(28 days)
The G-Lok® and G-Lok® XL Extender are intended to provide suspension fixation for soft tissue to bone in the repair of the natural ligament or tendon disruption or assist in reconstruction surgeries and to assist in the management of reconstructive surgeries.
The G-Lok® suspension fixation device is a single-use, titanium implant used for fixation of soft tissue to bone. The G-Lok® has two configurations: One has a Continuous Loop, made of ultra high molecular weight polyethylene, offered in several sizes to accommodate various bone tunnel lengths. The second configuration does not have a loop, and enables custom loop lengths to be tied using an appropriate material (not included). Both of these configurations have a Lead Suture and an optional Flipping Suture. The G-Lok® XL Extender is a single-use, titanium implant used for providing additional button width and length to the G-Lok®.
This document is a 510(k) premarket notification for the G-Lok® and G-Lok® XL Extender, which are metallic bone fixation fasteners. The purpose of this 510(k) is to demonstrate substantial equivalence to a predicate device (K101616 - GrappLR™ and GrappLR™ Extender).
The information provided does not describe clinical acceptance criteria or a study that proves the device meets such criteria in the way typically expected for an AI/CADe device. This document is for a medical implant (a bone fixation fastener), and the evaluation focuses on mechanical performance and substantial equivalence to a predicate device, not on diagnostic accuracy metrics like sensitivity or specificity.
Therefore, many of the requested points are not applicable to the information contained in this document. However, I will answer the applicable questions based on the provided text.
1. A table of acceptance criteria and the reported device performance
The document explicitly states: "The purpose of this 510(k) was to add an optional Flipping Suture. With respect to technology, the design is similar as confirmed by comparison, and the performance is the same as verified by validation. Based upon this, T.A.G. Medical Products Corporation, Ltd. believes that its device is safe and effective because it performs the same function in the same manner."
The "performance" referred to here is largely mechanical and functional equivalency to the predicate device. The Acceptance Criteria are implicitly that the modified device's mechanical performance is equivalent to or better than the predicate device.
| Acceptance Criteria (Implicit) | Reported Device Performance (Implicit) |
|---|---|
| Mechanical performance equivalent to the predicate device | "The performance is the same as verified by validation." |
| Ability to provide suspension fixation for soft tissue to bone | "Intended to provide suspension fixation for soft tissue to bone..." (Same as predicate) |
| Ability to assist in reconstruction surgeries | "...assist in reconstruction surgeries and to assist in the management of reconstructive surgeries." (Same as predicate) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "performance testing indicated equivalency to the predicate device," but it does not specify the sample size, data provenance, or whether the testing involved human subjects or was purely mechanical/bench testing. Given the nature of a bone fixation fastener, it's highly likely this refers to bench testing rather than clinical data from patients.
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. The "ground truth" for a mechanical device like this would be its physical and mechanical properties, not expert-labeled clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as there is no "test set" in the context of diagnostic performance requiring adjudication.
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 is not applicable. This is not an AI/CADe device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is not an AI/CADe device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Given the context of a 510(k) for a medical implant, the "ground truth" would be related to material properties, mechanical strength, biocompatibility, and functional performance as determined by engineering tests and regulatory standards. The document doesn't explicitly state the type of ground truth, but it would be based on validated scientific and engineering principles for mechanical functionality and safety.
8. The sample size for the training set
This is not applicable. There is no mention of a training set as this is not an AI/CADe device.
9. How the ground truth for the training set was established
This is not applicable. There is no mention of a 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.