(72 days)
Existing indications cleared in K021933:
The TempFix External Fixation System is indicated for external fixation of open or closed long bone fractures and correction of bony or soft tissue defects or deformities.
When used without adjunctive support, the TempFix External Fixation System is intended to be nonweight bearing.
DePuy also sceks the following additional indications:
The TempFix External Fixation System is MR safe when specific safety guidelines are followed relative to the use of 1.5-Tesla MR systems, only.
The TempFix External Fixation System consists of components that can be assembled to provide multiple degrees of freedom for positioning implantable threaded fixation pins on either side of a fracture or deformity. The unique frame materials provide radiolucent viewing of the fracture and are lightweight for patient comfort. The components are preassembled in kits with three basic frame configurations: a knee frame, a half pin ankle frame, a 400 mm bar, and a transfixing pin ankle frame. Each kit is provided in sterile and non-sterile versions.
The provided text from the 510(k) submission (K043113) for the TempFix™ External Fixation System, MR Safe, does not contain a detailed study report with specific acceptance criteria, reported device performance metrics, or information about sample sizes, ground truth establishment, or expert involvement for a clinical study.
Instead, this submission primarily focuses on establishing "MR safety" for the device based on material conformance to standards and comparison to previously cleared devices. The document does not describe a clinical performance study with the types of metrics requested (e.g., sensitivity, specificity, accuracy) that would apply to an AI/algorithm-based device.
Therefore, I cannot populate the requested table and answer many of the questions as the information is not present in the provided text.
Here is an attempt to address what can be extracted:
Device Acceptance Criteria and Performance (Based on MR Safety Claim)
The "acceptance criteria" here would relate to the device's ability to be considered "MR Safe" according to relevant standards and FDA guidance, rather than clinical performance metrics like diagnostic accuracy.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance/Conformance |
|---|---|---|
| MR Safety | Conformance to standards included in Section I under E. Materials (These specific standards are not detailed in the provided text). | The submission asserts the device is "MR safe when specific guidelines are followed relative to the use of 1.5-Tesla MR systems, only." The basis is material conformance and comparison to predicate devices, implying the materials used meet the safety requirements. |
Missing Information (Not available in the provided text):
- Specific quantitative metrics for MR safety (e.g., temperature rise limits, artifact size limits, force/torque limits) and actual measured values. The document only states "conformance of the material to the standards," but doesn't list the standards or the test results.
2. Sample size used for the test set and the data provenance
Not applicable. This was not a data-driven clinical performance study evaluating an algorithm or AI. The assessment was based on material characterization and potentially bench testing for MR safety.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth in the context of clinical performance (e.g., disease presence) was not established for this submission. The "ground truth" for MR safety would be derived from physical measurements and adherence to engineering standards.
4. Adjudication method for the test set
Not applicable. There was no test set requiring expert adjudication in the context of a clinical performance study for an algorithm.
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 submission is for an external fixation device, not an AI or imaging 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, not an algorithm.
7. The type of ground truth used
For the MR safety claim, the "ground truth" would be established by:
- Physical properties and composition of the device materials.
- Results from standardized bench tests (e.g., for magnetic force, torque, heating, artifact) according to relevant industry standards (though these specific tests and their results are not detailed in the provided text).
8. The sample size for the training set
Not applicable. There was no training set for an algorithm.
9. How the ground truth for the training set was established
Not applicable. No training set was used.
Summary based on given document:
The 510(k) submission K043113 primarily seeks to add an "MR Safe" claim to the existing TempFix™ External Fixation System. This claim is based on the conformance of the device's materials to established (but unspecified in the provided text) MR safety standards, and comparison to predicate devices that have already been cleared for MR safety. It is not a submission for a software, AI, or diagnostic device, and therefore the criteria for clinical performance studies as typically understood for such devices are not relevant here and thus, not present in the document.
