(131 days)
The BioPro Kwick-Wire™ Universal Screw System is indicated for use in the internal fixation of fractures, fusions and revisions. The system is intended for but not limited to hand surgery, orthopedic surgery and podiatric surgery - but is not intended for Spinal Use.
The BioPro Kwick-Wire™ Universal Screw System comes in two diameter pin sizes of 2.5mm and 3.0mm and in a length of 4.0in. and is used for reduction and fixation of fractures appropriate for the size of the device. A mating compression nut of either the 2.5mm or 3.0mm size is mated with the proper pin size. Both the pin and nut are manufactured from either high strength 6-4 Alloyed Titanium to ASTM F136 or high strength 316 LVM Stainless Steel to ASTM F138. Ancillary instrumentation is available for device implantation and removal. The implant is sold in a 'sterile' condition for single-use. The sterilization method used is Ethylene Oxide.
The provided document is a 510(k) summary for the BioPro Kwick-Wire™ Universal Screw System, which is a medical device for internal fixation of fractures, fusions, and revisions. It is a regulatory submission for premarket notification to the FDA, not a study evaluating the device's performance against specific acceptance criteria.
Therefore, the document does not contain information about acceptance criteria or a study that proves the device meets those criteria.
Specifically, the document states:
- "No nonclinical testing was used in the determination of substantial equivalence." (Page 1, Section "EQUIVALENCE")
- The determination of substantial equivalence is based on the device being "Similar in Material, Geometry Design/Markings, and Indications to other predicate system(s) currently sold in the U.S. market." (Page 1, Section "SUMMARY OF TECH-NOLOGICAL CHAR-ACTERISTICS")
This means the submission relies on the established safety and effectiveness of predicate devices, rather than presenting new performance data for the BioPro Kwick-Wire™ Universal Screw System.
As such, I cannot provide the requested information for the following points:
- A table of acceptance criteria and the reported device performance
- Sample sized used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- 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
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The sample size for the training set
- How the ground truth for the training set was established
§ 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.