(142 days)
Dental
The self-tapping screws and low profile emergency screws are intended for use in the fixation of bones of the maxillofacial and midfacial 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 self-tapping screws and low profile emergency screws are designed to be compatible with the components (plates, meshes) of the Delta Resorbable Fixation System K213777.
The subject devices, the Delta System self-tapping screw (STS) and low profile emergency screw (LPES), are intended for use in the fixation of bones of the maxillofacial and midfacial skeleton, affected by trauma or for reconstruction. The subject device can be used in pediatric patients older than 29 days and up to two (2) years of age (infants), but is not intended for use in the mandible and/or full load bearing procedures.
The scope of this submission covers the addition of the subject device screws to the previously cleared Delta System. Through this submission there is no change to the existing articles within the Delta System. The subject device screws are designed to be compatible with the existing components of the Delta System (plates, meshes), which have been previously cleared through K213777. Compared to the original Delta System, the subject STS and LPES have a limited patient population of pediatric patients older than 29 days and up to two (2) years of age (infants).
The document provided is a 510(k) summary for a medical device called the "Stryker Resorbable Fixation System". This summary outlines the device, its intended use, and comparative information to a predicate device to demonstrate substantial equivalence to a legally marketed device.
However, the provided text does not contain information about an AI/ML device or a study to prove that a device meets acceptance criteria related to AI/ML performance. The document focuses on regulatory approval for an orthopaedic fixation system, specifically resorbable screws, based on traditional engineering performance testing (e.g., mechanical tests, material properties) and comparison to a predicate device.
Therefore, I cannot provide the requested information regarding AI/ML acceptance criteria, study details, sample sizes, expert involvement, or MRMC studies, as these concepts are not applicable to the content of the provided document.
The document discusses "acceptance criteria" in the context of:
- Regulatory Acceptance: The FDA's determination of substantial equivalence.
- Performance Testing: Bench test "acceptance criteria" are implied by the "Passed" results for tests like Insertion, Shear, and Pull-out, and "Passed" for Inherent Viscosity. These are mechanical and material property tests, not AI/ML performance metrics.
- User Validation Testing: A validation study was done to confirm usability, comprehension of Instructions for Use, and that user needs are met, concluding a "passing result." This relates to human factors and usability, not AI/ML performance.
In summary, the provided text does not contain the information needed to answer the prompt's specific questions about AI/ML device acceptance criteria and proving device performance related to AI/ML.
§ 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.