(28 days)
The M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System is intended for use in skeletally mature patients for fracture fixation of small and long bones of the pelvis, and for sacroiliac joint fusion for patients suffering from sacrolliac joint disruptions and degenerative sacroiliitis.
The M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System is designed for sacroiliac joint fusion in degenerative sacroiliitis, as well as for the fixation of small and long bone fractures in trauma cases. The system consists of various sized screws, manufactured from Ti6Al4V ELI and coated with rough Hydroxyapatite (HA). The HA coating allows for biological fixation and potentially leads to arthrodesis. The sacroiliac (SI) joint screws are hollow-body threaded fusion devices with a multiplefenestrated pattern shaft to promote arthrodesis, a self-tapping design to facilitate screw insertion, and a tapered tip to aid in guidance through pilot hole. Radial windowed slots along the shaft facilitate bone ingrowth after implantation and "bone filling" after insertion. The SI joint screws are provided in standard and headless designs.
The provided document is a 510(k) premarket notification for a medical device, the M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System. It outlines the device's indications for use, its description, and a comparison with a predicate device.
However, this document does not describe a study involving an AI or algorithm-based device. It pertains to a physical medical implant (screws) and its performance is evaluated through material and mechanical testing, as well as a cadaver model, not through metrics associated with algorithmic performance (e.g., sensitivity, specificity, AUC).
Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI-based device, as this document does not refer to such a device.
To directly address the numbered points based on the provided document's content, I can say:
- A table of acceptance criteria and the reported device performance: Not applicable. The document lists performance testing related to material properties and mechanical strength (e.g., ASTM F543-13, ASTM F2193-14, ISO 13779-3), but it does not present specific acceptance criteria or reported numerical performance metrics in a table format. It states that "design verification testing supports there are no new risks associated with the subject devices" and that the device is "as safe and effective as the predicate device."
- Sample size used for the test set and the data provenance: A "cadaver model" was used for design validation on the headless screws. The sample size for this cadaver model is not specified, nor is the provenance of the cadavers (e.g., country of origin, retrospective or prospective).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The study involved a cadaver model for design validation, not interpretation of data requiring expert consensus or ground truth establishment in the context of an AI device.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 does not describe an AI or algorithm-based device, nor a study involving human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document does not describe an AI or algorithm-based device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of AI performance. The design validation was performed using a "cadaver model."
- The sample size for the training set: Not applicable. This document does not describe an AI or algorithm-based device with a training set.
- How the ground truth for the training set was established: Not applicable. This document does not describe an AI or algorithm-based device.
§ 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.