(82 days)
The Outlet Sacroiliac Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
The Outlet Sacroiliac Joint Fusion System consists of cannulated, fully threaded screws with double helix threads designed to be able to screw into pre-drilled bone. It is fabricated from medical grade titanium alloy, Ti-6AI-4V (ASTM F-136). The Outlet System implants come in various sizes and lengths to accommodate patient anatomy. Optional washers are included for each screw diameter to aid in conforming to patient anatomy.
The information provided pertains to a 510(k) premarket notification for a medical device called the "Outlet Sacroiliac Joint Fusion System." This document primarily focuses on establishing substantial equivalence to legally marketed predicate devices through technological characteristics and bench testing. It does not describe a study involving device performance in a clinical setting, nor does it detail acceptance criteria related to diagnostic accuracy, human-in-the-loop performance, or reader studies.
Therefore, many of the requested categories cannot be answered from the provided text, as they apply to studies evaluating diagnostic or clinical performance, which are not present here.
However, I can extract the relevant information regarding the bench testing conducted.
1. A table of acceptance criteria and the reported device performance
The document states, "The results of this non-clinical testing show that the strength of the Outlet Sacroiliac Joint Fusion System is substantially equivalent to legally marketed predicate devices." While specific numerical acceptance criteria are not provided, the implicit acceptance criterion is "substantial equivalence" to the predicate devices in terms of mechanical strength as measured by the listed tests. The reported performance is that this substantial equivalence was met.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Substantial equivalence in strength to legally marketed predicate devices, as demonstrated by mechanical testing. | The Outlet Sacroiliac Joint Fusion System's mechanical performance (strength) is substantially equivalent to predicate devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes "bench testing" which is laboratory-based mechanical testing. It does not refer to clinical test sets, data provenance such as country of origin, or retrospective/prospective study design, which are terms typically associated with clinical trials. The sample sizes for each specific mechanical test (e.g., number of screws tested for static bending) are not provided in this summary.
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 question is not applicable. "Ground truth" in the context of expert consensus, pathology, or outcomes data is relevant for studies evaluating diagnostic or clinical outcomes, not for mechanical bench testing of an orthopedic implant.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods are used in clinical studies, typically for resolving discrepancies in expert opinion or medical diagnoses, not for mechanical bench testing.
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
This question is not applicable. The document describes mechanical bench testing of a physical implant, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study or evaluation of human reader improvement with AI was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical orthopedic implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For mechanical bench testing, the "ground truth" is typically established by physical measurement against known engineering standards and specifications. The document implies compliance with ASTM standards (e.g., ASTM F2193-14, ASTM F543-13), which define methodologies for measuring mechanical properties.
8. The sample size for the training set
This question is not applicable. The document describes mechanical bench testing and does not involve specific training sets as would be used in machine learning or AI development.
9. How the ground truth for the training set was established
This question is not applicable, as there is no training set mentioned in the context of this device's evaluation.
§ 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.