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The GS Medical PYXIS 3D Titanium Cervical Cages indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. GS Medical PYXIS 3D Titanium Cervical Cages are used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. GS Medical PYXIS 3D Titanium Cervical Cages are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The GS Medical PYXIS 3D Titanium Cervical Cage System devices are designed for restoring the height of the intervertebral space after resection of the disc. The intervertebral body fusion devices are made of 3D printed titanium alloy (Ti-6Al-4V) in accordance with and manufactured as per ASTM F3001. The material and manufacturing process of the subject device, PYXIS 3D Titanium Cervical Cage is identical to the additional predicate (PYXIS 3D Titanium Cage System, K223868). The PYXIS 3D Titanium Cervical Cage System implants are available in various heights, footprints, and lordotic angles to suit the individual patient's pathology and anatomical conditions. The subject device cages ranging in height from 5mm-10mm in 1 mm increments with 0°, 4°, and 8° options. Also in 4.5mm hight for the 0° angle. The cages are provided in three distinct footprints.

This FDA document is a 510(k) premarket notification for a medical device called the PYXIS 3D Titanium Cervical Cage System. It describes the device and claims substantial equivalence to previously cleared predicate devices.

However, the provided text does not contain any information about acceptance criteria or a study that proves the device meets such criteria in the context of an AI/ML powered device, or any kind of AI/ML component at all.

The "PERFORMANCE DATA" section (page 5) simply states that "The worst-case cage of the PYXIS 3D Titanium Cage System underwent testing according to ASTM 2077, specifically static and dynamic axial compression testing, static and dynamic compression shear testing, static and dynamic Torsion testing; expulsion testing, and subsidence testing according to ASTM F2267." These are standard mechanical and structural tests for intervertebral body fusion devices, not performance metrics related to an AI/ML algorithm.

Therefore, I cannot fulfill your request to describe the acceptance criteria and study details for an AI/ML device based on the provided text. The device in question is a purely mechanical implant.

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The Spectrum Spine Cervical Cage System devices including those with macro-, micro- and nano-roughened surface textured features are indicated for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 to T1. These patients should have had at least six weeks of nonoperative treatment. The Spectrum Spine Cervical Cage System is indicated to be used with supplemental fixation cleared by the FDA for use in the cervical spine and autograft bone, allograft bone comprised of cancellous and/or corticocancellous bone, demineralized allograft with bone marrow aspirate, or a combination thereof.

The Spectrum Spine Cervical Cage System is composed of cervical interbody fusion devices. The Spectrum Spine Cervical Cage System is offered in five footprints with varying heights and lordotic angles designed to accommodate patient anatomy. Additionally, all interbody cages are offered with a smooth finish and a rough finish. The interbody devices also contain a large graft window through the body of the device to allow for placement of bone graft and facilitate fusion. All implant components are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136.

The Spectrum Spine Cervical Cage System also includes instruments to facilitate implantation of the subject implant devices. Instruments are manufactured from medical grade stainless steel.

The provided text does not contain any information about acceptance criteria or a study that proves a device meets those criteria, specifically concerning a digital health device or AI/ML product.

The document is a 510(k) clearance letter from the FDA for a Spectrum Spine Cervical Cage System, which is a physical implant used for spinal fusion. The information provided relates to the physical and mechanical properties of this implant, not a software or AI device.

Therefore, I cannot provide the requested information, as these details are not present in the given text.

To address your request, here's what the provided text does include, which is relevant to the Spectrum Spine Cervical Cage System (a physical medical device):

• Device Name: Spectrum Spine Cervical Cage System
• Intended Use: Anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, confirmed by imaging studies, resulting in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 to T1. Patients should have had at least six weeks of nonoperative treatment. To be used with supplemental fixation and specific bone graft materials.
• Performance Testing (Mechanical): Static and dynamic axial compression, static and dynamic compression shear, static and dynamic torsion per ASTM F2077-22, as well as subsidence per ASTM F2267-22 and expulsion. The results of these tests showed the device to be substantially equivalent to predicate interbody devices.

None of the requested points (acceptance criteria for digital device, sample size for test set, data provenance, expert ground truth, adjudication, MRMC study, standalone performance, ground truth type, training set size, training set ground truth establishment) are applicable or present in this document.

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icotec Cervical Cage: The icotec Cervical Cage is intended for spinal fusion procedures at one or more levels (C2-T1) in skeletally mature patients with degenerative cervical disc disease (defined as discogenic back pain with degeneration of the disc and/or myelopathy with herniated disc and/or osteophyte formation on posterior endplates confirmed by patient history and radiographic studies), instability, trauma including fractures, deformity defined as kyphosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion at one or more levels of the cervical spine with accompanying radicular symptoms. Implants are to be packed with autogenous bone. This device is intended to be used with a supplemental internal fixation system appropriate for use in the cervical spine. This device is intended to be used in patients who have had six weeks of non-operative treatment. When used with the icotec Anterior Cervical Plate System, the icotec Cervical Cage is intended to stabilize the cervical spinal column as an adjunct to fusion in patients with spinal infection (e.g., spondylodiscits, osteomyelitis) and spinal instability due to infection, surgical debridement, or decompression.

