(85 days)
The B.I.G. - Bone Injection Gun 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.
The B.I.G. - Bone Injection Gun consists of a trocar needle held by a piston. The piston is surrounded by a compressed spring. All components are contained in the device's housing. When the device is operated, the compressed spring is released and propels the trocar needle into the bone marrow.
The provided document, K062940, is a 510(k) summary for WaisMed's B.I.G.™ - Bone Injection Gun. This document primarily focuses on establishing substantial equivalence to predicate devices and does not contain detailed performance criteria or a study design description that would typically be found in a clinical trial report or a more comprehensive technical document.
Here's an analysis based on the available information:
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A table of acceptance criteria and the reported device performance
The document states: "The device was tested for both performance and safety. In all instances, the B.I.G. - Bone Injection Gun functioned as intended."
However, specific quantitative acceptance criteria (e.g., success rate, time to access, specific failure modes and their acceptable limits) and detailed reported device performance metrics are not provided in this summary. It only offers a general statement that the device functioned as intended. -
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not available in the provided 510(k) summary. The document does not describe any specific test set size for performance and safety testing, nor does it mention the provenance of any data used.
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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)
This information is not available. The summary does not describe a clinical study involving human experts establishing ground truth. The evaluation appears to be based on functional and safety testing of the device itself rather than an assessment by experts against a reference standard in a clinical context.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available. No description of adjudication methods is present, as there's no mention of a human-reviewed test set requiring such a process.
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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 to this device. The B.I.G. - Bone Injection Gun is an intraosseous infusion device, not an AI-powered diagnostic tool, and therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to its evaluation.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable to this device. As a mechanical medical device, the concept of "algorithm only" performance without human-in-the-loop is not relevant. The device requires human operation for its intended use.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not explicitly stated as part of a formal study with ground truth. For a mechanical device like the B.I.G., "ground truth" typically relates to its functional performance (e.g., successful insertion, fluid flow rate without leakage, structural integrity). The summary only states that the device "functioned as intended," implying that it met its functional design specifications, which would serve as the de-facto "ground truth" for its performance and safety tests.
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The sample size for the training set
This information is not applicable to this device. The B.I.G. - Bone Injection Gun is a mechanical device, not an algorithm that requires a training set.
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How the ground truth for the training set was established
This information is not applicable to this device, as it does not involve a training set.
In summary, the provided 510(k) summary for the B.I.G. - Bone Injection Gun states that the device was tested for performance and safety and "functioned as intended." However, it lacks specific details about the acceptance criteria, study design, sample sizes, expert involvement, or any quantitative results that would typically be provided in a comprehensive study report. The premarket notification focuses on demonstrating substantial equivalence to predicate devices (WaisMed, Ltd., B.I.G. - Bone Injection Gun (K981853) and Vidacare Corporation, Humeral Head EZ-IO (K052408)) based on similar intended uses, indications, technological characteristics, and principles of operation, rather than a detailed presentation of a de novo clinical or performance study with quantified acceptance criteria.
§ 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).