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The uCentum™ comprehensive posterior system is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and sacral spine (T1-S2). When used as a posterior spine thoracic/lumbar system, the uCentum is intended for the following indications: degenerative disc disease (as defined by back pain of discogenic with degeneration of the disc confirmed by patient history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e., degenerative scoliosis, kyphosis, and/or lordosis), fracture, spinal tumor, pseudarthrosis and failed previous fusion.

The uCentum™ comprehensive posterior system consists of rods, polyaxial pedicle screws and crosslinks with locking set screws. The components are available in various sizes to accommodate differing patient anatomy. Rods are available straight and curved in a variety of lengths. Polyaxial screws are available in a variety of diameterlength combinations. Crosslinks are offered in five lengths. The system can be implanted in open or minimally invasive procedures. The uCentum™ system components are manufactured from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136.

Here's an analysis of the provided text regarding the acceptance criteria and study for the uCentum™ comprehensive posterior system:

The provided text is a 510(k) summary for a medical device (spinal system). It outlines the rationale for substantial equivalence to predicate devices, primarily based on design and mechanical performance, rather than clinical performance data with specific acceptance criteria that would typically be seen in a study evaluating diagnostic accuracy or a new therapeutic efficacy.

Therefore, there isn't a traditional "study" in the sense of a clinical trial with human subjects proving performance against specific acceptance criteria for diagnostic accuracy or clinical outcomes. Instead, the "study" referred to is a mechanical testing comparison to establish substantial equivalence.

Here's the breakdown of the requested information based on the provided document:

Acceptance Criteria and Reported Device Performance

• Static compression bending
• Dynamic compression bending
• Static torsion | The mechanical test results demonstrated that uCentum™ performance is substantially equivalent to the predicate devices. |

Study Details

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: Not applicable in the context of a human test set. The "test set" refers to the mechanical constructs of the uCentum™ system. The document does not specify the number of constructs tested, only that "worst case uCentum™ constructs" were included.
   • Data Provenance: Not applicable in the context of human data. The data is generated from laboratory mechanical testing.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

   • Not applicable. The "ground truth" for mechanical testing is based on established engineering principles and standards (ASTM F1717), not expert human interpretation.

3. Adjudication Method for the Test Set:

   • Not applicable. Adjudication is typically used for human-reviewed data, not mechanical test results.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

   • No. An MRMC study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not pertinent to the mechanical testing of a spinal implant.

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

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

6. The Type of Ground Truth Used:

   • The "ground truth" for the mechanical performance comparison is the established performance characteristics of the predicate devices as defined by ASTM F1717 testing. The uCentum™ system is compared against these benchmarks to demonstrate substantial equivalence.

7. The Sample Size for the Training Set:

   • Not applicable. There is no "training set" in the context of mechanical testing for substantial equivalence of a physical device. This concept is typically associated with machine learning algorithms.

8. How the Ground Truth for the Training Set was Established:

   • Not applicable, as no training set was used.

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