(179 days)
The SBi Anatomic Ankle Athrodesis Interlocking Nail System is indicated for tibiotalocalcaneal arthrodesis of the ankle following:
- Post traumatic and degenerative arthritis involving both ankle and subtalar joints,
- Rheumatoid arthritis,
- Osteoarthritis,
- Pseudoarthrosis,
- Severe foot/ankle deformity, or
- Instability and skeletal defects after tumor resection.
These include neuro-osteoarthroplasty (Charcot's foot), avascular necrosis of the talus, failed joint replacement, failed ankle fusion, and for distal tibia fracture non-unions when used concomitantly with tibiotalocalcaneal pathology.
The SBi Anatomic Ankle Arthrodesis Interlocking Nail System consists of implants, associated instruments, and trays. The implants are made of implantable grade titanium while the instrument components and trays are made of several materials: Aluminum, stainless steel, PEEK, POM, and composite materials. The implants are intended for single use only and will be offered sterile and non-sterile.
The provided text is a 510(k) Premarket Notification Summary for a medical device called the "SBi Anatomic Ankle Arthrodesis Interlocking Nail System." This documentation describes a surgical implant, not an AI/ML-based device or a diagnostic tool that would typically have acceptance criteria and a study proving its performance in the way your request outlines (e.g., accuracy, sensitivity, specificity, human reader improvement, standalone performance).
Therefore, I cannot extract the information you requested about acceptance criteria and studies demonstrating device performance related to AI or diagnostic metrics because this document does not contain such information.
Specifically, the document focuses on:
- Device Description: What the device is made of and how it functions.
- Intended Use: The medical conditions it is designed to treat (tibiotalocalcaneal arthrodesis of the ankle for various forms of arthritis, deformity, etc.).
- Substantial Equivalence: Comparing the device to already legally marketed predicate devices (Stryker T2 Ankle Arthrodesis Nail and Synthes Titanium Cannulated Hindfoot Arthrodesis Nail Expert System). This is the primary method of approval for 510(k) devices.
- Non-clinical data: Fatigue testing, cadaver implantation evaluations, literature search and evaluation, finite element analysis, and engineering/dimensional analysis. These are engineering and mechanical performance tests, not clinical studies in the diagnostic/AI sense.
There is no mention of:
- Acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, AUC).
- A "study that proves the device meets the acceptance criteria" in the context of diagnostic accuracy.
- Sample sizes for test sets or training sets for an algorithm.
- Data provenance, experts establishing ground truth, adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Any AI/ML components.
In summary, the request is not applicable to the provided document.
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K112982 1/2
APR - 2 2012
510(k) Premarket Notification Summary of Safety and Effectiveness
Submission Information
| Manufacturer: | Small Bone Innovations, Inc.1380 South Pennsylvania AvenueMorrisville, PA 19067Ph: 215-428-1791 Fax: 215-428-1795 |
|---|---|
| Submitted By: | Small Bone Innovations, Inc.Joseph Eble1380 South Pennsylvania Avenue |
Morrisville, PA 19067
Date: October 4, 2011
Proprietary Name: SBi Anatomic Ankle Arthrodesis Interlocking Nail System
Classification name/Identification: Class II, An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures
Product Code: HSB
Common/Usual Name and Reference Number: Intramedullary fixation rod - 21 CFR 888.3020
Substantial Equivalence: Documentation is provided which demonstrated the SBi Anatomic Ankle Arthrodesis Interlocking Nail System to be substantially equivalent to other legally marketed devices.
Device Description: The SBi Anatomic Ankle Arthrodesis Interlocking Nail System consists of implants, associated instruments, and trays. The implants are made of implantable grade titanium while the instrument components and trays are made of several materials: Aluminum, stainless steel, PEEK, POM, and composite materials.
Intended Use: The SBi Anatomic Ankle Arthrodesis Interlocking Nail System intended for tibiotalocalcaneal arthrodesis of the ankle following: Post traumatic and degenerative arthritis involving both ankle and subtalar joints, osteoarthritis, Rheumatoid arthritis, Pseudoarthrosis, Severe foot/ankle deformity, or Instability and skeletal defects after tumor resection. These include neuro-osteoarthroplasty (Charcot's foot), avascular necrosis of the talus, failed joint replacement, failed ankle fusion, and for distal tibia fracture non-unions when used concomitantly with tibiotalocalcaneal pathology.
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The implants are intended for single use only and will be offered sterile and non-sterile.
Materials: The implants are made from implantable grade TiAl6V4 titanium (ASTM F136) while the instrument components and trays are made of several materials: Aluminum, stainless steel, PEEK, POM, and composite materials.
Predicate Devices: The subject devices are equivalent to Stryker T2 Ankle Arthrodesis Nail (K051590) and Synthes Titanium Cannulated Hindfoot Arthrodesis Nail Expert System (K051678).
Non-clinical data: Fatigue testing, cadaver implantation evaluations, literature search and evaluation, finite element analysis, and an engineering/dimensional analysis were performed in order to support substantial equivalence.
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Image /page/2/Picture/0 description: The image shows the logo of the Department of Health & Human Services (HHS) of the United States. The logo features a stylized caduceus symbol, which is a winged staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Small Bone Innovations, Inc. % Mr. John Minier 1380 South Pennsylvania Ave. Morrisville, PA 19067
APR - 2 2012
Re: K112982
Trade/Device Name: SBi Anatomic Ankle Arthrodesis Interlocking Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: February 2, 2012 Received: February 7, 2012
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. John Minier
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Pen Berts nes ligir
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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4 Statement of Indications for Use
510(k) Number: 长川2982
Device Name: SBi Anatomic Ankle Athrodesis Interlocking Nail System
Indications For Use:
The SBi Anatomic Ankle Athrodesis Interlocking Nail System is indicated for tibiotalocalcaneal arthrodesis of the ankle following:
-
Post traumatic and degenerative arthritis involving both ankle and subtalar joints,
-
Rheumatoid arthritis,
-
Osteoarthritis,
-
Pseudoarthrosis,
-
Severe foot/ankle deformity, or
-
Instability and skeletal defects after tumor resection.
These include neuro-osteoarthroplasty (Charcot's foot), avascular necrosis of the talus, failed joint replacement, failed ankle fusion, and for distal tibia fracture non-unions when used concomitantly with tibiotalocalcaneal pathology.
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)
Page 1 of 1
ue
(Dision Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
112482 510(k) Number
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.