(117 days)
The 10mm Ligament Fasteners are intended for use in the fixation of ligament and tendon bone block grafts in cruciate ligament reconstruction surgeries of the knee.
The Innovasive 10mm Ligament Fastener utilizes a central pin placed inside an outer sleeve resulting in the expansion of the outer sleeve and the ultimate fixation of the device into bone. The Innovasive Devices 10mm Ligament Fastener will be offered in a single size, 10mm outside diameter and 20mm long. The outer sleeve has threads on its exterior to hold to the bone and a central ID designed to accept the pin component. The central pin has ribs along its length designed to expand the outer sleeve as it is placed down the sleeve inside diameter. In addition, the central pin incorporates a "side-plate" with two transverse pegs to hold a bone plug for bone-patella-bone fixation of the soft tissue 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 provided text describes a medical device, the Innovasive 10mm Ligament Fastener, and its 510(k) submission for market clearance. It includes information about the device's comparison to predicate devices and performance data. However, the document is a 510(k) summary and not a detailed study report. Therefore, much of the requested information regarding acceptance criteria, study design specifics, expert involvement, and training set details are not present.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Testing: Ultimate holding strength in a bone model compared to the predicate device. | The Innovasive 10mm Ligament Fastener holding strength was found to be equivalent to the strength of the predicate device. |
Note: The specific quantitative acceptance criteria for "equivalent" are not provided in this document.
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 specified.
- Data Provenance: Not specified. This sounds like bench testing ("in a bone model"), so a country of origin for clinical data or a retrospective/prospective designation isn't applicable.
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)
- Number of Experts/Qualifications: Not applicable. This was mechanical testing in a bone model, not an expert-driven assessment of clinical outcomes or images.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. This was mechanical 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
- MRMC Study: No. This device is a ligament fastener, not an AI-powered diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: The "ground truth" for the mechanical testing was the ultimate holding strength of the predicate device in a bone model. This is a comparative mechanical performance rather than a clinical ground truth like pathology or expert consensus.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is not an AI/machine learning device that would require a training set. The device's "design" is based on the predicate device and engineering principles.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable for the reasons stated above.
In summary, the provided document is a regulatory submission for a physical medical device. The "study" referenced is a single mechanical test comparing the ultimate holding strength of the new device to a predicate device in a bone model. It is not a clinical study or an AI-related performance evaluation, which explains why much of the requested information is not present or applicable.
§ 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.