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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

The new Multitak SSTM Bone Anchor (cortical bone) demonstrated equivalent pullout strengths and failure modes to the predicate Multitak SSTM Titanium Anchor (K973015). |

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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The devices are intended for soft tissue to bone suture fixation for the following indications: Shoulder - Bankart lesion repairs - S.L.A.P. lesion repairs - Acromio-clavicular Repairs - Capsular Shift/Capsulolabral Reconstruction - Deltoid Repair - Rotator cuff tear repairs - Biceps tenodesis; Foot and Ankle - Medial/lateral repairs, reconstructions 1 - Achilles tendon repairs - Midfoot and forefoot repairs - Hallux Valgus reconstruction; Elbow - Ulnar or radial collateral ligament reconstructions - Tennis elbow repair - Biceps tendon reattachment; Knee - Extra-capsular repairs: -Medial collateral ligament Lateral collateral ligament Posterior oblique ligament - Iliotibial band tenodesis - Patellar tendon repair - -VMO advancement - Joint capsule closure; Hand/Wrist - Collateral ligament repair (Gamekeeper's Thumb) - -Scapholunate ligament reconstruction - Tendon transfers in phalanx - Volar plate reconstruction

The anchor is cylindrical in shape and is preassembled threaded with USP size 2-0 I he anchor is cynnurear in shape and if production Device holds the anchor and through 2 braided poryester suture. The mass of the sutures can then be used to secure the soft tissue to the bone.

The provided document describes a 510(k) premarket notification for a medical device called the "Multitak Suture System." This type of submission focuses on demonstrating substantial equivalence to a predicate device already on the market, rather than conducting new clinical studies to establish acceptance criteria and performance against those criteria.

Therefore, much of the requested information, specifically regarding detailed acceptance criteria, study methodologies (test set, ground truth, expert involvement, MRMC studies, standalone performance, training set details), and specific performance metrics in numerical terms, is not available in the provided text.

The document primarily focuses on:

• Identifying the device and its intended use.
• Listing predicate devices.
• Stating that performance data was collected (pullout testing).
• Concluding that the device is substantially equivalent to predicate devices based on this testing.

Here's an attempt to answer the questions based only on the provided text, highlighting what is missing:

1. Table of acceptance criteria and the reported device performance

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

• Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document only mentions "pullout testing," which implies laboratory or bench testing rather than human clinical data.

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

• Number of Experts: Not applicable, as this was likely bench testing, not an expert-driven ground truth assessment.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

• Adjudication Method: Not applicable, as this was likely bench testing.

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

• MRMC Study: No. This device is a surgical anchor, not an AI-assisted diagnostic tool, so an MRMC study is not relevant or described.

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

• Standalone Performance: No, this device is a physical surgical implant, not an algorithm.

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

• Type of Ground Truth: For the "pullout testing," the ground truth would inherently be against a quantitative measurement of the mechanical property (pullout strength) of the device itself and its predicate. It's not a clinical "ground truth" derived from patient outcomes or pathology.

8. The sample size for the training set

• Sample Size: Not applicable. This device is a physical medical device, not an AI model, and therefore does not have a "training set."

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

• Ground Truth Establishment: Not applicable, as there is no training set for this type of device.

Summary of the "Study" (Per the Document):

The document states that the Multitak Suture System underwent pullout testing. The "proof" that it meets acceptance criteria (which are implied to be "equal to or better than the predicate device's pullout strength") is the conclusion that the device "demonstrated pullout strength equal to or better than the predicate device(s)." This is a comparative biomechanical study, not a clinical trial with human subjects. The full details of this testing (e.g., specific test methods, number of samples, statistical analysis) are not provided in this summary.

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