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The SpineWorks Anterior Lumbar Device is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). SW ALD Interbody System implants are to be used with autogenous bone graft and implanted via an anterior, lateral or anterolateral approach. SW ALD Interbody System implants are to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.

The SpineWorks Anterior Lumbar Device (SW ALD) was developed for the stabilization of the lumbar spinal column. The body of the device is a rounded-trapezoidal shape with two large windows allowing placement of bone graft and facilitating fusion. The superior and inferior surfaces of the devices have a pattern of teeth to provide increased stability and inhibit movement of the implants. SW ALD implants are available in two lordotic configurations (6° and 11°) of various heights and widths to restore lumbar lordosis and the associated sagittal balance. SW ALD implants have three tantalum x-ray markers. The SW ALD device is single-use only.

Materials: Medical grade PEEK (ASTM F2026) machined from Vestakeep i4R extruded bar stock (Evonik Polymers Technologies GmbH, FDA master file MAF #1922). Medical grade tantalum (ASTM F560-08) was used to fabricate the radio opaque markers.

Function: SW ALD devices are used to maintain disc space distraction in skeletally mature adults requiring intervertebral body fusion.

This is a 510(k) premarket notification for a medical device (SpineWorks Anterior Lumbar Device), not an AI/ML medical device. Therefore, the requested information about acceptance criteria, study details, expert involvement, and training/test sets for an AI/ML model is not applicable and cannot be extracted from the provided text.

The document describes material and mechanical testing for the spinal implant to demonstrate substantial equivalence to predicate devices, which is a different type of evaluation from an AI software study.

Here's a breakdown of why I cannot fulfill your request based on the provided text:

• No AI/ML Component: The submission is for a physical medical device (an intervertebral body fusion device) made of PEEK and tantalum. There is no mention of any software, algorithm, or AI/ML component.
• Performance Data Type: The "Performance Data" section (G) refers to "Mechanical testing per the FDA Guidance Document for spinal devices and the information contained in Evonik's master file MAF # 1922." It explicitly mentions "static compression and dynamic compression" tests (ASTM F2077-03) and "subsidence" evaluation (ASTM F2267-04). These are physical and material property tests relevant to an implant, not AI algorithm performance metrics.
• "Acceptance Criteria" for an Implant: For this type of device, "acceptance criteria" would typically refer to specific thresholds for mechanical strength, fatigue life, biocompatibility, and other physical properties described in the referenced ASTM standards and FDA guidance for intervertebral body fusion devices. The text states: "All static and dynamic test results met or exceeded the requirements for intervertebral body fusion devices intended for use in the lumbar spine." This is the core "acceptance criteria" statement for this type of device and its performance.
• Irrelevant AI/ML Study Parameters: All points related to sample size (test/training), data provenance, experts, adjudication, MRMC studies, standalone performance, and ground truth types are specific to the evaluation of AI/ML algorithms and are not present in this physical device submission.

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The A-Wedge Anterior Interbody System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). A-Wedge Anterior Interbody System implants are to be used with autogenous bone graft and implanted via an anterior or anterolateral approach. The Anterior Interbody System implants are to be used with supplemental fixation. Patients should have at least (6) months of nonoperative treatment prior to treatment with an intervertebral cage. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.

The A-Wedge Anterior Interbody System (A-Wedge A.I.S.) implants were developed as implants for the posterior stabilization of the lumbar spinal column. The body is rounded trapezoidal in shape with two large windows allowing placement of bone graft and facilitating fusion. The superior and inferior surface of the device has a pattern of teeth to provide increased stability and inhibit movement of the implant.

Here’s an analysis of the provided text regarding the A-Wedge Anterior Interbody System, detailing the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document explicitly states: "No clinical studies were performed." Therefore, there is no "test set" in the context of clinical data, sample size, or patient provenance. The testing conducted was non-clinical (mechanical) on the device itself.

