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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 a pre-formed plate made of cured Simplex P bone cement that is shaped to match a specific patient's bony defect based on CT scans provided by the surgeon. The plate is fixed into place using compatible Stryker plate and screw systems.

The provided text describes a Special 510(k) submission for the Stryker® Patient Specific Polymer Implant, focusing on sterilization and a change in manufacturing location. The study's purpose is to demonstrate equivalence to the predicate nonsterile devices.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify sample sizes for the tests conducted (sterilization, pyrogenicity, bioburden, packaging validation). It also does not provide information on data provenance (country of origin, retrospective/prospective) beyond stating that "Testing has been performed."

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document. The studies performed are primarily laboratory-based equivalency testing (sterilization, pyrogenicity, packaging), not studies that would typically involve expert-established ground truth in the context of device performance in a clinical setting.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided in the document. Adjudication methods are typically used in clinical studies where expert review is needed to establish ground truth from ambiguous or complex cases. The tests described are objective laboratory analyses.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission focuses on device modifications related to sterilization and manufacturing, not on the clinical effectiveness or performance of the implant compared to human readers or other devices in a diagnostic or clinical decision-making context.

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

This is not applicable to this device. The Stryker® Patient Specific Polymer Implant is a physical implant, not a software algorithm or AI system for diagnostic or clinical decision support. While the manufacturing process involves commercially available software (Materialise), the submission does not detail standalone performance of this software in a clinical context but rather its integration and validation within the manufacturing process.

7. The Type of Ground Truth Used

For the studies mentioned (sterilization, pyrogenicity, bioburden, packaging validation), the "ground truth" is established by adherence to recognized international and national standards (ISO 11137-2, ANSI/AAMI ST72:2002) and validated laboratory testing protocols. These are not clinical ground truths (e.g., pathology, outcomes data) but rather objective measures of manufacturing and product quality.

8. The Sample Size for the Training Set

This is not applicable and therefore not provided. The device is a physical implant, and the submission describes manufacturing and sterilization validation, not the development of an AI algorithm or model that would require a training set. The "Materialise software" is mentioned as a commercially available tool integrated into the manufacturing process, implying it's not a newly developed algorithm by Stryker for this specific submission that would require a training set.

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

This is not applicable for the same reasons as point 8.

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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.

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