Search Results

MyLabSigma is intended to perform diagnostic general ultrasound studies including:

Fetal, Abdominal, Intraoperative (Abdominal), Laparoscopic, Pediatric, Small organs, Neonatal,

Neonatal Cephalic, Adult Cephalic, Transvaginal, Musculoskeletal (Conventional),

Musculoskeletal (Superficial), Urological, Cardiovascular Adult, Cardiovascular Pediatric,

Transoesophageal (cardiac), Peripheral Vessel.

The equipment provides imaging for guidance of biopsy and imaging to assist in the placement of needles and catheters in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

The ultrasonic medical diagnostic equipment is intended to mechanical and electronic ultrasound probes (convex array, linear array and phase array) and Doppler probes.

The upgraded 7410 system (MyLabSigma), is a portable system equipped with a handle. The system sizes and weights allow them to be carried using its handle. The primary modes of operation are: B-Mode, M-Mode, Tissue Enhancement Imaging (TEI), Multi View (MView), Doppler, Color Flow Mapping (CFM), Amplitude Doppler (AD), Tissue Velocity Mapping (TVM), 3D and 4D.

Model 7410 is equipped with a LCD color display where acquired images and advanced image features are shown. Model 7410 can drive Phased array. Linear array. Doppler probes and Volumetric probes (Bi-Scan probes). The control panel is equipped with a touchscreen that has an emulation of the Qwerty alphanumeric keyboard that allows data entry.

Model 7410 is equipped with wireless capability.

Model 7410 is already cleared via K161359.

The marketing name for new devices of Model 7410 will be:

• MyLabSigma ●
  MyLabSigma, defined herein. combine the cleared features of 7410 system with new capabilities, listed below:

• Addition of Auto NT (Automatic Nuchal Translucency) option, allows to automatically capture Nuchal Translucency measurement.

• Addition of Auto EF (Automatic Ejection Fraction) option, allows to automatically capture Ejection Fraction measurement.

• . Management of probes L3-11, L4-15, mC 3-11 and P2 3-11.

• . Full screen option.

• . Windows 10 Operative System.

The 7410 new version is manufactured under a quality system compliance with 21CFR 820 requirements and certified according to ISO 9001:2015 and ISO 13485:2016.

Here's a breakdown of the acceptance criteria and the study information based on the provided text, using the specified format. It's important to note that this document is a 510(k) summary for a medical device (ultrasound system), and therefore, the "study" described is a demonstration of substantial equivalence rather than a traditional clinical trial proving specific performance metrics beyond those of predicate devices.

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

The document does not explicitly present a quantitative table of acceptance criteria and reported device performance in the way a clinical study might for specific diagnostic metrics. Instead, it asserts substantial equivalence to predicate devices (K161359, K183191, K173291) by demonstrating that:

• The fundamental technological characteristics are the same.
• Clinical uses have not changed or are equivalent to those of previously cleared devices.
• Added options (Auto NT, Auto EF, certain probe management, capacitive touchscreen, full screen mode, Windows 10 OS) are identical or equivalent to features cleared on other Esaote models.
• The device conforms to relevant safety standards.
• Performance (Ergonomics, General Usability, and Image Quality) is in line with predicate and reference devices.

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

The document states, "No clinical tests were performed." Therefore, there is no specific patient-based test set or data provenance to report in this context. The evaluation was based on non-clinical tests (safety, software validation, performance characteristic comparisons).

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 and thus no "ground truth" was established from patient data. The ground truth for engineering and system performance would be defined by the relevant standards and specifications.

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

Not applicable, as 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. This submission is for an ultrasound system, not an AI-assisted diagnostic device, and no MRMC study was mentioned or performed.

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

Not applicable. This is not an algorithm-only device. The submission focuses on the ultrasound system and its integrated features.

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

The "ground truth" for this submission is based on adherence to recognized medical device safety standards (e.g., IEC, NEMA, ETSI standards) and the established performance and safety profiles of the predicate devices. For features like "Auto NT" and "Auto EF," the ground truth is their functional equivalence to previously cleared implementations on other Esaote models.

8. The sample size for the training set

Not applicable, as this is not a machine learning device that requires a training set in the typical sense. The software validation was performed as a part of a system function test.

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

Not applicable, as no training set for a machine learning model was used. Software validation involved testing functions and confirming their operation with traceability of anomalies, likely against predefined functional specifications and requirements.

