(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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.
June 3, 2020
Ossaware Biotech Co., Ltd. Meng Huang General Manager No. 51, Xinggong Rd. Shenkang Hsiang, 50971 Tw
Re: K192310
Trade/Device Name: CirFIX Cranial Bone Fixation System: Flap Fixator and Burr Hole Cover Regulation Number: 21 CFR 882.5250 Regulation Name: Burr Hole Cover Regulatory Class: Class II Product Code: GXR Dated: May 1, 2020 Received: May 1, 2020
Dear Meng Huang:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Adam D. Pierce, Ph.D. Acting Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K192310
Device Name
CirFIX Cranial Bone Fixation System: Flap Fixator and Burr Hole Cover
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) |
|---|
| Prescription Use (Part 84 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the CirFIX® Cranial bone fixation system Submission.
Date: June 3, 2020
| Submitted by | OSSAWARE BIOTECH CO., LTD.No. 51, Xinggong Rd., Shenkang Hsiang,Changhua(50971), Taiwan |
|---|---|
| Contact Person | Meng Feng HuangGeneral ManagerPhone: +886-4-7980819E-mail: FDA@CUSMED.COM |
| Trade Name | CirFIX® Cranial bone fixation system: Flap Fixator andBurr Hole Cover |
| Common Name | Burr hole cover |
| Proposed Class | Class II |
| Classification Name andReference | 882.5250 Burr hole cover |
| Device Product Code,Device Panel | GXR, Neurology |
| Predicate Device | Legally marketed predicate devices to which substantialequivalence is claimed:● Cranial Loop, Cranial Loop L And Cranial Loop XI AndCranial Bone Fixation System_K132044● Cranial Cover_K160739 |
| Device Description | The CirFIX® Cranial bone fixation system: Flap Fixator is abiocompatible, postoperative cranial bone fixationsystem that fixes the bone flap to the skull aftercraniotomy and Burr Hole Cover which is for covering asingle burr hole resulting from cranial surgery.The CirFIX® Cranial bone fixation system is provided insterile, for a single use. With available sizes for cranialthickness ranging from 3 mm to 14 mm and burr holeswith an epicranial diameter from 10 to 15 mm, made bystandard perforators or with spherical drills, can becovered. |
| Intended Use andIndications for Use | The CirFIX® Cranial bone fixation system: Flap Fixator isintended for use to post-craniotomy bone flap fixationand the Burr Hole Cover is to be used for covering asingle burr hole. |
| Summary of the TechnologicalCharacteristics | The subject CirFIX® Cranial bone fixation system: FlapFixator and Burr Hole Cover and the predicates areidentical in indications for use, surgical technique andanatomical implantation site. The subject CirFIX® Cranialbone fixation system and the predicates share similardesign features:• Method of fixation like a clamp.• Comparable size, material. |
| Summary of Non-Clinical Testing | Mechanical and performance testing confirms theCirFIX® Cranial bone fixation system: Flap Fixator andBurr Hole Cover performs as intended and substantiallyequivalent to the predicate device. |
| Conclusion | Based on the design features, the use of established wellknown materials, feature comparisons, indications foruse, and results of the mechanical testing, the CirFIX®Cranial bone fixation system has demonstratedsubstantial equivalence to the identified predicatedevices. |
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Technological characteristics and comparison to predicate devices
Documentation was provided to demonstrate that the CirFIX® Cranial bone fixation system: Flap Fixator and Burr Hole Cover is substantially equivalent to the legally marketed predicates. The CirFIX® Cranial bone fixation system: Flap Fixator and Burr Hole Cover is substantially equivalent to the predicate devices in indications for use, anatomical implantation site, materials, design features, mechanical performances, and operating principles. Mechanical testing shows the mechanical strength of the Subject device to be equivalent or better than the predicate devices.
