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The ELID (Endoscopic Less Invasive Decompression) system intended to provide lumbar decompression of the spine to treat various spinal condition(s) using minimally invasive techniques and instrumentation.

The ELID (Endoscopic Less Invasive Decompression) System consists of instrumentation intended to aid the user in completing steps necessary to perform lumbar decompression. Instruments include a bone needle, flat blade dilator, dilator tubes, and rongeurs. Instruments in the ELID (Endoscopic Less Invasive Decompression) System are supplied non-sterile, reusable, and manufactured from aluminum per ASTM B211, Nitinol per ASTM 2063, or stainless steel per ASTM A564.

The provided text is a U.S. FDA 510(k) Clearance Letter and a 510(k) Summary for the ELID (Endoscopic Less Invasive Decompression) System. While it describes the device, its indications for use, technological characteristics, and a list of performance tests conducted, it does not provide specific acceptance criteria or detailed study results that demonstrate the device meets those criteria.

The "Performance Data" section states that certain tests were conducted and their results "show that the strength of the ELID (Endoscopic Less Invasive Decompression) System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." However, it does not quantify this performance, nor does it specify the acceptance criteria for each test.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and the reported device performance. The document only lists the types of tests performed (Cleaning Validation, Sterilization Validation, Biocompatibility, Usability Testing, Particulate Analysis) but doesn't provide the detailed results or the specific quantitative acceptance thresholds for these tests.
• Sample sizes used for the test set and the data provenance. The document mentions "test modes" but does not detail the sample sizes for these tests or the origin of any data (e.g., human or ex-vivo samples, country of origin, retrospective/prospective).
• Number of experts and their qualifications for ground truth establishment. This type of information is typically relevant for AI/ML-based devices relying on expert annotations, which is not clearly indicated as a component of the ELID system described. The ELID system seems to be a set of physical surgical instruments.
• Adjudication method. Similar to the point above, this is generally for AI/ML performance evaluation against expert ground truth.
• MRMC comparative effectiveness study. This is typically for AI/ML devices assisting human readers/interpreters, which doesn't seem to be the primary function of the ELID system.
• Standalone performance. This again relates to AI/ML algorithms. The ELID system appears to be a set of manual surgical instruments.
• Type of ground truth used. For an AI/ML device, this could be expert consensus, pathology, or outcomes data. For the ELID system, ground truth would likely refer to engineering specifications and performance evaluations for mechanical properties, biocompatibility, etc. The document does not specify this in detail.
• Sample size for the training set. Not applicable, as this is a physical medical device, not an AI/ML algorithm requiring a training set.
• How the ground truth for the training set was established. Not applicable.

In summary, the provided document is a regulatory clearance letter acknowledging substantial equivalence based on a set of non-clinical performance tests, but it does not disclose the detailed quantitative acceptance criteria or the specific results of these tests, nor does it describe AI/ML related study methodologies like those you've requested. The "Performance Data" section only states that the results "show that the strength... is sufficient for its intended use and is substantially equivalent."

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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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