icotec PLIF Cage: The icotec PLIF Cage is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of nonoperative treatment. The device is intended for use level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use without integrated fixation and must be used in conjunction with posterior supplemental fixation (e.g., pedicle screws). The device system is intended to be used with autograft. When used with the VADER® Pedicle System, the icotec PLIF Cage is intended to stabilize the lumbar spinal column as an adjunct to fusion in patients with spinal infection (e.g., spondylodiscitis, osteomyelitis) and spinal instability due to infection, surgical debridement, or decompression.

icotec ETurn® TLIF Cage: The icotec ETurn® TLIF Cage is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in sketally mature patients who have had six months of nonoperative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by radios. The device system is designed for use without integrated fixation and must be used in conjunction with posterior supplemental fixation (e.g., pedicle screws). The device system is intended to be used with autograft. When used with the VADER® Pedicle System, the icotec ETurn TLIF Cage is intended to stabilize the lumbar spinal column as an adjunct to fusion in patients with spinal infection (e.g., spondylodiscitis, osteomyelitis) and spinal instability due to infection, surgical debridement, or decompression.

The icotec Interbody Cage System (i.e., icotec Cervical Cage, icotec PLIF Cage, and icotec ETurn® TLIF Cage) is an interbody cage system designed to restore the intervertebral height and to facilitate intervertebral body fusion of the spine. The devices are manufactured from high strength carbon fiber reinforced polyetheretherketone (Carbon/PEEK, BlackArmor®) and incorporate a rough titanium coating. The devices are intended to be used with supplemental spinal fixation. There is one type of cervical cage and two lumbar cages (i.e., PLIF and ETurn® TLIF) included in this portfolio. Each cage is provided sterile and is available in an assortment of heights, footprints, and/or lordosis angles to accommodate patient anatomy.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) premarket notification clearance letter from the FDA for the icotec Interbody Cage System, which primarily focuses on device description, indications for use, and a statement of substantial equivalence to predicate devices. It mentions "Performance Testing" but only states that clinical data supports substantial equivalence and explicitly notes that the data did not support additional benefit for infection-related indications due to the specific material or technological characteristics. No specific acceptance criteria or details of a study (like sample size, ground truth, expert qualifications, etc.) are provided.

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BEE Cervical Cages are intended for intervertebral body fusion devices in skeletally mature patients for the treatment of cervical disc degeneration and/or cervical instability as confirmed by imaging studies (radiographs, CT, MRI) that results in radiculopathy, myelopathy and/or pain at one or more contiguous levels from C2-T1. These patients should have had at least six weeks of nonoperative treatment. BEE Cervical Cages are to be used with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and in combination with supplemental fixation indicated for cervical fusion procedures.

The BEE Cervical Cage is an intervertebral body fusion device for treatment of cervical disc degeneration and/or cervical instability utilizing the anterior cervical discectomy and fusion surgical technique. The tapered nose design provides ease of insertion while the convex superior and flat inferior surfaces replicate the patient's vertebral anatomical architecture for maximum surface contact. The cranial and caudal surfaces have a honeycomb geometry that accepts packing of bone graft to help facilitate bony integration. The device consists of implants available in various sizes and configurations to be accommodate for varying patient anatomy. The BEE Cervical Cages are fabricated using a Direct Metal Printing (DMP) via additive manufacturing (AM) process using Ti-6Al-4V ELI powder.

The provided text describes the regulatory clearance (K231371) for the BEE Cervical Cage, a medical device used for intervertebral body fusion. It outlines the device's indications for use, its technical specifications, and the rationale for its substantial equivalence to previously cleared devices.

Here's the breakdown of the requested information:

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

The document primarily focuses on mechanical performance testing for the device. The reported performance is that the devices met the predefined acceptance criteria for each test. Specific numerical results are not provided in this regulatory summary.

2. Sample sized used for the test set and the data provenance

The document does not specify the sample sizes (number of devices) used for each mechanical test. The "test set" in this context refers to the physical devices subjected to mechanical testing, not a dataset for an AI algorithm. The provenance of the data is from performance testing conducted by NGMedical GmbH. It is a retrospective evaluation of a device, where the testing is performed to demonstrate substantial equivalence to previously cleared devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable to the provided document. The "ground truth" for this device is established through mechanical engineering standards (ASTM standards) and a comparison to predicate devices, not through expert human interpretation of data like in an AI/imaging study.

4. Adjudication method for the test set

This question is not applicable. Mechanical testing against industry standards (ASTM) does not involve adjudication methods like those used for expert consensus in medical image interpretation. The outcome is determined by whether the device meets the specified mechanical thresholds.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. The device is a physical intervertebral fusion cage, not an AI or imaging diagnostic tool. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant to this device's clearance.

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

This is not applicable. The device is a physical medical implant, not an AI algorithm.

7. The type of ground truth used

The ground truth used for this device is based on established mechanical engineering standards (ASTM) and a comparison to the performance of predicate devices. The device's safety and effectiveness are inferred by its ability to meet these standards and demonstrate substantial equivalence in design and performance to devices already cleared for market.

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of a physical medical device. The device's design is based on engineering principles and previous successful designs, not on machine learning training data.

