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The CREO® Stabilization System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is indicated for skeletally mature patients (including small stature) and for pediatric patients. These devices are indicated as an adjunct to fusion for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, and/or lordosis, Schevermann's Disease), tumor, stenosis, and failed previous fusion (pseudoarthrosis). When used as an adjunct to fusion, the CREO® Stabilization System is intended to be used with autograft and/or allograft.

In addition, the CREO® Stabilization System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fision by autogenous bone graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CREO® Stabilization System implants are indicated as an adjunct to treat adolescent idiopathic scoliosis. The CREO® Stabilization System is intended to be used with autograft and/or allograft. Pedicle screw fixation is limited to a posterior approach.

In order to achieve additional levels of fixation the CREO® Stabilization System rods may be connected to the REVERE Stabilization System (4.5mm, 5.5mm, or 6.35mm rod) or ELLIPSE® Occipito-Cervico-Thoracic Spinal System (3.5mm rod) using corresponding connectors. Refer to the REVERE® system package insert for instructions and indications of use.

In-Line Connector Growing Rods are indicated in patients under 10 years of age with potential for additional spine growth who require surgical treatment to obtain and maintain correction of severe, progressive, life-threatening, early onset spinal deformities associated with thoracic insufficiency, including early onset scoliosis, as part of a growing rod construct.

Globus Navigation Instruments are intended to be used during the preparation and placement of CREO® screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

When used for posterior fixation in conjunction with FORTRESS-Plus™ bone cement, the CREO® Fenestrated Screw System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. CREO® Fenestrated with FORTRESS™ and FORTRESS-Plus™ bone cements are for use at spinal levels where the structural integrity of the spine is not severely compromised.

Globus Navigation Instruments are intended to be used during the preparation and placement of Globus screws (QUARTEX®, CREO®, REVERE®, REVOLVE®, ELLIPSE®, PROTEX® CT, and SI-LOK®) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MRI based model, fluoroscopy images, or digitized landmarks of the anatomy.

The ExcelsiusGPS® is intended for use as an aid for precisely locating anatomical structures and for spatial positioning and orientation of an instrument holder or guide to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws and interbody spacers, and intracranial devices such as biopsy needles, electrodes, and tubes.

CREO® ONE Robotic Screws are polyaxial screws with a tapered distal awl tip to allow penetration of the cortex of the pedicle, for ease of use with the ExcelsiusGPS® robot and Globus Navigated Instruments. Implants are available in a variety of sizes to accommodate individual patient anatomy. CREO® ONE screws may be used with ExcelsiusGPS® instruments and CREO® Navigation instruments.

CREO® ONE Robotic Screws are composed of titanium alloy with optional hydroxyapatite (HA) coating.

This document describes the FDA's clearance of the CREO® ONE Robotic Screws, along with CREO® Stabilization System and Navigation Instruments, and the ExcelsiusGPS® system. However, the provided text does not contain any information about specific acceptance criteria or the study that proves the device meets those criteria in the context of human-in-the-loop performance, AI assistance, or standalone algorithm performance.

The "Performance Data" section is extremely brief and only states: "Verification and validation cadaveric testing was conducted, including planning and placement of CREO ONE screws, using the ExcelsiusGPS System and associated instruments to demonstrate that CREO ONE Robotic Screws meet performance and navigation accuracy requirements."

This summary indicates that performance and navigation accuracy requirements were met through cadaveric testing, but it does not provide details on:

• Specific acceptance criteria: What were the numerical thresholds for "performance" or "navigation accuracy"?
• Reported device performance values: What were the raw or statistical results from the cadaveric testing?
• Sample size: How many cadavers or screws were tested?
• Data provenance: Where did the cadavers come from? Was it a retrospective or prospective study?
• Experts for ground truth: Were experts involved in defining "ground truth" for navigation accuracy on cadavers? If so, how many and what were their qualifications?
• Adjudication method: How was accuracy adjudicated?
• MRMC comparative effectiveness study: No mention of human readers, AI assistance, or MRMC studies.
• Standalone algorithm performance: This is a physical device, not an AI algorithm, so this concept doesn't directly apply in the usual sense. The accuracy refers to the physical system's guidance.
• Type of ground truth: While it's cadaveric testing, the method of establishing the "true" anatomical position for comparison isn't detailed (e.g., micro-CT, physical measurement).
• Training set: This product is a medical device and navigation system, not an AI model requiring a separate "training set" in the context of machine learning. The term "training set" would not apply here.
• Ground truth for training set: Not applicable for this type of device.

