(220 days)
Cranial PSI Accessories are indicated for use as accessories to the OSSDSIGN Cranial PSI for the reconstruction of cranial defects. They are indicated for non-load bearing applications for patients in whom cranial growth is complete and for use with an intact dura, with or without duraplasty.
OSSDSIGN Cranial PSI Accessories are optional devices that support physician use of the OSSDSIGN Cranial PSI (K161090) parent device. They are additively manufactured from PA2200 polyamide material. Each Cranial PSI Accessory is patient-specific and corresponds to a patient's unique anatomical requirements. Cranial PSI Accessories are intended to support implantation of the corresponding Cranial PSI parent device; both devices are designed from the same patient-specific computed tomography image data set.
Anatomical Model Original supports OSSDSIGN Cranial PSI by facilitating visual and tactile orientation for the physician of the patient's anatomy. It is provided non-sterile, is not intended to be sterilized and is not to be brought into contact with Cranial PSI, Plastic Drawing Guide or the Cranial Implant Trial.
Anatomical Model Modified supports OSSDSIGN Cranial PSI by facilitating visual ● and tactile orientation for the physician after removal of physician-specified regions. It is provided non-sterile, is not intended to be sterilized and is not to be brought into contact with Cranial PSI, Plastic Drawing Guide or the Cranial Implant Trial.
Plastic Drawing Guide supports accurate placement and fitting of OSSDSIGN Cranial PSI by assisting physicians in marking of bone intended for removal. Provided sterile.
Cranial Implant Trial supports placement and fitting of OSSDSIGN Cranial PSI by . assisting physicians in confirming OSSDSIGN Cranial PSI fit, fixation point positions and soft tissue coverage. Provided sterile.
The provided text describes a 510(k) premarket notification for "OSSDSIGN Cranial PSI Accessories." This document focuses on demonstrating substantial equivalence to a predicate device and includes details on biocompatibility and performance testing of the accessories. However, it does NOT describe an AI/ML medical device, nor does it contain information about acceptance criteria or a study proving that an AI/ML device meets those criteria.
The document primarily focuses on physical, non-AI medical device accessories. Therefore, I cannot extract the requested information in the format of an AI/ML device study.
Here's why the prompt cannot be fulfilled from the provided text:
- No mention of AI/ML: The document does not refer to any artificial intelligence, machine learning, algorithms, or software intended for automated analysis or diagnosis.
- Device type: The described devices are physical accessories (Anatomical Model, Plastic Drawing Guide, Cranial Implant Trial) made from PA2200 polyamide, designed to aid in the implantation of a cranioplasty plate.
- Testing methods: The performance tests detailed are related to physical properties like deformation, particle generation, and dimensional integrity, not algorithmic accuracy or clinical outcome prediction by an AI model.
- Ground Truth/Experts: The concepts of "ground truth," "expert consensus," "human readers," "training set," or "test set" in the context of data used for AI model development or validation are absent.
Therefore, I must state that the provided text does not contain the information required to answer the prompt regarding acceptance criteria and a study proving an AI/ML device meets those criteria.
§ 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).