(76 days)
The Smith & Nephew FOOTPRINT Ultra PK Suture Anchor is intended for use for the reattachment of soft tissue to bone for the following indications:
Shoulder: Rotator cuff repair, Bankart repair, Slap lesion repair, Biceps tenodesis, Acromio-Clavicular separation, Deltoid repair, and Capsular shift or Capsulolabral reconstruction.
Foot/Ankle: Lateral stabilization, Medial stabilization, Achilles tendon repair, Hallux valgus reconstruction, Mid-foot reconstruction, Metatarsal ligament repair.
Knee: Medial collateral ligament repair, Lateral collateral ligament repair, Patellar tendon repair, Posterior oblique ligament repair, Iliotibial band tenodesis.
Hand/Wrist: Scapholunate ligament reconstruction, Ulnar collateral ligament reconstruction, Radial collateral ligament reconstruction.
Elbow: Biceps Tendon reattachment, Ulnar or radial collateral ligament reconstruction.
The FOOTPRINT Ultra PK is a suture anchor manufactured from PEEK (polyetheretherketone). The tap-in anchor incorporates an anchor and plug and is pre-assembled on an inserter. The anchor accommodates up to four strands of suture and is offered diameters of 4.5 mm and 5.5 mm.
This document describes a 510(k) premarket notification for the Smith & Nephew FOOTPRINT Ultra PK Suture Anchor, a medical device for reattaching soft tissue to bone. However, it does not contain information about acceptance criteria or a study proving the device meets said criteria in the way you've outlined for performance studies involving AI or diagnostic evaluations.
The provided text is a regulatory submission for a physical medical device, specifically a suture anchor. The "performance data" referred to in the document relates to mechanical properties and comparison to predicate devices, not to statistical performance metrics like sensitivity, specificity, or F1-score derived from a dataset with a defined ground truth.
Therefore, I cannot populate the table or answer most of your detailed questions because the provided text does not include the type of information you are asking for (e.g., test set, training set, expert adjudication, MRMC studies, ground truth types, etc.). This information is typically found in the context of AI/ML or diagnostic device submissions, which involve analyzing data to establish performance characteristics.
Here's what I can extract from the provided text regarding performance, along with why other sections cannot be completed:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| For this type of device (suture anchor), acceptance criteria would typically relate to mechanical properties (e.g., pull-out strength, insertion force, material properties, biocompatibility). These specific criteria are not detailed in this public 510(k) summary. | The performance testing conducted demonstrates that the insertion and fixation properties of the Smith & Nephew FOOTPRINT Ultra PK suture are substantially equivalent to the predicate Arthrex PushLock suture anchor, cleared via K051219. The testing also demonstrates the new device does not raise any new issues of safety and efficacy. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This information is not present in the provided 510(k) summary. The performance testing is mentioned in a general sense ("performance testing conducted") but details about the sample size, type of test specimens (e.g., cadaveric bone, synthetic bone), or provenance are not included.
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):
This is not applicable as the study described is not a diagnostic or AI-based study requiring expert ground truth establishment from medical images or clinical data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable for the type of device and study described.
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 physical medical device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For mechanical testing of a suture anchor, "ground truth" would typically refer to measured physical properties validated against engineering standards or established methods for assessing mechanical integrity. The document states "performance testing," which implies laboratory-based mechanical tests, but doesn't detail the specific "ground truth" (e.g., ultimate pull-out strength, fatigue life).
8. The sample size for the training set:
Not applicable. This device does not involve a "training set" in the context of AI/ML.
9. How the ground truth for the training set was established:
Not applicable.
In summary: The provided text is a 510(k) summary for a physical medical implant (suture anchor), focusing on its substantial equivalence to predicate devices based on intended use and technological characteristics, including performance testing of its insertion and fixation properties. It does not provide the detailed study design, sample sizes for datasets, expert involvement, or statistical performance metrics that would be found in a submission for an AI/ML-based diagnostic device.
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KO9389
SECTION IV 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
As required by the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which the substantial equivalence is based.
