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Needle guide(s) provides guidance for needles or other interventional devices during an ultrasound-guided procedure. It positions the needle relative to the transducer, so that the needle image is in a specified position in the ultrasound image during procedures. that require precise needle placement or biopsy.

The BK Medical Needle Guides described are designed to be used with BK Medical' Ultrasound system to provide alignment with an ultrasound intra-operative transducer, in order to guide a needle (biopsy device, or other interventional device) in relation to the ultrasound image. The components for the Needle Guides are all single use disposable, and delivered sterile. Note! The needle guides are delivered without needles.

The provided text describes a 510(k) premarket notification for a medical device (Needle Guide for BK Medical ultrasound transducers) and its comparison to a predicate device. The information is presented in the context of demonstrating substantial equivalence, not a study proving specific performance metrics against acceptance criteria.

Specifically, the document does not contain a study with acceptance criteria and reported device performance as typically understood for a detailed clinical or analytical validation study for an AI/ML device. The provided text is a summary of a regulatory submission (510(k)) that focuses on showing the new device is "substantially equivalent" to an already approved device. This process primarily relies on comparing technological characteristics and intended use.

Therefore, many of your requested points cannot be answered from the provided text. I will indicate where the information is missing or not applicable based on the nature of the document.

1. Table of Acceptance Criteria and Reported Device Performance

This table cannot be fully generated as the document does not specify formal acceptance criteria for device performance or report specific performance metrics in a study. The comparison table focuses on technological characteristics and intended use for substantial equivalence.

2. Sample size used for the test set and the data provenance

• Sample Size: Not applicable. This document is not a report of a performance study that uses a test set of data. It is a regulatory submission for substantial equivalence.
• Data Provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. No ground truth establishment from experts for a test set is described in this regulatory submission.

4. Adjudication method for the test set

• Not applicable. No adjudication method for a test set is described.

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

• No, an MRMC comparative effectiveness study was not done. This device is a physical needle guide, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• No, a standalone algorithm performance study was not done. This device is a physical needle guide.

7. The type of ground truth used

• Not applicable. No ground truth in the context of a performance study is mentioned. The "ground truth" for the 510(k) submission is the existence and characteristics of the legally marketed predicate device.

8. The sample size for the training set

• Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

• Not applicable.

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Needle Guides shall be single use only and are to be used by a mammographic x-ray specialist in a healthcare setting to aid in needle placement.

Needle Guide

This document is a 510(k) clearance letter from the FDA for a Needle Guide manufactured by Remington Medical, Inc. It explicitly states that the device is "substantially equivalent" to predicate devices, meaning it does not require a new study to prove its safety and effectiveness.

Therefore, the input does not provide information about:

• Acceptance criteria and reported device performance: Since it's a 510(k) clearance based on substantial equivalence, there are no specific performance acceptance criteria or study results presented in this document.
• Sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone studies, type of ground truth for test or training sets, or how ground truth was established. These are all elements of a de novo or PMA submission, not a 510(k) based on substantial equivalence.

The document essentially states that because a similar device is already on the market and the new device is substantially equivalent, it does not need to go through the rigorous testing and reporting described in your request.

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A needle guidance device for prostate biopsies or radiation seed placement/needles used as an accessory with an ultrasound transducer and system.

Needle Guide/Grid

The provided text is a 510(k) clearance letter from the FDA for a device called "Needle Guide/Grid for Ultrasound Transducer." This document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

The letter primarily concerns the substantial equivalence determination of the device to legally marketed predicate devices, allowing it to be marketed. It lists the regulatory class and Procode, and outlines general controls provisions.

Therefore, I cannot fulfill your request for information on the acceptance criteria and the study that proves the device meets them, as this data is absent from the provided document.

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