(81 days)
The GRYPHON PEEK Anchor is intended for: Shoulder: Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction; Foot/Ankle: Lateral Stabilization, Medial Stabilization, Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis; Elbow: Ulnar or Radial Collateral Ligament Reconstruction; Hip: Capsular repair, acetabular labral repair.
The Gryphon PEEK Anchors are non-absorbable threaded suture anchors manufactured of PEEK material. The barbed anchor comes preloaded on a disposable inserter assembly and is intended for fixation of #2 suture to bone. The Gryphon PEEK Anchor is provided as size 3.0mm. The Gryphon PEEK Anchors will be offered with partially absorbable Orthocord suture options, similar to the Gryphon P BR Anchor. Technologies characteristics including design and packaging are the same as the predicate cleared devices.
The provided text is a 510(k) summary for a medical device called the "Gryphon PEEK Anchor." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a standalone study with detailed performance metrics.
Therefore, the information you've requested regarding acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, and ground truth establishment methods for a new study is not present in this document.
The study described here is primarily a comparative assessment to existing, legally marketed devices (predicates) to establish substantial equivalence.
Here's what can be extracted from the document in relation to your questions, and what cannot:
1. A table of acceptance criteria and the reported device performance
- Not explicitly provided as a table with specific quantitative acceptance criteria or a detailed breakdown of reported performance values.
- The document states: "Non clinical Testing Verification activities were performed on the implant or its predicates. Testing assessments include pull out testing, shelf-life, sterilization and biocompatibility. Safety and Performance Results of performance and safety testing have demonstrated that the modified device is substantially equivalent to the predicate devices."
- This indicates that mechanical performance (pull-out strength) and other safety aspects were tested, and the results were found to be comparable to existing devices, satisfying the "substantial equivalence" criteria for regulatory approval. However, no numerical values or specific thresholds are given.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not specified. The document mentions "pull out testing" but does not give sample sizes, origin of data, or details on whether the testing was conducted on clinical samples or benchtop models.
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)
- Not applicable/Not specified. This scenario is for a mechanical device; "ground truth" as typically understood in AI/imaging studies (e.g., expert consensus on image interpretation) is not relevant here. Device performance is determined by engineering tests (e.g., measuring pull-out force).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified. See point 3.
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 surgical anchor, not an AI or imaging diagnostic tool. An MRMC study would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Mechanical testing results. The "ground truth" for a device like this would be derived from objective engineering measurements (e.g., the force at which the anchor pulls out of bone substitute).
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device. There is no concept of a "training set."
9. How the ground truth for the training set was established
- Not applicable. See point 8.
In summary:
The document describes a 510(k) submission for a non-absorbable threaded suture anchor. The "study" mentioned is focused on "Non clinical Testing Verification activities... includ[ing] pull out testing, shelf-life, sterilization and biocompatibility." The primary conclusion drawn from these activities is that the device is "substantially equivalent to predicate devices." This type of regulatory submission does not typically involve the detailed breakdown of performance metrics, sample sizes, and ground truth establishment methods that would be seen in an AI or diagnostic study.
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K103712
p11/2
510(k) SUMMARY
MAR 1 1 2011
Gryphon PEEK Anchor
| Submitter's Name andAddress: | DePuy Miteka Johnson & Johnson company325 Paramount DriveRaynham, MA 02767 | |
|---|---|---|
| Contact Person | Kristine ChristoProject Manager, Regulatory AffairsDePuy Miteka Johnson & Johnson company325 Paramount DriveRaynham, MA 02767Telephone:508-828-3359Facsimile:508-977-6355e-mail: | KChristo@its.jnj.com |
| Name of Medical Device | Classification Name: | Fastener, Fixation, Nondegradable, SoftTissue Smooth or threaded metallic bonefixation fasteners |
| Common/Usual Name: | Bone Anchor | |
| Proprietary Name: | Gryphon PEEK Anchor | |
| Substantial Equivalence | Gryphon PEEK Anchors are substantially equivalent to:K100012 Gryphon BR Anchor -Hip (April 30, 2010) K090124 Gryphon P BR Anchor (March 11, 2009); K071481 Healix Peek Anchor (August 9, 2007) K102298 TransTend Anchor (January 7, 2011) K073412 Gryphon BR and Healix BR Anchor (January 17, 2008) | |
| Device Classification | This device carries an FDA product code HWC and is classified asSingle/Multiple component metallic bone fixation appliances andfasteners under 21 CFR 888.3030. This device is offered withOrthocord suture (K040004, K043298). |
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Device Description The Gryphon PEEK Anchors are non-absorbable threaded suture anchors manufactured of PEEK material. The barbed anchor comes preloaded on a disposable inserter assembly and is intended for fixation of #2 suture to bone. The Gryphon PEEK Anchor is provided as size 3.0mm. The Gryphon PEEK Anchors will be offered with partially absorbable Orthocord suture options, similar to the Gryphon P BR Anchor. Technologies characteristics including design and packaging are the same as the predicate cleared devices. Indications for Use The GRYPHON PEEK Anchor is intended for: Shoulder: Bankart Repair. SLAP Lesion Repair. Bicens Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction: Foot/Ankle: Lateral Stabilization, Medial Stabilization, Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis; Elbow: Ulnar or Radial Collateral Ligament Reconstruction; Hip: Capsular Repair, Acetabular Labral Repair. Non clinical Testing Verification activities were performed on the implant or its predicates. Testing assessments include pull out testing. shelf-life, sterilization and biocompatibility. Safety and Performance Results of performance and safety testing have demonstrated that the modified device is substantially equivalent to the predicate devices. Gryphon PEEK Anchors are similar to: Gryphon P BR Anchor (K100012, K090124), Healix Peek Anchor (K071481) and TransTend Anchor (102298). Based on the indications for use, technological characteristics, and comparison to predicate devices, the Gryphon PEEK Anchors have been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with healthcare. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the left side of the logo.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DePuy Mitek % Ms. Kristine Christo Project Manager, Regulatory Affairs 325 Paramount Drive Raynham, Massachusetts 02767
MAR 1 1 291
Re: K103712
Trade/Device Name: Gryphon PEEK Anchor Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HWC Dated: December 17, 2010 Received: December 20, 2010
Dear Ms. Christo:
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.
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Page 2 - Ms. Kristine Christo
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 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/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.fda.gov/MedicalDevices/Safety/ReportalProblem/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Ary B. Rh
for
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): K \ 037\2
Device Name: Gryphon PEEK Anchor
Indications for Use:
The GRYPHON PEEK Anchor is intended for:
Shoulder: Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction;
Foot/Ankle: Lateral Stabilization, Medial Stabilization,
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis;
Elbow: Ulnar or Radial Collateral Ligament Reconstruction;
Hip: Capsular repair, acetabular labral repair.
Prescription Use X (Part 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)
Page 1 of 1
for M. Melson
(Division Sign-Off) (Division Sign-of-Surgical, Orthopedic, Division orders and Restorative Devices
510(k) Number
§ 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.