(77 days)
The EZ-IO is for emergency vascular access when standard venous access is not possible. Humeral head IO access is indicated when rapid fluid or pharmacological resuscitation is required and intravenous access is not possible.
The EZ-IO (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 penetrates through 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 via the humeral head.
The provided text describes the EZ-IO Humeral Head device and its substantial equivalence to a predicate device, the VidaPort Intraosseous Infusion System. It does not contain information about specific acceptance criteria, a study proving device performance against those criteria, sample sizes for test/training sets, expert qualifications, or detailed ground truth methodologies. The document is primarily a 510(k) premarket notification summary and an FDA clearance letter based on substantial equivalence.
Therefore, I cannot fulfill all parts of your request as the information is not present in the provided text. I can only extract what is available.
Here's what I can provide based on the given text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria or a study with reported numerical device performance against such criteria. Instead, it relies on substantial equivalence. The "performance" assessment is qualitative, comparing characteristics to the predicate device.
| Characteristic | EZ-IO Humeral Head | Predicate Device (VidaPort Intraosseous Infusion System) | Comparison Outcome |
|---|---|---|---|
| Indications for Use | Emergency vascular access when standard venous access is not possible; rapid fluid/pharmacological resuscitation required when IV access is not possible. Humeral head IO access. | (Implicitly similar) | Found to have similar technological characteristics and to be equivalent. |
| Target Population | (Implicitly similar) | (Implicitly similar) | Found to have similar technological characteristics and to be equivalent. |
| Drill Design | (Described as a reusable battery-powered driver) | (Implicitly similar or equivalent) | Found to have similar technological characteristics and to be equivalent. |
| Needle Design | Single-use disposable IO needle assembly | (Implicitly similar or equivalent) | Found to have similar technological characteristics and to be equivalent. |
| Technique | Penetrates cortex to desired depth, separates driver, removes stylet, Luer lock for attachment. | (Implicitly similar or equivalent) | Found to have similar technological characteristics and to be equivalent. |
| Performance | (Not specified quantitatively) | (Not specified quantitatively) | Found to have similar technological characteristics and to be equivalent. |
| Sterility | (Implicitly similar or equivalent) | (Implicitly similar or equivalent) | Found to have similar technological characteristics and to be equivalent. |
| Biocompatibility | (Implicitly similar or equivalent) | (Implicitly similar or equivalent) | Found to have similar technological characteristics and to be equivalent. |
| Mechanical Safety | (Implicitly similar or equivalent) | (Implicitly similar or equivalent) | Found to have similar technological characteristics and to be equivalent. |
| Anatomical Site | Humeral Head | (Implicitly similar or equivalent) | Found to have similar technological characteristics and to be equivalent. |
2. Sample size used for the test set and the data provenance
Not explicitly mentioned in the provided text. The submission is a 510(k) for substantial equivalence, which often relies on comparative analysis rather than new clinical trial data for direct performance measurements.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not explicitly mentioned in the provided text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not explicitly mentioned in the provided text.
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 a medical device (intraosseous infusion system), not an AI diagnostic tool involving human readers or AI assistance in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not explicitly mentioned in the provided text for establishing performance. The "ground truth" for the submission is the legally marketed predicate device (VidaPort Intraosseous Infusion System), against which the new device (EZ-IO Humeral Head) is compared for "similar technological characteristics and to be equivalent."
8. The sample size for the training set
Not applicable/not mentioned. This is a medical device clearance based on substantial equivalence, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
Not applicable/not mentioned. (See #8)
§ 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).