(537 days)
The Absorbable Cranial Flap Fixation System is intended to be used for fixation of cranial bone flaps following craniotomy.
The Absorbable Cranial Flap Fixation System is comprised of a lower disc, an upper disc, a connecting rod and a rotating lock. The lower disc consists of a circular disk through which the connecting rod is centrally extruded outward. The upper disc consists of a circular disk with a threaded hole to accept the connecting rod. The upper disc is driven to move axially along the connecting rod by rotating the rotating lock so that the discs tightly grip the bone flap and provide rigid attachment and coplanar alignment to the surrounding bone.
The Absorbable Cranial Flap Fixation System is made from poly-L-lactic acid. The device is supplied sterile and is intended for single use.
The Heat/Contouring Pen is an accessory used to cut off the excess connecting rod of the Absorbable Cranial Flap Fixation System. The Heat/Contouring Pen is a disposable, lithium battery powered handheld device that includes a cutting heating head and a smoothing head. The Heat/Contouring Pen is supplied sterile and is intended for single use.
The provided text describes the regulatory clearance of a medical device, the "Absorbable Cranial Flap Fixation System," by the FDA. It includes a summary of non-clinical testing performed to demonstrate its substantial equivalence to a predicate device. However, this document does not contain information about an AI-based device or a study involving AI with human readers.
Therefore, I cannot provide details on:
- Acceptance criteria specific to AI device performance.
- Sample sizes for test sets or training sets related to AI.
- Data provenance for AI studies.
- Number and qualifications of experts for AI ground truth.
- Adjudication methods for AI test sets.
- Multi-reader multi-case (MRMC) comparative effectiveness studies with AI.
- Standalone algorithm performance for AI.
- Type and establishment of ground truth for AI training sets.
The document entirely focuses on the mechanical and biological performance of a physical medical implant.
Here's the information that is available in the document regarding the non-AI device's acceptance criteria and related studies:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria (Implied by "Pass" and "No statistical difference") | Reported Device Performance |
|---|---|---|
| Tripping Force | The device's locking function is comparable to the predicate device, meaning there is no statistical difference in the tension force required to release the upper disc. | Pass. No statistical difference between the predicate and subject device. |
| Compression Force | The maximum force required for the device to deform or crack meets pre-defined acceptance criteria and shows no statistical difference compared to the predicate device. | Pass. The acceptance criteria were met, and the results showed no statistical difference between the subject and predicate device. |
| Torque Force | The maximum force required for the connecting rod to break shows no statistical difference compared to the predicate device. | Pass. No statistical difference between the subject and predicate device. |
| Biocompatibility: | ||
| In Vitro Cytotoxicity (ISO 10993-5) | Percent cell viability ≥ 70%. | The percent cell viability of the subject device was 94.7% (>70%). Conclusion: Non-Cytotoxic |
| Skin Sensitization (ISO 10993-10) | No visible change observed in the test article groups when compared to controls, indicating no sensitization. | Under the conditions of the study, no visible change was observed in the test article groups. Conclusion: Non-Sensitizer |
| Intracutaneous Reactivity (ISO 10993-10) | Overall mean score difference between the test article and vehicle |
§ 882.5250 Burr hole cover.
(a)
Identification. A burr hole cover is a plastic or metal device used to cover or plug holes drilled into the skull during surgery and to reattach cranial bone removed during surgery.(b)
Classification. Class II (performance standards).