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The Blustone Synergy Diamond SA Cervical System are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous bone graft when used as an adjunct to fusion in patients with cervical degenerative disc disease (DDD) at one level or two contiguous levels from C2 to T1. Degenerative Disc Disease is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six weeks of non-operative treatment. The Blustone Synergy Diamond SA Cervical System may be used with additional supplemental fixation.

The BluStone Synergy Diamond Stand Alone (SA) Cervical System consists of the Diamond cervical interbody plate and screws to be used in conjunction with the Blustone Synergy Interbody Fusion SLATE cervical interbody fusion devices to form the Diamond Stand Alone Cervical System. The Diamond Stand Alone cervical system is designed to be used with allograft and/or autograft. Use of the Diamond SA Cervical System is intended to expedite the Anterior Cervical Device instrumentation procedure, while minimizing tissue disruption through a minimally invasive approach. The Diamond plate includes anterior nail spikes to resist rotation and two holes for insertion of the included bone screws as well as an integrated locking plate to resist bone screw backout. The Diamond cervical interbody plate and screws are manufactured from titanium alloy. Previously cleared SLATE cervical cages to be used with the Diamond plate and screws are manufactured from PEEK and include tantalum markers. All implant components are available in various sizes to accommodate varying patient anatomy.

The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria in the context of AI/ML performance. The document is an FDA 510(k) clearance letter for a medical device called the "Blustone Synergy Diamond SA Cervical System," which is an intervertebral body fusion device.

The "Performance Testing" section mentions bench performance testing conducted on the device, including:

• Static and dynamic axial compression
• Static and dynamic axial compression shear
• Static and dynamic torsion per ASTM F2077-18
• Subsidence per ASTM F2267-04 (2018)
• Expulsion

It states that "Testing shows that the subject Blustone Synergy Diamond SA Cervical System performs equivalent to or better than the 5th percentile of FDA benchmark values." This implies there are FDA benchmark values that serve as acceptance criteria for mechanical performance.

However, the document does not discuss AI/ML device performance, acceptance criteria, or studies related to AI/ML device evaluation. It primarily focuses on the substantial equivalence of a physical surgical implant based on mechanical engineering tests.

Therefore, I cannot provide the requested information regarding AI/ML device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

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The DOLOMITE Stand-Alone Cervical Interbody Spacer is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at disc levels (C2-T1). Cervical degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients should have at least six weeks of nonoperative treatment with intervertebral cages. 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 Dolomite Spacer is an interbody fusion device intended to be used with supplemental fixation for one or two levels of the cervical spine.

The DOLOMITE Spacer and Plate assembly are an integrated interbody fusion device intended for stand-alone use at one or two levels of the cervical spine (C2-T1) and used with titanium alloy screws. Multiple full plate assembly configurations can't be used in conjunction for two contiguous levels of the cervical spine. When used with anchors, the assembly is intended for use at one level of the cervical spine with additional supplemental fixation that has been cleared by the FDA for use in the cervical spine.

The DOLOMITE Anterior Cervical Stabilization System are implants developed for the stabilization of the cervical column. The spacers are a 2-piece modular design which allows for interchangeable plate and spacer components. The plate and spacer components contain interlocking features in addition to a locking mechanism which allows for intraoperative assembly prior to implantation. The spacer components are available in a range of footprints and heights in PEEK OPTIMA LT120HA or machined Titanium alloy. The plates are offered in multiple fixation types and sizes to suit the individual pathology and anatomical conditions of the patient in machined Titanium alloy. The implants have a hollow center to allow placement of autogenous bone graft. The superior and inferior surfaces are open to promote contact of the bone graft with the vertebral end plates to allow bone growth.

The provided text is a 510(k) Premarket Notification from the U.S. Food and Drug Administration (FDA) regarding the Astura Medical, LLC's "DOLOMITE Anterior Cervical Stabilization System." This document is a regulatory notice of substantial equivalence for a medical device and does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria in the context of an AI/ML powered medical device, which is what the prompt is asking for.

The document explicitly states under "Clinical Test Summary" that "No clinical studies were performed." and under "Non-clinical Test Summary" that "The following analyses were conducted: Dynamic Compression Static Compression Dynamic Torsion Static Torsion. The results of these evaluations indicate that the Dolomite implants are equivalent to predicate devices."

