(39 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device K133469 in indications, design, function, and materials. | The modified Suture Anchor demonstrated substantial equivalence to the predicate in static and dynamic tension along and normal to the screw axis. |
Study Details
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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.
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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.
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Adjudication method for the test set:
- Not applicable. This was preclinical testing, not a study requiring adjudication of a test set.
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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.
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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.
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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.
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The sample size for the training set:
- Not applicable. There was no training set, as this was preclinical testing of a physical device.
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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.
§ 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.