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

This is not applicable as there is no training set for this type of device.

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The CarboClear Cervical Cage System is indicated for intervertebral body fusion procedures of the cervical spine in skeletally mature patients with degenerative disc disease (DDD) at levels C2 – T1. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

The implants are to be implanted via an open, anterior approach and packed with autograft comprised of cancellous and/or corticocancellous bone graft.

This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine.

Patients should receive at least six (6) weeks of non-operative treatment with the CarboClear Cervical Cage System.

The CarboClear Cervical Vertebral Body Replacement (VBR) System Spacers are vertebral body replacement devices intended for use in the cervical spine (C2 - T1).

The CarboClear Cervical VBR devices are intended for use in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. The spacers are 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 cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

The devices are intended to be used with supplemental internal spinal fixation systems that have been labeled for use in the cervical spine (i.e., posterior screw and rod systems, and anterior plate systems).

When used at more than two levels, supplemental fixation should include posterior fixation. The use of allograft or autograft with the CarboClear Cervical VBR device is optional.

1. CarboClear Cervical Cage System is composed of implants of various sizes, and of instruments. The CarboClear Cervical Cage is made of carbon fiber-reinforced polyetheretherketone (CFR-PEEK), with titanium alloy endplates.

2. The CarboClear Cervical VBR System is composed of implants (spacers) in various sizes, and of instruments. The CarboClear Cervical VBR spacers are made of carbon fiber-reinforced polyetheretherketone (CFR-PEEK), with titanium alloy endplates.

This appears to be a review of a 510(k) premarket notification for two spinal implant systems: the CarboClear® Cervical Cage System and the CarboClear® Cervical VBR System. This document does not describe a study that uses a test set, experts, or ground truth to evaluate device performance against acceptance criteria in the manner you are asking about for AI/software devices.

Instead, this is a regulatory document addressing the substantial equivalence of medical devices, primarily based on engineering and material performance testing rather than clinical efficacy studies in the AI/ML context.

Therefore, I cannot provide the requested information for acceptance criteria and the study proving the device meets them because the provided text does not contain that type of study.

Here's why and what kind of information is present:

• Type of Device: These are physical medical implants (cages and vertebral body replacement systems for the cervical spine), not AI/software.
• Regulatory Pathway: A 510(k) submission primarily demonstrates "substantial equivalence" to a predicate device already on the market, meaning it's as safe and effective as the existing device. It does not typically require new clinical effectiveness trials in the way a PMA (Pre-Market Approval) or studies for novel AI algorithms might.
• Performance Data: The document mentions "Performance Data" which refers to benchtop mechanical testing according to ASTM (American Society for Testing and Materials) standards. This is to ensure the implant's structural integrity, durability, and resistance to wear are comparable to predicate devices.

Specifically, the document mentions these performance tests:

• Static and dynamic axial compression tests (according to ASTM F2077)
• Static and dynamic compression-shear tests (according to ASTM F2077)
• Static and dynamic torsion tests (according to ASTM F2077)
• Wear debris evaluation
• Subsidence test (according to ASTM F2267)

It states: "as applicable to each of the devices, are comparable to those of predicate devices (where applicable), thus demonstrating that the devices are safe and effective for their intended use."

My answers to your specific points, based on the provided text, will reflect this distinction:

1. A table of acceptance criteria and the reported device performance:
   The document does not explicitly present a table of acceptance criteria with specific numerical targets and the device's performance against them. It broadly states that the performance characteristics are comparable to those of predicate devices. The specific benchmark values would be detailed in the confidential 510(k) submission, not typically in the public summary.

2. Sample sizes used for the test set and the data provenance: Not applicable. The "test set" here refers to the physical devices undergoing mechanical testing, not a dataset of patient information. The provenance is from benchtop testing, not clinical data, and the sample size for mechanical tests would typically refer to the number of implants tested, which is not detailed in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This device does not use an "expert ground truth" in the AI/ML sense. Mechanical tests are performed by engineers and technicians according to standardized protocols.

4. Adjudication method for the test set: Not applicable. This refers to consensus building among experts for labeling data, which is not relevant for mechanical testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/ML device.

6. If a standalone (i.e. 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: For mechanical testing, the "ground truth" is adherence to the specified ASTM standards and comparable performance to predicate devices demonstrated through physical measurements. This is not "expert consensus, pathology, or outcomes data."

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.

In summary, the provided document is a regulatory approval letter for physical medical implants based on engineering and material performance testing, not an AI/ML device study. Therefore, most of your questions, which are framed for AI/ML device evaluation, are not applicable here.

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The Stryker Spine Aero™ -AL is an intervertebral body fusion device indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.

DDD is defined as back pain of discogenic origin with degeration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.

The Aero™ - AL Lumbar Cage System is to be implanted via an anterior approach.

The Aero™ - AL Lumbar Cage System is intended to be used with supplemental spinal fixation systems that has been cleared for use in the lumbosacral spine (e.g., posterior pedicle screw and rod systems) in addition to the included fixation anchors.

The Stryker Spine AERO®-C Cervical Cage is indicated for use in cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from the C2-C3 disc to the C7-Tl disc.

DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have six weeks of non-operative therapy.

The AERO®-C Cervical Cage System is to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and is to be implanted via an open, anterior approach.

The AERO®-C Cervical Cage System is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine. In addition, the device must be used with the included fixation anchors.

The Stryker Spine Aero™ - LL is an intervertebral body fusion device indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.

The Aero™ -LL Lumbar Cage System is to be implanted via a lateral approach.

The Aero™ -LL Lumbar Cage System is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (e.g., posterior pedicle screw and rod systems). In addition, the device may be used with or without the included fixation anchors.

When used as a cervical intervertebral body fusion device, the Aleutian implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. Cervical IBF implants are intended for use at one level in the cervical spine, from C2 to Tl, for the treatment of cervical disc disease (defined as neck pain of disco genie origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment.

When used as a lumbar intervertebral body fusion device, the Aleutian implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The lumbar IBF implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S 1, for the treatment of degenerative disc disease (DOD) with up to Grade I spondylolisthesis. ODD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non-operative treatment.

When used as vertebral body replacement devices the Aleutian implants are indicated for use in the thoracolumbar spine (TI to LS) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body, resected or excised for the treatment of tumors or trauma/fracture in order to achieve anterior decompression of the spinal tissues, and to restore the height of a collapsed vertebral body. The Aleutian implants are designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.

For all the above indications the Aleutian implants are intended to be used with supplemental internal fixation appropriate for the implanted level. including K2M Pedicle Screw and Hook Systems, and K2M Spinal Plate Systems.

The Ascential IBD PEEK. Spacers are indicated for use in cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from the C2-C3 disc to the C7-T1 disc. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Ascential IBD PEEKc Spacers are to be used with autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and are to be implanted via an open, anterior approach.

The Ascential IBD PEEKc Spacer is intended to be used with supplemental fixation systems that have been cleared for use in the cervical spine. This cervical device is to be used in patients who have had six weeks of non-operative treatment.

The Stryker Spine AVS® AL and AVS® ALign PEEK Spacers are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous bone graft when the subject device is used an adjunct to fusion in patients with degenerative disc disease (DDD) and one level or two contiguous levels from L2 to S1.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.

Additionally, the AVS® AL and AVS® ALign PEEK Spacers can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.

The AVS® AL and AVS® ALign PEEK Spacers are to be implanted via anterior or anterolateral approach.

The AVS® AL and AVS® ALign PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine.

The Stryker Spine AVS® Anchor-C Cervical Cage System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The AVS® Anchor-C Cervical Cage is to be used with autogenous bone graft and implanted via an open, anterior approach.

The AVS® Anchor-C Cervical Cage must be used with the internal screw fixation provided by AVS® Anchor-C Fixation Screws. This cervical device is to be used in patients who have had six weeks of non-operative treatment.

The Stryker Spine AVS® Anchor-L is an intervertebral body fusion device indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.

DDD is defined as back pain of discogenic origin with degeration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.

The AVS® Anchor-L Lumbar Cage system is to be implanted via an open, anterior approach.

The AVS® Anchor-L Lumbar Cage system may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device, the AVS® Anchor-L Lumbar Cage must be used with the internal screw and plate fixation provided by the AVS® Anchor-L Fixation Screws and Locking Plate. If AVS® Anchor-L is used with less than three or none of the provided screws, then additional supplemental fixation that has been cleared by the FDA for use in the lumbar spine must be used to augment stability. The accompanying Locking Plate must be vice is used with any number of screws.

The Stryker Spine AVS® ARIA PEEK Spacers are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.

Additionally, the AVS® ARIA PEEK Spacers can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.

The AVS® ARIA PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine.

The Stryker Spine AVS® AS PEEK Spacers are indicated for use in cervical interbody fusion procedures in sketally mature patients with degenerative disc disease (DDD) at one level from the C2-C3 disc to the C7-T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The AVS® AS PEEK Spacers are to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and are to be implanted via an open, anterior approach.

The AVS® AS PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the cervical spine. This cervical device is to be used in patients who have had six weeks of non-operative treatment.

The Stryker Spine AVS® Navigator PEEK Spacers are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.

Additionally, the AVS® Navigator PEEK Spacers can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.

The AVS® Navigator PEEK Spacers are to be implanted via a posterolateral approach.

The AVS® Navigator PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine.

The Stryker Spine AVS® PL and AVS® UniLIF™ PEEK Spacers are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.

Additionally, the AVS® PL and AVS® UniLIFIM PEEK Spacers can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.

The AVS® PL PEEK Spacers and AVS® UniLIF™ PEEK Spacers are to be implanted via posterior approach.

The AVS® PL PEEK Spacers and AVS® UniLIF™ PEEK Spacers are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems).

The Stryker Spine AVS® TL PEEK Spacers are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used an adjunct to fusion in patients with degenerative disc disease (DDD) and one level or two contiguous levels from L2 to S1.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.

Additionally, the AVS® TL PEEK Spacers can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.

The AVS® TL PEEK Spacers are to be implanted via posterior approach.

The AVS® TL PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems).

The Stryker Spine AVS® PL and AVS® UniLIF™ PEEK Spacers are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.

