(89 days)
The Multitak Splinter 3.0 mm Resorbable Anchor System consists of a single use bone soft tissue resorbable anchor implant and is intended for use as a load bearing or non-load bearing suture anchor in the attachment of soft tissue to bone in various arthroscopic and open orthopedic procedures.
The Multitak Splinter 3.0 mm Resorbable Anchors are indicated for use in the following orthopedic soft tissue to bone fixation applications:
- Shoulder: Bankart lesion repairs Acromio-clavicular repairs · Deltoid repairs Rotator cuff tear repairs Biceps tenodesis
- Elbow: Ulnar or radial collateral ligament reconstruction
- Knee: Extra-capsular repairs Medial collateral ligament repair Lateral collateral ligament repair Posterior oblique ligament repair Illiotibial band tenodesis Patellar tendon repair VMO advancement Joint capsule closure
- Foot/Ankle: Medial/Lateral repairs/reconstructions Achilles tendon repairs
The Multitak Splinter 3.0 mm Resorbable Anchors are cylindrical suture anchors with a conical tip on one end. The resorbable anchors are injection molded from a poly-L-lactic acid resin and have two transverse suture holes. The resorbable implant comes threaded with up to USP Size No. 2 polyester suture preloaded on the tip of a single use disposable introduction device. The resorbable implant and suture is delivered into a predrilled bone site. The suture ends are pulled to engage cancellous bone and to toggle and lock the anchor in bony tissue. A curved needle attached to the suture end is used to secure soft tissue to bone.
The provided text describes a 510(k) premarket notification for the "Multitak Splinter 3.0 mm Resorbable Anchor." This document focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel safety and effectiveness through clinical trials with specific acceptance criteria in the manner one might find for a new diagnostic device or drug.
Therefore, the information requested regarding acceptance criteria, study details, expert involvement, and ground truth establishment, which are typical for diagnostic device performance studies, does not directly apply in the same way to this 510(k) submission.
However, I can extract information related to the device's performance based on the predicate comparison:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Mechanical strengths and failure modes comparable to predicate devices | "Performance testing comparing the mechanical strengths and failure modes of the Multitak Splinter 3.0 mm Resorbable Anchors to predicate devices demonstrated that the anchors are statistically equivalent." |
| Intended use comparable to predicate devices | "The Multitak Splinter 3.0 mm Resorbable Anchors are similar in intended use... to current commercially available poly-L-lactic acid resorbable implants..." |
| Materials comparable to predicate devices | "The Multitak Splinter 3.0 mm Resorbable Anchors are similar in... materials to current commercially available poly-L-lactic acid resorbable implants..." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided text. The term "performance testing" implies a laboratory-based study rather than a clinical one with human subjects.
- Data Provenance: Not explicitly stated, but given it's a 510(k) submission, the testing would have been conducted by the manufacturer, Bonutti Research, Inc. It's likely a retrospective comparison to existing data or concurrent in-house testing against predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable in this context. The "ground truth" here is based on defined engineering standards for mechanical strength and failure modes, rather than expert interpretation of a diagnostic output.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This method is used for establishing ground truth in diagnostic studies, which is not the type of study 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. This device is a medical implant (suture anchor), not a diagnostic AI device requiring human reader improvement studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the performance claims would be defined engineering specifications and measured mechanical properties (e.g., tensile strength, pull-out strength, torque to failure) for both the Multitak Splinter and the predicate devices. The claim of "statistically equivalent" suggests quantitative comparisons.
8. The sample size for the training set
- Not applicable. This refers to machine learning models, which is not relevant to this device.
9. How the ground truth for the training set was established
- Not applicable. This refers to machine learning models, which is not relevant to this device.
Summary based on the provided text:
The provided document describes a predicate comparison study for a medical implant device. The "study" involves performance testing focused on the mechanical strengths and failure modes of the Multitak Splinter 3.0 mm Resorbable Anchor. The primary finding is that the device is statistically equivalent to its predicate devices in these aspects. The "acceptance criteria" were implicitly met by demonstrating this statistical equivalence in the relevant mechanical properties. No clinical trial data, expert review, or AI-related information as typically requested was part of this 510(k) summary.
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K 0/2465
10Fd
OCT 2 9 2001
Bonutti Research, Inc. Multitak Splinter 3.0 mm Resorbable Anchor 510(k) Premarket Notification
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
The following information is submitted in accordance with the requirements of 21 CFR 807.92:
Patrick Balsmann, MS, RAC, Contact Person: Director, Regulatory/Clinical Affairs & QA Bonutti Research, Inc., P.O. Box 1367, Effingham, Illinois 62401 Phone: 217.342.3412, ext. 321
Date Prepared: July 31, 2001
Proprietary Name: Multitak Splinter 3.0 mm Resorbable Anchor
Common Name: Resorbable Soft Tissue Anchor
Classification Name: Fastener, Fixation, Biodegradable, Soft Tissue.
