(9 days)
The Synthes Low Profile Neuro Contourable Mesh Plates are intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
The Synthes Low Profile Neuro Contourable Mesh Plates are manufactured from Titanium and consists of a variety of shapes and sizes designed for various cranio-facial procedures. These plates are now available to the user sterile.
The provided text is a 510(k) summary for the Synthes (USA) Low Profile Neuro Contourable Mesh Plates. It is primarily a regulatory document for a medical device and therefore does not contain the detailed study information typically found in a clinical trial report or a performance study for an AI/ML medical device.
This document is for a physical medical device (bone plates) that falls under Class II regulation and is cleared based on substantial equivalence to a previously marketed predicate device, not on specific performance criteria derived from a study like those for AI/ML devices.
Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets them in the context of an AI/ML device. The categories you've asked for (sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth, training set size, etc.) are all relevant to the validation of AI/ML algorithms, which is not what this document describes.
The key takeaway from this document regarding the "study" is:
- Substantial Equivalence: The device's clearance is based on demonstrating substantial equivalence to a legally marketed predicate device (Synthes Low Profile Neuro System). This means it has the same intended use, technological characteristics, and safety and effectiveness as the predicate.
- "Study" Type: The "study" mentioned is likely the documentation and comparisons provided to the FDA to demonstrate substantial equivalence, focusing on material, design, manufacturing, and intended use, rather than a clinical performance study with specific metrics.
In summary, the provided text does not contain the information needed to answer your questions about acceptance criteria and a study proving the device meets those criteria, as it pertains to AI/ML device validation.
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OCT - 9 2003
Summary of Safety and Effectiveness Information [510(k) Summary] 3.0
| SPONSOR: | Synthes (USA)1690 Russell RoadPaoli, PA 19301(610) 647-9700Contact: Lisa M. Boyle |
|---|---|
| DEVICE NAME: | Low Profile Neuro Contourable Mesh Plates |
| CLASSIFICATION: | Class II , 21 CFR 872.4760 - Plate, Fixation, Bone |
| PREDICATE DEVICE: | Synthes Low Profile Neuro System |
| DEVICE DESCRIPTION: | The Synthes Low Profile Neuro Contourable Mesh Plates are manufacturedfrom Titanium and consists of a variety of shapes and sizes designed forvarious cranio-facial procedures. These plates are now available to the usersterile. |
| INTENDED USE: | The Synthes Low Profile Neuro Contourable Mesh Plates are intended foruse in selective trauma of the midface and craniofacial skeleton;craniofacial surgery; reconstructive procedures; and selective orthognathicsurgery of the maxilla and chin. |
| MATERIAL: | Titanium |
| SUBSTANTIALEQUIVALENCE: | Documentation is provided which demonstrates that the Synthes LowProfile Neuro Contourable Mesh Plates are substantially equivalent to otherlegally marketed Synthes devices. |
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle head facing right, composed of three thick, curved lines. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 9 - 2003
Ms. Lisa M. Boyle Regulatory Associate Synthes, (USA) 1690 Russell Road P.O. Box 1766 Paoli. Pennsylvania 19301
Re: K033160
Trade/Device Name: Synthes (USA) Low Profile Neuro Contourable Mesh Plates Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: September 26, 2003 Received: September 30, 2003
Dear Ms. Boyle:
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.
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Page 2 - Ms. Boyle
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental 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): | K033160 |
|---|---|
| Device Name: | Synthes (USA) Low Profile Neuro Contourable Mesh Plates |
| Indications: |
The Synthes Low Profile Neuro Contourable Mesh Plates are intended for use in selective trauma of the
midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective
orthognathic surgery of the maxilla and chin.
(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 |
|---|---|---|
| --------------------------------------- | ---- | ---------------------- |
Nor (Division Sign-Off) (Division Sign-Oil)
Division of Anesthesiology, General Hospital, Division of Ancolnectors, Infection Control.
Surfer
510(k) Number._
Special 510(k): Confidential Synthes (USA) Low Profile Neuro Contourable Mesh Plates
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.