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JAN 2 ] 2005
KO43113
510(k) Summary
| Name of Sponsor: | DePuy Orthopaedics, Inc.700 Orthopaedic DriveWarsaw, Indiana 46581-0988Est. Reg. No. 1818910 |
|---|---|
| 510(k) Contact: | Claudia S. SwansonSr. Regulatory SpecialistPhone: 574.371.4989FAX: 574.371.4987 |
| Trade Name: | TempFix TM External Fixation System, MR Safe |
| Common Name: | External Fixation Devices |
| Classification: | Class II per 21 CFR 888.3030:Multiple component metallic bone fixationappliances and accessories |
| Device Product Codes: | 87 KTT |
Substantially Equivalent Devices:
K021933 TempFix™ External Fixation System (predicate device) Synthes Medium External Fixation System (for MR safety) K011034 EBI® DynaFix®Vision ™External Fixation System (for MR safety) K961433
Device Description:
The TempFix External Fixation System consists of components that can be assembled to provide multiple degrees of freedom for positioning implantable threaded fixation pins on either side of a fracture or deformity. The unique frame materials provide radiolucent viewing of the fracture and are lightweight for patient comfort. The components are preassembled in kits with three basic frame configurations: a knee frame, a half pin ankle frame, a 400 mm bar, and a transfixing pin ankle frame. Each kit is provided in sterile and non-sterile versions.
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Indications for use:
The TempFix External Fixation System is indicated for: external fixation of open or closed long bone fractures and correction of bony or soft tissue defects or deformities.
When used without adjunctive support, the TempFix External Fixation System is intended to be non-weight bearing.
DePuy is seeking the following additional claim:
The TempFix External Fixation System is MR safe when specific guidelines are followed relative to the use of 1.5-Tesla MR systems, only.
Substantial equivalence:
The TempFix™ External Fixation System was originally cleared via K021933.
DePuy is seeking additional claims for MR safety based on the conformance of the material to the standards included in Section I under E. Materials. Other comparable devices cleared for MR safety are the Synthes Medium External Fixation System (K011034), and the Biomet EBI® DynaFix®Vision™External Fixation System (K961433).
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff entwined with a serpent, overlaid on a circular emblem. Encircling the caduceus is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font.
JAN 2 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Claudia S. Swanson Sr. Regulatory Specialist DePuy Orthopaedics, Inc. 700 Orthopaedic Drive P.O. Box 988 Warsaw, Indiana 46581
Re: K043113 Trade/Device Name: TempFix External Fixation System, MR Safe Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: November 8, 2004 Received: November 10, 2004
Dear Ms. Swanson:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your became in ad the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use sualed in the environment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, de nees mar na re ocen require approval of a premarket approval application (PMA). and Cosmetic For (100) market the device, subject to the general controls provisions of the Act. The r ou may, mererere, mains of the Act include requirements for annual registration, listing of general controld provider in 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 rr your device is elassinod (vor at controls. Existing major regulations affecting your device can may or our 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 r hat FDA has made a determination that your device complies with other requirements of the Act that I Dr Has Intal 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 form in radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Claudia S. Swanson
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter witi anow you to oegin manoung of substantial equivalence of your device to a legally prematicate 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 If you ucate specific advice for your 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 other general information on your response 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 yours,
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: TempFix External Fixation System, MR Safe
Indications for Use:
Existing indications cleared in K021933:
The TempFix External Fixation System is indicated for external fixation of open or closed long bone fractures and correction of bony or soft tissue defects or deformities.
When used without adjunctive support, the TempFix External Fixation System is intended to be nonweight bearing.
DePuy also sceks the following additional indications:
The TempFix External Fixation System is MR safe when specific safety guidelines are followed relative to the use of 1.5-Tesla MR systems, only.
Concurrence of CDRH, Office of Device Evaluation
Mark A. Milkeren
al, Restorative, and Neurological Devices
510(k) Number K043113
Prescription Use_ X (Per 21 CFR 801.109)
OR
Over-The-Counter Use
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.