Search Results

The Tornier, 3.4mm QuickDraw™ Convertible Fixation Implant is intended for use in arthroscopic or mini-open surgical procedures either as a standard bone anchor or as a knotless system for fixation of soft tissue to bone.

The QuickDraw™ Implant is intended for use in the following applications:

Shoulder: Rotator Cuff Repair, Bankart Repair, Anterior Shoulder Stabilization, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulabral Reconstruction

Foot/Ankle: Lateral or Medial Stabilization, Achilles Tendon Repair, Hallux Valqus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair, Bunionectomy

Elbow, Wrist and Hand: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondvlitis Repair

Knee: Extra-capsular Repairs, Patellar Realignment and Tendon Repairs, Iliotibial Band Tenodesis

The Implant system includes a 3.4mm diameter PEEK (polyether-etherketone) bone anchor, pre-mounted on a disposable inserter. The anchor is preloaded with USP size 2 Ultra High Molecular Weight Polyethylene suture, and a threading device. The device is designed to be inserted into a pre-drilled hole using a reusable drill guide. The anchor may be used as a tied implant, or it can be converted to a knotless fixation device by following the instructions for use. Thus, the QuickDraw™ Convertible Fixation Implant allows the user to select between tied or knotless fixation.

This is a 510(k) premarket notification for a medical device (3.4mm QuickDraw™ Convertible Fixation Implant), which primarily focuses on demonstrating substantial equivalence to predicate devices through device description, intended use, and a general statement of testing. It does not contain the detailed information necessary to answer all your questions regarding acceptance criteria and study particulars for an AI/ML powered device.

Here's what can be extracted based on the provided text, and where information is missing:

1. A table of acceptance criteria and the reported device performance

The document broadly states: "Data have been provided in the submission that demonstrates that in both the traditional knotted suture and knotless configurations the anchor pullout forces are equivalent or superior to referenced predicate devices."

This is a very high-level summary and does not provide a specific table of acceptance criteria or the reported device performance metrics.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the given 510(k) summary. The summary refers to "Data have been provided in the submission," but the specifics of that data (sample size, provenance) are not included in this document.

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 device is a physical implant, not an AI/ML powered diagnostic device. Therefore, the concept of "ground truth" established by experts in the context of image interpretation or similar tasks is not applicable. The "data" mentioned likely refers to mechanical testing results.

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

Not applicable for a physical implant.

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 for a physical implant.

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

Not applicable for a physical implant.

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

For this device, the "ground truth" would likely refer to established engineering and biomechanical principles, and the measurement of physical properties like "anchor pullout forces" using standardized testing methods. It would not be expert consensus, pathology, or outcomes data in the way it applies to AI/ML diagnostics.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI/ML algorithm that undergoes a "training phase" in the traditional sense.

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

Not applicable for a physical implant.

In summary:

The provided K103262 document is a 510(k) summary for a physical medical device (a surgical implant). It focuses on demonstrating substantial equivalence to predicate devices based on materials, intended use, and general performance (e.g., pullout forces). It does not contain the detailed study information, acceptance criteria tables, or specifics about expert involvement that would be present for an AI/ML powered device. Many of your questions are specifically tailored to AI/ML device evaluations and are therefore not addressed by this type of submission.

Ask a specific question about this device