The NeuroVention Cranial Fixation System is intended for use as a burr hole cover and/or skull bone fixation following craniotomy, cranioplasty, or craniectomy surgery.

Device Description

The NeuroVention Cranial Fixation System is a series of burr hole covers and plates with various configurations to facilitate surgeon selection of the implant he/she determines to be most appropriate for the patient and the surgical circumstances. Each is provided non-sterile single use and is made of titanium as per ASTM F67, titanium alloy (Ti-6AI4V ELI) implantable components that comply with ASTM F136 or PEEK per ASTM F2026. Class I exempt instrumentation is available for delivery and removal: Screwdriver Adapter (handle), Torx Drivers, Forceps. Additionally, a Class II Drill bit is included to create pilot holes for the screws.

AI/ML Overview

This document, K192162, describes a 510(k) premarket notification for the "NeuroVention Cranial Fixation System." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials. Therefore, the information provided primarily relates to mechanical performance and material biocompatibility.

Here's an analysis of the provided text in relation to your request about acceptance criteria and study proving device meets them:

Key Takeaway: This document does not describe a clinical study or an AI/algorithm-driven device. It is for a physical medical device (cranial fixation system) and relies on mechanical testing and material equivalence to demonstrate substantial equivalence to a predicate device.

Therefore, many of your requested points regarding AI/algorithm performance, human readers, ground truth establishment for training/test sets, and expert consensus are not applicable to this specific submission.

However, I can extract the relevant information from the document that addresses mechanical performance, which serves as the "study" for this type of device.

Acceptance Criteria and Reported Device Performance (Mechanical Testing)

The document primarily relies on mechanical testing to demonstrate substantial equivalence. The acceptance criteria for these tests are implicitly that the "Subject device [is] equivalent or better than the predicate devices" and that "All testing met or exceeded the requirements as established by the test protocols and applicable standards."

Here's a table summarizing the "acceptance criteria" (implied through performance comparison to predicates and standards) and the reported performance for the mechanical tests:

Acceptance Criterion (Implicit)	Reported Device Performance
Withstand expected loads without failure (General)	"A review of the mechanical data indicates that the components of the Subject device are capable of withstanding expected loads without failure."
Meeting established test protocols and applicable standards	"All testing met or exceeded the requirements as established by the test protocols and applicable standards."
Equivalent or better mechanical strength compared to predicates	"Mechanical testing shows the mechanical strength of the Subject device to be equivalent or better than the predicate devices.""All results passed acceptance criteria and were equivalent or better when compared to the predicates."
Static Compression	Passed acceptance criteria, equivalent or better than predicates.
Skull Conformity	Passed acceptance criteria, equivalent or better than predicates.
Screw Axial Pushout	Passed acceptance criteria, equivalent or better than predicates.
Screw Torque to Failure per ASTM F543-13	Passed acceptance criteria, equivalent or better than predicates.
Usability testing of Drill Bit	Passed acceptance criteria, equivalent or better than predicates.

Addressing Other Requested Information (and why some are not applicable):

Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified in terms of number of physical test articles for each mechanical test. This is common for 510(k) mechanical testing summaries, where the focus is on meeting standards rather than statistical clinical significance as in a clinical trial.
- Data Provenance: Not applicable as this is mechanical/biocompatibility testing, not clinical data from patients. The testing would have been conducted by the manufacturer or a contracted testing lab.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not Applicable. The "ground truth" for this device is established by engineering principles, mechanical test standards (e.g., ASTM F543-13), and material specifications (e.g., ASTM F67, F136, F2026). No clinical experts (like radiologists) are involved in establishing ground truth for mechanical performance.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods are relevant for subjective assessments, primarily in clinical data interpretation (e.g., reading medical images). Mechanical testing results are objective measurements against defined standards.
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. This is a physical cranial fixation system, not an AI or imaging system. No human reader studies (MRMC) would be relevant here.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is a physical medical device, not an algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Ground Truth: For mechanical testing, the "ground truth" is defined by widely accepted engineering test standards (e.g., ASTM standards) and the specifications of the predicate device. For biocompatibility, it's defined by the material's conformity to established standards (e.g., ASTM F67-13, ASTM F136, ASTM F2026) and its history of safe use as an implantable material.
The sample size for the training set:
- Not Applicable. There is no "training set" as this is not an AI/machine learning device.
How the ground truth for the training set was established:
- Not Applicable. There is no "training set" as this is not an AI/machine learning device.

