(94 days)
Synthes Large External Fixation Clamps - MR Safe are indicated for use in construction of an external fixation frame for treatment of long bone and pelvic fractures that require external fixation. Specifically, the Synthes MR Safe Large External Fixation Clamps and their accessories are intended for: Stabilization of open or closed fractures with soft tissue injuries; Polytrauma; Vertically stable pelvic fractures or as a treatment adjunct for vertically unstable pelvic fractures; Arthrodesis and osteotomies with soft tissue problems; Failures of total joints; Neutralization of fractures stabilized with limited internal fixation; Non-unions/septic non-unions; Intraoperative reduction/stabilization tool to assist with indirect reduction; Unilateral rectilinear bone segment transport or leg lengthening
Synthes MR Safe Large External Fixation Clamps are components of an external fixation frame that form a construct intended to treat long bone and pelvic fractures. They are all made from non-magnetic materials and are intended for use in the MR environment. Frame components for these MR Safe devices are designed for use with Synthes Ø11.0 mm carbon fiber rods and Synthes Schanz screws in diameters of 4.0 - 6.0 mm.
The provided document is a 510(k) Summary for a medical device (Synthes Large External Fixation Clamps - MR Safe) seeking clearance from the FDA. It does not contain information about acceptance criteria or specific studies proving the device meets those criteria in the context of algorithm performance evaluation.
This document focuses on the mechanical and MRI safety aspects of the device, which are evaluated through different types of testing (e.g., material testing, MRI compatibility assessments) rather than clinical studies with human readers or ground truth established by experts as would be the case for an AI/algorithm-based device.
Therefore, I cannot provide the requested information from this document because it is not relevant to the type of performance evaluation typically associated with acceptance criteria for AI or algorithm-driven medical devices.
Here's why and what kind of information is present instead:
- Device Type: The device is a "Large External Fixation Clamp - MR Safe," which is a physical, non-electronic, non-AI medical implant/component.
- Approval Basis: FDA clearance for such devices is primarily based on demonstrating substantial equivalence to a previously legally marketed predicate device. This involves comparing design, materials, indications for use, and performance claims.
- "Performance" in this context: Refers to mechanical properties (e.g., strength, durability) and MRI safety (e.g., magnetic field interactions, RF heating, image artifact). These are typically assessed through bench testing and simulations, not human reader studies or algorithm performance metrics like AUC, sensitivity, specificity.
To directly answer your request based on the lack of relevant information in the provided text:
- Table of acceptance criteria and reported device performance: Not applicable/provided in the context of AI/algorithm performance. The document describes the device and its intended use but does not present a table of quantitative performance metrics against acceptance criteria that would apply to an AI system. The performance described is its MR-safe property, which is a design characteristic.
- Sample size for the test set and data provenance: Not applicable. There is no test set of medical images or patient data to evaluate an algorithm.
- Number of experts used to establish the ground truth for the test set and qualifications: Not applicable, as there is no algorithm requiring ground truth annotation from experts.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This type of study is for evaluating human performance improvement with AI assistance, which is not relevant to a physical external fixation clamp.
- Standalone (algorithm only) performance study: Not applicable. The device is a physical clamp, not an algorithm.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable. There is no algorithm to train.
- How the ground truth for the training set was established: Not applicable.
The document states that the device is "MR Safe" and lists materials (Stainless steel, titanium alloy, cobalt alloy). Its performance evaluation would revolve around demonstrating that these materials and the device design do not pose risks in an MRI environment (e.g., excessive heating, strong magnetic attraction, significant image artifact) and that the clamp functions mechanically as intended. This type of evaluation is fundamentally different from that of an AI/ML algorithm.
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AUG - 8 2003
:
3.0
K031428
______________________________________________________________________________________________________________________________________________________________________________ Page
| 510(k) Summary | Page 1 of 1 |
|---|---|
| Sponsor: | Synthes (USA)1690 Russell RoadPaoli, PA 19301(610) 647-9700 |
| Device Name: | Synthes Large External Fixation Clamps - MR Safe:Synthes Multi-Pin Clamps, (four and six position) - MR Safe Synthes Rod Attachment for the Multi-Pin Clamp - MR Safe Synthes Tube-to-Tube Clamp - MR Safe Synthes Open Adjustable Clamp - MR Safe |
| Classification: | Class II, 21 CFR §888.3030 - Single/multiple component bone fixationappliances and accessories. |
| Predicate Devices: | Synthes Large External Fixation Clamps:Synthes Universal Clamp, (four and six position), and Rod Attachment Synthes Tube-to-Tube Clamp Synthes Adjustable Clamp |
| Device Description: | Synthes MR Safe Large External Fixation Clamps are components of anexternal fixation frame that form a construct intended to treat long bone andpelvic fractures. They are all made from non-magnetic materials and areintended for use in the MR environment. Frame components for these MR Safedevices are designed for use with Synthes Ø11.0 mm carbon fiber rods andSynthes Schanz screws in diameters of 4.0 - 6.0 mm. |
| Intended Use: | Synthes Large External Fixation Clamps - MR Safe are indicated for use inconstruction of an external fixation frame for treatment of long bone and pelvicfractures that require external fixation. Specifically, the Synthes MR Safe LargeExternal Fixation Clamps and their accessories are intended for:Stabilization of open or closed fractures with soft tissue injuries; Polytrauma; Vertically stable pelvic fractures or as a treatment adjunct for vertically unstable pelvic fractures; Arthrodesis and osteotomies with soft tissue problems; Failures of total joints; Neutralization of fractures stabilized with limited internal fixation; Non-unions/septic non-unions; Intraoperative reduction/stabilization tool to assist with indirect reduction; Unilateral rectilinear bone segment transport or leg lengthening. |
| Material: | Stainless steel, titanium alloy and cobalt alloy |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is a stylized image of an eagle with three lines representing its wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 8 2003
Ms. Bonnie J. Smith Senior Regulatory Affairs Associate Synthes (USA) 1690 Russell Road Paoli, PA 19301
Re: K031428
Trade/Device Name: Synthes Large External Fixation Clamps - Magnetic Resonance Safe Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component bone fixation applicances and accessories Regulatory Class: II Product Code: LXT Dated: April 30, 2003 Received: May 12, 2003
Dear Ms. Smith:
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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Page 2 - Ms. Bonnie J. Smith
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 (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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2.0 Indications for Use Statement
| Page | 1 | of | 1 | |
|---|---|---|---|---|
| 510(k) Number (if known): | K031428 | |||
| Device Name: | Synthes (USA) Large External Fixation Clamps – MR Safe | |||
| INDICATIONS: | Synthes Large External Fixation Clamps - MR Safe are indicated for use in construction of an external fixation frame for treatment of long bone and pelvic fractures that require external fixation. Specifically, the Synthes MR Safe Large External Fixation Clamps and their accessories are intended for: Stabilization of open or closed fractures with soft tissue injuries;Polytrauma;Vertically stable pelvic fractures or as a treatment adjunct for vertically unstable pelvic fractures;Arthrodesis and osteotomies with soft tissue problems;Failures of total joints;Neutralization of fractures stabilized with limited internal fixation;Non-unions/septic non-unions;Intraoperative reduction/stabilization tool to assist with indirect reduction;Unilateral rectilinear bone segment transport or leg lengthening | |||
| (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) |
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | |
|---|---|
| (Per 21 CFR 801.109) |
OR
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
K031428 510/k) Numher
§ 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.