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The EVOL® ha - Hyper C Cervical Interbody Fusion System is intended for intervertebral body fusion of the spine in skeletally mature patients. The EVOL® ha - Hyper C Cervical Interbody Fusion System is indicated for use for anterior cervical interbody fusion in patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, or scollosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies at up to two contiguous levels from C2 - T1.

The EVOL® ha – Hyper C Cervical Interbody Fusion System is intended to be used with supplemental fixation. The EVOL® ha - Hyper C Cervical Interbody Fusion System is intended for use with autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to facilitate fusion. The cervical devices are to be used in patients who have had at least six weeks of non-operative treatment.

The EVOL® ha – Hyper C Cervical Interbody Fusion System is designed for use as a cervical interbody fusion device and consists of various sizes to accommodate individual patient anatomy. The sizes vary by footprint (width and lordotic and lordotic ande. All sizes have a central window for bone graft. The inferior and superior faces have teeth to resist migration when placed in between the vertebral bodies. Each spacer has tantalum beads, per ASTM F560, imbedded in the device to aid visualization under fluoroscopy. The implants are manufactured from PEEK-OPTIMA® LT120 HA (Invibio) per ASTM F2026.

The provided FDA 510(k) Clearance Letter for the EVOL® ha - Hyper C Cervical Interbody Fusion System does not contain details about acceptance criteria or specific studies proving device performance against such criteria in the way you've described (e.g., related to AI/ML device performance metrics like sensitivity, specificity, MRMC studies, or ground truth establishment).

This document is a marketing clearance for a traditional medical device (an intervertebral body fusion system, which is a physical implant) and not a software-as-a-medical-device (SaMD) or an AI/ML powered device. The "acceptance criteria" and "studies" you're asking about are typically associated with the rigorous validation of diagnostic accuracy or clinical utility for AI/ML systems.

Instead, for this physical medical device, "acceptance criteria" would primarily relate to its mechanical and material performance to ensure it is substantially equivalent to a predicate device and safe/effective for its intended use. The "studies" mentioned are non-clinical (benchtop) tests to demonstrate this.

Here’s a breakdown based on the information provided, adapted to the context of a physical implant:

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

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

• Sample Size: Not specified in the document. For benchtop mechanical testing (like ASTM F2077 and expulsion testing), sample sizes are typically determined by the specific ASTM standard or internal quality protocols to achieve statistical significance for engineering parameters, but they are generally small (e.g., 5-10 devices per test condition depending on variability).
• Data Provenance: The tests are non-clinical, meaning they are laboratory/benchtop studies. There is no patient data involved (retrospective or prospective) for this type of device validation.

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. For a physical interbody fusion device, "ground truth" in the diagnostic AI sense does not apply. The "ground truth" for mechanical testing is established by the engineering specifications and performance standards defined in ASTM or similar bodies. Expert interpretation might be involved in initial design and test protocol development (e.g., biomechanical engineers), but not in establishing a diagnostic "ground truth" for a test set.

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

• Not Applicable. Adjudication methods are used to establish a consensus "ground truth" for diagnostic labels in medical imaging or pathology, often in the context of human reader studies for AI/ML devices. This is not relevant for the mechanical testing of a physical implant.

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:

• No. This type of study (MRMC for AI assistance) is not applicable to a physical intervertebral body fusion system.

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

• No. This is

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When used with the integrated fixation and as a standalone system:

The Genesys Spine AIS-C II Cervical Interbody Fusion System is a standalone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level 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. The Genesys Spine AIS-C II Cervical Interbody Fusion System is to be used with autogenous bone graft and implanted via an anterior approach.

When used without the integrated fixation:

The Genesys Spine AIS-C II Cervical Interbody Fusion System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation (i.e., cleared cervical plating system) and with autograft to facilitate fusion. These patients should have had six weeks of non-operative treatment.

The Genesys Spine AIS-C II Cervical Interbody Fusion will be offered in various device configurations based on surgical approach and patient anatomy. The AIS-C II System has two interbody options: Regular or Standalone.

The Regular Cervical Interbody System does not require the use of Anchors but is designed for use with supplemental fixation (i.e., cleared cervical plating system).

