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When used as a pedicle screw fixation system in the non-cervical posterior spine (T1-S1) in skeletally mature patients, the Presidio Surgical Viking Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), (5) spinal stenosis, (6) curvatures (i.e., scoliosis, and/or lordosis), (7) tumor, (8) failed previous fusion (i.e. pseudarthrosis).

The Presidio Surgical Viking Lumbar Polyaxial Screw System is a polyaxial pedicle screw system with straight or precontoured crosslink to provide optimal supporting structure for the spinal bodies. The pedicle screw system is a surgically implantable device which is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine. This premarket notification is to add a new crosslink design to the pedicle screw system that was previously cleared.

This document is a 510(k) premarket notification for a medical device, specifically a "Viking Lumbar Polyaxial Screw System." It seeks to demonstrate substantial equivalence to previously cleared devices. The document explicitly states that this premarket notification is to add a new crosslink design to the pedicle screw system that was previously cleared. This means the device in question is a surgical implant for spinal stabilization, not an AI/Software as a Medical Device (SaMD).

Therefore, the requested information regarding "acceptance criteria" related to device performance in diagnosis or treatment, "study that proves the device meets the acceptance criteria" in terms of AI performance metrics, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types are not applicable to this type of device and submission.

The "performance testing" described in the document is mechanical testing to demonstrate the structural integrity of the spinal implant.

Here's the relevant information that can be extracted from the provided text, adapted to the nature of the device:

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

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

• Test Set (for mechanical testing): Not explicitly stated in the provided text. It refers to "confirmatory mechanical testing," which implies testing a certain number of devices or components.
• Data Provenance: Not applicable in the context of human data. The testing is described as mechanical testing of the physical implant.

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

• Not Applicable. This is a mechanical device, not an AI/SaMD requiring expert ground truth for diagnostic or prognostic performance. The "ground truth" for mechanical testing would be defined by engineering specifications and standards (e.g., ASTM F1717).

4. Adjudication method for the test set

• Not Applicable. Mechanical testing results are typically evaluated against predefined engineering specifications, not through human adjudication.

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. This is a mechanical spinal implant, not an AI/SaMD.

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

• Not Applicable. This is a mechanical spinal implant.

7. The type of ground truth used

• Mechanical Integrity/Performance Standards: The "ground truth" for this device's performance would be compliance with mechanical testing standards (e.g., ASTM F1717 dynamic compression bending) and engineering specifications to ensure structural adequacy for its intended surgical use.

8. The sample size for the training set

• Not Applicable. There is no "training set" for this mechanical device.

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

• Not Applicable. There is no "training set" for this mechanical device.

In summary: The provided document describes a mechanical spinal implant attempting to gain market clearance through the 510(k) pathway by demonstrating substantial equivalence to predicate devices. The "performance testing" involved is physical, mechanical testing of the device's components (specifically a new crosslink design) against established engineering standards like ASTM F1717. The concepts of AI performance metrics, test/training sets of patient data, expert readers, and ground truth in the context of AI/SaMD are not relevant to this submission.

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