Smith & Nephew FOOTPRINT Ultra PK Suture Anchor
Date Prepared: December 17, 2009
MAR - 4 2010
A. Submitter's Name:
Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road Andover MA, 01810
B. Company Contact
Christina Flores Regulatory Affairs Specialist II (508) 261-3705 Phone: FAX: (508) 261-3620
C. Device Name
Trade Name: FOOTPRINT Ultra PK Suture Anchor Common Name: Suture Anchor Classification Name: Fastener, fixation, non-degradable, soft tissue
D. Predicate Devices
The Smith & Nephew FOOTPRINT Ultra PK suture anchor is substantially equivalent in Intended Use and fundamental scientific technology to the legally marketed Smith & Nephew Twinfix FP PK Suture Anchor cleared via K073509 and the Arthrex PushLock cleared via K051219.
Description of Device E.
The FOOTPRINT Ultra PK is a suture anchor manufactured from PEEK (polyetheretherketone). The tap-in anchor incorporates an anchor and plug and is pre-assembled on an inserter. The anchor accommodates up to four strands of suture and is offered diameters of 4.5 mm and 5.5 mm.
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K199389
F. Intended Use
The Smith & Nephew FOOTPRINT Ultra PK Suture Anchor is intended for use for the reattachment of soft tissue to bone for the following indications:
Shoulder: Rotator cuff repair, Bankart repair, Slap lesion repair, Biceps tenodesis, Acromio-Clavicular separation, Deltoid repair, and Capsular shift or Capsulolabral reconstruction.
Foot/Ankle: Lateral stabilization, Medial stabilization, Achilles tendon repair, Hallux valgus reconstruction, Mid-foot reconstruction, Metatarsal ligament repair.
Knee: Medial collateral ligament repair, Lateral collateral ligament repair, Patellar tendon repair, Posterior oblique ligament repair, Iliotibial band tenodesis.
Hand/Wrist: Scapholunate ligament reconstruction, Ulnar collateral ligament reconstruction, Radial collateral ligament reconstruction.
Elbow: Biceps Tendon reattachment, Ulnar or radial collateral ligament reconstruction.
G. Comparison of Technological Characteristics
The Smith & Nephew FOOTPRINT Ultra PK suture anchor is substantially equivalent in intended use, technological characteristics, and are as safe and effective as their currently marketed predicate devices, the Smith & Nephew Twinfix PK FP (K073509), and the Arthrex PushLock (K051219).
H. Summary Performance Data
The performance testing conducted demonstrates that the insertion and fixation properties of the Smith & Nephew FOOTPRINT Ultra PK suture and nixe substantially equivalent to the predicate Arthrex PushLock suture anchor, cleared via K051219 . The testing also demonstrates the new device does not raise any new issues of safety and efficacy.
Traditional 510(k) Section IV
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The seal is in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Smith & Nephew Inc., Endoscopy Division % Ms. Christina Flores Regulatory Affairs Specialist II 150 Minuteman Road Andover, Massachusetts 01810
MAR - 4 2010
Re: K093897
Trade/Device Name: Smith & Nephew FOOTPRINT Ultra PK Suture Anchor 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 18, 2009
Dear Ms. Flores:
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. Iisting 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 Ms. Christina Flores
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.fdagov/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.fdagov/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,
Sincerely yours,
Mark Milliken
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 (if known):
Device Name: Smith & Nephew FOOTPRINT Ultra PK Suture Anchor
Indications for Use:
The Smith & Nephew FOOTPRINT Ultra PK Suture Anchor is intended for use for the reattachment of soft tissue to bone for the following indications: -
Shoulder: Rotator cuff repair, Bankart repair, Slap lesion repair, Biceps tenodesis, Acromio-Clavicular separation, Deltoid repair, and Capsular shift or Capsulolabral reconstruction.
Foot/Ankle: Lateral stabilization, Medial stabilization, Achilles tendon repair, Hallux valgus reconstruction, Mid-foot reconstruction, Metatarsal ligament repair.
Knee: Medial collateral ligament repair, Lateral ligament repair, Patellar tendon repair, Posterior oblique ligament repair, Iliotibial band tenodesis.
Hand/Wrist: Scapholunate ligament reconstruction, Ulnar collateral ligament reconstruction, Radial collateral ligament reconstruction.
Elbow: Biceps Tendon reattachment, Ulnar or radial collateral ligament reconstruction.
| Prescription Use | X |
|---|---|
| (Per 21 CFR 801 Subpart D) |
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sousta of m xn
(Division Sign Off)
n of Surgical, Orthor and Restorative Devices
510(k) Number K093897
§ 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.