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The EUROPA™ Posterior Cervical Fusion System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the upper thoracic spine (T1 to T3):

• · Traumatic spinal fractures and/or traumatic dislocations
• · Instability or deformity
• · Failed previous fusions (e.g. pseudarthrosis)
• · Tumors involving the cervical/thoracic spine
• · Degenerative disease, including intractable radiculopathy and/or myelopathy
• · Neck and/or arm pain of discogenic origin as confirmed by radiographic studies
• · Degenerative disease of the facets with instability

The EUROPA™ Posterior Cervical Fusion System is also intended to restore the intearity 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.

In order to achieve additional levels of fixation, the EUROPA™ Posterior Cervical Fusion System may be connected to the EUROPA™ Pedicle Screw System via the rod to rod connectors.

The EUROPA™ Posterior Cervical Fusion System is a posterior cervical screw system intended to provide structural stability and mechanical support to the cervical spine following posterior cervical fusion.
The EUROPA™ Posterior Cervical Fusion System consists of rods manufactured from Molybdenum-47.5 Rhenium Alloy (MoRe) per ASTM F3273, pedicle screws and connectors manufactured from Titanium-6 Aluminum-4 Vanadium ELI per ASTM F136, and instrumentation manufactured from Stainless Steel per ASTM F899. The EUROPA™ Posterior Cervical Fusion System implants are offered in multiple configurations and different sizes to accommodate various patient anatomical requirements.
The rods are provided sterile packed and are intended for single use only. The pedicle screws and connectors must be steam sterilized prior to use.

The provided text is related to the FDA 510(k) clearance for the EUROPA™ Posterior Cervical Fusion System. It details the device's intended use, indications, and a summary of non-clinical tests conducted to demonstrate substantial equivalence to predicate devices.

However, the request asks for information about the acceptance criteria and the study that proves an AI/software device meets the acceptance criteria, including details like sample size, ground truth establishment, expert qualifications, and MRMC studies.

The EUROPA™ Posterior Cervical Fusion System is a physical medical device (a posterior cervical screw system), not an AI or software device. The provided document does not contain any information about AI/software performance, nor does it describe studies with human readers, radiologists, or ground truth established by experts for an AI system.

Therefore, I cannot extract the requested information regarding AI/software device acceptance criteria and study details from the provided text. The document focuses on demonstrating the mechanical performance and material equivalence of a physical implant system.

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The MiRus MoRe Lumbar Plating System is indicated for use via lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of the thoracic and thoracolumbar (T1-L5) spine or via an anterior approach below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine. The system is intended to provide additional support during fusion in skeletally mature patients in the following acute and chronic instabilities or deformities:

· Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies);

• · Pseudoarthrosis;
• · Spondylolysis:
• · Spondylolisthesis;
• · Spinal stenosis;
• · Tumors;
• · Trauma (i.e. Fractures or Dislocation);
• · Deformities (i.e. Scoliosis, Kyphosis or Lordosis);
• · Failed Previous Fusion

The MiRus MoRe Lumbar Plating System is a spinal intervertebral body fixation orthosis intended to provide structural stability and mechanical support to the lumbar spine following lumbar interbody fusion.

The MiRus MoRe Lumbar Plating System consists of implants manufactured from Molybdenum-47.5 Rhenium Alloy (MoRe) per ASTM F3273, screws and locking cam mechanism manufactured from Titanium-6 Vanadium ELI per ASTM F136, and instrumentation manufactured from Stainless Steel per ASTM F899. The MiRus MoRe Lumbar Plating System implants are offered in multiple configurations and different sizes to accommodate various patient anatomical requirements: ANTARES" Anterior Lumbar Plate and MiRus Lateral Lumbar Plate.

The plates are provided sterile packed and are intended for single use only. The screws must be steam sterilized prior to use.

The provided text describes a medical device, the "MiRus MoRe Lumbar Plating System," which is a spinal intervertebral body fixation orthosis. However, this document does not contain information about an AI/ML-driven medical device, nor does it provide details about acceptance criteria and studies for an AI/ML device's performance.

