(28 days)
The M.U.S.T. Sacral Illac 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 sacroiliac 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 M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System consists of various sized screws, manufactured from Ti6A14V 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 standard screw can be coupled to modular washers of different diameters to optimize and stabilize the contact between the screw head and the cortical bone and to improve the compression activity of the screw. The standard screws are provided sterile in three diameters (8, 9, and 10 mm) and multiple lengths (25 – 80 mm).
The headless screw has an anatomical shape which allows for full insertion into the bone. The headless screws are provided sterile in three diameters (7.5, 9, and 11 mm) and multiple lengths (30 - 75 mm). The M.U.S.T. Sacral Iliac Screws Extension introduces new sizes of these screws keeping the same diameters (7.5, 9, and 11 mm) with new lengths from 80 mm (5 mm increment).
The provided FDA 510(k) document does not describe acceptance criteria for a device, nor does it present the results of a study designed to prove the device meets specific acceptance criteria in the context of device performance as one might expect for AI/ML or diagnostic devices.
Instead, this document is a 510(k) submission for a medical device (M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System), seeking to demonstrate substantial equivalence to a previously cleared predicate device. Substantial equivalence is a regulatory pathway for medical devices in the US, where a new device is compared to a legally marketed predicate device, and it's shown that the new device is as safe and effective as the predicate.
The "performance data" section in this document refers to design verification and validation testing related to the physical characteristics and safety of the bone screws, not diagnostic accuracy or clinical effectiveness in the way an AI/ML device would be evaluated.
Therefore, many of the questions in your prompt are not applicable to the information contained in this 510(k) submission.
Here's an attempt to answer the applicable parts based on the provided text, while clearly indicating where information is not present:
1. Table of acceptance criteria and the reported device performance
This document does not define specific "acceptance criteria" in terms of performance metrics like sensitivity or specificity. Instead, the "acceptance" for this device is based on demonstrating substantial equivalence to a predicate device through engineering and material testing.
The document states that the introduction of new sizes for the M.U.S.T. SI-Joint Headless screws does not create a new worst case compared to the predicate device. Therefore, a comparative analysis was performed to determine if the line extension created a new worst-case product size, and it was determined that the subject devices are substantially equivalent to the previously cleared predicate device.
The "performance data" section lists the following tests that were leveraged from the predicate device:
| Test/Standard | Reported Performance/Outcome (Implied Acceptance) |
|---|---|
| ASTM F543-13 (Metallic Medical Bone Screws) | (Implied compliance for mechanical properties) |
| ASTM F2193-14 (Components in Spinal Skeletal System Fixation) | (Implied compliance for mechanical properties) |
| ISO 13779-3: 2008 (Hydroxyapatite - Chemical Analysis & Characterization) | (Implied compliance for HA coating quality) |
| ASTM F1185-03 (Reapproved 2014) (Composition of Hydroxyapatite) | (Implied compliance for HA coating composition) |
| Sterilization Validation | (Implied successful validation of sterilization method) |
| Shelf-life Testing | (Implied successful validation of shelf life) |
| Cadaver/Sawbones Workshop | (Implied successful demonstration of usability/functionality in simulated environment) |
| Comparative analysis to predicate device for new sizes (M.U.S.T. SI-Joint Headless screws) | Determined that new sizes do not create a new worst case and are substantially equivalent to predicate. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: Not explicitly stated for each test. These are typically engineering tests performed on a limited number of physical samples (e.g., screws) according to the respective ASTM/ISO standards.
- Data provenance: Not specified, but likely from internal Medacta International SA testing (Switzerland). These are not clinical studies with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable. This device is a bone fixation fastener, not a diagnostic or AI/ML device requiring expert ground truth for performance evaluation in the clinical sense. The "ground truth" here is compliance with engineering standards and demonstration of substantial equivalence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human reader consensus for "ground truth."
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
Not applicable. This is not an AI/ML or diagnostic device.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context is adherence to established engineering standards (ASTM, ISO) for material properties, mechanical performance, sterilization, and biocompatibility, as well as the device's physical and mechanical comparability to the predicate device. It does not involve clinical outcomes data or expert consensus in a diagnostic sense.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. As above, no training set.
§ 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.