(112 days)
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.
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance (Su-Por® Surgical Implants) |
|---|---|---|
| Biocompatibility | Cytotoxicity | Passed (demonstrates substantial equivalence to predicate devices) |
| ISO Systemic Toxicity | Passed (demonstrates substantial equivalence to predicate devices) | |
| ISO Intracutaneous Study | Passed (demonstrates substantial equivalence to predicate devices) | |
| USP Pyrogen Study | Passed (demonstrates substantial equivalence to predicate devices) | |
| ISO Muscle Implantation Study | Passed (demonstrates substantial equivalence to predicate devices) | |
| Sterility | Sterilization Validation (Ethylene Oxide - EtO) | Completed sterilization validation, demonstrating they are sterile devices for implantation, equivalent to predicate devices. |
| Mechanical Properties | Impact Testing | Completed. (Implies performance similar to predicate devices, contributing to substantial equivalence.) |
| Flexural Testing | Completed. (Implies performance similar to predicate devices, contributing to substantial equivalence.) | |
| Tensile Strength Testing | Completed. (Implies performance similar to predicate devices, contributing to substantial equivalence.) | |
| Material Purity | Purity Testing per USP | Completed. (Implies performance similar to predicate devices, contributing to substantial equivalence.) |
| Material Structure | Porosity Testing | Completed. (Implies comparable porous structure to predicate devices, allowing for tissue ingrowth as intended.) |
| Overall Equivalence | Intended Use & Indications for Use | Same as predicate devices. |
| Technological Characteristics & Principles of Operation | Same as predicate devices. | |
| Raw Materials, Manufacturing Processes, Packaging | Same as predicate devices. |
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.
§ 878.3500 Polytetrafluoroethylene with carbon fibers composite implant material.
(a)
Identification. A polytetrafluoroethylene with carbon fibers composite implant material is a porous device material intended to be implanted during surgery of the chin, jaw, nose, or bones or tissue near the eye or ear. The device material serves as a space-occupying substance and is shaped and formed by the surgeon to conform to the patient's need.(b)
Classification. Class II.