(53 days)
The SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System is intended for sacroiliac fusion for conditions including sacroillac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroilitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.
The SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System is also intended for sacroiliac fusion to augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients underqoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
The SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System consists of an X shaped implant designed to assist in the healing of sacroiliac (SI) joints for fusion by providing fixation of the sacroiliac joint. The implant is not intended to replace normal body structures. The implant is offered in one size. The implant is manufactured from titanium alloy per ASTM F136.
The SI-TECHNOLOGY® SI-DESIS® XTM Sacroiliac Joint Fusion System was designed as a less invasive alternative to traditional open posterior surgical SI joint fusion. The titanium implant consists of a sacrum engaging side and an ilium engaging side connected by a bridge. During the procedure, bone graft material is placed in the window of the implant to facilitate stabilization. The implant is intended for single-use only. Implants are provided clean and non-sterile and designed for routine steam sterilization prior to use.
This document is a 510(k) summary for the SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System. Based on the provided text, the device itself is an implant for sacroiliac joint fusion, not an AI/ML powered device. Therefore, the information requested about acceptance criteria and studies (especially those related to AI/ML performance, ground truth, experts, and multi-reader studies) is not applicable to this submission.
The 510(k) summary describes non-clinical performance testing for the physical device to demonstrate substantial equivalence to predicate devices, but it does not involve any AI/ML components or associated performance metrics.
Here's a breakdown of why each requested item is not applicable in this context:
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A table of acceptance criteria and the reported device performance: This typically refers to metrics like sensitivity, specificity, AUC for AI/ML devices. For a physical implant, "acceptance criteria" usually relate to mechanical strength, biocompatibility, and manufacturing quality. The document states "The results of these studies show the subject device is substantially equivalent to the predicate devices" for the performed mechanical tests, but does not provide specific numerical acceptance criteria or performance metrics in a table.
- Performed Tests (Physical Device):
- Static Shear Testing
- Dynamic Shear Testing
- Static Pushout Testing
- Biomechanical Cadaver Testing
- Simulated Use Testing
- Performed Tests (Physical Device):
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Sample sizes used for the test set and the data provenance: Not applicable. There is no "test set" in the context of an AI/ML model for this implant. The testing involved mechanical and cadaveric studies.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/ML performance evaluation (e.g., expert consensus on medical images) is not relevant for a physical implant's mechanical testing.
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Adjudication method for the test set: Not applicable for a physical implant.
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If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is for AI/ML software.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for AI/ML software.
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The type of ground truth used: Not applicable in the AI/ML sense. For the physical device, the "ground truth" would be established by validated biomechanical testing methods and standards.
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The sample size for the training set: Not applicable. This is for AI/ML software.
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How the ground truth for the training set was established: Not applicable. This is for AI/ML software.
Conclusion: The provided document is for a physical medical device (an implant) and does not describe an AI/ML powered device. Therefore, the questions tailored for AI/ML device evaluations are not pertinent to this submission. The device demonstrated substantial equivalence through non-clinical performance testing, including mechanical and biomechanical studies, against existing predicate devices.
§ 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.