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The ANAX™ 5.5 Spinal System is a posterior, noncervical pedicle fixation system intended to provide immobilization and stabilization of spinal segments in skeletallymature patients as an adjunct to fusion by autogenous bone graft in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar and sacral spine:

• Spondylolisthesis (Grade 3 and 4) .
• Degenerative spondylolisthesis with objective evidence of neurological . impairment
• Trauma (i.e., fracture or dislocation) .
• Spinal stenosis .
• Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) .
• Tumor .
• Pseudoarthrosis
• Failed previous fusion

The ANAX™ 5.5 Spinal System is manufactured by U&I corporation. The ANAX™ 5.5 Spinal System is a top-loading multiple component, posterior spinal fixation system and minimally invasive surgery system which consist of pedicle screws, rods, set screws, connectors, and a transverse (cross) linking mechanism. The ANAX™ 5.5 Spinal System allows surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The ANAX™ 5.5 Spinal System components are supplied non-sterile, single use and are fabricated from medical grade titanium alloy (ASTM F136) and medical grade cobait-chromium-molybdenum alloy (ASTM F1537).

The provided text describes a medical device, the ANAX™ 5.5 Spinal System, and its substantial equivalence to predicate devices, focusing on mechanical performance. This document pertains to a 510(k) submission to the FDA, which is primarily concerned with establishing substantial equivalence for medical devices based on predicate devices. It does not contain information about studies involving AI, human readers, or image-based diagnostics.

Therefore, many of the requested categories are not applicable to the provided text.

Here's a breakdown of the information that can be extracted or inferred from the provided text, and where the requested information is not present:

ANAX™ 5.5 Spinal System - Acceptance Criteria and Performance

The ANAX™ 5.5 Spinal System is a mechanical spinal fixation system designed to provide immobilization and stabilization of spinal segments. The provided document details its substantial equivalence to predicate devices based on mechanical performance.

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 explicitly stated. The testing was "bench testing" on the device itself.
• Data Provenance: Not applicable in the context of clinical data/patient data. The testing was non-clinical bench testing.

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

• This is not applicable. The ground truth for mechanical performance testing is based on established engineering standards (ASTM F1717) and comparison to predicate devices, not expert human interpretation for diagnostics.

4. Adjudication Method for the Test Set

• This is not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus on diagnostic interpretations, not for mechanical bench testing.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of how much Human Readers Improve with AI vs without AI Assistance

• This is not applicable. The device is a mechanical spinal fixation system, not an AI-assisted diagnostic tool or system designed to be read by human readers. Therefore, an MRMC study and AI improvement effect size is irrelevant to this submission.

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

• This is not applicable. The device is a mechanical system, not an algorithm.

7. The Type of Ground Truth Used

• Ground Truth: Established engineering standards (ASTM F1717 for mechanical testing) and the performance characteristics of legally marketed predicate devices.

8. The Sample Size for the Training Set

• This is not applicable. There is no "training set" in the context of a mechanical device's 510(k) submission. This term applies to machine learning models.

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

• This is not applicable. There is no training set for this type of device.

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