(24 days)
The Integrity-SI Fusion System is intended for sacroiliac joint fusion for the following conditions:
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Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the period and have persisted postpartum for more than 6 months.
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To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
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Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint
The Integrity-SI Fusion System consists of partially and fully threaded, self-tapping cannulated titanium implants designed to be inserted across sacroiliac joint providing stability for joint arthrodesis when used in conjunction with allograft or autograft. The surgical implants are available in various sizes to accommodate patient anatomy. The 10mm and 12mm diameter screws are offered in partially and fully threaded version in lengths from 40-110mm, in 5mm increments. All fastener sizes are available in non-coated or hydroxyapatite-coated (HA) versions. The 10mm and 12mm screws also include a pre-assembled washer for improved joint compression. The fully threaded 6.5mm diameter, optional secondary fasteners are offered for additional rotational stability in lengths of 30 - 70 mm, in 5mm increments and are only intended for use in conjunction with a primary 10mm or 12mm screw.
The provided FDA 510(k) clearance document for the "Integrity-SI Fusion System" does not contain information about acceptance criteria, device performance results from a study, or details about a clinical study involving AI or human reader performance.
This document is a standard 510(k) clearance letter and a summary, which primarily establishes substantial equivalence to a predicate device based on technological characteristics and intended use, rather than requiring new clinical performance data for devices like this one (a metallic bone fixation fastener).
Specifically, the document states two key points that explain why the requested information is not present:
- "There are no changes to the technological characteristics of the OsteoCentric Integrity-SI Fusion System. The device is identical to the predicate device with respect to the design, materials, sterilization, and manufacturing methods." (Section VI. Comparison of Technological Characteristics to the Predicate)
- "There were no changes in the design, materials, sterilization, or manufacturing methods of the device. Therefore, no new performance data was required to demonstrate the substantial equivalence of the subject device to the predicate device." (Section VII. Performance Data)
Because no new performance data was required, there is no mention of a test set, training set, ground truth establishment, expert consensus, MRMC studies, or standalone algorithm performance.
Therefore, I cannot provide the requested table and study details based on the information given in the input. The device is a physical implant (a bone fastener), not an AI/software device that would typically undergo the type of performance validation described in your prompt.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.