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The Solar-S™ PSI (Standalone) and Solar-A™ 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-S™ PSI and Solar-A™ PSI Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.

When used with three (3) screws, Solar-S™ 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-S™ PSI Spacers used with screws or tusks may be used at one or more levels.

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-M™ 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.

The 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.

This FDA 510(k) clearance letter pertains to medical devices, specifically patient-specific intervertebral body fusion implants, not an AI/ML-based diagnostic or prognostic device. As such, the typical acceptance criteria and study designs that would involve AI performance metrics (like sensitivity, specificity, AUC), ground truth experts, MRMC studies, and training/test sets are not applicable to the information provided in this document.

The acceptance criteria and performance testing described in the document are focused on the physical and biological characteristics of the implant and its manufacturing processes, rather than the performance of an AI algorithm.

However, I can extract and present the information available regarding the device's acceptance criteria and the studies performed, interpreted within the context of a medical implant, not an AI system.

Here's a breakdown of the requested information based on the provided FDA clearance letter, with an important disclaimer that this is not an AI/ML study:

The DeGen Medical Patient-Specific Implant (PSI) System is a series of patient-specific lumbar interbody spacers. The studies mentioned are primarily related to the safety and effectiveness of the physical implant as a medical device, and its manufacturing process, not an AI diagnostic tool. Therefore, many of the requested points regarding AI/ML study design (e.g., sample size for AI test/training sets, ground truth establishment by experts, MRMC studies) are not relevant or addressed in this type of FDA clearance document.

Acceptance Criteria and Reported Device Performance (Non-AI Context)

The acceptance criteria for a physical medical implant like the DeGen Medical PSI System revolve around its biological compatibility, physical integrity, and sterility, ensuring it is safe and performs as intended in the human body. The "performance" here refers to demonstrating these aspects, not diagnostic accuracy.

Note: The FDA 510(k) process primarily relies on demonstrating "substantial equivalence" to a legally marketed predicate device. The performance tests are conducted to show that the new device is as safe and effective as the predicate, especially with any changes (e.g., non-sterile offering, material changes). The exact "values" for the tests (e.g., specific TOC readings) are typically provided in the full submission, but the clearance letter confirms they met acceptance.

Additional Requested Information (Contextualized for Medical Implant Submission)

Since this is for a physical medical device and not an AI algorithm, most of the following points do not apply in the typical AI/ML sense. However, I will address them based on what can be inferred or explicitly stated about the device development and testing process described.

1. Sample size used for the test set and the data provenance:

   • Test Set (for physical testing): Not explicitly stated in terms of number of physical implants tested for each criterion (e.g., how many underwent sterilization validation or cytotoxicity testing). This information would be in the detailed test reports within the 510(k) submission, following relevant standards (e.g., ISO, ASTM, USP) which dictate sample sizes for specific tests.
   • Data Provenance: Not applicable in the sense of patient data for AI. For physical testing, the "data" comes from laboratory measurements on the device components or prototypes.
   • Retrospective or Prospective: Not applicable in the AI sense. These are typically prospective laboratory tests performed on device samples.

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

   • Ground Truth: For a physical medical device, "ground truth" isn't established by human experts reviewing data in the diagnostic sense. Instead, it's defined by objective scientific standards and measurements (e.g., biocompatibility standards, sterility assurance levels).
   • Experts: The "experts" involved are the engineers, scientists, and quality control personnel who design the tests, perform the measurements, and interpret the results according to established international and national standards (ISO, ASTM, USP as cited). Their qualifications would be in relevant scientific and engineering disciplines.

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

   • Adjudication: Not applicable. This concept is typically used in clinical studies or AI evaluations where human disagreement on classifications/annotations needs to be resolved. For laboratory-based device testing, results are typically quantitative and compared against predefined acceptance limits, rather than being subject to human adjudication for a "ground truth" label.

4. 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:

   • MRMC Study: No, an MRMC study was not done. This type of study is specific to evaluating diagnostic AI systems where human readers interpret medical images or data. The DeGen Medical PSI System is a physical implant, not an AI diagnostic tool.

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

   • Standalone Performance: Not applicable. There is no AI algorithm being evaluated for "standalone performance" in this context. The "device" itself (the physical implant) is evaluated for its material properties and safety.