Additionally, the AVS® PL and AVS® UniLIFIM PEEK Spacers can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.

The AVS® PL PEEK Spacers and AVS® UniLIF™ PEEK Spacers are to be implanted via posterior approach.

The AVS® PL PEEK Spacers and AVS® UniLIF™ PEEK Spacers are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems).

CAPRI Corpectomy Cages are vertebral body replacement devices intended for use in the cervical and thoracolumbar spine.

When used in the cervical spine (C2-T1), CAPRI Static and Expandable cages are intended for use in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal tissues in cervical degenerative disorders. These cages are intended to restore integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

When used in the thoracolumbar spine (T1-L5), CAPRI Static and Expandable cages are intended for use to replace a collapsed, damaged, or unstable vertebral body due to tumor and trauma (i.e. fracture). These are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

The interior of the cages can be packed with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft as an adjunct to fusion.

When used in the thoracolumbar spine, the CAPRI Static and Expandable Corpectorny cages are intended to be used with supplemental internal fixation appropriate for the implanted level, including K2M Pedicle Screw and K2M Spinal Plate Systems.

When used in the cervical spine at one or two levels, the CAPRI Static and Expandable cages with supplemental fixation cleared by the FDA for use in the cervical spine. When used at more than two levels, supplemental fixation should include posterior fixation which is cleared by the FDA.

The CASCADIA lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be sketally mature and have six months of nonoperative therapy. Additionally, the CASCADIA lumbar implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. CASCADIA lumbar implants are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.

The CASCADIA hyperlordotic lateral lumbar implants (≥22°), are intended for levels L2-L5 and are to be used with CAYMAN United plates in addition to posterior supplemental fixation. The CASCADIA non-hyperlordotic lateral lumbar implants may optionally be used with CAYMAN United plates, in addition to supplemental spinal fixation systems.

The CASCADIA cervical implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with cervical disc disease (DDD) at one level or two contiguous levels from C2 to T1. These patients should be sketally mature and have had six weeks of non-operative treatment. The CASCADIA cervical implants are also to be used with supplemental fixation; the hyperlordotic CASCADIA cervical implants (i.e., ≥10°) are required to be used with an atterior cervical plate as the form of supplemental fixation.

When used as a cervical intervertebral body fusion device, the CHESAPEAKE Stabilization System implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. Cervical IBF implants are intended for use at one level in the cervical spine, from C2 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment.

When used as a lumbar intervertebral body fusion device, the CHESAPEAKE Stabilization System implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The Lumbar IBF implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non-operative treatment.

The hyperlordotic lumbar implants (i.e., > 15°) must be used with supplemental fixation (i.e., posterior pedicle screw and rod system) cleared for use in the lumbar spine, in addition to the bone screws provided. Otherwise, the Chesapeake Stabilization System implants (i.e., ≤15°) may be used as a stand-alone device, which is intended to be used with the bone screws provided (i.e., 2 or 3 screws for the 2-screw and 3-screw implants, respectively).

The MOJAVE Expandable Interbody System implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DOD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radios. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy. Additionally, the MOJAVE lumbar implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. MOJAVE lumbar implants are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.

The Stryker Spine Monterey™ AL Interbody System - Stand-Alone) is an interbody fusion device indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of non-operative therapy.

Additionally, the Monterey™ AL Stand-Alone System can be used as adjunct to fusion in patients diagnosed with degenerative scoliosis.

The Monterey™ AL Stand-Alone System is intended to be implanted via an anterior approach.

The Monterey™ AL Stand-Alone System may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device, the Monterey™ AL Stand-Alone System must be used with the bone screws provided and requires no additional supplemental fixation. If Monterey™ AL Stand-Alone System is used with less than three or none of the provided bone screws, then additional supplemental fixation that has been cleared by the FDA for use in the lumbosacral spine must be used to augment stability. Hyperlordotic implants (>20° lordosis) are intended to be used with supplemental fixation (e.g., posterior fixation),

The Stryker Spine Monterey™ AL Interbody System – Spacer) is an intervertebral body fusion device indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of non-operative therapy.

Additionally, the Monterey™ AL Spacer System can be used as adjunct to fusion in patients diagnosed with degenerative scoliosis.

The Monterey™ AL Spacer System is intended to be implanted via an anterior approach.

The Monterey™ AL Spacer System is intended to be used with supplemental fixation systems that have been cleared by the FDA for use in the lumbosacral spine.

The SAHARA Stabilization System implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy. Additionally, the SAHARA implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.

Hyperlordotic (angles > 15°) and Lateral implants must be used with supplemental fixation (i.e., posterior pedicle screw and rod system) cleared for use in the lumbar spine, in addition to the bone screws provided. Additional supplemental fixation (i.e. pedicle screw and rod system) is needed when used as an adjunct to fusion for degenerative scoliosis. Otherwise, the SAHARA Stabilization System implants may be used as a stand-alone device, which is intended to be used with the bone screws provided.

SANTORINI Corpectomy Cages are vertebral body replacement devices intended for use in the cervical and thoracolumbar spine.

