(58 days)
Coronet Soft Tissue Fixation System is intended for fixation of tissue to bone and tissue to tissue.
This product is intended for the following indications:
- Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
- Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair
- Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair
- Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar and Radial Ligament Reconstruction
- Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar and Radial Ligament Reconstruction
The Coronet Soft Tissue Fixation System consists of a single-use, sterile implant used to fixate tissue to bone and tissue to tissue. The implant consists of an anchor and soft tissue washer interconnected via a continuous loop of suture. The implant comes pre-assembled to an inserter, which facilitates concurrent placement of the anchor and soft tissue washer. A drill bit is provided to allow for the creation of a properly sized pilot hole in the bone implantation site.
This document, a 510(k) premarket notification for the Coronet Soft Tissue Fixation System, focuses on demonstrating substantial equivalence to predicate devices, primarily through bench testing of mechanical properties and biocompatibility, rather than a clinical study evaluating diagnostic or prognostic performance with human subjects or AI-assisted interpretation.
Therefore, many of the requested elements for a study proving a device meets acceptance criteria, particularly those related to a diagnostic or AI-driven device, are not applicable to this submission. The device described here is a medical implant (Coronet Soft Tissue Fixation System), not an AI algorithm or a diagnostic tool that provides performance metrics like sensitivity, specificity, or AUC, which would require the detailed study design (sample size, expert consensus, MRMC studies, etc.) that you inquire about.
However, I will extract the relevant information from the provided text that pertains to the "acceptance criteria" and "proof" for this specific type of device, which largely involves bench testing to demonstrate performance characteristics and safety.
Here's a breakdown based on the document:
1. A table of acceptance criteria and the reported device performance
The document doesn't present a formal table of acceptance criteria with quantitative thresholds alongside reported device performance results in the way one would for a diagnostic model's statistical metrics. Instead, it states that "Benchtop testing comparing Coronet to the ZipE and TwinLoop predicates demonstrates the Coronet system is substantially equivalent and introduces no new for different questions of safety or effectiveness." This implies that the acceptance criterion for these tests was equivalence (or non-inferiority) to the predicate devices regarding their performance, but specific numeric acceptance thresholds and actual measured values are not provided in this summary.
Here are the categories of performance data mentioned:
| Testing Category | Specific Tests Performed | Implied Acceptance Criteria (Based on Substantial Equivalence) |
|---|---|---|
| Bench Testing | - Static pullout testing |
- Cyclic testing
- Insertion testing
- Fatigue limit testing | Performance (e.g., strength, durability, ease of use, resistance to forces) comparable or superior to predicate devices (ZipE, TwinLoop, Synthes Spiked Metallic Washer). The device "introduces no new or different questions of safety or effectiveness." Actual numeric values not disclosed. |
| Human Factors | - End-user validation | Successful and safe use by intended users. Acceptable ease of use and functionality. |
| Biocompatibility | - Cytotoxicity - Sensitization
- Irritation
- Pyrogen testing
- MEM elution testing
- Acute system injection
- Intramuscular implantation | Biologically safe; no adverse reactions in biological systems. Compliance with ISO 10993 standards. Implants must not induce harmful reactions. |
| Sterilization | - Bioburden - Relative resistance
- EO residual testing
- Endotoxin (LAL) validation | Device is effectively sterilized and safe for human use; no harmful residues or microbial contamination. |
| MR Compatibility | - Induced displacement testing - Induced torque testing
- Induced heating testing
- Image artifact testing | Device is safe for use in an MRI environment; no significant displacement, torque, heating, or image artifacts. |
| Packaging | - Package integrity tests - Accelerated aging | Packaging maintains sterility and device integrity over its shelf life. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated for each test. For mechanical bench testing, a certain number of devices would be tested, typically to statistical significance, but the exact N is not provided in this summary.
- Data Provenance: This is bench testing of physical devices. It is not patient or clinical data. Therefore, concepts like "country of origin of the data" (for patients) or "retrospective/prospective" studies are not applicable. The tests were performed on the manufactured Coronet Soft Tissue Fixation System samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This concept is not applicable for a device that relies on physical/mechanical and biocompatibility testing. "Ground truth" in this context is established by standardized testing protocols (e.g., ASTM, ISO standards) and measurable physical properties, not expert consensus on medical images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are used in studies involving human interpretation (e.g., radiologists reviewing images) to resolve discrepancies and establish a consensus ground truth. This is not relevant for bench testing of an implant.
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. An MRMC study is designed to evaluate the performance of human readers, often with and without AI assistance, in interpreting medical images. This device is an implant, not a diagnostic imaging AI, and thus no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is not an algorithm or AI device. "Standalone performance" as described (algorithm only) is not relevant. The "standalone performance" of the Coronet system refers to its physical and functional integrity in bench tests.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For bench testing: The "ground truth" is defined by established engineering and material science principles, regulatory standards (e.g., ISO, ASTM for pullout strength, fatigue, biocompatibility), and comparison to the known effective performance of legally marketed predicate devices. There is no "pathology" or "outcomes data" in this context, as these are pre-market safety and efficacy validations, not post-market clinical trials.
8. The sample size for the training set
- Not applicable. This device is not an AI model that requires a training set. Its design and manufacturing are based on established engineering principles for medical devices, not machine learning.
9. How the ground truth for the training set was established
- Not applicable for the same reason as #8.
§ 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.