Search Results

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:

Note: For the mechanical properties (Tripping, Compression, Torque Force), the acceptance criteria are largely implied by demonstrating "no statistical difference" when compared to the legally marketed predicate device (RapidFlap LS Cranial Fixation Flap System). The specific numerical thresholds for "Pass" are not detailed in this summary for these tests. For biocompatibility, the ISO standards define the acceptance criteria.

2. Sample size used for the test set and the data provenance:

• The document does not specify the exact sample sizes for each mechanical test (Tripping Force, Compression Force, Torque Force). It only states "The devices were fastened..." and "Apply pressure to the disk..." indicating testing was performed, likely on multiple samples to allow for statistical comparison, but the number is not provided.
• For biocompatibility tests, specific sample sizes (e.g., number of cells, number of animals) are not explicitly stated in this summary, but are typically defined by the referenced ISO standards (e.g., ISO 10993-5, 10, 11, 6, 3). For example, the pyrogenicity test mentions "three rabbits."
• Data Provenance: The tests were conducted by a Chinese company (Chengdu MedArt Medical Scientific Co., Ltd.) and were part of their submission to the U.S. FDA. The data provenance is internal testing performed by the manufacturer, likely in China. The data would be prospective for the purpose of demonstrating initial device performance to the FDA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This information is not applicable. The device is a physical medical implant, not an AI or diagnostic device that requires expert ground truth establishment for diagnostic interpretation. The "ground truth" for its performance is determined by direct mechanical and biological testing against engineering specifications and international standards, and comparison to a predicate device.

4. Adjudication method for the test set:

• Not applicable as this is a physical device and performance is assessed via objective tests (e.g., force measurements, biological reactions) rather than subjective interpretation requiring adjudication.

5. 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, as this is not an AI-based device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable, as this is not an AI-based device.

7. The type of ground truth used:

• For mechanical tests (Tripping Force, Compression Force, Torque Force): The "ground truth" for acceptable performance is established by comparison to the predicate device (RapidFlap LS Cranial Fixation Flap System) and adherence to internal engineering specifications (implied by "acceptance criteria were met").
• For biocompatibility tests: The "ground truth" is defined by the acceptance criteria specified in the referenced ISO 10993 series standards. These standards provide objective thresholds for cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, performance in implantation models, degradation, and genotoxicity.

8. The sample size for the training set:

• Not applicable, as this is not an AI-based device and does not involve training sets.

9. How the ground truth for the training set was established:

• Not applicable, as this is not an AI-based device and does not involve training sets.

Ask a specific question about this device