(63 days)
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):
| Characteristic | Test | Acceptance Criteria (Implied by "Passed") | Reported Performance | Standards Used |
|---|---|---|---|---|
| Sterilization Validation / Sterility | Product Adoption and Sterility | Passed | Achieved sterility | ISO 11135:2014 +AMD1:2018 |
| Sterilization / Biocompatibility | EO Residual | Passed | Below limits | ISO 10993-7:2008 +AMD1:2019 |
| Sterilization / Biocompatibility | Endotoxin Testing | Passed | Below limits | ISO 10993-1 +ANSI/AAMI ST72:2019 |
| Packaging Usability / Aseptic Transfer | Aseptic transfer performance | All test participants perform correctly | Passed | (Implicitly, no use errors or difficulties observed) |
Regarding the other questions, the document does not contain the required information as it is not an AI/ML device validation study:
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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.
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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."
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Adjudication method for the test set: Not applicable. For usability, direct observation of performance. For biochemical tests, measurement against established limits.
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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.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
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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.
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The sample size for the training set: Not applicable. This is not an AI/ML device.
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How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.