(137 days)
Intended for the reattachment of soft tissue to bone in the shoulder, foot/ankle, knee, elbow and hand/wrist for the following indications:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Scparation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Revair, Hallux Valgus Reconstruction, Mid-Foot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon Reconstruction, Tendon Transfer in the Foot and Ankle
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpal Ligament Reconstruction and Repair, Tendon Transfer in the Hand/Wrist
The PRO Fixation™ System is a sterile single use device intended for the reattachment of soft tissue to bone. The PRO Fixation System is comprised of an implantable non-absorbable anchor and a disposable inserter. The anchor allows for placement, suture tensioning, and fixation of soft tissue into bone. Anchors will be available in a range of sizes.
This submission is for a traditional 510(k) for the PRO Fixation™ System, a sterile single-use device intended for the reattachment of soft tissue to bone. Since this is a traditional 510(k), there is no AI/ML algorithm involved, therefore, questions regarding AI/ML studies are not applicable.
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Equivalent biocompatibility profile to predicate devices. | Biocompatibility results indicate that the device biocompatibility profile is equivalent to the predicate devices. |
| Pull-out Strength | Meet mechanical performance requirements for intended use and be comparable to predicate devices. | All test results demonstrated that the performance of PRO Fixation™ System is equivalent to the predicate devices. Specific values not provided in this summary. |
| Suture Integrity/Tensile Strength (following anchor insertion) | Meet mechanical performance requirements for intended use and be comparable to predicate devices. | All test results demonstrated that the performance of PRO Fixation™ System is equivalent to the predicate devices. Specific values not provided in this summary. |
| Suture Slip Resistance | Meet mechanical performance requirements for intended use and be comparable to predicate devices. | All test results demonstrated that the performance of PRO Fixation™ System is equivalent to the predicate devices. Specific values not provided in this summary. |
| Anchor and Driver Integrity | Meet mechanical performance requirements for intended use and be comparable to predicate devices. | All test results demonstrated that the performance of PRO Fixation™ System is equivalent to the predicate devices. Specific values not provided in this summary. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The submission does not specify the exact sample sizes used for the laboratory testing. The data provenance is laboratory testing focused on mechanical and biocompatibility properties of the device itself, rather than human or animal study data. Therefore, country of origin and retrospective/prospective designations are not applicable in the typical sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. Ground truth in this context typically refers to clinical or image-based diagnoses. This submission is for a mechanical medical device, and the "ground truth" for its performance is established through objective laboratory testing against established engineering and material science standards and comparison to predicate devices, not expert consensus on medical conditions.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically used in clinical studies involving interpretation (e.g., by experts) where there might be disagreement. This submission involves laboratory testing with quantifiable results.
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 is a traditional 510(k) for a medical implant (suture anchor system), not an AI/ML powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a traditional 510(k) for a medical implant (suture anchor system), not an AI/ML powered device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance is based on established engineering and material science standards relevant to medical devices, as well as the performance characteristics of
legally marketed predicate devices. This includes:
- Biocompatibility Standards: Evaluating the device's interaction with biological systems according to recognized standards.
- Mechanical Performance Standards: Quantifiable metrics for pull-out strength, suture integrity/tensile strength, suture slip resistance, and anchor and driver integrity.
- Predicate Device Comparison: Establishing equivalence to existing, legally marketed devices with a known safety and efficacy profile.
8. The sample size for the training set
Not applicable. This is a traditional 510(k) for a medical implant; there is no "training set" in the context of AI/ML or image processing.
9. How the ground truth for the training set was established
Not applicable. This is a traditional 510(k) for a medical implant; there is no "training set" or corresponding ground truth establishment in this context.
§ 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.