(30 days)
Synthes 2.0 mm Craniofacial Locking Plates are indicated for selective trauma of the midface and craniofacial skeleton; craniofacial surgery, reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
Synthes 2.0 mm Craniofacial Locking Plates provide a locking screw/plate interface. The plates contain threaded holes which allow the use of 2.0 mm Locking screws, 2.0 mm Cortex screws and 2.4 mm Emergency screws.
The provided text is a 510(k) summary for a medical device called "2.0 mm Craniofacial Locking Plates." It is not a study report demonstrating the device's performance against acceptance criteria. Instead, it's a submission to the FDA to demonstrate substantial equivalence to previously approved predicate devices, which is a regulatory pathway for clearance, not a performance study as typically understood in the context of AI/ML device evaluations.
Therefore, most of the requested information cannot be extracted directly from this document. The document describes the device, its intended use, and its predicate devices, and asserts substantial equivalence, but it does not detail specific acceptance criteria for performance, a study proving those criteria were met, or information regarding ground truth, expert involvement, or sample sizes for testing or training sets.
Here's an attempt to address the points based on what is available and what isn't:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
Explanation: This document is a 510(k) summary for demonstrating substantial equivalence, not a performance study against specific acceptance criteria. While the device (2.0 mm Craniofacial Locking Plates) is intended for certain surgical uses, the document does not define quantitative performance metrics or acceptance thresholds for its mechanical or clinical performance nor does it report the results of any such tests against these criteria. Instead, it asserts substantial equivalence to predicate devices.
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not applicable/Not specified.
- Data provenance: Not applicable/Not specified.
Explanation: This document is not a study report demonstrating performance on a test set. It describes a medical device and its intended use for FDA clearance based on substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not applicable/Not specified.
- Qualifications of experts: Not applicable/Not specified.
Explanation: No 'ground truth' or expert consensus process for a test set is described in this regulatory submission.
4. Adjudication method for the test set
- Adjudication method: Not applicable/Not specified.
Explanation: Since no test set or expert evaluation is detailed, no adjudication method is mentioned.
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
- MRMC study: No.
- Effect size: Not applicable.
Explanation: This device is a passive surgical implant (locking plates), not an AI/ML diagnostic or assistive device for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone performance study: No.
Explanation: This device is not an algorithm, so a standalone performance study as typically defined for algorithms is not applicable.
7. The type of ground truth used
- Type of ground truth: Not applicable/Not specified.
Explanation: No 'ground truth' is described as this is not a study assessing diagnostic or predictive performance.
8. The sample size for the training set
- Sample size for training set: Not applicable/Not specified.
Explanation: As this is a traditional surgical device, it does not involve machine learning and therefore does not have a 'training set'.
9. How the ground truth for the training set was established
- Method for establishing ground truth: Not applicable/Not specified.
Explanation: As this is a traditional surgical device, it does not involve machine learning and therefore does not have a 'training set' requiring ground truth establishment.
In summary, the provided text is a regulatory filing for a medical device, establishing substantial equivalence to predicate devices, rather than a study demonstrating performance against specific acceptance criteria for an AI/ML medical device. Therefore, most of the requested information regarding study design, sample sizes, expert involvement, and ground truth is not present in this document.
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OCT 2 9 2003
3. 510(k) Summary
| Sponsor: | Synthes (USA)1690 Russell RoadPaoli, PA 19301(610) 647-9700 |
|---|---|
| Company Contact: | Bonnie J. Smith |
| Device name: | 2.0 mm Craniofacial Locking Plates |
| Classification: | Class II, §872,4760 - Plate, fixation, bone. |
| Intended use: | Synthes 2.0 mm Craniofacial Locking Plates are indicated forselective trauma of the midface and craniofacial skeleton;craniofacial surgery, reconstructive procedures; and selectiveorthognathic surgery of the maxilla and chin. |
| Predicate device(s): | Synthes 2.0 mm Craniofacial Plates and Synthes 2.0 mmMandible Locking Plates |
| Substantial Equivalence: | Documentation is provided which demonstrates that the Synthes2.0 mm Craniofacial Locking Plates are substantially equivalentto the predicate devices. |
| Device description: | Synthes 2.0 mm Craniofacial Locking Plates provide a lockingscrew/plate interface. The plates contain threaded holes whichallow the use of 2.0 mm Locking screws, 2.0 mm Cortex screwsand 2.4 mm Emergency screws. |
| Material: | CP Titanium |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with three wavy lines above them. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 9 2003
Ms. Bonnie J. Smith Senior Regulatory Affairs Associate Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, Pennsylvania 19301
Re: K033065
Trade/Device Name: 2.0 mm Craniofacial Locking Plates Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: MON, JEY Dated: September 26, 2003 Received: September 29, 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 vour 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. Smith
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.
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.
Ques
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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Indications for Use Statement 2.
Page ____________ of _________________________________________________________________________________________________________________________________________________________
510(k) Number (if known):
Device Name:
2.0 mm Craniofacial Locking Plates
Indications for Use:
Synthes 2.0 mm Craniofacial Locking Plates are indicated for 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 (Per 21 CFR 801.109) | X |
| OR | |
| Over-The-Counter Use | |
| (Division Sign-Off) | Rei Muly for MSR |
| Division of Anesthesiology, General Hospital, Infection Control, Dental Devices | |
| Premarket Notification 510(k) Synthes 2.0 mm Craniofacial Locking Plates 510(k) Number: | K033065 |
000004
§ 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.