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The MONARCH Spine System is a pedicle screw system intended 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 the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The MONARCH Spine System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra 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 MONARCH Spine System is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).

The MONARCH Spine System when used with pedicle screws is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar and sacral spine.

Addition of 5.5mm diameter rod, screws, hooks and various connectors to the MONARCH Spine System. The MONARCH Spine System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.

The provided text describes a 510(k) premarket notification for the MONARCH Spine System, an addition of 5.5mm diameter rod, screws, hooks, and various connectors. It is a medical device submission, and therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to the performance data submitted to demonstrate substantial equivalence to predicate devices, rather than a clinical study with specific performance metrics against an AI algorithm.

Regarding your numbered requests, based only on the provided text, the following information can be extracted:

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

   Acceptance Criteria (Implied)	Reported Device Performance
   Safety and Effectiveness substantially equivalent to predicate devices	Performance data were submitted to characterize the MONARCH Spine System. (Specific results not detailed in the provided text.)
   Manufactured from ASTM F-136 implant grade titanium alloy	Manufactured from ASTM F-136 implant grade titanium alloy.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
   The document states "Performance data were submitted to characterize the MONARCH Spine System." However, it does not provide details on the sample size used for the test set, the provenance of the data (e.g., country of origin), or whether the data was retrospective or prospective. This information would typically be found in the detailed performance data report, which is not included in this summary.

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):
   As this is a mechanical medical device (spinal implant), the concept of "ground truth" established by human experts in the context of diagnostic interpretation (like radiologists) is not applicable here. The "performance data" would likely refer to mechanical testing, biocompatibility testing, and potentially animal or clinical performance data if submitted, but not expert consensus on images. The document does not mention experts establishing ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable for this type of device and performance data. The document does not mention any adjudication method.

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:
   This device is a spinal implant, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not done.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   This device is a spinal implant, not an algorithm. Therefore, "standalone (i.e. algorithm only without human-in-the-loop performance)" is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   For a spinal implant, "ground truth" would generally refer to established engineering standards for mechanical strength, fatigue, biocompatibility, and potentially clinical outcomes if a clinical study was performed. The document vaguely states "Performance data were submitted to characterize the MONARCH Spine System." It does not specify the type of ground truth used beyond the implicit requirement of meeting established regulatory and engineering standards for similar devices.

8. The sample size for the training set:
   This device is a physical implant, not a machine learning algorithm that requires a "training set." Therefore, the concept of a "training set" is not applicable.

9. How the ground truth for the training set was established:
   As there is no training set for this type of device, this question is not applicable.

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