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NewPort Spinal System: The NewPort Spinal System is intended for posterior, non-cervical pedicle fixation 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 for the following indications: degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies, spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal tumor, pseudoarthrosis, and/or failed previous fusion.

Daytona Small Stature Spinal System: The Daytona Small Stature Spinal System is intended for posterior, non-cervical pedicle fixation 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 indications for use are as follows: degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies; spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; deformities or curvatures (i.e., scoliosis, and/or lordosis); spinal tumor; pseudoarthrosis; and/or failed previous fusion. Except for hooks, when used as an anterolateral thoracic/lumbar system, the Daytona Small Stature Spinal System may be used for the above indications as an adjunct to fusion in skeletally mature patients. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Daytona Small Stature Spinal System is also indicated as an adjunct to fusion in the treatment of progressive spinal deformities (i.e., scoliosis, kyphosis) including adolescent idiopathic scoliosis (AIS), neuromuscular scoliosis, and congenital scoliosis. Additionally, the Daytona Small Stature Spinal System is intended to treat pediatric patients diagnosed with spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. The devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. The Daytona Small Stature Spinal System can be attached to other cleared SeaSpine posterior fixation systems (e.g., Atoll OCT, Sierra, Malibu, Daytona, and Mariner Spinal Systems) using the rod connectors. Refer to the package inserts for the indications for use for those systems.

Daytona Small Stature Growth Rod Conversion Set: The Daytona Small Stature Growth Rod Conversion Set is indicated in patients under 10 years of age with potential for additional spinal 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. The extended axial connectors may be used with any cleared Daytona Small Stature Spinal System rod construct. The Daytona Small Stature Growth Rod Conversion Set is not intended to be used in conjunction with staples.

Malibu Spinal System (including with the Daytona Deformity System): The intended use of the Malibu Spinal System. when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System, is to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. The indications for use are as follows: degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies, spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal tumor, pseudoarthrosis, and/or failed previous fusion. The intended use and indications of the Malibu Spinal System, when used as a Spinal Interlaminal Fixation Orthosis or Hook Spinal System, are limited to T1-L5 and are as follows: degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies, spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and/or failed previous fusion.

Mariner Pedicle Screw System, Mariner MIS Pedicle Screw System, Mariner Deformity System, and Mariner RDX System: The intended use of the Mariner Pedicle Screw System in a posterior or anterolateral approach is to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. The indications for use are as follows: degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies, spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal tumor, pseudarthrosis, and/or failed previous fusion.

Mariner Outrigger Revision System: When used with the Mariner, Daytona Small Stature, Malibu, Newport, and Coral Systems: The Mariner Outrigger Revision System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion as a pedicle screw fixation system (T1-S2/ilium) in the treatment of the following acute and chronic instabilities or deformities: 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), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis (i.e., failed previous fusions). When used with Daytona Small Stature Spinal System for posterior non-cervical pedicle screw fixation in pediatric patients, the Mariner Outrigger Revision System is also indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis (AIS), neuromuscular scoliosis, and congenital scoliosis. Pediatric pedicle screw fixation is limited to a posterior approach. The Mariner Outrigger Revision System is intended to be used with autograft.

NewPort Spinal System: The NewPort Spinal System. which consists of non-sterile pedicle screws. locking caps, rods. and cap/rod combos, is intended to act as a temporary or permanent posterior, non-cervical pedicle fixation system to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusion to occur. The implants are manufactured from titanium alloy (Ti-6AI-4V ELI per ASTM F136), with the screws having a cobalt washer (Co-28Cr-6Mo per ASTM F1537).

Daytona Small Stature Spinal System: The Daytona Small Stature Spinal System is a non-cervical spinal fixation device and instrumentation system intended for use as a posterior pedicle screw fixation system, as a posterior non-pedicle screw fixation system, or as an anterolateral fixation system. The system consists of single-use implants, including monoaxial, and uniplanar screws, rods, locking caps, crossbars, hooks, and connectors. All implants are manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136) and/or cobalt chrome alloy (Co-28Cr-6Mo per ASTM F1537 or Co-35Ni-20Cr-10Mo per ASTM F562).

Daytona Small Stature Growth Rod Conversion Set: The Daytona Small Stature Growth Rod Conversion Set is a non-cervical spinal device intended to convert a traditional fusion construct into a non-fusion, growth- enabling construct that can be surgically lengthened on a periodic basis as the patient grows. The system consists of single use extended axial connectors designed to interact with constructs consisting of hooks, screws, connectors, and rods. All implants are manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136).

