(66 days)
The Stryker® Custom Ti Implant is a titanium-mesh implant that is designed to custom-fit a patient's defect. This implant will utilize patient C.T. scan data to produce a custom-contoured titanium or titanium mesh implant that optimally fits each patient. The unique process of developing a Stryker® Custom Ti Implant converts patient CT-Scan data into 3-D images. These images are used to create anatomical models which are then used to build the customized implant.
The implant will be designed and molded for each patient to correct trauma and/or defects in mandibular, maxillofacial, or craniofacial bone.
The Stryker® Custom Ti Implant is designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial or craniofacial bone.
The Stryker® Custom Ti Implant is a titanium-mesh implant that is designed to custom-fit a patient's defect. This implant will utilize patient C.T. scan data to produce a custom-contoured titanium or titanium mesh implant that optimally fits each patient. The unique process of developing a Stryker® Custom Ti Implant converts patient CT-Scan data into 3-D images. These images are used to create anatomical models which are then used to build the customized implant.
The Stryker Custom Ti Implants will be manufactured using the same method as the Stryker Custom Cranial Implant (K043250) using titanium or titanium mesh similar to the Synthes (USA) Patient Specific Cranial/Craniofacial Implants (K033868).
The provided text describes a 510(k) summary for the Stryker® Custom Ti Implant. This is a premarket notification for a medical device rather than a study report describing an evaluation of an AI/ML device. Therefore, the information typically requested in a description of acceptance criteria and a study proving device performance (such as sample size, ground truth, expert qualifications, etc.) for an AI/ML product is not present in this document.
The document mainly focuses on establishing substantial equivalence to previously cleared devices. It states:
- Device Description: The Stryker® Custom Ti Implant is a titanium-mesh implant designed to custom-fit a patient's defect using patient CT-scan data to produce 3-D images and anatomical models.
- Intended Use: To correct trauma and/or defects in mandibular, maxillofacial, or craniofacial bone.
- Substantial Equivalence: It is substantially equivalent to the Stryker Custom Cranial Implant (K043250) and Synthes (USA) Patient Specific Cranial/Craniofacial Implants (K033868). Manufacturing methods are similar to K043250 and materials (titanium or titanium mesh) are similar to K033868.
As a result, based solely on the provided text, I cannot provide the requested information regarding acceptance criteria and performance study details typical for an AI/ML device. The document does not contain:
- A table of acceptance criteria and reported device performance.
- Sample size for a test set or data provenance.
- Number or qualifications of experts used for ground truth.
- Adjudication method.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study, nor effect sizes of human reader improvement with AI assistance.
- Standalone performance of an algorithm.
- Type of ground truth used.
- Sample size for a training set.
- How ground truth for a training set was established.
This is a regulatory submission for a custom-manufactured physical implant, not an AI/ML software device that typically undergoes performance studies against specific metrics.
§ 882.5330 Preformed nonalterable cranioplasty plate.
(a)
Identification. A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).