(53 days)
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.
| Acceptance Criteria | Reported Device Performance (from text) |
|---|---|
| Formal Acceptance Criteria (e.g., accuracy, precision for needle guidance) | Not provided in the document. The document aims to demonstrate substantial equivalence, not to quantify specific performance against defined metrics. |
| Intended Use Equivalence: "Needle guide 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." | Met: The "Conclusion" states, "The needle guides in this application have same intended use and the same characteristics as the predicate device." |
| Technological Characteristics Equivalence: (e.g., Needle Guide angle, Pre-sterilized, Removable options, For use with variety of Needles, Materials, Single Use/Disposable, Device Description) | Met: The table in the "510(k) Summary continue" section explicitly compares these characteristics, showing them to be the same or similar, leading to the conclusion of 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.
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.