(29 days)
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:
- UN III AXS Screws packed in sterile procedure packs, and
- 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
| Category / Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sterilization Methods (Gamma Radiation) | Established Method | Gamma Radiation (Terminally sterilized in final packaging) |
| Sterility Assurance Level (SAL) | SAL 1 x 10-6 for all products | Met SAL 1 x 10-6 for all products |
| Pyrogenicity | Acceptance Criteria met | Acceptance Criteria met |
| Process Cleaning Validation | (Implicit) Bioburden level, process residuals, endotoxin level within acceptable limits. | Performed and referenced in support of substantial equivalence. |
| Sealing Validation | (Implicit) Integrity and effectiveness of seals for sterile barrier systems. | Performed and referenced in support of substantial equivalence. |
| Process Sterilization Validation (Gamma Radiation) | (Implicit) VDmax25 Cycle effective for sterilization. | Performed and referenced in support of substantial equivalence. |
| Biocompatibility Assessment | (Implicit) No adverse biological effects due to additional manufacturing steps for sterile packaging. | Substantial equivalence proven. |
| Transport safety | (Implicit) Product and sterile barrier system integrity maintained during transport (weight/compression). | Met all pre-defined acceptance criteria. |
| Shelf-life and integrity of sterile barrier system | (Implicit) Barrier system maintains sterility for defined shelf-life duration. | Met all pre-defined acceptance criteria. |
| Handling test of overall packaging functionality | (Implicit) Packaging can be safely and effectively handled for its intended purpose. | Met all pre-defined acceptance criteria. |
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.
§ 882.5360 Cranioplasty plate fastener.
(a)
Identification. A cranioplasty plate fastener is a screw, wire, or other article made of tantalum, vitallium, or stainless steel used to secure a plate to the patient's skull to repair a skull defect.(b)
Classification. Class II (performance standards).