In summary, the provided document is a 510(k) clearance for a traditional physical medical device. The "study" proving it meets "acceptance criteria" consists of mechanical performance testing (as outlined in the table above) and biocompatibility assessments, which demonstrated substantial equivalence to a legally marketed predicate device (Stryker Universal Neuro 3 System). The concept of AI performance metrics, expert reviews, and large human data sets is outside the scope of this type of device and submission.

Summary

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March 13, 2020

NeuroVention, LLC Rohit Khanna President 645 S. Beach St. Daytona Beach, Florida 32114

Re: K192162

Trade/Device Name: NeuroVention Cranial Fixation System. NuCrani Plates, KTC Burr Hole Cover, DC Plate Regulation Number: 21 CFR 882.5250 Regulation Name: Burr Hole Cover Regulatory Class: Class II Product Code: GXR, GWO, HBW Dated: February 11, 2020 Received: February 12, 2020

Dear Rohit Khanna:

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.

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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 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 (QS) 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.

Matthew Krueger, M.S.E. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K192162

Device Name

NeuroVention Cranial Fixation System

Indications for Use (Describe)

The NeuroVention Cranial Fixation System is intended for use as a burr hole cover and/or skull bone fixation following craniotomy, cranioplasty, or craniectomy surgery.

Type of Use (Select one or both, as applicable)
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

(as required by 21 CFR 807.92)

Submitter	NeuroVention LLC
Address	645 S Beach StreetDaytona Beach, FL 32114
Telephone	386-238-9638
Fax	386-253-8174
Contact Person	Rohit Khanna, M.D.
email	khanna@neurovention.com
Date Prepared	January 27, 2020
Trade Name	Neurovention Cranial Fixation SystemIncludes: NuCrani Plates, DC Plate, and KTC burr hole cove
Common Name	Neuro plating system
Panel Code	Neurological Devices
Classification Name	Burr Hole Cover (GXR)Preformed Alterable Cranioplasty Plate (GWO)Cranioplasty Plate Fastener (HBW)Drills, Burrs, Trephines & Accessories- Manual (HBG)
Class	Class II
Regulation Number	21 CFR 888.5250 21 CFR 888.532021 CFR 888.536021 CFR 882.4300
Product Code	GXR, GWO, HBW, HBG

Predicate Device Name	510(k) Number	Manufacturer
Stryker Universal Neuro 3 System	K112557	Stryker

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Description

Indications and Intended Use

The NeuroVention Cranial Fixation System is intended for use as a burr hole cover and/or skull bone fixation following craniotomy, cranioplasty, or craniectomy surgery.

Technological Characteristics and Substantial Equivalence

Documentation was provided to demonstrate that the NeuroVention Cranial Fixation System is substantially equivalent to the legally marketed predicates. It consists of a storage module that contains the various shapes of implants, screws and implantation instruments. The devices and accessories included in the Subject device and the predicate devices are both burr hole covers, cranioplasty plates and screws. The NeuroVention Cranial Fixation System is substantially equivalent to the predicate devices in intended use, site of application, patient populations of use, mechanical performances, basic design, and operating principles. The NeuroVention Cranial Fixation System is comparable to its predicate in size and materials. Mechanical testing shows the mechanical strength of the Subject device to be equivalent or better than the predicate devices.

