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When intended to promote fusion of the cervical spine and the thoracic spine, (C1-T3), the GALAXY™ 3.2 Spinal System is indicated for the following:

DDD (neck pain of discogenic origin with degencration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.

Hooks and Rods

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Screws/Connectors

The use of screws is limited to placement in T1-T3 in treating thoracic conditions only.

Screws are not intended to be placed in the cervical spine.

Titanium ATLAS™ Cable used with the GALAXY™ 3.2 Spinal System allows for cable attachment to the posterior cervical or thoracic spine.

The GALAXY™ 3.2 Spinal System consists of a variety of shapes and sizes of screws, hooks, rods and connecting components, which can be rigidly locked to the rod in a variety of configurations, with each construct being tailor-made for the individual case. This system is intended for posterior use only.

Titanium implant components from other previously cleared Medtronic Sofamor Danek Spinal Systems can be used in conjunction with the GALAXY™ 3.2 Spinal System. These systems include the TSRH®, CD HORIZON®, DYNALOK™ PLUS, DYNALOK CLASSIC™ spinal systems and VERTEX™ Reconstruction Systems. Additionally, titanium ATLAS cable may be used with this system at the surgeon's discretion.

The GALAXY™ 3.2 Spinal System is fabricated from medical grade titanium or titanium alloy.

The GALAXY™ 3.2 Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, cervical and/or sacral spine. The GALAXY™ 3.2 Spinal System implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. If necessary, the GALAXY™ 3.2 Spinal System can be connected to the VERTEX™ Reconstruction System through a rod connector.

The provided text is a 510(k) summary for the GALAXY™ 3.2 Spinal System, which is a medical device for spinal fixation. This document is a regulatory submission for market clearance, not a study report proving a device meets acceptance criteria in the way a clinical trial or performance study would for an AI/software device.

A 510(k) submission primarily demonstrates "substantial equivalence" to a predicate device. This means the new device is as safe and effective as a legally marketed device and does not raise new questions of safety or effectiveness. The information provided does not describe a clinical study in the typical sense of testing the device's "performance" against specific acceptance criteria with a particular sample size, ground truth, or expert review for diagnostic accuracy.

Therefore, many of the requested elements (acceptance criteria table, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance) are not applicable or cannot be extracted from this type of regulatory document.

However, I can provide what information is available based on the request:

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

This document does not specify "acceptance criteria" for performance in the context of a clinical study or a comparative performance metric, nor does it report specific device performance metrics like sensitivity, specificity, or accuracy. The "performance" described is its intended use and mechanical function as a spinal fixation system.

The core "acceptance criteria" for a 510(k) is the demonstration of substantial equivalence to a predicate device.

The intended clinical performance is to stabilize the spine for conditions such as DDD, spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion, and tumors in the cervical (C1-T3) and thoracic spine. Specific uses for hooks, rods, and screws are detailed, with screws specifically limited to T1-T3 for thoracic conditions and not for the cervical spine. Titanium ATLAS™ Cable can be used for cable attachment to the posterior cervical or thoracic spine. |

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

Not applicable. This document is not a clinical study report that would involve a "test set" in the context of AI/software performance. It's a regulatory submission affirming substantial equivalence based on device design, materials, and intended use, often supported by mechanical testing data (which is not detailed here) and comparison to existing predicate devices.

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 establishment with experts is relevant for diagnostic devices or AI, not for a spinal implant system's 510(k) submission.

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

Not applicable. No test set adjudication method is described.

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 device is a physical spinal implant, not an AI or diagnostic tool. Therefore, MRMC studies and "human reader improvement with AI" are irrelevant.

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

Not applicable. This is not an algorithm or AI device.

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

Not applicable. No "ground truth" in this sense is established for the device itself. The "truth" in a 510(k) is that the device is substantially equivalent to a predicate, implying comparable safety and effectiveness based on established medical and engineering principles.

8. The sample size for the training set

Not applicable. No training set is involved for this type of device submission.

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

Not applicable. No training set or ground truth in this context.

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