(55 days)
The ReUnite™ Screws are indicated for use in the presence of appropriate immobilization in the following procedures:
- correction of hallux valgus (bunion)
- repair of metacarpal and phalangeal fusion and fractures
The ReUnite™ Screws are made of bioresorbable and biocompatible polymer that have been used in surgical procedures for a number of years. LactoSorb® resorbable copolymer is synthetic polyester derived from lactic and glycolic acids. Polylactic/polyglycolic (PLLA/PGA) acid copolymer degrades and resorbs IN VIVO by hydrolysis to lactic and glycolic acids, which are then metabolized by the body. The LactoSorb® material has been found to be biocompatible in both soft and hard bone tissues.
The provided text describes a medical device, the ReUnite™ Screws, and its substantial equivalence determination from the FDA. However, it does not contain information about acceptance criteria, device performance metrics, or a study design in the way you've outlined. The text focuses on the device's material, indications for use, and a statement about its mechanical strength relative to a predicate device.
Therefore, most of the requested information cannot be extracted from the provided document.
Here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Strength: | The ReUnite™ Screws are "as strong or stronger than the LactoSorb® Bone Pin." |
| Resorption Time: | The device "completely resorbs in approximately 12 months IN VIVO." |
(Note: These are indirect acceptance criteria based on the statements in the document, not formally presented as such.)
2. Sample sized used for the test set and the data provenance
This information is not provided in the document. The document refers to "mechanical testing" but does not detail the sample size or provenance of the data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document.
4. Adjudication method for the test set
This information is not provided in the document.
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 information is not provided in the document. The device is a bone screw, not an AI-assisted diagnostic tool, so an MRMC study related to AI would not be applicable here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided in the document. This is not an algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Based on the description of "mechanical testing" and "resorption in vivo," the ground truth likely involved:
- Mechanical Strength: Physical measurement against established mechanical standards or comparison to the predicate device's measured strength.
- Resorption: In vivo studies (animal or human, though not specified here) to observe the degradation and resorption over time, possibly with histological examination or imaging.
8. The sample size for the training set
This information is not provided in the document. As this is not an AI/algorithmic device, the concept of a training set is not directly applicable in the typical sense.
9. How the ground truth for the training set was established
This information is not provided in the document. Again, the concept of a training set and its ground truth is not applicable to this type of device in the context of the provided text.
§ 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.