(49 days)
The Biomet® Vision® FootRing System is intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by the use of the external fixation treatment modality.
The Biomet® Vision® FootRing System is an external fixation device. The devices in this 510(k) are additional modular components to the predicate Biomet® Vision® FootRing System, which is based upon the FootRing component as the frame for a construct.
The provided document is a 510(k) Summary for the Biomet® Vision® FootRing System, dated July 7, 2007. This summary outlines a request for substantial equivalence to existing legally marketed devices, primarily the EBI® DynaFix® Vision® FootPlate System (K052239).
This document describes a medical device (an external fixation system), not an AI/ML powered device or software. Therefore, the requested information pertaining to acceptance criteria and studies for AI/ML performance (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance) is not applicable or available in this submission.
The submission focuses on establishing substantial equivalence through non-clinical mechanical testing and makes no mention of performance metrics related to diagnostic accuracy, sensitivity, specificity, or other metrics typically associated with AI/ML systems.
Here's a breakdown of the available information based on the request:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Design Specifications/Performance Requirements) | Reported Device Performance |
|---|---|
| Static Design Specifications | Met (results were as expected) |
| Fatigue Design Specifications | Met (results were as expected) |
| Performance with respect to the predicate device (EBI® DynaFix® Vision® FootPlate System, K052239) | Functional within its intended use and substantially equivalent to the predicate device in performance characteristics. |
| For new connection components: Static Design Specifications | Met (results were as expected) |
Notes on Acceptance Criteria: The document states that mechanical testing was conducted "to verify the static and fatique design specifications and to determine performance with respect to the predicate" and "to verify static design specifications for new connection components." The acceptance criteria themselves (e.g., specific load limits, cycle numbers) are not detailed in this summary, but the results indicate they were met.
The following information is not applicable to this medical device submission as it is not an AI/ML powered device or software. No information regarding these aspects is present in the provided text.
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. The submission relies on mechanical testing of the device hardware, not data-driven performance.
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. No ground truth from experts in a clinical data context was established.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No adjudication method for clinical data was used.
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 is a hardware device; no human reader studies with or without AI assistance were conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. There is no algorithm or software for standalone performance testing.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable (in the AI/ML sense). The "ground truth" for this device's performance was its adherence to engineering design specifications and mechanical performance standards, verified through physical testing.
8. The sample size for the training set
- Not applicable. There is no AI/ML model to train.
9. How the ground truth for the training set was established
- Not applicable. There is no AI/ML model to train.
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K071395 Page 1/1
JUL - 9 2007
510(k) Summary
| Preparation Date: | July 7, 2007 |
|---|---|
| Applicant/Sponsor: | Biomet Trauma (formerly known as EBI, L.P.)100 Interpace ParkwayParsippany, NJ 07054 |
| Contact Person: | Debra L. BingDirector, Regulatory AffairsBiomet Trauma973-299-9300 |
| Proprietary Name: | Biomet® Vision® FootRing System |
| Common Name: | External Fixation Device |
| Classification Name: | Single/multiple component metallic bone fixation appliances and accessories, 2CFR 888.3030, KTT |
Legally Marketed Devices To Which Substantial Equivalence Is Claimed: EBI® DynaFix® Vision® FootPlate System, K052239 (Biomet Trauma), Sheffield Ring Fixator, K944092, K955848 and/or subsequent (Orthofix, Inc.)
Device Description: The Biomet® Vision® FootRing System is an external fixation device. The devices in this 510(k) are additional modular components to the predicate Biomet® Vision® FootRing System, which is based upon the FootRing component as the frame for a construct.
Intended Use: The Biomet® Vision® FootRing System is intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by the use of the external fixation treatment modality.
Summary of Technologies: The intented use is identical to the predicate Biom® FootRing System. The new modular components are geometrically similar or identical to components in the predicate device. The new components incorporate similar or identical connection mechanisms to the predicates. Finally the new components are made from the same materials and finishes, conforming to the same standards as the predicate device.
Non-Clinical Testing: Mechanical testing of the Biomet® Vision® FootRing System was conducted to verify the static and fatique design specifications and to determine performance with respect to the predicate. Mechanical Testing was also conducted to verify static design specifications for new connection components. The test results were as expected and demonstrate that the FootRing System is functional within its intended use, conforms to its design specifications and is substantially equivalent to the predicate device in performance characteristics. The minor technological differences between the Biomet® Vision® FootRing System and its predicate devices raise no new issues of safety and effectiveness. Performance
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data indicate that the Biomet® Vision® FootRing System is as safe and effective as the EBI® DynaFix® Vision® FootPlate System, K052239. Thus, the FootRing System is substantially equivalent.
Clinical Testing: None provided as a basis for substantial equivalence.
All trademarks are property of Biomet, Inc.
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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles an eagle or other bird in flight. The symbol is composed of three curved lines that converge at the bottom.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Biomet Manufacturing Corp. % Mr. Robert Friddle Regulatory Specialist P.O. Box 587 Warsaw, Indiana 46581-0587
JUL - 9 2007
K071395 Trade/Device Name: Vision® FootRing System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT Dated: May 18, 2007 Received: May 21, 2007
Dear Mr. Friddle:
Re:
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
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Page 2 - Mr. Robert Friddle
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 clectronic 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) 276-0120. 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 its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Beehup
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
K671395 510(k) Number (if known):_
Device Name: Biomet® Vision® FootRing System
Indications for Use:
The Biomet® Vision® FootRing System is intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by the use of the external fixation treatment modality.
Prescription Use Yes (Part 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)
Barbara Boelus
Division of Ge and Neurological De
510(k) Number K071395
Page 1 of 1
§ 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.