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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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Su-Por® Surgical Implants in block, sheet, and anatomical shapes are intended for non-weight bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. Su-Por® Surgical Implants are also intended for the augmentation or restoration of contour in the craniomaxillofacial skeleton.

The Su-Por® Surgical Implants are marketed as single use sterile implants with various shapes and sizes for different areas of the craniofacial skeleton. The applications include non-load bearing augmentation and/or reconstruction of the craniofacial skeleton. The raw material used for the Su-Por® Surgical Implants is high-density polvethylene when molded into the implants becomes a porous high-density polyethylene. Polvethylene has a long history of use in surgical implantable products. The interconnecting open pore structure of the Su-Por® Surgical Implants allow for tissue in growth. The material used to manufacture the Su-Por® Surgical Implants has been utilized in reconstruction and soft tissue repair for many years. There is a long history of the use of porous polyethylene implants for enucleation and evisceration, as well as for many applications in craniofacial reconstruction and augmentation, with a history of safety and performance. The implants are single use and provided sterile by ethylene oxide (EO) terminal sterilization.

Here's a summary of the device's acceptance criteria and the study that proves it meets them, based on the provided text:

Device: Su-Por® Surgical Implants

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Su-Por® Surgical Implants are established by demonstrating substantial equivalence to legally marketed predicate devices. This means that the Su-Por® implants must be as safe, as effective, and perform as well as or better than the predicate devices. The performance is assessed across several categories, including material properties, manufacturing processes, packaging, and biocompatibility.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state a "test set" in the context of a statistical study with a specific sample size. Instead, the evaluation focuses on bench testing and biocompatibility testing of the Su-Por® Surgical Implants themselves.

• Sample Size for Testing: Not specified as a number of "cases" or "patients." The testing involved samples of the device material and manufactured implants for various physical, chemical, and biological assessments.
• Data Provenance: The document does not specify the country of origin for the data or if it was retrospective or prospective. It describes laboratory and material testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This type of information (number of experts, qualifications, etc.) is typically associated with clinical studies or evaluations where human assessment of medical images or conditions defines the ground truth. This document describes the premarket notification (510(k)) process for a medical implant, which primarily relies on bench testing and established material science standards to demonstrate substantial equivalence to existing devices.

Therefore, there is no mention of experts establishing ground truth in this context, as it's not a diagnostic AI device or a clinical outcome study requiring such a setup.

4. Adjudication Method for the Test Set

As there is no "test set" in the sense of clinical cases requiring expert adjudication, no adjudication method is mentioned or applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of AI algorithms when used by human readers (e.g., radiologists, pathologists) for diagnostic tasks. The Su-Por® Surgical Implant is a physical implant, not a diagnostic tool or an AI-assisted interpretation system.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone algorithm performance study was not done. This is not an AI device. The evaluation is for a physical medical implant.

7. The Type of Ground Truth Used

The "ground truth" in this context is based on established material science standards, biocompatibility regulations, and predefined physical/chemical properties that define the safety and performance of porous polyethylene implants. The "truth" is whether the material and finished device meet these engineering and biological specifications, and whether they are comparable to predicate devices with a history of safe and effective use.

• Bench Test Results: Passing criteria for impact, flexural, tensile strength, purity, and porosity.
• Biocompatibility Standards: Meeting ISO and USP standards for cytotoxicity, systemic toxicity, intracutaneous reaction, pyrogenicity, and muscle implantation.
• Sterilization Validation: Demonstrated sterility via Ethylene Oxide (EtO).

8. The Sample Size for the Training Set

This concept is not applicable here. There is no AI algorithm being "trained." The Su-Por® Surgical Implant is a manufactured device.

9. How the Ground Truth for the Training Set Was Established

This concept is not applicable here, as there is no training set for an AI algorithm.

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