The document focuses on the regulatory clearance (510(k)) of a physical medical implant and its mechanical performance, comparing it against established ASTM standards and FDA guidance for spinal plating systems. The testing described is non-clinical mechanical testing (static and dynamic compression bending, static torsion) and does not involve AI/ML performance metrics, human readers, ground truth establishment through expert consensus or pathology, or training/test sets for an algorithm.

Therefore, I cannot provide the requested information regarding acceptance criteria and the study that proves an AI/ML device meets these criteria based on the provided text. The questions posed in your prompt (e.g., sample size for test/training sets, number of experts for ground truth, MRMC study, standalone performance) are relevant to AI/ML device evaluation, but the provided document is for a traditional medical device (implant).

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The RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System is a standalone anterior cervical interbody fusion system indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one or two contiguous disc levels from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of nonoperative treatment. Devices are to be used with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.

The RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System is intended for use with the bone screw fixation provided and requires no additional fixation.

The RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System is an integrated anterior cervical interbody fusion device used to provide structural stability following discectomy.

The RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System consists of cages additively manufactured from Titanium-6 Aluminum-4 Vanadium ELI per ASTM F3001, screws and locking cams manufactured from Titanium-6 Vanadium ELI per ASTM F136, and instrumentation manufactured from Stainless Steel per ASTM F899. The RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System implants are offered in several configurations of various sizes to accommodate different patient anatomy and surgical approaches.

The interbodies are provided sterile packed and are intended for single use only. The bone screws must be steam sterilized prior to use.

There is no information in the provided text regarding acceptance criteria, device performance, specific studies with sample sizes, ground truth establishment, expert involvement, or any aspects related to AI/software performance.

The document is a 510(k) summary for a medical device (RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System), which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device through mechanical performance testing.

The "Performance Data" section only mentions that mechanical performance was assessed through static and dynamic construct testing in accordance with ASTM standards (F2077-18 and F2267-04). It does not provide any specific acceptance criteria or reported device performance values for these tests.

Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance, nor can I provide information about sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth used, or details about a training set.

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The RIGEL™ 3DR Anterior Cervical Corpectomy System is indicated for vertebral body replacement in the cervical spine (C2-T1) in skeletally mature patients. The RIGEL™ 3DR Anterior Cervical Corpectomy System is intended to replace a diseased or damaged vertebral body caused by fracture, or tumor, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. The System is intended to be used with supplemental fixation that has been cleared by the FDA for use in the cervical spine. The System is designed for use with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion. The System is also 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 expectance is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

The RIGEL™ 3DR Anterior Cervical Corpectomy System is a vertebral body replacement device intended to provide structural stability and mechanical support to the cervical spine following corpectomy.

The RIGEL™ 3DR Anterior Cervical Corpectomy System consists of implants additively manufactured from Titanium-6 Aluminum-4 Vanadium ELI per ASTM F3001 and instrumentation manufactured from Stainless Steel per ASTM F899. The RIGEL™ 3DR Anterior Cervical Corpectomy System implants are offered in multiple configurations and different sizes to accommodate various patient anatomical requirements. The implants are provided sterile packed and are intended for single use only.

This document is a 510(k) Premarket Notification from the FDA regarding the RIGEL™ 3DR Anterior Cervical Corpectomy System. It primarily focuses on the substantial equivalence of this medical device to previously cleared predicate devices.

It is crucial to understand that this document describes a medical device (an implant), not an AI/Software as a Medical Device (SaMD). Therefore, many of the requested points related to AI/SaMD performance criteria, expert adjudication, MRMC studies, and ground truth for training sets are not applicable.

Here's an analysis based on the provided text, highlighting the non-applicability of SaMD-specific questions:

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

The document does not explicitly state acceptance criteria in a quantitative table format as one would expect for an AI/SaMD. Instead, it relies on the concept of "substantial equivalence" to predicate devices. The performance data presented are mechanical tests designed to show that the device meets established standards for spinal implants and performs comparably to its predicates.