Therefore, based solely on the provided text, I cannot complete the requested tables and information regarding acceptance criteria and performance with the level of detail requested for an AI/algorithm-focused study. The document confirms that testing was done to demonstrate performance and navigation accuracy, but the specifics are not disclosed in this public summary.

The document is a 510(k) summary for a medical device (surgical instruments and a navigation system), not a software or AI product requiring the type of performance evaluation typically detailed in the prompt. The "performance data" here refers to the physical accuracy and functionality of the instruments and navigation system working together, likely tested in a lab or cadaveric setting against engineering specifications.

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The CREO® Stabilization System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is indicated for skeletally mature patients (including small stature) and for pediatric patients. These devices are indicated as an adjunct to fusion for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, tracture or dislocation), deformities or curvatures (i.e., scoliosis, and/or lordosis, Schevermann's Disease), tumor, stenosis. and failed previous fusion (pseudoarthrosis). When used as an adjunct to fusion, the CREO® Stabilization System is intended to be used with autograft and/or allograft.

In addition. the CREO® Stabilization System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) of the LS-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CREO® Stabilization System implants are indicated as an adjunct to treat adolescent idiopathic scoliosis. The CREO® Stabilization System is intended to be used with autograft and/or allograft. Pediatic pedicle screw fixation is limited to a posterior approach.

In order to achieve additional levels of fixation, the CREO® Stabilization System rods may be connected to the REVERE® Stabilization System (4.5mm, 5.5mm, or 6.35mm rod) or ELLIPSE® Occipito-Cervico-Thoracic Spinal System (3.5mm rod) using corresponding connectors. Refer to the REVERE®, or ELLIPSE® system package insert for instructions and indications of use.

In-Line Connector Growing Rods are indicated in patients under 10 years of age with potential for additional spine growth who require surgical treatment to obtain and maintain correction of severe, progressive, life-threatening, early onset spinal deformities associated with thoracic insufficiency, including early onset scoliosis, as part of a growing rod construct.

Globus Navigation Instruments are intended to be used during the preparation and placement of CREO® screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

Globus Navigation Instruments are intended to be used during the preparation and placement of Globus screws (OUARTEX®, CREO®, REVERE®, REVOLVE®, ELLIPSE®, PROTEX® CT, and SI-LOK®) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medronic StealthStation System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MRI based model, fluoroscopy images, or digitized landmarks of the anatomy.

The ExcelsiusGPS® is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws.

CREO® Preferred Angle Screws are polyaxial screws with a preferred angle in one direction. They are composed of titanium alloy or cobalt chrome molybdenum alloy as specified in ASTM F136 and F1537, and are available with optional hydroxyapatite (HA) coating per ASTM F1185.

Navigation Instruments are nonsterile, reusable instruments that can be operated manually or under power using a power drill that are intended to be used with the Medtronic StealthStation® System.

ExcelsiusGPS® Instruments are nonsterile, reusable instruments that can be operated with the ExcelsiusGPS® robotic arm, or may be used for a freehand navigated surgical procedure.

The provided document is a 510(k) summary for the CREO® Stabilization System, Navigation Instruments, and ExcelsiusGPS®. It primarily focuses on demonstrating substantial equivalence to predicate devices through technological characteristics and mechanical testing. The document does not contain the specific information required to complete the detailed table and answer the questions about acceptance criteria and a study proving device performance in the context of AI/ML-based medical devices.

Here's why and what can be extracted:

Why the requested information is not available in the provided text:

The request asks for details typically found in studies for AI/ML-based medical devices, such as:

• Acceptance Criteria/Reported Device Performance (Table): This would typically include metrics like sensitivity, specificity, AUC, or accuracy for a diagnostic/predictive AI. The document discusses mechanical testing criteria for spinal implants and instruments, not performance metrics for an AI system.
• Sample size and data provenance for test set: Relevant for AI algorithm performance evaluation.
• Number of experts and qualifications for ground truth: Essential for establishing ground truth in AI studies.
• Adjudication method: How disagreements among experts are resolved for ground truth.
• MRMC comparative effectiveness study: Measures the improvement in human reader performance with AI assistance.
• Standalone performance: Performance of the algorithm without human intervention.
• Type of ground truth: Pathology, expert consensus, outcomes data.
• Training set sample size and ground truth establishment: Details about the data used to train an AI algorithm.

