(276 days)
The BowTie™ SI Joint Fusion System is indicated for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. When the Bow Tie SI Fusion System is implanted, both the Iliac and Transfix Screw components must be used.
The BowTie™ SI Joint Fusion System is intended to provide stabilization of the sacroiliac joint until fusion occurs. The device consists of an implant and a set of ancillary instruments. The implant is comprised of an interarticular component, an iliac screw, and a transfix screw. All implant components are titanium and available in various sizes to accommodate varying patient anatomy. The implant components are provided gamma sterilized and individually packaged. The ancillary instruments are provided non-sterile and will be sterilized by the end user.
This is a medical device, not an AI/ML powered device, so many of the requested fields are not applicable.
Here's a breakdown of the requested information based on the provided text, with "N/A" where the information is not present or not relevant to this type of device:
1. Table of Acceptance Criteria and Reported Device Performance
For this medical device (BowTie™ SI Joint Fusion System), "acceptance criteria" and "reported device performance" are typically demonstrated through biomechanical testing and comparison to predicate devices, rather than accuracy metrics seen in AI/ML solutions. The document states that testing was performed to demonstrate substantial equivalence and that there are no new risks.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biomechanical performance equivalent to predicate devices | Bench Testing Performed and Results (Summary): |
- Cadaveric Biomechanical Evaluation of SAIL Implant Construct
- Implant Static Torsion per ASTM F3574
- Fatigue Vertical Shear Testing per ASTM F3574
- Porous Coating Characterization per ASTM F1854
- Implant Fatigue Torsion Testing per ASTM F3574
- Static Vertical Shear Testing per ASTM F3574
- Bone Screw Mechanical Testing – Torsion Strength per ASTM F543
- Bone Screw Mechanical Testing – Insertion Torque per ASTM F543
- Bone Screw Mechanical Testing – Pull-Out per ASTM F543
- Bone Screw Mechanical Testing – Static Cantilever Bending Testing per ASTM F2193
- Bone Screw Mechanical Testing – Fatigue Cantilever Bending Testing per ASTM F2193
Conclusion: "rationales and mechanical testing of the BowTie™ SI Joint Fusion System indicated there are no new risks and demonstrated substantial equivalence in performance compared to a legally marketed predicate." |
| Materials meet specified ASTM standards and are biocompatible | Interarticular component: Ti-6Al-4V ELI per ASTM F3001
Screws: Ti-6Al-4V ELI per ASTM F136 |
| Device design is consistent with its intended use | "The BowTie™ SI Joint Fusion System implant components are made from similar materials and have equivalent design philosophy, sizing, configurations, fixation methods, sterilization and packaging, and surgical approach to the predicate device." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated for each test, but standard biomechanical tests involve a discreet number of samples. For the cadaveric study, the number of cadavers used is not specified.
- Data Provenance: N/A for this type of device submission. Biomechanical testing is conducted in a lab environment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: N/A. Ground truth is established through physical and mechanical testing according to recognized standards (e.g., ASTM).
- Qualifications of Experts: N/A.
4. Adjudication method for the test set
- Adjudication Method: N/A. Results are typically determined by direct measurement or observation during standardized testing.
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
- MRMC Study: No. This is not an AI-assisted diagnostic device.
- Effect Size: N/A.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: No. This is a physical implant device, not an algorithm.
7. The type of ground truth used
- Type of Ground Truth: Established through adherence to recognized industry standards (e.g., ASTM for material properties and mechanical performance) and comparison to a legally marketed predicate device. The cadaveric study provides real-world simulation for biomechanical evaluation.
8. The sample size for the training set
- Sample Size for Training Set: N/A. There is no "training set" in the context of this physical medical device. Device design and development involve engineering principles, material science, and iterative testing, not machine learning training.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: N/A. See above.
§ 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.