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Solar-S™ PSI (Anterior, Standalone, With Integrated Fixation) and Solar-A™ PSI Spacers (Anterior, Non-Standalone, With Integrated Fixation)
The Solar-STM PSI (Standalone) and Solar-ATM PSI (Non-Standalone, With Integrated Fixation) are lumbar interbody fusion devices intended for use in patients with degenerative disc disease (DDD) of the lumbosacral spine (L1-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. Solar-STM PSI and Solar-ATM PSI Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.

• Solar-STM PSI Used with Screws or Tusks:
When used with three (3) screws, Solar-STM PSI Spacers devices with a lordotic angle ≤20° can be used as standalone interbody fusion devices at 1 or 2 contiguous levels.
When used with three (3) tusks, interbody devices must always be used with supplemental fixation and may be used at one or more levels.
Hyperlordotic interbody devices (>20° lordosis) used with screws or tusks, must always be used with supplemental fixation, and may be used at one or more levels.
When used with supplemental fixation, all Solar-STM PSI Spacers used with screws or tusks may be used at one or more levels.

• Solar-ATM PSI:
These devices are intended to be used at one or more levels with supplemental fixation systems that have been cleared for use in the lumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, anterior screw and rod systems). Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation.

Solar-MTM PSI Spacers (Anterior, Without Integrated Fixation)
Solar-MTM PSI Spacers are lumbar interbody fusion devices indicated at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). 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. Solar-M™ PSI Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, anterior screw and rod systems). Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation.

ImpulseTM PSI Spacers (Posterior / Transforaminal)
The DeGen Medical Impulse™ PSI is an intervertebral body fusion device intended for use in skeletally mature patients with Degenerative Disk Disease (DDD) of the lumbar spine with up to Grade 1 Spondylolisthesis at one or more levels from L1-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. The DeGen Medical Impulse™ PSI is indicated to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and are intended to be used with supplemental fixation systems cleared for use in the lumbar spine. The device is to be used in patients who have had six months of nonoperative treatment.

The DeGen Medical Patient-Specific Implant (PSI) System is a series of patient specific lumbar interbody spacers intended for use in anterior (Solar™ PSI) or posterior / transforaminal (Impulse™ PSI) lumbar fusion procedures. The Impulse™ PSI spacers are available in two configurations: Impulse™ PSI and Impulse™ Hyperlordotic PSI. The Solar™ PSI patient specific spacers are available in three configurations; Solar-S™ (integrated fixation), Solar-A™ (anterolateral, with integrated fixation), and Solar-M™ (monolithic, without integrated fixation). The Solar™ PSI implants incorporate integrated fixation in the form of screws manufactured from Ti-6AL-4V ELI titanium alloy per ASTM F136 or tusks additively manufactured from Puri-Ti™ unalloyed titanium. The Solar-S™ PSI spacers must be used with three (3) integrated screws and the spacer must have ≤20° of lordosis to be considered for standalone use. Impulse™ and Solar™ PSIs are additively manufactured from Puri-Ti™ unalloyed titanium.

The Impulse™ and Solar™ PSIs are designed individually for each patient using patient imaging data (X-Ray, MRI, CT). Variable dimensions include anterior and posterior heights, bone graft window, lordosis, coronal angle, length, and width. When provided with an adequate CT scan, implants may also include patient-matched endplates. All implants are provided in their final geometry and are not intended to be altered or reshaped at the time of surgery

The provided text is an FDA 510(k) summary for the DeGen Medical Patient-Specific Implant (PSI) System. This document focuses on demonstrating substantial equivalence to predicate devices based on design, intended use, and mechanical performance testing, rather than an AI/ML-driven device that requires human-in-the-loop or standalone algorithm performance studies.

Therefore, the information required to answer the prompt regarding acceptance criteria, study details (sample size for test/training sets, data provenance, expert qualifications, ground truth, MRMC study, effect size, standalone performance) for an AI/ML device is not available in the provided text.

