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The SpineFrontier® PedFuse® 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 instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (Pseudarthrosis).

In addition, the SpineFrontier® PedFuse® Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine.

When used in a percutaneous approach with MIS instrumentation, the SpineFrontier® PedFuse® Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, failed previous fusion (Pseudarthrosis) and severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine.

The SpineFrontier® PedFuse® Pedicle Screw System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. The system consists of longitudinal rods, polyaxial screws, and cross connector. Hydroxyapatite (HA)-coated titanium alloy screws and Cobalt Chrome (CoCr) alloy rods are added to the System in this submission.

The provided text describes a 510(k) premarket notification for a medical device, the SpineFrontier® PedFuse® Pedicle Screw System. This specific submission focuses on modifications to an already cleared device, adding hydroxyapatite (HA)-coated titanium alloy screws and Cobalt Chrome (CoCr) alloy rods.

Therefore, the performance data presented is for the mechanical substantial equivalence of these new materials and components to previously cleared versions and predicate devices, rather than a usability or clinical effectiveness study of the entire system as an AI device or a novel medical device establishing its own set of acceptance criteria.

The document does not describe the use of AI in this device, nor does it detail a study involving human readers, test sets, ground truth establishment, or training sets in the context of AI performance. The study mentioned is purely mechanical testing of the physical components.

However, I can extract information related to the mechanical performance testing conducted to demonstrate substantial equivalence, framed in the context of acceptance criteria if we interpret "acceptance criteria" as meeting the performance standards of the predicate devices.

Description of Acceptance Criteria and Study for SpineFrontier® PedFuse® Pedicle Screw System (Mechanical Performance)

This 510(k) submission (K133153) describes an update to the SpineFrontier® PedFuse® Pedicle Screw System, specifically adding Hydroxyapatite (HA)-coated titanium alloy screws and Cobalt Chrome (CoCr) alloy rods. The study presented is a mechanical performance testing summary to demonstrate that these modifications maintain adequate and substantially equivalent mechanical strength compared to previously cleared versions and predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

For medical devices like pedicle screw systems, "acceptance criteria" for mechanical testing typically involve meeting or exceeding the performance established by recognized ASTM standards or demonstrating equivalence to predicate devices under those standards. The document states the purpose of the testing is to "demonstrate that the modifications... provide adequate and substantially equivalent mechanical strength for their intended use." While explicit numerical acceptance criteria are not provided in this summary, the implicit acceptance criterion is that the modified device's performance is comparable to or better than previously cleared devices and predicate devices when tested under specified ASTM standards.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify the exact sample size (number of devices or test repetitions) used for each mechanical test. Mechanical testing, especially for medical devices, typically involves multiple samples to ensure statistical validity, but the specific number is not disclosed in this summary.
• Data Provenance: The testing was conducted by SpineFrontier, Inc. in support of their 510(k) submission. This is internal testing performed by the manufacturer, likely in the USA where the company is based. It is a prospective generation of data specifically for this submission.

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 as the described study is mechanical performance testing of physical components, not a study involving human interpretation of data where "ground truth" would be established by experts.

4. Adjudication Method for the Test Set

This information is not applicable as the described study is mechanical performance testing and does not involve human readers or adjudication processes.

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 information is not applicable. This submission concerns mechanical properties of spinal implants, not an AI device or a study involving human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. This submission concerns mechanical properties of spinal implants, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is the established mechanical performance benchmarks set by:

• ASTM standards (specifically ASTM F1717-13).
• The known performance of the previously cleared SpineFrontier® PedFuse® Pedicle Screw System (K123164, K092420).
• The known performance of predicate devices (Medtronic TSRH® Spinal System K091797, Pioneer Quantum Spinal System K101790, Globus Transition™ Stabilization System K073439).

The aim of the study was to demonstrate that the modified device's mechanical properties met or were equivalent to these established benchmarks.

8. The Sample Size for the Training Set

This information is not applicable as the described study is mechanical performance testing and does not involve a training set for an algorithm.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as the described study is mechanical performance testing and does not involve a training set for an algorithm.

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