Device Description: The Multitak Splinter 3.0 mm Resorbable Anchors are cylindrical suture anchors with a conical tip on one end. The resorbable anchors are injection molded from a poly-L-lactic acid resin and have two transverse suture holes. The resorbable implant comes threaded with up to USP Size No. 2 polyester suture preloaded on the tip of a single use disposable introduction device. The resorbable implant and suture is delivered into a predrilled bone site. The suture ends are pulled to engage cancellous bone and to toggle and lock the anchor in bony tissue. A curved needle attached to the suture end is used to secure soft tissue to bone.
Intended Use: The Multitak Splinter 3.0 mm Resorbable Anchor System consists of a single use bone soft tissue resorbable anchor implant and is intended for use as a load bearing or non-load bearing suture anchor in the attachment of soft tissue to bone in various arthroscopic and open orthopedic procedures.
The Multitak Splinter 3.0 mm Resorbable Anchors are indicated for use in the following orthopedic soft tissue to bone fixation applications:
- Shoulder: Bankart lesion repairs Acromio-clavicular repairs · Deltoid repairs Rotator cuff tear repairs Biceps tenodesis
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K012465
2 OF 2
Bonutti Research, Inc. - Multitak Splinter 3.0 mm Resorbable Anchor 510(k) Summary of Safety and Effectiveness Page 2
Elbow: Ulnar or radial collateral ligament reconstruction
Knee: Extra-capsular repairs Medial collateral ligament repair Lateral collateral ligament repair Posterior oblique ligament repair Illiotibial band tenodesis Patellar tendon repair VMO advancement Joint capsule closure
Foot/Ankle: Medial/Lateral repairs/reconstructions Achilles tendon repairs
Predicate Device(s): The Multitak Splinter 3.0 mm Resorbable Anchors are similar in intended use and materials to current commercially available poly-L-lactic acid resorbable implants including the Mitek 3.5 mm Panalok Wedge Absorbable Suture System. The Multitak resorbable implants are similar in design and intended use to existing Multitak suture anchors determined to be substantially equivalent by FDA.
Predicate Comparison: Performance testing comparing the mechanical strengths and failure modes of the Multitak Splinter 3.0 mm Resorbable Anchors to predicate devices demonstrated that the anchors are statistically equivalent.
Submitted by:
Dicky Belamy
Patrick Balsmann Director, Regulatory/Clinical Affairs & QA
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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OCT 2 9 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Patrick Balsmann Director, Regulatory/Clinical Affairs and Ouality Assurance Bonutti Research, Inc. P.O. Box 1367 Effingham, Illinois 62401
Re: K012465
Trade/Device Name: Multitak Splinter 3.0 mm Resorbable Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastner Regulatory Class: Class II Product Code: HWC, MAI Dated: July 31, 2001 Received: August 1, 2001
Dear Mr. Balsmann:
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 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.
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Page 2 - Ms. Connie Ficklin
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
e. Mark N. Millburn
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K01>465
Bonutti Research, Inc. - Multitak Splinter 3.0 mm Resorbable Anchor 510(k) Premarket Notification
INDICATIONS FOR USE
Device Name: Multitak Splinter 3.0 mm Resorbable Anchor.
Indications for Use: The Multitak Splinter 3.0 mm Resorbable Anchor System consists of a single use bone soft tissue resorbable anchor implant and is intended for use as a load bearing or non-load bearing suture anchor in the attachment of soft tissue to bone in various arthroscopic and open orthopedic procedures.
The Multitak Splinter 3.0 mm Resorbable Anchors are indicated for use in the following orthopedic soft tissue to bone fixation applications:
-
Bankart lesion repairs Shoulder: Acromio-clavicular repairs Deltoid repairs Rotator cuff tear repairs Biceps tenodesis
Ulnar or radial collateral ligament reconstruction Elbow: -
Extra-capsular repairs Knee: Medial collateral ligament repair Lateral collateral ligament repair Posterior oblique ligament repair Illiotibial band tenodesis Patellar tendon repair VMO advancement Joint capsule closure
Medial/Lateral repairs/reconstructions Foot/Ankle: Achilles tendon repairs
R. Mark N. Melleksen
Division Sign-O to rative Division of General and Neurological Decess
510(k) Number
Phone: (USA only) (800) 879-0117
Facsimile: (217) 347-33 www.BonuttiResearch.co
§ 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.