When used in the cervical spine (C2-T1), SANTORINI cages are intended for use in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectorny performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. These cages are intended to restore integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

When used in the thoracolumbar spine (TI-L5), SANTORINI cages are intended for use to replace a collapsed, damaged, or unstable vertebral body due to tumor and trauma (i.e. fracture). These cages are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

The interior of the cages can be packed with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft as an adjunct to fusion.

When used in the thoracolumbar spine, the Santorini Corpectomy cages are intended to be used with supplemental internal fixation appropriate for the implanted level. including K2M Pedicle Screw and K2M Spinal Plate Systems.

When used in the cervical spine at one or two levels, the SANTORINI Corpectomy Cage System is intended to be used with supplemental fixation cleared by the FDA for use in the cervical spine. When used at more than two levels, supplemental fixation should include posterior fixation which is cleared by the FDA.

The Tritanium® C Anterior Cervical Cage is indicated for use in cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level or two contiguous levels from the C2 to T1 disc.

DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have six weeks of non-operative therapy.

The Trianium® C Anterior Cervical Cage System is to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and is to be implanted via an open, anterior approach.

The Tritanium® C Anterior Cervical Cage System is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine.

The Stryker Spine Tritanium® PL Cage is an intervertebral body fusion device indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD pairents may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.

Additionally, the Tritanium® PL Cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.

The Tritanium® PL Cage is to be implanted via a posterior approach.

The Tritanium® PL Cage is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.

The Stryker Spine Tritanium® TL cage is an intervertebral body fusion device indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.

Additionally, the Tritanium TL Cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.

The Tritanium TL Cage is to be implanted via a posterior approach.

The Tritanium TL Cage is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.

The Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage are intended for intervertebral body fusion with autografic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment.

Additionally, the Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.

The Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage are always to be used with supplemental internal spinal fixation. Additionally, the Tritanium® X PL Expandable Posterior Lumbar Cage and Trianium® X TL Expandable Curved Posterior Lumbar Cage are to be used with autograff and/or allogenic bone graft comprised of cancellous bone graft when the subject device is used as an adjunct to fusion.

The Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage are intended for intervertebral body fusion with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment.

Additionally, the Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.

The Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage are always to be used with supplemental internal spinal fixation. Additionally, the Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage are to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion.

Stryker Spine VLIFT™ is a vertebral body replacement system intended to replace a vertebral body or an entire vertebra. It is for use in the thoracolumbar spine (TI-LS) to replace a collapsed, or unstable vertebral body or vertebra resected or excised during total and partial corpectomy and vertebrectomy procedures due to turnor of trauma (i.e., fracture). For both corpectomy and vertebrectomy procedures, the VLIFT™ system is intended to be used with supplemental internal fixation systems. The supplemental internal fixation systems that may be used with VLIFTM include, but are not limited to Stryker Spine plate or rod system, Spiral Radius 90D, and Trio). The use of bone graft with VLIFTTM is optional.

VLIFT®-s Vertebral Body Replacement System is indicated for use in the cervical spine (C3-C7) and the thoracolumbar spine (TI-L5) in skeletally mature patial or total replacement of a diseased, collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e., fracture), or for reconstruction following corpectorny performed to achieve decompression of the spinal cord and neural tissue in degenerative disorders.

The VLIFT®-s Vertebral Body Replacement System is intended for use with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, as an adjunct to fusion. The VLIFT®-s Vertebral Body Replacement System is also 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 cervical, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

The VLIFT®-s Vertebral Body Replacement System is intended to be used with FDA-cleared supplemental spinal fixation systems that have been labeled for use in the cervical, thoracic, and/or lumbar spine (i.e., posterior screw and rod systems, anterior plate systems, and rod systems). When used at more than two levels, supplemental fixation should include posterior fixation.

The subject devices consist of a variety of intervertebral body fusion devices and spinal vertebral body replacement devices designed to provide support across implanted levels of the cervical, thoracolumbar, and lumbosacral spine until fusion is achieved and have been previously cleared by FDA. The purpose of this submission is to establish an MR Conditional labeling claim for these implants.

This document is a 510(k) Summary for a range of spinal implants. The purpose of this submission is to establish an MR Conditional labeling claim for these implants. The submission does not detail specific acceptance criteria or performance metrics beyond stating that MR Compatibility testing was performed and met acceptance criteria.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with specific quantitative acceptance criteria or reported device performance for the various spinal implants. It states generally:

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

• Sample Size: The document does not specify the exact sample size for the test set (number of devices tested).
• Data Provenance: The data appears to be from laboratory testing ("MR Compatibility testing per ASTM F2503-13 was performed"). There is no mention of country of origin for data or whether it was retrospective or prospective. Given the nature of MRI compatibility testing for medical implants, it would typically be prospective laboratory testing on a selection of devices.

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

This information is not applicable. The "ground truth" for MRI compatibility testing of physical implants is based on validated test methods (ASTM F2503-13) and physical measurements of artifacts, heating, and forces, not expert consensus on interpretations.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images by multiple readers to establish a "ground truth" for diagnosis or assessment. MRI compatibility testing involves physical measurements.

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

No. The document explicitly states this submission is to establish an MR Conditional labeling claim for physical implants. It is not a study comparing human reader performance with or without AI assistance.