The Standalone Cervical Interbody System requires the use of Anchors for integrated fixation. This version includes an integrated cam lock mechanism and various sizes of anchors. The cam lock mechanism may be used as a secondary aid in keeping the anchors from backing out of the interbody and vertebral bodies. After anchor deployment, a cam lock key is used to turn the lockwise) to engage the cam lock and secure the anchors. When engaged (closed), the wings of the cam lock cover the anchor channels and provide a backing plate for the anchors.

The subject and predicate devices are based on the same technological characteristics: Integrated fixation anchors provide additional biomechanical support to the interbody. lmplant materials are identical: PEEK, Titanium 6AL-4V ELI alloy, and tantalum. A single inserter can be used to position the interbody and deploy the anchors.

The provided text is a 510(k) summary for the Genesys Spine AIS-C II Cervical Interbody Fusion System. It describes the device, its indications for use, and a comparison to predicate devices, focusing on technological characteristics and mechanical testing. However, the document does not contain information related to software, artificial intelligence (AI), or clinical studies involving human readers or expert ground truth adjudication.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance related to AI or software.
• Sample sizes, data provenance, number of experts, qualifications of experts, or adjudication methods for test sets.
• Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Details on standalone algorithm performance.
• Type of ground truth used for AI/software evaluation.
• Sample size for the training set or how ground truth was established for a training set.

The document focuses on the mechanical performance of a physical medical implant (intervertebral body fusion device) and demonstrates substantial equivalence to predicate devices through non-clinical mechanical testing.

Here's the relevant information that is present in the document regarding the device's acceptance criteria and the study proving it:

1. Acceptance Criteria and Reported Device Performance (Mechanical Testing)

The acceptance criteria are implicitly defined by the guidance documents and consensus standards listed, aiming to demonstrate the mechanical performance of the device is equivalent or superior to predicate devices and generally accepted standards for intervertebral body fusion devices.

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

• Sample size: Not specified in the provided text. Mechanical testing typically involves a number of devices or components to establish statistical significance for properties like strength, fatigue, and subsidence, but the exact number is not detailed here.
• Data provenance: Not applicable in the context of human data or AI. The "data" refers to the results of in vitro mechanical tests conducted on the device itself.

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

• Not applicable. This is a physical device; its mechanical performance is measured directly by adherence to engineering standards and comparison to established benchmarks from other devices, not by expert consensus on clinical cases.

4. Adjudication method for the test set:

• Not applicable. Mechanical testing results are objective measurements against defined parameters.

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:

• No. The document explicitly states: "Clinical testing is not required." This device is not an AI-powered diagnostic or assistive tool for human readers.

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

• Not applicable. This is a physical surgical implant, not a standalone algorithm.

7. The type of ground truth used:

• Not applicable in the AI/software sense. The "ground truth" for this device's performance is established through internationally recognized engineering standards (ASTM, ISO) for static and dynamic mechanical properties, and comparative data from previously cleared devices, as measured in a laboratory setting.

8. The sample size for the training set:

• Not applicable. This device is not an AI/software product, so there is no training set.

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

• Not applicable. This device is not an AI/software product, so there is no training set or ground truth establishment relevant to AI.

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The Align Cervical Interbody Fusion is indicated for intervertebral body fusion of the spine in skeletally mature patients who have had at least six months of non-operative treatment. The device systems are designed for use with allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and/or autograft to facilitate fusion. One device is used per intervertebral body space. The Align Cervical Interbody Fusion System is intended for use at either one level or two contiguous levels in the cervical spine, from C2 to T1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Align Cervical Interbody Fusion is intended to be used with supplemental spinal fixation system cleared for use in the cervical spine.

The Align Cervical Interbody Fusion System consists of intervertebral body fusion devices that are implanted in the intervertebral body space via an anterior approach to improve stability of the spine while supporting fusion. Components are offered in different shapes and sizes to meet the requirements of the individual patient anatomy. Align cervical cages will be manufactured from titanium alloy per ASTM F3001 and will be offered with an optional hydroxyapatite (HA) coating. Implants will be provided sterile by gamma irradiation.

The provided text is a 510(k) summary for the "Align Cervical Interbody Fusion System," a medical device, and not an AI/ML device. Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and studies proving the device meets those criteria for an AI/ML device.

