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The catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.

Device Description

The AcuNav V ultrasound catheter is sterile, disposable, and licensed for single use only. The catheter is optimized for intracardiac scanning. With the catheter, the physician can maneuver the imaging plane located inside the catheter tip to see the region of interest. The physician can steer the catheter to optimize tissue visualization.

AI/ML Overview

The provided text is a 510(k) summary for the AcuNav V 10F Diagnostic Ultrasound Catheter. It discusses the device's indications for use, substantial equivalence to a predicate device, and nonclinical tests. However, it explicitly states that clinical data is not required to establish substantial equivalence because the submitted device uses the same technology, patient contact materials, and principles as the predicate device.

Therefore, many of the requested details regarding acceptance criteria and studies (especially those related to clinical performance, effectiveness, or comparative studies with human readers) are not available in this document.

Here's a breakdown of the information that can be extracted and what is not provided based on your request:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria for clinical performance or reported device performance in terms of diagnostic accuracy, sensitivity, specificity, or similar metrics. Instead, it focuses on substantial equivalence to a predicate device based on technological characteristics and safety standards.

The closest equivalent to "acceptance criteria" here relates to adherence to safety standards and equivalence to the predicate:

Feature/Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
Indications for Use	Substantially equivalent to predicate, including: Cardiac, Pediatric, Intra-luminal, Intra-cardiac visualization for imaging guidance.	Verified to be substantially equivalent to K081808.
Mode of operation	Substantially equivalent to predicate (2D, C, D, Volume).	Verified to be substantially equivalent to K081808.
Patient contact materials	Compliant with ISO 10993-1.	Compliant with ISO 10993-1 (unchanged from predicate).
Acoustic output	Conform to applicable medical device safety standards.	Evaluated and found to conform with UL 60601-1, IEC 60601-2-37, AIUM/NEMA UD-3, AIUM/NEMA UD-2.
Biocompatibility	Conform to applicable medical device safety standards (ISO 10993-1).	Evaluated and found to conform with ISO 10993-1.
Cleaning & Disinfection Effectiveness	Conform to applicable medical device safety standards.	Evaluated and found to conform.
Thermal, Electromagnetic, and Mechanical Safety	Conform to applicable medical device safety standards.	Evaluated and found to conform with UL 60601-1, EN/IEC 60601-1, EN/IEC 60601-1-1, EN/IEC 60601-1-2.
Quality System Compliance	Conform to 21 CFR 820 and ISO 13485:2003.	Manufacturer's design and development process conforms.

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 provided as no clinical test set or data provenance from a clinical study is described. The device's substantial equivalence was established without clinical data.

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 provided as no test set requiring expert ground truth or clinical evaluation was conducted.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided as no clinical test set requiring adjudication was conducted.

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

An MRMC comparative effectiveness study was not done. The document states that clinical data is not required because the device relies on existing technology and principles. This device is a diagnostic ultrasound catheter, not an AI-assisted diagnostic tool.

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

A standalone performance study was not done in the context of diagnostic accuracy. The "standalone performance" was assessed in terms of adherence to safety and performance standards for the device itself (acoustic output, biocompatibility, etc.), not as an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided as no clinical study requiring a diagnostic ground truth was conducted. For the non-clinical tests, the "ground truth" was the specifications and requirements of the safety standards (e.g., ISO 10993-1 for biocompatibility).

8. The sample size for the training set

This information is not provided as no training set for a diagnostic algorithm was used.

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

This information is not provided as no training set for a diagnostic algorithm was used.

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