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The Arsenal Spinal Fixation System is intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. Fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

When used for posterior non-cervical screw fixation in pediatric patients, the Arsenal Spinal Fixation System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally the Arsenal Spinal Fixation System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis / spondylolysis, and fracture caused by tumor and/or trauma. Pediatric pedicle screw fixation is limited to a posterior approach.

The Arsenal Spinal Fixation System is intended to be used with autograft and/or allograft.

The CBx screws are to be included in the currently marketed Arsenal Spinal Fixation System which is intended for posterior, non-cervical, spinal fixation as an adjunct to fusion for the treatment of degenerative disease, deformity, and trauma indications. The Arsenal System consists of a variety of shapes and sizes of screws, rods, and connectors that provide temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. The CBx screws are made of Titanium Alloy (Ti 6Al 4V ELI) and are designed for placement in the cortical areas of the pedicle where the bone is typically harder, stronger and stiffer than the cancellous portion of the pedicle/vertebra. The threadform of the CBx screws allows the surgeon to use the screw that best suits the patient's anatomy where either cortical bone or both cortical bone and cancellous bone are present.

The provided text describes a 510(k) premarket notification for the "Arsenal Spinal Fixation System," specifically introducing CBx screws as part of this system. This document is focused on demonstrating substantial equivalence to predicate devices for a medical device (pedicle screw system), not an AI or software device.

Therefore, the information typically requested in an acceptance criteria and study section for an AI/software device (e.g., sample sizes for test and training sets, expert qualifications, MRMC studies, standalone performance, ground truth establishment methods) is not applicable to this document. The document describes mechanical performance testing to prove substantial equivalence for a physical medical implant.

However, I can extract the relevant performance data and acceptance criteria as presented in the document concerning the mechanical aspects of the device.

Acceptance Criteria and Device Performance for the Arsenal™ Spinal Fixation System (CBx screws)

The document focuses on demonstrating substantial equivalence of the CBx screws to existing predicate devices (Zodiac Spinal Fixation System, K100685, and Arsenal Spinal Fixation System, K133221) based on mechanical performance. The "acceptance criteria" are implied by the performance of the predicate devices and the relevant ASTM standards, where the CBx screws must perform equivalently.

1. Table of Acceptance Criteria and Reported Device Performance

Study Description:

The study conducted was a mechanical performance testing program, rather than a clinical or AI performance study.

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

• Sample Size: Not explicitly stated in terms of number of physical screws tested. The document generally refers to "the CBx screw" undergoing testing. Typically, mechanical tests for medical devices involve a statistically significant number of samples, but the exact count is not provided here.
• Data Provenance: The tests were conducted to specific ASTM standards (ASTM F1717 and ASTM F1798). The data originates from laboratory mechanical testing of the physical device components. Country of origin for the data is not specified, but it would have been generated in a testing facility. The nature of the testing is by definition prospective for the device being evaluated, as the tests are performed on newly manufactured devices to assess their properties.

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

• Not applicable. This relates to mechanical performance, not diagnostic interpretations or clinical outcomes requiring human expert "ground truth." The "ground truth" is defined by the objective physical properties and performance metrics measured according to established engineering standards.

4. Adjudication method for the test set:

• Not applicable. This refers to methods for resolving discrepancies in expert opinions, which is not relevant for mechanical testing.

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 is a physical medical device, not an AI system or diagnostic tool used by human readers.

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

• Not applicable. This is a physical medical device, not an independent algorithm.

7. The type of ground truth used:

• For mechanical performance, the "ground truth" is defined by the measured physical properties and performance characteristics of the device under controlled laboratory conditions, as outlined by the specified ASTM standards. The performance of the predicate devices under the same tests serves as the benchmark for "substantial equivalence."

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device.

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

• Not applicable. This is not an AI/machine learning device.

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