| Device | Gap analysis | CirFIX® Cranial bone fixation system: Flap Fixator and Burr Hole Cover | Cranial Loop, Cranial Loop L And Cranial Loop XI And Cranial Bone Fixation System | Cranial Cover | |
|---|---|---|---|---|---|
| Company | - | OssAware Biotech Co., Ltd. | Neos Surgery S.L. | Neos Surgery S.L. | |
| 510(k) No. | - | K192310 | K132044 | K160739 | |
| Product Code | Same | GXR - burr hole cover | GXR - burr hole cover | GXR - burr hole cover | |
| Device Description | Same | 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 Cranial LOOP Cranial Bone Fixation Systems: Cranial LOOP, Cranial LOOP (L) and Cranial LOOP (XL), are long-term implantable devices indicated for postcraniotomy bone flap fixation. In cranial bone fixation procedures, the Cranial LOOP (FC050000) and Cranial LOOP L (FC50100) are for use with the calvarial gap while the Cranial LOOP (XL) (FC050200) is to be used for covering a standard 14 mm cranial burr hole only. | The Cranial COVER is intended for use to cover burr holes resulting from cranial surgery. With then available sizes, burr holes with an epicranial diameter between 10 and 14 mm, made with standard perforators or with spherical drills, can be covered. | |
| Anatomical site | Same | Burr hole | Cutting line or Burr hole | Burr hole | |
| Device Design | Same | Two platforms linked | Two platforms linked by | Two platforms linked by | |
| by a bolt, joined withlower platformallowing movement ofthe upper platformtowards the lowerplatform. The surgeontightens the upperplatform to the boneby gently rotate thedriver to covers theburr hole like a plug. | two adjustable cable ties,which are joined to thelower platform and havea locking system thatallows movement of theupper platform towardsthe lower platform butimpedes backwardmovements. The surgeontightens the lowerplatform to the bone andbone flap by gentlypressing with the applierand pulling on thehandle. | two adjustable cable ties,which are joined to thelower platform and havea locking system thatallows movement of theupper platform towardsthe lower platform butimpedes backwardmovements. The surgeontightens the upperplatform to the bone bygently pressing with theapplier and pulling on thehandle. | |||
| ApplierInstrument | Same | Not necessary | Not necessary | Not necessary | |
| MaterialComposition | Same | Platforms (Implantable parts)-PEEK | Platforms and ties(implantable parts) –PEEK | Platforms and ties(implantable parts) –PEEK | |
| Sizes | Same | Various sizes for thesystem, that available forburr hole of diameter11/7, 11/8, 13/9, 14/11,15/12 mm made withstandard perforators or10, 11, 12 mm withspherical drills, can becovered.They can fix skullthicknesses ranging from3mm to 14mm. | FC050000 and FC050100applicable in osteotomyline for bone flapfixation.FC050200, only sizeapplicable in burr holescover.They can fix cranicalthicknesses ranging from4mm to 24mm. | - FC050300: for burrholes of diameter 14/11mm and 13/9 mm- FC050400: for burrholes of diameter from10 to 12 mm | |
| Implant life | Same | Long-term implant | Long-term implant | Long-term implant | |
| Biocompatible | Same | Yes | Yes | Yes | |
| ProvidedSterile | Same | Yes | Yes | Yes | |
| SterileMethod | Same | Irradiation | Irradiation | Irradiation | |
| MRICompatibility | Same | MR Safe | MR Safe | MR Safe | |
| Method ofFixation toCranium | Same | Like a clamp | Like a clamp | Like a clamp |
A side-by-side comparison of the CirFIX® Cranial bone fixation system: Flap Fixator and Burr Hole Cover to the predicate devices as following:
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| Discussion of mechanical and performance testing | ||
|---|---|---|
| Test | Test Method Summary | Result |
| A. Functional testing | ||
| A.1.Functionality of the implantable parts | Goal :Verification the available sizes for cranial:(A) Burr hole diameter(B) Bone thicknessMethod: Fully assembled devices were tested. Simulated surgery to each size of burr hole diameter and bone thickness. | 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 the implantable parts and the driver | 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. | |
| 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. | 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. | |
| 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 bole | |
| 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. | ||
| C. Cadaver testing | Goal: Evaluation of the devices when | Correct implantation is |
| simulating their implantation on the skull | verified in a simulated real-life | |
| of patients in a clinical environment, | situation. The devices show | |
| following the procedures described in the | adequate performance and | |
| products' Instructions for Use. | safety. | |
| Method: The test was performed on two | The results demonstrate that | |
| cadaveric specimens with fully assembled | the CirFIX® Cranial bone fixation | |
| devices. Four different craniotomies were | system is equivalent, in terms of | |
| tested: | performance and safety and to | |
| ● Frontal-Parietal(Right side) | the relevant extent, to the | |
| ● Parietal-Temporal (Left side) | predicate devices. | |
| ● Frontal-Parietal-Temporal(Right side) | ||
| ● Frontal-Parietal-Sphenoid wing(Left | ||
| side) | ||
| Some of the most relevant aspects | ||
| analyzed include: | ||
| 1. Sufficient space for device placement. | ||
| 2. No danger for the surgeon during | ||
| device application. | ||
| 3. Correct positioning of the device. | ||
| 4. Rapid and simple application of the | ||
| device with minimum instruments. | ||
| 5. Absence of damage to the dura mater: | ||
| the tissue will be examined after | ||
| removal of the device to detect any | ||
| possible incidence. | ||
| 6. Easy removal of the system: after | ||
| implantation. | ||
| 7. Lateral and axial stability when the | ||
| device is moved. | ||
| 8. Low epicranial and subcranial platform | ||
| profiles. | ||
| 9. Adaptation to different cranium | ||
| curvatures. | ||
| 10.Adaptation to different cranium | ||
| thicknesses. | ||
| 11.No artifacts on neuroimaging. | ||
| 12.Fast and no special tools are required. |
Discussion of mechanical and performance testing
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§ 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).