(141 days)
The Innovasis Cranial System is intended for use in selective trauma of cranial skeleton, cranial surgery and reconstructive procedures.
The Innovasis« Cranial System Bone Plates are comprised of a variety of shapes and sizes intended for reconstruction, stabilization and/or rigid fixation of non loadbearing areas subsequent to craniotomy, craniectomy and cranial fractures in adults and adolescents (age 12 and higher). The single use devices are a variety of low profile plates and anchoring screws that fixate bone pieces together in the cranial area of the patient. The design features include:
- · Commercially Pure Titanium or 6 Al 4V Titanium Alloy
- · Straight and Square plates
- · Double Y plates
- Burr hole plates
- · Plates with Shunts
- · Self-Drilling/Self-Tapping Screws
- Mesh
- · Instrumentation to customize size, shape and placement of implants
- · Compact sterilization tray to optimize organization of implants
The provided document describes the Innovasis Cranial System, a medical device for cranial surgery and reconstructive procedures. It details the device's technical characteristics, comparison with a predicate device, and performance data from non-clinical testing.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" as numerical thresholds that were predefined and then met. Instead, it presents performance testing where the subject device (Innovasis Cranial System) was compared against a legally marketed predicate device (Jeil Medical Products LeForté Neuro System). The "acceptance criteria" implicitly used is that the subject device's performance should be equal to or exceed the predicate device's performance for the tested parameters.
| Test | Implicit Acceptance Criteria | Reported Device Performance (Innovasis Cranial System) |
|---|---|---|
| Material | Comparable or equivalent to predicate device material specifications (ASTM F67 Commercially Pure Grade 2/3 Titanium, ASTM F136 6Al4V Titanium). | Uses ASTM F67 Commercially Pure Grade 2 Titanium (plates), Grade 3 Titanium (mesh) and ASTM F136 6Al4V Titanium for Surgical Implants (Screws). (Generally comparable, with predicate offering additional grades). |
| Torsion Properties | The mean torsional strength of the subject screws should be equivalent to or exceed the predicate screws. | Exceeded: "The mean torsional strength for the subject screws exceeded the strength of the predicate screws thereby demonstrating substantial equivalence." |
| Static Axial Pullout | The mean pullout force of the subject screws should be equivalent to or exceed the predicate screws. | Exceeded: "The mean pullout force for the subject screws exceeded the pullout force of the predicate screws thereby demonstrating substantial equivalence." |
| Static Axial Compression | The mean bending stiffness, Peak Force, and Displacement at deformation of the subject plate should be equivalent to or exceed the predicate plate. | Exceeded: "The mean bending stiffness, Peak Force and Displacement at deformation of the Rev. 3 subject plate exceeded the bending stiffness, Peak Force and Displacement at deformation of the predicate plate demonstrating substantial equivalence." |
| Static 3 Point Bend | The mean bending stiffness of the subject plates should meet or exceed the bending stiffness of the predicate plate. | Met or Exceeded: "The mean bending stiffness of the subject plates met or exceeded the bending stiffness of the predicate plate demonstrating substantial equivalence." |
| Static 4 Point Bend | The mean bending stiffness of the subject plates should meet or exceed the bending stiffness of the predicate plate. | Met or Exceeded: "The mean bending stiffness of the subject plates met or exceeded the bending stiffness of the predicate plate demonstrating substantial equivalence." |
| Corrosion | The corrosion resistance of the subject plates should meet or exceed the corrosion resistance of the predicate plate. | Met or Exceeded: "The data show the corrosion resistance of the subject plates met or exceeded the corrosion resistance of the predicate plate thereby passing the requirement in the protocol and demonstrating substantial equivalence." |
| Biocompatibility | Biocompatibility evaluation conducted per FDA Blue Book Memorandum #G95-1 and ISO 10993-1. Components should be made of known biocompatible materials, and manufacturing process should not add contamination. Test results (Pyrogen, Cytotoxicity) below cutoff. | Passed: "The implants are composed of known biocompatible material... Testing was conducted to ensure manufacturing process did not add contamination. Test battery included Pyrogen Testing (LAL) and Cytotoxicity testing (MEM) All test results were below cutoff (pass)." (Demonstrating substantial equivalence). |
2. Sample Size Used for the Test Set and the Data Provenance
The document provides the testing standards (e.g., ASTM F543-13, F382-99, F2129-08) for each performance test. It mentions "subject and predicate sample groups were tested identically" and refers to "very small screw samples" for torsion testing. However, specific sample sizes (n-values) for each test set are not explicitly stated. The data provenance for these non-clinical tests is generally within a laboratory setting, not related to patient data. The document does not specify country of origin for the data, but the submission is to the U.S. FDA. These are laboratory-based, non-clinical tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable as the described performance study is non-clinical (laboratory-based mechanical and material testing), not an AI or diagnostic device study involving expert assessment of patient data.
4. Adjudication Method for the Test Set
This information is not applicable for the same reason as point 3. There is no human adjudication for mechanical or material performance tests.
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
This information is not applicable. This document describes the clearance of a physical medical implant (cranial system), not an AI or diagnostic device that assists human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is a physical implant, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical performance tests is based on established engineering standards and measurements. For example:
- Mechanical Properties: Measured physical strength (torsional strength, pullout force, bending stiffness, peak force, displacement at deformation) directly obtained from standardized testing methods (e.g., ASTM).
- Corrosion Resistance: Measured electrical potential or current, or visual assessment under a microscope, following ASTM standards.
- Biocompatibility: Results of standardized in-vitro (e.g., LAL, MEM cytotoxicity) assays and assessment of material composition against known biocompatible materials.
The "ground truth" is thus rooted in direct physical and chemical measurements against industry-recognized benchmarks and comparative performance to a predicate device.
8. The Sample Size for the Training Set
This information is not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the same reason as point 8.
§ 882.5320 Preformed alterable cranioplasty plate.
(a)
Identification. A preformed alterable cranioplasty plate is a device that is implanted into a patient to repair a skull defect. It is constructed of a material, e.g., tantalum, that can be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).