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The ISOBAR Spinal System consists of pedicle screws, rods, nuts and crosslink members utilized to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

As a pedicle screw system, the ISOBAR Spinal System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

The ISOBAR Spinal System consists of pedicle screws. rods, nuts and crosslink members. It can be used for single or multiple level fixation. All components are manufactured from titanium alloy (Ti-6A1-4V) that conforms to ASTM F136.

This system consists of pedicle screws that required rod attachment directly over the top of the screw (U-Line Screws) and a combination of screws and clamps that allow the rod to be offset from the screw (Hemispherical Headed Screws).

The provided text is a 510(k) summary for the ISOBAR Spinal System. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance criteria through a rigorous standalone study in the way an AI/software device would.

Therefore, many of the requested elements for an AI/software device's acceptance criteria and study design are not applicable to this spinal implant device. The "performance data" section in this document refers to mechanical testing to ensure the device meets engineering standards, not clinical performance or diagnostic accuracy.

Here's an attempt to answer the questions based only on the provided text, highlighting where the information is not applicable (N/A) for this type of medical device submission.

Acceptance Criteria and Study Information for ISOBAR Spinal System

1. Table of Acceptance Criteria and Reported Device Performance

Note: The FDA established no performance standards applicable to pedicle screw spinal systems at the time of this submission. The testing conducted was to an industry standard. The document states "was performed according to ASTM F1717-96," which implies the device met the requirements of this standard, but no specific numerical performance data (e.g., maximum load, cycles to failure) is provided in this summary.

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

N/A. This device is a physical pedicle screw system, not an AI/software device that would have a "test set" of data. The "testing" refers to mechanical integrity testing of the implants themselves. Data provenance (country of origin, retrospective/prospective) is not relevant to this type of mechanical testing.

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

N/A. Ground truth and expert adjudication are not applicable to the mechanical testing of a physical implant device for this type of submission.

4. Adjudication method for the test set

N/A. Adjudication method is not applicable to the mechanical testing of a physical implant device.

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

N/A. This is a physical spinal implant, not an AI or diagnostic imaging device. MRMC studies are not relevant.

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

N/A. This is a physical spinal implant, not an AI or diagnostic imaging device. Standalone algorithm performance is not relevant.

7. The type of ground truth used

N/A. This is a physical spinal implant. Mechanical testing relies on engineering specifications and measurements, not "ground truth" derived from clinical outcomes, pathology, or expert consensus in the diagnostic sense.

8. The sample size for the training set

N/A. This is a physical spinal implant. There is no "training set" in the context of AI/machine learning. If by "training set" it refers to the number of devices mechanically tested, that information is not provided in this summary.

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

N/A. Not applicable, as there is no "training set" or "ground truth" in the AI/ML context for this device.

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