(282 days)
CirFIX® Cranial Bone Fixation System: Flap Fixator is intended for use to post-craniotomy bone flap fixation and the Burr Hole Cover is to be used for covering a single burr hole.
The CirFIX® Cranial bone fixation system: Flap Fixator is a biocompatible, postoperative cranial bone fixation system that fixes the bone flap to the skull after craniotomy and Burr Hole Cover which is for covering a single burr hole resulting from cranial surgery.
The CirFIX® Cranial bone fixation system is provided in sterile, for a single use. With available sizes for cranial thickness ranging from 3 mm to 14 mm and burr holes with an epicranial diameter from 10 to 15 mm, made by standard perforators or with spherical drills, can be covered.
The provided document is a 510(k) summary for the CirFIX Cranial Bone Fixation System. It details the device's technical characteristics, its intended use, and a comparison to predicate devices, along with summaries of non-clinical, mechanical, and performance testing. However, the document does not contain information about studies involving human readers, AI assistance, ground truth established by experts for a test set, or specific acceptance criteria with quantitative reported performance metrics for an AI/algorithm-based device.
The questions posed are typical for the evaluation of AI/Machine Learning-enabled medical devices, particularly those involving image analysis or diagnostic support, where performance is often measured by metrics like sensitivity, specificity, or reader agreement. The CirFIX system described is a physical medical device (bone fixation system), not an AI/ML software device. Therefore, the questions related to AI/ML device performance validation are not applicable to the content provided.
However, I can extract the information relevant to the device's performance testing and acceptance criteria for a physical device as described in the document.
Acceptance Criteria and Study for CirFIX Cranial Bone Fixation System:
The document describes pre-market testing to demonstrate substantial equivalence to predicate devices, focusing on functional, biomechanical, and cadaver testing. The "acceptance criteria" are implicitly met if the device performs as intended and is equivalent or better than predicate devices in specified mechanical tests, and demonstrates safe and effective implantation in simulated clinical use.
Since this is a physical device, the concept of "ground truth" and "expert consensus" for diagnostic accuracy (as would be for an AI model) does not directly apply in the same way. Instead, performance is assessed against physical and mechanical benchmarks and practical surgical considerations.
Here's a breakdown of the provided information, noting where the requested AI-specific information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of quantitative acceptance criteria with specific numerical targets and matching reported performance values. Instead, it describes tests and states that the criteria were met, or that results were adequate or equivalent to predicate devices.
| Test Category | Test Method Summary | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| A. Functional Testing | |||
| A.1. Functionality of implantable parts (Burr hole diameter & Bone thickness) | Goal: Verification the available sizes for cranial: (A) Burr hole diameter (B) Bone thickness. Method: Fully assembled devices were tested. Simulated surgery to each size of burr hole diameter and bone thickness. | Device must fit and function correctly across the specified ranges of burr hole diameters (10-15 mm epicranial diameter, various sizes like 11/7, 11/8, 13/9, 14/11, 15/12 mm) and cranial bone thicknesses (3 mm to 14 mm). | "All tested samples meet the functionality acceptance criteria and relevancy the test result has demonstrated that the technological characteristics of CirFIX® Cranial bone fixation system is substantially equivalent to the predicate devices do not raise any new safety or effectiveness issues." |
| A.2. Functionality of implantable parts and the driver (Maximum torque force) | Goal: Determine the maximum torque force (breaking force) of the threads mechanism of the driver and upper platforms (Screw). Method: Fully assembled devices were tested. A calibrated dynamometer was used to apply a torque force on the driver until platforms or bolt broke. | The threads mechanism and driver should withstand a sufficient torque force without breaking, ensuring proper and safe implantation. (No specific numerical target provided, but breakage should occur above expected use forces). | (Result column is blank in the original document for this specific test, but the general conclusion for mechanical testing states performance as intended.) The overall conclusion notes that mechanical and performance testing confirms the device performs as intended and is substantially equivalent. |
| B. Biomechanical Testing | |||
| B.1. Strength to bone flap compression (Push-in) | Goal: Simulate strength to bone flap compression (Push-in) and determine the force required to sink the bone flap up to a maximum of 2 mm. Method: A push load was applied to model which simulates the cranium and bone flap with three Flap Fixators representing clinical use. | The device should withstand push-in forces up to a certain threshold (implicitly, without exceeding 2 mm sinking at expected forces), demonstrating adequate strength and stability for bone flap fixation. (No specific numerical force target provided). | "All tested samples meet the specifications. The devices have an adequate biomechanical behavior at push-in and pull-out. The relevancy of the test results in determining the substantial equivalence of the proposed device." |
