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510(k) Data Aggregation
(90 days)
TORNIER, PITON FIXATION IMPLANT SYSTEM
The Tornier PITON™ Fixation Implant is intended for fixation of soft tissue to bone.
The PITON™ Implant is intended for use in the following applications:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair. Illiotibial Band Tenodesis
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
Elbow: Biceps Tendon Reattachment, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency
Hip: Capsular Repair Acetabular Labral Repair
The PITON™ Fixation Implant System includes a 2.8 mm diameter bone anchor and a disposable pre-loaded anchor Inserter. The PITON™ Fixation Implant is designed to secure soft tissue to bone using USP #2 high strength non-absorbable UHMWPE braided suture. The device is designed for inserting the implant directly into bone without a predrilled, punched, or tapped pilot hole.
The PITON™ Anchor configuration is comprised of a curved titanium base and a flared nitinol clip.
This 510(k) summary describes a medical device, the Tornier PITON™ Fixation Implant System, which is a soft tissue fixation fastener. The document establishes substantial equivalence to predicate devices and describes the device's intended use and specific applications.
Acceptance Criteria and Device Performance
This 510(k) submission primarily focuses on establishing substantial equivalence to existing legally marketed predicate devices, rather than presenting a performance study with explicit acceptance criteria and corresponding reported performance metrics in a typical sense for an AI/CADe device.
For medical devices like the Tornier PITON™ Fixation Implant System (a physical implant), acceptance criteria are typically related to:
- Mechanical Strength and Durability: Ensuring the implant can withstand the forces it will experience in the body.
- Biocompatibility: Confirming the materials are safe for implantation in the human body.
- Sterility: Verifying the device is sterile when packaged.
- Design Specifications: Adherence to defined dimensions, material properties, and functionality.
- Functional Equivalence: Demonstrating the device performs similarly to predicate devices for its intended use.
The provided text does not include a table of acceptance criteria and reported device performance metrics in the manner usually associated with a performance study for an AI/CADe device. Instead, the "acceptance" is based on demonstrating that the device is substantially equivalent to predicate devices through established histories of use for its materials and applicable FDA guidelines for testing.
The statement "The materials from which the Tornier device is fabricated have an established history of use, and the devices have been tested in accordance with applicable FDA guidelines" serves as the reported device performance in the context of a 510(k) for this type of implant. This indicates that relevant tests (e.g., mechanical, biocompatibility) were conducted, and the results met the standards required for this class of device and for demonstrating equivalence to the predicate devices.
Summary based on information provided:
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Device performance is substantially equivalent to predicate devices for intended use. | The device's materials have an established history of use, and the devices have been tested in accordance with applicable FDA guidelines. This supports the position that the PITON™ Fixation Implant System is substantially equivalent to previously cleared devices (CINCH™ Fixation Implant System, TwinFix Ti, and BioRaptor Suture Anchors) for the same clinical applications. |
| Compliance with relevant performance standards and guidelines. | Testing was conducted "in accordance with applicable FDA guidelines." |
| Safe and effective when used as intended. | Implied by the FDA's clearance of substantial equivalence, which indicates the device is considered as safe and effective as the predicate devices. |
Regarding AI/CADe specific questions:
The provided document is a 510(k) submission for a physical medical implant, the Tornier PITON™ Fixation Implant System (a non-degradable soft tissue fixation fastener), not an AI-based or Computer-Assisted Detection/Diagnosis (CADe/CADx) device. Therefore, the following information is not applicable to this submission:
- Sample size used for the test set and the data provenance: Not applicable.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable (ground truth is for AI/diagnostic algorithms).
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
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