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The DePuy AcroMed VBR System is indicated for use in the thoracolumbar spine (i.e., 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 DePuy AcroMed VBR System is also indicated for treating fractures of the thoracic and lumbar spine. The DePuy AcroMed VBR 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 DePuy AcroMed VBR System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the DePuy AcroMed VBR System include DePuy AcroMed titanium plate or rod systems (i.e., Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss Miami, TiMX, MONARCH, and Profile).

Additional size components in various sizes and footprints. The DePuy AcroMed VBR System also contains Class 1 manual surqical instruments and cases that are considered exempt from premarket notification.

The provided text describes a medical device, the DePuy AcroMed VBR System, and its indications for use in the context of a 510(k) premarket notification. It does NOT contain information about acceptance criteria, device performance metrics, or any studies demonstrating that the device meets specific performance criteria.

The document states: "Performance data were submitted to characterize the additional components of the DePuy AcroMed VBR System." However, the actual performance data, acceptance criteria, or details of the study itself are not included in the provided text.

Therefore, according to the input, I cannot furnish the requested information.

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The DePuy AcroMed VBR System is indicated for use in the thoracolumbar spine (i.e., T1 to 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 DePuy AcroMed VBR System is also indicated for treating fractures of the thoracic and lumbar spine.
The DePuy AcroMed VBR 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 DePuy AcroMed VBR System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the VBR System include DePuy AcroMed titanium plate or rod systems (i.e., Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss Miami, TiMX, Monarch, and Profile).

The additional size cages are identical to the previously cleared stackable cages with regards to indications for use, function and material. The design of the cage is slightly different; the footprint of the device has been slightly modified.

The provided text describes specific details about a medical device known as the DePuy AcroMed VBR System, focusing on its acceptance criteria and the study used to demonstrate its performance.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document mentions that "worst case testing for the system has been provided in Test Report ACRO-0400-01" and that a "Design Risk Analysis was used to assess risk for the additional sizes... performed in accordance with DePuy AcroMed Design Control and Quality procedures using static testing."

• Sample Size for Test Set: Not explicitly stated in terms of number of devices or scenarios. The phrase "worst case testing" suggests a selection of samples representing the most challenging conditions.
• Data Provenance: The testing was "performed in accordance with DePuy AcroMed Design Control and Quality procedures," indicating an internal, manufacturer-driven study. The provided text doesn't specify the country of origin of the data or if it was retrospective or prospective, though internal product testing is typically prospective.

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

Not applicable. This study refers to mechanical testing of a spinal implant, not a diagnostic or algorithmic device that requires expert ground truth establishment for a test set.

4. Adjudication Method for the Test Set:

Not applicable. This is a physical device testing, not a study involving human interpretation or subjective assessment that would require an adjudication method.

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

No. This is a submission for a physical medical device (spinal implant), not an AI/software device that would typically involve an MRMC study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not applicable. This is a physical device submission.

7. The Type of Ground Truth Used:

The ground truth used for demonstrating compliance with acceptance criteria was mechanical performance metrics obtained through static testing. The performance of the new sizes was compared against the "previously cleared" predicate devices K990148 and K001340.

8. The Sample Size for the Training Set:

Not applicable. This is a physical device and does not involve machine learning algorithms with a "training set."

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As above, this is a physical device.

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