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The Delta Resorbable Fixation System is intended for use in the fixation of bones of the cranial skeleton affected by trauma or for reconstruction. The system can be used in both adult and pediatric patients.

The self-tapping screws and low profile emergency screws are intended for use in the fixation of bones of the cranial skeleton affected by trauma or for reconstruction, and can be used in pediatric patients older than 29 days and up to two (2) years of age (infants).

The Stryker Resorbable Fixation System (also referred to as Delta System or Stryker Delta Resorbable Fixation System; marketed as DualStart) is a cranio-maxillofacial plating system intended for use in the fixation of bones of the craniofacial and midfacial skeleton affected by trauma or for reconstruction. The reference device can be used in both adult and pediatric patients but is not intended for use in the mandible and/or full load bearing procedures. It consists of resorbable bone fixation plates, meshes, and screws made of a copolymer of poly lactide and poly glycolide.

Through this submission there is no change to the existing articles within the Delta System. The scope of this submission covers the addition of screws to the Delta System, which are shown as a modification of screws of the reference device to create the addition of self-tapping screws (STS) and low profile emergency screws (LPES). The subject STS and LPES, only, have a limited patient population of pediatric patients older than 29 days and up to two (2) years of age (infants).

The provided text describes the acceptance criteria and supporting studies for the Stryker Resorbable Fixation System (K231208).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the numerical sample size for the test set for the performance bench testing (e.g., number of screws tested for insertion or pull-out). It generically states "Verification and validation testing protocols were constructed to ensure testing captured this specific limited patient population."

• Data Provenance: The studies were conducted by Stryker Leibinger GmbH & Co. KG and are presumed to be internal company studies. The country of origin for the data is not specified, but the company address is in Freiburg, Germany. The studies are prospective in nature, as they are part of a premarket notification for a modified device.

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

For the usability validation, the document mentions "user validation testing" and "human factors and usability engineering," which would typically involve end-users (e.g., surgeons, medical staff). However, the number of experts used and their specific qualifications are not provided in this document.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method for the test sets (e.g., 2+1, 3+1, none). The "Passed" results imply direct measurement against established criteria.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study was done. The device in question is a physical fixation system (screws), not a diagnostic imaging AI, so an MRMC study comparing human readers with and without AI assistance is not applicable. The studies focus on the physical and functional performance of the device and its usability.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Not Applicable. This device is a physical medical implant, not an algorithm or AI system. Therefore, standalone algorithm performance is not a relevant concept here.

7. Type of Ground Truth Used

For the performance bench testing:

• The ground truth is established by objective engineering measurements against the performance requirements defined by the ASTM F2502 standard and internal specifications (e.g., successful insertion, specified pull-out strength, acceptable inherent viscosity).

For the usability validation:

• The ground truth is established by user validation through direct observation of task performance (evaluating for use error), assessment of knowledge (knowledge tasks), and subjective feedback (rating questions). This implies that the 'ground truth' for usability is defined by the absence of use errors, successful completion of knowledge tasks, and positive user ratings.

8. Sample Size for the Training Set

• Not applicable. This device is a physical medical device; there is no "training set" in the context of machine learning or AI models. The design and manufacturing processes are validated through traditional engineering methods and testing.

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

• Not applicable. As there is no training set for an AI/algorithm, there is no ground truth established for a training set.

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