The document discusses:

• Device Type: Intervertebral body fusion device
• Regulatory Classification: Class II
• Intended Use: Intervertebral body fusion of the cervical spine for degenerative disc disease.
• Materials: Titanium alloy with optional hydroxyapatite (HA) coating.
• Performance Testing: Confirmatory fatigue testing (dynamic compression shear, and dynamic torsion per ASTM F2077) – this is mechanical testing for an implant, not AI/ML performance.
• Substantial Equivalence: Comparison to predicate devices based on indications for use, materials, and geometry.

There is no mention of:

• Acceptance criteria for an AI/ML algorithm.
• Performance metrics like sensitivity, specificity, AUC, etc.
• Sample sizes for test or training sets related to AI/ML data.
• Experts establishing ground truth for AI/ML.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies for AI assistance.
• Standalone algorithm performance.
• Provenance of data (country, retrospective/prospective).
• Ground truth methods (pathology, outcomes data).

Therefore, I cannot populate the requested table or answer the questions related to AI/ML device acceptance criteria and study details based on the provided text.

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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 Curiteva Porous PEEK Cervical Interbody Fusion System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The Curiteva Porous PEEK Cervical Interbody Fusion System is intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The System is intended to be used with supplemental fixation. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

The Curiteva Porous PEEK Cervical Interbody Fusion System implants are sterile, single-use devices and available in a variety of different footprints, styles and sizes to accommodate the individual pathology and anatomical conditions of the patient. The implants are generally boxshaped with an open central corridor to permit packing with bone graft to facilitate fusion. The implants have a dense central ring with a porous structure lining the vertical graft corridor and on the superior and inferior surfaces of the construct. Each implant has been surface treated with a hydroxyapatite (HA) coating that is approximately 20nm thick. The Curiteva Porous PEEK Cervical Interbody Fusion System implants are manufactured from implant-grade PEEK (per ASTM F2026) with Titanium alloy markers (per ASTM F136).

This document is a 510(k) summary for a medical device called the "Curiteva Porous PEEK Cervical Interbody Fusion System." This type of document is used to demonstrate substantial equivalence to previously cleared devices rather than providing a study that proves the device meets specific acceptance criteria in the context of AI/ML or diagnostic performance. Instead, it demonstrates the device's functional and safety equivalence through non-clinical performance data.

Therefore, many of the requested elements pertaining to clinical study design, ground truth, expert adjudication, and AI performance metrics are not applicable to this type of regulatory submission. I will address the relevant sections based on the provided text.

Here's a breakdown of the requested information based on the provided 510(k) Summary:

Acceptance Criteria and Device Performance Study

The "Curiteva Porous PEEK Cervical Interbody Fusion System" is a medical implant, and its regulatory clearance process (510(k)) focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than meeting specific performance acceptance criteria related to AI/ML or diagnostic accuracy, which would typically involve clinical studies with human readers and ground truth.

For this device, the "acceptance criteria" are implicitly met by demonstrating that the device performs equivalently to the predicates when subjected to a battery of non-clinical (mechanical) tests. The "study that proves the device meets the acceptance criteria" refers to these non-clinical performance tests.

1. Table of Acceptance Criteria and Reported Device Performance

The concept of explicit quantitative "acceptance criteria" with a pass/fail threshold, as might be found for a diagnostic AI, is not detailed in this type of 510(k) summary for a spinal implant. Instead, the performance is demonstrated by showing the device withstands stresses comparable to predicate devices and industry standards. The reported device performance is that the device meets or is sufficient for its intended use and is substantially equivalent to the predicate devices. The specific numerical results of these tests are not included in the summary.

• Axial compression strength | Sufficient for intended use, substantially equivalent to predicate devices. |
  | - Compression-shear strength | Sufficient for intended use, substantially equivalent to predicate devices. |
  | - Torsion strength | Sufficient for intended use, substantially equivalent to predicate devices. |
  | - Subsidence resistance | Sufficient for intended use, substantially equivalent to predicate devices. |
  | - Wear debris characteristics | Sufficient for intended use, substantially equivalent to predicate devices. |
  | - (Additional tests like expulsion, impaction) | Sufficient for intended use, substantially equivalent to predicate devices. |
  | Material Compatibility:
• Biocompatibility (implied) | PEEK (ASTM F2026) with Titanium alloy markers (ASTM F136), HA coating. |

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

The "test set" in this context refers to the physical samples of the Curiteva Porous PEEK Cervical Interbody Fusion System that underwent mechanical testing. The specific number of samples tested for each mechanical test is not provided in the summary.

