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The SpineFrontier Lumbar Interbody Fusion Device System (Dorado IBC, Dorado PLIFT, Dorado ELIFT, Arena-L, Dorado TILT, Dorado TLIFT, Dorado Wide, and Ursa S-LIFT) is intended for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The device is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).

Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history or radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

The SpineFrontier Lumbar Intervertebral Body Fusion Device System is intended to be used with supplemental spinal fixation system(s) cleared for use in the lumbar spine.

The SpineFrontier Ti-Coated Lumbar Interbody Fusion Device System is a spinal intervertebral body fusion device system intended for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The system is comprised of devices made of titanium coated PEEK Optima® LT1, with varying widths, lengths, and heights to fit the anatomical needs of patients. The devices have raised contours on the superior and inferior surfaces that will resist device movement following implant.

The purpose of this submission is the addition of a CP-Ti coating on a previously cleared lumbar intervertebral fusion device.

The provided document describes a 510(k) premarket notification for the SpineFrontier Lumbar Interbody Fusion Device System. This document is a regulatory submission for a medical device and, as such, does not contain information about the performance of an AI/ML powered device, nor does it include a study that proves a device meets acceptance criteria in the context of an AI/ML algorithm.

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.

The document focuses on demonstrating substantial equivalence to legally marketed predicate devices through a comparison of technological characteristics and non-clinical mechanical performance testing. The 'Performance Data' section lists various ASTM standards used for mechanical testing of the device and its coating, but these are related to the physical properties and durability of the implantable device, not the performance of an AI/ML algorithm.

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The NuVasive CoRoent Ti-C System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous bone graft to facilitate fusion.

The CoRoent Ti-C System is 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 I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar devices are to be used in patients who have had at least six months of non-operative treatment. The System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.

The NuVasive® CoRoent Ti-C System is manufactured from PEEK-OPTIMA® (Polyetherether-ketone) conforming to ASTM F2026, commercially pure titanium conforming to ASTM F1580, Ti-6Al-4V ELI conforming to ASTM F136/1472 or Tantalum (Ta) conforming to ASTM F560 or ISO 13782. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.

The provided document is a 510(k) premarket notification for a medical device (CoRoent Ti-C System), which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical or performance study results for achieving specific acceptance criteria.

Therefore, the document does not contain the information requested for acceptance criteria and the study proving the device meets those criteria, specifically:

• A table of acceptance criteria and the reported device performance: This information is not provided. The document states "no new worst-case for performance testing" but does not detail specific performance thresholds or results against them.
• Sample sized used for the test set and the data provenance: No test set is described in the context of clinical performance.
• Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable as no clinical test set/ground truth is discussed.
• Adjudication method: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: The document explicitly states, "No non-clinical or clinical studies were conducted."
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical implant, not a software/algorithm device.
• The type of ground truth used: Not applicable.
• The sample size for the training set: Not applicable, as no training set for an algorithm is described.
• How the ground truth for the training set was established: Not applicable.

The performance data mentioned in the document (Section G, Page 4) is limited to nonclinical testing primarily for demonstrating equivalence to predicate devices:

• Static and dynamic axial compression and compression shear per ASTM F2077
• Wear debris testing per ASTM F2077, ASTM F1714 and ASTM F1877

The conclusion drawn from this testing is that "the subject CoRoent Ti-C System presents no new worst-case for performance testing, and the subject device was therefore found to be substantially equivalent to the predicate." However, specific acceptance criteria values and the device's numerical performance against those values are not detailed in this submission.

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The Irix-A Lumbar Integrated Fusion System is a stand-alone intervertebral body fusion device intended for use in patients with degenerative disc disease (DDD) at one (1) or two (2) contiguous levels of the lumbosacral spine (L2-S1 inclusive). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and at least six (6) months of non-operative treatment. In addition, these patients may have had a previous non-fusion spinal surgery at the involved level(s) and may have had up to a Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Irix-A System is intended to be used with autogenous bone graft material, and is to be used with three titanium alloy bone screws included as part of the system.

The Irix-A Lumbar Integrated Fusion System is a stand-alone intervertebral fusion device to restore biomechanical height and act as an aid in fusion of the lumbar spine in anterior discectomy procedures. The device is generally box-shaped with teeth on the superior and inferior faces of the drix-A implant is manufactured from both titanium alloy (Ti6Al4V) in accordance with ASTM F136 and Invibio PEEK-Optima LT1 in accordance with ASTM F2026, or from Ti6AMV titanium alloy alone. The device will be supplied with the option of having the superior and inferior surfaces of the device plasma coated with medical-grade commercially pure titanium (CP Ti) per ASTM F1580. The device is secured in location through the use of bone screws, also manufactured from titanium alloy (Ti6Al4V) per ASTM F136. The devices are provided in various sizes and screws are offered in multiple lengths to adjust for variations in patient anatomy.

The CP-Ti coated devices will be sterile packed with the balance of system components being provided clean and non-sterile. The non-sterile components are to be sterilized by a healthcare professional using a steam autoclave in accordance with the instructions for use provided by X-spine Systems Inc., as well as the instructions provided by the manufacturer of the autoclave.

The information provided describes the Irix-A™ Lumbar Integrated Fusion System, which is an intervertebral body fusion device, not a device that relies on AI algorithms or machine learning. Therefore, many of the requested categories related to acceptance criteria for AI/ML performance, such as sample sizes for test/training sets, ground truth establishment by experts, adjudication methods, and MRMC studies, are not applicable.

