(107 days)
The ACL TightRope is to be used for fixation of bone to bone or soft tissue to bone, and is intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, Arthrex will be offering this for Anterior Cruciate Ligament (ACL) Repair.
The ACL TightRope consists of an adjustable non-absorbable suture loop and titanium button. The proposed device contains a titanium button and non-absorbable suture which are similar to the predicate devices. The proposed device contains an adjustable suture loop when compared to the predicate devices which contain constant loop lengths.
The provided document describes a 510(k) premarket notification for the Arthrex ACL TightRope device. It does not contain information about an AI/ML powered device, nor does it detail acceptance criteria or a study proving device performance in the context of AI.
The document discusses the substantial equivalence of the ACL TightRope to predicate devices based on mechanical testing. It states: "From the mechanical testing completed the ultimate load and cyclic displacement are substantially equivalent for the proposed device when compared to the predicate devices."
Therefore, I cannot provide the requested information for acceptance criteria and a study proving an AI/ML device meets the acceptance criteria, as the input document is about an orthopedic surgical device, not an AI/ML system.
However, based on the information provided, I can infer the general nature of the "acceptance criteria" and "study" for this non-AI device:
Inferred Acceptance Criteria for the Arthrex ACL TightRope (Non-AI Device):
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Ultimate Load | Substantially equivalent to predicate devices (K062747: Arthrex RETROBUTTON™ and K031666: Arthrex Fiberwire® Button Repair Kit) |
| Cyclic Displacement | Substantially equivalent to predicate devices (K062747: Arthrex RETROBUTTON™ and K031666: Arthrex Fiberwire® Button Repair Kit) |
Inferred Study that Proves the Device Meets the Acceptance Criteria (Non-AI Device):
The document mentions "mechanical testing completed" as the basis for determining substantial equivalence. This would have been an in-vitro biomechanical study.
- Sample size used for the test set and the data provenance: Not explicitly stated in the document. This would typically involve a specific number of test samples of the ACL TightRope and the predicate devices subjected to mechanical loads. Data provenance would be from laboratory testing.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For mechanical testing, the "ground truth" is typically defined by established engineering standards and measurement accuracy, not expert consensus.
- Adjudication method for the test set: Not applicable. The results are quantitative measurements interpreted against pre-defined performance metrics or direct comparison to predicate device performance.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: No, this is not applicable as this is a mechanical device, not a diagnostic AI system with human readers.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used: Mechanical testing data, specifically ultimate load and cyclic displacement measurements. These are objective engineering measurements.
- The sample size for the training set: Not applicable. There is no "training set" for this type of mechanical device evaluation.
- How the ground truth for the training set was established: Not applicable.
Summary for the provided document (non-AI device):
The provided document describes a medical device (ACL TightRope) that is evaluated for substantial equivalence to predicate devices through mechanical testing. The "acceptance criteria" appear to be related to the device's ultimate load and cyclic displacement performance, which were found to be "substantially equivalent" to the predicate devices. The study involved biomechanical testing, not an AI/ML evaluation.
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K100452 p. 10f2
Arthrex SPECIAL 510(K): Arthrex ACL TIghtRope
JUN 2 8 LUN
ﺔ ﻓﻲ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ
4 510(k) Summary of Safety and Effectiveness
| Date | May 20, 2010 |
|---|---|
| Manufacturer/Distributor/Sponsor | Arthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USA |
| 510(k) Contact | Geena AugustineQuality EngineerArthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USATelephone: 239/643.5553, ext. 2207Fax: 239/566.5851Email: geena.augustine@arthrex.com |
| Trade Name | ACL TightRope |
| Common Name | Pin, fixation, smoothSuture, Nonabsorbable, synthetic, polyethylene |
| Classification Name | 21 CFR 888.3040: Smooth or threaded metallic bone fixationfastener21 CFR 878.5000: Nonabsorbable poly(ethylene terephthalatesurgical suture. |
| Product Code -Classification Name | GAT - Nonabsorbable poly(ethylene terephthalate) surgicalsuture.HTY- Smooth or threaded metallic bone fixation fastener. |
| Predicate Devices | K062747: Arthrex RETROBUTTON™K031666: Arthrex Fiberwire® Button Repair Kit |
| Device Description andIntended Use | The ACL TightRope consists of an adjustable non-absorbablesuture loop and titanium button.The ACL TightRope is to be used for fixation of bone to bone orsoft tissue to bone, and is intended as fixation posts, adistribution bridge, or for distributing suture tension over areas ofligament or tendon repair. Specifically, Arthrex will be offeringthis for Anterior Cruciate Ligament (ACL) Repair. |
| Substantial EquivalenceSummary | The ACL TightRope is substantially equivalent to the predicatedevices in which the intended uses is the same and basic featuresare very similar. Any differences between the ACL TightRopeand the predicate devices are considered minor and do not raisequestions concerning safety and effectiveness. |
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Arthrex SPECIAL 510(k): Arthrex ACL TightRope
| The proposed device contains a titanium button and non-absorbable suture which are similar to the predicate devices. The proposed device contains an adjustable suture loop when compared to the predicate devices which contain constant loop lengths. |
|---|
| From the mechanical testing completed the ultimate load and cyclic displacement are substantially equivalent for the proposed device when compared to the predicate devices. |
| Based on the indication for use, technological characteristics and the comparison to the predicate device, Arthrex, Inc. has determined that the ACL TightRope is substantially equivalent to the currently marketed predicate devices. |
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission of providing essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Arthrex, Inc. c/o Ms. Geena Augustine Quality Engineer 1370 Creekside Boulevard Naples, Florida 34108-1945
JUN 2 8 2010
Re: K100652
Trade/Device Name: ACL TightRope Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY, GAT Dated: May 21, 2010 Received: May 24, 2010
Dear Ms. Augustine:
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. Geena Augustine
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/CDRHOffices/ucm115809.html 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 Boehm
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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SPECIAL 510(k): Arthrex ACL Tight|Rope
Indications for Use Form
Indications for Use
510(k) Number:
Device Name:
ACL TightRope
The ACL TightRope is to be used for fixation of bone to bone or soft tissue to bone, and is intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, Arthrex will be offering this for Anterior Cruciate Ligament (ACL) Revair.
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
Orita for mxm
(Davision Sign-Off) Division of Surgica! Orthopedic, and Restorative Devices
510(k) Number K100652
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.