(120 days)
The Bifurcated Needle is intended for use in administering vaccines by the scarification method or administering epidermal allergens.
The proposed Bifurcated Needle have two prongs. A small drop of smallpox vaccine was placed between the prongs and approximately fifteen punctures would be made into the skin. The needles were sterilized by EO to achieve a SAL of 10-6 and supplied sterile in packaging with a shelf life of five years.
The provided document is a 510(k) summary for a "Bifurcated Needle" and primarily focuses on proving substantial equivalence to a predicate device based on material properties, manufacturing processes, and adherence to performance standards. It explicitly states that "No clinical study is included in this submission." Therefore, the document does not contain information regarding a study that proves the device meets acceptance criteria related to AI/algorithm performance, human reader improvement, or clinical effectiveness.
The request asks for details typically found in submissions for AI/ML-driven medical devices or diagnostic tools, which involve evaluating algorithm performance, human-in-the-loop studies, and the establishment of "ground truth" for test and training sets. Since this document is for a physical, non-AI medical device (a bifurcated needle for administering vaccines), these types of studies were not conducted or presented.
Therefore, I cannot fulfill the request as the necessary information is not present in the provided text. The document does not describe:
- A table of acceptance criteria and reported device performance in the context of AI/ML or diagnostic accuracy.
- Sample sizes for a test set for AI performance or data provenance.
- Number of experts or their qualifications for establishing ground truth for AI.
- Adjudication methods for AI test sets.
- MRMC comparative effectiveness studies.
- Standalone (algorithm only) performance.
- Type of ground truth (expert consensus, pathology, outcomes data) for AI performance.
- Sample size for training set for AI.
- How ground truth for training set was established for AI.
The "performance data" section in the document refers to biocompatibility, sterilization, shelf life, and general physical performance testing for the needle itself, against standards like ISO 10993, ISO 11135, and ASTM standards. This is for the device's physical properties and safety, not for diagnostic or AI/ML performance.
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).