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Esaote's Model 7340 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small Organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. The 7340 system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculo-skeletal applications. The 7340 system provides imaging for venous system measurements.

Model 7340 is a portable ultrasound system used to perform diagnostic general ultrasound studies. Its primary modes of operation are: B-Mode, Multi View (MView), Doppler, Color Flow Mapping (CFM), Amplitude Doppler (AD), Tissue Velocity Mapping (TVM) and Tissue Enhancement Imaging (TEI). The 7340 is equipped with a LCD Color Display. The full alphanumeric keyboard allows complete on-screen data entry of patient information and onscreen annotations. The 7340 can drive phased (PA), convex (CA), linear array (LA), Doppler probes and BiScan probes. The 7340 is equipped with an internal Hard Disk and with a DVD-RW disk drive that can be used for image storage. Data can also be stored directly to external archiving media (hard-disk, PC, server) via a LAN/USB port. Optional accessory devices available for the 7340 include an S-VHS video recorder; a monochrome or color page printer and a mobile trolley equipped with an insulation transformer. Model 7340 can be equipped with an internal battery that provides power when no main power is available.

The 7340 system has been cleared by FDA via K081794 and K091009.

Model 7340 upgrade, defined herein, combines the features of the Model 7340 with other, previously cleared software features and new software capabilities to assist a physician in making venous measurements. The venous imaging software package includes:

• 1. Dedicated Presets for Venous System Imaging, CFM and Doppler
• 2. QDP Quality Doppler Profiles Technology based on Multigate Doppler algorithm
• 3. Optimized Probe management for Venous Intracranial Doppler

The 7340 system is manufactured under an ISO 9001:2000 and ISO 13485 certified quality system.

The provided text is a 510(k) summary for the Esaote Model 7340 ultrasound system upgrade (K110688). This document primarily focuses on establishing substantial equivalence to predicate devices and detailing the intended uses and technological characteristics. It does NOT contain information about specific performance acceptance criteria or detailed study results for the device's clinical performance.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.

However, I can extract information related to general non-clinical testing and the type of ground truth implied by regulatory standards.

Here's a breakdown of what can be inferred or explicitly stated from the document regarding the study and acceptance criteria proving device performance:

1. Table of Acceptance Criteria and Reported Device Performance:

• None explicitly stated for clinical performance. The document focuses on demonstrating substantial equivalence to predicate devices and adherence to recognized standards for safety and performance, rather than reporting on specific clinical performance metrics with acceptance criteria benchmarks.

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

• Not specified. The document does not describe any specific clinical test or validation set with patient data. The non-clinical testing mentioned refers to engineering verification and validation against technical standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• Not applicable for clinical ground truth. Since no clinical test set is described, there's no mention of experts establishing ground truth for such a set.

4. Adjudication Method for the Test Set:

• Not applicable. No clinical test set or adjudication method 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:

• No MRMC study mentioned. This document predates widespread AI integration in medical devices and does not describe any such study. The device is an "Ultrasound Imaging System" with software features to assist in "venous measurements" and "venous system imaging."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• Not applicable. The device is an ultrasound system with software features, not a standalone AI algorithm. It's an imaging device for physician use.

7. The Type of Ground Truth Used:

• Implied ground truth through adherence to recognized standards and substantial equivalence. The primary "proof" that the device performs as intended relies on:
  • Substantial Equivalence: The device's "technological characteristics" (including clinical uses, flow profile capabilities, and safety standards) are deemed "equivalent" to those of previously cleared predicate devices (Esaote 7340, Aloka SD5500, Aloka 4000). The implication is that if the predicate devices were safe and effective, and this device is equivalent, then it is also safe and effective.
  • Non-Clinical Testing against Recognized Standards: Verification and validation tests were conducted "in accordance with design controls per CFR 820.30" and designed to meet specific international and national standards. These standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, AIUM/NEMA UD-3, AIUM/NEMA UD-2) effectively serve as the "ground truth" for the device's technical and safety performance. This includes electrical safety, electromagnetic compatibility, essential performance, and acoustic output measurements.

8. The Sample Size for the Training Set:

• Not applicable. The document does not describe a machine learning algorithm with a training set. The "upgrade" consists of dedicated presets, a specific Doppler technology, and optimized probe management, which are software features, not a trainable AI model.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable. As no training set for a machine learning model is mentioned, there's no information on how its ground truth would have been established.

Summary of what the document does provide:

• Device Name: Model 7340 upgrade
• Intended Use: Diagnostic general ultrasound studies across various applications (Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small Organs, Musculoskeletal, Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative, Laparoscopic, Urologic). Includes imaging for guidance of biopsy, needle placement, peripheral nerve blocks, and venous system measurements.
• Predicate Devices: Esaote 7340 (K081794, K091009), Aloka SD5500 (K032875, K033311), Aloka 4000 (K003739, K040719).
• New Features in Upgrade: Dedicated Presets for Venous System Imaging (CFM and Doppler), QDP Quality Doppler Profiles Technology (based on Multigate Doppler algorithm), Optimized Probe management for Venous Intracranial Doppler.
• Safety and Performance Validation: Non-clinical testing conducted per CFR 820.30 and adherence to recognized standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, AIUM/NEMA UD-3, AIUM/NEMA UD-2.
• Quality System: Manufactured under ISO 9001:2000 and ISO 13485 certified quality system.

The document demonstrates the device's "substantial equivalence" to previously cleared devices and its compliance with established safety and performance standards for diagnostic ultrasound systems. It does not provide data from clinical trials or specific performance metrics with acceptance criteria as one might expect for a novel AI-driven diagnostic device today.

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