(51 days)
The SBi Mini Rail External Fixation System is intended for fixation, compression, and distraction osteo-genesis of small bones, such as metacarpal and metatarsal. The system also includes the instruments with which to place the pins and assemble the construct. A tray is available for conveying and storing the system. The system is not intended for spinal use.
The SBi Mini Rail External Fixation System is indicated for use in external fixation of fractures and/or reconstruction of small bones, including metacarpal and metatarsal.
The SBi Mini Rail External Fixation System consists of pins of various diameters and lengths as well as the rails and accessories with which to connect and stabilize them. The system also includes instruments to implant the pins and connect the external components. A tray is included to store and transport the set. The devices are supplied non-sterile.
This document, K093550, is a 510(k) premarket notification for the "SBi Mini Rail External Fixation System". It primarily focuses on demonstrating substantial equivalence to a predicate device and obtaining FDA clearance for marketing.
Therefore, the document does not contain the detailed clinical study information typically associated with establishing acceptance criteria and proving device performance through a study, especially for AI/algorithm-based devices.
The provided text describes a medical device (an external fixator) and its intended use, materials, and substantial equivalence to a prior device. It's a regulatory submission for product clearance, not a study report or a document detailing performance metrics.
Based on the provided text, I cannot extract the requested information regarding acceptance criteria and the study proving the device meets them because such information is not present in this type of FDA submission.
Here's a breakdown of why each specific point cannot be addressed from the given document:
- A table of acceptance criteria and the reported device performance: This document does not describe performance metrics or acceptance criteria for the device in the way you would expect for an AI algorithm study. It describes the physical device, its components, and its intended use, rather than quantifiable performance outcomes from a study.
- Sample size used for the test set and the data provenance: No clinical or performance study data (test set, training set) is presented. The document states a modified device is equivalent to a cleared predicate (K964094), implying the basis for clearance is engineering and material equivalence, not clinical performance study data in the typical sense for AI.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there is no test set or ground truth described for an AI/algorithm.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as there is no test set or ground truth described for an AI/algorithm.
- 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 document describes a physical medical device (external fixator), not an AI diagnostic or aid.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as there is no ground truth described for an AI/algorithm.
- The sample size for the training set: Not applicable, as there is no training set mentioned.
- How the ground truth for the training set was established: Not applicable, as there is no training set mentioned.
In summary, the provided document is a regulatory submission for a physical medical device based on substantial equivalence, and it does not contain the information required to answer your questions regarding acceptance criteria and study data for an AI or imaging diagnostic tool.
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.. K093550
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'JAN - 7 2010 \
6. 510(k) Premarket Notification Summary of Safety and Effectiveness
Submission Information Manufacturer: Small Bone Innovations, Inc. 1380 South Pennsylvania Avenue Morrisville, PA 19067 Ph: 215-428-1791 Fax: 215-428-1795
Submitted By: Small Bone Innovations, Inc. John Minier 1380 South Pennsylvania Avenue Morrisville, PA 19067
Proprietary Name: SBi Mini Rail External Fixation System
Classification name: Class II, 21 CFR 888.3030 - Single/multiple component metallic bone fixation appliances and accessories
Product Code: KTT
Common/Usual Name and Reference Number: appliance, fixation, nail/blade/plate combination, multiple component, 21 CFR 888.3030
Substantial Equivalence: Documentation is provided which demonstrated the SBi Mini Rail External Fixation System to be substantially equivalent to other legally marketed devices.
Device Description: The SBi Mini Rail External Fixation System consists of pins of various diameters and lengths as well as the rails and accessories with which to connect and stabilize them. The system also includes instruments to implant the pins and connect the external components. A tray is included to store and transport the set. The devices are supplied non-sterile.
Intended Use: The SBi Mini Rail External Fixation System is intended for fixation, compression, and distraction osteo-genesis of small bones, such as metacarpal and metatarsal. The system also includes the instruments with which to place the pins and assemble the construct. A tray is available for conveying and storing the system. The system is not intended for spinal use.
The pins and external connecting components are intended for single use only. The implants are intended for single use only.
Materials: The pins are made from implant grade 316LS stainless steel (ASTM F138). The external components are made from medical grade aluminum and stainless steel.
Predicate Devices: The modified device is equivalent to the cleared SBi (formerly Fixano) MiniFIX External Fixator K964094.
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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". Inside the circle is a stylized symbol of a bird or eagle, with its wings spread and head facing left. The symbol is composed of three curved lines that suggest movement and flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Small Bone Innovations, Inc. % Mr. John Minier Regulatory Affairs Director 1380 South Pennsylvania Avenue Morrisville, Pennsylvania 19067
Re: K093550
Trade/Device Name: SBi Mini Rail External Fixator 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: December 10, 2009 Received: December 11, 2009
JAN - 7 2010
Dear Mr. Minier:
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 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); medical device reporting (reporting of medical
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Page 2 - Mr. John Minier
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Oerbeie Buelup
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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6093550 5. Statement of Indications for Use
510(k) Number:
Device Name: SBi Mini Rail External Fixation System
Indications For Use:
The SBi Mini Rail External Fixation System is indicated for use in external fixation of fractures and/or reconstruction of small bones, including metacarpal and metatarsal.
Prescription Use V (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)
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Senatur for mxn
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
510(k) Number K093550
§ 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.