(85 days)
The OsteoFab® Suture Anchors are intended to be used for the fixation/reattachment of soft tissue to bone in the shoulder, knee, hand and wrist, elbow, and foot and ankle in the following procedures:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction, Anterior Shoulder Instability Repair.
Knee: Extra Capsular Ligament Repair, Patellar Realignment and Tendon Repairs, and Illiotibial Band Tenodesis.
Hand and Wrist: Ulnar or Lateral Collateral Ligament Reconstruction, Collateral Ligament Reconstruction or Repair.
Elbow: Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair, Biceps Tendon Repair.
Foot and Ankle: Hallux Valgus Repairs, Medial or Lateral Instability Repairs and Reconstructions, Achilles Tendon Repairs and Reconstructions, Midfoot Reconstructions, Metatarsal Ligament/Tendon Repairs and Reconstructions, Bunionectomy.
The OsteoFab® Suture Anchor is a single procedure suture anchor device for the reattachment of soft tissue to bone in shoulder, knee, hand and wrist, elbow, and foot and ankle procedures. This reattachment of damaged soft tissue is achieved with suture that is threaded through an anchor which is fixated in bone via interference fit between the anchor and bone. The anchor is mounted on a custom inserter and threaded with recommended suture before deployment. The OsteoFab® Suture Anchors are manufactured from polyetherketone (PEKK) polymer in Oxford Performance Materials, Inc.'s proprietary additive manufacturing process. The OsteoFab® Suture Anchors are available in three sizes (4.5, 5.5, ad 6.5mm) and are provided non-sterile.
The provided text describes a medical device (OsteoFab® Suture Anchors) and its performance data submitted to the FDA for 510(k) clearance. This means the primary focus is on establishing substantial equivalence to a predicate device, rather than proving novel efficacy through clinical trials. Therefore, much of the information typically found in an AI/Software as a Medical Device (SaMD) study (like detailed test set specifics, expert qualifications for ground truth, MRMC studies, or training set details) is not present here as it is not applicable to a device like a physical suture anchor.
However, I can extract the relevant information from the document regarding acceptance criteria and the studies performed to demonstrate substantial equivalence.
Acceptance Criteria and Study for OsteoFab® Suture Anchors
The OsteoFab® Suture Anchors are physical medical devices, not an AI/SaMD. As such, the "acceptance criteria" and "study" are focused on mechanical performance, biocompatibility, and substantial equivalence to a legally marketed predicate device, rather than diagnostic accuracy or human reader improvement.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Tests Performed | Reported Device Performance (Summary) |
|---|---|---|
| Mechanical Performance | Insertion Testing | Demonstrated adequate mechanical strength and function. |
| Static Pullout Testing | Demonstrated adequate mechanical strength and function. | |
| Fatigue Testing | Demonstrated adequate mechanical strength and function. | |
| Biocompatibility | Cytotoxicity | Deemed biocompatible for long-term implantation. |
| Sensitization | Deemed biocompatible for long-term implantation. | |
| Intracutaneous Reactivity | Deemed biocompatible for long-term implantation. | |
| Systemic Toxicity | Deemed biocompatible for long-term implantation. | |
| Pyrogenicity | Deemed biocompatible for long-term implantation. | |
| Genotoxicity | Deemed biocompatible for long-term implantation. | |
| Implantation | Deemed biocompatible for long-term implantation. | |
| Chronic Toxicity | Deemed biocompatible for long-term implantation. | |
| Carcinogenicity | Deemed biocompatible for long-term implantation. | |
| Endotoxin Testing | Deemed biocompatible for long-term implantation. | |
| Sterilization & Cleaning | Sterilization effectiveness | Instructions provided "per validated methods and parameters." |
| Cleaning effectiveness | Instructions provided "per validated methods and parameters." |
The overarching acceptance criterion for the 510(k) submission is to demonstrate substantial equivalence to the predicate device (K122314 Cayenne Quattro Link Knotless Anchors) in terms of safety and effectiveness. The performance data listed above were presented to support this conclusion.
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify the exact sample sizes (e.g., number of anchors tested) for the mechanical bench tests or the biocompatibility tests. Product safety and performance tests are typically conducted on a representative sample of finished devices according to validated protocols.
- Data Provenance: The studies were internal company tests ("Performance Bench Testing," "Biocompatibility Testing"). No information is provided regarding the specific geographical origin of data beyond the company's US location.
- Retrospective/Prospective: These are laboratory and bench tests, not clinical studies, so the terms "retrospective" or "prospective" are not applicable in this context.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This concept is not directly applicable to the evaluation of a physical medical device like a suture anchor. The "ground truth" for mechanical and biocompatibility testing is established through standardized engineering and biological test methods, often specified by international standards (e.g., ISO standards for biocompatibility). The results are objectively measured (e.g., force, displacement, cellular response) rather than requiring expert consensus on subjective interpretations.
4. Adjudication Method for the Test Set
Not applicable. As described above, these are objective physical and biological tests, not evaluations requiring human adjudication of subjective data.
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/SaMD designed to assist human readers or provide diagnostic information.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical suture anchor, not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device consists of:
- Mechanical performance standards: Established engineering principles and, likely, comparison against the predicate device's known mechanical properties. The goal is to demonstrate that the new device meets or exceeds appropriate strength and durability.
- Biocompatibility standards: International standards (e.g., ISO 10993 series) for evaluating biological response to medical devices.
- Predicate device performance: The performance of the legally marketed predicate device (K122314 Cayenne Quattro Link Knotless Anchors) serves as a benchmark for demonstrating substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set was Established
Not applicable. As a physical medical device, there is no "training set" or "ground truth" in the AI/ML sense.
§ 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.