(118 days)
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:
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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. -
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.
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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. Ground truth as typically defined for diagnostic AI (e.g., expert consensus on images, pathology reports) is not relevant for this mechanical testing.
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Adjudication method: Not applicable.
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If a multi reader multi case (MRMC) comparative effectiveness study was done: No.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, as it's not an algorithm/AI device.
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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.
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The sample size for the training set: Not applicable, as this is not an AI/ML device.
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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.
§ 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.