(79 days)
The B.I.GTM. Bone injection Gun for Pediatrics 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 up to 12 years of age.
The B.I.GTM. Bone injection Gun for Pediatrics is an instant, intravascular (IV) access device. The device comprises a housing with a spring loaded mechanism that inject a trocar needle into the bone marrow of a patient and allows for subsequent connection of a syringe or intravascular administration set.
This document is a 510(k) summary for the WaisMed LTD. B.I.G.TM - Bone Injection Gun for Pediatrics. It is a premarket notification for a medical device and, as such, does not typically contain the detailed information requested regarding clinical studies with specific acceptance criteria, sample sizes for training/test sets, ground truth establishment, or expert involvement in the way a clinical trial report or a journal publication would.
The provided document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed de novo clinical study with quantitative performance metrics against pre-defined acceptance criteria.
I can, however, extract related information to address some of your points based on what is available:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the 510(k) summary. The document focuses on demonstrating substantial equivalence based on technological features, principles of operation, and intended use, rather than presenting specific quantitative performance data against pre-defined acceptance criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The summary states "supportive data including in vitro studies, clinical data and literature survey," but does not specify sample sizes, country of origin, or whether the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. The 510(k) summary does not describe any specific process for establishing ground truth involving experts. It relies on the clinical context of intraosseous access for emergencies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. As an adjudication method would typically be part of a detailed clinical study, its absence is consistent with the nature of a 510(k) summary focused on substantial equivalence.
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
This information is not applicable/provided. The device is a mechanical bone injection gun, not an AI-powered diagnostic tool requiring human readability or interpretation. Therefore, an MRMC study related to AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. The device is a mechanical device for gaining intraosseous access, not an algorithm. Standalone algorithm performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not explicitly stated in the context of the requested detailed study. However, for a device like an intraosseous access gun, the "ground truth" for its effectiveness would inherently relate to the successful establishment of intraosseous access and its ability to deliver fluids/medications. This would typically be confirmed by direct observation during use, fluid flow, and patient physiological response, which falls under outcomes data in a broad sense (i.e., whether the device successfully achieves its intended physical function). The 510(k) summary states it provides "intraosseous access in the proximal tibia, as an alternative to IV access during emergencies." The "clinical data" mentioned would likely pertain to demonstrating this function.
8. The sample size for the training set
This information is not provided. There is no mention of a "training set" in the context of machine learning. The device is mechanical.
9. How the ground truth for the training set was established
This information is not provided/not applicable as there is no training set for a machine learning model.
Summary of available information from the 510(k) Summary:
The 510(k) summary primarily asserts substantial equivalence to predicate devices based on:
- Intended Use: To provide intraosseous access in the proximal tibia as an alternative to IV access during emergencies, for pediatric patients up to 12 years of age.
- Technological Features and Principles of Operation: Stated to be the same as the predicate Adults' B.I.G.TM device.
- Performance Data: "Supportive data including in vitro studies, clinical data and literature survey" were used to demonstrate that minor differences from predicate devices do not raise new types of safety or effectiveness issues. However, specific details of these studies (acceptance criteria, sample sizes, ground truth, etc.) are not provided in this summary.
This type of 510(k) summary is common for devices demonstrating substantial equivalence, where the focus is on showing similarity to already cleared devices rather than presenting a novel device with extensive new clinical trial data against pre-defined performance thresholds.
§ 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).