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The Polaris Spinal Growth System is indicated in patients with potential growth under 10 years of age who require surgical treatment to obtain and maintain correction of severe, progressive, life-threatening, early-onset spinal deformities, including early-onset scoliosis, which are associated with or at risk of thoracic insufficiency syndrome.

The Polaris Spinal Growth System may be used with any cleared traditional Polaris Spinal System construct, including any cleared Polaris Spinal System compatibilities.

The Polaris Spinal Growth System is a non-cervical spinal fixation device made from titanium alloy (Ti-6Al-4V) per ASTM F136 and Cobalt Chrome Alloy (Co-28Cr-6Mo) per ASTM F1537. The system is comprised of Growth Connectors which are intended to be used with the Polaris Spinal System implants and instruments. The design and size offerings of the Polaris Spinal Growth System connectors are identical to those currently available in the Polaris Spinal System but are indicated for growth rod constructs. These growth rod constructs typically require repeated plannedlengthening procedures until a determination is made that the patient is ready for a final fusion procedure. After the spine is fused, these devices serve no functional purpose and may be removed.

The provided text describes a 510(k) submission for a medical device called the "Polaris Spinal Growth System." This submission is a declaration of substantial equivalence to a predicate device, as opposed to a new device requiring extensive clinical trials and complex acceptance criteria for AI/Software-as-a-Medical-Device (SaMD) performance.

The document primarily focuses on mechanical testing to demonstrate that the Polaris Spinal Growth System performs as intended and is substantially equivalent to existing, legally marketed devices. It does not contain information relevant to AI/SaMD performance, such as:

• Acceptance criteria for an algorithm's diagnostic or therapeutic performance. The device is a physical implant, not a software algorithm.
• Study design for evaluating algorithm performance (test sets, ground truth, expert review, MRMC studies).
• Sample sizes for training sets for machine learning models.
• Effect size for human reader improvement with AI assistance.

Therefore, I cannot extract the information required to answer your prompt in detail. The available information relates to the acceptance criteria for the mechanical performance of a physical implant, not the performance of an AI/SaMD.

Here's what I can provide based on the document, focusing on the mechanical performance. Please note that this is not related to AI/SaMD and will not fill all requested fields:

Acceptance Criteria and Device Performance (for Mechanical Properties):

Study Details (for Mechanical Testing):

• Sample size used for the test set and data provenance: The document states "mechanical testing of the Polaris Spinal Growth System constructs were assessed and tested." It does not specify the exact number of constructs tested (sample size) or where these tests were physically performed (data provenance in terms of country of origin). It is not a clinical study with retrospective/prospective human data.
• Number of experts used to establish ground truth: Not applicable. Ground truth for mechanical testing is based on engineered specifications and standardized test methods (ASTM F1717, ASTM F1798).
• Adjudication method: Not applicable. Mechanical tests have objective, measurable outcomes.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not applicable. This is not a study assessing human readers or AI assistance.
• Standalone (algorithm only) performance: Not applicable. This device is a physical implant.
• Type of ground truth used: Engineering standards (ASTM F1717, ASTM F1798) for mechanical properties.
• Sample size for the training set: Not applicable. This is not an AI/ML device.
• How the ground truth for the training set was established: Not applicable.

In summary, the provided document details the regulatory clearance for a traditional medical device (spinal implant) based on mechanical testing and substantial equivalence, not an AI/SaMD. As such, it does not contain the information requested in your prompt regarding AI/SaMD performance evaluation.

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