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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 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, 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 pediatic patients, the CREO® Stabilization System implants are indicated as an adjunct to freat adolescent idiopathic scoliosis. The CREO® 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, the CREO® Stabilization System rods may be connected to the REVERE® Stabilization System (4.5mm, 5.5mm rod) or ELLIPSE® Occipito-Cervico-Thoracic Spinal System (3.5mm rod) using corresponding connectors. Refer to the REVERE® system package insett 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® serews 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.

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 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.

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.

The CREO® Stabilization System consists of rods, hooks, monoaxial screws, uniplanar screws, polyaxial screws, reduction screws, fenestrated 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. Implant components can be rigidly locked into a variety of configurations for the individual patient and surgical condition.

CREO® implants are composed of titanium alloy, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F136, F1295, F1472, F1537 and F138. Rods are also available in commercially pure titanium, as specified in ASTM F67. 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 chromiummolybdenum alloy implants.

CREO® Stabilization System include surgical instruments manufactured from stainless steel, as specified in ASTM F899.

Navigation Instruments are nonsterile. reusable instruments that can be operated manually or under power using a power drill such as POWEREASE 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 for K182375 is an FDA 510(k) clearance letter and summary for a medical device called the CREO® Stabilization System, Navigation Instruments, and ExcelsiusGPS®. However, the document primarily focuses on bench testing (mechanical testing and bacterial endotoxin testing) to demonstrate substantial equivalence to predicate devices, rather than a clinical study evaluating the device's diagnostic performance against specific acceptance criteria.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and comparative effectiveness studies is not available in the provided text because a clinical study of that nature was not described for this submission.

The document states:

• "Mechanical testing (static and dynamic compression and static torsion) was conducted in accordance with ASTM F1717 and the 'Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s,' May 3, 2004 to demonstrate substantial equivalence of the subject CREO implants to the predicate devices."
• "Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011."
• "Subject CREO® implants, Navigation instruments, and ExcelsiusGPS® instruments have the same technological characteristics as the predicate devices including design, intended use, material composition, and range of sizes."
• "Subject CREO® implants and instruments are similar to the predicate device with respect to technological characteristics, performance, design, and intended use. The information provided within this premarket notification supports substantial equivalence to the predicate devices."

This indicates that the clearance was based on demonstrating the physical and mechanical equivalence of the new device to existing cleared devices, and on demonstrating biocompatibility (via bacterial endotoxin testing), not on a clinical performance study with predefined acceptance criteria for diagnostic output.

Therefore, I cannot populate the table or answer the specific questions about clinical study design parameters, as this information is not present in the provided 510(k) summary.

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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.

CREO® Stabilization System: In-Line Connector Growing Rods consist of rod-to-rod connectors which can be surgically lengthened on a periodic basis as the patient grows. These connectors may be used as part of a growing rod construct consisting of rods, screws, hooks, offset connectors, and cross-connectors, and are limited to a posterior approach. When used as part of a growing rod system, In-Line Connector Growing Rods are intended for use only with CREO® Stabilization System fusion constructs cleared for pediatric use. In-Line Connector Growing Rods are manufactured from titanium alloy.

REVERE® Stabilization System: In-Line Connector Growing Rods consist of rod-to-rod connectors which can be surgically lengthened on a periodic basis as the patient grows. These connectors may be used as part of a growing rod construct consisting of rods, screws, hooks, offset connectors, and cross-connectors, and are limited to a posterior approach. When used as part of a growing rod system, In-Line Connector Growing Rods are intended for use only with REVERE® Stabilization System fusion constructs cleared for pediatric use. In-Line Connector Growing Rods are manufactured from titanium alloy.

The provided documents are a 510(k) summary and FDA clearance letters for the CREO® Stabilization System and REVERE® Stabilization System. These documents pertain to medical devices, specifically stabilization systems for spinal deformities, not AI/ML-driven diagnostic or prognostic tools. Therefore, much of the requested information about acceptance criteria, study design for AI performance, expert adjudication, MRMC studies, standalone performance, training set details, and ground truth establishment, which are typical for AI/ML device evaluations, is not applicable to this submission.

The FDA clearance is based on the substantial equivalence of the devices to legally marketed predicate devices, not on a study proving the device meets specific acceptance criteria in the context of AI/ML performance metrics (like sensitivity, specificity, AUC).

Here's a breakdown of the applicable information:

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

Since this is a substantial equivalence submission for medical devices (spinal stabilization systems) and not an AI/ML diagnostic tool, traditional performance metrics like sensitivity, specificity, or AUC with predefined acceptance criteria are not provided. The "performance" is demonstrated by showing that the technological characteristics and intended use are substantially equivalent to existing, legally marketed predicate devices.

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

Not applicable. This submission is for substantial equivalence of a physical medical device. It does not involve a "test set" in the context of evaluating an AI/ML algorithm's performance on a dataset. The "data" provenance mentioned is a "clinical literature review."

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. There was no "ground truth" to establish for a test set in the context of AI/ML performance. The review of clinical literature would have been performed by the manufacturer's regulatory and clinical affairs team to support their claims of safety and equivalence.

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

Not applicable. There was no "test set" requiring adjudication for AI/ML performance.

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 not an AI algorithm.

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

Not applicable in the context of AI/ML. The "ground truth" for this medical device submission is the established safety and effectiveness of the predicate devices and the scientific and engineering principles demonstrating the equivalence of the new device. The submission mentions a "clinical literature review" which would draw from published studies, which in turn might report on pathology, outcomes data, or expert clinical observations for the predicate and similar devices.

8. The sample size for the training set

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

Not applicable. There is no training set for which a ground truth needs to be established.

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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, 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. Implant components can be rigidly locked into a variety of configurations for the individual patient and surgical condition

CREO® implants are composed of titanium alloy, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F136, F1295, F1472, F1537 and F138. Rods are also available in commercially pure titanium, as specified in ASTM F67. 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 chromiummolybdenum alloy implants.

This document is a 510(k) premarket notification for the CREO® Stabilization System. It details the device's indications for use, its description, and the basis for its substantial equivalence to previously cleared devices. The document highlights mechanical testing conducted to demonstrate this equivalence.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly state "acceptance criteria" with numerical targets and then list "reported device performance" against those targets in a table format. However, it does state that mechanical testing was conducted to demonstrate substantial equivalence to predicate devices.

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

The document does not specify the sample size for the mechanical testing or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions that "mechanical testing (static and dynamic compression and static torsion) was conducted."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This type of information is not applicable to this submission. The "ground truth" concept is typically relevant for studies evaluating diagnostic or AI-based devices where human expert consensus is used to label data. This document describes a medical device (spinal fixation system) cleared based on mechanical performance and substantial equivalence, not a diagnostic or AI device.

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

This information is not applicable for the same reasons as point 3. Adjudication methods are used in studies involving human interpretation or labeling of data, which is not the primary method for evaluating this type of medical device for 510(k) clearance.

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 type of study is not applicable. An MRMC study evaluates the performance of human readers, typically in the context of diagnostic imaging, with and without AI assistance. This document pertains to a spinal fixation system and its mechanical and material properties, not an AI-based diagnostic tool.

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

This information is not applicable as this is not an AI algorithm. The device is a physical medical implant.

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

The "ground truth" in this context is the established performance standards and material properties defined by ASTM and FDA guidance documents for spinal systems. The device's performance is compared against these engineering and material specifications.

8. The sample size for the training set

This information is not applicable as this is not an AI algorithm that undergoes training.

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

This information is not applicable as this is not an AI algorithm that undergoes training.

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