(111 days)
The Synthes Sternal Fixation System is intended for use in primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion.
The Synthes (USA) Titanium 2.4 mm Universal Locking Plates (12, 13 and 20 hole) are indicated for use in primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion.
The Synthes (USA) Sternal Fixation System consists of machined titanium plates, a quick-release pin and 3.0 mm locking screws. The plates utilize screw fixation to create the construct.
This submission pertains to the Synthes Sternal Fixation System - Modification to Surgical Technique (K093772). The provided documents are a 510(k) summary and an FDA approval letter. This type of submission generally focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than comprehensive performance studies with acceptance criteria for a new AI/software-based device.
Therefore, the requested information regarding acceptance criteria, study data, sample sizes, expert involvement, and ground truth establishment, which are typical for software-as-a-medical-device (SaMD) or AI-augmented device submissions, is not available in the provided documents.
The documents indicate that this is a modification to an existing sternal fixation system, and the primary demonstration is of substantial equivalence to existing predicate devices. This typically involves comparing design, materials, intended use, and potentially bench testing to ensure the modification does not raise new questions of safety or effectiveness.
Based on the provided text, the specific details for acceptance criteria and a study proving device meets acceptance criteria as typically understood for AI/software devices are not present. The summary states:
- Substantial Equivalence: "Documentation provided in this submission demonstrates the Synthes Sternal Fixation System - Modification to Surgical Technique to be substantially equivalent to other legally marketed devices."
This indicates that the "study" conducted was primarily a substantial equivalence comparison, not a performance study against specific acceptance criteria for a diagnostic or therapeutic output, as would be relevant for AI.
To directly answer your numbered points based only on the provided text:
- A table of acceptance criteria and the reported device performance: Not provided. The submission focuses on substantial equivalence to predicate devices, not on meeting specific performance metrics with acceptance criteria for a new function.
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided. Data related to human subject testing or algorithm performance is not included.
- 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/Not provided. Ground truth establishment as it pertains to AI/diagnostic performance is not relevant to this submission type.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/Not provided.
- 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 mechanical sternal fixation system, not an AI-assisted diagnostic or therapeutic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-based device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable/Not provided.
- The sample size for the training set: Not applicable. This device does not involve a training set for an algorithm.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document relates to a traditional medical device (sternal fixation system) and its modification, seeking clearance based on substantial equivalence. It does not provide the type of information requested for AI or software performance studies.
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K093772
Image /page/0/Picture/1 description: The image shows the logo for Synthes. The logo consists of a circular symbol on the left and the word "SYNTHES" in bold, sans-serif font on the right. There is a registered trademark symbol after the word "SYNTHES".
MAR 2 9 2010
| 3.0 | 510(k) Summary | Page 1 of 1 |
|---|---|---|
| ----- | ---------------- | ------------- |
| Sponsor: | Synthes1301 Goshen ParkwayWest Chester, PA 19380 |
|---|---|
| Contact: | Contact: Andrea M. Taskertasker.andrea@synthes.com(610) 719-6290 |
| Device Name: | Synthes Sternal Fixation System-Modification to Surgical Technique |
| Classification: | 888.3030 - Plate, Fixation, Bone, Non-Spinal, Metallic (HRS)888.3040 - Screw, Fixation, Bone, Non-Spinal, Metallic (HWC) |
| PredicateDevices: | Synthes Sternal Fixation SystemSynthes Sterile Sternal Fixation SystemEthicon Stainless Steel Suture Wire |
| DeviceDescription: | The Synthes (USA) Sternal Fixation System consists of machinedtitanium plates, a quick-release pin and 3.0 mm locking screws. Theplates utilize screw fixation to create the construct. |
| Intended Use: | The Synthes Sternal Fixation System is intended for use in primary orsecondary closure/repair of the sternum following sternotomy orfracture of the sternum to stabilize the sternum and promote fusion. |
| The Synthes (USA) Titanium 2.4 mm Universal Locking Plates (12,13 and 20 hole) are indicated for use in primary or secondaryclosure/repair of the sternum following sternotomy or fracture of thesternum to stabilize the sternum and promote fusion. | |
| ContraindicationsThe Synthes Titanium 2.4 mm Universal Locking Plates arecontraindicated for use in acute cardiac patients. | |
| SubstantialEquivalence: | Documentation provided in this submission demonstrates the SynthesSternal Fixation System - Modification to Surgical Technique to besubstantially equivalent to other legally marketed devices. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Synthes (USA) % Ms. Andrea M. Tasker 1301 Goshen Parkway West Chester, Pennsylvania 19380
MAR 2 9 2010
Re: K093772 Trade/Device Name: Synthes Sternal Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS. HWC
Dated: February 9, 2010 Received: February 16, 2010
Dear Ms. Tasker:
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 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 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.
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Page 2 - Ms. Andrea M. Tasker
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.
Barbara Buehler
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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2.0
Indications for Use
| 510(k) Number (if known): | K093772 |
|---|---|
| Device Name: | Synthes Sternal Fixation System |
| Indications for Use: | The Synthes Sternal Fixation System is intended for use in primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion.The Synthes (USA) Titanium 2.4 mm Universal Locking Plates (12, 13 and 20 hole) are indicated for use in primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion. |
| Contraindications | The Synthes Titanium 2.4 mm Universal Locking Plates are contraindicated for use in acute cardiac patients. |
| Prescription Use(Per 21 CFR 801.109) | XAND/OROver-The-Counter Use(21 CFR 807 Subpart C) |
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Set for murrence of CDRH, Office of Device Evaluation (ODE)
Division Sigh-Off)
Division of Surgical, Orthopedic, and Restorative Devices
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510(k) Number K093772
PAGE 86
§ 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.