The devices described (CREO® Stabilization System, various Navigation Instruments, and ExcelsiusGPS®) are spinal implants and surgical navigation systems, which are hardware devices. The text mentions "precisely locating anatomical structures" and "spatial positioning and orientation," which are functions of a navigation system, but it doesn't describe the use of an AI algorithm for diagnostic or predictive purposes that would necessitate the above detailed performance metrics. The navigation systems are designed for use with existing systems like Medtronic StealthStation® and ExcelsiusGPS® robotic arm.

What can be extracted or inferred:

While a table of acceptance criteria for an AI study cannot be created, here's what the document implies about how substantial equivalence was demonstrated:

Addressing the specific questions based on the provided text:

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

   • Acceptance Criteria: Mechanical testing (static and dynamic compression, static torsion) per ASTM F1717 and FDA Guidance for Spinal System 510(k)s. Bacterial endotoxin testing (BET) per ANSI/AAMI ST-72:2011.
   • Reported Device Performance: The document states that the testing was conducted "to demonstrate substantial equivalence" and that the "information provided within this premarket notification supports substantial equivalence to the predicate devices." Specific numerical performance data is not provided in this 510(k) summary.

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 for this type of submission which relies on mechanical testing rather than clinical data or AI algorithm performance data. The "test set" here refers to the physical devices and materials tested.

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. Ground truth as understood in AI/ML is not established for mechanical testing of physical medical devices.

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: No, an MRMC study was not done as this is not an AI-assisted diagnostic or interpretive device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, this is not an AI algorithm. The ExcelsiusGPS® is a navigation system that aids surgeons, but its function as described does not involve an AI algorithm that would have standalone performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for the mechanical testing would be the engineering specifications and established standards (ASTM F1717, ANSI/AAMI ST-72:2011).

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

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

In summary, the provided FDA 510(k) document is for a traditional medical device (spinal implants and surgical navigation instruments) and not an AI/ML-based device. Therefore, the bulk of the questions asking about AI-specific validation metrics cannot be answered from this text.

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The CREO® Stabilization System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is indicated for skeletally mature patients (including small stature) and for pediatric patients (CREO® 4.75 only). These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, and failed previous fusion (pseudoarthrosis). When used as an adjunct to fusion, the CREO® Stabilization System is intended to be used with autograft and/or allograft.

In addition, the CREO® Stabilization System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CREO® 4.75 Stabilization System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The CREO® 4.75 Stabilization System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

In order to achieve additional levels of fixation in skeletally mature patients, the CREO® Stabilization System rods may be connected to the REVERE® Stabilization System (5.5mm or 6.35mm rod), REVERE® 4.5 Stabilization System (4.5mm rod) or ELLIPSE® Occipito-Cervico-Thoracic Spinal System (3.5mm rod) using corresponding connectors. In order to achieve additional levels of fixation in pediatric patients, the CREO® Stabilization System rods may be connected to the REVERE® 4.5 Stabilization System using corresponding connectors. Refer to the REVERE®, REVERE® 4.5, or ELLIPSE® system package insert for instructions and indications of use.

The CREO® Stabilization System consists of rods, hooks, monoaxial screws, uniplanar screws, polyaxial screws, reduction screws, locking caps, t-connectors, head offset connectors, trans-iliac connectors, staples, and associated manual surgical instruments. Implants are available in a variety of sizes to accommodate individual patient anatomy. CREO® implants mate with 4.75mm. 5.5mm. and 6.35mm diameter rods. Implant components can be rigidly locked into a variety of configurations for the individual patient and surgical condition. Polyaxial screws, hooks, and t-connectors are intended for posterior use only. Staples are intended for anterior use only. Rods and monoaxial screws may be used anteriorly or posteriorly. Locking caps are used to connect screws or hooks to the rod and trans illac connectors.

