(89 days)
The Synthes Craniofacial 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 Orbital Plates come in a variety of shapes and sizes to meet the anatomical need of the patient. The plates are sterile / non-sterile and for single use only.
The provided document is a 510(k) premarket notification for Synthes Orbital Plates. It details the device's classification, predicate devices, description, intended use, and material. However, this document does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor does it contain information about AI or software performance.
The 510(k) submission process for devices like general bone plates primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new performance studies against specific acceptance criteria for software or AI. The assessment of substantial equivalence typically involves comparing device design, materials, intended use, and sometimes mechanical or bench testing data to ensure it is as safe and effective as the predicate.
Therefore, I cannot fulfill the request to provide information based on the given document regarding:
- A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on demonstrating substantial equivalence, not on a performance study against specific acceptance criteria.
- Sample size used for the test set and the data provenance: Not applicable, as no performance study is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- 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. The device is a physical orbital plate, not an AI software.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a physical orbital plate, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The document states: "Documentation is provided which demonstrates that the Synthes Orbital Plates are substantially equivalent to other legally marketed Synthes devices." This indicates that the regulatory pathway relied on demonstrating equivalence, not on conducting new clinical or performance studies with acceptance criteria as one would for novel software or AI.
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SEP = 3 2003
Summary of Safety and Effectiveness Information 3.0
| SPONSOR: | Synthes (USA) |
|---|---|
| 1690 Russell Road | |
| Paoli, PA 19301 | |
| (610) 647-9700 | |
| Contact: Lisa M. Boyle | |
| DEVICE NAME: | Orbital Plates |
| CLASSIFICATION: | Class II , 21 CFR 888.3030: Single/multiple component metallic bonefixation appliances and accessories |
| PREDICATE DEVICE: | Synthes Maxillofacial Titanium Micro SetSynthes Orbital Mesh Plates |
| DEVICE DESCRIPTION: | The Synthes Orbital Plates come in a variety of shapes and sizes to meet theanatomical need of the patient. The plates are sterile / non-sterile and forsingle use only. |
| INTENDED USE: | The Synthes Craniofacial Plates are intended for use in selective trauma ofthe midface and craniofacial skeleton; craniofacial surgery; reconstructiveprocedures; and selective orthognathic surgery of the maxilla and chin. |
| MATERIAL: | CP Titanium |
| SUBSTANTIALEQUIVALENCE: | Documentation is provided which demonstrates that the Synthes OrbitalPlates are substantially equivalent to other legally marketed Synthesdevices. |
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Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an abstract symbol that resembles a stylized eagle or bird in flight. The symbol is composed of three curved lines that form the body and wings of the bird.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 3 2003
Ms. Lisa Boyle Regulatory Associate Synthes (USA) 1690 Russell Road Post Office Box 1766 Paoli, Pennsylvania 19301
Re: K031761
Trade/Device Name: Synthes (USA) New / Sterile Orbital Plates Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: June 5, 2003 Received: June 6, 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,
Susan Runne
Susan Runner, DDS, MA Interim 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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Indications for Use Statement 2.0
Page __ 1_________ of ________________________________________________________________________________________________________________________________________________________
:
| 510(k) Number (if known): | K031761 |
|---|---|
| --------------------------- | --------- |
Device Name:
Indications:
The Synthes Craniofacial 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.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X | OR | Over-The-Counter Use_ |
|---|---|---|---|
| (Per 21 CFR 801.109) |
| (Division Sign-Off) | |
|---|---|
| Division of Anesthesiology, General Hospital, Infection Control, Dental Devices | |
| 510(k) Number: | K 031761 |
Confidential
§ 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.