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The Ion 3D Facet Screw may be used in conjunction with the Ion 3D GraftRasp to perform posterior spinal fusion. The Ion 3D GraftRasp may be used to rasp or decorticate bone from the facets and/or transverse processes and for the delivery of hydrated allograft or autograft. The Ion 3D Facet Screw is indicated for the posterior surgical treatment at C2-S1 (inclusive) spinal levels for the following:

• · Spondylolisthesis
• · Spondvlolysis
• · Pseudoarthrosis or failed previous fusions which are symptomatic
  · Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies and/or degenerative disease of the facet with instability
  The Ion 3D Facet Screw is intended for use with bone graft material (allograft, or autograft).

The Ion 3D contains various sized facet screws with and without graft windows for bilateral stabilization of the facets from C2-S1. The Ion 3D is provided in various configurations, including single-use, and reusable. The Instruments are offered in sterile and non-sterile configurations. All implants are manufactured from Ti6Al4V per ASTM F136.
The purpose of this 510(k) is to add new Ion 3D Facet Screws and new instruments to the system.

The provided text is a 510(k) Pre-market Notification summary for a medical device (Ion 3D Facet Screw) and does not describe a clinical study with an AI component or detailed performance criteria in the way a diagnostic AI device would. Instead, it focuses on demonstrating substantial equivalence to predicate devices through engineering justifications and non-clinical performance testing.

Therefore, many of the requested details, such as sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and training set information, are not applicable or available within this document.

Here's a breakdown of the information that can be extracted and a clear indication of what is not present:

1. Table of acceptance criteria and reported device performance:

The document doesn't provide specific numerical acceptance criteria or performance metrics in a table format as would be seen for a diagnostic AI device. Instead, it relies on demonstrating that the device's mechanical performance is not "worst-case" compared to predicates and that it meets standards for biocompatibility and sterilization.

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

• Sample Size for Test Set: Not applicable in the context of this 510(k) submission, as it focuses on non-clinical testing (mechanical, biocompatibility, sterilization, cleaning) rather than a clinical performance study with test data. The "test set" here refers to the physical devices and materials tested.
• Data Provenance: Not applicable. The testing is primarily laboratory-based and simulated.

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

• Not applicable. Ground truth as typically understood for AI or diagnostic devices (e.g., expert consensus on pathology images) is not relevant to this type of mechanical and material testing. The "ground truth" for these tests would be the established scientific and engineering principles and standards (e.g., ISO 10993).

4. Adjudication method for the test set:

• Not applicable. There is no mention of adjudication, as this type of testing does not involve subjective expert review for establishing ground truth from clinical data.

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:

• No. An MRMC study was not conducted. This device is a surgical implant (facet screw) and associated instruments, not an AI-powered diagnostic or assistive tool for human readers.

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

• No. This device is a physical implant and surgical tools; there is no standalone algorithm to evaluate.

7. The type of ground truth used:

• For mechanical performance: Engineering principles and simulation models (Finite Element Analysis) as surrogate for clinical performance under defined loads.
• For biocompatibility: International standard ISO 10993.
• For sterilization and cleaning: Industry-accepted validation protocols and standards.

8. The sample size for the training set:

• Not applicable. This document refers to a physical medical device, not an AI algorithm that requires a training set.

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

• Not applicable. No training set is involved for this type of device submission.

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The Sacrix® Sacroillac Joint Fusion Device System is intended for fusion of the sacroillac joint for conditions including sacroiliac joint disruptions and degenerative sacroillitis.

The InSpan® ScrewLES Fusion System is a posterior non-pedicle supplemental fixation system intended for use in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion for the following indications: spondylolisthesis, trauma (fracture or dislocation), tumor, or degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), or lumbar spinal stenosis. The device is intended for use with bone graft material and is not intended for stand-alone use.

The Invue® MAX™ + Invue Inset Anterior Cervical Plate System is intended for anterior spine fixation for use in providing temporary stabilization during the development of cervical spinal fusions. The levels of treatment range from C2 to T1. Indications include symptomatic cervical spondylolisthesis, trauma; (fracture or dislocation), spinal stenosis, deformities or curvatures (scoliosis, kyphosis and or lordosis), tumor, pseudloarthrosis, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), and reoperation for failed fusion or instability following surgery for above indications.

