(42 days)
The TiLink-L Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
The TiLink-L Joint Fusion System contains various sized titanium alloy sacroiliac screws for stabilization of the sacroiliac joint. The TiLink-L Joint Fusion System also contains various orthopedic instruments to assist the user in implanting a titanium alloy sacroiliac implant into the sacroiliac joint to fixate the joint. There are various sacroiliac implant sizes available for implanting to accommodate a range of sacroiliac joint sizes and geometries.
I regret to inform you that the provided text does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria for the "TiLink-L Joint Fusion System."
The document is a 510(k) premarket notification summary from the FDA for a medical device. It focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving performance against specific acceptance criteria through a standalone study.
Here's a breakdown of why the requested information cannot be extracted:
- No Acceptance Criteria or Performance Data: The document states that "The following non-clinical performance data were provided to demonstrate substantial equivalence of the subject device to the predicates: Torsional strength testing per ASTM F543." However, it does not specify any acceptance criteria (e.g., "torsional strength must be greater than X Nm") nor does it report the device's actual performance against such criteria. It only mentions that torsional strength testing was performed.
- Focus on Substantial Equivalence: The entire premise of this 510(k) is to show that the new device is "substantially equivalent" to a predicate device (TiLink-L SI Joint Fusion System - K230446). This means it's asserting that if the predicate was safe and effective, this new device, being sufficiently similar, is also safe and effective. It's not about proving absolute performance against a set of independent criteria.
- No Clinical Study Details: The document only mentions "non-clinical performance data" (torsional strength testing). It does not describe any clinical studies, human reader studies, or trials with patient data. Therefore, none of the questions related to clinical study design, sample size, ground truth, experts, or MRMC studies can be answered.
- No Training Set Information: Since no AI/algorithm is described, there's no mention of a training set or how its ground truth was established.
In summary, the provided document is a regulatory filing for substantial equivalence and does not contain the detailed performance study information you are asking for.
Therefore, I cannot populate the table or answer the specific questions based on the given input.
§ 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.