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

Neuro: 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 Stryker Resorbable Fixation System 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 system 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.

The provided text describes a 510(k) premarket notification for the Stryker Resorbable Fixation System. This submission focuses on design modifications related to the sterilization process and packaging, not on validating the core performance of a new device or an AI/ML algorithm. Therefore, the information needed to answer the prompt, particularly regarding acceptance criteria and studies proving the device meets those criteria in the context of an AI/ML device, is not present in the provided document.

The document states:

• "Performance bench testing was not required as a basis for substantial equivalence."
• "Animal testing was not required as a basis for substantial equivalence."
• "Clinical testing was not required as a basis for substantial equivalence."

The "studies" mentioned are limited to:

• Sterilization Validation: Product Adoption and Sterility, EO Residual, Endotoxin Testing. These confirm the new sterilization process achieves sterility and meets safety limits for ETO residuals and endotoxins.
• Summative Usability Validation of Packaging: A study to confirm correct aseptic transfer despite a packaging change.

Since the prompt specifically asks about acceptance criteria and studies for a device (implying a functional, potentially AI/ML, device performance) and the document indicates these types of performance tests were not required for this particular 510(k) submission (which focused on demonstrating substantial equivalence for manufacturing/packaging changes), I cannot fill out the requested table or answer the questions as they pertain to the performance validation of an AI/ML device.

However, I can extract the information provided about the limited validation studies that were performed for the changes described in the document:

1. Table of acceptance criteria and the reported device performance (for the changes evaluated):

Regarding the other questions, the document does not contain the required information as it is not an AI/ML device validation study:

2. Sample sizes used for the test set and the data provenance:

   • Packaging Usability: Sample size of 19 representative users.
   • Data Provenance: Not specified, but generally, usability studies are prospective.
   • For sterilization tests, "product adoption" would involve a specific number of units, but this detail is not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for sterility is laboratory measurement against standards. For packaging usability, "correct performance" by representative users serves as the "ground truth."

4. Adjudication method for the test set: Not applicable. For usability, direct observation of performance. For biochemical tests, measurement against established limits.

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/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Sterilization: Laboratory measurements and standardized biological indicators (implicit in ISO standards).
   • Packaging Usability: Observational performance of users against defined correct steps.

8. The sample size for the training set: Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

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Stryker® Injectable Cement is a self-setting calcium phosphate cement indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, craniofacial, spine, and pelvis). These defects may be surgically created or osseous defects created from traumatic injury to the bone. The Stryker Injectable Cement is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure.

Stryker® Injectable Cement is a self-setting calcium phosphate cement.

The provided text is a 510(k) summary for a medical device (Stryker® Injectable Cement) and its FDA clearance letter. It does not contain any information about acceptance criteria, device performance, or human studies for the device itself.

The document primarily focuses on:

• Device Identification: Name, common name, regulatory class, product codes.
• Submitter and Manufacturer Information.
• Date of Summary Preparation.
• Intended Use Statement.
• Substantial Equivalence Information: Listing predicate devices (K043334 BoneSource® HAC Rapid Setting Cement, K041842 Norian SRS® Fast Set Putty, and K024336 Wright Medical MIIG II).
• FDA Clearance Letter: Confirming substantial equivalence to predicate devices and allowing the device to be marketed.

Therefore, I cannot fulfill your request for information regarding acceptance criteria, device performance, sample sizes, expert qualifications, study types (MRMC, standalone), or ground truth establishment based on the provided text. This type of detail is typically found in the full 510(k) submission or associated test reports, which are not included here.

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