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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.

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.

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:

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

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. The sample size for the training set:

   • Not Applicable. There is no "training set" as this is not an AI/machine learning device.

8. 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.

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The NeuroVention LamiFix Laminoplasty Plating System is intended for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The NeuroVention LamiFix Laminoplasty Plating System holds or buttresses the allograft in place in order to prevent the allograft from expulsion or impinging on the spinal cord.

The NeuroVention LamiFix Laminoplasty Plating System is comprised of various sized, pre-bent miniplates that are designed to fit the anatomy of the vertebral arch (i.e., between the pedicle and spinous process). The plates have screw holes located at the center and both ends of the plate to allow for attachment to the bone. The center hole in the plate is used for attachment to bone allograft spacers that are provided in a variety of sizes. The screws intended for use with the mini-plates are available in a variety of lengths and diameter and are designed to match the anatomical requirements.

This submission describes a medical device, the NeuroVention LamiFix Laminoplasty Plating System, which is a spinal implant. The "study" mentioned here refers to the mechanical performance testing conducted to ensure the device's structural integrity and equivalence to predicate devices, not a clinical study involving human or animal subjects in the way an AI/software device would typically be evaluated for diagnostic accuracy.

Here's the breakdown of the information requested, based on the provided text:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and the Reported Device Performance:

Explanation: The acceptance criteria are implicitly defined by the modified ASTM F1717-11 standard and the need to demonstrate substantial equivalence to the predicate device (Synthes Arch™ Fixation System (AFS)). The reported performance is that the device was tested according to these standards, and the conclusion drawn is that its overall technology characteristics and mechanical performance data lead to the conclusion of substantial equivalence. Specific numerical results or direct comparisons to predicate device data are not provided in this summary.

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

• Sample Size: Not explicitly stated. For mechanical testing of medical devices, samples typically refer to the number of physical device units tested. The ASTM standard would specify minimum test sample sizes.
• Data Provenance: The device itself was tested, not patient data. The testing was performed in accordance with modified ASTM F1717-11, which is an industry standard for spinal implant constructs. Since it's mechanical testing, there's no concept of country of origin for "data" or retrospective/prospective. The testing was laboratory-based.

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

• Not applicable. This is mechanical testing of a physical device, not an assessment requiring expert interpretation of clinical data. The "ground truth" is established by the physical properties and performance of the material and device under stress, measured using calibrated equipment.

4. Adjudication method for the test set:

• Not applicable. As this is mechanical testing, there is no human adjudication of "ground truth" as there would be for, say, image interpretation. Testing results are quantitative measurements against predefined specifications.

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. This is a physical medical device (spinal implant), not an AI/software device that would involve human readers or AI assistance.

6. 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.

7. The type of ground truth used:

• Quantitative Mechanical Properties: The "ground truth" for this type of device is its ability to withstand specified mechanical forces (axial compression bending, torsion, dynamic axial bending compression) as defined by a recognized standard (modified ASTM F1717-11). The measurements obtained from the physical tests represent the objective performance of the device.

8. The sample size for the training set:

• Not applicable. This is a physical device, not a machine learning algorithm that requires a training set.

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

• Not applicable. As above, there is no training set for a mechanical device.

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