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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.

Device Description

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.

AI/ML Overview

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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K Number

K182770

Device Name

Adult Intraosseous Infusion Device

Manufacturer

Einstein Works, L.L.C

Date Cleared

2019-04-09

(193 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K142086

Predicate For

K191258

Intended Use

The NIO is intended to provide intraosseous access in the proximal tibia, as an alternative to IV access during emergencies. The device is for use in adult patients only.

The NIO is indicated for use in providing intraosseous access as an alternative to IV access during emergencies. Humeral head IO access is indicated when rapid fluid or pharmacological resuscitation is required, and intravenous access is not possible. The device is for use in adult patients only.

Device Description

The Adult NIO 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.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA regarding an "Adult Intraosseous infusion device" (K182770). It explicitly states that no performance testing (clinical or non-clinical) was required or submitted to prove the device meets acceptance criteria.

The basis for substantial equivalence is that the Einstein Works, L.L.C. Adult Intraosseous infusion device (NIO) is identical to the legally marketed predicate device, WaisMed LTD NIO-A Intraosseous Infusion Device (K142086), in terms of intended use, technological characteristics, design, components, and safety mechanisms.

Therefore, your request for acceptance criteria and study details cannot be fully answered from the provided text, as such information was not part of this 510(k) submission.

Here's what can be extracted based on the document's content:

1. A table of acceptance criteria and the reported device performance

The document states:

"Performance data were not required to determine substantial equivalence."
"There are no clinical data submitted with this Notification."

Therefore, no acceptance criteria or reported device performance are provided in this document as they were not a requirement for this specific 510(k) clearance due to the device being identical to a previously cleared predicate. The "performance" in this context refers to the device being functionally identical to the predicate.

Acceptance Criteria Category	Acceptance Criteria (Not Explicitly Stated as Performance Criteria for This Submission)	Reported Device Performance (as stated for substantial equivalence)
Intended Use	Must match predicate device's intended use.	Matches predicate (NIO is intended to provide intraosseous access in the proximal tibia and humeral head, as an alternative to IV access during emergencies, for adult patients only).
Technological Characteristics	Must match predicate device's technological characteristics.	Matches predicate (Design, Mechanism of Action, Components, Dimensions, Weight, Safety Mechanisms). For instance, the penetration depth is $25 \pm 3$ mm, identical to the predicate.
Materials	Must match predicate device's materials.	Matches predicate (Stainless steel, Brass 360 nickel-plated, Makrolon® Rx2530 Polycarbonate).
Standards Met	Must meet the same recognized standards as the predicate.	Meets ISO 594, ISO 9626, ISO 7864, identical to the predicate.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. No test set data of this nature were submitted or required for this 510(k) notification. The substantial equivalence was based on direct comparison to an existing device rather than new performance testing.

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 ground truth was performed or submitted.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set requiring adjudication was performed or submitted.