(67 days)
The Arthrex Bio-Composite SutureTak Anchors family is intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, and shoulder. Please see indications for use form for specific indications.
The Arthrex Bio-Composite SutureTak Anchors family is similar to the predicate devices in overall design. The difference lies in the introduction of smaller SutureTak models made with Bio-Composite material (PLLA or PLDLA combined with TCP).
The provided document, K091844 for Arthrex Bio-Composite SutureTak Anchors, is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving performance against specific acceptance criteria.
Therefore, the information typically requested in your prompt regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment is not available in this 510(k) summary. These types of detailed studies are generally part of the design validation phase and are summarized or referenced in the 510(k) submission, but the full details are not typically provided in the public summary document.
The document states that the new device is "substantially equivalent" to its predicate based on "basic features and intended uses" being the same, and any differences are "minor and do not raise questions concerning safety and effectiveness." This indicates that the equivalence was likely established through a combination of design comparison, material characterization, and potentially some mechanical testing to ensure performance similar to the predicate, rather than a clinical study with detailed performance metrics against pre-defined acceptance criteria as one might see for an AI/ML device.
Here's a breakdown of why each point of your request cannot be fully addressed by this document:
- A table of acceptance criteria and the reported device performance: This document does not specify quantitative acceptance criteria or report specific performance metrics from a study against such criteria. The comparison is made to the predicate device, K071177.
- Sample sized used for the test set and the data provenance: No information on test set sample sizes or data provenance is provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is a medical device (suture anchor) and not an AI/ML diagnostic system requiring expert-established ground truth.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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, as this is not an AI/ML diagnostic device for image interpretation.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable in the context of an AI/ML diagnostic. For a mechanical device like a suture anchor, ground truth would typically relate to mechanical properties, biocompatibility, and clinical performance (e.g., healing rates, retear rates), which are not detailed here. The ground truth for proving substantial equivalence to the predicate would be demonstrations of equivalent design, materials, and functional performance.
- The sample size for the training set: Not applicable (no AI/ML training set).
- How the ground truth for the training set was established: Not applicable (no AI/ML training set).
In summary, the provided K091844 document demonstrates substantial equivalence, not a detailed performance study against specific acceptance criteria as you would typically find for an AI/ML device.
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K0918YY
AUG 2 8 2009
4 .510(k) Summary of Safety and Effectiveness
| Manufacturer/Sponsor | Arthrex, Inc. 1370 Creekside Boulevard Naples, Florida 34108-1945 |
|---|---|
| 510(k) Contact | Ivette GalmezRegulatory Affairs AssociateTelephone: 239/643.5553, ext. 1263Fax: 239/598.5508Email: igalmez@arthrex.com |
| Trade Name | Arthrex Bio-Composite SutureTak Anchors |
| Common Name | Suture Anchor |
| Product Code -Classification Name | MAI - Fastener, Fixation, Biodegradable, Soft TissueHWC - Screw, Fixation, Bone |
| Predicate Device(s) | Arthrex Bio-Composite Suture Anchors: K071177 |
| Device Descriptionand Intended Use | The Arthrex Bio-Composite SutureTak Anchors familyis similar to the predicate devices in overall design. Thedifference lies in the introduction of smaller SutureTak modelsmade with Bio-Composite material (PLLA or PLDLA combinedwith TCP).The Arthrex Bio-Composite SutureTak Anchors family is intendedto be used for suture or tissue fixation in the foot, ankle, knee, hand,wrist, elbow, and shoulder. Please see indications for use form forspecific indications. |
| SubstantialEquivalence Summary | The Arthrex Bio-Composite SutureTak Anchors family issubstantially equivalent to the Arthrex Bio-Composite Suture Anchorspredicate, in which the basic features and intended uses are thesame. Any differences between the Bio-Composite SutureTakAnchors and the predicate K071177 are considered minor and do notraise questions concerning safety and effectiveness. Based on theinformation submitted, Arthrex, Inc. has determined that the new Bio-Composite SutureTak Anchors family is substantially equivalent tocurrently marketed predicate devices. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
AUG 2 8 2009
Arthrex, Inc. c/o Ms. Ivette Galmez Regulatory Affairs Associate 1370 Creekside Blvd. Naples, Florida 34108-1945
Re: K091844
Trade/Device Name: Arthrex Bio-Composite SutureTak Anchors Regulation Number: 21 CFR 888.3030 Regulation Name: Smooth or threaded metallic bone fastener Regulatory Class: Class II Product Code: MAI, HWC Dated: July 29, 2009 Received: July 30, 2009
Dear Ms. Galmez:
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 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 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
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Page 2 - Ms. Ivette Galmez
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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Barbara Buchner
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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Indications for Use
510(k) Number: Device Name:
691844
Device Name:
Arthrex Bio-Composite Tak
The Arthrex Bio-Composite Tak 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 and are size appropriate per patient needs:
| Elbow: | Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction. |
|---|---|
| Shoulder: | Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction. |
| Hand/Wrist: | Scapholunate Ligament Reconstruction, Carpal 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. |
| 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. |
Prescription Use X AND/OR Over-The-Counter Use J
(21 CFR 801 Subpart C) (Per 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) PAGE 1 of 1
Souetu for mcm
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091844
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.