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The ST360° Spinal Fixation System is intended for posterior, non-cervical pedicle and nonpedicle fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, and/or lordosis), turnor, pseudoarthrosis, and failed previous fusion. Pedicle screw fixation is limited to skeletally mature patients.

When used as a sacral screw system, the ST360° Spinal Fixation System is intended for use in the treatment of degenerative disease (as defined as chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), idiopathic scoliosis, spondylolisthesis, kyphotic or lordotic, deformity of the spine, loss of stability due to turnors, spinal stenosis, vertebral fracture or dislocation, pseudoarthrosis, and previous failed spinal fusion. When used for this indication, screws of the ST360° Spinal Fixation System are intended for the sacral iliac attachment only. Transverse connectors of the system are intended for posterior thoracic and/or lumbar use only. As a whole, the levels of use for sacral screw fixation of this system are T1 to the sacrum.

The ST360°® Spinal Fixation System is a temporary implant system used to correct spinal deformity and facilitate the biological process of spinal fusion. This system is intended for posterior use in the thoracic. Iumbar and sacral areas of the spine. Implants of this system consist of screws connected to rods and are intended to be removed after solid fusion has occurred. This system includes polyaxial screws of varying diameters and lengths, rods in varving lengths, and fixed and adjustable transverse connectors. The implants in this system are manufactured from titanium alloy (Ti-6AI-4V ELI), conforming to ASTM F136.

This system's screws, rods, and connectors can be rigidly locked into a wide range of configurations, thereby allowing each construct to be formed to the needs of an individual patient. The ST360° Spinal Fixation System is intended to be used with bone graft which is required to provide additional spinal support.

The provided text is a 510(k) Summary for the ST360°® Spinal Fixation System. It details the device, its intended use, technological characteristics, and importantly, the summary of performance testing conducted to demonstrate substantial equivalence to predicate devices.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the ST360°® Spinal Fixation System are implicitly derived from the performance standards outlined in the ASTM guidelines and the requirement of "substantial equivalence" to the predicate devices. The reported device performance is that it met these standards.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document does not explicitly state a numerical sample size for the "bench testing" components (screws, rods, connectors). However, it implies that components of the system were tested. For the human factors/usability testing, it states "a cadaver specimen" was used, which suggests a single specimen.
• Data Provenance: Not explicitly stated (e.g., country of origin). The testing seems to be internal to Zimmer Spine or conducted by external labs on their behalf. The studies are prospective in nature, as they involve testing the actual device components and design changes.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The "cadaver lab testing" would likely involve orthopedic surgeons or spine specialists, but their number and specific qualifications are not detailed.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable or not specified. This type of device evaluation (bench testing, biocompatibility, cadaver lab for human factors) typically does not involve adjudication in the sense of multiple experts independently reviewing and then resolving discrepancies on a dataset, as would be the case for image-based diagnostic AI. The "ground truth" for the bench tests are measured physical properties against established ASTM standards. For cadaver testing, it's an evaluation of usability and interaction.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic systems where human readers interpret data (e.g., images) and their performance (with and without AI assistance) is compared. The ST360°® Spinal Fixation System is a surgical implant, not a diagnostic AI system.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Performance: Not applicable in the context of AI. The "standalone" performance here refers to the device's inherent mechanical properties and material characteristics as tested against established standards, as well as its usability in a simulated environment (cadaver lab). These tests evaluate the device itself, without constant human 'loop' interaction in the sense of a diagnostic interpretation, though human operators are involved in the surgical implantation. The bench tests are essentially "standalone" device performance evaluations in a controlled setting.

7. The Type of Ground Truth Used

• Ground Truth:
  • Bench Testing: The ground truth is established by the ASTM F1717-12 and ASTM F1798-97 (Reapproved 2008) standards. These standards define the acceptable mechanical performance limits for spinal implant systems and intervertebral body fusion device systems, respectively. The "ground truth" is that the device must meet or exceed the performance parameters specified in these consensus standards.
  • Biocompatibility: The ground truth is the established biocompatibility standards and tests (often ISO 10993 series) for medical devices in contact with biological tissue.
  • Sterilization: The ground truth is the established sterilization efficacy standards (e.g., AAMI/ISO standards).
  • Cadaver Lab: The ground truth for human factors is subjective expert evaluation of ease of use, instrument interaction, and overall system functionality during simulated surgical procedures.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This submission concerns a physical medical device (spinal fixation system), not an AI/machine learning algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

• Ground Truth for Training Set Establishment: Not applicable, as there is no AI training set involved.

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