Malibu Spinal System (including with the Daytona Deformity System): The Malibu Spinal System, which consists of non-sterile implants and the associated instruments, is used to build constructs within the body to act as temporary or permanent posterior, non-cervical spinal fixation system to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusion to occur. The system consists of a variety of titanium alloy (Ti-6Al-4V ELI per ASTM F136) and/or cobalt chrome allov (Co-28Cr-6Mo per ASTM F1537 or Co-35Ni-20Cr-10Mo per ASTM F562) implants. including uni-planar and polyaxial pedicle screws, rods, locking caps, hooks, connectors, crossbars, set screws, and sublaminar wire.

Mariner Pedicle Screw System: The Mariner Pedicle Screw System is a non-cervical spinal fixation system used to build constructs within the body to act as temporary or permanent non-cervical spinal fixation devices and is intended for use as a posterior pedicle screw fixation system, a posterior nonpedicle fixation system, and/or an anterolateral fixation system to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusion to occur. The Mariner Pedicle Screw System includes a variety of non-sterile implants manufactured from titanium alloy (Ti-6AI-4V ELI per ASTM F136) and/or cobalt chrome alloy (Co-28Cr-6Mo per ASTM F1537 or Co-35Ni-20Cr-10Mo per ASTM F562) and is comprised of fixed, uni-axial, uni-planar, polyaxial, and motion-limiting modular pedicle screws, as well as connecting spinal rods, hooks, connectors, crossbars, and a separate locking element. The Mariner Pedicle Screw System is comprised of several sub-systems whose components are compatible with one another and may be designed for use together, depending on the type of procedure and surgical approach. The sub-systems are as follows:

Mariner Outrigger Revision System: The Mariner Outrigger Revision System is a thoracolumbar revision system designed to help reduce the trauma associated with revision surgeries by allowing the user the option to leave the existing hardware in and extend the construct or remove and replace with new SeaSpine hardware. The system includes closed polyaxial heads, Z-rods, and a variety of connectors, including axial, parallel, and L-shaped connectors. The Mariner Outrigger Revision System is compatible with other SeaSpine posterior spinal fixation systems (e.g., Mariner, Daytona Small Stature, Malibu, Newport, and Coral Spinal Systems) which offer titanium and/or cobalt chrome alloy rods ranging in sizes from Ø4.5mm to Ø6.35mm.

Mariner MIS Pedicle Screw System: The Mariner MIS Pedicle Screw System includes instruments and implants designed to facilitate the placement of the Mariner system through a minimally invasive surgical approach. providing an additional surgical approach option for surgeons. The system includes additional rods and extended tab modular screw heads that provide access for instrumentation and implant placement via a minimally invasive surgical approach.

Mariner Deformity System: The Mariner Deformity System provides additional implants and instruments designed to expand the functionality of Mariner to address adult deformity applications. The system is comprised of a range of implants, such as pre-contoured and constrained rods, uni-planar, uni-axial, and fenestrated screws, hooks, lateral connectors, and modular screw heads, including those with a rigidly attached rod connector, as well as instruments for pedicle subtraction osteotomy, iliac fixation, reduction, derotation, and correction.

Mariner RDX System: The Mariner RDX System provides additional implants and instruments that are designed to facilitate implant-based reduction techniques with an open or minimally invasive approach. The system is comprised of a locking cap and a variety of standard tab, extended tab, and MIS screw heads, as well as associated instruments.

This FDA 510(k) premarket notification describes the addition of MR Conditional labeling to several spinal systems manufactured by SeaSpine Orthopedics Corporation. It is not an AI/ML device, therefore many of the requested categories are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes (number of implants tested) for each ASTM standard. However, the testing was conducted in accordance with the specified ASTM standards, which inherently include methodologies for appropriate sample selection for validating specific physical properties. The data provenance is related to in-vitro testing of the devices themselves, not patient data (retrospective or prospective). The country of origin for the data (where the testing was performed) is not explicitly stated.

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

Not applicable. This submission is for the addition of MR Conditional labeling based on physical performance testing of the device components according to recognized ASTM standards, not on clinical or image-based ground truth established by experts.

