Search Results

The Optimus Neuro Plating System is intended for use in selective trauma of the cranial skeleton, cranial surgery and reconstructive procedures.

The Neuro Plating 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 comes in 3 anodized colors (silver, blue and gold). The screws range in diameter from 0.8mm to 1.95mm and in lengths of 3.0mm to 6.0mm. They are made of Ti- 6Al-4V ELI titanium alloy (ASTM F136) and come in 3 anodized colors (silver, green and gold).

The Neuro Plating System consists of plates and screws to provide fixation and aid in the alignment and stabilization of fractures in the reconstructive process. The plate is placed on the fractured bone and the screw is inserted into the bone through a plate hole to achieve fixation. If necessary, the plate may be bent or cut to meet the anatomical needs of the patient.

The Neuro Plating System has two types of sterilization methods: 1.) the Neuro Plating System is non-sterile state packed in a PE bag which must be sterilized before use; and 2.) the Neuro Plating System - Sterile Kit is provided sterile using gamma sterilization packed in Tyvek and PET. Both are single use only.

The provided text describes the regulatory clearance of a medical device, the Optimus Neuro Plating System, and details its substantial equivalence to predicate devices. It does not present a study proving the device meets specific acceptance criteria in terms of AI or algorithm performance.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this document refer to regulatory acceptance for market clearance based on substantial equivalence to existing devices, rather than performance metrics for an AI-powered system or diagnostic accuracy study.

Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone algorithm performance) are not applicable to this type of submission.

Here's how the provided information relates to your request:

1. A table of acceptance criteria and the reported device performance:

The document doesn't present "acceptance criteria" in the sense of performance metrics for an AI system. Instead, it presents a comparison table demonstrating the "substantial equivalence" of the modified device to its predicate devices across various attributes. The "performance" here refers to the device proving it is as safe and effective as the predicate, not a quantifiable clinical outcome or AI accuracy.

Table: Comparison of Modified Device to Predicate Devices for Substantial Equivalence

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

• Test Set Description: The "test set" in this context refers to the samples of the physical device that underwent non-clinical laboratory testing (e.g., mechanical strength, sterilization validation).
• Sample Size: The document does not specify the exact number of units used for each test (e.g., how many plates/screws for the 4-point bending test). It only states that "The following tests were performed on the modified devices."
• Data Provenance: The tests were performed by Osteonic Co., Ltd. (the manufacturer) in South Korea. The data would be internally generated "non-clinical tests." The provenance typically refers to the source of the clinical data (e.g., patient records), which is not relevant here as this is a device clearance based on engineering and material testing. The tests are prospective as they were conducted for this submission.

3. 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. This submission is for a physical medical implant, not an AI or diagnostic imaging device that requires interpretation by medical experts to establish ground truth for performance evaluation. The "ground truth" for the device's characteristics (e.g., material strength, sterility) is established by standardized engineering tests and established quality control methods, not expert consensus on medical images.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. This refers to a method used to resolve discrepancies in expert interpretations (e.g., for image annotations or diagnoses), which is not relevant to the non-clinical engineering and material tests performed for this device.

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 type of study performed for diagnostic AI tools to evaluate their impact on human interpretation. This submission is for a physical neuro plating system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This describes the performance evaluation of an AI algorithm in isolation. The Optimus Neuro Plating System is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For the physical device, the "ground truth" for demonstrating substantial equivalence is based on:
  • Engineering specifications and standards: ASTM F67, ASTM F136, ISO 10993.
  • Validated test methods: 4 Point Bending Test, Torsion Test, Axial Pullout Strength Test, Packaging Process Validation Test, Gamma Sterilization Validation, Shelf life, MR safety tests.
  • Comparison to predicate device performance data in these established physical and biological safety metrics.

8. The sample size for the training set:

• Not applicable. This is relevant for AI/ML models. This document describes a physical medical device.

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

• Not applicable. Relevant for AI/ML models.

Ask a specific question about this device

Optimus Neuro System is intended for use in selective trauma of the 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 3colors (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, green and gold) by anodizing.

The device is packed separately in a PE bag. The plate and screw are single use only, non-sterile products. The devices must be sterilized before use.

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

This document describes the Optimus Neuro System, a device intended for use in cranial surgery and reconstructive procedures. It's important to note that this submission focuses on the device itself (plates and screws), not an AI algorithm. Therefore, many of the requested AI-specific details are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for the "4 Point Bending Test" or "Packaging Process Validation Test." It refers to "the subject device and the predicate devices," suggesting that a sufficient number of units were tested to draw conclusions.

• Data Provenance: The manufacturing company, Osteonic Co., Ltd., is based in Seoul, Korea. The tests were likely conducted in a controlled lab environment. The study is retrospective in the sense that it's comparing a modified device to an existing predicate, and the testing isn't on human subjects for clinical outcomes, but rather on the physical properties of the device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as this is a submission for a medical device (plates and screws), not an AI algorithm requiring expert ground truth for image or data interpretation. The "ground truth" here is based on engineering standards and physical test results.

4. Adjudication Method for the Test Set

This is not applicable as it pertains to expert disagreement in AI-driven diagnostic tasks, which is not relevant to this device's testing.

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 is not applicable as this is a medical device (plates and screws), not an AI algorithm.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This is not applicable as this is a medical device (plates and screws), not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

• Engineering Standards: Adherence to material specifications (ASTM F67, ASTM F136) and performance standards (e.g., implied stress/strain limits for the 4-point bending test).
• Physical Test Results: Direct measurements of mechanical properties (bending strength) and packaging integrity.
• Previous Validation Data: Relying on sterilization and biocompatibility data from the primary predicate device (K141911).

8. The Sample Size for the Training Set

This is not applicable as this is a medical device (plates and screws) and does not involve AI or machine learning models that require a training set.

9. How the Ground Truth for the Training Set was Established

This is not applicable for the same reasons as above.

Ask a specific question about this device

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

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.

Ask a specific question about this device