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

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 in 3 colors (silver, blue and gold) by anodizing. The range of screw diameter is from 0.8mm to 1.95mm in lengths of 3.0 to 6.0mm. It is made of Ti-6Al-4V ELI titanium alloy (ASTM F136) and in 3 colors (silver, green and gold) by anodizing.

Neuro Plating System consists of plates and screws to provide fixation and aid in the alignment and stabilization of fractures in reconstructive processes. The plate is 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 Neuro Plating System has two types of sterilization method; Neuro Plating System is non-sterile state packed in PE bag which must be sterilized before use and Neuro Plating System - Sterile Kit is provide sterile state with gamma sterilization packed in Tyvek and PET. Both are single use only.

The provided text is a 510(k) Pre-Market Notification for the Neuro Plating System, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study.

Therefore, much of the requested information about acceptance criteria, study design, sample sizes, expert involvement, and ground truth is not directly available or applicable in the context of this 510(k) summary. This document primarily relies on non-clinical (mechanical and sterilization) testing to show equivalence.

However, I can extract information related to non-clinical testing and the comparison to predicate devices, which serves as the "proof" for substantial equivalence in this regulatory context.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission based on substantial equivalence, there isn't a table of specific clinical "acceptance criteria" with numerical targets and reported clinical device performance. Instead, the "acceptance criteria" are implied by the performance of the predicate device, and the "reported device performance" refers to the non-clinical tests conducted on the subject device to show it is equivalent.

• Comparable bending strength
• Comparable torsion strength
• Comparable axial pullout strength | Non-clinical tests performed:
• 4 Point Bending Test
• Torsion Test & Axial Pullout Strength Test
  Rationale for equivalence: "The subject device's titanium grade is the same as the predicate device's, but the subject device is thicker than the predicate device. Therefore, the performance testing of the subject device is expected to be substantially equivalent to the predicate device." (This implies the subject device met or exceeded the predicate's performance in these tests, although specific numerical results are not provided in this summary.) |
  | Sterilization Efficacy:
• Achieves sterility for pre-sterilized kits
• Compatibility with steam sterilization for non-sterile components | Non-clinical tests performed:
• Packaging Process Validation Test (only Neuro Plating System - Sterile Kit)
• Gamma Sterilization Validation (only Neuro Plating System - Sterile Kit)
  Rationale for equivalence: "Validation of sterilization parameters... of the subject device are supported by sterilization validation... as provided in the primary predicate K190811." |
  | Biocompatibility:
• Biocompatible materials and design, similar to predicate | Rationale for equivalence: "...biocompatibility of the subject device are supported by... biocompatibility testing as provided in the primary predicate K190811." |
  | Shelf Life:
• Maintained functionality and sterility over intended shelf life (for pre-sterilized kits) | Non-clinical tests performed:
• Shelf life (only Neuro Plating System - Sterile Kit) |

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

• Sample Size for Test Set: Not specified in the provided summary. For mechanical tests, this would typically involve a specific number of samples for each test (e.g., n=5 or n=10 per test), but the exact numbers are not present.
• Data Provenance: Not specified, but implied to be from laboratory testing conducted on device samples. Country of origin for testing is not stated. The data is "non-clinical" (bench testing), not patient data, so "retrospective or prospective" is not applicable.

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

This information is not applicable as the submission relies on non-clinical, laboratory bench testing (mechanical and sterilization) rather than clinical data requiring expert review or ground truth establishment.

4. Adjudication Method for the Test Set

This information is not applicable as the submission relies on non-clinical, laboratory bench testing. Adjudication methods are typically relevant for clinical studies where subjective assessments or multiple interpretations of patient data might occur.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic imaging aids or AI assistance where human readers interpret cases. The Neuro Plating System is a surgical implant, not a diagnostic tool.

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

• No, a standalone (algorithm only) performance study was not done. This concept applies to AI/software as a medical device. The Neuro Plating System is a physical implant.

7. The Type of Ground Truth Used

• Not applicable in the sense of clinical ground truth (e.g., pathology, outcomes data). For the non-clinical tests, the "ground truth" would be the engineering specifications and established acceptable performance limits (often derived from the predicate device or relevant ASTM standards). For example, a "ground truth" for the 4-point bending test would be a minimum bending force or deformation standard that the device must meet, typically aligned with or surpassing the predicate's performance.

8. The Sample Size for the Training Set

• Not applicable. The Neuro Plating System is a physical medical device, not an AI/machine learning algorithm that requires a "training set."

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

• Not applicable. As above, there is no "training set" for this device.

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The Stryker Universal Neuro III System is intended for reconstruction and/or rigid fixation of non loadbearing bony areas subsequent to cramictomy, cramiectomy and cranial fractures in adults and adolescents (age 12 and higher).

The Stryker Universal Neuro III System (UN III) consists of an assortment of different bone plates and screws. The predicate device, the UN III AXS screw, is a part of the overall UN III System, and was cleared in K151387. Here, this special 510(k) is submitted to show the ability to market the UN III AXS screw sterile in two different sterile packaging configurations which are:

1. UN III AXS Screws packed in sterile procedure packs, and
2. UN III AXS Screws packed in a sterile screw cartridge.

This document describes the performance data for the Stryker Universal Neuro III System AXS Screw, specifically regarding the transition to sterile packaging configurations. The focus of the provided text is on demonstrating substantial equivalence to a predicate device, not on validating the performance of an AI algorithm. Therefore, many of the requested categories for AI device studies are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The "acceptance criteria" are often implied as "met" or "proven" in this summary rather than explicitly stated with numerical values, which is common for regulatory submissions demonstrating equivalence to an existing product, especially for changes in manufacturing or packaging.

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

The document does not specify the exact sample sizes used for each individual test (e.g., sterilization validation, packaging tests). Instead, it states that "validations were performed and referenced."

• Data Provenance: The tests were conducted to support the market clearance of a device by Stryker Leibinger GmbH& Co. KG (Germany) for the US market. The nature of these tests (e.g., sterilization, packaging integrity) suggests they are laboratory-based, prospective studies conducted by the manufacturer or a third-party testing facility.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is not an AI algorithm requiring expert ground truth for its performance. The tests described are engineering and manufacturing validations.

4. Adjudication method for the test set

Not applicable. This is not an AI device requiring diagnostic adjudication.

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 not an AI device.

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

Not applicable. This is not an AI device.

7. The type of ground truth used

Not applicable in the context of an AI device. The "ground truth" for the tests performed relates to established engineering standards, regulatory requirements for sterility, pyrogenicity, biocompatibility, and packaging integrity. For example:

• Sterility: Achieved based on a demonstrated SAL of 1 x 10-6.
• Biocompatibility: Determined through assessment against ISO standards for medical device biocompatibility.
• Packaging Integrity: Evaluated against industry standards for sterile barrier systems (e.g., ASTM, ISO).

8. The sample size for the training set

Not applicable. This is not an AI device that utilizes a training set.

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

Not applicable. This is not an AI device.

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