(79 days)
The LinX Tibial Ligament Fastener is intended for use in direct bone fixation of ligament and tendon grafts during cruciate ligament reconstruction surgeries.
The LinX Tibial Ligament Fasteners are intended for use in the fixation of ligament and tendon grafts in cruciate ligament reconstruction surgeries of the knee.
The Innovasive LinX Tibial Ligament Fastener utilizes a central pin placed inside an outer sleeve resulting in direct fixation of the device into bone. The Innovasive Devices LinX Tibial Ligament Fastener will be offered in five configurations:
#1) 8mm x 40mm
#2) 8mm x 40m Short (short refers to eyelet size)
#3) 8mm x 55mm
#4) 10mm x 40mm
#5) 10mm x 55mm
The central pin has ribs along its length designed to lock into the outer sleeve as it is inserted into the sleeve inside diameter. The central pin has an eyelet through which the soft tissue graft is threaded and four through-holes located above the eyelet that may be used to suture the graft to the pin; or a pin with a short eyelet (8mm x 40mm Short) may be used, that only accepts the suture that is sutured to the graft. The front of the pin has a through-hole to accept a piece of suture to guide the pin into the sleeve during the deployment of the device. The suture is then removed and discarded.
The outer sleeve has a central ID designed to accept the pin component, and an angled plate designed to lay flush against the tibia on the outside of the knee.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Innovasive LinX Tibial Ligament Fastener:
The provided 510(k) summary (K980491) for the Innovasive LinX Tibial Ligament Fastener describes a medical device undergoing regulatory review for substantial equivalence. It is important to note that this document is a 510(k) summary for a premarket notification, not a full scientific paper detailing a comprehensive study. As such, it will not contain all the typical elements of a detailed study report.
Based on the information provided, here’s a breakdown:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Ultimate holding strength (Implicitly, to be substantially equivalent to predicate devices) | The Innovasive LinX Tibial Ligament Fastener holding strength was found to be substantially equivalent to the Soft Tissue Screw and Washer System (a predicate device). |
2. Sample size 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. The document mentions "human cadaver," indicating the type of test medium but not the number of cadavers or individual tests performed.
- Data Provenance: The study was conducted using "human cadaver." No information about the country of origin or whether it was retrospective or prospective is provided. Given the nature of a 510(k) submission, this would typically involve laboratory testing.
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)
- Not applicable. This was a mechanical performance study, not a diagnostic or interpretive study requiring expert consensus for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This was a mechanical study measuring holding strength, not an interpretation of images or clinical outcomes 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
- Not applicable. This device is a mechanical implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a mechanical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Ground Truth: The "ground truth" in this context is the measured ultimate holding strength of the predicate device (Innovasive Devices Soft Tissue Screw and Washer System). The new device's performance was compared directly to this established performance benchmark. There isn't an "expert consensus" or "pathology" type of ground truth here, but rather a direct physical measurement.
8. The sample size for the training set
- Not applicable. This is a mechanical device study, not a machine learning study. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
- Not applicable. As above, there is no training set for this type of study.
Summary of Device Performance and Substantial Equivalence:
The core of the performance data section is the mechanical testing. The crucial aspect for a 510(k) clearance is demonstrating substantial equivalence to existing predicate devices.
- Test Performed: Mechanical testing to assess ultimate holding strength.
- Test Medium: Human cadaver.
- Comparison: The Innovasive LinX Tibial Ligament Fastener was compared to the Soft Tissue Screw and Washer System (another device marketed by Innovasive Devices).
- Finding: The holding strength of the new device was found to be "substantially equivalent" to the predicate device. This is the primary acceptance criterion for this type of regulatory submission – that the new device performs acceptably similarly to a legally marketed device for its intended use, without raising new questions of safety or effectiveness.
§ 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.