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

Not applicable. No clinical test set or ground truth established by experts for performance evaluation. The "ground truth" for non-clinical mechanical testing would be the physical properties and performance characteristics of the predicate devices.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve With AI vs Without AI Assistance

Not applicable. This is a medical device (spinal implant), not an AI/imaging diagnostic tool. No MRMC study was performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a medical device (spinal implant), not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical mechanical tests, the ground truth was the established mechanical performance and safety specifications of the predicate devices. The A-Wedge A.I.S. demonstrated "equivalence" to these predicate devices based on the test results.

8. The Sample Size for the Training Set

Not applicable. No clinical studies were performed, and this is not a machine learning/AI device that requires a training set. The "design input" for the device would be the specifications and performance of the predicate devices.

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

Not applicable. No training set as this is not a machine learning/AI device. The "ground truth" for the device's design and expected performance was established by the existing, legally marketed predicate devices. The study aimed to demonstrate that the A-Wedge A.I.S. met the established performance characteristics of these predicates.

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The SpineWorks FixxSure Cross Link is intended work with the Talon Pedicle Screw system 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 thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

The SpineWorks FixxSure Cross Link must be used with the Talon Pedicle Screw system.

The SpineWorks FixxSure Cross Link allows spinal surgeons to convert a dual-rod construct into a frame and increase overall construct strength. The FixxSure Cross Link comes in a multi-span and fixed design, both of which can be rigidly locked onto a dual-rod construct and has the capability of being manipulated into various planes of angulation. The SpineWorks implant has a proprietary dual locking mechanism allowing maximum Cross Link/rod connection while offering superior ease of insertion/use.

The provided text describes a 510(k) premarket notification for a medical device called the SpineWorks FixxSure Cross Link. It is a submission to the FDA seeking to demonstrate substantial equivalence to legally marketed predicate devices, not a study evaluating the device's performance against specific acceptance criteria in a clinical setting with AI.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details cannot be extracted from this document.

The document states:

• Nonclinical Tests: "Testing was conducted according to ASTM F1717 and F1798 with adequate strength." This refers to mechanical and material testing, not clinical performance or AI evaluation.
• Comparison: "The FixxSure Cross Link is similar to the predicate device in terms of material, design and indications." This is the basis for the 510(k) submission (substantial equivalence), not a detailed performance study against specific criteria.

In summary, this document does not contain the information required to populate the requested table and provide descriptions of a study proving the device meets acceptance criteria related to AI or clinical performance.

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The Stansion Matrix™ ("Stansion Matrix") is indicated for use in the thoracolumbar spine (i.e., T1 to L5) to replace a portion of a diseased vertebral body that is resected or excised for the treatment of tumors, where the defect is contained within a single vertebral body, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The device is also indicated for treating fractures of the thoracic and lumbar spine. The Stansion Matrix is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period of time. The device is intended for use with supplemental rigid posterior pedicle screw fixation.

The device is a single piece titanium VBR that is open on all sides to maximize bone ingrowth. It is available in three sizes. The device is implanted via the posterior approach, according to similar methods as the predicates. An insertion tool is provided with the device to facilitate its implantation.

The provided text is a 510(k) summary for the Stansion Matrix™ Vertebral Body Replacement device. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria, device performance from studies, or details about the rigorous testing methodologies often associated with AI/software devices.

The Stansion Matrix is a physical medical device (vertebral body replacement), not an AI or software device. Therefore, the questions related to AI/software performance metrics (like acceptance criteria for algorithms, sample sizes for test sets, expert adjudication, MRMC studies, standalone performance, training sets, etc.) are not applicable to the content provided.

The document discusses the physical characteristics of the device and its similarity to predicate devices, focusing on materials, shape, and method of use to establish substantial equivalence. Performance testing is only mentioned generally: "Any minor differences in technological features do not raise new issues of safety or effectiveness, as confirmed by performance testing." It does not provide details of such tests.

Therefore, I cannot fulfill the request as the input document does not contain the necessary information about acceptance criteria or studies proving device performance from the perspective of an AI/software device.

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