(121 days)
The ReelX STT Suture Anchor System is indicated for use in fixating suture or soft tissue fixation to bone in the shoulder, foot and ankle, knee, and elbow. The anchor is indicated for use in the following procedures:
Shoulder:
Rotator Cuff Repair
Bankart Repair
SLAP Lesion Repair
Biceps Tenodesis
Acromio-Clavicular Separation Repair
Deltoid Repair
Capsular Shift/Capsulolabral Reconstruction
Knee:
Medial Collateral Ligament Repair
Lateral Collateral Ligament Repair
Patellar Tendon Repair
Posterior Oblique Ligament Repair
Illiotibial Band Tenodesis
Foot and Ankle:
Lateral Stabilization
Medial Stabilization
Achilles Tendon Repair
Hallux Valgus Reconstruction
Midfoot Reconstruction
Metatarsal Ligament Repair
Elbow:
Biceps Tendon Reattachment
The ReelX STT Suture Anchor System is intended for single-use only.
The ReelX STT Suture Anchor System Line Extension (here forth referred to as the 3.9mm ReelX STT Suture Anchor) is an anchor designed to facilitate fixation of soft tissue to bone. The system is comprised of a PEEK polymer and titanium suture anchor preloaded on a disposable inserter. This anchor design allows the surgeon to adjust the tension of the tissue after the anchor has been inserted in bone.
This submission to the FDA is for a 510(k) premarket notification for a medical device, the Stryker ReelX STT™ Suture Anchor System Line Extension. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical efficacy or diagnostic accuracy through extensive clinical trials. Therefore, the device does not have acceptance criteria and a study proving the device meets those criteria in the typical sense for a diagnostic AI device.
However, based on the provided document, we can describe the "acceptance criteria" and "study" in the context of a 510(k) submission for a physical medical device:
Acceptance Criteria and Device Performance for Stryker ReelX STT™ Suture Anchor System Line Extension
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (based on substantial equivalence to predicates) | Reported Device Performance (3.9mm ReelX STT Suture Anchor) |
|---|---|
| Insertion Strength: Substantially equivalent to predicate devices (K090530, K051219, K970896). | Performance indicates substantial equivalence to predicate devices. |
| Fixation Strength: Substantially equivalent to predicate devices (K090530, K051219, K970896). | Performance indicates substantial equivalence to predicate devices. |
| Intended Use: Function within the specified indications for use (fixating suture or soft tissue to bone in shoulder, foot/ankle, knee, elbow). | Testing indicates the device will function within its intended use. |
| Design, Materials, Performance Attributes, Operational Principles: Consistent with predicate devices. | Stated to be substantially equivalent to other commercially available soft tissue anchors in these aspects. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "non-clinical ultimate tensile strength testing." It does not specify the exact sample size used for this testing. The data provenance is industrial data from a laboratory setting (Stryker/Howmedica Osteonics Corp.), not patient or clinical data. There is no mention of retrospective or prospective data as it's a non-clinical, mechanical test.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. For a mechanical device, "ground truth" is typically established by engineering standards, validated test methods, and comparison against the performance of legally marketed predicate devices, not by expert medical opinion on a test set. Engineering principles and established material testing methodologies guide the performance evaluation.
4. Adjudication Method for the Test Set
Not applicable. Mechanical testing results are objective measurements of physical properties (tensile strength) and are compared directly to predicate device performance or industry standards, not adjudicated by experts in the way clinical or image-based studies are.
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 device is a physical suture anchor, not an AI or diagnostic imaging device. No MRMC study was conducted or is relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical implant, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's evaluation is primarily established by:
- Performance of predicate devices: The mechanical properties (insertion and fixation strength) of the 3.9mm ReelX STT Suture Anchor were compared directly to those of the legally marketed predicate devices (Spin-Loc Suture Anchor System/5.5mm ReelX STT Suture Anchor, Arthrex PushLock, DePuy Mitek Panalok Anchor).
- Engineering standards: Implied that the tests were conducted according to recognized engineering and material testing standards to ensure accurate and reproducible results for ultimate tensile strength.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical implant and does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
Summary of the Study Proving Acceptance Criteria (in the context of 510(k)):
The study conducted was non-clinical ultimate tensile strength testing. This testing aimed to characterize the mechanical performance of the 3.9mm ReelX STT Suture Anchor, specifically its insertion strength and fixation strength.
The purpose of this testing was to demonstrate substantial equivalence to existing legally marketed predicate devices:
- K090530 - Spin-Loc Suture Anchor System (legally marketed as Stryker ReelX STT Suture Anchor)
- K051219 - Arthrex PushLock
- K970896 - DePuy Mitek Panalok Anchor
The results of this non-clinical testing indicated that the performance of the 3.9mm ReelX STT Suture Anchor System "is substantially equivalent to the predicate devices, and the subject anchors will function within the intended use."
Clinical testing was explicitly stated as "not required for this submission," further emphasizing the non-clinical nature of the evidence provided to meet the requirements for initial market clearance through the 510(k) pathway.
§ 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.