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The DOMINION Expandable Corpectomy System is indicated for vertebral body replacement in the cervical spine (C2-Tl) and the thoracolumbar spine (T1-L5). The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion.

When used in the cervical spine (C2-T1), DOMINION spacers are in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor fracture or osteomyelitis, or for reconstruction following corpectorny performed to achieve decompression of the spinal cord and neural tissues in the cervical degenerative disorders. These spacers are 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 expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion. The System is intended to be used with supplemental fixation that has been cleared by the FDA for use in the cervical spine. When used in the thoracolumbar spine (T1-L5), DOMINION spacers are intended for use to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). These spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

The system is intended to be used with supplemental fixation that has been cleared by the FDA for use in the thoracolumbar spine (i.e. posterior screw and rod systems, and anterior screw and rod systems). When used at more than two levels, supplemental fixation should include posterior fixation.

The Dominion Expandable Corpectomy system is a modular system comprised of Expandable Columns, Modular Endplates, and optional screws. The primary purpose of the Expandable Column is to provide mechanical support to the anterior column of the spine after a vertebral corpectomy is performed. The primary function of the Modular Endplates is to provide attachment points for the Expandable Column to the vertebral endplates. The screws are an optional device that can provide enhanced fixation to the vertebral endplates when desired. The system contains Inserters which allow the insertion and expansion of the Expandable Columns.

The document provided is a 510(k) premarket notification for a medical device (DOMINION Expandable Corpectomy System) and does not describe a study involving humans or AI for diagnostic purposes. Therefore, most of the requested information regarding acceptance criteria and study details cannot be extracted from this document because it is not relevant to this type of device submission.

Here's a breakdown of what can be inferred from the document and why other points cannot be addressed:

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

The document lists several non-clinical tests that were performed, which inherently have acceptance criteria. However, the specific acceptance criteria values (e.g., minimum compression strength, maximum torsion deformation) and the reported device performance values (the actual measurements from the tests) are not detailed in this summary. It only states that the following analyses were conducted:

The summary states, "Astura Medical considers the DOMINION Expandable Corpectomy Spacer to be equivalent to the predicate devices listed above. This conclusion is based upon the devices' similarities in principles of operation, technology, materials and indications for use." This implies that the non-clinical tests demonstrated performance comparable to or better than the predicate devices, thereby meeting relevant acceptance criteria established for such devices.

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

This information is not provided in a 510(k) summary for non-clinical (mechanical) testing. Sample sizes for mechanical tests are typically dictated by testing standards (e.g., ASTM standards) rather than patient data. Data provenance like country of origin or retrospective/prospective is not applicable to mechanical performance 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 as the device is a spinal implant, and the "ground truth" for its performance is established through mechanical testing against engineering standards, not through expert human interpretation of medical images or patient data.

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

Not applicable. Mechanical test results are objective measurements and do not typically require adjudication by experts in the same way clinical or diagnostic studies do.

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

The document explicitly states: "No clinical studies were performed." Therefore, an MRMC comparative effectiveness study was not done. This device is not an AI-powered diagnostic tool.

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

Not applicable. This is not an AI algorithm.

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

For this medical device, the "ground truth" for its safety and effectiveness is established through the adherence to recognized international and national mechanical testing standards (e.g., ASTM F2077, ASTM F2267) and the comparison of its performance to legally marketed predicate devices. It is based on engineering principles and material science, not clinical outcomes or expert consensus in a diagnostic sense.

8. The sample size for the training set

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

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

Not applicable. As above, this device is not an AI system.

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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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