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Spineology Pedicular Fixation Systems are 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); turnor; pseudoarthrosis; and/ or failed previous fusion.

Spineology Fortress™, Threshold™ V2, and Palisade™ Pedicular Fixation Systems consist of screws (titanium alloy), curved and straight rods (see table below for diameters and material), and ConneX™ Connector (see table below for configurations and materials) devices to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. All screws are available with or without a hydroxyapatite coating. These systems 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 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 titanium alloy implants that are intended to connect the rod on one side of a 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. Connextor devices are 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.

Spineology ConneX Rod Connector devices are titanium alloy 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 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 Spineology Power Adapter is an instrument accessory intended to facilitate the preparation and placement of pedicle screws using powered instrumentation as an optional alternative to the existing manual technique. The Power Adapter is intended for exclusive use with Spineology Fortress, Threshold, Threshold V2, and Palisade System surgical instruments. The Power Adapter serves as a mechanical interface between the power driver and surgical instruments. When the Power Adapter is attached, the power driver provides appropriate power to rotate the surgical instrument for preparation and placement of pedicle screws.

The provided text describes modifications to existing pedicular fixation systems and a new power adapter for surgical instrumentation, rather than a standalone AI device with specific acceptance criteria and a study to prove its performance in the typical sense of AI/ML evaluation (e.g., sensitivity, specificity, AUC, etc.).

Therefore, the requested information elements related to AI/ML device evaluation metrics, expert ground truth development, MRMC studies, or training sets are not applicable or derivable from this submission, as the submission pertains to a conventional medical device and not an AI/ML-driven diagnostic or prognostic tool.

However, I can extract the non-clinical testing performed to establish substantial equivalence for the modifications and the new Power Adapter, which functionally serve as "acceptance criteria" and the "study" demonstrating they meet those criteria within the context of a 510(k) submission for a non-AI device.

1. Table of Acceptance Criteria and 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)

• Sample Size: Not explicitly stated in terms of number of devices tested for each test. The tests are described by type (e.g., ASTM F1798, ASTM F1717, simulated clinical use for the Power Adapter). For screw modifications, "a thorough review, risk assessment, and comparison" was performed.
• Data Provenance: Not specified. Standard mechanical and performance tests (e.g., ASTM standards) are typically conducted in a laboratory setting. The "simulated use environment" for the Power Adapter implies lab-based testing rather than clinical data. No country of origin for data is mentioned. The studies appear to be laboratory-based and prospective in the sense that they were conducted for this specific submission, but not prospective clinical trials.

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. This is a conventional medical device submission, not an AI/ML device relying on expert-annotated "ground truth" for performance evaluation. The "ground truth" is typically defined by engineering specifications, material properties, and adherence to performance standards.

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

• Not applicable. This is not an AI/ML device requiring human adjudication of results from a diagnostic or prognostic algorithm.

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-assisted device.

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

• Not applicable. This is a physical medical device and an instrument accessory, not an algorithm.

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

• For the rods: Engineering specifications, material properties, and established mechanical testing standards (ASTM F1798, ASTM F1717).
• For the pedicle screws: Comparison to the primary design characteristics, materials, manufacturing processes, existing mechanical performance testing, and product experience of already cleared equivalent devices.
• For the Power Adapter: Functional performance in simulated use conditions, adherence to mechanical and functional specifications (e.g., screw loading, screw insertion, compatibility).

8. The sample size for the training set

• Not applicable. There is no AI/ML component, and therefore no "training set."

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

• Not applicable. Since there is no training set, there is no ground truth established for it.

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The Spineology Threshold™ V2 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 Threshold Pedicular Fixation System consists of solid standard and reduction screws (titanium alloy), curved and straight rods (titanium alloy), and adjustable ConneX Cross Connector 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. Threshold solid standard and reductions 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 solid standard and reduction 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 describes the Spineology Threshold™ V2 Pedicular Fixation System, a medical device, and its clearance through a 510(k) premarket notification. The information provided is primarily focused on demonstrating substantial equivalence to previously marketed predicate devices, rather than a standalone clinical study with detailed acceptance criteria and performance metrics for a diagnostic or AI-driven device.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, MRMC study, ground truth for training set) are not applicable to this type of regulatory submission and device. This is a spinal fixation system, not a device that relies on interpretation, diagnostic accuracy, or AI.

However, I can extract the relevant information regarding acceptance criteria derived from non-clinical testing and the studies that demonstrate compliance.

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

For a spinal fixation system, "acceptance criteria" and "reported device performance" are typically defined by compliance with established mechanical testing standards and comparison to predicate device performance. The document explicitly states:

• "New mechanical testing was not required to establish the performance of Threshold V2 pedicle screws, pre-bent rods, and set screws. These devices were previously cleared under a separate 510(k) and have not been modified since their initial clearance." This implies that their previous performance met the relevant standards.
• "New mechanical testing was not required to support the performance of Threshold V2 reduction screws. These screws are identical to previously cleared Threshold V2 pedicle screws with the exception of the integrated removable (non-implanted) extension towers on the tulip of the device." Again, reliance on previous clearance and identical mechanical properties.
• For Straight Rods and ConneX™ Cross Connectors and ConneX™ Rod Connectors, specific ASTM tests were conducted. The "acceptance criteria" for these would be to meet or exceed the performance of the predicate devices and the requirements outlined in the referenced ASTM standards and FDA Guidance. While specific numerical performance values are not provided in this summary, the conclusion of the submission is that the device "has been shown to be substantially equivalent to the legally marketed predicate devices," implying successful performance in these tests.

Therefore, the table would look like this, with the understanding that "reported performance" is demonstrated by substantial equivalence and meeting standard requirements rather than specific numerical data points explicitly stated here:

2. Sample size 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 applicable in the context of clinical studies for diagnostic accuracy. For mechanical testing, representative "worst-case" devices were tested, a standard practice for non-clinical verification. Specific numerical sample sizes for each test are not provided in this summary but would be detailed in the full test reports.
• Data Provenance: Not applicable for a clinical study. The mechanical testing data would originate from the manufacturer's testing facilities or a certified lab. The document does not specify the country of origin for the testing itself, but Spineology Inc. is located in Saint Paul, MN, USA.
• Retrospective or Prospective: Not applicable, as this is non-clinical mechanical testing, not a clinical study.

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. This device is a pedicular fixation system (an implant for spine surgery), not a diagnostic device requiring expert interpretation or ground truth establishment for a test set.

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 is not an AI-assisted diagnostic or interpretation device.

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

• Not applicable.

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

• Not applicable for clinical ground truth. For mechanical testing, the "ground truth" is compliance with established engineering standards (ASTM and FDA Guidance) and performance comparable to predicate devices.

8. The sample size for the training set

• Not applicable. This device does not have a "training set" in the context of machine learning or AI.

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

• Not applicable.

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