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The DYNAMIS™ Implant System is indicated for sacroiliac joint fusion for:

• Sacroiliac joint dysfunction including sacroiliac joint disruption and degenerative sacroiliitis.
• Augmenting immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.

The DYNAMIS™ Implant System is also indicated for fracture fixation of the pelvis, including acute, non-acute and nontraumatic fractures.

The DYNAMIS™ Implant System consists of threaded, fenestrated, cannulated, 3D-printed implants and associated instruments. The implants are constructed from medical grade titanium alloy (Ti-6Al-4V ELI per ASTM F3001). The implants are fully threaded with a lag design and a cannulated central threaded body. To accommodate varying patient anatomy, the DYNAMIS™ Implants are available in multiple diameters and length offerings. The implants allow for packing of autograft and allograft materials. Using the designated instrument system, two or more implants should be inserted across the SI Joint to apply a compressive force across the joint and to provide stabilization and fusion. The DYNAMIS™ implants are single use devices that are provided sterile. The DYNAMIS™ Implant System is comprised of DYNAMIS™ Screws and DYNAMIS™ TRU-NANO Screws.

DYNAMIS™ TRU-NANO Screws: The surfaces of the DYNAMIS™ TRU-NANO Screws incorporate a micro- and nano-roughened surface that demonstrates the requirements for nanotechnology. The surface of the screws have been deliberately manipulated to produce nanoscale dimensions which exhibit specific properties. These screws are electrochemically treated to possess a controlled nanotopography composed of nanotube arrays having a pore size diameter between 30-97 nanometers. Calcium and phosphate are incorporated into the nanotube surface.

This document describes the DYNAMIS™ Implant System, a medical device for sacroiliac joint fusion and pelvic fracture fixation. The FDA 510(k) clearance letter determines the device to be substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain acceptance criteria for device performance or a detailed study description proving that the device meets those criteria, as typically found in a clinical study report or a more comprehensive technical document.

Instead, the performance data section mentions:

• Testing per ASTM standards:
  • Static cantilever bending and dynamic cantilever bending (ASTM F3574)
  • Static axial pullout, static torsion, and driving torque (ASTM F543)
• In vitro evaluations for nanotechnology: Quantitated mineralization of extracellular matrix by osteoblasts (OB) and mesenchymal stem cells (MSC) on titanium alloy surfaces.
• Bacterial endotoxin testing: In accordance with AAMI ST72:2011.

The statement reads: "The results demonstrate that the DYNAMIS™ Implant System is substantially equivalent to the predicate devices." and "in vitro study results demonstrated that the DYNAMIS™ TRU-NANO Screw nanosurface develops statistically significantly greater mineralization in both osteoblast and mesenchymal stem cell cultures compared to other surfaces."

Without further information, I cannot provide the specific details requested in your prompt regarding acceptance criteria, sample sizes, ground truth establishment, expert qualifications, or MRMC studies. The provided document is a regulatory clearance letter, which summarizes the basis for clearance, but does not include the detailed technical study reports.

Thus, I can only provide the information that is present in your input.

Based on the provided FDA 510(k) clearance letter (K251075) for the DYNAMIS™ Implant System, the following information can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list specific numerical acceptance criteria for the mechanical tests. Instead, it states that the performance testing results "demonstrate that the DYNAMIS™ Implant System is substantially equivalent to the predicate devices." For the nanotechnology aspect, the acceptance criterion implicitly relates to superior mineralization.

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

The document does not specify the sample sizes for any of the tests (mechanical, in vitro, or endotoxin).

Regarding data provenance:

• The mechanical and biological testing appears to be laboratory-based performance testing on the device itself and its components.
• The document implies the tests were conducted by the manufacturer or a contracted lab for regulatory submission.
• There is no mention of patient data (e.g., country of origin, retrospective/prospective clinical data) as this device is not an AI/imaging device. The testing is for the physical device's performance.

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

This information is not applicable or not provided in the context of the described device testing.

• For mechanical tests, the "ground truth" is derived from engineering standards (ASTM) and predicate device performance. No human experts are typically involved in establishing "ground truth" for these tests in the way they would for medical image interpretation or clinical outcomes.
• For in vitro biological tests, expert understanding of cell biology and statistical analysis is involved, but not in the sense of adjudicating a "ground truth" from a test set of patient cases.

