(88 days)
The PRO-TOE™ VO Hammertoe Implant system is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe and mallet toe.
The PRO-TOE™ VO Hammertoe Implant System will be offered in two sizes and two different blade angles. The implants will be manufactured from stainless steel.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Study Type) | Reported Device Performance |
|---|---|
| Cantilever Bend Strength | "The results of the test show that the subject PRO-TOE™ VO Hammertoe implants can be expected to perform at least as well as the legally marketed predicate newdeal® K-wires." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified in the provided text. The study involved a cantilever bend test on the PRO-TOE™ VO Hammertoe Implants and the newdeal® K-wires, but the number of implants/wires tested is not detailed.
- Data Provenance: The study appears to be an in-vitro (laboratory) test, not involving human or animal data. Thus, "country of origin" or "retrospective/prospective" are not applicable in the typical sense for clinical studies. It was conducted by Wright Medical Technology, Inc., located in Arlington, TN, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
Not applicable. This was a mechanical engineering test (cantilever bend test) where the "ground truth" is determined by the physical properties and performance measured, not by expert interpretation.
4. Adjudication Method for the Test Set:
Not applicable. Mechanical tests do not typically involve adjudication methods like those used for expert consensus in medical imaging studies. The results are obtained directly from instrumental measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and 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 device is a physical implant, not an AI or imaging diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This is a physical medical device, not an algorithm. The "standalone" performance refers to the device's mechanical integrity as tested in the cantilever bend test.
7. The Type of Ground Truth Used:
The ground truth used was the mechanical performance (specifically, strength under cantilever bend) of both the subject device (PRO-TOE™ VO Hammertoe Implants) and the predicate device (newdeal® K-wires) as measured in a controlled laboratory setting.
8. The Sample Size for the Training Set:
Not applicable. This is a physical medical device, and the evaluation involved mechanical testing, not a machine learning model requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As above, there was no machine learning training set for this device evaluation.
§ 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.