(143 days)
The Stryker® Patient Specific Polymer Implant is designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial, or craniofacial bone.
The Stryker® Patient Specific Polymer Implant is made from PMMA, specifically Surgical Simplex P Radiopaque Bone Cement. Surgical Simplex P Radiopaque Bone Cement is a biocompatible nonresorbable material that will maintain its shape after implantation and provide protection to the skull. Surgical Simplex P Radiopaque Bone Cement is a porous composite material comprised of polymethylmethacrylate (PMMA). The implant will be designed and molded for a specific patient to correct trauma and/or defects in mandibulsa, maxilloficial, or craniofacial bone. A Patient Specific Polymer Implant provides for replacemant of an amorphous shaped implant not contained within standard product offerings.
The provided text describes a 510(k) premarket notification for the Stryker® Patient Specific Polymer Implant. However, it does not include a detailed study proving the device meets specific acceptance criteria in the way a clinical performance study would.
Instead, the submission focuses on substantial equivalence to previously approved predicate devices, a common pathway for medical device approval under 510(k). The safety and effectiveness are established by referencing the long-standing use and biocompatibility of the material (PMMA, specifically Surgical Simplex P Radiopaque Bone Cement) and its predicate devices.
Therefore, many of the requested elements (like acceptance criteria tables, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, etc.) are not applicable in this type of submission. The device is not cleared based on novel clinical performance data demonstrating specific metrics, but rather on its similarity to already approved devices and materials with established safety profiles.
Here's a breakdown based on the information available:
1. A table of acceptance criteria and the reported device performance
- Not Applicable. This submission does not provide a table of acceptance criteria with corresponding performance metrics from a dedicated clinical study for the Stryker® Patient Specific Polymer Implant. The basis for approval is substantial equivalence to predicate devices and the established safety and efficacy of the PMMA material.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. No specific "test set" in the context of a clinical performance study is described for this device. The submission relies on the historical use and safety profile of the PMMA material and its predicate devices. The text mentions "Clinical use of Surgical Simplex P Radiopaque Bone Cement has been used in thousands of cases proving to be safe and effective," but this refers to the historical aggregated experience with the material, not a specific, controlled test set for this particular patient-specific implant.
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. No ground truth establishment by experts for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set or adjudication method is described.
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 not an AI/software device. No MRMC study was conducted or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI/software device. No standalone performance study was conducted or described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. The "ground truth" for this submission is historical clinical evidence and regulatory acceptance of the PMMA material (Surgical Simplex P Radiopaque Bone Cement) and its predicate devices. The safety and effectiveness are inferred from decades of clinical use of the material and similar devices.
8. The sample size for the training set
- Not Applicable. No "training set" in the context of machine learning or a clinical trial is described. The device's design is patient-specific and its material properties are well-established.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set mentioned, there is no description of how ground truth for it was established.
Summary of the "Study" Proving Acceptance:
The "study" or evidence proving the device meets acceptance criteria in this 510(k) application is primarily based on:
- Substantial Equivalence: The device is deemed substantially equivalent to legally marketed predicate devices (Hard Tissue Replacement - Patient Match Implant K924935, Hard Tissue Replacement --Malleable Facial Implant, Hard Tissue Replacement--MX K904111, Surgical Simplex P Radiopaque Bone Cement N-17-004). This implies that its safety and effectiveness are comparable to these established devices.
- Material Biocompatibility and Historical Use: The implant is made from PMMA (Surgical Simplex P Radiopaque Bone Cement), a "biocompatible nonresorbable material" that "has been used for decades in various applications from clinical orthopaedics to oral surgery since the 1900's." The document states, "Clinical use of Surgical Simplex P Radiopaque Bone Cement has been used in thousands of cases proving to be safe and effective." This long history of safe and effective use of the core material is a key proof point.
In essence, the device is cleared because its material and intended use are demonstrably similar to products already on the market with a proven track record of safety and effectiveness, rather than through a new, dedicated clinical performance study with defined acceptance criteria.
§ 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.