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Multitak SS™ bone anchors are intended for use as a load bearing or nonload bearing suture anchor used in the attachment of soft tissue to bone in various orthopedic procedures.

Multitak SS™ bone anchors are indicated for use in the following orthopedic soft tissue to bone fixation applications:

Shoulder: Bankart lesion repairs, S.L.A.P. lesions repairs, Acromio-clavicular repairs, Capsular shift/capsulolabral reconstruction, Deltoid repairs, Rotator cuff tear repairs, Biceps tenodesis
Elbow: Biceps tendon reattachment, Tennis elbow repair, Ulnar or radial collateral ligament reconstruction, Extra-capsular repairs
Knee: Medial collateral ligament repair, Lateral collateral ligament repair, Posterior oblique ligament repair, Illiotibial band tenodesis, Patellar tendon repair, VMO advancement, Joint capsule closure, Medial/Lateral repairs/reconstructions
Foot/Ankle: Achilles tendon repairs, Midfoot and forefoot repairs, Hallus valgus reconstruction
Hand/Wrist: Collateral ligament repair (Gamekeeper's Thumb), Scapholunate ligament reconstruction, Tendon transfers in phalanx, Volar plate reconstruction

Multitak SS™ bone anchors are cylindrical suture anchors with an overall ratio of approximately 2:1, length to diameter. The suture anchors are processed from human cortical bone and provided sterile and are intended for single use. The bone soft tissue anchors with attached suture are inserted into a predrilled bone hole site with a single use disposable or a reusable introduction device. The suture ends are pulled to engage cancellous bone and to toggle and lock the anchor in bony tissue. A curved needle attached to the suture end(s) is used to secure soft tissue to bone.

The provided text describes a 510(k) premarket notification for a medical device, the Multitak SSTM Bone Anchor. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving novel safety and effectiveness through clinical trials with defined acceptance criteria and statistical performance. The information requested (acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets) is typically associated with AI/ML device submissions or devices requiring clinical performance data for approval, which is not the case here.

However, based on the provided text, we can infer the "acceptance criteria" and "study" in the context of a 510(k) submission as demonstrating substantial equivalence to a predicate device through comparative performance testing on mechanical properties.

Here's an interpretation based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify the exact sample size used for the performance testing comparing the new cortical bone anchor to the titanium predicate. It simply states "Performance testing."
• Data Provenance: The data is generated from in vitro performance testing (mechanical testing) of the physical devices, not from human or animal subjects. Details on the location of the testing are not provided. The data is prospective for this specific comparison study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• This concept is not applicable here. Ground truth in this context would be objective physical measurements of mechanical properties (pullout strength, failure modes). These are determined by mechanical testing equipment and protocols, not by expert consensus.

4. Adjudication Method for the Test Set

• Not applicable. Mechanical testing results are quantitative and do not typically require adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC study was not done. This type of study is relevant for diagnostic imaging devices or devices where human interpretation of medical data is involved. The Multitak SSTM Bone Anchor is a physical surgical implant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. This device is not an algorithm or AI system.

7. The Type of Ground Truth Used

• Objective Mechanical Measurements: The "ground truth" was established through direct
  measurement of physical properties, specifically pullout strength and failure modes, using standardized mechanical testing methods relevant to surgical anchors.

8. The Sample Size for the Training Set

• Not applicable. This device doesn't involve an AI/ML algorithm requiring a training set.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. There is no training set for this device.

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