(210 days)
Optimus Neuro System is intended for use in selective trauma of the cranial skeleton, cranial surgery and reconstructive procedure.
The Optimus Neuro System is comprised of plates and screws. The range of plate sizes is from 0.3mm to 0.6mm thick. It is made of commercially pure titanium of Gr 1, 2 and 3 (ASTM F67) and in 3 colors (silver, blue and gold) by anodizing. The range of screw diameter is from 0.8mm to 1.8mm in lengths of 3.0 to 6.0mm. It is made of Ti-6AI-4V ELI titanium alloy (ASTM F136) and in 3 colors (silver, greenand gold) by anodizing. The plate and screw are a single use only, non-sterile product and they must be sterilized by the user before use. Each component is individually packed in a PE bag. Optimus NEURO System consists of plates and screws to provide fixation and aid in the alignment and stabilization of fractures in reconstructive processes. The placed on the fractured bone and the screw is inserted into the bone through a plate hole to fix. If necessary, the plate may be bent or cut to meet the anatomical needs of patient.
The provided text describes the "Optimus Neuro System," a medical device for cranial surgery and reconstructive procedures. However, the document primarily focuses on demonstrating substantial equivalence to predicate devices through bench testing (mechanical, sterilization, cleaning, and packaging validation), rather than a clinical study involving human or animal subjects that would typically involve acceptance criteria for diagnostic or clinical performance.
Therefore, the information required to directly answer some of your questions, particularly those related to a study proving diagnostic or clinical performance (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details), is not present in this document. This is common for devices like cranioplasty plates and screws, where substantial equivalence is often established through material testing, mechanical performance, and comparisons to existing devices with a long history of safe and effective use.
Here's a breakdown of what can be answered based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Sterilization Validation Test | Sterility assurance level (SAL) of 10⁻⁶ for steam sterilization. | Sterility assurance level (10⁻⁶) for the recommended steam sterilization parameters is met. |
| Mechanical Test | Pre-set criteria for mechanical characteristics (not specified). | Worst case test articles have passed the pre-set criteria. The subject devices have been validated in mechanical characteristics. |
| Cleaning Process Validation | Bioburden level and endotoxin criteria of 2.15 EU/device. | The subject devices showed low bioburden level and met criteria of 2.15 EU/device for endotoxin. The cleaning process at the manufacturing sites has been validated. |
| Packaging Validation Test | Complete sealing of final packaging. | Final packaging of the subject device has passed the testing for its complete sealing. The subject device will be well protected until use in its packaging. |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not specified. The document refers to "worst case test articles" for mechanical testing, implying a limited number of samples were tested for each specified test type. These are bench tests on physical devices, not a clinical study on patient data.
- Data Provenance: Not applicable in the context of a clinical test set. The tests described are laboratory/bench tests on manufactured devices, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. The ground truth for bench testing is established by technical specifications and validated test methods, not expert clinical consensus.
4. Adjudication method for the test set
- Not applicable. This is not a clinical study with image interpretation or similar expert-dependent outcomes.
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 device is a mechanical implant (plates and screws), not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a mechanical implant, not an algorithm. Performance relates to its physical and material properties.
7. The type of ground truth used
- For the bench tests, the ground truth or reference standard is based on pre-set criteria, technical specifications, and recognized standards (e.g., ASTM F67, ASTM F136 for materials, and established parameters for sterilization, bioburden, and packaging integrity).
8. The sample size for the training set
- Not applicable. This device does not involve a "training set" in the context of machine learning or algorithms.
9. How the ground truth for the training set was established
- Not applicable. As above, this is a mechanical device, not an AI model.
Summary of Study Type:
The "study" described in the provided text is a set of non-clinical bench tests and validation activities, typical for demonstrating the safety and performance of medical implants like cranioplasty plates and screws. These tests are designed to confirm material properties, mechanical strength, sterility, cleanliness, and packaging integrity, which are crucial for the intended use of such a device in surgery. The objective is to demonstrate substantial equivalence to already legally marketed predicate devices, primarily through engineering and material science evaluations, rather than clinical efficacy studies on patient outcomes or diagnostic accuracy.
§ 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).