The most common use of this screw, hook, and rod system in the posterior thoracolumbar and sacral spine is two rods, each positioned and attached lateral to the spinous process via pedicle screws and/or lamina, pedicle or transverse process hooks.

The most common use of this screw, hook, and rod system in the anterior thoracolumbar spine is one rod, positioned and attached to the vertebral bodies via monoaxial screws through an appropriate size staple.

Screws and hooks attach to the rods using a locking cap with an inner set screw. The size and number of screws are dependent on the length and location of the rod. Screws are inserted into a pedicle of the thoracolumbar and/or sacral spine. Screws may be used with a staple. The type and number of hooks are also dependent on the location in the spine needing correction and/or stabilization. Hooks are attached to the laminae, pedicles, or transverse process of the posterior spine.

T-connectors are modular components designed to connect the two rods of a construct and act as a structural cross member. The rod-clamping set screws secure the t-connectors to the rods. Additional set screws secure the adjustable cross members at the desired length. Additional connectors may be used to connect two rods, and are also secured using set screws.

CREO® Stabilization System S-rods and unit rods are specifically excluded for use in adolescent idiopathic scoliosis patients.

CREO® implants are composed of titanium alloy, commercially pure titanium, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F136, F1295, F1472, F67, F1537 and F138. Screws are also available with hydroxyapatite (HA) coating per ASTM F1185. Due to the risk of galvanic corrosion following implantation, stainless steel implants should not be connected to titanium, titanium alloy, or cobalt chromium-molybdenum alloy implants.

This document is a 510(k) premarket notification for the "CREO® Stabilization System"
It is for the purpose of seeking clearance for additional cobalt chrome implants for the system.
Thus, this is NOT a study of whether the system itself meets acceptance criteria but rather for additional components of such system.

Therefore, the requested information cannot be fully provided as the document is a submission for additional implants, not a primary study detailing full device performance for the initial clearance. However, I can extract the information available from the document regarding the justification for the additional implants.

Here's an attempt to answer based on the provided text, recognizing the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document describes mechanical testing as part of the performance data.

• Sample Size: Not explicitly stated for specific tests.
• Data Provenance: Not stated (e.g., country of origin, retrospective/prospective). The tests were conducted to support a US FDA 510(k) submission, so it's likely conducted in compliance with US standards.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This is not applicable to this type of submission. The performance criteria are based on mechanical and material engineering standards (ASTM F1717 and F1185, FDA Guidance), not clinical ground truth established by medical experts during a study.

4. Adjudication Method for the Test Set

Not applicable. This pertains to clinical studies involving interpretation of data by multiple readers. The evaluation here is based on engineering test results against established standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This document does not mention any MRMC comparative effectiveness study. The submission is for additional implants for an already cleared system, relying on mechanical testing for equivalence.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This is a spinal fixation device, an implantable medical device, not a software algorithm.

7. Type of Ground Truth Used

The "ground truth" in this context refers to established engineering and material standards (ASTM F1717, ASTM F1185, FDA Guidance for Spinal System 510(k)s, May 3, 2004) to which the new implants' mechanical properties are compared. There is no biological/clinical "ground truth" as typically understood in diagnostic device studies.

8. Sample Size for the Training Set

Not applicable. This is not a study involving training data.

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

Not applicable.

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The CREO™ Stabilization System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is indicated for skeletally mature patients (including small stature) and for pediatric patients (CREO™ 4.75 only). These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis. Scheuermann's Disease), tumor, stenosis, and failed previous fusion (pseudoarthrosis). When used as an adjunct to fusion, the CREO Stabilization System is intended to be used with autograft and/or allograft.

In addition, the CREO™ Stabilization System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CREO™ 4.75 Stabilization System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The CREO™ 4.75 Stabilization System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

In order to achieve additional levels of fixation in skeletally mature patients, the CREO™ Stabilization System rods may be connected to the REVERE® Stabilization System (5.5mm or 6.35mm rod), REVERE® 4.5 Stabilization System (4.5mm rod) or ÉLLIPSE® Occipito-Cervico-Thoracic Spinal System (3.5mm rod) using corresponding connectors. In order to achieve additional levels of fixation in pediatric patients, the CREO™ Stabilization System rods may be connected to the REVERE® 4.5 Stabilization System using corresponding connectors. Refer to the REVERE®, REVERE® 4.5, or ELLIPSE® system package insert for instructions and indications of use.

