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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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ANAX™ OCT Spinal System is intended to provide immobilization 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 ANAXIN 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.

ANAX™ OCT Spinal System is manufactured by U&I corporation. 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. ANAX™OCT Spinal System allows surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The singleuse ANAX™ OCT Spinal System components are supplied as non- sterile and are fabricated from medical grade titanium alloy (ASTM F136). All polyaxial screws have self-tapping function in the ANAX™ OCT Spinal System. Specialized instruments made from surqical instrument grade stainless steel are available for the application and removal of the ANAX™ OCT Spinal System implants.

The provided document is a 510(k) premarket notification for the ANAX™ OCT Spinal System. This type of document focuses on establishing substantial equivalence to a predicate device rather than detailing extensive clinical studies with specific acceptance criteria for diagnostic performance. Therefore, most of the requested information regarding diagnostic accuracy, sample sizes for test sets, expert adjudication, MRMC studies, and ground truth for training data is not present in this document.

However, the document does describe performance testing related to the device's mechanical properties.

Here's the information that can be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance

The document states: "The mechanical performance of ANAX™ OCT Spinal System met the acceptance criteria which have been established from the predicate device." and "All tests met all acceptance criteria and that verifies performance of the ANAX™ OCT Spinal System is substantially equivalent to predicate devices."

However, specific numerical acceptance criteria (e.g., minimum load, maximum deflection) for each test are not provided in this summary. The table below outlines the tests performed and the general statement about their performance.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: The document mentions "worst case constructs" for the mechanical tests, but does not specify the number of samples or constructs tested for each test.
• Data Provenance: The tests were conducted in a "non-clinical setting (bench testing)". The document does not specify the country where the tests were performed, but the manufacturer is based in the Republic of Korea. It is lab-based testing, not human-origin data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the described study is mechanical bench testing, not a study involving diagnostic interpretation or human expert assessment of a medical condition.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable as the described study is mechanical bench testing and does not involve expert adjudication of a test set.

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

There is no MRMC or comparative effectiveness study mentioned in the document. The study described is mechanical bench testing of an implantable device, not an AI-powered diagnostic tool.

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

This is not applicable as the ANAX™ OCT Spinal System is a physical implantable device, not an algorithm or AI system.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For mechanical testing, the "ground truth" is defined by the standards (ASTM F2706, ASTM F1717, ASTM F1798) and the acceptance criteria established from the predicate device. These standards define parameters for measuring mechanical integrity (e.g., load to failure, fatigue life) which serve as the "ground truth" for evaluating the device's performance.

8. The sample size for the training set

This is not applicable as the document describes mechanical testing of a physical device, not an algorithm requiring a training set.

9. How the ground truth for the training set was established

This is not applicable for the same reason as point 8.

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