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The Enovare system's ultrasound scanner connected with a probe enables real time diagnostic ultrasound imaging for Bmode, Tissue and Contrast Harmonic Imaging, PWD, Power Doppler and combined mode imaging. Signal Analysis and display. Guidance of biopsy and therapy needles, geometrical measurements and calculation of parameters. The system offers optional probes each type optimized to image structure and orientation of tissues during specific clinical applications. These include general Abdominal, Intraoperative, Cardiac, Neurosurgery, Transrectal, Small organs, Urological, Transvaginal, Musculoskeletal.

The Enovare supports the following scanning modes and combinations thereof: B-mode (incl. Tissue Harmonic Imaging), PWD mode, CFM mode, Amplitude (Power) Doppler mode.

The system consists of:

• system cart
• keyboard ●
• ultrasound probe(s) ●
• LCD monitor ●

The system can perform simple geometric measurements and perform calculations in the vascular and urology areas.

The provided document is a 510(k) summary for the Enovare Ultrasound System. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than directly presenting acceptance criteria and a study proving the device meets those criteria.

However, based on the information provided, we can extract some relevant details concerning safety and effectiveness.

Here's an analysis of the provided information, addressing your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as performance metrics with thresholds for the Enovare system in a typical table format you might expect for a new performance study. Instead, it demonstrates equivalence to predicate devices by claiming:

• Identical Operation: "This device operates identically to the predicate devices in that the piezoelectric material in the transducer used as an ultrasound source to transmit sound waves into the body. Sound waves are reflected back to the transducer and converted to electrical signals that are processed and displayed as images." (Page 8)
• Safety Compliance: "The Enovare is compliant to IEC 60601-1 Edition 3.1, International Electrotechnical Commission, Safety of Medical Electrical Equipment, Class II, Type BF." (Page 8)
• Biocompatibility: "Enovare was tested in accordance with the testing requirements of the ISO 10993 recognized standards and found to be safe for its intended use." (Page 8)
• Acoustic Output: "All transducers are within Track III requirements." (Page 9) This is a key safety parameter.
• Biometric Measurements (listed for predicate Sonalis, implied for Enovare due to "Same as Sonalis predicate"):
  • Distance: 6% - 14%
  • Area: 10%
  • Ellipse: 6% - 23%

Therefore, the "acceptance criteria" here are largely met by demonstrating adherence to safety standards and analogous performance to predicate devices for specific functionalities. A direct table of acceptance criteria for the Enovare's performance is not presented.

2. Sample Size Used for the Test Set and Data Provenance

The document does not report a specific test set sample size or data provenance (e.g., country of origin, retrospective/prospective) for a clinical performance study using the Enovare system.

The "study" or rather, the evidence presented, is a technical comparison and compliance assessment against established safety standards and predicate devices. No new clinical performance study is detailed with specific patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided. As there's no detailed clinical performance study with a test set of images or cases described, there's no mention of experts establishing ground truth for such a set.

4. Adjudication Method

This information is not provided. Again, without a clinical performance study involving a test set and expert review, an adjudication method is not applicable or mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

No. The document does not mention an MRMC comparative effectiveness study where human readers improve with or without AI assistance. The Enovare is an ultrasound system for diagnostic imaging, not an AI-powered diagnostic tool. The submission focuses on device equivalence and safety.

6. If a Standalone (algorithm only without human-in-the-loop performance) study was done

No. The Enovare is a diagnostic ultrasound system, not an AI algorithm. Therefore, a standalone algorithm performance study is not applicable or mentioned.

7. The type of ground truth used

For the safety and equivalence assessment:

• Engineering Standards: Ground truth for safety (e.g., electrical safety, biocompatibility, acoustic output) is established by adherence to recognized international standards like IEC 60601-1 and ISO 10993.
• Predicate Device Specifications: Ground truth for functional performance (e.g., scan modes, types of transducers, biomechanical measurements) is established by comparing to the specifications and cleared indications for use of the predicate devices (Sonalis K043189 and B & K Medical Flex Focus 1202).

8. The Sample Size for the Training Set

Not applicable. This document describes a traditional medical imaging device submission, not an AI/Machine Learning device. There is no concept of a "training set" in this context.

9. How the Ground Truth for the Training Set was Established

Not applicable. As above, there is no training set for this type of device.

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