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The Stryker Facial iD System is intended for osteotomy, stabilization of maxillofacial fractures and reconstruction in adults and adolescents (age 12 and higher).

Specific Indications for Use:

• Orbital reconstructive/ trauma surgery

The Stryker Facial iD System (Subject Device) is intended for osteotomy, stabilization and rigid fixation of maxillofacial fractures and reconstruction in adults and adolescents (age 12 and higher), with the specific Indications for Use in orbital reconstructive and/or trauma surgery. The Subject Device is not intended for use in the orbital roof and can only be used if no exposure of the intracranial compartment is presented, and not intended for cranial use.

The Subject Device implants are additively manufactured patient-specific implants, and the patient-specific design of the implants allows certain features to be configured to meet the individual needs of each patient. The Subject Device implants are provided with a Design Proposal, an electronic Instruction for Use (IFU) and an optional Anatomical Additionally, the Subject Device is compatible with a separately provided Model. Customized Surgical Guides, Templates and Anatomical Models.

Here's a breakdown of the acceptance criteria and study information for the Stryker Facial iD System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly present a formal table of "acceptance criteria" with quantitative targets for each test, followed by the measured "device performance." Instead, it describes various performance tests and states that the "acceptance criteria were met" or that the device "met all pre-defined acceptance criteria."

I'll synthesize the information into a table format based on the tests performed and the outcomes mentioned:

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

• Mechanical Bench Testing: The document states that "All tests have been performed with the corresponding worst-case design considering the entire design envelope and all design features." It does not specify a numerical sample size (e.g., number of implants tested).
  • Data Provenance: Not explicitly stated, but it's in vitro bench testing.
• Biocompatibility Testing: Not specified.
  • Data Provenance: Not explicitly stated, but it's in vitro laboratory testing.
• Cleaning & Sterilization: Not specified.
  • Data Provenance: Not explicitly stated, but it's in vitro laboratory testing.
• End-User Testing: Not specified.
  • Data Provenance: Not explicitly stated, but it implies internal testing or simulation scenarios.

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

This information is not provided in the document. The studies described are primarily laboratory and bench testing, not clinical studies involving expert interpretation of patient data to establish ground truth.

4. Adjudication Method for the Test Set

This information is not applicable as the studies are technical performance tests (mechanical, biocompatibility, sterilization) and not clinical studies requiring human interpretation and adjudication of results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The document states "Clinical testing was not required as a basis for substantial equivalence." The studies focused on technical performance and comparison to predicate and reference devices.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done

This concept is not directly applicable to the Stryker Facial iD System as described. The "system" involves the design and manufacturing of patient-specific implants. While there's likely software involved in generating the designs from CT scans (similar to the predicate KLS Martin IPS software), the document focuses on the implant's performance rather than the standalone performance of a diagnostic algorithm or AI for interpretation. The device itself is an implant, not an AI software intended for standalone diagnostic use.

7. The Type of Ground Truth Used

• Mechanical Bench Testing: The ground truth is established by the performance characteristics of the Reference Device (K221855), against which the Subject Device's mechanical stability was compared for "substantial equivalence."
• Biocompatibility Testing: The ground truth is established by the international standards (ISO 10993-1, DIN EN ISO 10993-5, DIN EN ISO 10993-12) for biocompatibility.
• Cleaning & Sterilization: The ground truth is established by international standards (DIN EN ISO 17665-1, ISO 17665-2, ISO 14937) for sterilization and sterility assurance levels.
• End-User Testing: The ground truth is the "intended performance" under specified use conditions.

8. The Sample Size for the Training Set

This information is not applicable. The Stryker Facial iD System is a patient-specific implant system, not an AI model that requires a "training set" in the context of machine learning. The design of each implant is based on individual patient CT data.

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

This information is not applicable for the reasons stated above (not an AI model with a training set). The patient-specific designs are generated from individual patient CT scans based on established engineering principles and medical design specifications, informed by the capabilities proven by the predicate and reference devices.

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