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The Patriot Spinal Fixation System, when used in the non-cervical posterior spine (TI to S1), 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: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudoarthrosis, and failed previous fusion.
In addition, when used placed between L5 and S1, the Patriot Spinal Fixation System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) in skeletally mature patients receiving fusion with autologous bone graft.

The Patriot Spinal Fixation System is a posterior, non-cervical, spinal fixation system consisting of a variety of shapes and sizes of rods, screws, and crosslinks, to provide temporary internal fixation and stabilization during bone graft healing as an adjunct to fusion of the thoracic, lumbar and sacral spine.

I am sorry but this document does not contain the information you are looking for. This document is a 510(k) premarket notification for a medical device called the "Patriot Spinal Fixation System." It primarily focuses on demonstrating the device's substantial equivalence to previously marketed predicate devices based on its design, materials, manufacturing, indications for use, and mechanical testing results.

The document does not contain information about:

• Acceptance criteria and reported device performance in the context of an AI/algorithm-based medical device.
• Sample sizes used for test sets or data provenance for such studies.
• Number of experts or their qualifications for establishing ground truth for AI model testing.
• Adjudication methods for test sets.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or effect sizes of human reader improvement with AI assistance.
• Standalone (algorithm only) performance studies.
• Types of ground truth used in AI model development (e.g., expert consensus, pathology, outcomes data).
• Sample sizes for training sets for AI models.
• How ground truth for training sets was established for AI models.

The "testing performed" mentioned in the document refers to mechanical integrity testing of the spinal fixation system components (static and dynamic compression, static torsion per ASTM F1717), not performance validation of an AI algorithm.

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The Liberty Anterior Cervical Plate System is interior screw fixation of the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with:

• degenerative disc disease (as defined by neck pain of discogenic origin with the degeneration of the disc confirmed by patient history and radiographic studies),

• spondylolisthesis.

• trauma (i.e. fractures or dislocations),

• tumors.

• deformity (i.e. kyphosis, lordosis or scoliosis),

• pseudarthrosis.

• failed previous fusion,

• spinal stenosis

The Liberty Anterior Cervical Plate is intended for anterior screw fixation of the plate to the cervical spine. The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with self-drilling and self-tapping bone screws using an anterior approach. Plates are available in a variety of lengths (10 mm – 100 mm), addressing multiple levels of fixation (one to five). The plate incorporates graft visualization holes on the longitudinal center line for intraoperative visualization. Bone screws are available in two diameters (4.0 mm, and 4.5 mm) and a variety of lengths (10 mm - 18 mm).

This document describes the premarket notification (510(k)) for the Liberty Anterior Cervical Plate System. It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study proving the device meets specific acceptance criteria based on clinical performance with an AI component.

Therefore, we cannot extract information about acceptance criteria, device performance from a clinical study, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone algorithm performance, ground truth establishment, or training set details as these are not relevant to this type of medical device submission.

The provided document describes a Class II medical device (Spinal Intervertebral Body Fixation Orthosis), for which the FDA typically requires non-clinical performance testing to demonstrate substantial equivalence to legally marketed predicate devices, rather than extensive clinical efficacy studies with human-in-the-loop or AI components.

Here's what can be extracted based on the document:

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

• Acceptance Criteria: No specific numerical acceptance criteria are stated in terms of clinical performance (e.g., accuracy, sensitivity, specificity). The acceptance criteria were based on demonstrating substantial equivalence to predicate devices through non-clinical mechanical testing.
• Reported Device Performance: The document states: "The results of these tests [Static and dynamic compression (per ASTM F1717), Static torsion (per ASTM F1717)] indication that the Liberty Anterior Cervical Plate is substantially equivalent to the predicate devices."
  • No specific numerical performance values (e.g., load capacity, fatigue cycles) are provided in this summary document, only that the device met the standards to demonstrate equivalence.

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

• This is a mechanical device lacking an AI component, so there is no "test set" in the context of clinical data. The "tests" refer to laboratory mechanical testing of physical implants.
• Sample Size for Mechanical Testing: Not specified in the provided summary. Mechanical testing typically involves a set number of physical prototypes or production units.
• Data Provenance: Not applicable. The data comes from in-vitro mechanical testing, not clinical 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):

• Not applicable as this is a mechanical device subject to non-clinical testing, not a diagnostic AI device requiring expert ground truth for clinical performance.

4. Adjudication method (e.g. 2+1, 3+1, none) 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. This device does not involve human readers, AI assistance, or diagnostic interpretation.

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

• Not applicable. This is not an algorithm.

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

• For mechanical testing, the "ground truth" is defined by established engineering standards (ASTM F1717) and the performance of predicate devices. There is no clinical "ground truth" in this context.

8. The sample size for the training set:

• Not applicable. This device does not use an AI algorithm that requires training data.

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

• Not applicable.

Summary of Device and Performance Demonstrated:

• Device Type: Liberty Anterior Cervical Plate System (a mechanical implant for spinal fixation).
• Regulatory Class: Class II (Spinal Intervertebral Body Fixation Orthosis).
• Basis for Clearance: Substantial equivalence to predicate devices.
• Testing Performed: Non-clinical mechanical testing:
  • Static and dynamic compression (per ASTM F1717)
  • Static torsion (per ASTM F1717)
• Conclusion: The device was found to be substantially equivalent to predicates, meaning it demonstrated comparable safety and effectiveness based on the non-clinical mechanical tests.

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