(29 days)
The OSSIOfiber® Suture Anchors are indicated for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow, 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.
- Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair and Bunionectomy.
- Knee: Anterior Cruciate Ligament Repair (4.75-5.5 Anchors Only), Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Quadriceps Tendon Repair and Meniscal Root Repair. Secondary or adjunct fixation of ACL/PCL reconstruction or repair (4.75 – 5.5 Anchors only).
- Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collament Reconstruction.
- Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis repair (Tennis Elbow).
The OSSIOfiber® Suture Anchor consists of an eyelet and anchor body preloaded on an inserter. The anchor body and eyelet are made from poly (L-lactide-co-D,L-lactide) (PLDLA) reinforced with continuous mineral fibers. OSSIOfiber® implants have been shown to be biocompatible. The polymer content degrades by hydrolysis into alpha-hydroxy acids that are metabolized by the body. The fibers are made from minerals that are found in natural bone. As the OSSIOfiber® implants degrade, the load transfers to the surrounding anatomy throughout the healing period of the bone. Substantial degradation takes place within approximately 18 months as shown in pre-clinical studies, thus eliminating the requirement for future hardware removal surgery. Sutures, needles and suture snare may also be provided with the device depending on configuration.
The OSSIOfiber® Suture Anchors are sterile, single-use, and non-pyrogenic.
The provided FDA 510(k) clearance letter and summary for the OSSIOfiber® Suture Anchor (K251309) primarily focus on non-clinical performance data to support substantial equivalence. It's important to note that this document does not describe a study involving human subjects or AI-assisted diagnosis/treatment. Instead, it details a mechanical device and its performance for surgical fixation.
Therefore, many of the requested elements pertaining to AI, human readers, ground truth establishment for clinical data, and training/test set samples for AI models are not applicable to this specific submission.
However, we can extract information regarding the acceptance criteria and the study (non-clinical) that proves the device meets the acceptance criteria as presented in the document.
Analysis of Acceptance Criteria and Device Performance (Non-Clinical)
The submission for the OSSIOfiber® Suture Anchor (K251309) is a Special 510(k) premarket notification to expand the existing indications for use to include "Meniscal Root Repair." The core of the justification for substantial equivalence relies on demonstrating that the device's performance for this new indication is comparable to its predicate devices, primarily through non-clinical (mechanical) testing.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly present a table with numerical acceptance criteria and corresponding reported device performance values in the format typically seen for clinical or AI studies. Instead, the "acceptance criteria" are implied by demonstrating equivalent or superior mechanical performance to the predicate devices for critical aspects relevant to a suture anchor (e.g., fixation strength, degradation characteristics).
The study that proves the device meets (or aligns with) these implied criteria is the non-clinical testing previously conducted and referenced.
| Category of Performance | Implied Acceptance Criterion (Compared to Predicate) | Reported Device Performance (Summary from K213415) |
|---|---|---|
| Mechanical Strength | Equivalent or superior static pull-out strength in relevant anatomical models. | "[A rationale was provided to support the addition of the Meniscal Root Repair indication, which was based on the comparative static pull-out and cyclic pull-out testing included within K213415.]" This implies the previous testing demonstrated the OSSIOfiber® Suture Anchor's static pull-out strength was sufficient and comparable to predicates. (Specific numerical values for acceptance and performance are not provided in this summary.) |
| Cyclic Loading/Durability | Equivalent or superior cyclic pull-out strength/resistance to fatigue under physiological loads. | "[A rationale was provided to support the addition of the Meniscal Root Repair indication, which was based on the comparative static pull-out and cyclic pull-out testing included within K213415.]" This implies the previous testing demonstrated the device's cyclic pull-out strength was sufficient and comparable to predicates. (Specific numerical values for acceptance and performance are not provided in this summary.) |
| Biocompatibility | Biocompatible, without adverse tissue reactions during and after degradation. | "Biocompatibility and magnetic resonance (MR) safety compatibility was established within the primary predicate submission (K213415)." This indicates the device passed biocompatibility testing. |
| Material Degradation | Degradation profile (rate and byproducts) that is safe and allows load transfer to healing tissue. | "The polymer content degrades by hydrolysis into alpha-hydroxy acids that are metabolized by the body. The fibers are made from minerals that are found in natural bone. As the OSSIOfiber® implants degrade, the load transfers to the surrounding anatomy throughout the healing period of the bone. Substantial degradation takes place within approximately 18 months as shown in pre-clinical studies..." |
| MR Safety | MR Safe or MR Conditional. | "Biocompatibility and magnetic resonance (MR) safety compatibility was established within the primary predicate submission (K213415)." |
Note: The document only provides meta-information about the testing (that it was done, and what kind), not the raw numerical results or specific acceptance thresholds. The "rationale" refers to the interpretative analysis of that data.