	NeuroVention CranialFixation System	Stryker Universal Neuro 3 System
Manufacturer	NeuroVention	Stryker
510(k)number	This application	K112557
ProductCode	GXR, GWO, HBW	GXR, GWO, HBW
ClassificationRegulation	21 CFR 882.5250, 882.5320,882.5360	21 CFR 882.5250, 882.5320,882.5360
CommonName	Burr Hole Cover, PreformedAlterable Cranioplasty Plate,Cranioplasty Plate Fastener	Burr Hole Cover, PreformedAlterable Cranioplasty Plate,Cranioplasty Plate Fastener
Class	II	II
Implantablecomponents	Yes	Yes
AnatomicLocations	Skull	Skull
IntendedUse	Cover burr holes and skullbone fixation followingcraniotomy, cranioplasty, orcraniectomy surgery.	Cover burr holes and skull bonefixation following craniotomy,cranioplasty, or craniectomysurgery.
Indicationsfor UseStatement	The NeuroVention CranialFixation System is intendedfor use as a burr hole coverand/or skull bone fixationfollowing craniotomy,cranioplasty, or	The Stryker Universal Neuro 3System is intended forreconstruction, stabilization, and/orrigid fixation of non-loadbearingareas subsequent to craniotomy,craniectomy, and cranial fractures
	craniectomy surgery.	In adults and adolescents (age 12 and higher).
Implant Material	Titanium, Titanium alloy (Ti6AL4V ELI)PEEK (VESTAKEEP) per ASTM F2026	Titanium, Titanium alloy (Ti6AL4V ELI)
Instrument materials	Stainless Steel	Stainless Steel
Sterilization	Provided non-sterile to be steam sterilized by user facility	Provided non-sterile to be steam sterilized by user facility
MRI compatibility	Non-clinical testing has demonstrated the NeuroVention Cranial Plate System is MR Conditional. A patient with this device can be safely scanned in an MR system meeting the following conditions:• Static magnetic field of 1.5 T and 3.0 T;• Maximum spatial field gradient of 6,200 G/cm (62 T/m);• Quadrature driven, Circular Polarized (CP) Mode Only• Maximum MR system-reported, whole-body averaged specific absorption rate (SAR) of 2 W/kg (Normal Control Mode).• Maximum Head SAR of 3.2 W/kg.Under the scan conditions defined above, the NeuroVention Cranial Plate System is expected to produce a maximum temperature rise of less than 2.5 °C after 15 minutes of continuous scanning at 1.5 T and less than 3.5 °C after 15 minutes of continuous scanning at 3.0 T.In non-clinical testing, the image artifact caused by the device extends approximately 13 mm from the NeuroVention Cranial Plate System when imaged with a gradient echo pulse sequence and a 3 T MRI system.	"has not been evaluated for safety and compatibility in the MR environment" and that it "has not been tested for heating or migration in the MR environment."

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Name ofDevice	NeuroVention Cranial Fixation System	Stryker UniversalNeuro 3 System
Implant SizeRanges	NuCrani Small Rectangular 4 hole plate, 12 x 20 mm· NuCrani Medium Circular 8 hole plate· NuCrani Large Circular 7 hole Plate, 20 x 27 mm• KTC Burr Hole Cover 26.5 mm• DC plate, 15 x 24 mm· 2.0mm Self Tapping Screws, 6-10 mm· 2.3 mm Self Tapping Rescue Screws, 6-10 mm	• 2 hole dogboneplate· Straight plate 2hole· Straight plate 8hole· Straight plate 16hole· Double Y plate• Box plate 2x2 hole· Rectangle plate· X plate· Gap plate, small· Gap plate, large• Burr hole cover,7mm• Burr hole cover,10mm• Burr hole cover14mm• Burr hole cover,20mm• Burr hole cover,24mm• Round malleableplate, 42-58 mm· Suboccipitalmalleable plate,62 x 30 mm· Subocciptialmalleable plate,65 x 40 mm• Temporalmalleable plate,47 x 29 mm• Translabyrithinemalleable plate, 54x 52 mm· Translabyrinthinemalleable plate, 60x 60 mm· 1.5 mm Self DrillingScrews, 3-5 mm• 1.5 mm SelfTapping screws, 4-6 mm· 1.7 mm EmergencyScrews, 4mm
Manual Drill Bit	1.5 mm diameter	1.2 mm diameter

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Performance Data The potential hazards have been evaluated and controlled through Risk Management.

All testing met or exceeded the requirements as established by the test protocols and applicable standards. A review of the mechanical data indicates that the components of the Subject device are capable of withstanding expected loads without failure. The Subject device was therefore found to be substantially equivalent to the Predicates. Clinical data was not needed to support the safety and effectiveness of the Subject Device.

The following mechanical testing was performed:

Static Compression
. Skull Conformity
Screw Axial Pushout •
. Screw Torque to Failure per ASTM F543-13
. Usability testing of Drill Bit

All results passed acceptance criteria and were equivalent or better when compared to the predicates.

Biocompatibility The components of the predicate device for the implantable components, are manufactured from the same titanium and titanium alloy for implantable components in conformity with ASTM F67-13 and ASTM F136. The Subject device also has a PEEK configuration made from VESTAKEEP by Evonik Industries per ASTM F2026. The instruments are made of the same stainless steel in conformance with ASTM F899. These materials are well known and well characterized have been used in other commercially available cranial implants. The predicate devices are used for the same duration and come into contact with the patient in the same manner and in the same body parts. The materials are considered to be biocompatible and have a long history of safe use as part of medical devices marketed in the United States and around the world. The Subject and predicate devices as well as a large number of implantable devices are manufactured in the same way with the same materials.

Conclusion Based on design, materials, intended use, technological characteristics, and comparison to predicate devices, the Subject Neurovention Cranial Fixation System has been shown to be substantially equivalent to legally marketed predicate device.

Regulation Number and Section

§ 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).