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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:

1. 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.

2. 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.

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)

   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.

4. 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.

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 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.

6. 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.

7. 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.

8. 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.

9. 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.

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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.

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The Bone Injection Gun (B.I.G.) 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.

Bone Injection Gun (B.I.G.)

This document is a 510(k) clearance letter from the FDA for the Bone Injection Gun (B.I.G.) device, confirming its substantial equivalence to a legally marketed device. It does not contain information about the device's acceptance criteria, reported performance, or any studies conducted to prove it meets acceptance criteria.

Specifically, the document does not provide any of the following information requested:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size
6. If a standalone performance (algorithm only) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

This letter is a regulatory approval document, not a clinical study report or a technical performance specification.

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