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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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The Olympus GF-UE160-AL5 Ultrasonic Endoscope is intended to be used for endoscopic ultrasonic inaging of the gastrointestinal wall, bile and pancreatic ducts and surrounding organs. It is to be used with the Aloka SSD-5000 (K033311) Diagnostic Ultrasound system and various other video and light source accessories.

The Olympus GF-UE160-AL5 is an ultrasonic gastro video endoscope to be used with an Aloka diagnostic ultrasound system, video system center, light source, video monitor, endo-therapy accessories for endoscopic ultrasound imaging of the gastrointestinal wall, bile and pancreatic ducts and surrounding organs.

The Olympus GF-UC140P-A15 is an electronic radial scan ultrasound endoscope providing a 360° view angle.

The provided document is a 510(k) summary for the Olympus GF-UE160-AL5 Endoscope used with the Aloka SSD-5000 Diagnostic Ultrasound System. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance acceptance criteria through a clinical study. As such, it does not contain the detailed information necessary to fully address all aspects of your request regarding acceptance criteria and a study proving their fulfillment.

Here's a breakdown of what can be extracted and what is missing:

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

The document does not explicitly state "acceptance criteria" in terms of clinical performance metrics. Instead, it compares the technological characteristics of the subject device to its predicate devices to demonstrate substantial equivalence. The implication is that if the new device has similar characteristics, it will perform equivalently.

The "acceptance criteria" here are implicitly that the new device's specifications are comparable to, or within acceptable variations of, the predicate devices, thereby ensuring equivalent safety and effectiveness.

2. Sample size used for the test set and the data provenance

The document describes a submission for substantial equivalence based on technological characteristics and intended use comparison. It does not refer to a clinical "test set" in the context of performance evaluation with patient data. Therefore, there is no information on:

• Sample size used for a test set.
• Data provenance (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Since no clinical test set for performance evaluation is described, there is no information on:

• Number of experts used to establish ground truth.
• Qualifications of those experts.

4. Adjudication method for the test set

Similarly, as there is no clinical test set for performance evaluation, there is no information on an adjudication method.

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

The device is an endoscope and ultrasound system, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned in the document.

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

This point is not applicable as the device is not an algorithm for standalone performance. It is a medical imaging device used by a human operator.

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

The document does not describe a study involving "ground truth" as typically understood in performance validation of diagnostic accuracy (e.g., against pathology). The "ground truth" for this 510(k) submission is effectively the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

The document describes a comparison to predicate devices, not a machine learning model. Therefore, there is no information on a "training set" sample size.

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

As there is no training set for a machine learning model, this question is not applicable.

Summary of the Study (as described in the 510(k) submission):

The "study" presented here is a comparison to predicate devices to demonstrate substantial equivalence, as required for a 510(k) submission to the FDA. It is not a clinical study designed to test novel performance claims against specific acceptance criteria.

• Purpose: To demonstrate that the Olympus GF-UE160-AL5 Endoscope used with the Aloka SSD-5000 Diagnostic Ultrasound System is substantially equivalent to legally marketed predicate devices, specifically the Olympus GF-UC140P-AL5 Endoscope (K011314) and the GF-UM130 Endoscope (K971660).
• Methodology: Direct comparison of technological characteristics (physical specifications, optical characteristics, angulations, etc.) and intended use between the subject device and the predicate devices.
• Conclusion: The submission concludes that "When the GF-UE 160-AL5 is compared to its predicates, the device does not incorporate any significant changes in intended use, method of operation, material or design that could affect the safety and effectiveness." The FDA concurred with this finding of substantial equivalence.
• Key Finding for Equivalence: The key "performance" demonstrated is that the device's technical specifications and intended use are similar enough to existing, cleared devices that it can be considered equally safe and effective without requiring new clinical performance data.

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