(90 days)
The Powered PD-IO Intraosseous Infusion System provides intraosseous access in the proximal tibia, as an alternative to IV access during emergencies. The device is for use in pediatric patients, from birth to 21 years of age (approximate weight range: 3 kg - 39 kq).
The Powered PD-IO Intraosseous Infusion System (which looks similar to a cordless drill) consists of a reusable battery powered driver connected to a single use disposable intraosseous (IO) needle assembly. Upon activation, the drill bit rapidly penetrates the cortex of the bone to a desired depth within the bone marrow. The driver then separates from the hub of the IO needle assembly, leaving the cannula securely seated in the bone. The trocar/stylet containing the drill bit is then removed. A standard Luer lock (part of the needle assembly) then permits attachment of standard syringes and IV lines for administration of drugs and fluids.
Based on the provided text, here's an analysis of the acceptance criteria and study data for the Powered PD-IO Intraosseous Infusion System:
It's important to note that the provided document is a 510(k) premarket notification summary and an FDA clearance letter. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study results with specific acceptance criteria and performance metrics typically found in a full clinical study report. Therefore, some of the requested information (like specific numerical acceptance criteria, direct device performance against those criteria, and detailed ground truth methodology for studies) is not explicitly present. The document primarily discusses the comparison of technological characteristics to demonstrate equivalence.
Here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't provide a table of pre-defined numerical acceptance criteria for a study. Instead, it relies on demonstrating substantial equivalence to predicate devices by comparing their technological characteristics. The "performance" assessment is qualitative, affirming similarity across various aspects.
| Acceptance Criteria Category (Inferred from Equivalence Claims) | Reported Device Performance (as stated in the document) |
|---|---|
| Indications for use | Similar to predicate devices |
| Target population | Similar to predicate devices (pediatric patients, birth to 21 years of age, 3 kg - 39 kg) |
| Drill Design | Similar to predicate devices |
| Needle Design | Similar to predicate devices |
| Technique | Similar to predicate devices |
| Performance | Similar to predicate devices (implicitly, it performs the function of providing intraosseous access) |
| Sterility | Similar to predicate devices |
| Biocompatibility | Similar to predicate devices |
| Mechanical Safety | Similar to predicate devices |
| Anatomical site | Similar to predicate devices (proximal tibia) |
| Where used | Similar to predicate devices (emergencies, as alternative to IV access) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a clinical study with a "test set" in the sense of a dataset used to evaluate the device's performance against specific ground truth. It's a submission for regulatory clearance based on substantial equivalence to existing devices. Therefore, details like sample size for a test set, country of origin, or retrospective/prospective nature of a clinical study are not provided. The comparison is primarily against the specifications and known performance of the predicate devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since a "test set" with established ground truth for a clinical performance evaluation is not described, this information is not available in the document. The ground truth for the equivalence assessment relies on regulatory standards, engineering principles, and the established safety and effectiveness of the predicate devices.
4. Adjudication Method for the Test Set
Not applicable as a traditional "test set" with expert adjudication is not 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. The Powered PD-IO Intraosseous Infusion System is a medical device for physical access (a needle system), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or AI-assisted improvement effect size is not relevant or mentioned.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as it is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" used for this 510(k) submission is the established safety and effectiveness of the predicate devices (PD-IO Disposable Intraosseous Infusion Needle K043490 and VidaPort Intraosseous Infusion System K032885). The new device is deemed substantially equivalent if its technological characteristics and performance are similar enough to these already-cleared devices, implying it also meets their established performance and safety profiles.
8. The Sample Size for the Training Set
Not applicable. The document describes a medical device, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for a machine learning model.
§ 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).