Data Provenance: The data comes from non-clinical (laboratory) testing conducted on the manufactured device models. There is no mention of country of origin of the data or whether it's retrospective/prospective, as these terms are generally applicable to clinical human data.

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

This question is not applicable to this type of device and submission. "Ground truth" established by experts (like radiologists for imaging devices) is relevant for diagnostic performance studies. For an intervertebral body fusion device, mechanical properties are evaluated against engineering standards and comparison to predicate devices, not against expert interpretation of patient data.

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

This question is not applicable. Adjudication methods are used in clinical studies, particularly for diagnostic devices, to establish a consensus "ground truth" among multiple readers. For mechanical testing of an implant, the results are derived from physical measurements and engineering analyses, not from human interpretation requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This question is not applicable. MRMC studies are typically performed for diagnostic imaging devices where human readers interpret medical images, often with or without AI assistance. This submission pertains to a physical spinal implant.

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

This question is not applicable. This refers to AI algorithm performance. The Curiteva Porous PEEK Cervical Interbody Fusion System is a physical medical implant, not an algorithm.

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

This question is not applicable in the traditional sense of clinical "ground truth." For mechanical tests, the "ground truth" is defined by established engineering principles, ASTM (American Society for Testing and Materials) standards (e.g., ASTM F2077, ASTM F2267, ASTM F1877), and the performance characteristics of previously cleared predicate devices. The device's performance is compared against these engineering benchmarks and predicate device data.

8. The sample size for the training set

This question is not applicable. A "training set" refers to data used to train an AI/ML algorithm. This device is a physical implant and does not involve AI/ML.

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

This question is not applicable. As there is no AI/ML training set, there is no ground truth established for it.

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The Eminent Spine 3D Cervical Interbody Fusion is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radios. The device system is designed for use with supplemental fixation and autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The Eminent Spine 3D Cervical Interbody Fusion System is comprised of various sizes and configuration to accommodate individual patient anatomy. The device is a hollow rectangular shaped block, which is available in a parallel or lordotic configurations. The device is hollow to allow for placement of bone graft. There are teeth on the superior and inferior surfaces of the device to inhibit movement of the device.

This submission is to introduce additively manufactured versions of the implants to the existing Eminent Spine Copperhead Interbody Fusion System.

This document is a 510(k) premarket notification for the Eminent Spine 3D Cervical Interbody Fusion System. It aims to prove the substantial equivalence of the new device to existing predicate devices.

Here's the breakdown of the acceptance criteria and the study information as requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document refers to "mechanical testing" and "results," but does not specify the sample size for the test set used in the mechanical tests.
The data provenance is from mechanical testing of the device, likely conducted in a laboratory setting. The country of origin and whether it was retrospective or prospective is not mentioned for the mechanical testing data.

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

This information is not applicable as the study presented is a mechanical performance study, not a clinical study involving expert interpretation for ground truth.

4. Adjudication method for the test set

This information is not applicable for a mechanical testing study.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This document focuses on the mechanical substantial equivalence of a medical implant, 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 as this is not an AI algorithm.

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

For the mechanical testing, the "ground truth" is established by the specified ASTM standards (F2077 and F2267) and potentially by comparing the performance to the predicate devices. These standards define the acceptable mechanical properties for such devices.

8. The sample size for the training set

This information is not applicable as there is no mention of a "training set" for AI or other data-driven modeling in this device submission. The device is a physical implant, and the testing described is mechanical.

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

This information is not applicable as there is no training set mentioned or implied in the provided document.

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The Tailored-C Cervical Interbody Fusion Devices are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Tailored-C Cervical implants are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at one disc level (C2-T1) using autograft bone. Tailored-C Cervical implants are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The Tailored-C Cervical Interbody Fusion System is an intervertebral spinal fixation system comprised of additively manufactured cervical interbody spacers. They are designed to provide mechanical support to the cervical spine while arthrodesis occurs. The implant has a partially porous construction and an open architecture with a large variety of footprints and lordosis angles to optimize patient fit. The footprints are offered at 11x13mm, 12x14mm, 14x16mm, 16x18mm, and 17x19mm. The lordosis is offered at 0°, 4°, and 7°. The height ranges from 5mm to 12mm in 1mm increments. All implant components are manufactured from Ti-6A1-4V per ASTM F3001.