2. Sample sized 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 mechanical testing of a physical implant, not a software device evaluated on a dataset. The "test set" in this context refers to the physical samples of the implant tested as per ASTM standards. The specific number of physical samples for each test (e.g., how many implants underwent compression testing) is not detailed. Data provenance such as country of origin or retrospective/prospective is not relevant for mechanical device 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. Ground truth, in the context of SaMD, refers to establishing the correct diagnosis or outcome from medical images/data, often by expert consensus. For a physical implant, "ground truth" is established by adherence to engineering specifications and performance against recognized ASTM standards. There are no medical experts establishing ground truth for the performance of the implant itself in this context, although clinical expertise guides the design and intended use.

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

This is not applicable for a physical device. Adjudication methods are used in SaMD studies to resolve discrepancies between expert readers on a test set to establish a definitive ground truth. For mechanical testing, the "adjudication" is inherent in the standardized test procedures and their objective measurements.

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

This is not applicable. MRMC studies are specifically designed to evaluate the impact of AI on human reader performance. This document concerns a physical device, not an AI.

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

This is not applicable. A standalone performance evaluation refers to an AI algorithm making decisions without human intervention. This document is about a physical spinal implant.

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

As mentioned, the concept of "ground truth" as it applies to SaMD is not applicable here. For this physical device, the "truth" of its performance is derived from standardized mechanical testing (ASTM F2077-18 for static and dynamic compression/torsion, ASTM F2267-04 for subsidence). These tests provide objective, measurable data points against established industry standards for material strength, durability, and biocompatibility rather than a clinical ground truth.

8. The sample size for the training set

This is not applicable. Training sets are used to train AI algorithms. This document describes a physical medical device. While there's a design and development process for the implant, it doesn't involve "training" in the AI sense.

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

This is not applicable for the same reasons as above.

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The MiRus™ 3DR Lumbar Interbody Fusion System is indicated for intervertebral body fusion procedures in sketally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L1-L2 to L5-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Devices are to be used with autogenous or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral body fusion device.

When used with or without the MiRus MoRe Lateral Lumbar Plating System, the system is indicated for use with supplemental fixation cleared by the FDA for use in the lumbar spine.

The MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation is a spinal intervertebral body fusion device used to provide structural stability following lateral lumbar interbody fusion for lumbar degenerative disorders.

The MiRus 3DR LLIF is additively manufactured from Titanium-6 Aluminum-4 Vanadium ELI per ASTM F3001.

The MiRus MoRe Lateral Lumbar Plating System consists of a lateral plate manufactured from Molybdenum-47.5 Rhenium Alloy (MoRe) per ASTM F3273, bone screws, locking cam mechanism, and a connecting screw manufactured from Titanium-6 Aluminum-4 Vanadium ELI per ASTM F136.

Instrumentation is manufactured from Stainless Steel per ASTM F899. The system is offered in several configurations of various sizes to accommodate different patient anatomy and surgical approaches.

This is an FDA 510(k) clearance letter for a medical device, the MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation. This document does not describe:

• A table of acceptance criteria and reported device performance related to AI/algorithm performance. It describes mechanical performance testing of the physical device.
• Sample sizes, data provenance, expert ground truth establishment, or adjudication methods for an AI model.
• Any mention of a Multi-Reader Multi-Case (MRMC) study or standalone algorithm performance.
• Training set details for an AI model.

The document focuses on the mechanical testing of the interbody fusion system to demonstrate its substantial equivalence to predicate devices, not the performance of an AI or algorithmic medical device.

Therefore, I cannot provide the requested information about acceptance criteria and study details for an AI/algorithm-based device from the provided text. The text specifically details the mechanical performance assessment of a physical implantable device.

