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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, PILOT® Spinal System, PILOT® Posterior Lumbar Plating System, and CONQUEST® Spinal System, when properly used, are intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. They provide stabilization and immobilization of spinal segments as an adjunct to fusion.

When used as posterior spine thoracic/lumbar systems, the ARX Spinal System, PILOT Spinal System, PILOT Posterior Lumbar Plating System, and CONQUEST Spinal System are 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, kyphosis, and/or lordosis), (4) spinal tumor, (5) failed previous fusion, (6) pseudoarthrosis, (7) spinal stenosis, (8) spondylolisthesis.

The Life Spine Interspinous Fixation System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous processes for the purpose of achieving, in conjunction with autogenous bone graft, single level supplemental fusion in the following conditions: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies), (2) trauma (i.e., fracture or dislocation), (3) spinal tumor, (4) spondylolisthesis. The Life Spine Interspinous Fixation System is not intended for standalone use.

The Life Spine Interspinous Fixation System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). Implants are manufactured from titanium alloy per ASTM F136 and are available in a range of sizes to suit the individual pathology and anatomical conditions of the patient.

The implants are designed to sit between two spinous processes in order to maintain distraction between the vertebrae. There are plates on both sides of the spinous processes, and the plates are translationally adjustable to one another to accommodate different widths. The plates include spikes which anchor the implant to the spinous processes to prevent migration.

This is a 510(k) premarket notification for a medical device (Life Spine Interspinous Fixation System), not a study evaluating a device's performance against acceptance criteria in the typical sense of a clinical trial or AI/software validation study.

The acceptance criteria for this type of submission are not performance metrics like sensitivity or specificity, but rather demonstration of substantial equivalence to a legally marketed predicate device. The "study" proving this is a comparison of the new device to predicate devices across various attributes.

Here's the breakdown based on the provided text, reinterpreting the concepts for this type of regulatory submission:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (for Substantial Equivalence): The new device (Life Spine Interspinous Fixation System) must be substantially equivalent in:

• Design
• Materials
• Function
• Indications for Use

Reported Device Performance (against Substantial Equivalence criteria):

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

• Sample Size: Not applicable. This is a mechanical testing study on the device itself, not a clinical study with patients or data. The "test set" refers to the physical devices undergoing mechanical tests. The number of devices tested is not specified but would be typical for biomechanical evaluations.
• Data Provenance: Not applicable in the context of human data. The "data" comes from in vitro mechanical testing of the physical implants.

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

• Number of Experts/Qualifications: Not applicable. This is not a study requiring expert readers or interpretation of medical images/patient data to establish ground truth. The "ground truth" for mechanical testing is established by engineering standards (ASTM Standard F1717-04).

4. Adjudication method for the test set

• Adjudication Method: Not applicable. No human adjudication of data is mentioned or required for in vitro mechanical testing against a standard.

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

• MRMC Study: Not applicable. This is a 510(k) submission for a physical implant, not an AI or software device.

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

• Standalone Performance: Not applicable. This is a physical implant, not an algorithm.

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

• Type of Ground Truth: The "ground truth" for the mechanical testing is established by a modified version of ASTM Standard F1717-04. This standard provides the benchmark for acceptable biomechanical performance of spinal fixation devices.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This is not a machine learning study.

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

• Ground Truth for Training Set: Not applicable. This is not a machine learning study.

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