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

This information is not applicable. This submission is for physical medical devices (spinal implants) and their MRI compatibility, not an algorithm or AI system.

7. Type of Ground Truth Used

The ground truth for this type of submission is established through physical measurements and adherence to recognized standards (ASTM F2503-13) for evaluating MRI safety and compatibility of medical implants.

8. Sample Size for the Training Set

This information is not applicable. There is no AI or algorithm that requires a training set mentioned in this submission.

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

This information is not applicable, as there is no training set for an AI/algorithm.

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The UniSpace™ SA Cervical Cage is a standalone anterior cervical interbody fusion device indicated for skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radios. The UniSpace™ SA Cervical Cage implants are to be used with either autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and implanted via an open, anterior approach. The cage of the UniSpace™ SA Cervical Cage must be used with the two internal fixation screws provided. UniSpace™ SA Cervical Cage implants with ≥ 20° lordosis must be used with an additional supplemental fixation system that has been cleared by the FDA for use in the cervical spine," in addition to the two integrated fixation screws provided. This cervical device is to be used in patients who have had six weeks of non-operative treatment.

The UniSpace™ SA Cervical Cage is product for cervical spinal column stability. The implants of the UniSpace™ SA SA Cervical Cage consist of the cages manufactured through additive manufacturing (ASTM F3001) and the machined variable screws and locking cover plate (ASTM F136). The locking cover plate consists of a locking plate and a locking screw and is an optional device for the anti-backout of the variable screw. This optional implant can provide the more stability to prevent the anti-backout besides the self-locking mechanism. The cages and variable screws are offered in a variety of sizes to accommodate each patient's individual clinical case. The cages are designed to be used with either autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The cage of the UniSpace™ SA Cervical Cage is provided as a sterile pack. The UniSpace™ SA Cervical Cage is implanted by using the instruments manufactured from stainless steel material that conform to ASTM F899.

The information provided describes the UniSpace™ SA Cervical Cage, a medical device, and its successful application for 510(k) clearance based on substantial equivalence to predicate devices. The documentation focuses on engineering (bench) testing, not on clinical studies involving human patients or AI performance. Therefore, I cannot provide details on AI-specific criteria, sample sizes for medical imaging data, expert qualifications, or multi-reader multi-case studies.

Here's an analysis based on the provided text for the aspects that are covered:

Acceptance Criteria and Device Performance (Bench Testing)

The "acceptance criteria" for this device are established by demonstrating that its mechanical performance is "substantially equivalent" to predicate devices, and that it meets specific ASTM (American Society for Testing and Materials) standards. The reported device performance is that "The testing meets all acceptance criteria and verifies that performance of the UniSpace™ SA Cervical Cage is substantially equivalent to the predicate devices."

Specifically, the device performance is within the established ranges for the predicate devices across the following tests:

Non-applicable/Not Provided Information (as per the document's scope)

• Sample size used for the test set and the data provenance: Not applicable. The "test set" in this context refers to physical device units undergoing bench testing, not a dataset of medical images or patient records. No information on the number of devices tested is provided, nor is data provenance relevant in the AI context.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for AI performance requires expert labeling of data, which is not part of this device's mechanical performance evaluation.
• Adjudication method: Not applicable for a mechanical bench test.
• 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 device is a physical intervertebral cage, not an AI diagnostic or assistive tool.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. No algorithm is involved.
• The type of ground truth used: For mechanical testing, the "ground truth" is defined by the physical properties measured according to the ASTM standards and the performance of the established predicate devices. No expert consensus, pathology, or outcomes data is relevant for the mechanical aspects of this submission.
• The sample size for the training set: Not applicable. No AI model was trained.
• How the ground truth for the training set was established: Not applicable. No AI model was trained.

In summary, this FDA submission focuses solely on the mechanical and material equivalence of a physical medical device (intervertebral cage) through bench testing, not on the performance of a medical AI device.

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The Romero Cervical Cage consists of an interbody device indicated for use in anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one or two contiguous levels from the C2 to the T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The Romero Cervical Cage includes cages with and without screw holes. For cages with internal screw holes, the provided screws must be used for internal fixation. The Romero Cervical Cage requires additional supplemental fixation cleared for the cervical spine. The Romero Cervical Cage is designed for use with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft, to facilitate fusion and is to be implanted via an open, anterior approach. This cervical device is to be used in patients who have had six weeks of nonoperative treatment. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.

The Romero Cervical Cage is an anterior cervical interbody device consisting of a PEEK HA or PEEK OPTIMA interbody cage with tantalum radiographic markers and two Titanium (Ti-6Al-4V ELI) fixation screws for cages with screw holes. The PEEK material used conforms to ASTM F2026, the Titanium screws conforms to ASTM F136 and the Tantalum radiographic markers conforms to ASTM F560. The interbody cage is provided in 6° lordosis, anatomic (domed), and lordotic (tapered) profiles in footprints ranging from (WxD) 14x12 to 20x16 (by increments of 2 mm in either direction) and sizes ranging from 5.5 mm (H04) to 14.5 mm (H13) (excluding H04 and H05 in the (WxD) 14x12 to 14x16 footprint for the self-anchored cages). The two radiographic markers are present on the posterior wall to confirm position and orientation relative to the AP plane. The bone screws are provided as self-drilling and self-tapping options in 3.5 mm and 4.0 mm diameters and 8-20 mm lengths and feature an anti-backout / tri-lobe screw head design. Both cages and screws are available in separate, single-use sterile packaging.

