(86 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 Craniofacial Plates are titanium plates in a variety of shapes and sizes designed for various cranio-facial procedures.
This looks like a 510(k) premarket notification for a medical device. This type of document focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than establishing acceptance criteria and proving performance through a standalone study as would be seen for a novel device or a PMA application.
Therefore, many of the requested elements for a study proving acceptance criteria will not be present in this document. The document explicitly states:
"Documentation was provided which demonstrated the Synthes Craniofacial Plates to be substantially equivalent to other legally marketed devices."
And the FDA's letter confirms:
"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..."
Given this, I cannot extract information about acceptance criteria, detailed study designs, sample sizes, expert qualifications, or multi-reader multi-case studies as these are not part of a substantial equivalence claim for a device like this.
Here's how I can address what is available:
Acceptance Criteria and Device Performance
Since this is a substantial equivalence submission, there are no specific performance-based acceptance criteria or a dedicated study described to prove performance against such criteria in the provided text. The "acceptance criteria" here implicitly relate to demonstrating equivalence to predicate devices in terms of material, design, and intended use. The "reported device performance" is not quantified in the way you might expect for a novel diagnostic algorithm; rather, it's inferred to be similar to the predicate devices.
| Acceptance Criteria (Implicit) | Reported Device Performance (Implicit) |
|---|---|
| Material is Titanium | Device is made of Titanium, same as predicate. |
| Design is plates for craniofacial procedures | Device consists of titanium plates in various shapes and sizes, described as similar to predicate. |
| Intended Use for craniofacial fixation | 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, which aligns with predicate devices. |
| Compliance with general controls | Device is expected to comply with general controls provisions of the Act. |
Study Information (Based on Substantial Equivalence, Not Performance Study)
- Sample size used for the test set and the data provenance: Not applicable. No test set for performance evaluation is described. The "test" for a 510(k) is often a comparison of technical characteristics and intended use to a predicate device.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for a test set is described.
- Adjudication method 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. This device is a physical bone plate, not an AI or diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for a 510(k) is the established performance and safety of legally marketed predicate devices.
- The sample size for the training set: Not applicable. No training set for a performance model is described.
- How the ground truth for the training set was established: Not applicable.
In essence, for a 510(k) of a device like the Synthes Craniofacial Plates, the "study" is the comparison against predicate devices, and the "acceptance criteria" revolve around demonstrating that the new device is as safe and effective as those already on the market, rather than meeting specific quantifiable performance metrics from a new dataset.
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AUG 1 4 2002
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 Craniofacial Plates |
| Device Classification(s) | Class II, §872.4760 - Plate, Fixation, Bone |
| Substantial Equivalence | Documentation was provided which demonstrated the SynthesCraniofacial Plates to be substantially equivalent to other legallymarketed devices. |
| Device Description | The Synthes Craniofacial Plates are titanium plates in a variety ofshapes and sizes designed for various cranio-facial procedures. |
| Indications | The Synthes Craniofacial Plates are intended for use in selectivetrauma of the midface and craniofacial skeleton; craniofacial surgeryreconstructive procedures; and selective orthognathic surgery of themaxilla and chin |
| Material | Titanium |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 image of three birds in flight, arranged in a row. The birds are facing to the left. The logo is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 4 2002
Mr. Matthew M. Hull Senior Regulatory Affairs Associate Synthes (USA) 1690 Russell Road Paoli, Pennsylvania 19301
Re: K021642
Trade/Device Name: Synthes Craniofacial Plates Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: May 17, 2002 Received: May 20, 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.
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Page 2 -- Mr. Hull
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.
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613dditionally, 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.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Patrici Cucinotta for
Timothy A. Ulatowski 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. Indications for Use Statement
510(k) Number (if known):
Device Name:
Indications for Use:
Synthes Craniofacial Plates
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use レ (Per 21 CFR 801.109)
OR
Over-The-Counter Use
Suza Pena
(Division Sign-C Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number:
Synthes(USA) Synthes Craniofacial Plates 510(k) 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.