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The Spectrum Spine Expandable Titanium PLIF/TLIF System includes interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).

Spectrum Spine Expandable Titanium PLIF/TLIF System implants are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation.

The Spectrum Spine Expandable Titanium PLIF/TLIF System consists of lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The Expandable Titanium PLIF/TLIF System implants are provided in various shapes to accommodate posterior lumbar interbody fusion (PLIF) and transforaminal lumbar interbody fusion (TLIF) surgical approaches. These implants can expand to a set height and lordosis as appropriate. The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. The Expandable Titanium PLIF/TLIF System is to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.

The Expandable Titanium PLIF/TLIF System is manufactured from titanium alloy per ASTM F136.

The system provides several footprints in multiple height and angle configurations. The cage's ability to be inserted at a nominal height and then expand to a set height and angle to fill the joint space once properly positioned minimizes damage to the bony end-plate caused by impaction.

The purpose of this special 510(k) is to gain clearance for modifications made to the Expandable Titanium PLIF/TLIF System.

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The Spectrum Spine Lumbar Cage System devices with roughened surface textured features, are indicated for use in skeletally mature patients with lumbar degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 – S1 whose condition requires the use of interbody fusion, confirmed by imaging studies (radiographs, CT, MRI). DDD is defined as discogenic pain with degeneration of the disc. DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had at least six months of nonoperative treatment. The Spectrum Spine Lumbar Cage System is indicated to be used with supplemental fixation cleared by the FDA for use in the lumbar 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 Lumbar Cage System is composed of lumbar interbody fusion devices. The Spectrum Spine Lumbar Cage System is offered in multiple 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 Lumbar Cage System also includes instruments to facilitate implantation of the subject implant devices. Instruments are manufactured from medical grade stainless steel.

The provided FDA 510(k) clearance letter for the Spectrum Spine Lumbar Cage System does not contain any information about a study proving the device meets acceptance criteria related to AI/ML device performance, human reader improvement with AI assistance, or the establishment of ground truth for such studies.

The document pertains to the clearance of an intervertebral body fusion device, which is a medical implant made of titanium alloy. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" described in the document relate solely to the mechanical and physical performance of the implant itself, not to the performance of an AI/ML algorithm.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving device performance in the context of AI/ML, as the provided text does not contain this information.

Based on the provided text, here's what can be extracted regarding the "acceptance criteria" and "study" for the physical device:

1. Table of Acceptance Criteria and Reported Device Performance (Mechanical/Physical Device):

Note: The specific numerical performance values are not provided in this regulatory summary; only the conclusion of "substantial equivalence" is stated.

2. Sample Size and Data Provenance (Mechanical/Physical Device):

• Sample Size: Not specified in the document.
• Data Provenance: The tests are described as "Mechanical testing... performed on the subject Spectrum Spine Lumbar Cage devices." This implies laboratory testing on physical samples, not human or patient data.

Regarding your other points (relevant to AI/ML devices), the document provides NO information:

• Number of experts used to establish ground truth: Not applicable/not mentioned.
• Adjudication method: Not applicable/not mentioned.
• MRMC comparative effectiveness study: Not applicable/not mentioned.
• Standalone (algorithm-only) performance: Not applicable/not mentioned.
• Type of ground truth used: Not applicable/not mentioned (for AI/ML devices).
• Sample size for training set: Not applicable/not mentioned.
• How ground truth for training set was established: Not applicable/not mentioned.

In summary, the provided FDA clearance letter is for a physical medical device (spinal implant) and its mechanical properties, not an AI/ML diagnostic or therapeutic device. Therefore, the details requested for AI/ML device validation are not present in this document.

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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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