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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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