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SU-POR Patient-Specific Surgical Implant in Customized shapes to meet the needs of Individual patients are intended for non-weight-bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. SU-POR Patient-Specific Surgical Implants are also intended for the augmentation or restoration of contour in the craniomaxillifacial skeleton.

The SU-POR Patient-Specific Surgical Implant is provided as a kit of two identical implants, one of which serves as a back-up implant. The SU-POR Patient-Specific Surgical Implant also provides the surgeon an option of a non-sterile non-implantable template made of the same high-density porous polyethylene to be utilized by the surgeon to assist in modifying the implant prior to placement. The SU-POR Patient-Specific Surgical Implant is manufactured from high-density porous polyethylene to fit the individual needs of a patient based on design input identified by the surgeon. The interconnecting porous structure of the material allows for host tissue ingrowth. The SU-POR Patient-Specific Surgical Implant may be fixed into place using surgical plates and screws. The SU-POR Patient-Specific Surgical Implant is provided as a single-use sterile device.

I am sorry, but the provided text does not contain the acceptance criteria and study details you are asking about. The document is an FDA 510(k) clearance letter and summary for a medical device (SU-POR Patient-Specific Surgical Implant).

It primarily focuses on establishing substantial equivalence to predicate devices based on:

• Device Description: Material (porous high-density polyethylene), design (patient-specific), sterility, sterilization method (EtO), packaging, biocompatibility, and reusability.
• Indications for Use: Non-weight-bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma, and augmentation or restoration of contour in the craniomaxillofacial skeleton.
• Technological and Operational Characteristics: Implants are designed using individual patient data (CT scan, physical model, drawing, etc.) in collaboration with a surgeon.
• Performance Data Summary:
  • Biocompatibility Testing: Not required for this submission because the material, duration, location of contact, and sterilization method are unchanged from the cleared predicate SU-POR Surgical Implants (K140437).
  • Performance Bench Testing: Not required for this submission because there is no functionality or performance change compared to the cleared predicate SU-POR Surgical Implants (K140437).
  • Software Verification and Validation Testing: Software is only used in the design process, not in the implant itself or its manufacturing. No new testing was required.
  • Animal Testing: Previously conducted for the predicate device (K140437) and no additional testing was required for this submission.
  • Clinical Testing: Not required as a basis for substantial equivalence.

The document does not describe specific acceptance criteria in terms of numerical performance metrics (like sensitivity, specificity, accuracy) for a device, nor does it detail a study proving the device meets such criteria. Instead, it concludes substantial equivalence based on a comparison to existing, legally marketed predicate devices without requiring new performance testing for the reasons stated above.

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