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510(k) Data Aggregation
(166 days)
The NIO-P for pediatric is intended to provide Intraosseous access in the proximal tibia, as an alternative to IV access during emergencies. The device is for use in pediatric patients in age 3-12 years of age.
The Einstein Works NIO Pediatric (NIO- P) Intraosseous Infusion Device permits intraosseous access through the Proximal Tibia and the Humeral Head. The NIO device is comprised of a trocar needle, spring, piston and housing and it resembles a syringe. When activated, a loaded spring is released, and the device injects the needle to a predetermined depth into the bone marrow cavity. The NIO device also features the same safety latch and trigger mechanism which is found with the predicate device.
The provided document is a 510(k) summary for the Einstein Works NIO Pediatric (NIO-P) Intraosseous Infusion Device. It's a regulatory submission to the FDA, not a research paper detailing a study that proves a device meets specific acceptance criteria. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving performance against new, explicit acceptance criteria through a dedicated study.
Therefore, much of the requested information regarding "acceptance criteria," "study," "sample size," "experts," "adjudication," "MRMC study," "stand-alone performance," and "ground truth" establishment for a medical device software or AI solution is not applicable to this document.
The document explicitly states:
- "No additional performance testing was performed to support the proposed changes because the device is identical."
- "Changes to labeling did not require bench testing to support substantial equivalence."
- "There are no clinical data submitted with this Notification."
The "acceptance criteria" here are implicit in the FDA's substantial equivalence pathway: demonstrating that the new device is as safe and effective as a legally marketed predicate device. The "study" proving this largely relies on comparison of design, materials, and intended use to the predicate.
Given this context, I will address what can be extracted from the document related to the requested points, and explicitly state when information is not present or not applicable.
1. A table of acceptance criteria and the reported device performance
As this submission is for substantial equivalence of an identical device with labeling changes, there are no new "acceptance criteria" or measured "device performance" in the traditional sense of a new performance study. The acceptance is based on its identity to the predicate.
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (as demonstrated by equivalence to predicate) |
|---|---|
| Identical design to predicate device | Reported: Yes, "The proposed device and the predicate device are the same device." |
| Identical materials to predicate device | Reported: Yes, "The proposed device and the predicate device are the same device." |
| Identical principle of operation to predicate device | Reported: Yes, "Same." (Mechanism of Action) |
| Identical indications for use to predicate device | Reported: Yes, "Same," and "There are no differences in indications for use." |
| Identical technological characteristics to predicate device | Reported: Yes, "Same" for all characteristics listed (Sponsor, Target Population, Anatomical Sites, Environment Used, Design, Mechanism of Action, Components, Dimensions, Weight, Safety Mechanisms, Materials, Hub Interface, Needle Fixation). |
| Performance demonstrated as safe and effective as predicate | Reported: "Based on the results of non-clinical testing [meaning the comparison to predicate], the Einstein Works intraosseous infusion device performs safely, as intended, and the comparative discussion of intended use, principle of operation, and technological characteristics, it is determined that the Einstein Works intraosseous infusion device is substantially equivalent to the predicate device..." |
2. Sample size used for the test set and the data provenance
- Sample size: Not applicable. No test set was used for a performance study. The submission relies on demonstrating identity to the predicate.
- Data provenance: Not applicable. No new data was generated from a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No test set was created or ground truth established for a performance study.
4. Adjudication method for the test set
- Not applicable. No test set requiring adjudication was used.
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 device is an intraosseous infusion device, a physical medical device, not an AI/software product that would involve human readers or AI assistance.
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 or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. No ground truth for a performance study was established as no new performance study was conducted. The "truth" in this submission relies on the established safety and efficacy of the predicate device.
8. The sample size for the training set
- Not applicable. This refers to a dataset for training AI/machine learning models. This document is for a physical medical device and does not involve AI development.
9. How the ground truth for the training set was established
- Not applicable. As above, this document does not involve AI or machine learning models that would require a training set with ground truth.
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