(66 days)
The Arthrex Graft-Anchor is intended to be used for suture or tissue fixation in the foot/ankle, knee, hand/wrist, elbow, and shoulder. Specific indications are listed below:
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Hand/Wrist: Scapholunate Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
The Arthrex Graft-Anchor is a one-piece titanium “push-in” anchor and comes pre-loaded on a driver.
This is a 510(k) summary for a medical device called the Arthrex Graft-Anchor, which is a bone fixation screw. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical trials to prove efficacy or deriving acceptance criteria from such trials. Therefore, the information requested regarding acceptance criteria and studies demonstrating that the device meets those criteria, as typically understood for AI/diagnostic devices, is not directly applicable in the same way.
However, based on the provided text, I can infer and extract information relevant to the substantial equivalence argument, which serves a similar function to demonstrating device performance.
Here's an analysis based on your questions:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria in this context are tied to the concept of substantial equivalence to the predicate device (K063479: Arthrex Mini PushLock). The primary performance characteristic used for comparison is pull-out strength.
| Acceptance Criteria (Inferred from Substantial Equivalence) | Reported Device Performance (Arthrex Graft-Anchor) |
|---|---|
| Mechanical Performance: Pull-out strength meets or exceeds that of the predicate device (Arthrex Mini PushLock). | "The mechanical testing demonstrates that the pull-out strength of the proposed devices meets or exceeds the pull-out strength of the predicate device." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the provided document. The "test set" here refers to the number of Arthrex Graft-Anchors used in the mechanical testing.
- Data Provenance: Not specified, but given it's mechanical testing by the manufacturer (Arthrex, Inc., based in Naples, FL, USA), it's highly likely to be internal, prospective mechanical testing conducted in the USA.
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. For a mechanical device like a bone fixation screw, the "ground truth" for performance is established through physical mechanical testing according to recognized standards, not by expert consensus or interpretation of clinical data in the same way an AI diagnostic would be. There are no experts in this context establishing "ground truth" for device performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for subjective interpretations (e.g., image reading). Mechanical testing results are objective measurements.
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. This is a medical device (bone fixation screw), not an AI diagnostic algorithm or an assistive technology for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance claim (pull-out strength) is established through physical mechanical testing and measurement. This typically involves laboratory setups designed to apply controlled forces and measure the point at which the anchor fails or dislodges from a surrogate material (e.g., synthetic bone).
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model that requires a "training set."
9. How the ground truth for the training set was established
Not applicable. As above, this device does not involve a training set.
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AUG 1 9 2011
Arthrex SPECIAL 510(k): Arthrex Scapholunate Anchor
2 510(k) Summary of Safety and Effectiveness
| Date Summary Prepared | June 9, 2011 |
|---|---|
| Manufacturer/Distributor/Sponsor | Arthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USA |
| 510(k) Contact | Courtney SmithManager, Regulatory AffairsArthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USATelephone: 239/643.5553, ext. 1720Fax: 239/598.5508Email: courtney.smith@arthrex.com |
| Trade Name | Graft-Anchor |
| Common Name | Screw, Fixation, Bone |
| Product Code -Classification Name | HWC – Screw, fixation, boneMBI – Fastener, fixation, nondegradable, soft tissue21 CFR 888.3030: Single/multiple component metallic bone fixation appliances and accessories.21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener |
| Predicate Devices | K063479: Arthrex Mini PushLock |
| Device Description andIntended Use | The Arthrex Graft-Anchor is a one-piece titanium “push-in” anchor and comes pre-loaded on a driver.The Arthrex Graft-Anchor is intended to be used for suture or tissue fixation in the foot/ankle, knee, hand/wrist, elbow, and shoulder. |
| Substantial EquivalenceSummary | The Arthrex Graft-Anchor is substantially equivalent to the Arthrex Mini PushLock predicate, in which the basic features, and intended uses are the same. Any differences between the Graft-Anchor and the predicate are considered minor and do not raise questions concerning safety and effectiveness.The mechanical testing demonstrates that the pull-out strength of the proposed devices meets or exceeds the pull-out strength of the predicate device. Based on the indication for use, technological characteristics, and the comparison to the predicate device, Arthrex, Inc. has determined that the Arthrex Graft-Anchor is substantially equivalent to currently marketed predicate device. |
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight. The symbol is composed of three curved lines that converge at the top and then separate into three distinct shapes at the bottom.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring MD 20993-0002
Arthrex, Inc. % Ms. Courtney Smith Manager Regulatory Affairs 1370 Creekside Boulevard Naples, Florida 34108-1945
AUG 1 9 2011
Re: K111661
Trade/Device Name: Arthrex Graft-Anchors Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI, HWC Dated: August 3, 2011 Received: August 4, 2011
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.
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 - Ms. Courtney Smith
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/AboutfiDA/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/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,
E. M. Keith
- So 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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1 Indications for Use Form
Indications for Use
510(k) Number:
Device Name:
K11661 Arthrex Graft-Anchor
Indications For Use:
Indications for Use:
The Arthrex Graft-Anchor is intended to be used for suture or tissue fixation in the foot/ankle, knee, hand/wrist, elbow, and shoulder. Specific indications are listed below:
| Elbow: | Biceps Tendon Reattachment, Ulnar or Radial Collateral LigamentReconstruction |
|---|---|
| Shoulder: | Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, BicepsTenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair,Capsular Shift or Capsulolabral Reconstruction |
| Hand/Wrist: | Scapholunate Ligament Reconstruction, Repair/Reconstruction ofcollateral ligaments, Repair of Flexor and Extensor Tendons at the PIP,DIP and MCP joints for all digits, digital tendon transfers, CarpalLigament Reconstruction and Carpometacarpal joint arthroplasty (basalthumb joint arthroplasty) |
| Foot/Ankle: | Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair,Metatarsal Ligament Repair, Hallux Valgus reconstruction, digitaltendon transfers, Mid-foot reconstruction |
| Knee: | Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair,Patellar Tendon Repair, Posterior Oblique Ligament Repair, IliotibialBand Tenodesis |
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. Malkerson
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K111661
N/A