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Internal fixation implants are load-sharing devices intended to stabilize and maintain alignment until normal healing occurs. Implants are not intended to replace normal body structures or bear the weight of the body in the presence of incomplete bone healing.

The PILOT® Spinal System, when properly used, is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization and immobilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities.

When used as a posterior spine thoracic/lumbar system, the PILOT® Spinal System is indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) trauma (i.e. fracture or dislocation), (3) curvatures (scoliosis, kyphosis, and/or lordosis), (4) spinal tumor, (5) failed previous fusion (6) pseudarthrosis, (7) spinal stenosis, (8) spondylolisthesis.

The PILOT® Spinal System consists of an assortment of rods, screws, and bodies in various shapes ITIC I THE PILOT® Spinal System side loading bodies are designed to accept either a 5.5mm or 6.35mm diameter rod. The rods are either pre-lordosed or straight.

The proposed modification to the PILOT Spinal System enhances the ease of use of the system by increasing the force transfer efficiency.

The PILOT® Spinal System implant components are made from titanium alloy described by ASTM F 136. Stainless steel and titanium implant components must not be used together in a construct. Do r 150. Sameess steel and notes spinal System components with the components from any other system or manufacturer. The PILOT® Spinal System components should never be reused under any circumstances.

The provided document is a 510(k) summary for the PILOT® Spinal System, a medical device. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against acceptance criteria through a clinical study with real-world data and expert ground truth.

Therefore, many of the requested information points, such as sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types for AI/ML device studies, are not applicable to this document as it describes a physical hardware device validated through mechanical testing, not an AI/ML algorithm.

However, I can extract the relevant information regarding performance data.

1. Table of Acceptance Criteria and Reported Device Performance

This device is not an AI/ML device, so "acceptance criteria" here refers to the standards for mechanical performance.

Note: The document states that the performance data (static and fatigue testing per ASTM F1717) was presented to "demonstrate the substantial equivalency of the PILOT Spinal System" to its predicate devices. Specific numerical results for these tests are not provided in this summary but would have been part of the full 510(k) submission.

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

This is not applicable as the document describes mechanical testing of a spinal implant system, not an AI/ML algorithm evaluated on a dataset. The "test set" would refer to the physical devices tested.

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

This is not applicable. Ground truth, in the context of AI/ML, involves human interpretation or pathology. For mechanical device testing, the "ground truth" is established by the objective physical properties and behavior under defined loads, as measured by testing equipment according to established standards.

4. Adjudication method for the test set

This is not applicable. Adjudication methods are relevant for subjective human assessments in clinical or AI/ML ground truth establishment. Mechanical tests have objective pass/fail criteria based on standards.

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, as this is not an AI-assisted diagnostic device.

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

This is not applicable, as this is a physical medical device, not an algorithm.

7. The type of ground truth used

This is not applicable in the AI/ML sense. For this mechanical device, the "ground truth" for performance is based on established engineering standards and physical measurements (e.g., load-bearing capacity, fatigue life) according to ASTM F1717.

8. The sample size for the training set

This is not applicable, as this device does not involve a "training set" in the context of AI/ML.

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

This is not applicable, as this device does not involve a "training set" or "ground truth" in the context of AI/ML.

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