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The disposable guide KDNG00 is dedicated for endocavity diagnosis ultrasound needle guided procedure. It is intended for clinicians and assistant clinic and hospital, to guide linear instrument with a transrectal approach.

The products concerned are plastic guides designed to be clipped on an endocavity ultrasound probe (KOELIS probes K3DEC00/K3DEC00-2 cleared under K170521), to guide a linear instrument through transrectal access. The disposable guides KDNG00 are packaged individually in pouches and delivered sterile. Pouches are then gathered in dispenser boxes (24 guides/dispenser box).

This is a 510(k) premarket notification for a medical device called "Disposable Guide KDNG00". The document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study.

Therefore, the requested information about acceptance criteria and a study proving the device meets them, especially in the context of an AI/human-in-the-loop system, is not available in the provided text. The document explicitly states: "The subject of this premarket submission did not require clinical studies to support substantial equivalence."

This device, a disposable guide for ultrasound-guided needle procedures, is a hardware accessory and not an AI or software-driven diagnostic tool. The "performance" discussed is primarily related to its physical characteristics, biocompatibility, and sterilization, which are evaluated through non-clinical testing and comparison to existing predicate devices.

Here's a breakdown of why each requested point cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance: Not available. The document demonstrates substantial equivalence through a comparison of technological characteristics, materials, and safety/effectiveness principles, not against a predefined set of performance metrics of an AI system.
2. Sample size used for the test set and the data provenance: Not applicable. No test set for an AI model or clinical study is mentioned.
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 for an AI model is established.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set or ground truth adjudication process is mentioned.
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: Not applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No ground truth generation for an AI model is mentioned. The "effectiveness" mentioned refers to its mechanical function and secure fit, analogous to hardware performance, not diagnostic accuracy.
8. The sample size for the training set: Not applicable. This is not an AI device requiring a training set.
9. How the ground truth for the training set was established: Not applicable. No ground truth for a training set is established.

The provided document details a 510(k) submission for a physical medical device. The "performance" is assessed through comparison to predicate devices, focusing on:

• Intended Use and Indications for Use: Both the subject device and predicates provide a fixed path for the needle for transrectal ultrasound-guided procedures (Pages 4, 5).
• Design: Plastic vs. Inox (stainless steel) with similar clipping mechanisms for stability (Page 6).
• Materials: Polycarbonate (medical grade) for the subject device compared to stainless steel and thermoplastics for predicates (Page 6).
• Safety (Biocompatibility): Tested for cytotoxicity, irritation, and sensitization in accordance with ISO 10993-1 and FDA Good Laboratory Practices (GLP). Sterilization effectiveness (EtO) tested per ISO 11135-1. These tests concluded the device is biologically safe (Pages 6-7).
• Effectiveness (Mechanical): Designed for secure and aligned fit, accurate needle path, and contoured for patient comfort (Page 7).

The conclusion explicitly states: "KOELIS considers the subject device to be as safe, as effective and with performance substantially equivalent to the predicate devices." (Page 7)

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The ExactVu High Resolution Micro-Ultrasound System is intended for use by qualified medical professionals for diagnostic ultrasound imaging or fluid flow analysis of the human body. The indications for use are:
Small Organ (prostate) Transrectal
The system may be used with patients of all ages, but is not designed for pediatric or fetal use.

The ExactVu high resolution micro-ultrasound system is intended for use by qualified medical professionals for diagnostic ultrasound imaging, data processing and guidance of puncture and biopsy. The ExactVu System comprises transducers responsible for ultrasound signal generation and recording, needle guides and a main unit that controls the transducers, processes the acoustic data, and processes and displays images.

The provided text does not contain detailed information about specific acceptance criteria or the study that definitively proves the device meets those criteria with performance metrics. The document focuses on demonstrating substantial equivalence to a predicate device and adherence to various safety and performance standards.

However, based on the information provided, here's a breakdown of what can be inferred and constructed:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the nature of the submission (510(k) for an ultrasound system) and the provided text, the "acceptance criteria" appear to be compliance with relevant safety and performance standards, and comparison to existing legally marketed devices. As no specific performance metrics are given in the provided text, the table is structured to reflect this.

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

The document explicitly states: "The ExactVu System, transducers and needle guides, subject of this submission, did not require clinical studies to support the determination of substantial equivalence. An analysis of clinical literature, adverse event and recall data is provided in the clinical evaluation justifies the safety and efficacy of the functionality of the ExactVu device without pre-market clinical investigation."

Therefore, no specific test set or clinical study data (including sample size or data provenance) is provided for the subject device (ExactVu 2.0) in this submission. The determination of substantial equivalence relies on non-clinical tests and comparison to a predicate device.

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

As per point 2, no specific clinical test set was used to establish ground truth because clinical studies were not required for this submission.

4. Adjudication method for the test set:

As per point 2, no specific clinical test set was used, so no adjudication method 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 MRMC comparative effectiveness study was done, nor is there any mention of AI assistance in improving human reader performance. The submission is for an ultrasound system, not an AI-powered diagnostic tool.

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

Not applicable. This submission is for an ultrasound imaging system, which inherently involves human operation and interpretation. There is no mention of a standalone algorithm or AI performance.

7. The type of ground truth used:

Given the absence of clinical studies for this submission, the "ground truth" for demonstrating safety and effectiveness relied on:

• Conformance to recognized industry standards: (e.g., IEC 60601-1, ISO 10993-1, NEMA UD 2 & 3). Third-party testing and certification against these standards serve as the "ground truth" for the device's adherence to established safety and performance benchmarks.
• Substantial equivalence to a legally marketed predicate device: The predicate device (ExactVu 1.0, K162972) implicitly provides the "ground truth" of a device that has already been deemed safe and effective for its intended use. The submission argues that the new device is sufficiently similar to share this established safety and effectiveness profile.

8. The sample size for the training set:

Not applicable. There is no mention of machine learning or AI components requiring a training set in this submission.

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

Not applicable. As no training set is mentioned (see point 8).

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