(67 days)
The Acufex Screw Cannula is used for fixation of bone-tendon-bone grafts during Anterior or Posterior Cruciate Ligament (ACL/PCL) reconstruction procedures.
The Acufex Screw Cannula is a cylindrical device that has a distal, screw holding end, and an open back end. The proximal end is shaped to allow for secure grasping of the cannula during insertion. The distal end contains a feature that allows the screw to be held snugly in the cannula. This is accomplished by creating an interference fit between the screw and the cannula walls.
The provided text is a 510(k) summary for a medical device called the "Acufex Screw Cannula." It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and performance data in the context of AI or diagnostic performance.
Therefore, many of the requested categories for a study proving device performance against acceptance criteria cannot be answered from the given document. The document describes a traditional medical device submission (a surgical instrument for ACL/PCL reconstruction), not a diagnostic device or an AI-powered system that would typically have performance metrics like sensitivity, specificity, or reader studies.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Cannot be answered from the text. The document does not describe quantitative performance criteria for the Acufex Screw Cannula beyond its basic function and material specifications, which are compared to a predicate device. There are no "reported device performance" metrics in the sense a diagnostic or AI device would have (e.g., accuracy, sensitivity, specificity).
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be answered from the text. This document does not describe a "test set" in the context of diagnostic performance or AI model evaluation. It's a 510(k) submission for a surgical instrument, focusing on substantial equivalence to an existing device rather than a clinical trial with a test set of data.
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)
- Cannot be answered from the text. This concept is not applicable to the type of device and submission described. There's no "ground truth" establishment in the context of diagnostic assessment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be answered from the text. Not applicable to this type of device submission.
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
- Cannot be answered from the text. This is not an AI-powered device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be answered from the text. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be answered from the text. Not applicable to this type of device submission.
8. The sample size for the training set
- Cannot be answered from the text. This is not an AI/machine learning device that would have a "training set."
9. How the ground truth for the training set was established
- Cannot be answered from the text. Not applicable.
Summary of what the document does provide in relation to "acceptance criteria" and "study":
The document demonstrates substantial equivalence to a predicate device as its "acceptance criteria" for market clearance, rather than meeting specific performance metrics from a study as understood for AI or diagnostic devices.
The "study" in this context is the 510(k) submission process itself, which involves comparing the new device to a legally marketed predicate device.
Here's the relevant information:
- Device Name: Acufex® Screw Cannula
- Intended Use: Fixation of bone-tendon-bone grafts during Anterior or Posterior Cruciate Ligament (ACL/PCL) reconstruction procedures.
- Predicate Device: Arthrex® Sheathed Interference Screw (K915424)
Table demonstrating "Substantial Equivalence" (acting as the "acceptance criteria" for this type of submission):
| Attribute | Current Product
Acufex®
Screw Cannula | Substantially Equivalent Product
Arthrex® Sheathed Interference
Screw
510K#: K915424 |
|---------------------|-------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Indication | Bone Tendon Bone Graft Fixation
ACL & PCL Reconstruction | Bone Tendon Bone Graft Fixation
ACL & PCL Reconstruction |
| Screw Configuration | Interference | Interference |
| Screw Size | Outer Length: 20 - 30 mm
Diameter: 5.5 - 9 mm | Length: 25 - 55 mm
Diameter 6 - 9 mm |
| Screw Material | Titanium | Titanium |
| Cannula/Sheath | Polypropylene | Polyethylene |
| Labeling | Sterile, Single Use Only | Sterile, Single Use Only |
Explanation of how the device "meets the acceptance criteria":
The Acufex Screw Cannula meets the acceptance criteria by demonstrating that its design, function, materials, and intended use are similar enough to a legally marketed predicate device (the Arthrex® Sheathed Interference Screw) such that no new questions of safety or effectiveness are raised. The comparison table above directly presents how the new device aligns with the predicate across key attributes. The FDA's "Substantial Equivalence" letter (pages 3-4) confirms that the device has met this standard. The "risks to health have been addressed through the specified materials, processing controls, quality assurance, and compliance to the Medical Device Good Manufacturing Practices regulations," as stated in section G.
This document serves as an example of a 510(k) submission for a Class II medical device, which generally relies on demonstrating equivalence rather than extensive clinical efficacy trials with quantitative performance metrics typical for new drugs or high-risk devices.
§ 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.