(94 days)
The Allofix™ Push-In Anchor is indicated for use in soft tissue to bone fixation of the shoulder, elbow, ankle, and knee in association with adequate postoperative immobilization.
The anchor, suture, and inserter are all packaged together. The kit contains one allograft anchor, loaded with one or two strands of #0 or #2 polyethylene or polyester suture, one white-blue co-braid and one white. The anchor and suture are housed in an inserter. The anchor resides at the tip of the tube while the bulk of the suture resides within the inserter handle. The inserter, with the loaded anchor, et al, delivers the product to the site. The inserter is composed of a plastic body and a stainless steel tube. A drill or punch is provided to create a hole to deliver the anchor. The inserter contents are housed within a plastic tray. All components are single use and sterile.
The Allofix™ Push-In Anchor is a medical device for soft tissue to bone fixation. The provided text outlines the device, its indication for use, and a summary of studies performed.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Design Requirements) | Reported Device Performance |
|---|---|
| Meets design input requirements for strength (Chapter 7, 8) | "The conclusion of the anchor insertion and fixation test confirmed that the Allofix™ Push-In Anchor meets design input requirements for strength (Chapter 7, 8)." |
| Allofix™ Push-In Anchor dimensions within design requirements | "The tests also confirmed that the Allofix™ Push-In Anchor dimensions were within design requirements." |
| Acceptable insertion repeatability | "Insertion repeatability was found to be acceptable..." |
| Pullout values for fixation strength must be at least comparable to predicate/similar devices | "...and pullout values for fixation strength exceeded those of metal and polymeric devices used for similar types of fixation." |
Note: The specific numerical values or thresholds for these "design requirements" are not detailed in the provided text. The text only states that the device "meets" or "exceeded" them.
Study Details
Based on the provided text, the study conducted was a Biomechanical Testing study.
-
Sample size used for the test set and the data provenance:
- Sample Size: The text does not specify the exact sample size (number of anchors or test repetitions) used for the biomechanical testing.
- Data Provenance: The text does not provide information on the country of origin of the data or whether it was retrospective or prospective. Given it's a pre-market submission, it would inherently be considered prospective testing for the device's performance.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This type of information is not applicable to a biomechanical testing study. Biomechanical studies typically involve objective measurements of physical properties (e.g., strength, dimensions, pullout force) rather than expert interpretation of data points to establish a "ground truth."
-
Adjudication method for the test set:
- Not applicable. As this was a biomechanical study, there would be no need for expert adjudication of results; the measurements are objective.
-
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:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI devices, where human readers interpret medical images. The Allofix™ Push-In Anchor is a physical medical device, and its evaluation relies on mechanical properties, not interpretation by human readers. Therefore, there's no discussion of human reader improvement with or without AI.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. As the Allofix™ Push-In Anchor is a physical implantable device, the concept of an "algorithm only" or "human-in-the-loop" performance study does not apply. The device itself performs its function (fixation).
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" in this context refers to the pre-defined design input requirements for strength, dimensions, insertion repeatability, and fixation strength. The tests directly measured these physical properties against those engineering specifications.
-
The sample size for the training set:
- Not applicable. This study is a biomechanical evaluation of a physical device, not an AI/machine learning model that requires a training set.
-
How the ground truth for the training set was established:
- Not applicable. There was no training set for this biomechanical study.
§ 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.