Search Results

The NeuroPro® Low Profile Cranial Plating System Family is intended for:

1. Internal fixation of fractures and osteotomies of the cranial skeleton.
2. Internal fixation of cranial bone flap osteotomies.
3. Reconstruction of bony defects and deficits in the cranial skeleton.

The NeuroPro® Low Profile Cranial Plating System is not indicated for use in the spine or high load bearing applications.

The NeuroPro® Low Profile Cranial Plating System provides rigid fixation of cranial bone flaps with a thin profile for reduced palpability. The system consists of bone screws and mating bone plates and panels with a beveled plate edge and thinner profile to reduce palpability. Malleable bone plates and panels are easily shaped by hand and/or with stainless steel instruments. The bone screws are used to secure various shapes of bone plates and panels to the cranium. The NeuroPro® Low Profile plates and panels are manufactured from Commercially Pure Titanium and meet all of the specifications of ISO 5832-2 or ASTM F-67. The NeuroPro® Low Profile screws are manufactured from 6AV4V ELI (Extra Low Interstitial) Titanium Allov and meet all of the specifications of ISO 5832-3 or ASTM F-136.

The NeuroPro® Low Profile Cranial Plating System is a modification of the standard NeuroPro® Cranial Plating System to be made thinner than those in the original submission (K964362), with exception of the hex panels which are the same thickness.

The NeuroPro® Low Profile Cranial Plating Screws are a modification of the standard NeuroPro® Quick Tap® Bone Screws to have a shorter screw head height than those in the original submission (K982927). The plates, panels and screws are similar in sizes, dimensions and identical in functionality as the standard NeuroPro® Cranial Plating System which was cleared as part of the original 510(k) submission (K964362).

The NeuroPro® Low Profile Cranial Plating System is identical to the standard NeuroPro® Cranial Plating System in terms of intended use, indications for use, material of construction, manufacturing process, functionality, compatibility of the plates and panels with all screw types, shelf life, biocompatibility, packaging and sterilization method.

The provided text describes the NeuroPro® Low Profile Cranial Plating System, a medical device for internal fixation of cranial bone, and its substantial equivalence to predicate devices, rather than an AI/ML powered device. Therefore, many of the requested categories related to AI/ML device evaluation (such as sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable or cannot be extracted from this documentation.

Here's an analysis of the available information:

Acceptance Criteria and Device Performance for NeuroPro® Low Profile Cranial Plating System

The document states that "The testing met all acceptance criteria and verifies that the performance of the NeuroPro® Low Profile Cranial Plating System is substantially equivalent to the predicate devices." However, specific numerical acceptance criteria and reported performance values are not detailed in a table. Instead, the performance is described qualitatively in relation to established standards and predicate devices.

• Plates and panels: Manufactured from Commercially Pure Titanium, meeting specifications of ISO 5832-2 or ASTM F-67.
• Screws: Manufactured from 6AV4V ELI (Extra Low Interstitial) Titanium Alloy, meeting specifications of ISO 5832-3 or ASTM F-136.
• Acceptance: Materials conform to international and/or FDA recognized consensus standards for the type of material, with a long successful history in similar neurosurgical implant applications. |
  | Mechanical Performance |
• Bone plates and panels: Subjected to bend testing according to ASTM F67-06.
• Bone screw testing: Consisted of Kinamed test methods for:
  • Rate of Insertion (Amount of screw advancement per revolution)
  • Ease of Insertion (Driving torque required per revolution)
  • Torsional Strength
  • Screwdriver Interface Integrity
  • Simulated Use in Animal Bone
• Acceptance: All testing met pre-defined acceptance criteria, verifying substantial equivalence to predicate devices. |
  | Design & Functionality |
• Profile: Thinner profile for reduced palpability compared to the standard NeuroPro® Cranial Plating System (exception: hex panels are same thickness).
• Screw head height: Shorter screw head height compared to standard NeuroPro® Quick Tap® Bone Screws.
• Malleability: Malleable bone plates and panels are easily shaped by hand and/or with stainless steel instruments.
• Acceptance: "Similar in sizes, dimensions and identical in functionality as the standard NeuroPro® Cranial Plating System." The new Low Profile System has "some thinner plates/panels, shorter screw head height and is a differentiating color." |
  | Substantial Equivalence |
• Acceptance: Substantially equivalent to predicate devices (K964362 NeuroPro® Cranial Plating System and K982927 NeuroPro® Quick Tap® Bone Screws) with respect to:
  • Same intended use
  • Same indications for use
  • Same raw material
  • Same method of manufacture
  • Same design
  • Similar sizes and dimensions
  • Same type of mating components
  • Same shelf life
  • Same biocompatibility
  • Same sterilization and packaging methods |

Details Not Applicable or Not Provided for AI/ML Devices:

1. Sample size used for the test set and the data provenance: Not applicable. This is a mechanical device, not an AI/ML algorithm requiring a data test set. Testing was conducted on "worst case component size and option/design."
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of AI/ML. The "ground truth" here is the performance against engineering standards and comparison to predicate devices, verified through physical and mechanical testing.
7. The sample size for the training set: Not applicable.
8. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device