The CREO™ Stabilization System consists of rods, hooks, monoaxial screws, uniplanar screws, polyaxial screws, reduction screws, locking caps, t-connectors, head offset connectors, trans-iliac connectors, staples, and associated manual surgical instruments. Implants are available in a variety of sizes to accommodate individual patient anatomy. CREO™ implants mate with 4.75mm, 5.5mm, and 6.35mm diameter rods. Implant components can be rigidly locked into a variety of configurations for the individual patient and surgical condition. Polyaxial screws, hooks, and t-connectors are intended for posterior use only. Staples are intended for anterior use only. Rods and monoaxial screws may be used anteriorly or posteriorly. Locking caps are used to connect screws or hooks to the rod and trans iliac connectors.

The most common use of this screw, hook, and rod system in the posterior thoracolumbar and sacral spine is two rods, each positioned and attached lateral to the spinous process via pedicle screws and/or lamina, pedicle or transverse process hooks.

The most common use of this screw, hook, and rod system in the anterior thoracolumbar spine is one rod, positioned and attached to the vertebral bodies via monoaxial screws through an appropriate size staple.

Screws and hooks attach to the rods using a locking cap with an inner set screw. The size and number of screws are dependent on the length and location of the rod. Screws are inserted into a pedicle of the thoracolumbar and/or sacral spine. Screws may be used with a staple. The type and number of hooks are also dependent on the location in the spine needing correction and/or stabilization. Hooks are attached to the laminae, pedicles, or transverse process of the posterior spine.

T-connectors are modular components designed to connect the two rods of a construct and act as a structural cross member. The rod-clamping set screws secure the tconnectors to the rods. Additional set screws secure the adjustable cross members at the desired length. Additional connectors may be used to connect two rods, and are also secured using set screws.

CREO™ Stabilization System S-rods and unit rods are specifically excluded for use in adolescent idiopathic scoliosis patients.

The rods are composed of titanium alloy, commercially pure titanium, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F136, F1295, F1472, F67, F1537 and F138. All other CREO™ implants are composed of titanium alloy or stainless steel, as specified in ASTM F136, F1295, F67 and F138. Screws are also available with hydroxyapatite (HA) coating per ASTM F1185. Due to the risk of galvanic corrosion following implantation, stainless steel implants should not be connected to titanium, titanium alloy, or cobalt chromium-molybdenum alloy implants.

Here's a breakdown of the acceptance criteria and the study information for the CREO™ Stabilization System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided 510(k) summary does not mention a test set in the context of clinical data for a pre-market notification. The "Performance Data" section specifically refers to mechanical testing, not patient or image data. Therefore, there is no information on sample size for a test set, data provenance, or retrospective/prospective nature of such a study.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable as the submission relies on mechanical testing against established standards and predicate device equivalence, not clinical studies requiring expert ground truth for interpretation.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as #3.

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

No, an MRMC comparative effectiveness study was not conducted or reported in this 510(k) summary. The submission focuses on mechanical performance and substantial equivalence.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This information is not applicable as the device is a physical spinal stabilization system, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on:

• Mechanical Testing Standards: Adherence to ASTM F1717.
• FDA Guidance: Compliance with the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s," May 3, 2004.
• Predicate Device Performance: The underlying assumption is that the predicate devices have established safety and effectiveness.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical product, not an AI model that requires a training set of data.

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

This information is not applicable for the same reasons as #8.

Summary of the Study:

The "study" that proves the CREO™ Stabilization System meets its acceptance criteria is primarily mechanical testing. This testing was conducted in accordance with:

• ASTM F1717: A standard specific to spinal implant mechanics.
• "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s," May 3, 2004: FDA's specific recommendations for spinal system submissions.

The results of this mechanical testing demonstrated "substantial equivalence" to the predicate devices (REVERE® Stabilization System, REVERE® 4.5 Stabilization System, Medtronic CD Horizon® Spinal System, Synthes USS, and DePuy VIPER® 2 System). This equivalence means the CREO™ system is considered to be "as safe, as effective, and perform as well as or better than the predicate device." The study did not involve clinical trials with human subjects or AI algorithm performance evaluations.

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