(28 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 parallel pin clamp - MR safe; 4.0/2.5 Schanz Screws, 2.0 mm K-wires; and 4.0 mm Titanium Rods. The components of this system are designed for use in the MR environment. The rods and Schanz Screws are available in various lengths.
Based on the provided text, the "Synthes Mandible External Fixator" is a medical device. The document is a 510(k) summary, which is typically for demonstrating substantial equivalence to a predicate device, not for a study proving device performance against acceptance criteria in the traditional sense of a clinical trial for a new drug or novel medical device.
Therefore, many of the requested categories for a study proving device performance against acceptance criteria are not applicable to this type of regulatory submission (a 510(k) for substantial equivalence).
Here's the breakdown of what can and cannot be answered from the provided text:
1. A table of acceptance criteria and the reported device performance
- Not Applicable. This document establishes substantial equivalence to a predicate device, not performance against specific, pre-defined acceptance criteria from a clinical study. The device is assessed based on its similarity in design, materials, and intended use to an already legally marketed device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. Since there isn't a performance study described in the document, there's no test set, sample size, or data provenance to report in this context.
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. As no performance study is described, there is no "ground truth" establishment by experts for a test set mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set or related adjudication method is mentioned in this 510(k) summary.
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
- Not Applicable. This device is a mechanical external fixator, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human readers and AI is irrelevant.
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, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. No performance study generating ground truth is described.
8. The sample size for the training set
- Not Applicable. This is a physical medical device, not an AI or machine learning algorithm requiring a training set.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
Summary of Relevant Information from the Document:
While the document does not provide details of a study meeting the requested criteria, it does describe the basis for its regulatory acceptance: Substantial Equivalence.
- Device Name: Synthes Mandible External Fixator
- Intended Use: "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."
- Predicate Device: Synthes Mandible External Fixator
- Basis for Acceptance: "Documentation is provided which demonstrates that Synthes Mandible External Fixator is substantially equivalent to other legally marketed Synthes devices."
In the context of this 510(k) submission, the "acceptance criteria" are the FDA's regulatory requirements for demonstrating substantial equivalence to a predicate device, and the "study" is the submission of documentation (which could include engineering analysis, biocompatibility testing, material characterization, performance testing on components, etc., but not a clinical study showing superior or equivalent outcomes compared to a control group in the manner you're asking) demonstrating that the new device is as safe and effective as the predicate. The document states that such documentation was provided to the FDA.
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3.0 510(k) Summary
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| Sponsor: | Synthes (USA)1302 Wrights Lane EastWest Chester, PA 19380(610) 719-5000 | MAR 1 5 2005 |
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| Device Name: | Synthes Mandible External Fixator | |
| Classification: | Class II, 21 CFR §872.4760Bone Plate | |
| Predicate Device: | Synthes Mandible External Fixator | |
| Device Description: | Synthes Mandible External Fixator consists of the followingcomponents: An adjustable parallel pin clamp - MR safe; 4.0/2.5Schanz Screws, 2.0 mm K-wires; and 4.0 mm Titanium Rods. Thecomponents of this system are designed for use in the MRenvironment. The rods and Schanz Screws are available in variouslengths. | |
| Intended Use: | Synthes Mandible External Fixator is intended to stabilize andprovide treatment for fractures of the maxillofacial area, includingsevere open mandibular fractures, highly comminuted closedfractures, nonunions and delayed unions (especially associated withinfection), fractures associated with infections, tumor resections,facial deformity corrections, gunshot wounds, pan facial fractures,burn maintenance, and bone grafting defects. | |
| SubstantialEquivalence: | Documentation is provided which demonstrates that SynthesMandible External Fixator is substantially equivalent to otherlegally marketed Synthes devices. |
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized graphic of a caduceus, a symbol often associated with healthcare, featuring a staff with a serpent entwined around it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Sheri L. Musgnung Senior Regulatory Affairs Specialist Synthes (USA) 1690 Russell Road Paoli, Pennsylvania 19301
MAR 1 5 2005
Re: K050378
Trade/Device Name: Synthes Mandible External Fixator Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: MQN Dated: February 14, 2005 Received: February 15, 2005
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 (240) 276-0115. 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/industry/support/index.html.
Sincerely vours,
Chiu Lin, Ph.D.
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
| 510(k) Number (if known): | K050378 |
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| Device Name: | Synthes Mandible External Fixator |
| Indications: | Synthes Mandible External Fixator is intended to stabilize andprovide treatment for fractures of the maxillofacial area,including severe open mandibular fractures, highly comminutedclosed fractures, nonunions and delayed unions (especiallyassociated with infection), fractures associated with infections,tumor resections, facial deformity corrections, gunshot wounds,pan facial fractures, burn maintenance, and bone grafting defects. |
Prescription Use _ X (Per 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use_ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Quann
. , at Anacthesiology, General Hospital onon Control. Dental Devices
Number: L050875
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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.