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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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Esaote's Model 6250 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac. Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic. Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. The 6250 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.

The Virtual Navigator is a MyLab optional license that provides additional image information from a second modality like CT or MR, during a clinical ultrasound session. The second modality provides additional security in assessing the morphology of the ultrasound image.

Virtual Navigator can be used in the following application: Abdominal, Musculo-skeletal, Urologic, and Vascular.

The second modality image is not intended to be used as a standalone diagnostic image since it represents information of a patient that could not be congruent with the current (actual) patient position and shall therefore always been seen as an additional source of information.

The Virtual Navigator tracking system should not be used on or around persons with a cardiac pacemaker, and should not be used around life supporting equipment.

The 6150 is a mainframe ultrasound system, used to perform diagnostic general ultrasound studies. Its primary modes of operation are: B-Mode, XView, Multi View (MView), Trapezoidal View (TPView), Doppler, Color Flow Mapping, Amplitude Doppler (AD), Tissue Velocity Mapping (TVM) and Tissue Enhancement Imaging (TEI). The system is equipped with a LCD Color Display, a control panel and is capable of operating Linear, Convex, and Phased array probes.

The modified 6150, with respect to the cleared version 6150 via K051308, K052805, K060827, K081386 and K091009, is due to the improvements of the system. These modifications, that do not affect the intended use or alter the fundamental scientific technology of the device, are the following:

• a. New keyboard (control panel), where some control keys (knobs and keys) have been replaced by a touch screen.
• b. New plastic housing of the system both to include the touch screen and to give a new style
• c. New keyboard group PCBs lay out to interface the touch screen and to match the new organization of the panel keys.
• Software/Firmware modification to translate the touch screen information for the d. software: main software characteristics and performances have not been changed.

The 6250 is the model name of the modified 6150. The set of probes of the 6150 is exactly the same.

The 6250 system is manufactured under an ISO 9001:2000 and ISO 13485 certified quality system.

The provided Special 510(k) Summary for the Esaote 6250 System describes modifications to a previously cleared ultrasound system (6150). The document does not describe a new study to establish acceptance criteria or device performance, but rather attests that the modifications do not alter the fundamental scientific technology or intended use. Therefore, the device meets the previously established acceptance criteria by demonstrating substantial equivalence to the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a Special 510(k) for device modifications, explicit "acceptance criteria" for a new study are not presented. Instead, the justification relies on the modified device (6250) maintaining the same performance and safety characteristics as the predicate devices (6150 cleared via K051308, K052805, K060827, K081386 and K091009). The "performance" assessment is based on the nature of the modifications not affecting clinical functionality.

The document implicitly refers to the performance of the predicate device for all clinical applications. The "Reported Device Performance" for the 6250 system is therefore considered to be equivalent to the previously cleared 6150 system, as the modifications were primarily cosmetic (new keyboard, plastic housing, PCB layout) and software/firmware changes not affecting main software characteristics and performances.

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

The document does not describe a new test set or a new study with a specific sample size. The modifications are justified based on their nature, not requiring new clinical performance data to demonstrate equivalence. Therefore, there is no mention of sample size or data provenance (country of origin, retrospective/prospective). This is typical for a Special 510(k) submission where changes are considered minor and do not impact safety or effectiveness.

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

Since no new test set or clinical study is described, there is no mention of experts establishing ground truth for a test set.

4. Adjudication Method for the Test Set

As no new test set or clinical study is described, no adjudication method is mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was performed or is mentioned in this Special 510(k) summary, as the modifications did not warrant a new clinical efficacy trial. The submission seeks to demonstrate substantial equivalence based on the nature of the changes.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This device is an ultrasound imaging system with optional features (Virtual Navigator). It is not an "algorithm-only" or AI-driven diagnostic device as understood in the context of standalone performance studies for AI. The modifications described pertain to hardware and user interface elements, and minor software updates that did not change the core performance. Therefore, a standalone performance study is not applicable and not described.

7. Type of Ground Truth Used

No new ground truth was established for this Special 510(k). The regulatory approval relies on the ground truth previously established for the predicate 6150 system, which would have been based on established clinical and technical standards for ultrasound imaging.

8. Sample Size for the Training Set

Since no new algorithms or machine learning components are introduced that require a training set, the document does not mention any sample size for a training set.

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

Not applicable, as no new training set or machine learning algorithms are described in this Special 510(k) submission.

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Esaote's Model 6150 (MyLab70) and Model 6100 (MyLab90) are mainframe ultrasound systems used to perform diagnostic general ultrasound studies including Cardine unc Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative: Abdominal, and Other: Urologic. Additionally, the MyLab90 is indicated for Laparoscopic use.

