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The Universal Mesh is indicated for reconstruction, stabilization subsequent to craniotomy, craniectomy, cranioplasty, and cranial fractures in adults and adolescents (age 12 and higher).

The 3D Preformed meshes are added to the Universal Mesh system in order to offer a more comprehensive selection of mesh solutions for cranial reconstruction. Simply put, the 3D Preformed meshes are the 1.5/1.7mm Dynamic Mesh predicate design provided in a preformed shape. The 3D Preformed meshes are provided non-sterile in 2 different variations; these meshes are offered in a Symmetrical Preformed mesh and an Anatomically preformed lateral mesh. The Anatomically preformed lateral 3D meshes add a 1.0mm thick mesh option to the portfolio, which was not available with the predicate device.

The provided text describes the Stryker Universal Mesh, a device indicated for reconstruction, stabilization, and/or rigid fixation subsequent to craniotomy, craniectomy, cranioplasty, and cranial fractures in adults and adolescents (age 12 and higher). The information needed to answer the request is scattered throughout sections V, VI, and VII of the document.

Here's an analysis of the acceptance criteria and the studies that prove the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:
The document does not specify sample sizes for any of the performance bench tests. It also does not provide information on data provenance (e.g., country of origin, retrospective or prospective) for these tests, as these are typically laboratory bench tests rather than clinical studies with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
For the "End User Validation Testing" (surgeon evaluation), the document simply states "Surgeon evaluation" but does not specify the number of surgeons or their qualifications.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
The document does not provide information on adjudication methods for any of the tests.

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 MRMC comparative effectiveness study was done. This device is a physical implant (mesh), not an AI-assisted diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This question is not applicable as the device is a physical implant, not an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the physical performance tests (static load, sterilization, MR compatibility), the ground truth is established by meeting defined engineering standards and regulations (e.g., ASTM F67, ISO standards, FDA guidance). For the user validation tests, the 'ground truth' is subjective user (surgeon/non-trained user) evaluation against implicit criteria of usability and fit.

8. The sample size for the training set:
This question is not applicable as the device is a physical implant and not an AI/algorithm-based product that requires a training set.

9. How the ground truth for the training set was established:
This question is not applicable for the same reason as above.

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The Universal Mesh is indicated for non-load-bearing reconstruction in the maxillofacial skeleton of patients in whom skeletal growth is complete.

The Universal Mesh, which is the brand name of the subject device, consists of mesh implants in different sizes (40x40mm, 90x90mm, 120x120mm, 200x200mm), thicknesses (0.3mm, 0.6mm and 0.8mm), and perforation patterns, which include the 1.2mm and 1.5/ 1.7mm Dynamic Mesh pattern and Hybrid Mesh pattern. The meshes can be modified with trimming and bending instruments for an anatomical fit and are malleable for threedimensional adaptations. The mesh can be fixated to the bone with screws from the previously marketed Stryker CMF implant systems. In addition, the necessary instrumentation for mesh modification and storage is included with the system.

The implants of the Universal Mesh are provided non-sterile and are for single use only. The instrumentation and storage system is reusable.

The provided text describes a 510(k) premarket notification for the "Stryker Universal Mesh," which is a bone plate intended for non-load-bearing reconstruction in the maxillofacial skeleton. This is not an AI/ML device, and as such, the requested information pertaining to AI/ML device studies (such as sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) is not applicable and hence not present in the provided document.

However, I can extract information related to the acceptance criteria and the studies performed to demonstrate the device's substantial equivalence to a predicate device, as applicable to this medical device.

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document explicitly states that the "Subject device met all pre-defined acceptance criteria and standards and was found to not represent a new worst case."

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

• Not applicable (N/A). This device is a physical medical implant (bone mesh), not an AI/ML software. The provided document details bench testing, not a clinical study involving a "test set" of patient data in the context of AI/ML evaluation. The tests were performed on the device itself or its materials.

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

• N/A. As this is not an AI/ML device, the concept of "ground truth" established by experts for a test set of data does not apply in the same manner. Safety and effectiveness are demonstrated through adherence to recognized standards and comparative performance against a predicate device.

