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The Spineology Palisade™ Pedicular Fixation System is intended for posterical fixation as an adjunct to fusion in skeletally mature patients for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis and/or lordosis); tumor; pseudoarthrosis; and/or failed previous fusion.

The Spineology Palisade Pedicular Fixation System consists of screws (titanium alloy), curved and straight rods (cobalt chrome), adjustable Connex Cross Connector (titanium alloy), and fixed ConneX Rod Connector (titanium alloy) devices to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Palisade screws are available with or without a hydroxyapatite coating. The system is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. The screws can be placed in the pedicles in a variety of trajectories ranging from the standard anatomic transpedicular path projected medially toward the ventral vertebral body, to a caudocephalad path sagittally and a laterally directed path in the transverse plane.

This document is a 510(k) premarket notification decision letter from the FDA for the Spineology Palisade™ Pedicular Fixation System. It grants clearance for the device based on its substantial equivalence to a legally marketed predicate device.

The document does not contain any information about a study that proves the device meets specific acceptance criteria in terms of performance metrics like sensitivity, specificity, accuracy, or any other quantifiable performance measure that would be typically established for an AI-powered device or for clinical outcome studies.

The "acceptance criteria" and "device performance" discussed in this document relate to the substantial equivalence of a modified medical device to a previously cleared predicate device. This is a regulatory pathway, not a clinical performance study against specific, pre-defined outcome metrics.

Here's why the requested information cannot be fully provided based on the given text:

• No acceptance criteria for performance: The document confirms the device meets regulatory requirements for substantial equivalence, but it doesn't define specific performance criteria (e.g., "sensitivity > 90%") or report quantitative performance results from a study designed to measure clinical effectiveness or diagnostic accuracy.
• No study to prove device performance in a clinical context: The "Non-Clinical Testing" section describes verifications and adoptions for new instruments and rods (e.g., Sawbones Verification Lab, Drawing Verification, Sterilization Adoption). These are engineering and material compatibility tests, not studies assessing clinical outcomes or diagnostic performance.
• No AI component: The device described is a pedicular fixation system, which is a physical implant, not an AI-powered diagnostic or therapeutic device. Therefore, questions related to AI performance, ground truth, expert consensus, and MRMC studies are not applicable.

Therefore, many parts of your request are not applicable or cannot be answered from the provided text.

However, I can extract the relevant information regarding the basis for its regulatory clearance:

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

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

• Not applicable. This device is a physical pedicular fixation system. The "testing" involved non-clinical engineering verifications (e.g., Sawbones lab, drawing verification) and regulatory adoptions (sterilization, packaging). There was no "test set" in the context of clinical data or AI performance evaluation.

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. No clinical ground truth was established from expert review for this type of device and submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not applicable. No test set requiring expert 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 not an AI device.

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

• Not applicable. This is not an AI device.

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

• Not applicable. As a physical implant, the "ground truth" for regulatory clearance is based on engineering specifications, material properties, and comparison to the predicate device's established safety and effectiveness.

8. The sample size for the training set

• Not applicable. No training set was used as this is not an AI device.

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

• Not applicable. No training set or ground truth in this context.

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The Spineology Palisade™ Pedicular Fixation System is intended for posterior, non-cervical fixation as an adjunct to fusion in skeletally mature patients for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudoarthrosis; and/ or failed previous fusion.

The Spineology Palisade Pedicular Fixation System consists of screws (titanium allov), curved and straight rods (cobalt chrome), adjustable Connex Cross Connector (titanium alloy), and fixed ConneX Rod Connector (titanium alloy) devices to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Palisade screws are available with or without a hydroxyapatite coating. The system 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 the thoracic, lumbar, and sacral spine. The screws can be placed in the pedicles in a variety of trajectories ranging from the standard anatomic transpedicular path projected medially toward the ventral vertebral body, to a caudocephalad path sagittally and a laterally directed path in the transverse plane.

The provided text is a 510(k) premarket notification for a medical device, the Spineology Palisade™ Pedicular Fixation System. This document focuses on demonstrating substantial equivalence to predicate devices through a comparison of intended use, indications, technology, materials, and non-clinical mechanical testing results.

Crucially, this document does not contain information about clinical studies involving human patients, nor does it present acceptance criteria and performance data in the context of an "AI/algorithm" or "device performance" as might be expected for diagnostic or AI-driven medical devices. The device in question is a surgical implant (pedicle screw system), and its clearance is based on mechanical testing and comparison to existing, already-cleared predicate devices.

Therefore, many of the requested categories for acceptance criteria and study details are not applicable to the content of this 510(k) submission. I will address the points as best as possible with the available information.

Acceptance Criteria and Study for Spineology Palisade™ Pedicular Fixation System (Additions: ConneX™ Cross Connector, ConneX™ Rod Connector, and 4.75mm cobalt chrome Straight Rod)

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

Since this is a mechanical device, performance is evaluated through non-clinical mechanical testing, demonstrating that the device components can withstand relevant forces and stresses. The "acceptance criteria" are implied by successful completion of these tests, showing comparable or acceptable performance to predicate devices and industry standards. Specific numerical acceptance values and direct comparisons to predicate device values are not explicitly given in this summary document, but the statement of "substantial equivalence" implies successful achievement.

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

The document does not specify the exact number of units or "sample size" for each mechanical test. However, it states "representative worst case" devices were tested. Data provenance is implied to be from internal Spineology Inc. testing facilities ("non-clinical testing"). The data is entirely retrospective in the sense that it evaluates manufactured device components against predefined standards. As this is a mechanical device, country of origin related to human data is not applicable here.

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

This is not applicable. The "ground truth" for mechanical testing is established by engineering standards (ASTM) and FDA guidance for spinal systems. There are no human experts establishing a "ground truth" for diagnostic or clinical outcomes in this type of submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. Adjudication methods are relevant for clinical studies where expert consensus is needed to determine outcomes, which is not the case for mechanical performance testing.

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. This is a surgical implant, not a diagnostic imaging device or an AI-assisted system. No human reader studies were conducted or are relevant for this type of device clearance.

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

This is not applicable. There is no algorithm/AI component in this medical device.

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

For the mechanical testing, the "ground truth" is defined by adherence to recognized engineering standards (ASTM) and FDA guidance for spinal systems. The performance of the device components under various loading conditions is compared against these established benchmarks and implicitly against the performance of predicate devices.

8. The sample size for the training set

This is not applicable. There is no "training set" as this is not an AI/ML device.

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

This is not applicable. There is no "training set" or "ground truth" for a training set as this is not an AI/ML device.

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