(79 days)
Synthes Mandible External Fixator is intended to stabilize and provide treatment for fractures of the maxillofacial area, including severe open mandibular fractures, highly comminuted closed fractures, nonunions and delayed unions (especially associated with infection), fractures associated with infections, tumor resections, facial deformity corrections, gunshot wounds, pan facial fractures, burn maintenance, and bone grafting defects.
Synthes Mandible External Fixator consists of the following components: An Adjustable Clamp - MR Safe; 4.0/2.5 Schanz Screws; 2.5 mm K-wires; 4.0 mm Pre-bent Titanium Rods; and 4.0 mm Carbon Fiber Rods. The components of this system are designed for use in the MR environment. The rods and Schanz Screws are available in various lengths.
The input document is a 510(k) Summary for the Synthes Mandible External Fixator. This document indicates the device's classification and its substantial equivalence to a predicate device based on mechanical test results. Product 510(k) summaries for surgical tools and implants typically include mechanical testing and comparison to predicate literature. These do not typically include clinical studies or data from AI models. Therefore, the requested information (performance criteria in a clinical study for an AI model) cannot be extracted from the provided text.
Based on the provided text, here's what can be answered:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The device is considered substantially equivalent to the predicate device.
- Reported Device Performance: "The new device is considered to be substantially equivalent to the predicate device based on mechanical test results."
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- This information is not available in the provided text. The evaluation was based on mechanical test results, not a test set of human data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not applicable. The evaluation was based on mechanical test results, not expert review of a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. The evaluation was based on mechanical test results, not expert review of a test set.
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
- No, a multi-reader multi-case comparative effectiveness study was not done. This device is a physical medical device (external fixator), not an AI-based diagnostic tool.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
- Not applicable. This device is a physical medical device (external fixator), not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for demonstrating substantial equivalence was the performance of the predicate device, as established through mechanical test results.
8. The sample size for the training set
- Not applicable. There is no mention of a training set for an AI model.
9. How the ground truth for the training set was established
- Not applicable. There is no mention of a training set for an AI model.
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Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a stylized figure inside. To the right of the word is a circled "R" symbol, indicating a registered trademark.
| 3.0 | 510(k) Summary | APR 1 4 2004 | Page 1 of 1 |
|---|---|---|---|
| Sponsor: | Synthes (USA)1690 Russell RoadPaoli, PA 19301(610) 647-9700 | ||
| Device Name: | Synthes Mandible External Fixator | ||
| Classification: | Class II, 21 CFR §888.3030 - Single/multiple component bone fixationappliances and accessories. | ||
| Predicate Devices: | Synthes Mini External Fixator | ||
| Device Description: | Synthes Mandible External Fixator consists of the followingcomponents: An Adjustable Clamp - MR Safe; 4.0/2.5 Schanz Screws;2.5 mm K-wires; 4.0 mm Pre-bent Titanium Rods; and 4.0 mm CarbonFiber Rods. The components of this system are designed for use in theMR environment. The rods and Schanz Screws are available in variouslengths. | ||
| Intended Use: | Synthes Mandible External Fixator is intended to stabilize and providetreatment for fractures of the maxillofacial area, including severe openmandibular fractures, highly comminuted closed fractures, nonunionsand delayed unions (especially associated with infection), fracturesassociated with infections, tumor resections, facial deformitycorrections, gunshot wounds, pan facial fractures, burn maintenance,and bone grafting defects. | ||
| SubstantialEquivalence: | The new device is considered to be substantially equivalent to thepredicate device based on mechanical test results. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 4 2004
Ms. Sheri L. Musgnung Regulatory Affairs Specialist Synthes (USA) 1690 Russell Road Post Office Box 1766 Paoli, Pennsylvania 19301-0800
Re: K040169
Trade/Device Name: Synthes Mandible External Fixator Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: MQN Dated: January 23, 2004 Received: January 26, 2004
Dear Ms. Musgnung:
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. Musgnung
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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2.0 Indications for Use Statement
Page _________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known):
Cynthia Meredith, Extension Educator
1040169
Device Name:
Synthes Mandible External Fixator
Indications:
Synthes Mandible External Fixator is intended to stabilize and provide treatment for fractures of the maxillofacial area, including severe open mandibular fractures, highly comminuted closed fractures, nonunions and delayed unions (especially associated with infection), fractures associated with infections, turnor resections, facial deformity corrections, gunshot wounds, pan facial fractures, burn maintenance, and bone grafting defects.
(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 | |
|---|---|---|---|---|
| ------------------------------------------ | ----------------------------------------- | ---- | ---------------------- | -- |
Sma Anner
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
| 510(k) Number: | -4/13/04 K040169 |
|---|---|
| ---------------- | ------------------ |
CONFIDENTIAL
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§ 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.