(63 days)
The PD-IO Disposable Intraosseous Infusion Needle and Handle provides intraosseous access in the proximal tibia, as an alternative to IV access during emergencies. The device is for use in pediatric patients.
The PD-IO Disposable Intraosseous Infusion Needle and Handle consists of a sterile single use handle with trocar and a sterile disposable single use intraosseous (IO) catheter with standard Luer lock. During use, the PD-IO needle is manually inserted through the cortex of the bone to a desired depth within the bone marrow. The insertion handle with trocar is then separated from the hub of the catheter by turning the handle counter clockwise and then removed leaving the catheter securely seated in the bone. The catheter has a standard Luer lock that permits attachment of standard syringes and IV tubing for administration of drugs and fluids.
The provided document is a 510(k) premarket notification for a medical device (PD-IO Disposable Intraosseous Infusion Needle and Handle). It is a regulatory submission for demonstrating substantial equivalence to a predicate device, not a study designed to prove the device meets specific acceptance criteria through performance metrics. Therefore, most of the requested information regarding acceptance criteria, reported performance, sample sizes, expert involvement, and ground truth cannot be extracted directly from this document.
However, I can provide what is available and explain why other information is not present.
Here's the breakdown:
1. A table of acceptance criteria and the reported device performance
This document does not contain a table of acceptance criteria or reported device performance metrics in the way a clinical study report would. The 510(k) process focuses on demonstrating substantial equivalence to a predicate device, not on meeting predefined performance thresholds for a novel device.
The "Summary of the technological characteristics" section (page {1}) lists areas where the submitted device was compared to predicate devices for similarity, not for performance against specific acceptance criteria. These areas are:
- Indications for use
- Design features
- Needle design
- Technique
- Sterility
- Biocompatibility
- Anatomical site
- Where used
- Standards met
- Target population
- Mechanical safety
The document states that the submitted device was "found to have similar technological characteristics and to be equivalent to the PD-IO Disposable Intraosseous Infusion Needle" in these areas. This is the "performance" relative to the 510(k) process – demonstrating equivalence, not achieving a specific numerical metric.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This document does not describe a clinical study with a test set of data. The "comparison" is based on technological characteristics and design features relative to the predicate devices. There is no mention of data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No test set requiring expert-established ground truth is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring adjudication is described.
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
Not applicable. This is not an AI/software device and no MRMC study is mentioned.
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.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No ground truth is established as there's no diagnostic task or performance measurement against a definitive standard. The "ground truth" for a 510(k) is essentially the established safety and effectiveness of the legally marketed predicate devices.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that would involve a training set.
9. How the ground truth for the training set was established
Not applicable. As above, no training set or ground truth in that context.
§ 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).