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Internal fixation implants are load-sharing devices intended to stabilize and maintain alignment until normal healing occurs. Implants are not intended to replace normal body structures or bear the weight of the body in the presence of incomplete bone healing.

The ARX® Spinal System, when properly used, is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization and immobilization of spinal segments as an adjunct to fusion.

When used as a posterior spine thoracic/lumbar system, the ARX® Spinal System is indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) trauma (i.e. fracture or dislocation), (3) curvatures (scoliosis, and/or lordosis), (4) spinal tumor, (5) failed previous fusion (6) pseudarthrosis, (7) spinal stenosis, (8) spondylolisthesis.

The Life Spine Cross Connector is a titanium alloy, multiple component system comprised of a variety of non-sterile single use components that allow the surgeon to build a spinal implant construct. The system is attached to the vertebral body by means of screws to the non-cervical spine.

The Life Spine Cross Connector is available in various sizes. This device is an addition to the current systems (K070995) and therefore is fully cross-functional within the current systems.

The provided text describes the 510(k) summary for the Life Spine Cross Connector, a medical device. Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of acceptance criteria and the reported device performance

Note: The document doesn't explicitly state numerical acceptance criteria (e.g., "must withstand X N of force"). Instead, it references performance standards (ASTM F1717) and general equivalence to a predicate device.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "Biomechanical testing in accordance with ASTM F1717 was conducted." However, it does not provide details on the sample size used for the test set, nor does it specify the data provenance (e.g., country of origin, retrospective or prospective). The testing would typically involve laboratory specimens (e.g., synthetic bone models or cadaveric spines) rather than human patient data in this context.

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)

This type of information is not applicable to this device and study. The study involves biomechanical testing, not clinical evaluation with human interpretation that would require expert ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable as the study is a biomechanical test, not a clinical study involving human readers or interpretation.

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 is not applicable. This document describes a medical device for spinal fixation, not an AI or diagnostic imaging device.

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

This is not applicable. This document describes a physical medical device, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For the biomechanical testing, the "ground truth" would be the physical measurements and observations of the device's mechanical properties (e.g., stiffness, fatigue life, failure load) as defined by the ASTM F1717 standard. This is an objective measurement in a laboratory setting, not subjective expert consensus or pathology.

8. The sample size for the training set

This is not applicable. This device is a physical implant, not an AI model that requires a training set.

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

This is not applicable. As it's not an AI model, there is no training set or ground truth in that context.

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