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The IVUS option for the CFM product family is intended for intravascular applications at all system control settings. When used with a Vingmed Color Flow Mapping (CFM) imaging system the device can be used to obtain, store and retrieve 2D images and perform measurements and analysis on them.

The IVUS option is intended for use by duly licensed physician who has received appropriate training in proper operation of the device.

As with any procedure of this sort, the physician conducting the examination must exercise sound medical judgment in the selection of patients for this product, and be skilled in interpreting the echocardiographic data obtained from intra-vascular ultrasound devices.

The IVUS option is intended to be used with a Vingmed Color Flow Mapping (CFM) imaging system to apply ultrasound energy from an intra-vascular catheter to:

• · Produce 2D images that can be used to detect abnormalities.
• · Store images in the CFM system or via the CFM system to other storage media.

Images can be retrieved from the CFM system or storage media for measurement and analysis.

The IVUS consists of a basic scanner unit integrated into the CFM 775/800 ultrasound system. The basic scanner unit consists of a card rack mounted into the CFM 775/800; a video switch board mounted into the CFM 775/800 card rack; cables for interconnections; a connector for the motor drive and components that are common with the CFM 775/800. These common components include the keyboard and display, connectors for ECG and AUX, power supply, and internal computer (EchoPac) for video grabbing and archival (CFM 800 only), and peripherals such as a VCR printer. The system is used with specified off-the-shelf motor pod and ultrasound catheters not manufactured by Vingmed Sound A/S.

The provided text describes a 510(k) summary for the Vingmed Sound Intra Vascular Ultrasound System (IVUS) option. Unfortunately, it does not contain specific acceptance criteria or a detailed study proving the device meets them. The document focuses on demonstrating substantial equivalence to a predicate device and adherence to safety and electromagnetic compatibility (EMC) standards.

Here's an analysis based on the information provided and what is missing:

The document states: "Vingmed Sound A/S has concluded that the Intra Vascular Ultrasound System (IVUS) option... is safe, effective, ad performs as well as or better than the legally marketed device in 3 above." This conclusion is based on a comparison matrix and non-clinical testing.

Missing Information:

• Specific quantitative acceptance criteria for performance (e.g., sensitivity, specificity, accuracy, image resolution metrics).
• Details of a formal study (clinical or analytical) designed to prove the device meets specific performance criteria.
• Mention of a "test set" with ground truth, sample size, or expert involvement for performance evaluation.
• Any details about training data or how ground truth for training data was established.
• Information regarding MRMC studies or standalone algorithm performance.

Based on the provided text, here's what can be extracted and what is explicitly missing regarding an acceptance criteria study:

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not specified. The document mentions "Nonclinical tests" but provides no details of a test set for performance evaluation of image quality or diagnostic capability.

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)

• Not specified. There's no mention of experts or ground truth establishment for a test set.

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

• Not specified. No test set or 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, an MRMC study was NOT done. The device described is an imaging system, not an AI-powered diagnostic tool, and the document predates widespread AI in medical devices by decades.

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

• Not applicable/Not specified. This is an imaging system, not an algorithm being evaluated. Its performance is inherent to its image generation.

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

• Not specified. No ground truth for performance evaluation is mentioned. The "ground truth" for the non-clinical tests would be the established standards (e.g., IEC, FDA guidance) for safety, EMC, and acoustic output.

8. The sample size for the training set

• Not applicable/Not specified. This refers to a conventional ultrasound system, not a machine learning model, so there is no "training set."

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

• Not applicable/Not specified. As there is no training set mentioned, this information is not provided.

Summary of the "Study" described in the document:

The provided document describes a 510(k) Pre-market Notification submission, which primarily aims to demonstrate substantial equivalence to a predicate device (CVIS Insight III, K921750).

The "study" or evidence provided to support the claims of safety and effectiveness consists of:

• Comparison Matrix (Section 6): A detailed table comparing the new device's features, intended use, and technical specifications to the predicate device. The conclusion is that they are substantially equivalent.
• Nonclinical Tests (Section 7):
  • Electrical Patient Safety: Compliance with IEC 601-1 and EN 60601-1-2.
  • EMC Protections: Compliance with EN 55011 and IEC 801-2/-3-/-4/-5.
  • Acoustic Output: Measurements performed in accordance with FDA guidance (December 1985).
  • Software Development: Developed in accordance with a software development plan, with a "moderate" level of concern as per FDA guidance (August 1991).

The conclusion (Section 8) is based on these comparisons and nonclinical tests, asserting that the device is safe, effective, and performs "as well as or better than" the predicate device. There is no detailed clinical or analytical performance study described in this summary that establishes specific quantitative performance metrics against a defined ground truth using a test set. This is typical for a 510(k) submission where substantial equivalence is the primary pathway.

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