(156 days)
The Stryker All Suture Anchors are intended to be used for soft-tissue to bone fixation in the foot, ankle, knee, hip, hand, wrist, elbow and shoulder. See indications below.
Shoulder: Rotator Cuff repair, Bankart repair, SLAP lesion repair, Biceps tendonesis, Acromioclavicular separation repair, Deltoid Repair, Capsular shift or capsulolabral repair
Elbow: Biceps Tendon re-attachment, ulnar or radial collateral ligament reconstruction
Hand/Wrist: Scaphulolunate ligament reconstruction, carpal ligament reconstruction, repair/reconstruction of collateral ligaments, repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joint for all digits, digital tendon repair
Foot/Ankle: Lateral stabilization, Medial stabilization, Achilles tendon repair, metatarsal ligament repair, hallux valgus reconstruction, digital tendon transfers, mid-foot reconstruction
Knee: Medial Collateral Ligament repair, Lateral Collateral Ligament repair, Patellar tendon repair, Posterior oblique ligament repair, iliotibial band tendonesis.
Hip: Capsular repair, acetabular labral repair
The Stryker All Suture Anchors are supplied sterile and intended for single use only.
The Stryker All Suture Anchors are soft-tissue fixation devices with a push-in design, provided preloaded on a disposable inserter. They are composed of a sheath structure that contains one or more working sutures. The sheath bunches as the anchor is deployed to fixate in bone.
Here's the breakdown of the acceptance criteria and study information for the Stryker All Suture Anchors, based on the provided text:
This device is not an AI/ML powered device, so many of the requested fields are not applicable.
Acceptance Criteria and Device Performance
| Acceptance Criteria (Measured Performance Aspect) | Reported Device Performance (Comparison to Predicate) |
|---|---|
| Insertion Strength | Statistically equivalent to predicate devices |
| Fixation Strength | Statistically equivalent to predicate devices |
Study Details
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Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated. The text mentions "ultimate tensile strength testing and an FEA analysis" indicating a certain number of tests were performed, but the exact number of anchors or tests is not provided.
- Data Provenance: Not explicitly stated, but it was "Non-clinical bench testing" which typically means in-lab testing rather than human subject data.
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Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable. This was non-clinical bench testing of a physical medical device (soft tissue anchor), not an AI/ML or diagnostic device requiring expert interpretation for ground truth.
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Adjudication Method for the Test Set:
- Not Applicable. See point 2.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This type of study is for evaluating diagnostic accuracy or reader performance with AI assistance, which is not relevant for a soft tissue anchor.
- Effect Size: Not applicable.
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Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Not Applicable. This is a physical medical device, not an algorithm.
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Type of Ground Truth Used:
- The "ground truth" for this device involved direct physical measurements of mechanical properties (insertion strength, fixation strength) through ultimate tensile strength testing and FEA (Finite Element Analysis). This is objective biomechanical data, not expert consensus, pathology, or outcomes data in the traditional sense.
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Sample Size for the Training Set:
- Not Applicable. This is not an AI/ML device that requires a training set.
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How the Ground Truth for the Training Set Was Established:
- Not Applicable. This is not an AI/ML device that requires a training set.
§ 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.