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The EUROPA™ Navigated Instruments are intended to be used in the preparation and placement of the EUROPA™ pedicle screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the stereotactic navigation system Medtronic StealthStation® 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 EUROPA™ Navigated Instruments is intended to be used with the EUROPA™ Pedicle Screw System. The EUROPA™ Navigated Instruments are non-sterile, re-usable instruments including probes, taps, and drivers that can be operated manually. These instruments are intended to be used with the Medtronic StealthStation ® System and are manufactured from Stainless Steel per ASTM F899.

The provided text does NOT include acceptance criteria or a study proving the device meets those criteria. The document is an FDA 510(k) clearance letter and a 510(k) summary for the "EUROPA™ Navigated Instruments."

This type of document primarily focuses on establishing substantial equivalence to already legally marketed predicate devices, rather than presenting a detailed clinical study with specific acceptance criteria, test sets, ground truth establishment, or human reader performance metrics. The information provided is high-level and generalized, stating that "Design validation testing included testing per ASTM F2554-18, and a one-to-one dimensional comparison to demonstrate substantially equivalent geometry that is critical to navigation accuracy. Testing, including anatomical and navigated simulated use and accuracy and reliability testing, has been conducted to verify that the EUROPA™ Navigated Instruments are appropriate for their intended use, to ensure functionality, accuracy, and compatibility with the Medtronic StealthStation® System using the NavLock Tracker, and to demonstrate substantial equivalence to the predicate instruments."

Therefore, I cannot fulfill your request for the specific details of acceptance criteria and the study that proves the device meets them from the provided text. The document does not contain the information required to construct the table or answer the specific questions about sample size, expert ground truth, adjudication, MRMC studies, standalone performance, or training set details.

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The CYGNUS™ MoRe Anterior Cervical Plate System is a spinal intervertebral body fixation orthosis which is intended to provide temporary immobilization of the anterior spine during the development of cervical spine fusions (C2 to C7) in patients with: (1) Degenerative disc disease, DDD (as defined by neck pain with degeneration of disc confirmed by patient history and radiographic studies); (2) Trauma (including fractures or dislocations); (4) Spinal cord stenosis; (5) Deformity or curvatures (i.e. kyphosis, lordosis); (6) Tumors: (7) Pseudoarthrosis: (8) Failed previous fusions.

The CYGNUS™ MoRe Anterior Cervical Plate System is a spinal intervertebral body fixation orthosis used to provide structural stability following anterior cervical discectomy and fusion for cervical degenerative disorders. The CYGNUS™ MoRe Anterior Cervical Plate System consists of implants manufactured from Wrought Molybdenum-47.5 Rhenium Alloy (MoRe) per ASTM F3273, Titanium-6 Vanadium ELI per ASTM F136, and instrumentation manufactured from Stainless Steel per ASTM F899. The system is offered in several configurations of various sizes to accommodate different patient anatomy and surgical approaches.

The provided text is a 510(k) summary for the CYGNUS™ MoRe Anterior Cervical Plate System. It describes the device, its intended use, and comparisons to predicate devices. However, this document does not include information about AI/ML models, image analysis, or any study involving "device performance" in terms of diagnostic accuracy, sensitivity, specificity, or human-AI collaboration.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details for AI performance, sample sizes for test/training sets, expert qualifications, ground truth establishment, or multi-reader studies. All the points in your request are relevant to AI/ML device submissions, which this document is not.

The document focuses on the mechanical and material performance of an orthopedic implant (spinal plate system) as per FDA guidelines for such devices. The "performance data" section only lists mechanical testing (e.g., static and dynamic compression bending, torsion testing) and bacterial endotoxin testing, which are standard for implantable medical devices to demonstrate structural integrity and biocompatibility.

In summary, this document does not contain the information needed to address your specific questions about AI/ML device performance or studies.

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The ANTARES 3DR™ Standalone Anterior Lumbar Interbody Fusion System is an interbody fusion device system placed via a variety of open or minimally invasive approaches and indicated for use:

• · In skeletally mature patients at one or more levels of the lumbosacral spine (L2-S1)
• · In patients having have received 6 months of nonoperative treatment prior to treatment
• With or without screws
• · With autograft bone and/or allogenic bone graft comprised of cancellous or corticocancellous bone graft

Standalone Use (with screws)
ANTARES 3DR™ Standalone Anterior Lumbar Interbody Fusion System is intended for stand-alone use in patients with DDD or with degenerative spondylolisthesis at one or two contiguous levels only when used with (1) at least three screws per implant (including at least one screw in each endplate) and (2) when ≤ 20° lordotic implants are used.