The FacetFuse® Screw Fixation System is intended to stabilize the spine as an aid to fusion by transfacet fixation. The subject device is indicated for posterior surgical treatment of any or all of the following at the L1 to S1 (inclusive) spinal levels including: 1) Trauma, including spinal fractures and/ or dislocations: 2) Spondylolisthesis: 3) Spondylolysis: 4) Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity; 5) Degenerative diseases which include: (a) degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or (b) degenerative disease of the facets with pain and/or instability on plain flexion and extension lateral radiographs where there is movement of the vertebral bodies relative to each other of more than 4mm.

The Sacrix® Sacroiliac Joint Fusion Device System implants consist of Solid and Fenestrated Screws. Solid and Fenestrated Screws are available in varying diameters and lengths. Solid and Fenestrated Screws are fabricated from medical grade titanium alloy, Ti-6AI-4V ELI per ASTM F136. Solid and Fenestrated Screws have a cannulated core to allow packing of allograft or autograft material. Solid Screws have a solid outer wall, while Fenestrated Screws have fenestrations on the outer wall.

The Inspan® ScrewLES Fusion System consists of a variety of sizes of plates, set screws, and associated instruments. The plates are offered in five hub diameters (8 mm in 2 mm increments) and five wing length configurations (35 mm to 47 mm increments). The device height (measured from the base of the central hub to the top of the wing) is fixed across all configurations at 18.85 mm for InSpan® and 13.89 mm for InSpan® Slim. Spikes are present on the sides of the plate that interface with the spinous process to restrain the plate from rotating post-operatively. The components of the Inpan® ScrewLES Fusion System are fabricated from medical grade titanium alloy Ti-6AI-4V ELI per ASTM F136.

The Invue® MAX™ + Invue Inset Anterior Cervical Plate System consists of a variety of shapes and sizes of plates, screws, and the associated instruments. The plates are available in four levels to accommodate one to four levels of fixation. The one level plates have lengths ranging from 17 mm in 2 mm increments, two level plates range from 33 mm in 2 mm increments, three level plates range from 48 mm to 78 mm in 3 mm increments, and the four-level plates range from 61 mm in 4 mm increments. A lock is integrated in the plate and screw to secure the screw from backout. Ø4.2 mm self-drilling screws and Ø4.5 mm self-tapping screws are offered. All screws are offered in lengths of 12 mm, 16 mm, 18 mm, and 20 mm. The Invue® MAX™ + Invue Inset Anterior Cervical Plate System components are single use and are fabricated from titanium alloy Ti-6AI-4V ELI per ASTM F136.

The FacetFuse® Screw Fixation System is designed to provide bilateral, transfacet fixation of the spinal facet joint in the lumbar spine. The FacetFuse® Screw Fixation System offers partially threaded screws. The partially threaded screws are available in Ø4.5 mm diameter screw (in 0.5 mm increments) offered in lengths of 25 mm to 50 mm (in 5 mm increments). The fully threaded screws are available in diameters Ø4.5 mm and Ø5.0 mm in lengths from 20 mm in 5 mm increments. The device is fabricated from titanium alloy Ti-6Al-4V ELI per ASTM F136. The devices are offered with a built in washer or without a washer. The washers are intended to increase the load bearing area of the screw in contact with the bone. These washers are designed to angulate about the head of the bone screws to provide optimal bony contact over a range of screw trajectories.

The purpose of this submission is to offer sterile packaged options of each implant.

The provided text is a 510(k) summary for several medical devices (Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue® MAX™ + Invue Inset Anterior Cervical Plate System, and FacetFuse® Screw Fixation System). It focuses on establishing substantial equivalence to previously cleared predicate devices, primarily due to changes in sterilization and packaging.

The document does not contain information about an AI/ML-based device or a study involving human readers and AI assistance. Therefore, I cannot provide details regarding acceptance criteria, performance data, ground truth establishment, or multi-reader multi-case studies for an AI/ML device from this text.

The "Performance Data" section explicitly states that "The results of these non-clinical tests showed that each system is substantially equivalent to legally marketed predicate devices. The changes in sterilization and packaging do not affect mechanical performance and require no additional bench testing for this submission." This indicates that the performance evaluation was based on previously conducted mechanical and physical testing of the devices, not on data from clinical studies or AI/ML evaluations.

In summary, the provided document does not contain the information required to answer your questions regarding acceptance criteria and study proving device performance for an AI/ML component.

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