4. Adjudication Method for the Test Set

This information is not applicable or not provided as there is no human interpretation or consensus process described for the test results. The tests are laboratory-based and yield objective measurements compared against standards or predicate devices.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or AI-assisted interpretation devices to assess human reader performance with and without AI. The DYNAMIS™ Implant System is a physical orthopedic implant, not a diagnostic or AI software.

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

This information is not applicable. The DYNAMIS™ Implant System is a physical medical implant, not an algorithm or AI software, so the concept of "standalone performance" for an algorithm does not apply.

7. The Type of Ground Truth Used

The "ground truth" for the performance claims appears to be:

• Engineering Standards: For mechanical tests, adherence to and performance relative to ASTM F3574 and ASTM F543 requirements.
• Predicate Device Performance: Comparative performance against the DYNAMIS™ SI Screw System (K243565) and Nanovis Nano FortiFix (K193211) for mechanical properties.
• Biological Activity (Quantitative Measurement): For the nanosurface, quantifiable measurements of secreted extracellular matrix mineralization by specific cell types (osteoblasts and mesenchymal stem cells) in an in vitro laboratory setting.
• Regulatory Standards: For bacterial endotoxin testing, compliance with AAMI ST72:2011.

8. The Sample Size for the Training Set

This information is not applicable or not provided. "Training set" refers to data used to train machine learning models. This device is a physical implant, not an AI or software device that requires a training set.

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

This information is not applicable. As established above, there is no mention of an AI/ML component or a "training set" for this physical device.

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The DYNAMIS™ SI Screw System is indicated for sacroiliac joint fusion for:

· Sacroiliac joint dysfunction including sacroiliac joint disruption and degenerative sacroillitis.

· Augmenting immobilization and stabilization of the sacroiliac joint in skeletally mature patients

undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.

The DYNAMIS™ SI Screw System is also indicated for fracture fixation of the pelvis, including acute, non-acute and nontraumatic fractures.

The DYNAMIS™ SI Screw System consists of threaded, fenestrated, cannulated, 3D-printed implants and associated instruments. Implants are constructed from medical grade titanium alloy (Ti-6Al-4V ELI per ASTM F3001). The implants are fully threaded with a lag design. To accommodate varying patient anatomy, the DYNAMIS™ SI Screw Implants are available in multiple diameters and length offerings. The DYNAMIS™ SI Screw Implants consist of a cannulated central threaded body. The implants allow for packing of autograft and allograft materials. Using the designated instrument system, two or more implants should be inserted across the SI Joint to apply a compressive force across the joint and to provide stabilization and fusion. The DYNAMIS™ SI Screw implants are single use devices that are provided sterile.

This FDA 510(k) summary for the DYNAMIS™ SI Screw System does not describe an AI/ML device or a study involving human readers. Therefore, much of the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert involvement, adjudication methods, and MRMC studies is not applicable.

The document primarily focuses on establishing substantial equivalence for a physical medical device (a sacrioiliac joint screw system) through mechanical performance testing against established ASTM standards and comparison to predicate devices.

However, I can extract the following relevant information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document states the device "demonstrate[s] that the DYNAMIS™ SI Screw System is substantially equivalent to the predicate devices" for all tests, implying its performance met or exceeded the performance of the predicate devices based on these mechanical tests. Specific numerical acceptance criteria and performance values are not provided in this summary.

The following numbered points are not applicable or cannot be extracted from the provided text as the document pertains to a physical medical device clearance, not an AI/ML software device performance study:

2. Sample sizes used for the test set and the data provenance: Not applicable. This is not a study assessing AI/ML model performance on a dataset of patient data. The "test set" refers to the physical screws undergoing mechanical testing. While not specified, these would be a sample of the manufactured screws.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI/ML validation (e.g., expert labels on medical images) is not relevant here. The ground truth for mechanical testing is established by the specified ASTM standards and the physical properties of the materials and design.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No human adjudication is involved in assessing mechanical test results against established ASTM standards.
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 document is not about an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document is not about an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of typical AI/ML ground truth. For this device, the "ground truth" for performance is defined by the objective mechanical testing standards (ASTM F3574, ASTM F543) and comparison to the predicate devices.
8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device that requires a training set or associated ground truth.

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