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The EGPS Navigated Instruments are indicated for use during the preparation and placement of Astura Medical screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The EGPS Navigated Instruments are reusable and are specifically designed for use with the Globus Medical Excelsius GPS® Robotic Navigation Platform which is intended for precisely locating anatomical structures and for the special position of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. Use of the EGPS Navigated Instrument System is limited to use only with the Olympic and Masada spinal fixation systems (Olympic K153446, Olympic MIS K182239, Masada K231694).

Astura Medical EGPS Navigated Instruments are non-sterile, reusable instruments including a drill and drivers that can be operated manually. These instruments are intended to be used with the Globus Medical Excelsius GPS® Robotic Navigation Platform to aid in implantation of associated Astura Medical screw implants. The instruments are manufactured from stainless steel per ASTM F899.

The provided text is a 510(k) summary for the Astura Medical EGPS Navigated Instruments. It does not describe a study involving an AI/Machine Learning device or a diagnostic device that would have typical acceptance criteria and a study design as outlined in your request.

Instead, this document pertains to a Class II surgical instrument (Stereotaxic Instrument) that is intended for use with a pre-existing robotic navigation platform. The FDA's review for this type of device typically focuses on substantial equivalence to a predicate device, which involves demonstrating similar performance, design, materials, and indications for use.

Therefore, most of the specific points in your request regarding acceptance criteria for device performance, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment are not applicable to this submission, as it's not a diagnostic AI/ML device.

However, I can extract the relevant information concerning the non-clinical tests that were performed to demonstrate substantial equivalence for this surgical instrument.

Here's the closest interpretation of your request based on the provided text:

Device: EGPS Navigated Instruments

Device Type: Surgical Instrument (Stereotaxic Instrument) for spinal surgery, used with a robotic navigation platform.

Nature of FDA Submission: 510(k) Premarket Notification, seeking substantial equivalence to a predicate device.

Absence of AI/ML Study Data: The document explicitly states "No clinical studies were performed" and the "Non-clinical Test Summary" only lists "Comparative dimensional analysis of subject instruments with predicate." This indicates that the device's acceptance was based on non-clinical engineering and design verification, not on clinical performance metrics typically associated with AI/ML or diagnostic devices.

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

The document does not present specific quantitative acceptance criteria or detailed performance metrics in the format of a clinical performance study for an AI/ML device. Instead, it relies on demonstrating equivalence through design and material comparisons.

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

• Sample Size for Test Set: Not applicable in the context of an AI/ML test set. The non-clinical test involved "Comparative dimensional analysis," which refers to comparing the manufactured subject instruments to the specifications or dimensions of the predicate, likely involving engineering measurements rather than a "sample set" of patient data.
• Data Provenance: Not applicable. The "data" here would be engineering measurements and material specifications, not patient data from a specific country or collected retrospectively/prospectively.

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

• Not applicable. Ground truth, in the context of AI/ML, refers to validated clinical outcomes or expert labels. For a surgical instrument, "ground truth" would relate to engineering specifications and manufacturing tolerances, which are established by design engineers and quality control personnel, not typically clinical experts for labeling.

4. Adjudication method for the test set

• Not applicable. There was no "test set" of clinical data requiring expert 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

• No. This is a surgical instrument, not an AI/ML diagnostic or assistive technology that would be subject to an MRMC study.

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

• Not applicable. This device is not an algorithm. It is a physical instrument intended for use by a surgeon, assisted by a separate robotic navigation platform.

7. The type of ground truth used

• The "ground truth" for this device's acceptance is based on engineering specifications, material standards (ASTM F899), and documented design equivalence to the predicate device. There is no clinical "ground truth" in the typical sense of pathology or outcomes data for this specific submission.

8. The sample size for the training set

• Not applicable. There is no AI/ML training set involved.

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

• Not applicable. There is no AI/ML training set involved.

In summary, this 510(k) submission for the EGPS Navigated Instruments is for a physical surgical device, not a software-based AI/ML diagnostic tool. Therefore, the questions related to clinical study design for AI/ML devices are not relevant to this document. The manufacturer demonstrated substantial equivalence primarily through non-clinical comparative analysis of the instrument's design, materials, and intended use with its predicate.

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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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