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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 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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The Threshold Pedicular Fixation System and Palisade Pedicular Fixation System 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 radies), 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 titanium alloy screws and rods to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. 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 Palisade Pedicular Fixation System consists of titanium screws and cobalt chrome rods which allow a surgeon to build a spinal implant construct to accommodate the anatomical and physiological needs of the patient. 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 provided document is a 510(k) premarket notification summary for the Spineology Threshold Pedicular Fixation System and Palisade Pedicular Fixation System. It describes the devices and their intended use, but it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria related to the device's function or clinical outcomes.

The purpose of this 510(k) submission is to obtain clearance for the addition of a hydroxyapatite (HA) coating to existing pedicle screws. The core argument for substantial equivalence is that the HA-coated screws are fundamentally the same as the predicate devices, with the coating being a minor change.

Here's a breakdown of the requested information based on the document, noting where information is absent:

1. Table of acceptance criteria and the reported device performance:
   The document states: "Testing was not required to support this change. Spineology's risk analysis is sufficient to demonstrate the substantial equivalence of the HA-coated Threshold and Palisade pedicle screws to the predicate devices."
   Therefore, there are no specific acceptance criteria or reported device performance metrics for the device's functional performance or clinical outcomes presented in this document. The submission relies on substantial equivalence to predicate devices, which means their performance characteristics are considered similar to devices already cleared for market.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
   As no performance testing was required or reported, there is no test set sample size or data provenance mentioned.

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, as no test set requiring ground truth establishment is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable, as no test set requiring adjudication is described.

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. The device is a pedicle fixation system, not an AI diagnostic or assistance tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable. The device is a pedicle fixation system, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   Not applicable, as no study requiring ground truth is described.

8. The sample size for the training set:
   Not applicable, as this is not an AI/machine learning device requiring a training set.

9. How the ground truth for the training set was established:
   Not applicable, as this is not an AI/machine learning device.

In summary, this 510(k) submission for the Spineology Threshold and Palisade Pedicular Fixation Systems (with HA coating) relies on the demonstration of substantial equivalence to legally marketed predicate devices, rather than on new performance testing to meet predefined acceptance criteria. The change is considered minor (addition of HA coating), and no new clinical or non-clinical performance studies were presented as part of this particular submission to prove specific performance metrics.

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The 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 and/or lordosis); tumor; pseudoarthrosis; and/or failed previous fusion.

The Palisade Pedicular Fixation System consists of titanium screws and cobalt chrome rods which allow a surgeon to build a spinal implant construct to accommodate the anatomical and physiological needs of the patient. 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.

This document is a 510(k) premarket notification for a medical device called the "Palisade Pedicular Fixation System." It is primarily focused on demonstrating substantial equivalence to predicate devices, rather than presenting a study proving the device meets specific acceptance criteria in terms of clinical performance or diagnostic accuracy.

Therefore, many of the requested elements (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth for training set) are not applicable to this type of submission. This document describes a mechanical device used in spinal surgery, not an AI/diagnostic device.

However, I can extract the relevant information from the document regarding the performance testing that was conducted to demonstrate the substantial equivalence of the device.

Here's an interpretation of the provided document in the context of your request, focusing on what is available:

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

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail manner for clinical performance, as it is a mechanical device. Instead, it relies on demonstrating mechanical equivalence to predicate devices through various ASTM standard tests. The "reported device performance" is essentially that the device passed these tests in accordance with applicable standards.

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 for each mechanical test. However, typically mechanical testing involves a specific number of samples (e.g., 6 or more) per test configuration as defined by the ASTM standards. This is for product samples, not patient data.
• Data provenance: Not applicable. The data is generated from laboratory mechanical testing of the device components, not from human or animal subjects.

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 mechanical testing, not a diagnostic or clinical study requiring expert ground truth.

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

Not applicable. This is mechanical 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

Not applicable. This is a mechanical spinal fixation system, not an AI or diagnostic device.

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

Not applicable. This is a mechanical device.

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

Not applicable in the sense of clinical ground truth. The "ground truth" for these tests are the established performance requirements and methodologies outlined in the ASTM standards for spinal implant mechanical testing.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

Not applicable.

Summary of the Study Discussed in the Document (Performance and Biological Testing):

The document reports on performance tests conducted in accordance with applicable standards and test methods to determine the endurance, strength, and durability of the Palisade Pedicular Fixation System.

• Tests Performed:

  • ASTM F1798
  • ASTM F1717
  • Static Compression Bending
  • Flexural Grip
  • Axial Grip
  • Static Torsion
  • Torsional Grip
  • Dynamic Compression Bending

• Conclusion regarding these tests: Spineology states that the device "passed" these tests and demonstrated substantial equivalence to the predicate devices. The exact quantitative results (e.g., specific load values, cycles to failure) are not provided in this summary document but would have been submitted to the FDA separately.

• Biological Safety Testing: "Not required as there was no change in materials from the predicate device." This implies that the materials used in the Palisade system are identical to those of legally marketed predicate devices, for which biological safety has already been established.

• Packaging and Sterilization Testing: "Not required as there was no change to the sterile barrier system, sterilization method, sterilization parameters, or sterility assurance level (SAL) from the predicate device." This indicates that these aspects of the device delivery are the same as those previously cleared predicate devices.

In essence, this document demonstrates substantial equivalence of a new mechanical spinal fixation device to existing, legally marketed devices by showing it has the same intended use, indications for use, fundamental scientific technology, biological safety, packaging, and sterilization method, supported by mechanical testing that confirms similar performance characteristics as defined by international standards.

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