(66 days)
The intended use of the Stryker Wedge Suture Anchor System is for securing soft tissue to bone in such procedures as rotator cuff tear repair, bankart lesion repair, and SLAP lesion repair in the shoulder, as well as achilles tendon repair in the foot/ankle, medial collateral ligament repair in the knee, scapholunate ligament reconstruction in the hand/wrist, and biceps tendon reattachment in the elbow. The Stryker Wedge Suture Anchor system is intended for the fixation of surgical suture material to the pelvis only for the purpose of bladder neck suspension female urinary incontinence due to urethral hyper mobility or intrinsic sphincter deficiency. The suture anchor engages in bone so as to provide a stable bony attachment site for the soft tissue. This device is intended to be used primarily in arthroscopic repairs, but is suitable in open procedure as well, and is intended for single-use only. This device is intended for use only for the fixation of non-absorbable synthetic sutures.
Stryker Wedge Suture Anchors are titanium alloy implants used to anchor suture within bone sites for firmly securing soft tissue to bone. The Anchors are self-drilling, self-tapping, threaded devices. The Anchor is supplied with non-absorbable braided polyester suture assembled to a disposable inserter. The sutures are color-coded white and green for visual identification of the individual strands during use.
The provided text describes the Stryker Wedge Suture Anchor System and its comparison to a predicate device, the Arthrex FASTak™ Suture Anchor, to demonstrate substantial equivalence for regulatory approval. The primary study presented focuses on pull-out strength in bone.
Here's the breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in a numerical format that must be met. Instead, it demonstrates substantial equivalence to a predicate device, Arthrex FASTak™ Suture Anchor, primarily by comparing pull-out strength in bone. The implication is that if the Stryker device performs similarly or better than the predicate, it meets the "acceptance criterion" of substantial equivalence.
| Characteristic / Study Parameter | Acceptance Criteria (Implied by Predicate Performance) | Reported Stryker Wedge Suture Anchor Performance |
|---|---|---|
| Pull-out Strength (lbf): | ||
| 2.4mm Anchor (Arthrex FASTak) | Diaphyseal: 38 | |
| Metaphyseal: 43 | ||
| Cancellous: 43 | ||
| 1.9mm Anchor | Greater than or equal to Arthrex 2.4mm anchor | Diaphyseal: 43.5 |
| Metaphyseal: 51.8 | ||
| Cancellous: 40.7 (slightly lower than predicate's 43 for cancellous bone)* | ||
| 2.7mm Anchor | Greater than or equal to Arthrex 2.4mm anchor | Diaphyseal: 53.9 |
| Metaphyseal: 47.6 | ||
| Cancellous: 49.9 | ||
| 3.4mm Anchor | Greater than or equal to Arthrex 2.4mm anchor | Diaphyseal: 73.7 |
| Metaphyseal: 72.9 | ||
| Cancellous: 74.7 | ||
| 4.5mm Anchor | Greater than or equal to Arthrex 2.4mm anchor | Diaphyseal: 73.6 |
| Metaphyseal: 72.8 | ||
| Cancellous: 75.4 | ||
| 4.9mm Anchor | Greater than or equal to Arthrex 2.4mm anchor | 18 pcf foam: 47.6 |
Note: While 40.7 lbf in cancellous for the 1.9mm anchor is slightly below the predicate's 43 lbf, the device has various sizes, many of which significantly exceed the predicate's strength, supporting overall substantial equivalence. The document does not specify a minimum threshold for substantial equivalence, relying on comparative performance.
2. Sample Size Used for the Test Set and Data Provenance
The document states "Study performed by Barber and Lorang, Plano Orthopedic & Sports Medicine J t Center". It also mentions "Testing performed using 18 pcf density foam block to simulate cancellous bone".
- Sample Size for Test Set: Not explicitly stated. The table shows pull-out strength values, but does not specify how many individual tests were performed for each anchor size and bone type.
- Data Provenance: The study was performed by "Barber and Lorang, Plano Orthopedic & Sports Medicine J t Center". The text doesn't explicitly state the country of origin, but "Plano" suggests the USA. The data is retrospective in the sense that it refers to previously conducted tests, including a published reference for the predicate device's data ("Barber, M.D., 'Suture Anchor Strength Revisited' Arthroscopy: The Journal of Arthroscopic and Related Surgery, February, 1996.").
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The concept of "ground truth" established by experts, as typically seen in diagnostic AI studies, does not directly apply here. The "ground truth" for this device's performance is the mechanical pull-out strength, which is an objective measurement obtained through physical testing, not expert interpretation.
4. Adjudication Method for the Test Set
Not applicable. This is a physical mechanical test, not reliant on human interpretation or adjudication.
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
Not applicable. This is a medical device (suture anchor), not an AI-powered diagnostic or interpretive tool. There are no "human readers" or "AI assistance" involved in its direct function.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device.
7. The Type of Ground Truth Used
The ground truth used for performance evaluation is objective physical measurement of pull-out strength in bone (or simulated bone). This is a direct measure of the device's mechanical performance.
8. The Sample Size for the Training Set
Not applicable. This document describes a physical medical device, not a machine learning algorithm. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there's no training set for an algorithm, there's no ground truth established for it.
§ 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.