(86 days)
The Arthrex Tibial GraftBolt is intended to be used for fixation of tissue including ligament or tendon to bone and bone tendon during rruciate ligament reconstruction procedures.
The Arthrex Tibial GraftBolt consists of a pre-packaged mating sheath and screw pair offered in three sizes. 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 provided text is for a 510(k) summary for the "Arthrex Tibial GraftBolt," a bone fixation screw. This document focuses on demonstrating substantial equivalence to predicate devices based on device description and intended use, rather than presenting a study with specific acceptance criteria that the device's performance, as measured by a study, needs to meet.
Therefore, many of the requested elements for describing an acceptance criteria study are not present in the provided text. The document does not describe a performance study for the Arthrex Tibial GraftBolt that measures specific performance metrics against pre-defined acceptance criteria.
Here's a breakdown of the requested information based on the provided text, indicating where information is not available:
1. A table of acceptance criteria and the reported device performance
- Not Available. The provided document does not contain a table of acceptance criteria or reported device performance metrics from a study. The 510(k) is based on showing substantial equivalence in design and intended use to predicate devices, not on a performance study with specific quantitative outcomes.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Available. No specific test set or data provenance from a study 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 Available. This information is relevant to studies involving expert review for ground truth, which is not described here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Available. This is relevant to studies requiring expert adjudication, which is not described here.
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. The device is a bone fixation screw, not an AI or imaging diagnostic tool. An MRMC study is not relevant to this type of medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. The device is a bone fixation screw, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Available. No ground truth for a study is mentioned. The "ground truth" for this 510(k) process is the established safety and effectiveness of the predicate devices based on their prior clearance and market history.
8. The sample size for the training set
- Not Available. No training set for a study is mentioned.
9. How the ground truth for the training set was established
- Not Available. No training set or its ground truth establishment is mentioned.
Summary based on the provided document:
The Arthrex Tibial GraftBolt 510(k) (K093912) demonstrates substantial equivalence to predicate devices (K032167: Bio-Intrafix™ Tibial Screw and Sheath - Mitek Worldwide and K083607: AperFix® Tibial Implant with Inserter -- Cayenne Medical). The argument for substantial equivalence is based on the device's basic features and intended uses being very similar to the predicate devices. The document explicitly states: "Any differences between the Arthrex Tibial GraftBolt and the predicate devices are considered minor and do not raise questions concerning safety and effectiveness." This type of 510(k) submission does not rely on a dedicated performance study with acceptance criteria and measured device performance in the way described in your request.
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Arthrex TRADITIONAL 510(k): Arthrex Tibial GraftBott
3 510(k) Summary of Safety and Effectiveness
| Manufacturer/Distributor/Sponsor | Arthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USA |
|---|---|
| 510(k) Contact | David D'AlessandroQuality EngineerArthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USATelephone: 239/643.5553, ext. 1117Fax: 239/566.5851Email: david.d'alessandro@arthrex.com |
| Trade Name | Arthrex Tibial GraftBolt |
| Common Name | Screw, Fixation, Bone |
| Product Code- | MBI |
| Classification Name | Smooth or threaded metallic bone fixation fastener |
| Regulation No. | 888.3040 |
| Predicate Devices | K032167: Bio-Intrafix™ Tibial Screw and Sheath - Mitek WorldwideK083607: AperFix® Tibial Implant with Inserter -- Cayenne Medical |
| Device Descriptionand Intended Use | The Arthrex Tibial GraftBolt consists of a pre-packaged matingsheath and screw pair offered in three sizes. The Arthrex TibialGraftBolt is intended to be used for fixation of tissue includingligament or tendon to bone and bone tendon during cruciate ligamentreconstruction procedures. |
| SubstantialEquivalenceSummary | The Arthrex Tibial GraftBolt is substantially equivalent to thepredicate devices in which the basic features and intended uses arevery similar. Any differences between the Arthrex Tibial GraftBoltand the predicate devices are considered minor and do not raisequestions concerning safety and effectiveness.Based on theinformation submitted, Arthrex, Inc. has determined that the ArthrexTibial GraftBolt is substantially equivalent to the currently marketedpredicate devices similar |
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" encircles the eagle. The seal is in black and white and has a simple, official design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Arthrex, Inc. % Mr. David D'Alessandro Quality Assurance Engineer 1370 Creekside Boulevard Naples, Florida 34108
MAR 1 8 2010
Re: K093912
Trade/Device Name: Arthrex Tibial GraftBolt Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MBI Dated: December 17, 2009 Received: December 22, 2009
Dear Mr. D'Alessandro:
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. David D'Alessandro
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/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,
Barbara Buehn
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 TRADITIONAL 510(k): Arthrex Tibial GraftBot1
2 Indications for Use Form
510(k) Number:
Device Name:
Arthrex Tibial GraftBolt
The Arthrex Tibial GraftBolt is intended to be used for fixation of tissue including ligament or tendon to bone and bone tendon during rruciate 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)
1 of 1
Souther for mxn
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K093912
N/A