| B.2. Push-in | Goal: Simulate patient's pressure on the device and determine the force required to sink the devices up to a maximum of 2 mm. Method: Fully assembled devices were tested in holes equivalent to those in which they will be implanted. The implanted devices were placed under a calibrated dynamometer and a cylindrical tool used to apply force on the upper platform. | The device should resist sinking beyond 2 mm under simulated patient pressure, ensuring stability in vivo. (No specific numerical force target provided). | (Result column is blank in the original document, but the general conclusion for biomechanical testing covers this as "adequate biomechanical behavior.") |
| B.3. Pull-out | Goal: Simulate pulling forces caused by increased ICP, to determine the maximum force that the device can withstand before sliding out from the burr hole. Method: Fully assembled devices were tested in holes equivalent to those in which they will be implanted. A calibrated dynamometer was used to apply a traction force on the button of lower platform until the lower platform slid out from the hole. | The device must withstand a sufficient pulling force simulating increased intracranial pressure (ICP) without sliding out, ensuring secure fixation. (No specific numerical force target provided). | (Result column is blank in the original document, but the general conclusion for biomechanical testing covers this as "adequate biomechanical behavior.") |
| C. Cadaver Testing | Goal: Evaluation of the devices when simulating their implantation on the skull of patients in a clinical environment, following the procedures described in the products' Instructions for Use. Method: The test was performed on two cadaveric specimens with fully assembled devices, testing four different craniotomies. Various aspects were analyzed (see "Test Method Summary" column for list). | Device must demonstrate: 1. Sufficient space for placement; 2. No danger to surgeon; 3. Correct positioning; 4. Rapid/simple application; 5. Absence of dura mater damage; 6. Easy removal; 7. Lateral and axial stability; 8. Low profiles; 9. Adaptation to curvatures; 10. Adaptation to thicknesses; 11. No artifacts on neuroimaging; 12. Fast application with no special tools. This implies safe, effective, and user-friendly performance in a simulated surgical environment. | "Correct implantation is verified in a simulated real-life situation. The devices show adequate performance and safety. The results demonstrate that the CirFIX® Cranial bone fixation system is equivalent, in terms of performance and safety and to the relevant extent, to the predicate devices." |
2. Sample size used for the test set and the data provenance
- Manufacturing/Mechanical Testing: The document mentions "All tested samples" for functionality and biomechanical tests, but does not specify the exact numerical sample size for these tests.
- Cadaver Testing: "The test was performed on two cadaveric specimens with fully assembled devices."
- Data Provenance: The tests are reported as "Non-Clinical Testing" and "Mechanical and performance testing." Given they are laboratory and cadaver tests, the data provenance is prospective (generated for this submission). The origin is not explicitly stated as a country for the labs, but Ossaware Biotech Co., Ltd. is based in Taiwan.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A. As this is a physical medical device (bone fixation system), "ground truth" and "expert qualifications" in the context of diagnostic accuracy/AI model performance are not applicable. The cadaver testing described would involve the expertise of the individuals performing the simulated surgical procedures and evaluating the outcomes, but these are not referred to as "experts establishing ground truth" for a diagnostic test.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
N/A. Adjudication methods like 2+1 or 3+1 are typically used for establishing consensus "ground truth" in image interpretation or diagnostic studies, which is not relevant for this physical device's mechanical and functional testing.
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
N/A. This is a physical medical device, not an AI/ML-enabled diagnostic device. No MRMC study was conducted or is relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
N/A. This is a physical medical device, not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
N/A. For this physical device, "ground truth" refers to established engineering principles, material properties, and surgical requirements for bone fixation. Performance is assessed against these physical and functional benchmarks rather than diagnostic accuracy.
8. The sample size for the training set
N/A. This is a physical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
N/A. This is a physical device, not an AI/ML model that requires a training set.
§ 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).