(87 days)
The Synthes Pilon Plate is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal tibia.
The Synthes Pilon Plate is a metal plate that offers screw to plate locking designed for various fracture modes of the distal end of the tibia.
The provided document is a 510(k) premarket notification for the Synthes Pilon Plate, a medical device for bone fixation. It does not contain information about acceptance criteria or a study proving the device meets said criteria in the context of an AI/algorithm-based diagnostic or predictive tool.
The document primarily focuses on establishing "substantial equivalence" of the Synthes Pilon Plate to existing legally marketed devices. This process, common for Class II medical devices, means demonstrating that the new device is as safe and effective as a predicate device already on the market. It does this by comparing material, design, indications for use, and mechanical properties (though mechanical testing details are not provided in these specific excerpts).
Therefore, I cannot fulfill your request for the specific points related to acceptance criteria, device performance from a study, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance. These concepts are relevant to the evaluation of AI or diagnostic devices, not primarily to the substantial equivalence review of a bone fixation plate.
Here's what I can extract from the provided text, recognizing it doesn't fit your AI-centric framework:
1. Table of "Acceptance Criteria" and "Reported Device Performance":
- Acceptance Criteria (Implicit for 510(k) Substantial Equivalence): The device must be as safe and effective as a legally marketed predicate device. This is determined by comparing intended use, technological characteristics, and performance data (mechanical, biocompatibility, etc.).
- Reported Device Performance (from summary):
- Intended Use: Fixation of complex intra- and extra-articular fractures and osteotomies of the distal tibia.
- Design: Metal plate offering screw-to-plate locking for various fracture modes of the distal end of the tibia.
- Materials: Stainless Steel or Titanium.
- Equivalence: Documentation was provided which demonstrated the Synthes Pilon Plate to be substantially equivalent to other legally marketed devices.
The rest of the points are not applicable to the provided document:
- 2. Sample size used for the test set and the data provenance: Not applicable. This document refers to a physical device (bone plate), not an AI algorithm evaluated on a data set. The "test set" for substantial equivalence would involve mechanical testing, biocompatibility testing, etc., typically on device prototypes, not patient data in the way you're describing.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in this context, would relate to clinical outcomes or pathology, which are not detailed as part of the 510(k) substantial equivalence submission for a bone plate.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 for AI diagnostic tools, not a bone plate.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not explicitly stated as a "ground truth" method for this device. The regulatory pathway relies on demonstrating equivalent safety and effectiveness to predicate devices through design, material, and typically mechanical performance data.
- 8. The sample size for the training set: Not applicable.
- 9. How the ground truth for the training set was established: Not applicable.
In summary, the provided text describes a regulatory filing for a medical implant (a bone plate), not an AI-powered diagnostic or predictive device. Therefore, the questions related to AI algorithm evaluation, data sets, and ground truth establishment are not addressed by this document.
{0}------------------------------------------------
Koaoooa
page 1 of 1
3. Summary of Safety and Effectiveness Information
:
| Sponsor | Synthes (USA)1690 Russell RoadPaoli, PA 19301 |
|---|---|
| Company Contact | Matthew M. Hull(610) 647-9700 ext. 7191 |
| Name of the Device | Synthes Pilon Plate |
| Device Classification(s) | Class II, §888.3030 - Plate, Fixation, Bone |
| Substantial Equivalence | Documentation was provided which demonstrated the Synthes PilonPlate to be substantially equivalent to other legally marketed devices. |
| Device Description | The Synthes Pilon Plate is a metal plate that offers screw to platelocking designed for various fracture modes of the distal end of thetibia. |
| Indications | The Synthes Pilon Plate is intended for fixation of complex intra- andextra-articular fractures and osteotomies of the distal tibia. |
| Materials | Stainless Steel or Titanium |
Synthes (USA) Synthes Pilon Plate 510(k) CONFIDENTIAL
{1}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 0 2002
Mr. Matthew M. Hull Senior Regulatory Affairs Specialist Synthes (USA) 1690 Russell Road PO Box 1766 Paoli, PA 19301
Re: K020602
Trade/Device Name: Synthes Pilon Plate Regulation Number: 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: February 19, 2002 Received: February 22, 2002
Dear Mr. Hull:
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.
{2}------------------------------------------------
Page 2 - Mr. Matthew M. Hull
This letter will allow you to begin marketing your device as described in your Section 510(k) I mo letter will and h your e FDA finding of substantial equivalence of your device to a legally premated predicated on "ceresults 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Mark A. Milhenser
Celia Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
page 1 of 1
Indications for Use Statement
510(k) Number (if known):
Device Name:
Indications for Use:
C20602
Synthes Pilon Plate
The Synthes Pilon Plate is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal tibia.
(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
la Mark N. Milkinson
(Division Sign-Off) Division of General, Restoreralve and Neurological Device
510(k) Number K020607
Synthes (USA) Synthes Pilon Plate 510(k) CONFIDENTIAL
§ 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.