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The Creaspine SupStance Vertebral Body Replacement System, Line Extension, (SupStance VBR System) is a vertebral body replacement system intended to replace a vertebral body. The SupStance VBR System is designed for use in the thoraco-lumbar spine (T1- L5) to replace a collapsed, damaged, or unstable vertebral body during tumor or trauma (i.e., fracture) management procedures. The SupStance VBR System is intended to be used with supplemental internal fixation systems. Anterior thoracolumbar plates and screws or pedicle screw and rod systems are among the options for the surgeon to use.

The use of allograft and/or autograft with the SupStance VBR System is optional.

The proposed Creaspine SupStance VBR System, Line Extension, is a modification of the original Creaspine SupStance VBR System that was the subject of K072537. This device modification has been submitted as a Special 510(k) Premarket Notification because the proposed SupStance VBR System, Line Extension, is identical in intended use and fundamental scientific technology to the parent SupStance VBR System originally described in K072537.

The modifications made to the parent device to produce the proposed SupStance VBR System, Line Extension, are limited to the expansion of the implant (cage) dimensions available.

The provided document is a 510(k) summary for a medical device: the Creaspine SupStance Vertebral Body Replacement System, Line Extension. This document primarily focuses on establishing substantial equivalence to previously cleared devices through mechanical testing and does not describe a clinical study involving human patients or a software algorithm evaluated with clinical data.

Therefore, many of the requested items regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, and standalone algorithm performance are not applicable to this type of submission.

Here's a breakdown of the information that can be extracted based on the provided text, and where certain requested information is N/A:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size for test set: Not applicable for a software algorithm evaluated with clinical data. This submission is for mechanical testing of a physical implant. The document does not specify the number of physical devices or tests performed, only that "Performance testing included the types of mechanical testing recommended..."
• Data provenance: Not applicable. The data is generated from mechanical testing in a lab setting, not from a clinical patient population.

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

• Not applicable. This submission involves mechanical testing of a physical implant, not a clinical study requiring expert ground truth for interpretation.

4. Adjudication Method for the Test Set

• Not applicable. This submission involves mechanical testing of a physical implant, not a clinical study requiring adjudication of interpretations.

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

• No. An MRMC study is not relevant for this type of device (a physical spinal implant) or the type of data presented (mechanical testing). This study does not involve human readers interpreting clinical cases with or without AI assistance.

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

• Not applicable. This device is a physical spinal implant, not a software algorithm.

7. The Type of Ground Truth Used

• For the mechanical testing, the "ground truth" would be the engineering specifications and performance benchmarks established for vertebral body replacement systems, likely based on relevant standards and predicate device performance. The study aims to demonstrate that the new device's mechanical properties meet these established engineering benchmarks and are comparable to predicate devices.

8. The Sample Size for the Training Set

• Not applicable. This is mechanical testing of a physical medical device, not a machine learning model. There is no "training set" in this context.

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

• Not applicable. See point 8.

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The Creaspine SupStance Vertebral Body Replacement System (SupStance VBR System) is a vertebral body replacement system intended to replace a vertebral body. The SupStance VBR System is designed for use in the thoracolumbar spine (T1- L5) to replace a collapsed, damaged, or unstable vertebral body during tumor or trauma (i.e., fracture) management procedures. The SupStance VBR System is intended to be used with supplemental internal fixation systems. Anterior thoracolumbar plates and screws or pedicle screw and rod systems are among the options for the surgeon to use.

The use of allograft and/or autograft with the SupStance VBR System is optional.

The Creaspine SupStance Vertebral Body Replacement System (SupStance VBR System) is a vertebral body replacement system, intended for use as an aid in spinal fusion. The SupStance VBR System consists of the SupStance VBR implant and the associated instrumentation required for implantation of the device. The SupStance VBR implant is a cage constructed of fused hollow cylindrical tubes with integral endcaps and open sides for introduction of bone graft material and bone reconstruction. The SupStance VBR cages are available in three diameters (22mm, 25mm, 28mm) and cover a range of heights from 35mm to 55mm with a total fixed sagittal angle of 5°.

The SupStance VBR cages are fabricated from poly-ether-ether-ketone (PEEK) and include markers made from titanium alloy. The implants are provided non-sterile and will be implanted via an antero-lateral approach.

The provided text describes the 510(k) summary for the Creaspine SupStance Vertebral Body Replacement System. However, it does not contain information regarding acceptance criteria or a study that proves the device meets specific performance criteria in terms of diagnostic accuracy or effectiveness related to AI or human-in-the-loop performance.

The document focuses on demonstrating substantial equivalence to predicate devices through mechanical testing, which is a different type of evaluation.

Therefore, the following information cannot be extracted from the provided text:

1. Table of acceptance criteria and reported device performance: Not available. The document refers to "Performance testing included the types of mechanical testing recommended for vertebral body replacement systems (static and dynamic compression testing, static and dynamic torsion testing, and expulsion testing)" and states "The data collected confirms that the mechanical properties of the proposed SupStance VBR System are comparable to those of the predicate devices." However, specific quantitative acceptance criteria or reported performance values are not provided.
2. Sample size used for the test set and data provenance: No test set related to diagnostic or AI performance is mentioned. The mechanical testing details do not include sample sizes in this summary.
3. Number of experts and their qualifications: Not applicable, as there's no diagnostic or AI performance study described.
4. Adjudication method: Not applicable.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable. The device is a physical implant, not an AI-assisted diagnostic tool.
6. Standalone (algorithm only without human-in-the-loop performance) study: Not applicable.
7. Type of ground truth used: Not applicable in the context of diagnostic performance. For mechanical testing, the "ground truth" would be established engineering standards or predicate device performance.
8. Sample size for the training set: Not applicable, as no AI model is being trained.
9. How the ground truth for the training set was established: Not applicable.

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