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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 NAUTILUS 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 NAUTILUS 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, kyphosis, and/or lordosis), (4) spinal tumor, (5) failed previous fusion (6) pseudarthrosis, (7) spinal stenosis, (8) spondylolisthesis.

The NAUTILUS Thoracolumbar Spinal System consists of an assortment of rods, screws, cross connectors, and axial and offset connectors. The bone screw, head, and taper lock are assembled together during manufacturing to create the NAUTILUS Thoracolumbar Spinal System screw assembly component. The cross, axial, and offset connectors are also assembled during manufacturing. The NAUTILUS Thoracolumbar Spinal System implant components are made from titanium alloy (Ti-6AI-4V ELI) as described by ASTM F136 and cobalt chrome per ASTM 1537. Do not use any of the NAUTILUS Thoracolumbar Spinal System components with the components from any other system or manufacturer.

This document describes a spinal system called the NAUTILUS Spinal System and details its substantial equivalence to predicate devices, which is the basis for its 510(k) clearance. Because this is a spinal implant and not an AI/ML device, the typical AI/ML-focused acceptance criteria and study components requested in the prompt (e.g., sample size for test set, expert ground truth, MRMC study, training set details) are not applicable.

Here's a breakdown of the information provided in the context of the prompt:

1. A table of acceptance criteria and the reported device performance

• Study that proves the device meets the acceptance criteria: The device's compliance with acceptance criteria is established through a substantial equivalence determination to predicate devices (NAUTILUS Spinal System K132760 and CD Horizon Spinal System K132471). This is supported by performance data from static, torsional, and dynamic compression testing per ASTM F1717, as well as axial grip, torsional grip, and moment bending testing per ASTM F1798. These tests demonstrate that the NAUTILUS Spinal System performs comparably to the predicate devices in terms of mechanical properties.

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

• Not Applicable (N/A). This is a submission for a medical device (spinal implant) based on substantial equivalence, not an AI/ML diagnostic or predictive device. There is no "test set" in the context of medical images or patient data to evaluate an algorithm. The "test set" here refers to the mechanical tests performed on the physical device components. The document does not specify sample sizes for the mechanical tests, nor does it provide details on data provenance beyond stating the tests performed to demonstrate substantial equivalency.

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)

• Not Applicable (N/A). As this is a mechanical device, ground truth is established by engineering standards and test results, not by expert medical review of images or patient data.

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

• Not Applicable (N/A). Adjudication methods are relevant for subjective interpretations (e.g., image reading) by multiple experts. For mechanical testing, the results are objectively measured against established standards.

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 (N/A). This study is irrelevant for a spinal implant device. MRMC studies are used to evaluate the diagnostic accuracy of imaging or AI systems with human readers.

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

• Not Applicable (N/A). This study is irrelevant for a spinal implant device. "Standalone" performance refers to the accuracy of an AI algorithm without human input, which does not apply here.

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

• The "ground truth" for this device is based on established engineering standards and material specifications (e.g., ASTM F136, ASTM 1537, ASTM F1717, ASTM F1798) and the performance characteristics of legally marketed predicate devices. The goal is to demonstrate that the new device's mechanical properties and safety are equivalent to those already accepted.

8. The sample size for the training set

• Not Applicable (N/A). This concept applies to AI/ML algorithms, not to the mechanical testing of a medical implant.

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

• Not Applicable (N/A). This concept applies to AI/ML algorithms.

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The NEO™ Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. This system is indicated for use in temporary stabilization of the anterior spine from C2 to T1 during the development of a cervical spinal fusions with degencrative disc disease (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies); spondylolisthesis; trauma (including fractures or dislocations); spinal cord stenosis; deformity or curvatures (i.e. kyphosis. lordosis or scoliosis); tumors; pseudarthrosis; and / or failed previous fusions.

WARNING: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

The NEO Anterior Cervical Plate System consists of various sizes of anterior cervical bone plates. screws and screw locking tabs. Components are available in a variety of sizes to fit patient anatomy. All components are manufactured from implant grade titanium alloy 6A1-4V ELI per ASTM F-136. The NEO ACPS components will be supplied clean and "NON-STERILE".

Here's an analysis of the provided text regarding the Life Spine, LLC NEOTM Cervical Plating System, focusing on acceptance criteria and study details.

Important Note: The provided document is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a formal clinical study with strict acceptance criteria for a novel device. Therefore, the information requested in your prompt regarding acceptance criteria, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not explicitly detailed in this type of document. The study described is mechanical testing, not a clinical study.

Acceptance Criteria and Device Performance (Based on provided text)

The document primarily discusses mechanical testing to demonstrate substantial equivalence, not clinical performance metrics or specific acceptance criteria for diagnostic accuracy (which would be relevant for devices that process medical images or data).

Study Details (Based on provided text):

Since this is a 510(k) summary for a spinal implant, the "study" referred to is mechanical bench testing, not a clinical trial evaluating human performance or AI accuracy. Therefore, many of your requested fields are not applicable or cannot be extracted from this document.

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not specified for the mechanical testing.
   • Data Provenance: Not applicable in the context of mechanical testing of physical implants. The materials are specified as implant grade titanium alloy 6A1-4V ELI per ASTM F-136.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For mechanical testing, the "ground truth" is defined by established engineering standards and measurements, not by expert medical consensus.

3. Adjudication method for the test set: Not applicable for mechanical testing.

4. 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 document is for a spinal implant, not an AI-powered diagnostic device.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This document is for a spinal implant.

6. The type of ground truth used: For the mechanical testing, the ground truth is established physical properties and performance benchmarks derived from standardized testing methods (e.g., ASTM standards) and comparison to the predicate devices.

7. The sample size for the training set: Not applicable. This is not an AI/ML device, and no training set is mentioned.

8. How the ground truth for the training set was established: Not applicable.

Summary of Device and Approval:

The Life Spine, LLC NEOTM Anterior Cervical Plate System is a medical device for temporary stabilization of the anterior spine from C2 to T1 during cervical spinal fusions. It is indicated for various conditions including degenerative disc disease, trauma, and tumors. The device consists of titanium alloy plates, screws, and locking tabs.

The 510(k) submission (K040844) demonstrated substantial equivalence to two predicate devices: Interpore Cross International Anterior Cervical Plate System (K002592) and Howmedica Osteonics Corporation Reflex Anterior Cervical Plate System (K031702). The primary evidence for this equivalence was mechanical testing (static and fatigue strength) which showed comparable properties to the predicate devices. The FDA reviewed the submission and determined that the device was substantially equivalent, allowing it to be marketed.

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