(79 days)
The Arthrex Tibial GraftBolt is intended to be used for fixation of tissue including ligament or tendon to bone and bone tendon during cruciate ligament reconstruction procedures
The Arthrex Tibial GraftBolt consists of a pre-packaged mating sheath and a screw pair offered in two new sizes which extend the current size range.
The Arthrex Tibial GraftBolt is a medical device for fixing tissue to bone during cruciate ligament reconstruction. The provided text describes the device and its substantial equivalence to a predicate device, but it does not contain acceptance criteria or detailed study results that prove the device meets specific performance criteria beyond general statements about "ultimate load strength."
Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about sample sizes, ground truth establishment, expert qualifications, or MRMC studies for this specific device from the provided text.
Here's what can be extracted based on the limited information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document. The document mentions "minimum acceptance criteria" but does not define them. | "the submitted mechanical testing data demonstrated that the ultimate load strength of the proposed devices meets or exceeds the minimum acceptance criteria." |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective). The study is described as "mechanical testing data."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. The "ground truth" for mechanical testing would typically refer to established engineering standards or physical measurements, not expert consensus on medical images or diagnoses.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set:
- Adjudication Method: Not applicable. Mechanical testing typically involves objective measurement against pre-defined standards, not human adjudication.
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:
- MRMC Study Done: No. This device is a mechanical implant, not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Study: The "mechanical testing data" can be considered a form of standalone testing, as it evaluates the device's physical properties independently. However, this is not an "algorithm only" study.
7. The type of ground truth used:
- Type of Ground Truth: Mechanical testing standards and physical measurements of "ultimate load strength."
8. The sample size for the training set:
- Sample Size: Not applicable. This is a physical device undergoing mechanical testing, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established:
- How Ground Truth Established: Not applicable.
Summary of what is known from the provided text:
- The device is "Arthrex Tibial GraftBolt."
- It is intended for fixation of tissue during cruciate ligament reconstruction.
- It was compared for substantial equivalence to a predicate device (K093912: Arthrex Tibial GraftBolt).
- Mechanical testing was performed to demonstrate that its ultimate load strength "meets or exceeds the minimum acceptance criteria." The specific criteria are not detailed.
- The mechanical testing is the "study" that supports the device meeting its performance claims for substantial equivalence in terms of strength.
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Arthrex SPECIAL 510(k): Arthrex GraftBolt
4 510(k) Summary of Safety and Effectiveness
| Date Summary Prepared | October 13, 2010 |
|---|---|
| Manufacturer/Distributor/Sponsor | Arthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USA |
| 510(k) Contact | Courtney SmithRegulatory Affairs Project ManagerArthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USATelephone: 239/643.5553, ext. 1720Fax: 239/598.5508Email: csmith@arthrex.com |
| Trade Name | Arthrex Tibial GraftBolt |
| Common Name | Screw, Fixation, Bone |
| Product Code -Classification Name | HWC - Screw, fixation, bone |
| Predicate Devices | K093912: Arthrex Tibial GraftBolt |
| Device Description andIntended Use | The Arthrex Tibial GraftBolt consists of a pre-packaged matingsheath and a screw pair offered in two new sizes which extendthe current size range.The Arthrex Tibial GraftBolt is intended to be used for fixationof tissue including ligament or tendon to bone and bone tendonduring cruciate ligament reconstruction procedures. |
| Substantial EquivalenceSummary | The Arthrex Tibial GraftBolt is substantially equivalent to theArthrex Tibial GraftBolt (K093912), in which the basic features,materials and intended uses are the same. Any differencesbetween the Tibial GraftBolt and the predicate are consideredminor and do not raise questions concerning safety andeffectiveness.The submitted mechanical testing data demonstrated that theultimate load strength of the proposed devices meets or exceedsthe minimum acceptance criteria.Based on the indication for use, technological characteristics, andthe comparison to the predicate devices, Arthrex, Inc. hasdetermined that the Arthrex Tibial GraftBolt is substantiallyequivalent to currently marketed predicate devices. |
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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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird-like figure with three stylized lines representing its body and wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
JAN 5 2011
Arthrex. Inc. c/o Ms. Courtney Smith Regulatory Affairs Project Manager 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K103060
Trade/Device Name: Arthrex Tibial GraftBolt Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: December 19, 2010 Received: December 22, 2010
Dear Ms. Smith:
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 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 - Ms. Courtney Smith
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 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/CDRHQffices/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
erely yours,
N. Melkerson
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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Arthrex SPECIAL 510(k): Arthrex GraftBolt
3 Indications for Use Form
Indications for Use
510(k) Number:
KI03060
Device Name:
Arthrex Tibial GraftBolt
Indications For Use:
The Arthrex Tibial GraftBolt is intended to be used for fixation of tissue including ligament or tendon to bone and bone tendon during cruciate ligament reconstruction procedures
Prescription Use _ X_AND/OR Over-The-Counter Use _
(Per 21 CFR 801 Subpart D)
(21 CFR 801 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
for M. Melkerson
(Division Sign-Oft)
Division of Surgical, Orthopedic,
Restorative Devices
Division of Surgical, of Surgical, of Surgices
and Restorative Devices
and Restorative Devices and Restorative and
510(k) Number
N/A