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Esaote's Model 6400 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, and Other: Urologic. The 6400 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 Musculoskeletal applications.

Esaote's Model 7400 is a compact ultrasound system ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, and Other: Urologic. The 7400 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 Musculoskeletal applications.

6400 is a mainframe system equipped with wheels allowing to move the system. 7400 is a portable system equipped with a handle. The system size and weight allow it to be carried using its handle. The primary modes of operation are: B-Mode, M-Mode, Tissue Enhancement Imaging (TEI), XView, Multi View (MView), Trapezoidal View (TPView), Doppler, Color Flow Mapping (CFM), Amplitude Doppler (AD) and Tissue Velocity Mapping (TVM). Both 6400 and 7400 are equipped with a LCD color display where acquired images and advanced image features are shown. Both 6400 and 7400 can drive Phased, Convex, Linear array, Doppler probes and Volumetric probes. 6400 control panel is equipped with a pull-out Qwerty alphanumeric keyboard that allows data entry. On 7400 model the touchscreen has an emulation of the Qwerty alphanumeric keyboard that allows data entry. Both 6400 and 7400 systems are equipped with wireless capability. The 6400 and 7400 systems are manufactured under an ISO 9001:2000 and ISO 13485 certified quality system.

The provided text is a 510(k) summary for the Esaote 6400 and 7400 Ultrasound Systems. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than efficacy through clinical studies and acceptance criteria as would be expected for a novel device. As such, the information typically requested in your prompt (e.g., acceptance criteria, test set, experts, adjudication, MRMC studies, standalone performance, ground truth for test/training sets, and training set size) is not explicitly present in this document.

The document explicitly states: "No clinical tests were performed." This indicates that the device's performance was not evaluated against specific acceptance criteria through a clinical study in the way your prompt describes. Instead, the submission relies on demonstrating similarity to existing, legally marketed predicate devices.

However, I can extract information related to the device's characteristics and the non-clinical tests performed to support its safety and performance.

Here's the summary of what can be inferred and what is explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as this is a 510(k) submission based on substantial equivalence, not a novel device requiring new efficacy criteria. The "acceptance criteria" here are effectively demonstrating equivalence to the predicate devices.
• Reported Device Performance: The primary performance characteristic claimed is "substantial equivalence" to predicate devices, meaning it performs similarly in its intended uses. The document highlights functional equivalence and compliance with safety standards.

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

• Not applicable. The document explicitly states "No clinical tests were performed." Therefore, there is no test set in the context of clinical performance evaluation. Non-clinical tests were performed on the devices themselves to ensure compliance with standards.

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 applicable. As no clinical tests were performed, there was no test set requiring ground truth established by experts.

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

• Not applicable. No clinical tests were performed.

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:

• Not applicable. No clinical tests were performed, and this device is an ultrasound imaging system, not an AI-powered diagnostic tool that assists human readers.

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

• Not applicable. This is an ultrasound imaging system, not a standalone algorithm.

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

• Not applicable. No clinical tests were performed to evaluate an algorithm against ground truth. The "ground truth" in this submission relates to compliance with engineering and safety standards (e.g., whether acoustic output measures meet NEMA standards, or whether the device can perform the listed modes of operation as intended).

8. The sample size for the training set:

• Not applicable. This submission is for an ultrasound imaging system, not an AI/ML algorithm that requires a training set.

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

• Not applicable. This submission is for an ultrasound imaging system, not an AI/ML algorithm that requires a training set and associated ground truth.

Conclusion from the Document:

The Esaote 6400 and 7400 Ultrasound Systems received 510(k) clearance based on demonstrating substantial equivalence to existing predicate devices (Esaote 7350, 7340, and 8100). The submission focuses on showing that the new devices have the same technological characteristics, intended uses, and meet the same non-clinical safety and performance standards as the legally marketed predicates. No clinical studies were performed to establish performance against specific acceptance criteria for a novel functionality.

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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric and Intraoperative Abdominal. For Model 6150 (MyLab70), Urological is also included.

The 7300 (MyLab30), 7350 (MyLab50) and 6150 (MyLab70) system designs remain the same as those previously cleared by FDA via K040596, K050326, and K051308, respectively. They are compact ultrasound systems used to perform diagnostic general ultrasound studies. Their primary modes of operation are: B-Mode, M-Mode, Doppler and Color Flow Mapping and, on lower frequency probes, Tissue Enhancement Imaging (TEI). The systems are equipped with an LCD Color Display and can drive phased (PA), convex (CA) and linear array (LA) and Doppler probes.

The provided 510(k) summary for the MyLab30, 50, 70 Systems from Esaote, S.p.A. is a premarket notification for a diagnostic ultrasound imaging system. It establishes substantial equivalence to previously cleared predicate devices.

This document does not contain information about specific acceptance criteria, a study proving device performance against those criteria, sample sizes for test or training sets, expert qualifications, adjudication methods, multi-reader multi-case studies, or standalone algorithm performance data.

The document is a regulatory submission for a medical device that outlines its intended use, describes the device, references predicate devices, and lists requested new indications for various transducers and systems. It primarily focuses on showing that the new device (or updates to existing devices) is substantially equivalent to legally marketed predicate devices, as required by the FDA 510(k) process.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance or details about a study that proves the device meets those criteria, as this information is not present in the provided text.

Based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance: Not available in the provided text.
2. Sample Sizes and Data Provenance (Test Set): Not available in the provided text.
3. Number and Qualifications of Experts (Ground Truth for Test Set): Not available in the provided text.
4. Adjudication Method (Test Set): Not available in the provided text.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: Not available in the provided text.
6. Standalone (Algorithm Only) Performance Study: Not applicable or not available in the provided text, as this is an ultrasound system, not an AI algorithm.
7. Type of Ground Truth Used: Not available in the provided text.
8. Sample Size for Training Set: Not applicable or not available in the provided text, as this is an ultrasound system, not an AI algorithm requiring a training set in the conventional sense.
9. How Ground Truth for Training Set was Established: Not applicable or not available in the provided text.

The document primarily focuses on:

• Device Description: The MyLab30, MyLab50, and MyLab70 are compact/mainframe ultrasound systems for diagnostic general ultrasound studies, including various clinical applications (Cardiac, Peripheral Vascular, Abdominal, Fetal, etc.). They operate in B-Mode, M-Mode, Doppler, Color Flow Mapping, and Tissue Enhancement Imaging (TEI).
• Predicate Devices: K040596 (MyLab30), K050326 (MyLab50), K051308 (MyLab70), and K051837 (MyLab90).
• New Indications/Features: The submission adds specific probes (2.0 CW, 5.0 CW Doppler Probes, IOE323 probe), Biopsy Attachment (ABS15), VPAN, Compound Imaging, and for some models, Intelligent Real Time Processing, and an "Intraoperative Abdominal" indication for use across various modes with specified transducers. The forms indicate "N" (new indication) for certain clinical applications and modes for the new IOE323, 2 CW, and 5 CW transducers, confirming these as the newly sought clearances.
• Regulatory Compliance: The systems are manufactured under ISO 9001:2000 and ISO 13485 certified quality system. The FDA letter grants substantial equivalence subject to a post-clearance special report containing acoustic output measurements based on production line devices.

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