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

   • Ground Truth (for implant): For the physical device, the "ground truth" for demonstrating safety and effectiveness relies on adherence to scientifically established standards and regulations:
     • Biocompatibility: Based on ISO 10993 series for medical devices.
     • Sterility: Based on ISO 17665 and AAMI ST72 for sterilization and endotoxin testing.
     • Material Properties: Based on ASTM standards for materials (e.g., Ti-6AL-4V ELI titanium alloy per ASTM F136).
     • Cleaning: Based on USP and ASTM standards.
     • Design and Function: Demonstrated through comparison to the predicate device and engineering principles.

7. The sample size for the training set:

   • Training Set: Not applicable. There is no AI training set in the context of this device clearance. The "training" for the device's design comes from engineering principles, existing medical knowledge, and performance of predicate devices.

8. How the ground truth for the training set was established:

   • Training Set Ground Truth: Not applicable for an AI training set. The "ground truth" for the design and manufacturing of this physical implant is established through compliance with established industry standards, regulations, and scientific principles related to medical device design, material science, and manufacturing processes.

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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 Solar-STM (Standalone) and Solar-A™ (Non-Standalone) are lumbar 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 radition, these patients may have up to Grade 1 spondylolisthesis at the involved level(s). These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. Solar-A™ ALIF Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.

• Solar-STM Used With Screws or Tusks:
When used with three (3) screws, interbody 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 1 or 2 levels.

Hyperlordotic interbody devices (>20° lordosis) used with screws, must always be used with supplemental fixation, and may be used at 1 or 2 levels.

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

Solar-MTM ALIF Spacers (Without Integrated Fixation)
Solar-M™ ALIF 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 disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolilsthesis, deformity (degenerative scoliosis or kyphosis), 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 has at least six (6) months of non-operative treatment. Solar-M™ ALIF 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 (200 lordosis) must be used with at least anterior supplemental fixation.

The Solar™ Lumbar Interbody Fusion System is a lumbar interbody fusion device for anterior lumbar fusion procedures. The Solar™ system includes various widths, depths, and heights. The Solar™ device is comprised of a single component that is additively manufactured. The superior and inferior endplates feature a porous surface to mitigate subsidence and expulsion. The standalone (Solar-S™), anterolateral (Solar-A™), and monolithic (Solar-M™) configurations feature an anterior face with threaded holes and slots to rigidly connect to an instrument for surgical insertion. Superior and inferior faces feature a central aperture to constrain bone graft. The DeGen Medical Solar™ spacers are additively manufactured from Puri-Ti™ unalloyed titanium. The Solar-S™ and Solar-A™ incorporate integrated fixation in the form of screws manufactured from Titanium-6AL-4V ELI Alloy per ASTM F136 or tusks additively manufactured from Puri-Ti™ unalloyed titanium. The Solar-S™ Lumbar Interbody Spacer must be used with three (3) integrated screws and the spacer must have

This document describes the DeGen Medical Solar™ Lumbar Interbody Fusion System and its 510(k) clearance (K240326). It does not contain information about an AI/ML device or its performance criteria.

Therefore, I cannot provide a response based on the requested information categories as they pertain to AI/ML device studies. The document describes a traditional medical device (an intervertebral body fusion device), and the "performance testing" mentioned refers to non-clinical mechanical testing, not software performance.

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Solar-S™ (Standalone, With Integrated Fixation) and Solar-A™ (Non-Standalone, With Integrated Fixation) The Solar-STM (Standalone) and Solar-A™ (Non-Standalone) are lumbar 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. In addition, these patients may have up to Grade 1 spondylolisthesis at the involved level(s). These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. Solar-A™ ALIF Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.

· Solar-STM Used With Screws:

When used with three (3) screws, interbody devices with a lordotic angle 20° lordosis) used with screws, must always be used with supplemental fixation, and may be used at 1 or 2 levels.

· Solar-ATM:

These devices are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior screw and rod systems). Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation.

Solar-M™ ALIF Spacers (Without Integrated Fixation) Solar-M™ ALIF 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 (DD), disc herniation (with myelopathy and/or radiculopathy), spondylolilsthesis, 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 has at least six (6) months of non-operative treatment. Solar-MIM ALIF 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.