The provided text is an FDA 510(k) summary for the Romero Cervical Cage, an intervertebral body fusion device. It does not describe a study involving an AI/Machine Learning (AI/ML) device, nor does it contain information about "device performance," "acceptance criteria," "sample sizes for test or training sets," "expert ground truth," "adjudication methods," or "MRMC studies."

The document focuses on demonstrating substantial equivalence of a physical medical device (a cervical cage) to predicate devices through mechanical performance testing. The "Performance Testing" section states: "Mechanical testing was performed to demonstrate substantial equivalence using static compression, static compression shear, static torsion, dynamic compression, dynamic compression shear, and dynamic torsion testing per ASTM F2077-18. Subsidence testing per ASTM F2267-04, expulsion and axial push out testing. The result showed that the worst-case constructs were substantially equivalent to legally marketed devices. No clinical or animal studies were performed."

Therefore, I cannot fulfill your request for information related to AI/ML device acceptance criteria and study details based on the provided text. The device in question is a physical implant, not an AI/ML algorithm.

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The Velofix™ SA Cervical Cage is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The Velofix™ SA Cervical Cage implants are to be used with either autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and implanted via an open, anterior approach. The Velofix™ SA Cervical Cage must be used with the internal screw fixation provided by screws of the Velofix™ SA Cervical Cage. This cervical device is to be used in patients who have had six weeks of non-operative treatment.

The Velofix™ SA Cervical Cage consists of spacers, screws, locking plate and set screw. The spacers are available in various heights, width and have only 7° lordotic angle with an open architecture to accept packing of autograft or autogenous bone graft, while the medical grade titanium alloy screws have various diameters and length for fixing the spacers. The locking plate, made of radiolucent PEEK and titanium alloy, is to prevent screw loosening. The medical grade titanium alloy set screw is intended for fixation of the locking plate. The Velofix™ SA Cervical Cage has three types: 1) All PEEK Type, 2) Ti plate Type, 3) Ti plate-N type. The Velofix™ SA Cervical Cage is implanted as a single device via an anterior approach.

The provided text is a 510(k) premarket notification letter and summary for the Velofix™ SA Cervical Cage. It describes the device, its intended use, and its substantial equivalence to predicate devices, primarily based on mechanical performance testing.

However, the document does not contain information about acceptance criteria and a study that proves the device meets those criteria in the context of software or AI performance. The entire document focuses on the mechanical and material properties of an intervertebral fusion device.

Therefore, I cannot extract the requested information regarding:

1. A table of acceptance criteria and reported device performance (for software/AI).
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study.
6. Standalone (algorithm only) performance.
7. Type of ground truth for software.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document is for a medical device (an implantable cage), not a software or AI product. The "performance testing" mentioned refers to mechanical strength evaluation of the physical implant, not algorithmic performance.

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The Lucero Medical Cervical Spacer is intended for anterior intervertebral body fusion in skeletally mature patients who have had at least six weeks of non-operative treatment. The Lucero Medical Cervical Spacer is indicated to treat cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The Lucero Medical Cervical Spacer is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone to facilitate fusion and to be used with supplemental fixation cleared for use in the cervical spine.

The Lucero Medical Cervical Spacer is an additively manufactured interbody device. These cervical implants have basic keystone cross-sectional shape and an open structural architecture. A variety of height, length, width and anteroposterior angulation combinations are available to accommodate the anatomic requirements of individual patients. The devices are provided sterile.

This document describes the Lucero Medical Cervical Spacer System, an intervertebral body fusion device. The acceptance criteria and performance are based on mechanical testing.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific number of Lucero Medical Cervical Spacers used in the mechanical testing (the test set sample size). It refers to "worst-case Lucero Medical Cervical Spacer." The data provenance is internal testing performed by Lucero Medical, LLC, to demonstrate substantial equivalence to legally marketed predicate devices.

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

Not applicable. This is a medical device for orthopedic surgery, and the "ground truth" for mechanical testing is established by adherence to recognized ASTM standards (F2077, F2267) rather than expert clinical consensus.

4. Adjudication Method for the Test Set

Not applicable. Mechanical testing results are objective measurements against established engineering standards.

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

No, an MRMC comparative effectiveness study was not done. The device is a physical implant, not an AI or imaging-based diagnostic tool. The performance evaluation is based on mechanical properties and substantial equivalence to existing devices.

6. Standalone Performance Study (Algorithm Only)

No, a standalone performance study was not done as this is a physical medical device, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" used for device performance is based on established engineering standards for intervertebral body fusion devices, specifically ASTM F2077 for static and dynamic compression and static torsion, and ASTM F2267 for subsidence.

8. Sample Size for the Training Set

Not applicable. Mechanical testing of physical devices does not involve a "training set" in the context of machine learning or AI.

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

Not applicable. There is no training set for this type of device evaluation.

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