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The AcuNav™ Diagnostic Ultrasound 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.

As described in the previously cleared 510(k) submissions, (K992631 on December 15, 1999, and K010950 on June 27, 2001), the AcuNav catheter is comprised of a single-use, disposable ultrasonic phased-array imaging transducer and a catheter which is 10 Fr (3.33 mm) in diameter and 90 cm in insertable length. The device is capable of imaging at multiple frequencies and obtaining blood flow data in multiple ultrasound modes. The distal portion of the catheter can be deflected in four directions in two orthogonal planes: leftright (in a plane perpendicular to the image plane) and anterior-posterior (in a plane coincident with the image plane). The range of deflection is 160° in each direction. The AcuNav catheter is comprised of three major components: (1) the catheter itself; (2) the steering mechanism; and (3) the reusable system cable.

The provided 510(k) summary for the AcuNav 90/10 Diagnostic Ultrasound Catheter (K033650) details the device's technological comparison to a predicate device and its intended use. However, it does not include information on acceptance criteria for specific performance metrics, nor does it describe a study demonstrating how the device meets such criteria.

The document primarily focuses on regulatory categorization, device description, and a comparison to a previously cleared predicate device (ACUSON AcuNav® 90/10 Diagnostic Ultrasound Catheter, K992631) to establish substantial equivalence.

Therefore, many of the requested details about acceptance criteria and a study to prove their fulfillment cannot be extracted from this document, as they are not present.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

This information is not provided in the document. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific performance acceptance criteria and results from a study against those criteria. It states that the device has been designed to meet certain safety standards (UL 2601-1, CSA C22.2 No. 601-1, CISPR 11, IEC 601-1-1, IEC 601-1-2, ISO 10993 Biocompatibility), but it does not list measurable acceptance criteria or reported performance results for these.

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 in the document. The 510(k) summary does not describe any specific clinical or performance test sets, their sample sizes, or data provenance.

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 in the document. No test sets or ground truth establishment processes are described.

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

This information is not provided in the document. No test sets or adjudication methods are 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

This information is not provided in the document. The device is a diagnostic ultrasound catheter, not an AI-assisted diagnostic tool. No MRMC studies are mentioned.

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

This information is not provided in the document. The device is a hardware catheter, not an AI algorithm.

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

This information is not provided in the document, as no specific performance studies are detailed.

8. The sample size for the training set

This information is not provided in the document. No training sets are mentioned.

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

This information is not provided in the document. No training sets or ground truth establishment processes are described.

Summary of what the document does provide regarding the device's safety and effectiveness:

The 510(k) summary establishes substantial equivalence of the AcuNav 90/10 Diagnostic Ultrasound Catheter to the predicate ACUSON AcuNav® 90/10 Diagnostic Ultrasound Catheter (K992631). The basis for this equivalence is a direct technological comparison, noting that both are ultrasound-tipped catheter devices used for intravascular or intracardiac ultrasound imaging.

The document states that the new device has been designed to meet the following product safety standards:

• UL 2601-1, Safety Requirements for Medical Equipment
• CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment
• CISPR 11, Class A
• IEC 601-1-1
• IEC 601-1-2
• ISO 10993 Biocompatibility

However, the document does not include a study explicitly demonstrating the device meets quantitative "acceptance criteria" related to specific performance metrics beyond stating conformance to these general safety and biocompatibility standards. The approval is based on the finding of substantial equivalence to a legally marketed predicate device, implying that the safety and effectiveness are similar to the already approved device, rather than a de novo evaluation against novel performance criteria.

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