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The MonoPoly Pedicle Screw system is intended to help provide immobilization and stabilization of the spinal segments as an adjunct to fusion in skeletally mature patients of the thoracic, lumbar and/or sacral spine (T1-S1), specifically as follows:

When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the MonoPoly Pedicle Screw System is indicated for one or more of the following: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) spinal tumor, and/or (6) failed previous fusion (pseudarthrosis).

When used as a non-cervical and non-pedicle screw fixation system, the MonoPoly Pedicle Screw System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) trauma (fracture, dislocation), (5) pseudarthrosis, (6) tumor resection and/or (7) failed previous fusion.

The MonoPoly Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle screws sizes, couplers, a set screw, cross links, a washer, rods and hooks. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-Eli). This premarket notification addresses the introduction of cannulated versions of the MonoPoly pedicle screw component of the system.

The provided text describes a 510(k) summary for the MonoPoly Pedicle Screw System, specifically addressing the introduction of cannulated versions of the pedicle screw component. This document is a premarket notification to the FDA to demonstrate substantial equivalence to a predicate device.

Key takeaway: This document describes a medical device (pedicle screw system), not an AI/ML device. Therefore, the questions related to AI/ML device performance, ground truth, expert consensus, and training/test sets are not applicable.

However, I can extract the relevant device information and acceptance criteria as outlined for a traditional medical device submission.

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

This submission is for a traditional medical device (pedicle screw system), not an AI/ML device. Therefore, the concepts of sensitivity, specificity, F1 score, ROC AUC, ground truth establishment, reader studies, and training/test sets for AI/ML models are not applicable.

The acceptance criteria for this device are established by demonstrating substantial equivalence to a predicate device through conformity to recognized standards and verification of mechanical properties.

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study conducted to prove the device meets acceptance criteria is primarily bench testing to confirm mechanical properties and a comparison to the predicate device to establish substantial equivalence.

• Study Type: Mechanical testing (bench testing) and comparative analysis with a predicate device.
• Methodology: Mechanical properties were evaluated according to the recognized international standard ASTM F1717-04, which specifies test methods for spinal implant assemblies in a spinal construct. This standard would involve testing parameters such as static and dynamic bending strength, stiffness, and fatigue resistance under simulated physiological loading conditions.
• Conclusion: The submission concludes that "The modification to the original device does not adversely affect performance and the modified device is substantially equivalent to the unmodified predicate device."

Regarding the AI/ML-specific questions, they are not applicable as this is not an AI/ML device.

2. Sample size used for the test set and the data provenance: Not applicable (not an AI/ML device). The "test set" here refers to the physical devices subjected to mechanical testing. The sample size for ASTM F1717-04 testing would typically involve a statistically relevant number of devices to ensure robustness of results, but the document does not specify this number. Data provenance would be from laboratory bench tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable (not an AI/ML device). "Ground truth" in this context is determined by the physical properties and performance metrics established by standardized mechanical tests.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable (not an AI/ML device). Adjudication methods are relevant for human interpretation of data, not for direct mechanical testing results.

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 (not an AI/ML device). MRMC studies are for evaluating diagnostic performance with human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable (not an AI/ML device). This refers to AI algorithm performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable (not an AI/ML device). The "ground truth" for this medical device is based on established engineering principles, material science, and performance standards (e.g., ASTM F1717-04).

8. The sample size for the training set: Not applicable (not an AI/ML device).

9. How the ground truth for the training set was established: Not applicable (not an AI/ML device).

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The MonoPoly 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 (T1-S1), specifically as follows:

When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the is indicated for one or more of the following: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (4) dislocation, (5) spinal tumor, and/or (6) failed previous fusion (pseudarthrosis).

When used as a non-cervical and non-pedicle screw fixation system, the MonoPoly Pedicle Screw System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) trauma (fracture, dislocation), (5) pseudarthrosis, (6) tumor resection and/or (7) failed previous fusion.

The MonoPoly Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle screws sizes, couplers, a set screw, cross links, a washer, rods and hooks. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-Eli).

This document describes a medical device, the MonoPoly Pedicle Screw System, and its regulatory filing, but it does not contain acceptance criteria for device performance or a study demonstrating that the device meets such criteria.

Instead, the provided text is a 510(k) summary and associated FDA correspondence, which focuses on demonstrating substantial equivalence to previously cleared predicate devices. This means the manufacturer is asserting their device is as safe and effective as existing legally marketed devices, rather than establishing de novo performance criteria.

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria and performance studies. The "Performance Testing" section explicitly states: "The pre-clinical testing performed indicated that the MonoPoly Pedicle Screw System is substantially equivalent to predicate devices." This implies the testing was comparative in nature against existing devices, not against a predefined set of acceptance criteria for a new device.

Here's a breakdown of what is and is not present in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not present. The document does not define specific performance acceptance criteria (e.g., in terms of strength, fatigue life, or other biomechanical properties). It also does not report specific quantitative performance data for the device against such criteria. The "Performance Testing" section only states that the testing indicated substantial equivalence to predicate devices.

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

• Not present. The document does not describe a clinical "test set" for performance evaluation in the way you're asking. The testing mentioned is "pre-clinical," likely referring to mechanical or biomechanical bench testing. No sample sizes for any test sets are provided, nor is any information about data provenance (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not applicable. Ground truth is generally relevant for diagnostic or AI-driven devices where a human expert's judgment is used to label data. This document describes a mechanical implant, not a diagnostic device.

4. Adjudication Method:

• Not applicable. See point 3.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• Not applicable. This type of study is used for diagnostic imaging devices to assess human reader performance with and without AI assistance. The MonoPoly Pedicle Screw System is a surgical implant.

6. Standalone (Algorithm Only) Performance Study:

• Not applicable. This is a mechanical implant, not an algorithm or AI system.

7. Type of Ground Truth Used:

• Not applicable. See point 3.

8. Sample Size for the Training Set:

• Not applicable. A "training set" is relevant for machine learning algorithms. This document describes a physical medical device.

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

• Not applicable. See point 8.

Summary from the provided text:

The MonoPoly Pedicle Screw System is a Class III spinal implant comprising various screws, rods, and connectors made from titanium alloy. It is intended to aid in spinal segment immobilization and stabilization as an adjunct to fusion for various spinal conditions. The pre-clinical testing indicated substantial equivalence to four predicate devices: Cross Medical Synergy VLS System (K974749), U&I Optima Xia System (K031585), GSS Medical GS System (K053573), and Signus Medical OvalTwist System (K061577). The document does not provide details of specific performance criteria or a study demonstrating the device meets such criteria, as its 510(k) clearance path relies on equivalence to existing devices.

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