2. Sample Size and Data Provenance (for the mechanical test)
- Sample Size: The document states that the rationale for the new indication was "based on the comparative static pull-out and cyclic pull-out testing included within K213415." However, the exact sample sizes (e.g., number of anchors tested, number of cycles) for the static and cyclic pull-out tests are not specified in this 510(k) summary. This information would typically be found in the full test reports referenced in the initial K213415 predicate submission.
- Data Provenance: The testing is non-clinical (laboratory-based mechanical testing). It's not data from human subjects or collected from real-world patients. The origin of the data is from the device manufacturer's (Ossio Ltd.) internal testing, likely at a certified testing facility.
- Country of Origin: Not explicitly stated for the testing, but Ossio Ltd. is based in Caesarea, Israel.
- Retrospective or Prospective: This distinction doesn't fully apply to mechanical testing in the same way it does to clinical studies. The tests were performed prospectively according to established protocols to generate data for regulatory submission.
3. Number of Experts and their Qualifications (for mechanical testing)
This question is Not Applicable in the context of this mechanical device submission, as the "ground truth" is established through physical measurements and engineering principles, not expert human interpretation like in AI/imaging studies. The "experts" involved would be engineers and technical specialists conducting and analyzing the mechanical tests according to industry standards.
4. Adjudication Method (for mechanical testing)
This question is Not Applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements in human expert interpretations (e.g., radiology reads). For mechanical testing, the "ground truth" is directly measured, and results are verified through standard quality control and robust test methodologies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not Applicable. This is a question relevant to AI-assisted diagnostic or imaging devices, not a mechanical surgical implant. No human readers or AI assistance in interpretation are involved in the use or evaluation of a suture anchor.
6. Standalone (Algorithm Only) Performance
Not Applicable. This would apply to AI algorithms. The OSSIOfiber® Suture Anchor is a physical medical device, not an algorithm.
7. Type of Ground Truth Used (for the mechanical testing)
- The "ground truth" for this device's performance is established through physical, quantifiable measurements from standardized mechanical tests.
- Static Pull-out: The maximum force required to pull the anchor out of simulated bone material.
- Cyclic Pull-out: The anchor's resistance to displacement or failure under repeated loading cycles.
- Material Degradation: Chemical and physical analysis of the material over time (e.g., mass loss, molecular weight changes, mechanical property retention).
- It is not expert consensus, pathology, or outcomes data in the clinical sense.
8. Sample Size for the Training Set (for a mechanical device)
Not Applicable. This concept applies to machine learning models. For a mechanical device, there isn't a "training set" in the AI sense. Design and material selection are based on engineering principles and prior knowledge, not iterative training on data.
9. How the Ground Truth for the Training Set was Established (for a mechanical device)
Not Applicable. As there is no AI training set, this question is not relevant. The "truth" about the materials and design comes from established scientific and engineering principles, material characterization, and prior performance data of similar devices and materials. The non-clinical data demonstrates the performance of the final device, not establishes ground truth for a training set.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.