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The Illico MIS Posterior Fixation System is intended for posterior, non-cervical, spinal fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion. It is intended to provide stabilization during the development of fusion utilizing autograft or allograft bone graft. It is intended that this device, in any system configuration, be removed after development of solid fusion mass.

The Illico MIS Posterior Fixation System is a Noncervical Pedicle Screw and Rod System intended to facilitate the surgical correction of spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. The Illico MIS Posterior Fixation System provides implants and instruments for percutaneous and "mini-open" access and includes:

• Non-cannulated titanium polyaxial pedicle screws assemblies .
• Cannulated titanium polyaxial pedicle screws assemblies .
• Titanium set screws .
• Titanium and Cobalt Chrome rods ●
• Instrumentation unique to the Illico MIS Systems .

The provided text describes the Illico MIS Posterior Fixation System, a pedicle screw system, seeking 510(k) clearance. The document focuses on establishing substantial equivalence to previously cleared devices through non-clinical performance testing.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

The document states "Construct testing was conducted in accordance with ASTM F-1717". While it indicates the type of testing performed, it does not specify the sample size used for these tests. Data provenance is not explicitly mentioned, but as the tests were conducted for a US 510(k) submission, it is implied that the testing was carried out in a controlled laboratory setting (likely in the US) and is prospective in nature for the purpose of demonstrating device performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable to this submission. The "ground truth" for the non-clinical performance testing is established by the specifications and pass/fail criteria defined within the ASTM F-1717 standard itself, not by expert consensus on clinical data.

4. Adjudication method for the test set:

This information is not applicable. As these are non-clinical engineering tests, the results are objectively measured against pre-defined engineering criteria, rather than requiring adjudication by experts.

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:

This is not applicable. The submission is for a medical device (pedicle screw system), not an AI-powered diagnostic or interpretive tool. Therefore, a MRMC comparative effectiveness study involving human readers and AI assistance was not performed.

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

This is not applicable. The device is a surgical implant, not an algorithm.

7. The type of ground truth used:

The "ground truth" for the non-clinical performance testing is the established engineering specifications and performance criteria defined by the ASTM F-1717 standard for spinal implant constructs.

8. The sample size for the training set:

This information is not applicable. There is no "training set" in the context of this type of non-clinical, mechanical performance evaluation for a pedicle screw system.

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

This information is not applicable. As there is no training set, there is no ground truth for it to be established.

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