The proposed device is a suture-anchor to be used for soft tissue fixation to bone. The Gryphon Anchor is a cannulated, ribbed anchor, made of either non-absorbable PEEK (Polyetheretherketone) or absorbable Biocryl® RapideTM (composite of β-TCP and PLGA copolymer). Size #1 blue Permacord™ suture (UHMWPE braided suture) is preloaded on the anchor. The suture incorporates a pre-tied sliding knot (ProKnot knot). The Permacord suture is a non-absorbable suture that conforms to USP except for oversized diameter. The device is provided as sterile; the device is for single patient use only.

AI/ML Overview

The provided document describes a 510(k) submission for a medical device, the GRYPHON™ ANCHOR w/PROKNOT™ Technology. This submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets new acceptance criteria through a clinical or performance study with a test set, ground truth experts, and MRMC studies as typically seen in AI/Software as a Medical Device (SaMD) submissions.

The "study" in this context is the non-clinical testing performed to show the new device performs similarly to the predicate device.

Here's how to interpret the information based on the provided text, addressing your points where possible, and noting when the information is not applicable to this type of device submission:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (an orthopedic anchor), the "acceptance criteria" are typically related to mechanical performance characteristics that demonstrate equivalence to the predicate.

Acceptance Criteria (What was tested)	Reported Device Performance (How the GRYPHON™ ANCHOR w/PROKNOT™ Technology performed)
Fixation Strength Testing (To ensure substantial equivalence of device performance compared to predicate devices)	Data demonstrated substantial equivalence of product performance when compared to predicate devices (GRYPHON™ Anchor w/PROKNOTT™ Technology (K132241), GRYPHON BR Anchor (K100012, K090124), GRYPHON PEEK Anchor (K103712), and Healix Advance Anchor w/Permacord suture (K133794)).
Suture Knot Strength Testing (To ensure substantial equivalence of device performance compared to predicate devices)	Data demonstrated substantial equivalence of product performance when compared to predicate devices. Specific values and thresholds are not provided in this summary but were presumably met.
Suture Fray Testing (To ensure substantial equivalence of device performance compared to predicate devices)	Data demonstrated substantial equivalence of product performance when compared to predicate devices. Specific values and thresholds are not provided in this summary but were presumably met.
Suture per USP (United States Pharmacopeia) Standards (For the Permacord suture)	Suture testing on the Permacord suture was conducted per USP standards. (It's implied it met these standards, though specific results are not detailed).

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

Sample Size for Test Set: Not explicitly stated. For mechanical testing of medical devices like this, the "sample size" refers to the number of physical anchors and sutures tested. This is typically determined by engineering standards and statistical power calculations to demonstrate a certain level of confidence in the performance. The document only states "Fixation strength testing, suture knot strength testing and suture fray testing were conducted."
Data Provenance: The testing was "conducted" by DePuy Mitek. The provenance of the "data" itself (e.g., patient data, country of origin, retrospective/prospective) is not applicable here as this is mechanical testing of the device itself, not clinical data from patients.

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

This is not applicable for this type of device submission. Ground truth, in the context of expert review, is relevant for diagnostic devices or AI/SaMD where human interpretation or clinical outcomes are the gold standard. For an orthopedic anchor, the "truth" is established by physical measurements and engineering specifications, not expert consensus.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are used in studies involving human interpretation or clinical outcomes to resolve discrepancies in ground truth labeling. For mechanical testing, the "adjudication" is based on objective measurements and established thresholds.

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. MRMC studies are specific to diagnostic imaging devices, particularly those involving AI. This device is a surgical implant (an anchor), not an imaging or diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device does not have an algorithm component.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance relies on engineering specifications, standardized test methods (e.g., ASTM standards, USP for sutures), and direct physical measurements (e.g., force required for fixation failure, suture break strength, degree of fraying). The "truth" is objective, measurable, and compared against established performance criteria from the predicate devices.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning. The design and manufacturing processes are established through engineering principles, not data-driven training.

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

Not applicable. As there is no training set, there is no ground truth to establish for it.

