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The Acumed Suture Anchor System is designed to be used for soft tissue fixation in the foot, ankle, knee, hand, wrist, elbow, and shoulder.

The Acumed Suture Anchor System is intended to be used for suture (soft tissue) fixation to bone in the foot, ankle, knee, hand, wrist, elbow, and shoulder.

Shoulder: Rotator Cuff Repair, Bankhart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular shift or Capsulolabral Reconstruction.

Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Foot/Ankle: Lateral Stabilization, Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair and Bunionectomy.

Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair and Illiotibial Band Tenodesis.

Hand/Wrist: Scapholunate Ligament Reconstruction and Ulnar or Radial Collateral Ligament Reconstruction.

Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair.

The Acumed Suture Anchor System is a system for anchoring soft tissue grafts), using #2 high-strength suture, back to the bone for reattachment. It is available in diameters of 4.5 mm & 5.5 mm in order to accommodate differing anatomic requirements.

The anchor is a screw designed to provide fixation to bone that comes with two, #2 high-strength suture (pre-attached) in order to secure soft tissue (or soft tissue grafts) to the anchor. The system includes Class 1 instruments.

The provided document describes a medical device, the Acumed Suture Anchor System, and its acceptance criteria for 510(k) clearance. However, the study supporting this clearance is a preclinical testing rather than a study involving human subjects or AI algorithms. As such, many of the requested categories related to AI performance, human expert involvement, and ground truth establishment are not applicable.

Here's the information derived from the provided text:

Acceptance Criteria and Reported Device Performance

Study Details

1. Sample Size used for the test set and the data provenance:

   • Not applicable. The study involved preclinical testing of the modified suture anchor, not a test set of data or human subjects.

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

   • Not applicable. The ground truth was based on the physical properties and performance of the device in preclinical testing. No human experts were used to establish a ground truth for a test set.

3. Adjudication method for the test set:

   • Not applicable. This was preclinical testing, not a study requiring adjudication of a test set.

4. 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 was preclinical testing of a medical device, not an MRMC study involving human readers or AI.

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

   • Not applicable. This was preclinical testing of a physical medical device, not an algorithm.

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

   • Preclinical Testing Results: The ground truth was established through physical testing (static and dynamic tension tests) comparing the modified device's performance to the predicate device.

7. The sample size for the training set:

   • Not applicable. There was no training set, as this was preclinical testing of a physical device.

8. How the ground truth for the training set was established:

   • Not applicable. There was no training set. The "ground truth" for the preclinical performance was established via engineering and biomechanical testing standards.

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The Acumed Suture Anchor System is intended to be used for suture (soft tissue) fixation to bone in the foot, ankle, knee, hand, wrist, elbow, and shoulder.

Shoulder: Rotator Cuff Repair, Bankhart 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, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair and Bunionectomy.

Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair and Illiotibial Band Tenodesis.

Hand/Wrist: Scapholunate Ligament Reconstruction and Ulnar or Radial Collateral Ligament Reconstruction.

Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis repair.

The Acumed Suture Anchor System is a system for anchoring soft tissue (or soft tissue grafts), using #2 high-strength suture, back to the bone for reattachment. It is available in diameters of 3.5mm & 4.5mm in order to accommodate differing anatomic requirements.

The anchor is a screw designed to provide fixation to bone that comes with two, #2 high-strength suture (pre-attached) in order to secure soft tissue (or soft tissue grafts) to the anchor.

The system includes Class 1 instruments.

The provided document describes the Acumed Suture Anchor System, a medical device for soft tissue fixation to bone. The information primarily focuses on the device's description, intended use, indications for use, technological characteristics, and a comparison to a predicate device for substantial equivalence.

However, the provided text does not contain information related to acceptance criteria or a study proving the device meets specific performance metrics in the way a diagnostic AI/ML device would. This document describes a traditional medical implant, where "performance data" refers to mechanical testing for strength and equivalence to an existing device, not diagnostic accuracy, sensitivity, or specificity.

Therefore, for your specific request that includes acceptance criteria, sample sizes for test sets, ground truth establishment, expert involvement, MRMC studies, or standalone algorithm performance, the provided document does not contain this information.

The "Performance Data" section states:

"The Acumed Suture Anchor System and the predicate were subjected to static and dynamic tension along the axis of the screw as well as static and dynamic tension normal to the axis of the screw. The results demonstrate that the subject components are substantially equivalent to the predicate."

This indicates engineering/mechanical testing to show the new device performs similarly to a previously approved device (the predicate). It does not involve a clinical study with human patients, diagnostic performance metrics, or the establishment of ground truth in a diagnostic sense.

To directly answer your numbered points based on the provided text:

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

   • Acceptance Criteria: Not explicitly stated as pass/fail thresholds for specific engineering metrics. Instead, the criterion for approval is "substantial equivalence" to the predicate device based on mechanical performance.
   • Reported Device Performance: "The results demonstrate that the subject components are substantially equivalent to the predicate."

   Performance Metric	Acceptance Criteria (Implicit)	Reported Device Performance
   Mechanical Strength (Static and Dynamic Tension along/normal to screw axis)	Performance comparable to predicate device (Arthrex 3.7 mm Bio-Corkscrew (K061863))	Demonstrated substantial equivalence to the predicate.

2. Sample sized used for the test set and the data provenance: Not applicable. This was mechanical testing, not a clinical trial with a "test set" of patients or data provenance in the context of diagnostic AI.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for diagnostic AI (e.g., expert consensus on images, pathology reports) is not relevant for this mechanical testing.

4. Adjudication method: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, as it's not an algorithm/AI device.

7. The type of ground truth used: For mechanical testing, the "ground truth" would be the measured physical properties (e.g., tensile strength, fatigue resistance) of the devices under controlled conditions, compared against the known properties of the predicate device. This isn't "expert consensus" or "pathology" in the diagnostic sense.

8. The sample size for the training set: Not applicable, as this is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) summary for a traditional medical device (a suture anchor), and the "performance data" described relates to mechanical testing for substantial equivalence, not the diagnostic performance criteria typically associated with AI/ML devices that would require the detailed information requested in your prompt.

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