(43 days)
The Magnum Nail is intended for use in fixation of stable and unstable fractures of the proximal femur. The types of proximal femoral fractures include pertrochanteric, intertrochanteric, basal neck fractures, high subtrochanteric fractures and combinations of these fractures. The Magnum Nail is also indicated for use in osteotomy, nonunions and malunions, bone reconstruction following tumor resection, grafting and pathological fractures and revision procedures.
The Magnum Nail consists of nails, distal bone screws, cannulated lag screws, cannulated blades and set screws in a variety of sizes to accommodate differing anatomic requirements.
The provided text {0} discusses substantial equivalence based on basic design, intended use, indications, anatomic sites, and "mechanical performance." However, it does not explicitly define acceptance criteria or detail a specific study proving the device meets these criteria in the context of clinical performance or diagnostic accuracy. The document is a 510(k) summary for a medical device (Magnum Nail) and focuses on demonstrating substantial equivalence to predicate devices, primarily through design, intended use, and mechanical properties, not through a study demonstrating acceptance criteria for an AI/algorithm-driven device.
Therefore, most of the requested information (items 1-9) cannot be extracted directly from this document as it pertains to a different type of device evaluation (mechanical fixation rather than AI/algorithm performance).
However, I can extract the following relevant information based on the provided text:
1. A table of acceptance criteria and the reported device performance
Not applicable. The document assesses "mechanical performance" for substantial equivalence of a fixative nail, not diagnostic or algorithmic performance. No specific acceptance criteria or quantitative performance metrics are provided in the context of an AI/algorithm evaluation.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No test set for an AI/algorithm is mentioned.
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 establishment for an AI/algorithm is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set for an AI/algorithm is mentioned.
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. No MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. No standalone algorithm performance is mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No ground truth for an AI/algorithm is mentioned.
8. The sample size for the training set
Not applicable. No training set for an AI/algorithm is mentioned.
9. How the ground truth for the training set was established
Not applicable. No training set for an AI/algorithm is mentioned.
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NOV 1 8 2009
| NOV 18 2009 | |
|---|---|
| 8. 510(k) Summary | |
| Sponsor: | Robert Reid Inc.4-22-2, Koishikawa, Bunkyo-kuTokyo 112-0002 JapanPhone +81-3-3830-7375Fax +81-3-3830-7376 |
| Contact Person: | Teiji Nakamura, Marketing Director |
| Proposed Trade Name: | Magnum Nail |
| Device Classification | Class II |
| Classification Name: | Rod, fixation, intramedullary and accessories |
| Regulation: | 888.3020 |
| Device Product Code: | HSB |
| Device Description: | The Magnum Nail consists of nails, distal bone screws, cannulated lagscrews, cannulated blades and set screws in a variety of sizes toaccommodate differing anatomic requirements. |
| Intended Use: | The Magnum Nail is intended for use in fixation of stable and unstablefractures of the proximal femur. The types of proximal femoral fracturesinclude pertrochanteric, intertrochanteric, basal neck fractures, highsubtrochanteric fractures and combinations of these fractures. The MagnumNail is also indicated for use in osteotomy, nonunions and malunions, bonereconstruction following tumor resection, grafting and pathologicalfractures and revision procedures. |
| Materials: | The Magnum Nail components are manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136. |
| SubstantialEquivalence: | Documentation was provided which demonstrated the Magnum Nail to besubstantially equivalent to previously cleared devices (Fixion™Interlocking Proximal Femoral Nailing System, K010988 and TrochantericFixation Nail System, K011857). The substantial equivalence is based uponequivalence in basic design, intended use, indications, anatomic sites andmechanical performance. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around the perimeter. In the center is a stylized emblem that resembles a caduceus, a symbol often associated with medicine and healthcare. The emblem is composed of a series of curved lines that form a wing-like shape.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
NOV 1 3 2009
Robert Reid Inc. % Karen E. Warden, Ph. D. Consultant 8202 Sherman Road Chesterland, Ohio 44026-2141
Re: K093089
Trade/Device Name: Magnum Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: September 28, 2009 Received: October 1, 2009
Dear Dr. Warden:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Karen E. Warden, Ph.D.
forth in the quality systems (OS) 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/ReportalProblem/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.
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Sincerely yours,
gnata 3
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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7. Indications for Use Statement
510(k) Number: K. 093080
Device Name: Magnum Nail
Indications for Use:
The Magnum Nail is intended for use in fixation of stable fractures of the proximal femur. The types of proximal fractures include pertrochanteric, intertrochanteric, basal neck fractures, high subtrochanteric fractures and combinations of these fractures. The Magnum Nail is also indicated for use in osteotomy, nonunions and malunions, bone reconstruction following tumor resection, grafting and pathological fractures and revision procedures.
Prescription Use X Over-the-Counter Use AND/OR (21 CFR 807 Subpart C) (21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Danuta for mxn
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number. K093089
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§ 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.