The Solar™ Lumbar Interbody Fusion System is a lumbar interbody fusion device for posterior and transforaminal lumbar fusion procedures. The Solar™ system includes various widths, depths, and heights. The Solar™ device is comprised of a single component that is additively manufactured. The superior and inferior endplates feature a porous surface to mitigate subsidence and expulsion. The standalone (Solar-S™), anterolateral (Solar-A™), and monolithic (Solar-M™) configurations feature an anterior face with threaded holes and slots to rigidly connect to an instrument for surgical insertion. Superior and inferior faces feature a central aperture to constrain bone graft. The DeGen Medical Solar™ spacers are additively manufactured from Puri-Ti™ unalloyed titanium. The Solar-S™ and Solar-A™ incorporate integrated fixation in the form of screws manufactured from Titanium-6AL-4V ELI Alloy per ASTM F136. The Solar-S™ Lumbar Interbody Spacer must be used with three (3) integrated screws and the spacer must have ≤20° of lordosis to be considered for standalone use.

The provided text describes the DeGen Medical Solar™ Lumbar Interbody Fusion System. It is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving specific clinical performance metrics. Therefore, the document does not describe acceptance criteria, a study proving the device meets those criteria, or clinical performance metrics like effect size with human readers.

However, it does describe non-clinical performance testing. Here's what can be extracted and inferred from the document:

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

The document does not explicitly state quantitative acceptance criteria or a specific performance table in the way a clinical study would for metrics like sensitivity, specificity, or AUC. Instead, for a 510(k), the "acceptance criteria" are implied by demonstrating that the device performs equivalently to legally marketed predicate devices through specific non-clinical tests. The "reported device performance" refers to the successful completion of these tests, confirming substantial equivalence.

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 applicable as the document describes non-clinical, mechanical and material testing, not a clinical study involving human patients or data sets.

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 information is not applicable as the document describes non-clinical, mechanical and material testing. Ground truth in the context of expert review is reserved for clinical studies or AI performance assessments.

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

This information is not applicable as the document describes non-clinical, mechanical and material testing. Adjudication methods are relevant for expert-based assessments in clinical studies.

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

There is no MRMC comparative effectiveness study described in this document. This submission is for a physical medical device (interbody fusion system), not an AI-assisted diagnostic tool.

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

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

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

For the non-clinical performance testing, the "ground truth" used would be the established standards and methodologies defined by the specific ASTM (American Society for Testing and Materials) standards mentioned (e.g., ASTM F2077, ASTM F2267, ASTM F1877). These standards specify precise test conditions, measurement techniques, and acceptable ranges for material and mechanical properties, serving as the benchmark against which the device performance is evaluated.

8. The sample size for the training set

This information is not applicable as the document describes non-clinical, mechanical and material testing for a physical device. There is no concept of a "training set" in this context.

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

This information is not applicable for the same reasons as above.

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The DeGen Medical Impulse AM™ implant 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 two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. The DeGen Medical Impulse AM™ System 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.

DeGen Medical Impulse AM™ System is a lumbar interbody fusion device for posterior and transforaminal lumbar fusion procedures. The Impulse AM™ system includes various lengths, widths, heights, and endplate shapes (curvatures include neutral, lordotic, and anatomic). The DeGen Medical Impulse AM™ device is comprised of a single component that is additively manufactured. The superior and inferior endplates feature porous surfaces to facilitate fusion and mitigate subsidence and expulsion. The anatomic, lordotic, and neutral configurations feature a posterior face with a threaded hole and slots to rigidly connect to an instrument for surgical insertion. The hyperlordotic configuration features a posterior face with slots to rigidly connect an instrument for surgical insertion. Superior and inferior faces feature a central aperture to constrain bone graft. DeGen Medical's Impulse AM™ Spacers are additively manufactured from Puri-Ti™ unalloyed titanium.

This document is a 510(k) summary for the DeGen Medical Impulse AM™ System, an intervertebral body fusion device. It does not contain information about acceptance criteria and performances from a study related to an AI device.

