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The Surgical Titanium Mesh System is indicated for use in the thoracolumbar spine (T1-L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.

The Surgical Titanium Mesh System is also indicated for treating fractures of the thoracic and lumbar spine.

The Surgical Titanium Mesh System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.

The Surgical Titanium Mesh System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the Surgical Titanium Mesh System include DePuy AcroMed titanium plate or rod systems (e.g. Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss Miami, TiMX, Monarch and Profile).

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The provided text describes the regulatory clearance for the "Surgical Titanium Mesh™ System" as a medical device, focusing on its intended use and general performance data (biomechanical testing). It does NOT contain information about acceptance criteria for device performance, a study to prove it meets those criteria, sample sizes for test sets, data provenance, expert qualifications for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or how ground truth for training sets was established.

Therefore, most of the requested information cannot be extracted from the given text.

Here's what can be extracted based on the provided document:

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

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified. This document pertains to a 510(k) submission for a medical device and typically such submissions detail testing protocols and results, but this specific excerpt doesn't provide those details.

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 as this is a physical medical device (implant) and not related to AI or diagnostic image analysis where expert-established ground truth for a test set would be relevant.

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

• Not applicable for a physical medical 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 physical medical device, not an AI diagnostic tool.

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

• Not applicable. This is a physical medical device, not an AI algorithm.

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

• Not applicable. Performance for this device would be based on engineering and biomechanical standards, not a clinical "ground truth" as typically defined for diagnostic AI. The "performance data" mentioned is biomechanical testing.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI algorithm.

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

• Not applicable. This is a physical medical device, not an AI algorithm.

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The Surgical Titanium Mesh System is indicated for use in the thoracolumbar spine (T1-L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.

The Surgical Titanium Mesh System is also indicated for treating fractures of the thoracic and lumbar spine.

The Surgical Titanium Mesh System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. Bone graft material is recommended to be packed inside of the mesh cage prior to implantation.

The Surgical Titanium Mesh System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the Surgical Titanium Mesh System include DePuy AcroMed titanium plate or rod systems (e.g. Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss Miami, TiMX and Profile).

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The provided text describes a medical device, the "Surgical Titanium Mesh™ System," and its intended use, materials, and performance data, as submitted in a 510(k) summary to the FDA. However, the document does not contain the level of detail required to answer all the questions about acceptance criteria and a specific study proving the device meets those criteria, particularly for an AI/algorithm-based device as implied by the questions asking for "standalone" performance, MRMC studies, or training/test set details.

This document describes a physical medical implant, not an AI or software device. Therefore, many of the questions are not applicable to the information provided.

Here's an analysis based on the provided text, addressing what can be answered and clearly stating what cannot:

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

The document does not explicitly state "acceptance criteria" in a quantitative format for specific performance metrics of the device itself. It mentions "Biomechanical testing, including static axial compression and dynamic axial compression," were conducted, and that "Clinical data were provided to demonstrate the performance of the device in patients with spine tumors."

However, no specific numerical acceptance thresholds or the results against those thresholds are provided. The FDA's 510(k) clearance process determined "substantial equivalence" to predicate devices, which implies the device's performance was deemed acceptable relative to established standards for similar devices already on the market.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the 510(k) summary. It only states that "Clinical data were provided."

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)

This information is not provided. The term "ground truth" is typically associated with AI/ML model validation, which is not applicable to a physical implant in this context. The clinical data would have been evaluated by medical professionals as part of standard clinical practice and regulatory review.

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

This information is not provided. Adjudication methods are usually relevant for expert reviews in image analysis or similar diagnostic tasks, not physical device performance in biomechanical or clinical studies as described here.

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, an MRMC study was not done, as this is a physical implant, not an AI or diagnostic imaging device that requires human readers.

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

No, a standalone algorithm performance study was not done, as this is a physical implant, not an algorithm or AI.

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

For biomechanical testing, the "ground truth" would be the measured physical properties and fatigue life under specified loads, measured against engineering standards. For clinical data, the "ground truth" would be patient outcomes, such as successful spinal stabilization, fusion (if applicable), pain reduction, neurological improvement, and absence of device-related complications, as documented in medical records. The document only generally states "Clinical data were provided to demonstrate the performance of the device in patients with spine tumors."

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

Not applicable. This is a physical medical device.

Summary of what is provided in the document related to "acceptance criteria" and "study":

The document states that the performance data included:

• Biomechanical testing: "static axial compression and dynamic axial compression." This testing likely involved established engineering standards for spinal implants to assess their strength and durability. The acceptance criteria would be defined by these standards (e.g., ability to withstand a certain number of load cycles at a specified force without failure, or a minimum static strength). The reported performance would be the results of these tests, demonstrating compliance. However, the specific numerical criteria and results are not detailed in this summary.
• Clinical data: "Clinical data were provided to demonstrate the performance of the device in patients with spine tumors." This data would show the safety and effectiveness of the device in a real-world setting. The acceptance criteria for clinical data would typically involve demonstrating favorable patient outcomes (e.g., spinal stabilization, successful tumor resection with hardware in place, acceptable complication rates) comparable to predicate devices or established treatment methods. Again, specific details of this clinical data or its full methodology are not included in this 510(k) summary.

In conclusion, based solely on the provided text, it is impossible to complete a detailed table of acceptance criteria and reported device performance with specific quantitative figures, nor can most of the questions relating to AI/algorithm development and validation be answered, as the document describes a physical medical implant.

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