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The Range Spinal System is a non-cervical spinal fixation devices intended for posterior, non-pedicle 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; curvatures ( i.e. scoliosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The Range Spinal System is also intended for non-cervical pedicle screw fixation for the following indications: trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures ( i.e. scoliosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. They are also indicated 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 Natural Bridge LP Transverse Connectors are devices intended to be used in conjunction with K2M's currently available pedicle screw and/or hook systems for stabilization of the spine. The connectors are available in a variety of sizes to match more closely the patient's anatomy.

Materials: The devices are manufactured from Ti6Al-4V ELI alloy per ASTM and ISO standards.

Function: The devices are designed for attachment to the rods to enhance the torsional stability of the implanted spinal construct.

The provided text describes a 510(k) premarket notification for the Natural Bridge LP Transverse Connectors, a medical device for spinal stabilization. This submission primarily focuses on demonstrating substantial equivalence to previously marketed predicate devices through material and functional comparisons, along with biomechanical testing.

However, the document does not contain the kind of detailed information about a clinical study, acceptance criteria, ground truth establishment, or human-in-the-loop performance that would be required to answer many of the questions you've posed. The provided text is a regulatory filing for a medical device that establishes substantial equivalence, primarily through non-clinical data (biomechanical testing) and comparison to existing devices, rather than a clinical trial with specific performance metrics against an established ground truth.

Here's an attempt to answer the questions based on the available information, noting where information is absent:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria or report device performance in the format of a clinical study with detailed metrics like sensitivity, specificity, or accuracy. The "acceptance criteria" in this context are implicitly met by demonstrating substantial equivalence through:

• Materials: Same as predicate (Ti6Al-4V ELI alloy per ASTM and ISO standards).
• Intended Use: Identical to predicate.
• Function: Designed for attachment to rods to enhance torsional stability, with no significant difference in performance as demonstrated by biomechanical testing.

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

• Sample Size: Not applicable in the context of a clinical test set from this document. The "test set" here refers to the biomechanical testing. The document does not specify the number of samples or constructs used in the biomechanical testing.
• Data Provenance: Not applicable for a human test set. Biomechanical testing data would be generated in a lab setting. The country of origin for the device submission is the USA (Leesburg, VA). The biomechanical testing results are the "data" that supports the performance claim.

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

• This is not applicable as the submission relies on biomechanical testing as opposed to expert-derived ground truth from clinical images or data. No human experts are mentioned as establishing ground truth for device performance in this context.

4. Adjudication Method for the Test Set

• Not applicable, as there is no human-interpreted test set requiring adjudication in this regulatory submission. Biomechanical testing results are typically quantitative and directly measured.

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 device is a mechanical implant, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI assistance evaluation was performed or reported.

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

• Not applicable. This is a medical device (spinal implant), not an algorithm or AI system. Its performance is evaluated through material properties, design, and biomechanical testing, not algorithmic output.

7. The Type of Ground Truth Used

• For the biomechanical performance, the "ground truth" would be the quantitative measurements obtained from controlled biomechanical tests (e.g., measuring forces, torques, displacement, or fatigue life) which are then compared to established standards and/or the predicate device's measured performance. The document explicitly states "no significant difference in performance as demonstrated by biomechanical testing."

8. The Sample Size for the Training Set

• Not applicable. This device does not involve a "training set" in the machine learning sense. The design and manufacturing processes are likely informed by engineering principles, material science, and prior device designs, but not through training on a dataset.

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

• Not applicable, as there is no "training set" for an AI or algorithmic device.

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