The provided text describes a medical device, its indications for use, technological characteristics, and performance testing to demonstrate substantial equivalence to a predicate device. It specifically states: "Non-clinical testing was performed to demonstrate minor modifications in manufacturing of the subject device do not negatively impact the final device as compared to the originally cleared system in K210090." The performance tests mentioned are "Static and dynamic compression testing per ASTM F2077" and "Dynamic compression shear testing per ASTM F2077". These are engineering tests for the physical device itself, not performance metrics for an AI algorithm.

Therefore, I cannot extract the requested information (acceptance criteria, device performance, sample size for test/training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment) as it pertains to AI device evaluation because this document does not describe such a device or study.

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The DeGen Medical Navigated Instrumentation is intended to be used during the preparation and placement of DeGen Medical F 1 MPS and E3 MIS screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. DeGen Medical Navigated Instrumentation is specifically designed for use with the Medtronic System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

The DeGen Navigated Instrumentation is nonsterile, reusable drivers that are intended to be used with the Medtronic StealthStation® Application 1.2.0 (1.2.0-20) and are manufactured from stainless steel per ASTM F899.

I'm sorry, but this document does not contain the detailed information necessary to answer your request about the acceptance criteria and the study proving the device meets those criteria. Specifically, the document is a 510(k) clearance letter and summary, which confirms regulatory clearance but does not include:

• A table of acceptance criteria and reported device performance. The document mentions "Anatomical simulated use and navigation accuracy" as a non-clinical test, but no specific performance metrics or acceptance thresholds are provided.
• The sample size used for the test set or its provenance.
• The number and qualifications of experts used to establish ground truth.
• The adjudication method for the test set.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect size of human improvement with AI assistance.
• Whether standalone (algorithm only) performance was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.), though it implies simulated use.
• The sample size for the training set.
• How the ground truth for the training set was established.

The document primarily focuses on demonstrating substantial equivalence to a predicate device based on intended use, indications for use, design, function, technology, and non-clinical tests (dimensional analysis and anatomical simulated use/navigation accuracy). It concludes that the device is "as safe and effective" as the predicate based on these comparisons, but does not provide the specific performance data you are looking for.

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The DeGen Medical Cyclop™ Anterior Cervical Plate System is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation. The Cyclops™ Anterior Cervical Plate system is intended for anterior intervertebral screw fixation of the cervical spine at levels C2 to T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with following indications:

• Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
• · Spinal Stenosis
• · Trauma (i.e. fracture or dislocation)
• · Deformity or curvatures (including scoliosis, kyphosis, or lordosis)
• Spinal Tumors
• Pseudoarthrosis or failed previous fusion
• · Spondylolisthesis
• · Decompression of the spinal following total or partial cervical vertebrectomy

The DeGen Medical Cyclops™ Anterior Cervical Plate Systems (CACP) consists of cervical plates and bone screws. All implants are intended to provide stabilization of the cervical vertebrae. The CACP provides anterior fixation from either fixed or variable angle construct in self-tapping or self-drilling bone screw options. The system is provided non-sterile and is constructed from Titanium alloy (Ti-6Al-4V ELI) per ASTM F136.

The purpose of this submission is to add additional two-level plate lengths to the Cyclops™ Anterior Cervical Plate System

The provided document does not contain information regarding a study that proves a device meets acceptance criteria related to AI or algorithm performance.

Instead, this document is an FDA 510(k) clearance letter for a medical device called the "Cyclops™ Anterior Cervical Plate System." This system is described as an implantable device used for spinal fusion and stabilization in the cervical spine.

The document discusses:

• Device Name: Cyclops™ Anterior Cervical Plate System
• Regulation Number and Name: 21 CFR 888.3060, Spinal intervertebral body fixation orthosis
• Regulatory Class: Class II
• Indications for Use: Aid in cervical spinal fusion, temporary stabilization of the anterior spine for various conditions (Degenerative Disc Disease, Spinal Stenosis, Trauma, Deformity, Spinal Tumors, Pseudoarthrosis, Spondylolisthesis, Decompression).
• Substantial Equivalence: The clearance is based on the device being substantially equivalent to previously cleared predicate devices (K191786 Cyclops™ Anterior Cervical Plate System and K150759 DeGen Medical Hyper-C Anterior Cervical Plate System). The equivalence is established through comparison of design, intended use, material composition, function, and range of sizes.
• Non-Clinical Performance Testing: A risk review was conducted on existing verification and validation data for the Cyclops™ Anterior Cervical Plate System regarding the addition of two-level plates. The conclusion was that no impacts to safety or effectiveness would result.