4. Adjudication method for the test set:

• N/A. This is not relevant to the type of device and studies conducted.

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:

• N/A. This device is not an AI system, so no MRMC study was performed.

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

• N/A. This device is not an algorithm.

7. The type of ground truth used:

• N/A. For this physical device, "ground truth" is established through adherence to engineering standards (e.g., ASTM F67, ASTM F382), biocompatibility standards (e.g., ISO 10993 series), and validated reprocessing/sterilization methods (e.g., ISO 17664, AAMI standards). The predicate device's established safety and effectiveness also serve as a comparative "ground truth" for substantial equivalence.

8. The sample size for the training set:

• N/A. This is not an AI/ML device, hence no training set.

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

• N/A. This is not an AI/ML device, hence no training set and no associated ground truth establishment method.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is a series of non-clinical performance bench tests and biocompatibility evaluations. These studies were conducted to demonstrate the substantial equivalence of the Universal Mesh to its primary predicate device (Universal CMF System - K022185).

The performance data included:

• Biocompatibility Testing: Conducted according to FDA guidance and international standards (ISO 10993-1, ISO 10993-5, ISO 10993-18) to ensure the material (titanium conforming to ASTM F67) is safe for implantation.
• Performance Bench Testing:
  • Lifetime Reprocessing: Verified the ability of the device, instruments, and storage container to withstand reprocessing cycles per internal standards.
  • Cleaning Validation: Verified the cleaning process as per ISO 17664, AAMI TIR 30, and AAMI TIR 12.
  • Sterilization Validation: Validated sterilization instructions using standards like ISO 14937, ISO 17664, ISO 17665, AAMI TIR 12, AAMI ST 81, AAMI ST79.
  • Mechanical Performance Testing: Included 4-point bending static and dynamic load tests according to ASTM F382, compared against the Primary Predicate Device, to ensure structural integrity and mechanical properties.
  • Corrosion Testing: Verified the corrosion behavior of the subject device and associated components.
  • MR Compatibility: Tested according to FDA guidance documents (e.g., "Assessment of Radiofrequency - Induced Heating" and "Establishing Safety and Compatibility of Passive Implants") to determine safe use in an MR environment.

The document explicitly states: "The Subject device met all pre-defined acceptance criteria and standards and was found to not represent a new worst case. Overall, the results of the performance bench tests support the substantial equivalence of the Subject device."

Neither animal testing nor clinical testing was required as a basis for substantial equivalence for this particular device submission.

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The Universal Mesh is indicated for reconstruction, stabilization subsequent to craniotomy, craniectomy, cranioplasty, and cranial fractures in adults and adolescents (age 12 and higher).

The Stryker Universal Mesh consists of mesh implants in different shapes, thicknesses and perforation patterns which include the 1.2mm and 1.5/ 1.7mm Dynamic Mesh implants and Hybrid Mesh implants. The meshes can be modified with trimming and bending instruments for an anatomical fit and are malleable for three-dimensional adaptations. The necessary instrumentation for mesh modification, Mesh Cutter (coarse), Mesh Step Bender, and the Mesh Clipper are included with the system. The Stryker Universal Mesh implants are provided nonsterile and are for single use only. The instrumentation and storage system is reusable.

Also, the mesh can be fixated to the bone with screws available in previously marketed Stryker CMF implant systems. The previously marketed screws are not specifically packaged with the subject device, but the implant tray of the Universal Mesh Storage system contains space to store the screw disc if that option is chosen.

The provided document describes the Stryker Universal Mesh, a cranioplasty plate, and its substantial equivalence determination by the FDA. However, the document does not contain information related to an AI/ML device. Therefore, it does not include studies with acceptance criteria for device performance, sample sizes for test or training sets, expert ground truth establishment, adjudication methods, or MRMC studies.

The document focuses on non-clinical performance testing for a medical device (cranioplasty plate) made of titanium, assessing its biocompatibility, reprocessing, cleaning, sterilization, mechanical performance, corrosion, and MR compatibility. These tests are standard for a physical medical device and do not involve AI/ML.

Given the absence of information regarding an AI/ML device, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria for an AI/ML context.

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