(57 days)
The Stryker® External Fixation System 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.
Not Found
This document is a 510(k) summary for a medical device (Stryker® External Fixation System) and does not contain detailed information about specific acceptance criteria or an analytical study proving that the device meets those criteria.
510(k) submissions typically demonstrate substantial equivalence to a predicate device, rather than proving performance against specific quantitative acceptance criteria through a standalone study data as described in the prompt. The focus is on showing that the new device is as safe and effective as a legally marketed predicate device. Therefore, the information requested in the prompt (sample size for test/training sets, expert details, adjudication, MRMC studies, etc.) is generally not found in a 510(k) summary for this type of device.
Based on the provided text, I can extract the following relevant information:
- Device Name: Stryker® External Fixation System
- Intended Use/Indications for Use: 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 Devices: Hoffman II Compact MRI External Fixation System (K053038), Hoffman II Compact External Fixation System (K961916, K971755 & K973321), Synthes Medium External Fixation System-MR Safe (K040258) and Synthes Sterile Mandible External Fixator (K062299).
- Regulatory Classification: Class II
To answer your specific questions, directly from the provided text:
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A table of acceptance criteria and the reported device performance:
- The document does not provide a table of acceptance criteria with reported device performance metrics in the way one would for an AI/diagnostic device. The basis for clearance is substantial equivalence (SE) to predicate devices, implying similar performance for its intended use without specific quantitative metrics documented here.
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Sample sizes used for the test set and the data provenance: Not applicable. This 510(k) summary does not describe a performance study with a test set that would have a sample size or data provenance in the context of an AI/diagnostic device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This information is not present as the submission is for a mechanical fixation system and not an AI/diagnostic tool requiring ground truth established by experts.
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Adjudication method for the test set: Not applicable for the reasons stated above.
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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 an external fixation system, not an AI or diagnostic tool that would involve human readers or MRMC studies.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This applies to AI algorithms, not a mechanical external fixation system.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an external fixation system. Its performance evaluation is typically through mechanical testing, biocompatibility, and clinical use experience of its predicates, not "ground truth" derived from expert consensus on diagnostic cases.
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The sample size for the training set: Not applicable. This device is not an AI algorithm requiring a training set.
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How the ground truth for the training set was established: Not applicable. This device is not an AI algorithm.
In summary, the provided 510(k) pertains to a physical medical device (an external fixation system) and therefore does not contain the types of information requested, which are typically relevant for AI/diagnostic software devices. The clearance is based on substantial equivalence to existing devices, implying similar safety and effectiveness without direct performance studies against numerical acceptance criteria presented in this summary.
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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS: Stryker® Twist Drills
General Information
| Proprietary Name: | Stryker® External Fixation System |
|---|---|
| Common Name: | External Fixation System |
| Proposed Regulatory Class: | Class II |
| Device Classification: | MQN (21 CFR 872.4760) External Mandibular Fixator and/orDistractorKTT (21 CFR 888.3030) Single/multiple component metallic bonefixation appliances and accessories. |
| Submitter: | Stryker® Craniomaxillofacial750 Trade Centre WaySuite 200Kalamazoo, MI 49002877-534-2464 x 4250 |
| Submitter's Registration #: | 3005101424 |
| Manufacturer's Registration #: | 8010177 |
| Contact Person: | Tennille FolkRegulatory Affairs RepresentativePhone: 877-534-2464 x 4250Fax:269-323-4215 |
| Summary Preparation Date: | June 11, 2007 |
Intended Use
The Stryker® External Fixation System 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.
Substantial Equivalency Information
Stryker® considers the Stryker® External Fixation System are substantially equivalent to the already cleared Hoffman II Compact MRI External Fixation System (K053038), Hoffman II Compact External Fixation System (K961916, K971755 & K973321), Synthes Medium External Fixation System-MR Safe (K040258) and Synthes Sterile Mandible External Fixator (K062299).
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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 three heads facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Stryker® Craniomaxillofacial % Ms. Tennillee Folk Senior Regulatory Affairs Representative 750 Trade Centre Way Suite 200 Kalamazoo, MI 49002
AUG 1 0 2007
Re: K071628
Trade/Device Name: Stryker® External Fixation System Regulation Number: 21 CFR 872.4760 Regulation Name: External Mandibular Fixator and/or Distractor Regulatory Class: II Product Code: MQN, KTT Dated: June 11, 2007 Received: June 14, 2007
Dear Ms. Folk:
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. 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.os 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.
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Page 2 -- Ms. Tennillee Folk
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) 276-0120 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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html
ncerely vours.
Barbara Borchert
Mark N. Melke Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(K) Number (if known): K
Device Name: Stryker® External Fixation System
Indications for Use:
The Stryker® External Fixation System 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.
Prescription Use (21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Aarbara Buchen
(Division Sign Off) by Page _ of _
(Posted November 13, 2003)
Division of General, Restorative,
and Neurological Devices
510(k) Number K071628
§ 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.