Therefore, I cannot provide the requested information about acceptance criteria and study details for an AI/algorithm-based device as this document is for a physical implantable medical device, not a software or AI product.

The questions posed (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set size) are relevant for evaluating AI/ML-based medical devices, but not for the type of device described in this 510(k) summary.

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The DeGen Medical Impulse AM™ implant 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 two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. The DeGen Medical Impulse AM™ System 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.

DeGen Medical Impulse AM™ System is a lumbar interbody fusion device for posterior and transforaminal lumbar fusion procedures. The Impulse AM™ system includes various lengths, widths, heights, and endplate shapes (curvatures include neutral, lordotic, and anatomic). The DeGen Medical Impulse AM™ device is comprised of a single component that is additively manufactured. The superior and inferior endplates feature porous surfaces to mitigate subsidence and expulsion. The anatomic, lordotic, and neutral configurations feature a posterior face with a threaded hole and slots to rigidly connect to an instrument for surgical insertion. The hyperlordotic configuration features a posterior face with slots to rigidly connect an instrument for surgical insertion. Superior and inferior faces feature a central aperture to constrain bone graft. DeGen Medical's Impulse AM™ Spacers are additively manufactured from Puri-Ti™ titanium powder having a chemical composition conforming to ASTM B348

This FDA 510(k) summary is for a medical device, the DeGen Medical Impulse AM™ Interbody Fusion System, which is an intervertebral body fusion device. The document focuses on demonstrating substantial equivalence to predicate devices, rather than providing a study that establishes acceptance criteria for new performance claims for the device itself.

Therefore, the information requested about acceptance criteria and a study proving the device meets those criteria (especially regarding AI/algorithm performance) is not available in the provided text. This document describes the device and its intended use, and then lists non-clinical performance testing against established ASTM standards and FDA guidance for intervertebral body fusion devices, which are mechanical performance tests rather than clinical or AI algorithm performance evaluations.

Here's a breakdown of what can be extracted from the provided text, and what cannot:

Information Not Available in the Provided Text:

• Acceptance Criteria for an AI/Algorithm: The document does not describe acceptance criteria for an AI or algorithm's performance, as the device itself is a physical intervertebral body fusion system, not an AI software.
• Reported Device Performance (for AI/Algorithm): Since there's no AI/algorithm, there's no reported performance for one.
• Sample size for test set and data provenance: Not applicable.
• Number of experts used to establish ground truth & qualifications: Not applicable.
• Adjudication method: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
• Standalone (algorithm-only) performance: Not applicable.
• Type of ground truth (for AI/algorithm): Not applicable.
• Sample size for training set (for AI/algorithm): Not applicable.
• How ground truth for training set was established (for AI/algorithm): Not applicable.

Information Related to Device Performance (Non-Clinical/Mechanical) that is Available:

The "Performance Testing" section (on page 3 of the input) indicates that non-clinical testing was performed to demonstrate substantial equivalence to other predicate devices. This testing was conducted in accordance with "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s" (May 3, 2004) and "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device" (June 12, 2007).

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

Note: The specific numerical acceptance criteria (e.g., minimum load to failure, maximum subsidence) are not provided in this summary but would be detailed in the full test reports referenced by the ASTM standards and FDA guidance documents. The summary only states that the device met these criteria, demonstrating substantial equivalence.

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

The document does not specify the sample sizes (e.g., number of devices tested) for each of the non-clinical mechanical tests. Data provenance is implied to be from laboratory testing performed by DeGen Medical (or its contractors) specifically for the purpose of this 510(k) submission. These are in vitro tests, not clinical data from patients.

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

Not applicable, as this refers to a physical device undergoing mechanical testing, not a diagnostic or AI algorithm requiring human expert ground truth.

4. Adjudication method for the test set

Not applicable.

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 a medical device, not an AI diagnostic tool.

