The Arthrex Blunt Tip Screws are intended to be used as stand-alone bone screws for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur and fibula. When used in conjunction with FiberTape, they can be used to treat patella fractures.
The Arthrex FiberTape suture products are intended for use in approximation and/or ligation of soft tissue, including use of allograft tissue for orthopedic surgeries. When used in conjunction with the Arthrex Blunt Tip Screws, Fiber Tape can be used to treat patella fractures.

Device Description

The Arthrex Blunt Tip Screws with FiberTape is a construct that includes stainless steel, blunt tip, partially threaded, cannulated low profile screws and FiberTape.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called "Arthrex Blunt Tip Screws with FiberTape." This type of document is a submission to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed device (predicate device).

Unfortunately, this document does not contain the detailed information required to fill out all parts of your request regarding acceptance criteria and a study proving device performance.

Here's what I can extract and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states that the device is "substantially equivalent" to predicate devices based on "Geometrical analysis" and "the summary of data submitted." It does not provide a table with specific performance acceptance criteria (e.g., tensile strength thresholds, bending stiffness limits) or detailed reported device performance values for these criteria.

Acceptance Criteria (Example)	Reported Device Performance (Example)
No specific criteria or performance values provided in text.	No specific criteria or performance values provided in text.
(Hypothetical: Tensile Strength > 100N)	(Hypothetical: 120N)
(Hypothetical: Fatigue Life > 1,000,000 cycles)	(Hypothetical: 1,500,000 cycles)

2. Sample size used for the test set and data provenance:

The document mentions "Geometrical analysis" and a "summary of data submitted" but does not specify numerical sample sizes for any test sets. It also does not discuss data provenance (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and qualifications:

Not applicable to this type of submission. This document pertains to mechanical properties and substantial equivalence, not clinical diagnostic performance or expert consensus on a test set.

4. Adjudication method for the test set:

Not applicable.

5. Multi-reader multi-case (MRMC) comparative effectiveness study:

Not applicable. This is a medical device for internal bone fixation and soft tissue approximation, not a diagnostic imaging device typically evaluated with MRMC studies.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) study:

Not applicable, as this is a physical medical device, not an algorithm.

7. Type of ground truth used:

The "ground truth" in this context is the performance of the legally marketed predicate devices. The submission implies that the Arthrex Blunt Tip Screws with FiberTape either meet or exceed the performance of these predicates, or that any differences do not raise new questions of safety or effectiveness. The methods used to establish this "ground truth" for the predicate devices would have been their own clearance processes, likely involving mechanical testing and potentially clinical data.

8. Sample size for the training set:

Not applicable. This is not a machine learning device.

9. How the ground truth for the training set was established:

Not applicable.

Summary of what is present in the document relevant to your query:

Device: Arthrex Blunt Tip Screws with FiberTape
Purpose of Submission: To obtain clearance for the device for internal bone fixation for bone fractures in the patella.
Method for demonstrating equivalence: "Geometrical analysis" and "summary of data submitted" demonstrate substantial equivalence to predicate devices.
Predicate Devices:
- K103705: Arthrex Low Profile Screws
- K032245: Arthrex FiberTape Family
- K142442: Zimmer Magna-FX Cannulated Screw Fixation System

Conclusion Regarding your Request:

The provided 510(k) clearance letter and summary confirm the FDA's determination of substantial equivalence for the Arthrex Blunt Tip Screws with FiberTape to predicate devices. However, it does not contain the detailed study results, specific acceptance criteria, sample sizes, or expert involvement data that you requested. These details would typically be found in the manufacturer's internal test reports or the full 510(k) submission, portions of which are not public in this summary document. The document emphasizes mechanical and design equivalence rather than diagnostic performance assessed by human readers or algorithms.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol depicts a stylized human figure with three faces in profile, representing the department's focus on health and human well-being.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 9, 2015

Arthrex. Incorporated Mr. David L. Rogers Regulatory Affairs 1370 Creekside Boulevard Naples, Florida 34108

Re: K143702

Trade/Device Name: Arthrex Blunt Tip Screws with FiberTape Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY, GAT Dated: January 13, 2015 Received: January 14, 2015

Dear Mr. Rogers:

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 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

{1}------------------------------------------------

Page 2 - Mr. David L. Rogers

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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K143702

Device Name Arthrex Blunt Tip Screws with FiberTape

Indications for Use (Describe)

The Arthrex FiberTape suture products are intended for use in approximation and/or ligation of soft tissue, including use of allograft tissue for orthopedic surgeries. When used in conjunction with the Arthrex Blunt Tip Screws, Fiber Tape can be used to treat patella fractures.

Type of Use (Select one or both, as applicable)
* Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

2.5 510K SUMMARY OF SAFETY AND EFFECTIVENESS

Date Summary Prepared	April 6, 2015
Manufacturer/Distributor/	Arthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USA
Sponsor	Naples, FL 34108-1945 USA
510(k) Contact	David L RogersRegulatory AffairsArthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USATelephone: 239/643.5553, ext. 71924Fax: 239/598.5508Email: david.rogers@arthrex.com
Trade Name	Arthrex Blunt Tip Screws with FiberTape
Common Name	Screw, Fixation, Suture
Product Code,Classification Name, CFR	HWC, GAT21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener21 CFR 878.5000: Nonabsorbable Poly(ethylene) Terephthalate Surgical Suture
Predicate Device	K103705: Arthrex Low Profile ScrewsK032245: Arthrex FiberTape FamilyK142442: Zimmer Magna-FX Cannulated Screw Fixation System
Purpose of Submission	This traditional 510(k) premarket notification is submitted to obtain clearance forthe Arthrex Blunt Tip Screws with FiberTape for internal bone fixation for bonefractures in the patella.
Device Description	The Arthrex Blunt Tip Screws with FiberTape is a construct that includes stainlesssteel, blunt tip, partially threaded, cannulated low profile screws and FiberTape.
Intended Use	The Arthrex Blunt Tip Screws are intended to be used as stand-alone bone screwsfor internal bone fixation for bone fractures, fusions, osteotomies and non-unionsin the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna,tibia, calcaneous, femur and fibula. When used in conjunction with FiberTape,they can be used to treat patella fractures.The Arthrex FiberTape Family suture products are intended for use inapproximation and/or ligation of soft tissue, including use of allograft tissue fororthopedic surgeries. When used in conjunction with the Arthrex Blunt TipScrews, FiberTape can be used to treat patella fractures.
SubstantialEquivalence Summary	The Arthrex Blunt Tip Screws with FiberTape is substantially equivalent to thepredicate devices, in which the basic design features and intended uses are thesame. Any differences between the Arthrex Blunt Tip Screws with FiberTape andthe predicates are considered minor and do not raise questions concerning safetyand effectiveness.Geometrical analysis demonstrates that the Arthrex Blunt Tip Screws aresubstantially equivalent to the Magna-FX Cannulated Screws.Based on the indication for use, technological characteristics, and the summary ofdata submitted, Arthrex, Inc. has determined that the Arthrex Blunt Tip Screwswith FiberTape is substantially equivalent to currently marketed predicatedevices

Regulation Number and Section

§ 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.