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ANAX™ OCT Spinal System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. ANAX™ OCT Spinal System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, ANAX™ OCT Spinal System may be connected to Perfix™ Spinal System and ANAX™ 5.5 Spinal System rods with the rod connectors. Transition rods with differing diameters may also be used to connect ANAX™ OCT Spinal System to Perfix™ Spinal System and ANAX™ 5.5 Spinal System.

The ANAX™ OCT Spinal System is for fixation the cervicocranium (Occiput/C2), the true subaxial region (C3/C6), and the cervicothoracic junction (C7 to T2) by one system. The ANAX™ OCT Spinal System consists of polyaxial screws, polyaxial shank screws, hooks, rods, set screws, transverse (cross) links and occipital plate. Connectors are also provided for surgical convenience. The ANAX™ OCT Spinal System allows surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The single-use ANAX™ OCT Spinal System components are supplied as non-sterile and are fabricated from medical grade titanium alloy (ASTM F136) and medical grade cobalt-chromium-molybdenum alloy (ASTM F1537). All polyaxial screws have self-tapping functions in the ANAX™ OCT Spinal System.

Specialized instruments made from surgical instrument grade stainless steel are available for the application and removal of the ANAX™ OCT Spinal System implants.

The provided FDA 510(k) Clearance Letter for the ANAX™ OCT Spinal System does not describe acceptance criteria or a study that proves the device meets specific acceptance criteria based on performance metrics such as sensitivity, specificity, or accuracy.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices. This is a common pathway for medical device clearance, where the new device is shown to be as safe and effective as a legally marketed device that does not require Pre-Market Approval (PMA).

Here's an analysis based on the information provided, highlighting why certain questions cannot be answered from this document:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The "acceptance criteria" here are implicitly related to demonstrating that the new CoCr rods perform at least as well as, or better than, the existing titanium rods in terms of mechanical properties and do not alter the overall system's safety or intended function. The FDA's acceptance of the 510(k) implies that these criteria were met.

Regarding the specific study details for AI/software-based devices, the following cannot be answered from this document because the ANAX™ OCT Spinal System is a physical implantable medical device, not an AI or software device.

2. Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to physical components tested.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical components is typically derived from engineering specifications and material science, not expert consensus in the diagnostic sense.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a physical device, "ground truth" relates to material properties (e.g., tensile strength, yield strength), dimensional accuracy, and mechanical performance under simulated physiological loads, established by engineering standards (e.g., ASTM F136, F1537, F1717, F1798).
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable.

Summary of Relevant Information from the Document:

• Device Type: Physical implantable spinal fixation system (ANAX™ OCT Spinal System).
• Modification: Addition of cobalt-chromium-molybdenum (CoCr) rods.
• Mechanism of Proof: Substantial equivalence to predicate devices.
• Key Evidence for Substantial Equivalence:
  • Indications for Use: Identical to predicate devices.
  • Design & Components: Equivalent overall construct, dimensions, and components, with the only change being rod material.
  • Material Properties: CoCr rods demonstrate higher tensile and yield strength than the previously cleared titanium (Ti) rods.
  • Manufacturing: CoCr rods are manufactured and processed using the same methods and surface treatments as the Ti rods.
  • Performance Testing: Comprehensive mechanical testing (e.g., ASTM F1717, F1798) was conducted, including a worst-case configuration.
  • Failure Analysis: All observed failure modes occurred at the screw-housing interface, not within the rod itself, suggesting the rods are sufficiently strong.
• Conclusion of Study: The mechanical integrity of the CoCr rods was confirmed, and the comparative material analysis showed comparable or superior performance, leading to the conclusion that the addition of CoCr rods does not raise new questions of safety or effectiveness.

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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 skeletally-mature 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:

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

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 cobalt-chromium-molybdenum alloy (ASTM F1537). All pedicle screws have self-tapping function in ANAX™ 5.5 spinal System. The double lead thread is applied to the all pedicle screws to shorten the operation time. ANAX™ 5.5 Spinal System with CoCr rods may be used to provide immobilization and stabilization of spinal segment when the rigid system is need. (Recommendation: trauma or deformities) The product life time of ANAX™ 5.5 SPINAL SYSTEM is 2 years based on mechanical test result.

MIS Extended Screw, Set Screw for MIS, and Straight and Curved MIS Rod have newly added in the system and they are intended for use in minimally invasive surgery (MIS).

Specialized instruments made from surgical instrument grade stainless steel are available for the application and removal of ANAX™ 5.5 Spinal System implants.

The provided document is a 510(k) premarket notification from the FDA regarding a spinal system, not an AI/ML device. Therefore, it does not contain the information required to answer the specific questions about acceptance criteria for an AI/ML device's performance study.

The document discusses the substantial equivalence of the ANAX™ 5.5 Spinal System to previously cleared predicate devices based on design, material, mechanical performance, function, and intended use. It mentions that "mechanical performance of ANAX™ 5.5 Spinal System met the acceptance criteria which have been established from the predicate devices" and that "Additional mechanical testing (bench testing) was not conducted on the ANAX™ 5.5 Spinal System. However, the justification report was conducted to compare data of modified device to the ANAX™ 5.5 Spinal System (K132101, K143417) and determined no new worst case was introduced."

This statement refers to mechanical performance for a physical implant, not the diagnostic performance of an AI/ML algorithm. Consequently, I cannot extract details such as:

• A table of acceptance criteria and reported device performance for an AI/ML model.
• Sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or types of ground truth relevant to an AI/ML diagnostic study.
• Training set details for an AI/ML model.

The document focuses on the regulatory clearance for a medical device (a spinal implant system) based on substantial equivalence to existing devices, primarily through engineering and mechanical testing or justification, rather than a clinical performance study of an AI/ML algorithm.

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