The text describes mechanical and usability testing for a patient-specific interbody fusion device. It mentions:

• Non-clinical testing: Static and dynamic compression testing (ASTM F2077), static and dynamic compression shear testing (ASTM F2077), subsidence testing (ASTM F2267), expulsion testing, and wear debris characterization (ASTM F1877). These were leveraged from predicate devices as the patient-specific nature did not create a new mechanical worst-case configuration.
• Patient-specific validation testing:
  • Intra- and inter-designer variability evaluation.
  • Objective cadaveric study of the usability, form and fit, and accuracy of the patient-specific topographical implants.

The text states that "All testing showed that the subject device PSIs are able to be designed and manufactured using the specified work instructions and the manufactured device is able to successfully implement the surgical plan." It concludes that the device is "substantially equivalent" based on these tests.

Since the device is a patient-specific implant (hardware) and not an AI/ML software, the requested information about AI/ML specific acceptance criteria and study designs (e.g., number of experts, ground truth establishment for AI, MRMC studies) is not applicable or present in this 510(k) submission.

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The DOMINION Expandable Corpectomy System is indicated for vertebral body replacement in the cervical spine (C2-Tl) and the thoracolumbar spine (T1-L5). The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion.

When used in the cervical spine (C2-T1), DOMINION spacers are 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 the cervical degenerative disorders. These 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 System is intended to be used with supplemental fixation that has been cleared by the FDA for use in the cervical spine. When used in the thoracolumbar spine (T1-L5), DOMINION spacers are intended for use to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). These spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

The system is intended to be used with supplemental fixation that has been cleared by the FDA for use in the thoracolumbar spine (i.e. posterior screw and rod systems, and anterior screw and rod systems). When used at more than two levels, supplemental fixation should include posterior fixation.

The Dominion Expandable Corpectomy system is a modular system comprised of Expandable Columns, Modular Endplates, and optional screws. The primary purpose of the Expandable Column is to provide mechanical support to the anterior column of the spine after a vertebral corpectomy is performed. The primary function of the Modular Endplates is to provide attachment points for the Expandable Column to the vertebral endplates. The screws are an optional device that can provide enhanced fixation to the vertebral endplates when desired. The system contains Inserters which allow the insertion and expansion of the Expandable Columns.

The document provided is a 510(k) premarket notification for a medical device (DOMINION Expandable Corpectomy System) and does not describe a study involving humans or AI for diagnostic purposes. Therefore, most of the requested information regarding acceptance criteria and study details cannot be extracted from this document because it is not relevant to this type of device submission.

Here's a breakdown of what can be inferred from the document and why other points cannot be addressed:

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

The document lists several non-clinical tests that were performed, which inherently have acceptance criteria. However, the specific acceptance criteria values (e.g., minimum compression strength, maximum torsion deformation) and the reported device performance values (the actual measurements from the tests) are not detailed in this summary. It only states that the following analyses were conducted:

The summary states, "Astura Medical considers the DOMINION Expandable Corpectomy Spacer to be equivalent to the predicate devices listed above. This conclusion is based upon the devices' similarities in principles of operation, technology, materials and indications for use." This implies that the non-clinical tests demonstrated performance comparable to or better than the predicate devices, thereby meeting relevant acceptance criteria established for such devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in a 510(k) summary for non-clinical (mechanical) testing. Sample sizes for mechanical tests are typically dictated by testing standards (e.g., ASTM standards) rather than patient data. Data provenance like country of origin or retrospective/prospective is not applicable to mechanical performance testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the device is a spinal implant, and the "ground truth" for its performance is established through mechanical testing against engineering standards, not through expert human interpretation of medical images or patient data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Mechanical test results are objective measurements and do not typically require adjudication by experts in the same way clinical or diagnostic studies do.

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

The document explicitly states: "No clinical studies were performed." Therefore, an MRMC comparative effectiveness study was not done. This device is not an AI-powered diagnostic tool.

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

Not applicable. This is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For this medical device, the "ground truth" for its safety and effectiveness is established through the adherence to recognized international and national mechanical testing standards (e.g., ASTM F2077, ASTM F2267) and the comparison of its performance to legally marketed predicate devices. It is based on engineering principles and material science, not clinical outcomes or expert consensus in a diagnostic sense.

8. The sample size for the training set

Not applicable. This device is not an AI system that requires a "training set."

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

Not applicable. As above, this device is not an AI system.

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