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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™ 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 cannulated screws (titanium allov), curved and straight rods (titanium alloy), and adjustable 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. Threshold cannulated 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 cannulated 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.

This document is a 510(k) premarket notification for a medical device, the Spineology Threshold™ Pedicular Fixation System. It focuses on demonstrating that new components (ConneX™ Cross Connector, ConneX™ Rod Connector, and 5.5 titanium Straight Rod devices) are substantially equivalent to previously cleared predicate devices. Therefore, the information provided primarily concerns non-clinical testing to support this substantial equivalence, rather than a clinical study evaluating the device's diagnostic performance for a specific condition.

Based on the provided text, here's a breakdown regarding acceptance criteria, study details, and related information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical "acceptance criteria" in terms of specific performance metrics (like accuracy, sensitivity, specificity) for a diagnostic device, nor does it report "device performance" in similar terms. Instead, the "acceptance criteria" are implied by the performance standards outlined in ASTM F1717, ASTM F1798, and ASTM F2193 for mechanical testing, and ANSI/AAMI ST-72:2011 for bacterial endotoxin testing. The "reported device performance" is a statement that the devices were tested in accordance with these standards.

Note: The document states that these tests were performed and implies successful completion to demonstrate substantial equivalence, but it does not provide the raw data or specific quantitative results of these tests, which would typically be included in a full submission rather than this summary letter.

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

• Test Set Sample Size: The document does not specify a "sample size" in terms of individual patients or cases for diagnostic accuracy. Instead, it refers to "representative worst case" devices for mechanical testing. The number of devices tested for each mechanical or bacterial endotoxin test is not disclosed.
• Data Provenance: The data is from non-clinical (laboratory) testing, not from human subjects. Therefore, there is no country of origin or retrospective/prospective distinction for patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This section is not applicable as the document describes non-clinical mechanical and biological (endotoxin) testing of manufacturing components, not a clinical study requiring expert assessment for ground truth.

4. Adjudication Method for the Test Set

This section is not applicable as the document describes non-clinical mechanical and biological (endotoxin) testing.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not reported in this document. This type of study is typically conducted for diagnostic or AI-assisted devices to evaluate human performance with and without AI. This submission is for surgical implants, and the testing focuses on the mechanical and biological safety of the components.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not reported. This device is not an algorithm or AI system, but rather physical implant components.

7. The Type of Ground Truth Used

For the mechanical testing, the "ground truth" (or reference standard) is the published performance specifications and methodologies within the cited ASTM standards. For bacterial endotoxin testing, the ground truth is the validated limits and methodologies within ANSI/AAMI ST-72:2011.

8. The Sample Size for the Training Set

This section is not applicable. This document describes the clearance of physical medical device components (implants), not an AI/ML algorithm that would have a training set.

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

This section is not applicable as there is no training set for an AI/ML algorithm.

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The Threshold™ 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); turnor; pseudoarthrosis; and/ or failed previous fusion.

Spineology's Threshold Pedicular Fixation System consists of cannulated and solid titanium alloy screws and rods to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Threshold cannulated and solid 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 cannulated and solid screws can be placed in the pedicles in a variety of trajectories ranging from 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 acceptance criteria and studies for the Threshold™ Pedicular Fixation System, specifically for the addition of uncoated and hydroxyapatite (HA) coated Threshold solid pedicle screws.

1. Table of Acceptance Criteria and Reported Device Performance:

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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 Spineology Threshold™ 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 Spineology Threshold ™ Pedicular Fixation System is an addition to Spineology's Fortress pedicle screw family. The Threshold System consists of cannulated titanium 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 devices are provided sterile. The associated instruments are provided non-sterile.

The provided text is a 510(k) summary for the Spineology Threshold™ Pedicular Fixation System. It describes a medical device, a pedicle screw spinal system, and does not contain information about an AI/ML device or its performance criteria. Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving a device meets them for an AI/ML system.

The document discusses the substantial equivalence of the Threshold™ Pedicular Fixation System to a predicate device (Spineology Fortress™ Pedicle Screw System) based on intended use, materials, technological features, and comparative performance testing, specifically "Static testing ... performed to verify the design and demonstrate that the Threshold Pedicular Fixation System is substantially equivalent to the Fortress Pedicle Screw System. The performance testing included static compression loading in accordance with ASTM F1717."

This is a physical medical device, not an AI/ML algorithm.

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