(39 days)
The DePuy Mitek Super QUICKANCHOR Plus is intended for fixation of USP size #2 through #5 suture to bone for the indications listed below.
Shoulder: Rotator cuff repair; capsular repair; biceps repair; deltoid repair.
Ankle: Achilles tendon repair/reconstruction.
Knee: Extra capsular repairs; reattachment of: medial collateral collateral ligament, posterior oblique ligament or joint capsule to tibia and joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions.
The DePuy Mitek GII Anchor (QUICKANCHOR) is intended for fixation of USP size #2 suture to bone for the indications listed below.
Shoulder: Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsulo-labral reconstruction, biceps tenodesis, deltoid repair.
Ankle: Lateral instability, medial instability, achilles tendon repair/reconstruction, midfoot reconstruction.
Foot: Hallux valgus reconstruction.
Wrist: Scapholunate ligament.
Hand: Ulnar or lateral collateral ligament reconstruction.
Elbow: Tennis elbow repair, biceps tendon reattachment.
Knee: Extra capsular repairs; reattachment of: medial collateral ligament, lateral ligament, posterior oblique ligament or joint capsule to tibia and joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions.
The HEALIX Ti Dual Threaded Suture Anchor is intended for:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction;
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair;
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis, Patellar Tendon repair and secondary fixation in ACL/PCL reconstruction repair.
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.
Hip: Capsular repair, acetabular labral repair.
Rotator Cuff Anchors: (I) SHOULDER 1. Rotator Cuff
The DePuy Mitek RC QUICKANCHOR Anchor Plus is intended for fixation of USP size #2 suture to bone for the indications listed below. Shoulder: Rotator cuff repair.
Super Anchors: (I) SHOULDER 1. Biceps tenodesis 2. Capsule shift/capsulolabral reconstruction 3. Deltoid repair 4. Rotator cuff (II) ANKLE 1. Achilles tendon repair/reconstruction (III) KNEE 1. Extra capsular reconstruction, ITB tenodesis 2. Joint capsule closure to anterior proximal tibia 3. Lateral collateral ligament 4. Medial collateral ligament 5. Patellar ligament and tendon avulsion repairs 6. Posterior oblique ligament or joint capsule to tibia
The only proposition of this 510(k) submission is to add a generic "MR-Conditional" statement and symbol to the product package inserts and labels. There are no changes being made to the indications, product designs, material, packaging, and to the manufacturing processes.
This document describes MRI safety testing for various DePuy Mitek metal implant devices. It is a 510(k) summary for adding an "MR-Conditional" statement and symbol to product labeling. It is not a study assessing the clinical performance of a diagnostic or therapeutic device using human data. Therefore, many of the requested categories related to clinical study design, such as sample size for test/training sets, data provenance, expert ground truth, adjudication methods, and MRMC studies, are not applicable.
Here's the information derived from the provided text regarding the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Test Performed) | Reported Device Performance |
|---|---|
| Magnetic field interaction at 3.0 Tesla | "MR-conditional" |
| MRI-related heating at 3.0 Tesla | "MR-conditional" |
| Presence of artifacts at 3.0 Tesla | "MR-conditional" |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated for each individual implant, but testing was performed on "DePuy Mitek metal implant devices" (plural), indicating multiple devices were tested.
- Data Provenance: The tests were non-clinical (laboratory/engineering tests) rather than human or animal studies. The location of the testing facility or country of origin is not specified, but the submission is from DePuy Mitek, Inc. in Raynham, MA, USA, to the FDA. The tests are prospective in the sense that they were conducted specifically for this 510(k) submission.
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. These were non-clinical engineering tests (magnetic field interaction, heating, artifacts), not clinical evaluations requiring expert interpretation of medical images or patient outcomes. The "ground truth" was established by the technical measurements themselves against defined standards for MRI compatibility.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This was a non-clinical engineering test, not a subjective assessment requiring human expert adjudication.
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 submission concerns the MRI compatibility of medical implants, not the performance of AI-assisted diagnostic tools.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This relates to the physical properties of a medical device in an MRI environment, not an algorithm's performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for these tests was established by objective physical measurements using MRI scanners and related equipment to assess magnetic field interaction, temperature change, and image artifact size, according to recognized standards for MRI compatibility (though the specific standards are not cited in this excerpt).
8. The sample size for the training set
Not applicable. There was no "training set" as this was not a machine learning model but rather a physical property test.
9. How the ground truth for the training set was established
Not applicable, as there was no training set.
§ 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.