Use with Supplemental Fixation (with or without screws)
ANTARES 3DR™ Standalone Anterior Lumbar Interbody Fusion System is intended for use with supplemental fixation in patients with Degenerative disc disease (DD) defined as back pain with degeneration of the disc confirmed by patient history and radiographic studies, Spinal deformity (degenerative scoliosis), Spondylolisthesis or retrolisthesis, or failed previous fusion (pseudoarthrosis).

When used at more than 2 contiguous levels, with fewer than 3 accompanying screws, or when using implants greater than a 20° lordotic angle, the system must be supplemented by posterior fixation (e.g., pedicle screw system) cleared for use in the lumbar spine.

The ANTARES 3DR™ Standalone Anterior Lumbar Interbody Fusion System is an integrated anterior lumbar interbody fusion device used to provide structural stability following discectomy.

The system consists of an interbody cage additively manufactured from Titanium-6 Aluminum-4 Vanadium ELI per ASTM F3001, screws and locking mechanism manufactured from Titanium-6 Aluminum-4 ELI per ASTM F136, and instrumentation manufactured from Stainless Steel per ASTM F899.

The ANTARES 3DR™ Standalone Anterior Lumbar Interbody Fusion System cages are offered in several configurations of various sizes to accommodate different patient anatomy and surgical approaches.

I am sorry, but the provided text from the FDA 510(k) notification for the ANTARES 3DR™ Standalone Anterior Lumbar Interbody Fusion System does not contain any information regarding acceptance criteria or a study proving the device meets these criteria in the context of an AI/ML-driven medical device, as implied by the detailed questions about ground truth, expert readers, and training/test sets.

The document is a clearance letter for a physical medical device (an interbody fusion system), not an AI/ML software as a medical device (SaMD). The "Performance Data" section (Section IX on page 5) references mechanical testing standards for implants (ASTM F2077-18, ASTM F2267-04, ASTM Draft Standard F-04.25.02.02), which are standard for orthopedic implants to assess their structural integrity, compression, shear, and subsidence. These are not related to the performance of an algorithm or an AI model.

Therefore, I cannot extract the information required by your prompts regarding:

• Acceptance criteria for an AI/ML device and reported device performance
• Sample size and data provenance for a test set
• Number of experts and qualifications for ground truth establishment
• Adjudication method
• MRMC comparative effectiveness study
• Standalone algorithm performance
• Type of ground truth (expert consensus, pathology, outcomes data)
• Sample size and ground truth establishment for a training set

To provide a response to your request, I would need a document detailing the validation of an AI/ML medical device, not a physical implant.

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The IO™ Expandable Lumbar Interbody Fusion System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L1-L2 to L5-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Devices are to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.

The IO™ Expandable Lumbar Interbody Fusion System is an expandable lumbar interbody fusion device used to provide structural stability in skeletally mature individuals following discectomy. The IO™ Expandable Lumbar Interbody Fusion System consist of implants manufactured from titanium alloy (ASTM F136). Expansion mechanism components and the drive screw are manufactured from molybdenum rhenium (MoRe) alloy (ASTM F3273). The system is offered in various sizes to accommodate different patient anatomy requirements. Implants will be provided sterile and are intended for single use only.

This document describes the IO™ Expandable Lumbar Interbody Fusion System (K210800), a Class II medical device. The information provided outlines the performance data and equivalence to a predicate device, but it does not contain information related to software or AI performance, or any "acceptance criteria" or "study" that would involve a test set, ground truth, or expert review in the context of AI or diagnostic algorithms.