Summary

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K140643 Page 1/2

0 DePuv Synthes

MITEK SPORTS MEDICINE PANIES OF Goknomagehauen

JUI 0882014

510(k) SUMMARY GRYPHON™ ANCHOR w/PROKNOT™ TECHNOLOGY

Date SummaryPrepared	May 2, 2014
Submitter'sName andAddress	DePuy Miteka Johnson & Johnson company325 Paramount DriveRaynham, MA 02767
Contact Person	Yayoi FujimakiRegulatory Affairs Senior AssociateDePuy Miteka Johnson & Johnson company325 Paramount DriveRaynham, MA 02767, USATelephone: 508-828-3541Facsimile: 508-977-6911e-mail: yfujima1@its.jnj.com
Name of theDevice	Trade Name: GRYPHON™ Anchor w/PROKNOTT™ TechnologyCommon Name: fastener, fixation, biodegradable, soft tissue
DeviceClassification	MAI - Single/multiple component metallic bone fixation appliances andaccessories, classified as Class II, regulated per 21 CFR 888.3030.MBI - Smooth or threaded metallic bone fixation fastener, classified as ClassII, regulated per 21 CFR 888.3040.Orthopedic panel
PredicateDevice	The proposed device is substantially equivalent to:GRYPHON™ Anchor w/PROKNOTT™ Technology (K132241);GRYPHON BR Anchor (K100012, K090124);GRYPHON PEEK Anchor (K103712).The following predicate devices were referenced:Healix Advance Anchor w/Permacord suture (K133794);Force Fiber Blue Polyethylene Non-Absorbable Surgical Suture (K092533,Teleflex Medical Incorporated)
Indications forUse	Shoulder: Bankart Repair, SLAP Lesion Repair, Capsular Shift or CapsulolabralReconstructionHip: Capsular Repair, Acetabular Labral Repair
DeviceDescription	The proposed device is a suture-anchor to be used for soft tissue fixation tobone. The Gryphon Anchor is a cannulated, ribbed anchor, made of either non-absorbable PEEK (Polyetheretherketone) or absorbable Biocryl® RapideTM(composite of β-TCP and PLGA copolymer). Size #1 blue Permacord™ suture(UHMWPE braided suture) is preloaded on the anchor. The suture incorporatesa pre-tied sliding knot (ProKnot knot). The Permacord suture is a non-absorbable suture that conforms to USP except for oversized diameter. Thedevice is provided as sterile; the device is for single patient use only.
Comparison ofTechnologicalCharacteristics	The anchors are existing Gryphon anchors. The blue #1 Permacord suture ismade from the same materials as the blue #2 Permacord suture that is used forthe Healix Advance Anchor w/Permacord suture. No other new technologicalcharacteristics are introduced to the proposed device compared with thepredicate device. Fixation strength testing ensured substantial equivalence ofdevice performance. No new issue of safety and efficacy has been raised.
Safety andPerformance	Non-clinical TestingFixation strength testing, suture knot strength testing and suture fray testing wereconducted and the data were compared with the data of the predicate devices.The data demonstrated substantial equivalence of product performance. Theproposed device has raised no new issue of safety and efficacy. Suture testing onthe Permacord suture was also conducted per USP.
SubstantialEquivalence	Based on technological characteristics comparison and performance evaluation,the proposed device is concluded to be substantially equivalent to the predicatedevice.

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(0) DePuy Synthes

mitek sports medicine COMPRMICS OF Specifican Coknova

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Public Health Service

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

July 8, 2014

DePuy Mitek Ms. Yayoi Fujimaki Senior Regulatory Affairs Associate 325 Paramount Drive Raynham, Massachusetts 02767

Re: K140643

Trade/Device Name: Gryphon Anchor w/ProKnot Technology Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and Accessories Regulatory Class: Class II Product Code: MAI, MBI Dated: June 3, 2014 Received: June 5, 2014

Dear Ms. Fujimaki:

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 (reporting of medical

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Page 2 - Ms. Yayoi Fujimaki

device-related adverse events) (21 CFR 803); 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 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/ResourcesforYou/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 yours, Lori A. Wigqins

for

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

Enclosure

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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 on last page.

510(k) Number (if known)

K140643

Device Name Gryphon Anchor w/ProKnot Technology

Indications for Use (Describe)

Gryphon Anchor w/ProKnot Technology is indicated for followings.

Shoulder: Bankart Repair, SLAP Lesion Repair, Capsular Shift or Capsulolabral Reconstruction Hip: Capsular Repair, Acetabular Labral Repair

Type of Use (Select one or both, as applicable)

[x] Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

: FOR FDA USE ONLY ----------

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Casey L. Hanley, Ph.D.

Division of Orthopedic Devices

Page 1/1

Regulation Number and Section

§ 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.