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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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