4. Adjudication Method for the Test Set

Not applicable. The evaluation relies on standardized physical testing protocols, not expert adjudication of clinical outcomes or interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to the defined limits and acceptable ranges specified within the ASTM consensus standards for each tested parameter (e.g., maximum allowable displacement force, torque, temperature rise, and characteristics of artifacts). Compliance with these limits, as determined by laboratory measurements, constitutes meeting the acceptance criteria.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

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The intended use of the Orthobond Mariner Pedicle Screw System in a posterior or anterolateral approach is to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.

The indications for use are as follows:

• . Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,
• Spondylolisthesis. .
• Trauma (i.e., fracture or dislocation), .
• Spinal stenosis. .
• . Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
• Spinal tumor. .
• Pseudarthrosis, and/or .
• Failed previous fusion. .

The Orthobond coating is intended to reduce bacterial contamination prior to implantation resulting from deposition in the operating room on the surface of the device. The clinical impact associated with the Orthobond coating, including prevention of infection or reduction of infection risk in patients, has not been evaluated in human clinical trials. The Orthobond coating is not intended to treat existing infections and does not act within or on the body.

The device is a pedicle screw system, with instrumentation for implantation and removal, intended for spinal fusion as shown in Figure 1. The Ti6Al4V ELI implants are coated with 12-Methacryloyloxydodecyl Pyridinium Bromide (MDPB), a type of quaternary ammonium compound, which is intended to reduce bacterial contamination on the surface of the implant prior to implantation which may occur from deposition in the operating environment. Based on in vitro testing, this coating may result in immobilization and/or lysis of some challenge organisms. The pedicle screw system is comprised of screws, rods, connectors, and hooks of various sizes. The instruments included in the Mariner Pedicle Screw System facilitate the placement, adjustment, final locking, and removal, if necessary, of the system implants, and accessories to the system include trays and caddies for storage, protection, and organization prior to and during the steam sterilization process.

The provided text describes the regulatory information and technical specifications of the Orthobond Mariner Pedicle Screw System, particularly focusing on its non-clinical and animal studies to demonstrate safety and performance. However, it does not contain any information about a standalone AI algorithm, a multi-reader multi-case (MRMC) comparative effectiveness study, or a study involving human readers or expert consensus for ground truth establishment related to an AI device.

The document is solely about a physical medical device (pedicle screw system with a coating) and its mechanical, biological, and material performance testing, not an AI/ML powered device. Therefore, I cannot extract the requested information regarding acceptance criteria and study details for an AI-powered device from the provided text.

The text specifies performance criteria for the physical device based on bench testing (e.g., static and dynamic compression bending, static torsion) and animal studies, but these are not related to an AI/ML algorithm's performance.

If you have a document describing an AI device and its validation studies, please provide that.

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The intended use of the Mariner Pedicle Screw System in a posterior or anterolateral approach is to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.

The indications for use are as follows:

· degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,

· spondylolisthesis,

• · trauma (i.e., fracture or dislocation),
  · spinal stenosis,

• · deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),

• · spinal tumor,

• pseudarthrosis, and/or

• · failed previous fusion.

The Mariner Pedicle Screw System is a non-cervical spinal fixation system used to build constructs within the body to act as temporary or permanent non-cervical spinal fixation devices and is intended for use as a posterior pedicle screw fixation system, a posterior non-pedicle fixation system, and/or an anterolateral fixation system to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusion to occur.

The Mariner Pedicle Screw System includes a variety of single-use implants manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136) and/or cobalt chrome alloy (Co-28Cr-6Mo per ASTM F1537 or Co-35Ni-20Cr-10Mo per ASTM F562) and is comprised of fixed, uni-planar, and polyaxial and motion-limiting modular pedicle screws, as well as connecting spinal rods, hooks, connectors, crossbars, and a separate set screw locking element. The instruments included in the Mariner Pedicle Screw System facilitate the placement, final locking, and removal, if necessary, of the system implants, and accessories to the system include trays and caddies for storage, protection, and organization prior to and during the steam sterilization process.

The purpose of this submission is to add an additional set screw to the Mariner Pedicle Screw System.

This document describes a 510(k) premarket notification for the Mariner Pedicle Screw System (K212692). The relevant sections indicate that this is a medical device, not an AI/Software as a Medical Device (SaMD).

Therefore, the requested information regarding AI/SaMD acceptance criteria and study details (such as sample size for test/training sets, data provenance, expert ground truth establishment, MRMC studies, standalone performance, etc.) is not applicable to this submission.

The "Clinical Testing" section explicitly states "Not applicable. The determination of substantial equivalence is not based on an assessment of clinical performance data." This further confirms that no clinical studies as you've described for AI/SaMD were performed or required for this device's clearance.

