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The Spineology Fortress™ 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 Fortress 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. The Fortress System 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.

Spineology Connex Cross Connector devices are transversely-placed implants that are intended to connect the rod on one side of the spinal construct to the rod on the other side. These devices are manufactured from titanium alloy and are adjustable to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. ConneX Cross Connector devices are intended to be used with Spineology's Fortress™, Threshold V2™, and Palisade™ Pedicular Fixation Systems which are 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.

Spineology Connex Rod Connector devices are implants that are intended to connect two rods in a spinal construct. These devices are manufactured from titanium alloy and the components allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Connex Rod Connector devices are intended to be used with Spineology's Fortress™, Threshold™, Threshold V2™, and Palisade™ Pedicular Fixation Systems which are 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 provided document is a 510(k) clearance letter for a medical device called the "Fortress™ Pedicular Fixation System." This type of document is for device clearance, not a study proving the device meets acceptance criteria.

The 510(k) process in the US FDA framework establishes "substantial equivalence" to a legally marketed predicate device, rather than requiring new clinical studies to prove effectiveness or safety from scratch, especially for Class II devices like this one.

Therefore, many of the requested details about acceptance criteria, efficacy studies, sample sizes, ground truth, and expert involvement are not applicable to this document or the 510(k) clearance process described. This document focuses on demonstrating that new components added to an existing system are "substantially equivalent" to already-cleared devices, primarily through non-clinical (mechanical) testing.

Here's how to address your questions based on the provided text:

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

• Acceptance Criteria: The document does not explicitly state "acceptance criteria" in terms of specific performance thresholds for clinical outcomes. Instead, the "acceptance criteria" for the 510(k) clearance are implicitly demonstrating substantial equivalence to predicate devices through mechanical testing. The core "acceptance" is that the device behaves mechanically similarly to other cleared spinal fixation systems.
• Reported Device Performance: The document doesn't provide specific numerical performance results from the mechanical tests (e.g., specific bending strength values). It only lists the tests performed and states that the devices "have been shown to be substantially equivalent."

Since specific numerical acceptance criteria and performance data are not detailed in this regulatory document, a table cannot be constructed with these specifics. The document simply confirms that mechanical testing (ASTM F1717, ASTM F1798, ASTM F2193, and Bacterial Endotoxin Testing) was conducted according to FDA guidance and applicable standards, and the conclusion was that the devices are "substantially equivalent."

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

• Sample Size for Test Set: Not specified for the mechanical tests. Mechanical testing typically uses a certain number of representative samples for each test condition, but the exact count is not given in this summary document.
• Data Provenance: The testing appears to be non-clinical (mechanical and endotoxin) rather than human subject data. Therefore, "country of origin of the data" and "retrospective or prospective" are not applicable. The tests were conducted according to US FDA Guidance and ASTM standards.

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)

• This question is not applicable. The "test set" here refers to mechanical testing of physical device components, not diagnostic or clinical data requiring expert interpretation or "ground truth" establishment in a biological sense. The "ground truth" for mechanical testing is derived from engineering principles and standards.

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

• This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or expert review panels for clinical data, not for mechanical laboratory testing of device components.

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 question is not applicable. This document is about a spinal fixation system (physical implant for surgery), not an AI/imaging diagnostic device that would involve human readers or AI assistance.

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

• This question is not applicable. This document is about a spinal fixation system (physical implant), not an algorithm or software device.

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

• The "ground truth" for the non-clinical testing comprises the established mechanical properties and safety profiles (e.g., sterilization/biocompatibility) required for spinal implant components, as defined by FDA guidance and
  ASTM standards (e.g., F1717, F1798, F2193, ANSI/AAMI ST-72). There isn't "expert consensus" or "pathology" in the typical sense for this type of device clearance.

8. The sample size for the training set

• This question is not applicable. This is not a machine learning or AI device, so there is no "training set."

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

• This question is not applicable. As there is no training set for this type of device, there is no ground truth to establish for one.

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