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

Not applicable. This is a physical medical device.

7. The type of ground truth used

For mechanical testing, the "ground truth" is typically defined by the physical properties of the materials and the design, measured against established engineering standards (ASTM standards in this case) using calibrated equipment.

8. The sample size for the training set

Not applicable. There is no AI algorithm with a training set described.

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

Not applicable.

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The DeGen Medical Navigated Instrumentation is intended to be used during the preparation and placement of DeGen Medical F 1 MPS and E3 MIS screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. DeGen Medical Navigated Instrumentation is specifically designed for use with the Medronic SteathStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

The DeGen Navigated Instrumentation is nonsterile, reusable drivers that are intended to be used with the Medtronic StealthStation® Application 1.2.0 (1.2.0-20) and are manufactured from stainless steel per ASTM F899.

The provided text describes the DeGen Medical Navigated Instrumentation and its 510(k) summary, but does not contain the detailed information necessary to answer all parts of your request regarding acceptance criteria and a study proving the device meets those criteria.

Specifically, the document focuses on regulatory approval (510(k)) and establishing substantial equivalence to predicate devices, rather than presenting a performance study with specific acceptance criteria and detailed results.

Here's what can be extracted and what cannot:

Information Present in the Document:

• Device Name: DeGen Medical Navigated Instrumentation
• K Number: K203816
• Indications for Use: Intended to be used during the preparation and placement of DeGen Medical F1 MPS and E3 MIS screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Specifically designed for use with the Medtronic StealthStation® System.
• Predicate Devices: K140454 Medtronic Navigated CD Horizon Solera Screwdriver / Taps and K172166 Astura Olympic Navigated Instruments.
• Non-Clinical Test Summary: "Dimensional analysis compared to predicate Anatomical simulated use and navigation accuracy." The document states, "The results of these evaluations indicate the subject device is equivalent to the predicate device."
• Type of Ground Truth Used (Indirectly): The "non-clinical test summary" mentions "navigation accuracy" and "anatomical simulated use," which implies that the ground truth for these tests would likely be based on physical measurements against established anatomical models or precise reference points, rather than expert consensus, pathology, or outcomes data in a clinical setting.

Information NOT Present in the Document:

• A table of acceptance criteria and reported device performance: The document only states that evaluations were conducted and "indicate the subject device is equivalent to the predicate device," but no specific numerical performance criteria or results are provided.
• Sample size used for the test set and data provenance: No details on the number of cases, specimens, or the origin (country, retrospective/prospective) of the data for the "anatomical simulated use and navigation accuracy" tests.
• Number of experts used to establish ground truth and their qualifications: Not applicable, as the ground truth appears to be based on physical measurements/simulations rather than human expert interpretation of images or clinical data.
• Adjudication method for the test set: Not applicable based on the information provided.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No indication of such a study. The device is a navigated instrumentation, not an AI diagnostic tool that would typically involve human readers.
• If a standalone (algorithm only without human-in-the-loop performance) was done: This device is physical instrumentation used with a navigation system, not an algorithm in the typical sense of AI standalone performance.
• The sample size for the training set: Not applicable, as this is a physical device, not an AI/ML model that requires a training set.
• How the ground truth for the training set was established: Not applicable.

Summary based on the provided text:

The document is a 510(k) clearance letter and summary for a medical device. Its purpose is to demonstrate substantial equivalence to existing legally marketed devices, not to detail the performance of an AI/ML algorithm or a new diagnostic tool using a large-scale clinical study dataset. The "study" mentioned is a "Non-Clinical Test Summary" which included "Dimensional analysis compared to predicate Anatomical simulated use and navigation accuracy." The conclusion is that these evaluations demonstrated the device is "equivalent to the predicate device" in terms of safety and effectiveness, based on "technological characteristics and non-clinical performance data."

To answer your request comprehensively, you would need a more detailed performance report or study design document for the DeGen Medical Navigated Instrumentation, which is not included in these FDA communication pages.

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The DeGen Medical Impulse implant is an intervertebral body fusion device intended for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the lumbar spine with up to Grade 1 Spondylolisthesis at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. The DeGen Medical Impulse System 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.

