(110 days)
The OsteoMED Low Profile Neuro Fixation System is indicated for use in osteotomies, fractures or reconstructions of the cranial bones.
Implants and drills are single use only.
The OSTEOMED Low Profile Neuro Fixation System is comprised of plates, screws and instrumentation. The system features plates ranging from 0.25mm to 1.0mm thick, 1.2 mm to 1.6mm diameter standard screws in lengths from 2.0mm to 8.0mm and Auto-Drive screws in 1.2mm to 1.6mm diameters in lengths from 3.0mm to 8.0mm.
The instruments include drill bits, plate bending forceps, plate holding forceps, plate cutters, cannulae, taps, countersinks and screwdrivers to facilitate the placement of screws and modification of plates.
The screws are made from Titanium Alloy (ASTM F-136). The plates are made from Titanium Alloy (ASTM F-136) or commercially pure Titanium (ASTM F-67). The instrumentation is made from various grades of surgical grade stainless steel, anodized aluminum, and/or medical grade plastic.
The OsteoMed Low Profile Neuro Fixation System is a medical device used for cranial bone fixation.
Here's an analysis of its acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Strength | Equivalent or greater strength than existing neuro predicate devices | "performed equivalent or with greater strength than the existing neuro predicate devices based on verification testing." |
| Biocompatibility | Materials are biocompatible and already part of predicate neuro devices | "Materials used for the device are the same as the predicate device with changes from CP Ti to Ti-Alloy to maintain equivalent or greater strength to the predicate devices. These materials are biocompatible and already part of the predicate neuro devices." |
| Material Equivalence | Similar materials to predicate devices (with justified improvements) | "Materials used for the device are the same as the predicate device with changes from CP Ti to Ti-Alloy to maintain equivalent or greater strength to the predicate devices." |
| Design Equivalence | Similarities in design to predicate devices | Basis of substantial equivalence is "based on the similarities in design... to the predicate device." |
| Function Equivalence | Similarities in function to predicate devices | Basis of substantial equivalence is "based on the similarities in ... function... to the predicate device." |
| Performance Equivalence | Similarities in performance (as demonstrated by mechanical testing/FEA) | "Verification consisted of mechanical testing and finite element analysis comparisons against the predicate neuro plates." |
| Sterilization Equivalence | Similar sterilization methods to predicate devices | Basis of substantial equivalence is "based on the similarities in ... sterilization... to the predicate device." |
| Intended Use Equivalence | Similar intended use to predicate devices | Basis of substantial equivalence is "based on the similarities in ... intended use to the predicate device." |
| Endotoxin Level | LAL testing conducted in accordance with ANSI/AAMI ST72:2002 to ensure low endotoxin levels. | "Limulus Amebocyte Lysate (LAL) testing was conducted in accordance to ANSI/AAMI ST72:2002." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a sample size for a "test set" in the traditional sense of clinical trials or AI model evaluation. The performance evaluation was primarily based on mechanical testing and finite element analysis (FEA) rather than a test set of patient data.
The data provenance is retrospective, comparing the new device's mechanical characteristics to existing predicate devices. It does not involve prospective data collection from human or animal subjects for performance evaluation in this context.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The "ground truth" for this device's performance was established through engineering principles and established mechanical testing standards, not expert human interpretation of medical images or clinical outcomes. The "experts" involved would be mechanical engineers and material scientists who designed the tests and analyzed the results.
4. Adjudication Method for the Test Set
Not applicable. There was no "adjudication method" in the context of clinical or diagnostic testing. The evaluation was based on objective mechanical measurements and computational modeling (FEA).
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
No. This device is a surgical implant (fixation system) and not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to its evaluation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not directly applicable. The device itself is a physical component. Its "standalone performance" refers to its mechanical integrity and biocompatibility, which were assessed through the described mechanical testing, FEA, and material analysis. There is no "algorithm" in this context.
7. The Type of Ground Truth Used
The ground truth used for assessing the device's performance was:
- Mechanical properties of predicate devices: The established strength and performance characteristics of legally marketed predicate neuro plates served as the benchmark.
- Engineering specifications and standards: Mechanical testing was conducted according to established engineering principles and likely internally defined specifications, as well as biocompatibility standards (e.g., ASTM F-136, ASTM F-67, ANSI/AAMI ST72:2002).
- Material properties: The known properties of Titanium Alloy and commercially pure Titanium contributed to the "ground truth" regarding material strength and biocompatibility.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, there is no ground truth to establish for it in this context.
§ 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).