal tibia, medial and lateral distal femur, treatment of bone and joint deformities, fractures, and malalignment caused by injury or disease such as osteoarthritis. . Information presented supports the substantial equivalence of the Substantial TomoFix Medial High Tibia Plate, Small to the predicate device. The Equivalence: proposed plate has the same indications for use, is similar in shape/design, incorporates the same fundamental product technology and is composed of the same materials. Additionally, preclinical testing - including dynamic fatigue and static 3-point bend testing was performed comparing the proposed plate to the predicate plate and the results support substantial equivalence.
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right. The eagle is composed of three thick, curved lines, and below it are three wavy lines that suggest water or movement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
APR - 8 2010
Synthes (USA) % Karl J. Nittinger 1301 Goshen Parkway West Chester, PA 19380
Re: K100676
Trade/Device Name: Synthes (USA) TomoFix™ Medial High Tibia Plate, Small Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliance and accessories Regulatory Class: Class II Product Code: HRS Dated: February 18, 2010 Received: March 10, 2010
Dear Mr. Nittinger:
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 marked in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendmonts, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Dr to 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, inst a of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract and warranties. We remind you, however, that device labeling must be truthful and not midler
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 devine 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 not 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 – Mr. Karl J. Nittinger
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 yours,
Sincerely yours,
Mark M. Mulkerner
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
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name:
2.0
Synthes (USA) TomoFix™ Medial High Tibia Plate, Small
Indications for Use:
The Synthes TomoFix™ Osteotomy System is intended for open and closed wedge osteotomies of the medial proximal tibia, lateral proximal tibia, medial and lateral distal femur, treatment of bone and joint deformities, fractures, and malalignment caused by injury or disease such as osteoarthritis.
Prescription Use X (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)
Soutte for mxm
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K100676
§ 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.