The acceptance criteria and supporting study for this device are based on mechanical performance testing to demonstrate substantial equivalence to existing predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance
This is a medical device (spinal implant) and not an AI/ML device relying on a test set of data in the common sense. The "test set" refers to the physical devices and materials tested. The summary does not specify the exact number of units or samples tested for each mechanical test, but implies sufficient testing was conducted to meet the ASTM standards and satisfy FDA requirements for substantial equivalence.
Data provenance: The testing was conducted by X-spine Systems, Inc. in Miamisburg, OH, USA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" for this type of device is established by meeting engineering and mechanical standards, not by expert consensus on data interpretation. Performance is objectively measured against specified limits in the ASTM standards.

4. Adjudication method for the test set
Not applicable. Mechanical testing results are objective measurements against pre-defined engineering standards, not subjective interpretations requiring adjudication.

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, and thus no MRMC study involving human readers and AI assistance was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical spinal implant, not an algorithm.

7. The type of ground truth used
The "ground truth" in this context is based on established engineering principles, materials science, and biomechanical performance standards (e.g., ASTM F2077, ASTM F2267). The device's performance is objectively measured against the requirements of these standards and compared to the performance of predicate devices.

8. The sample size for the training set
Not applicable. This is not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established
Not applicable.

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The CAPSTONE PTC™ Spinal System is indicated for interbody fusion with autogenous bone graft in patients with Degenerative Disc Disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. 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 six months of non-operative treatment. Additionally, the CAPSTONE PTC™ Spinal System is indicated to assist in the setting of spinal deformity as a supplement to pedicle screw fixation in patients diagnosed with degenerative scoliosis. These implants may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via an anterior and/or transforaminal approach. These implants are to be used with autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the Food and Drug Administration (FDA) for use in the lumbar spine.

CLYDESDALE PTC™ Spinal System is designed to be used with autogenous bone graft to facilitate interbody fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The CLYDESDALE PTC™ Spinal System is used for patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. 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 six months of non-operative treatment. These implants may be implanted via a minimally invasive lateral approach.

The CAPSTONE PTCTM and CLYDESDALE PTC™ Spinal Systems consist of PEEK cages of various widths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft. The CAPSTONE PTC™ and CLYDESDALE PTC™ Spinal Systems will be available in all the same sizes as the predicate systems. The CAPSTONE PTC™ and CLYDESDALE PTC™ System implants (subject devices) and the CAPSTONE® and CLYDESDALE® Spinal System implants (predicate devices), are both made from PEEK material with tantalum markers. The only difference in the subject and predicate devices is the subject devices also have a commercially pure titanium coating. In addition, the predicate and subject devices are both convex, bullet-nosed interbody devices designed to contain graft material and facilitate a fusion between two vertebral bodies.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the MEDTRONIC Sofamor Danek CAPSTONE PTCTM and CLYDESDALE PTC™ Spinal Systems:

This document is a 510(k) Summary for a medical device seeking substantial equivalence to previously cleared devices. It describes non-clinical testing performed to demonstrate that the new devices (which incorporate a titanium coating) are as safe and effective as their uncoated predicates.

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: This document primarily focuses on demonstrating substantial equivalence through non-clinical performance to existing predicate devices. It does not explicitly state numerical acceptance criteria or specific performance values for the new devices, but rather relies on compliance with established ASTM standards and implicitly, that the new devices perform comparably to or better than the predicate devices tested under the same standards. The conclusion explicitly states the belief that the devices are "substantially equivalent to the predicates," which is the ultimate acceptance criterion for a 510(k) submission.

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

• Test Set (Non-Clinical): The document details various non-clinical mechanical and material tests. For each ASTM standard, there would be a defined sample size (e.g., number of test specimens). However, the document does not explicitly state the specific sample sizes used for each mechanical or material test.
• Data Provenance: The data provenance is laboratory testing (mechanical, material, and in-vivo animal testing). It is not human clinical data, so country of origin and retrospective/prospective distinctions are not applicable in the typical sense. The testing was conducted to U.S. (ASTM) standards.

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

• Not Applicable. For non-clinical, mechanical, and material testing, "ground truth" is established by adherence to universally accepted standards (ASTM standards in this case) and scientific principles, not by expert consensus on subjective interpretations. The expertise lies in the engineers and technicians performing the tests and interpreting the results in accordance with the specified standards.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods like 2+1 or 3+1 are typically used for clinical image interpretation or diagnostic performance studies where expert consensus is needed to establish ground truth for a subjective assessment. This document describes objective, non-clinical engineering and material science tests.

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 submission is for an intervertebral body fusion device (an implant), not a diagnostic device or AI software. Therefore, an MRMC study related to human readers improving with AI assistance is irrelevant to this device.

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

• Not Applicable. This is a physical implant, not an algorithm or software device.

7. The Type of Ground Truth Used

• Engineering and Material Standards Compliance, and Animal Study Outcomes.
  • For the mechanical and material tests (ASTM F1854, F1160, F1044, F1147, F1978, F2077, F2267, F04.25.02.02, F1877), the ground truth is the specified performance criteria within the respective ASTM standards. The device's performance is compared against these objective, quantitative criteria.
  • For biocompatibility, the ground truth is established through animal testing outcomes (canines) demonstrating tissue compatibility and the absence of adverse biological reactions to the CP Ti coating.

8. The Sample Size for the Training Set

• Not Applicable. This submission describes mechanical and biocompatibility testing for an implant, not a machine learning model. Therefore, there is no "training set" in the context of AI or algorithm development.

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

• Not Applicable. As there is no training set for an AI/algorithm, this question is not relevant.

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