The Virtual Navigator is a MyLab optional license that provides additional image information from a second modality like CT or MR, during a clinical ultrasond session. The second modality provides additional security in assessing the morphalogy of the ultrasound image.

Virtual Navigator can be used in the following application: Abdominal, Musculo-skeletal, Urologic, and Vascular.

The second modality image is not intended to be used as a standalone diagnostic image since it represents information of a patient that could not be congreent with the current (actual) patient position and shall therefore always been as an additional source of information.

The Virtual Navigator tracking system should not be used on or around persons with a cardiac pacemaker, and should not be used around life supporting equipment.

The MyLab70 and MyLab90 system designs remain the same as those previously cleared by FDA via K051837, K051308, and K060827, respectively, except for those features being added via this submission.

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 and, Tissue Enhancement Imaging (CE), The systems are equipped with an optional LCD Color Display and can drive phased (PA), convex (CA) and linear array (LA) and Doppler probes.

The MyLab70 and MyLab90 systems are able to produce Real Time 2D images and 3D images (in manual mode) with all probes. The MyLab70 and MyLab90 systems are manufactured under an ISO 9001:2000 and ISO 13485 certified quality system.

This is a 510(k) Pre-market Notification for the Esaote MyLab70 and MyLab90 Systems, seeking clearance for a new feature called "Virtual Navigator software" and transducers. The information provided is heavily based on claims of substantial equivalence to previously cleared predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not contain an explicit table of acceptance criteria or quantitative performance metrics for the new Virtual Navigator software or the newly cleared transducers. Instead, it relies on demonstrating substantial equivalence to previously cleared devices. The "performance" for the new features is implicitly considered to meet the safety and effectiveness standards of the predicate devices.

For the Virtual Navigator software, the performance is described qualitatively by comparing its technological characteristics to predicate devices:

For the transducers, the performance is implied by their classification and intended use being equivalent to previously cleared transducers on the predicate devices. The document lists the following new transducers and indicates their clearance as part of this submission by stating "P" (Previously Cleared) next to a K-number, or "N" (New) if it were a new mode/application, but for transducers specific K-numbers are provided for clearance. The tables across the document for each transducer model indicate which clinical applications and modes are cleared for that specific transducer, often referencing prior K-numbers (e.g., K051837 for MyLab 90, K051308 for MyLab 70).

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

The document does not explicitly state the sample size for any test set or the data provenance. It mentions that the MyLab70 and MyLab90 systems were "previously cleared by FDA via K051837, K051308, and K060827" and that this submission is for added features. This implies that the safety and effectiveness of the core device have been established, and this notification is for modifications. For the Virtual Navigator, the comparison matrix against predicate devices indicates the basis for clearance.

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

No information is provided regarding the number or qualifications of experts used to establish ground truth for any test set, as quantitative studies with new data are not presented in this summary. The submission relies on equivalence to devices cleared previously.

4. Adjudication Method for the Test Set

No information regarding adjudication methods is provided, as no new clinical test data for the device's performance is presented in this summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No information about an MRMC comparative effectiveness study is mentioned. The submission focuses on substantial equivalence for a new software feature and additional transducers.

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

The Virtual Navigator is described as providing "additional image information from a second modality like CT or MR, during a clinical ultrasond session." It also states: "The second modality image is not intended to be used as a standalone diagnostic image since it represents information of a patient that could not be congruent with the current (actual) patient position and shall therefore always been as an additional source of information." This explicitly indicates that the Virtual Navigator is not a standalone diagnostic device. Therefore, a standalone (algorithm only) performance study as typically understood for AI algorithms would not be applicable, and no such study is described.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Given that the submission is for substantial equivalence and describes a navigation system rather than a diagnostic performance algorithm, no specific type of ground truth against expert consensus, pathology, or outcomes data is mentioned as being used in this summary. The validation would have likely focused on the accuracy of alignment and visualization against physical phantoms or established imaging modalities, rather than diagnostic accuracy against patient outcomes.

8. The Sample Size for the Training Set

No information about a training set size is provided, as this is a traditional medical device 510(k) submission for an ultrasound system with a navigation feature, not an AI/ML-driven diagnostic algorithm that typically requires explicit training data.

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

Not applicable, as no training set or AI/ML algorithm requiring explicit ground truth for training is described in this summary. The Virtual Navigator is a software feature for image fusion and navigation, validated against predicate devices of similar technological characteristics.

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