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SpineFab® Vertebral Body Replacement (VBR) System is intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to turnor or trauma (i.e. fracture). The VBR device is intended for use with autograft and/or allograft bone graft material and must be used with supplemental fixation systems.

The SpineFab® VBR implant is a non-custom implant. The SpineFab® VBR Implants consist of 48 different variations and each one of six different configurations (Small Parallel, Medium Parallel, Large Parallel, Small Lordotic, Medium Lordotic, and Large Lordotic) with the only difference on each configuration being the height. This device is manufactured using polyetherketoneketone (PEKK) polymer using additive manufacturing and contains tantalum radiographic markers.

The implants have an open shaft to allow for the placement of allograft or autograft. The implants have several other features:

• Notches that are an aid to implant insertion,
• Tantalum markers which allow for easy radiographic visualization, and
• Teeth-like structures meant to engage the vertebral endplates for stabilization in vivo.

SpineFab® Vertebral Body Replacement (VBR) System is shipped non-sterile and the sterilization recommendations documented in the instructions for use (IFU) are according to ANSI/AAMI ST79 "Comprehensive Guide to Steam Sterility Assurance in Health Care Facilities" have been validated.

This document describes the premarket notification (510(k)) for the SpineFab® Vertebral Body Replacement (VBR) System. It focuses on demonstrating the device's substantial equivalence to existing predicate devices, primarily through bench testing.

Here's an analysis of the acceptance criteria and study detailed in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly present a formal table of quantified acceptance criteria with specific performance values for the SpineFab® VBR System. Instead, it states that performance testing was conducted according to recognized ASTM and ISO standards, and the results "were found to be within acceptance criteria described in the ISO 10993-3, 5, 6, 10, 11, and 18 standards" for biocompatibility and that mechanical testing was performed according to ASTM standards for compression, torsion, subsidence, and expulsion.

For the purpose of this analysis, we can infer the acceptance criteria are adherence to these established standards.

• ISO 10993-3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
• ISO 10993-5: Tests for in vitro cytotoxicity
• ISO 10993-6: Tests for local effects after implantation
• ISO 10993-10: Tests for irritation and skin sensitization
• ISO 10993-11: Tests for systemic toxicity
• ISO 10993-18: Chemical characterization of materials | Test results obtained from PEKK test specimens were found to be within acceptance criteria described in the ISO 10993-3, 5, 6, 10, 11, and 18 standards. |
  | Mechanical Performance (Compression, Torsion, Subsidence, Expulsion) | Testing performed according to:
• ASTM F2077-11 "Test Methods for Intervertebral Body Fusion Devices"
• ASTM F2267-04(2011) "Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression"
• ASTM draft F-04.25.02.02: Static Expulsion (The specific acceptance limits from these standards are not detailed in the document but are implied to be met) | Mechanical testing evaluations were substantially equivalent to predicate devices, having been evaluated according to ASTM standards for static and dynamic axial compression bending, static and dynamic torsion, static subsidence, and static expulsion. |
  | Sterilization | Sterilization recommendations documented in the instructions for use (IFU) are according to ANSI/AAMI ST79 "Comprehensive Guide to Steam Sterility Assurance in Health Care Facilities." (Implies meeting sterility assurance levels outlined in this standard.) | The device is shipped non-sterile, and the sterilization recommendations in the IFU are according to ANSI/AAMI ST79 and "have been validated." |

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

• Sample Size for Mechanical Testing: The document mentions a specific test specimen design (15x12x50 mm) considered the "worst case design" for compression, torsion, subsidence, and expulsion testing. However, the number of specimens tested ("sample size") for each mechanical test is not explicitly stated in the provided text.
• Data Provenance: The document does not specify the country of origin for the data or whether the tests were retrospective or prospective. Given that this is bench testing, "provenance" typically refers to the testing laboratory and design/manufacturing controls rather than patient data.

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

This information is not applicable in the context of this 510(k) submission. The document describes bench testing of a physical device, not a diagnostic or AI device that relies on expert interpretation to establish ground truth for a test set. The "truth" for mechanical properties is determined by the physical outcome of the tests against engineering specifications and validated standards.

4. Adjudication Method for the Test Set

This information is not applicable. Since the testing involves physical measurements against engineering standards and not human interpretation of complex data (like medical images), there is no need for an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not performed, nor is it relevant to this type of device submission. This study type is typically used for diagnostic devices (e.g., AI algorithms for image interpretation) to show how an AI system impacts human reader performance. The SpineFab® VBR System is an implantable surgical device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone performance study was not performed, nor is it relevant to this device. This concept applies to AI algorithms. The SpineFab® VBR System is a physical medical device.

7. Type of Ground Truth Used

The "ground truth" for this device evaluation is established by engineering and material science standards and specifications. Specifically:

• Biocompatibility: Adherence to established ISO 10993 series standards, which define acceptable biological responses.
• Mechanical Performance: Adherence to established ASTM standards (F2077, F2267, and a draft F-04.25.02.02), which define acceptable mechanical properties and testing methodologies for intervertebral body fusion devices.

8. Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of this device. The SpineFab® VBR System is a physical implant, not a software algorithm that undergoes machine learning training.

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

This information is not applicable. As there is no training set for a software algorithm, the concept of establishing ground truth for it does not apply here.

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