This FDA 510(k) summary describes a physical medical device (an intervertebral fusion system), not a software or AI-based device. Therefore, the requested information regarding acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance), and training set information is not applicable.

The document discusses the mechanical performance testing of the Tailored-C Cervical Interbody Fusion System. Here's a breakdown of the relevant performance data and conclusion provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative table format with corresponding reported values. Instead, it lists the types of performance tests conducted and generally states that the results show the device is "sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."

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

Not applicable. This is a mechanical device, and testing involves physical samples of the device itself rather than data from human subjects. The testing standards are ASTM F2077 and F2267, which are international standards for intervertebral body fusion 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):

Not applicable. Ground truth, in the context of AI/software, refers to verified labels or diagnoses. For a mechanical device, performance is measured against engineering specifications and industry standards.

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

Not applicable. Adjudication is relevant for human interpretation or labeling tasks, not for mechanical testing.

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 interbody fusion system, not an AI or imaging device involving human readers.

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

Not applicable. This is a physical device, not an algorithm.

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

Not applicable in the AI/software sense. The "ground truth" for mechanical testing would be the established engineering specifications and performance requirements defined by standards like ASTM F2077 and F2267, against which the device's physical performance is measured.

8. The sample size for the training set:

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

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

Not applicable.

In summary: The provided text details the mechanical testing performed on the Tailored-C Cervical Interbody Fusion System to demonstrate its substantial equivalence to predicate devices, focusing on its physical strength and durability according to established ASTM standards. The concepts of AI/software performance evaluation requested in the prompt do not apply to this type of medical device submission.

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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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When used as a cervical intervertebral body fusion device, the Republic Spine Restore Cervical Interbody Fusion System is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The Republic Spine Restore Cervical Interbody Fusion System will be offered in various device configurations based on surgical approach and patient anatomy, and consist of a Republic Spine Restore cervical interbody fusion device, which is intended to be implanted as a single device via an anterior approach.

The provided text is a 510(k) premarket notification for a medical device (Republic Spine Restore Cervical Interbody Fusion System). It does not contain information related to an AI/ML-based medical device study, acceptance criteria, or performance data for such a study.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving a device meets these criteria based on the input provided. The document describes mechanical testing for an implantable device, not a study evaluating an AI system's performance.

To answer your request, I would need a document detailing the clinical performance study of an AI-powered medical device, including information on its acceptance criteria, study design, expert involvement, and ground truth establishment.

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The RIGEL™ PEEK 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™ Interbody Fusion System consist of implants manufactured from medical implant grade VESTAKEEP®i4R PEEK per ASTM F2026-17 with tantalum markers fabricated from medical implant grade ASTM F560-17. The Interbody Fusion Devices are offered in three footprints, various heights, and lordosis to accommodate different patient anatomy and an anterior surgical approach. The implants will be provided non-sterile and are intended for single use only.

This document is a 510(k) premarket notification for the RIGEL™ PEEK Anterior Cervical Interbody Fusion System. It primarily focuses on demonstrating substantial equivalence to predicate devices based on mechanical performance and design specifications, rather than AI-driven diagnostic or assistive technology. Therefore, the information requested for AI/software-based device evaluation (e.g., acceptance criteria for AI performance, clinical study details, ground truth establishment, MRMC studies, training/test set details) is not present in this document.

The document discusses:

• Acceptance Criteria: While not explicitly listed as "acceptance criteria" in a table for performance metrics (as might be expected for an AI device), the studies performed (Static and dynamic compression, static and dynamic shear per ASTM F2077-17, and Subsidence testing per ASTM F2267-04) served as the basis for demonstrating equivalence in mechanical performance. The "acceptance criteria" here is implicitly that the device performs mechanically comparably to the predicate devices as per these ASTM standards.
• Device Performance: The document states, "The preclinical testing listed above that was performed on the RIGEL™ PEEK Anterior Cervical Interbody Fusion System indicate that it is substantially equivalent to the predicate devices in mechanical performance." No specific numerical performance values are provided.

Therefore, since the device is a physical interbody fusion system and not a software/AI product, the detailed information about AI-specific acceptance criteria, study methodologies for AI performance, expert adjudication, MRMC studies, and training/test set ground truth (points 1-9 in your request) is not applicable or available in this submission.

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