DeGen Medical Impulse System is a lumbar interbody fusion device for posterior and transforaminal lumbar fusion procedures. The Impulse system includes various lengths, widths, heights, and endplate shapes (curvatures include neutral, lordotic, and anatomic). The DeGen Medical Impulse device is comprised of a single component that is traditionally machined. The superior and inferior endplates are coated with a porous coating to facilitate bony ingrowth and mitigate subsidence and expulsion. The anatomic, lordotic, and neutral configurations feature a posterior face with a threaded hole and slots to rigidly connect to an instrument for surgical insertion. The hyperlordotic configuration features a posterior face with slots to rigidly connect an instrument for surgical insertion. Superior and inferior faces feature a central aperture to constrain bone graft. DeGen Medical Impulse System is made from Titanium (ASTM F67) and Titanium alloy (Ti-6Al-4V ELI) per ASTM F136.

The provided text describes the DeGen Medical Impulse Interbody Fusion System and its FDA 510(k) clearance. However, it does not contain the specific information requested in your prompt regarding acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

This document is a 510(k) summary, which is a regulatory filing demonstrating substantial equivalence to a legally marketed predicate device, as opposed to a full clinical study report demonstrating new safety and effectiveness. The performance testing mentioned is primarily non-clinical (mechanical testing) and is conducted to show that the device performs similarly to predicate devices, not to establish specific clinical performance metrics against defined acceptance criteria in the way you might see for an AI/ML device or a novel therapeutic.

Here's a breakdown of what can be extracted and what is missing:

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

• Acceptance Criteria: Not explicitly stated as pass/fail metrics. The "acceptance" for this type of device is demonstrating substantial equivalence to predicate devices through a battery of non-clinical tests.
• Reported Device Performance:
  • Non-clinical testing performed:
    • Static and dynamic compression testing per ASTM F2077
    • Static and dynamic compression shear testing per ASTM F2077
    • Subsidence testing via ASTM F2267
    • Expulsion Testing
    • Wear debris analysis via ASTM F1877
  • Results: "The results of these studies show the subject DeGen Medical Impulse System is substantially equivalent to the other predicate devices."

What is missing: Specific numerical results of these tests and their direct comparison to pre-defined numerical acceptance criteria for a "device performance" table as typically seen for AI/ML or diagnostic devices. The acceptance is implied by the comparison to predicates and relevant ASTM standards.

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

• Missing: This information is not present. The document focuses on non-clinical (mechanical) testing, not clinical data sets, and therefore doesn't discuss test sets in the context of patient data or data provenance.

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)

• Missing: This information is not present. No clinical ground truth or expert review is described for the evaluation of this medical device in this summary.

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

• Missing: This information is not present. No clinical adjudication method is described.

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

• Missing: This information is not present. This device is an intervertebral body fusion system, not an AI/ML diagnostic or assistive device, so MRMC studies in this context are not applicable.

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

• Missing: This information is not present. This device is an implantable surgical device, not an algorithm.

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

• Ground Truth (for mechanical testing): The "ground truth" for the mechanical performance of this device is established by adherence to recognized ASTM standards (e.g., F2077, F2267, F1877) and demonstrating performance equivalent to legally marketed predicate devices. This is a non-clinical "ground truth."
• Missing: Clinical ground truth, pathology, or outcomes data related to device performance in patients is not detailed in this 510(k) summary.

8. The sample size for the training set

• Missing: This information is not present. No training set is involved in the evaluation described.

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

• Missing: This information is not present as there is no training set mentioned.

Summary of what the document does provide:

• Device Name: Impulse Interbody Fusion System
• Indications for Use: Skeletally mature patients with Degenerative Disc Disease (DDD) of the lumbar spine (L2-S1) with up to Grade 1 Spondylolisthesis at one or two contiguous levels. Used with autograft/allograft and supplemental fixation systems, after 6 months of nonoperative treatment.
• Technological Characteristics Comparison: Compared to predicates in intended use, indications for use, design, function, and technology.
• Performance Testing: Static/dynamic compression, compression shear, subsidence, expulsion, and wear debris analysis (all per specific ASTM standards).
• Conclusion: Substantially equivalent to predicate devices based on indications for use, technological characteristics, and performance testing.

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