Therefore, I cannot provide the requested information about acceptance criteria and a study proving a device meets them, specifically in the context of an AI/ML powered medical device, based on the provided text. The text describes a conventional medical device (an intervertebral body fusion device) and its regulatory clearance process, which relies on demonstrating substantial equivalence to predicate devices through mechanical testing, rather than performance against specific acceptance criteria in a clinical study of an AI/ML product.

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The Elevation Spine Saber-C System is a cervical interbody for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) and is for use at a single spinal level. DDD is defined as discogenic 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) weeks of non-operative treatment. The SABER-C Spacer is to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.

The SABER-C Spacer is intended to be used with supplemental fixation, such as anterior cervical plates or posterior cervical screw fixation. When the SABER-C Spacer is used with the SABER-C Anterior Cervical Plate and screws, the plate-spacer-screw assembly can be used as a stand-alone device with the SABER-C Anterior Cervical Plate acting as the supplemental fixation. When the SABER-C Spacer is used with the SABER-C Anterior Cervical Plate and spikes, the plate-spacer-spike assembly should be used with additional supplemental fixation such as posterior cervical screw fixation.

The SABER-C Anterior Cervical Plate, when used without the spacer component and with screws, is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis. The Anterior Cervical Plate is not to be used with spikes when used without the Spacer component.

The SABER-C System is a cervical interbody fusion device used to provide structural stability in skeletally mature individuals following discectomy. The SABER-C System is inserted through an anterior cervical approach and is available in various geometric and material options to fit the clinical needs of the patient. The SABER-C System Anterior Cervical Plate is an anterior cervical fixation device this is available in various geometric and fixation options and can be used with various types of interbody spacers.

The SABER-C System is made from radiolucent polymer, with titanium alloy or tantalum markers, as specified in ASTM F2026. ASTM F136. ASTM F1295, and ASTM F560. The SABER-C Anterior Cervical Plate and two fixation options, spike or screws, are manufactured from titanium alloy, as specified in ASTM F136 and ASTM F1295. The plate is not to be used with spikes when used without the Spacer component.

The provided text describes a 510(k) submission for the Elevation Spine Saber-C System, an intervertebral body fusion device. The document focuses on demonstrating substantial equivalence to predicate devices through performance testing.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: The document does not specify the exact numerical sample size for individual mechanical tests (e.g., number of devices tested for axial compression). It only states that "Three configurations of the Elevation Spine Saber-C System were tested". For the cadaver implantation study, the sample size is also not specified, only that "a cadaver implantation study was performed".
• Data Provenance: The data provenance is not explicitly mentioned (e.g., country of origin, specific testing facility). However, given that it's an FDA submission, the testing would typically be performed in a controlled laboratory setting, likely in the US or a country with comparable regulatory standards. The studies appear to be prospective in nature, as they involve testing the actual device configurations.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

• This type of information is not applicable to the mechanical and cadaveric testing described. These tests rely on objective physical measurements and adherence to engineering standards (ASTM), not on expert human interpretation of data for ground truth establishment.

4. Adjudication Method for the Test Set:

• This is not applicable as the tests performed are objective mechanical and implantation studies, not studies involving human interpretation or consensus.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• A MRMC comparative effectiveness study was not conducted. The provided text describes mechanical performance testing and a cadaver implantation study, not studies involving human readers and interpretation of medical images.

6. Standalone (Algorithm Only) Performance Study:

• A standalone performance study of an algorithm was not conducted. This device is a physical intervertebral fusion system, not an AI/algorithm-based diagnostic or therapeutic tool. The testing focuses on its mechanical and physical performance.

7. Type of Ground Truth Used:

• The "ground truth" for the performance testing is based on objective engineering standards and physical measurements. For mechanical tests, this means adherence to the specifications and performance envelopes outlined in ASTM F2077-14 and F2267-11, and comparison to predicate device performance. For the cadaver study, successful implantation and observation of stability would serve as the "ground truth" for that aspect.

8. Sample Size for the Training Set:

• This information is not applicable. This submission details a physical medical device. There is no AI model or algorithm that requires a "training set" in the context described.

9. How the Ground Truth for the Training Set Was Established:

• This information is not applicable as there is no training set for an algorithm.

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