The "Non-Clinical Testing" section describes mechanical testing performed to demonstrate substantial equivalence, but this pertains to the physical performance of the pedicle screw system, not an AI algorithm.

In summary, because this is a physical medical device (a pedicle screw system) and not an AI/SaMD, the questions about acceptance criteria for an AI algorithm and the detailed study design for an AI/SaMD are not relevant to this specific FDA submission.

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The intended use of the Mariner Pedicle Screw System is to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.

The indications for use are as follows:

• degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,

• severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion,

• spondylolisthesis,

• trauma (i.e., fracture or dislocation),

• spinal stenosis,

• deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis).

• spinal tumor,

• pseudoarthrosis, and/or

• failed previous fusion.

The Mariner Pedicle Screw System is a non-cervical spinal fixation device and instrumentation system intended for use as a posterior pedicle screw fixation system, a posterior non-pedicle screw fixation system, or as an anterolateral fixation system. The system consists of single-use implants including fixed, polyaxial, cephalad/caudal restricted-motion, and medial/lateral restricted motion pedicle screws as well as connecting spinal rods and a separate locking element.

The Mariner implants are manufactured from titanium alloy Ti-6Al-4V ELI (per ASTM F136), and cobalt chrome (Co-35Ni-20Cr-10Mo per ASTM F562 and Co-28Cr-6Moalloy 1 (warm worked) per ASTM F1537). The instruments included in the Mariner Pedicle Screw system facilitate the placement, removal, adjustment, and final locking of the system implants. Other accessories to the system also include the trays and caddies for storage, protection, and organization prior to and during the steam sterilization process.

This document is a 510(k) summary for the SeaSpine Mariner Pedicle Screw System and does not contain information about the acceptance criteria or a study proving the device meets that criteria. The relevant sections explicitly state:

• "Non-Clinical Testing": "The SeaSpine Mariner Pedicle Screw System demonstrated similar performance to the predicate systems through static and dynamic mechanical testing with reference to ASTM F1717 and ASTM F1798." This indicates performance similarity to predicates based on established engineering standards but does not define specific acceptance criteria or report performance data.
• "Clinical Testing": "Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data." This confirms that no clinical studies were performed to establish performance against acceptance criteria.

Therefore, I cannot provide the requested information based on the provided text. The document is primarily focused on demonstrating substantial equivalence to predicate devices, not on proving performance against a specific set of acceptance criteria through a dedicated study.

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The intended use of the Mariner Pedicle Screw System is to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.

The indications for use are as follows:

• degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,

• severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion,

• spondylolisthesis,

• trauma (i.e., fracture or dislocation),

• spinal stenosis.

• deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),

• spinal tumor,

• pseudoarthrosis, and/or

• failed previous fusion.

The SeaSpine Mariner Pedicle Screw system is a system consisting of instruments and single-use implants intended to build constructs within the body to act as a temporary or permanent posterior, non-cervical pedicle fixation system, or an anterolateral fixation system to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur.

The Mariner implants are manufactured solely from titanium alloy (Ti-6Al-4V ELI per ASTM F136). The instruments included in the Mariner System facilitate the placement, removal, adjustment, and final locking of the system implants. The instruments also include the trays and caddies for storage, protection, and organization prior to and during the steam sterilization process.

This document is a 510(k) premarket notification from the FDA regarding the Mariner Pedicle Screw System by SeaSpine Orthopedics Corporation. It establishes substantial equivalence to previously marketed devices and does not describe acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving a device meets them because:

• This document is for a traditional medical device (pedicle screw system), not an AI/ML medical device. The questions posed are highly specific to the evaluation of AI/ML algorithms, particularly the use of test sets, ground truth establishment by experts, and analysis of AI-augmented human reader performance.
• The document explicitly states "Clinical Testing: Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data." This further confirms that no clinical study (or AI/ML performance study) was conducted or presented in this 510(k) submission to demonstrate performance against specific acceptance criteria for an AI/ML algorithm.

The non-clinical testing mentioned refers to mechanical testing of the physical screw system components (static and dynamic cantilever mechanical testing with reference to ASTM F1717 and screw head disassociation testing), which is standard for orthopedic implants, not AI/ML software.

The document's purpose is to establish that the new pedicle screw system is substantially equivalent in design, materials, and intended use to predicate devices already on the market, thereby demonstrating safety and effectiveness without requiring new clinical trials.

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