The performance data listed in the document refers to mechanical performance of the physical device, not the performance of an algorithm or software. Therefore, the requested information regarding acceptance criteria, sample size for test sets, data provenance, expert ground truth establishment, MRMC studies, standalone studies, or ground truth for training sets cannot be extracted from this document.

The provided text focuses on the device's physical and mechanical properties and its substantial equivalence to a predicate device for FDA clearance.

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The RIGEL™ 3DR Anterior Cervical Interbody Fusion System is an anterior cervical interbody indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level or two contiguous levels from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. Devices are to be used with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation.

The RIGEL™ 3DR (3D-printed Randomized-lattice) Anterior Cervical Interbody Fusion System consist of implants manufactured from Titanium 6AL-4V ELI per ASTM F3001-14 and instrumentation manufactured from stainless steel per ASTM F899. The Interbody Fusion Device is offered in various footprints, heights, and lordosis to accommodate different patient anatomy and the Anterior Cervical Surgical Approach. The implants will be provided sterile and are intended for single use only.

This document describes the RIGEL™ 3DR Anterior Cervical Interbody Fusion System, which is a medical device. The information provided is for regulatory clearance (510(k) submission) and focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study of its clinical performance with acceptance criteria in the typical sense of algorithm evaluation.

Therefore, many of the requested elements for an AI/algorithm-based device study (like sample size for test sets, data provenance, ground truth establishment by experts, MRMC studies, standalone performance, training set details) are not applicable to this submission as it is for a physical medical implant.

However, I can extract information related to the device's mechanical performance data which serves as the "study" for this type of device.

1. Table of Acceptance Criteria and Reported Device Performance

For this physical interbody fusion system, the "acceptance criteria" are implied by the standards chosen for mechanical testing, and the "reported device performance" is that it successfully met these standards. The specific numerical acceptance criteria (e.g., minimum load before failure) are not explicitly stated in this summary, but the conclusion of the submitted study is that the device meets the relevant performance requirements for 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)

• Sample size used for the test set: Not explicitly stated in this summary (e.g., number of devices tested). For mechanical testing, this would typically involve a specific number of samples for each test type, determined by statistical considerations for materials testing.
• Data provenance: Not applicable in the context of clinical data. This is mechanical engineering test data, likely performed in a lab setting.

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)

• Not applicable. Ground truth for mechanical testing is established by the physical testing itself and adherence to engineering standards. There are no "experts" in the human diagnostic sense establishing ground truth here.

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

• Not applicable. This is for mechanical testing, not a clinical trial requiring adjudication of patient outcomes or diagnoses.

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 physical medical implant, not an AI-assisted diagnostic device.

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

• Not applicable. This is a physical medical implant.

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

• The "ground truth" for this device's performance is its ability to withstand specified mechanical forces and conditions as defined by universally accepted ASTM (American Society for Testing and Materials) standards for intervertebral body fusion devices. This is a form of engineering standard compliance and physical performance measurement.

8. The sample size for the training set

• Not applicable. This is a physical medical implant; there is no "training set" in the context of an algorithm.

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

• Not applicable. This is a physical medical implant; there is no "training set" in the context of an algorithm.

Summary of Conclusions from the Document regarding Performance:

The document states under "IX. PERFORMANCE DATA":
"The mechanical performance profile of the RIGEL™ 3DR Anterior Cervical Interbody Fusion System was assessed through static and fatigue construct testing in accordance with the following test methods:

• Static and dynamic compression testing (ASTM F2077-18)
• Static and dynamic compression shear testing (ASTM F2077-18)
• Static and dynamic torsion testing (ASTM F2077-18)
• Subsidence testing (ASTM F2267-04)
• Expulsion testing"

And under "X. CONCLUSIONS":
"Performance data demonstrate that the RIGEL™ 3DR Anterior Cervical Interbody Fusion System is substantially equivalent to legally marketed predicate systems."

This indicates that all required mechanical tests were performed and the device successfully met the performance characteristics expected for substantial equivalence, as defined by the referenced ASTM standards and comparison to predicate devices.

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