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Benefix™ Interspinous Fixation System is a posterior, non-pedicle supplemental fixation device, intended for single level use in the non-cervical spine (T1-S1). It is intended for single level plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); trauma (i.e., fracture or dislocation); and/or tumor. Benefix™ Interspinous Fixation System is intended for use with bone graft material and is not intended for stand-alone use.

Benefix™ Interspinous Fixation System is manufactured by U&I Corporation. The System consists of various barrels, plates, and set screws. All implant components are made of titanium alloy in accordance with ASTM F136. Benefix™ Interspinous Fixation System is intended to provide immobilization and stabilization of the spinous processes to support fusion. The components can be assembled in a various configurations so that adaptations can be made to take into pathology and individual patient anatomy. All implants are intended for single use only and should not be reused under any circumstances.

This document is a 510(k) premarket notification for the Benefix™ Interspinous Fixation System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data for acceptance criteria based on diagnostic accuracy or clinical outcomes.

Therefore, many of the requested categories related to AI/algorithm performance and clinical study design are not applicable to this document. The "acceptance criteria" here refer to "performance criteria" derived from bench testing to demonstrate mechanical equivalence to predicates.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated for each test, but the tests were performed "in a non-clinical setting (bench testing)." This implies a sufficient number of devices were tested to statistically support the conclusions of substantial equivalence to the predicate.
• Data Provenance: The data is from bench testing conducted by U & I Corporation. The country of origin of the data is not specified beyond the manufacturer's location in South Korea. It is prospective data for the device, as it was generated specifically for this submission.

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

• Not applicable. This device is a physical implant, not an AI/algorithm. Ground truth in this context would refer to mechanical properties and performance, not expert-derived labels from medical images or clinical observations. The "ground truth" for the bench tests are the established standards and expected mechanical properties, determined through engineering principles and comparison to predicate devices.

4. Adjudication Method for the Test Set

• Not applicable. As this is bench testing for mechanical properties, there is no need for human expert adjudication of results in the traditional sense. The 'adjudication' is based on whether the measured mechanical properties meet the engineering specifications and are comparable to predicate devices.

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

• No. This document describes a medical device (spinal fixation system), not an AI algorithm. MRMC studies are used to assess the impact of AI on human reader performance, which is not relevant here.

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

• No. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance testing is mechanical performance data measured through standardized bench tests (modified ASTM F1717, spike pull-off, locking mechanism strength). The targets for this "ground truth" are derived from the established performance characteristics and safety profiles of the legally marketed predicate devices.

8. The Sample Size for the Training Set

• Not applicable. This is a physical medical device, not an AI algorithm that requires a training set.

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

• Not applicable. As there is no training set for an AI algorithm, this question is irrelevant.

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