Ask a specific question about this device

MyLabX6 and MyLabX7 are intended to perform diagnostic general ultrasound studies including: Fetal, Abdominal, Intraoperative (Abdominal), Laparoscopic, Pediatric, Small organs, Neonatal Cephalic, Adult Cephalic, Transvaginal, Musculoskeletal (Conventional), Musculosketal (Superficial), Urological, Cardiovascular Adult, Cardiovascular Pediatric, Transoesophageal (cardiac), Peripheral Vessel.

The equipment provides imaging for guidance of biopsy and imaging to assist in the placement of needles and catheters in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

The ultrasonic medical diagnostic equipment is intended to mechanical and electronic ultrasound probes (convex array, linear array and phased array) and Doppler probes.

The upgraded 6400 systems, (MyLabX6 and MyLabX7), are a mainframe systems equipped with wheels allowing to move the system. The primary modes of operation are for both models: B-Mode, M-Mode, Tissue Enhancement Imaging (TEI), Multi View (MView), Doppler, Color Flow Mapping (CFM), Amplitude Doppler (AD), Tissue Velocity Mapping (TVM), 3D and 4D. Model 6400 manages Qualitative Elastosonography (ElaXto).

Model 6400 is equipped with a LCD color display where acquired images and advanced image features are shown. Model 6400 can drive Phased array, Linear array, Linear array, Doppler probes and Volumetric probes (Bi-Scan probes). The control panel is equipped with a pull-out Owerty alphanumeric keyboard that allows data entry.

Model 6400 is equipped with wireless capability.

Model 6400 is already cleared via K161359.

The marketing name for new devices of Model 6400 will be:

• MyLabX6
• . MyLabX7

MyLabX6 and MyLabX7, defined herein, combine the cleared features of 6400 system with new capabilities, listed below:

• 1. Addition of Auto NT (Automatic Nuchal Translucency) option, allows to automatically capture Nuchal Translucency measurement.
• 2. MicroV option, only for MyLabX7, recognizes the lowest speeds with ultra-sensitivity for small vessels and slow flow detection.
• 3. QPack option (Quantification Curves), only for MyLabX7, provides capabilities to evaluate time/intensity curves of Doppler or CnTI signals within the organ under examination.
• 4. 4D STIC option, only for MyLabX7, allows Time/Intensity analysis.
• 5. Management of probes L3-11, L4-15, mC 3-11, P 1-5, P 2-9 and P2 5-13. P 1-5, P 2-9 and mc 3-11 are available only for MyLabX7.
• 6. Full screen option.
• 7. Windows 10 Operative System.

The 6400 new version is manufactured under a quality system compliance with 21CFR 820 requirements and certified according to ISO 9001:2015 and ISO 13485:2016.

This FDA 510(k) summary for the Esaote 6400 Ultrasound System (MyLabX6, MyLabX7) does not contain detailed information about specific acceptance criteria for image quality or clinical performance and the results of a study proving those criteria are met. The document focuses on establishing substantial equivalence to previously cleared predicate devices based on technological characteristics and adherence to safety standards.

Here's a breakdown of the requested information based on the provided text, and what is explicitly stated as not applicable or not provided:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document for specific image quality or clinical performance metrics. The submission focuses on substantial equivalence based on overall indications for use and technological similarity to cleared predicate devices, rather than a new performance study with specific acceptance criteria that are numerically defined. The clinical applications listed represent the intended use and are not acceptance criteria for a performance study.

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

Not applicable/Not provided. No specific clinical test set or data provenance is mentioned as this was not a clinical performance study. The submission relies on the established performance of predicate devices.

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

Not applicable/Not provided. No specific test set with ground truth established by experts is mentioned.

4. Adjudication method for the test set

Not applicable/Not provided. No specific 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

Not applicable/Not provided. The document does not describe any AI component or MRMC study. The device is an ultrasound system, not an AI-powered diagnostic tool.

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

Not applicable/Not provided. The device is an ultrasound system, not a standalone algorithm.

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

Not applicable/Not provided. No specific ground truth methodology is mentioned as this was not a clinical performance study for image accuracy or diagnostic efficacy.

8. The sample size for the training set

Not applicable/Not provided. This document describes an ultrasound system, not a device trained on a dataset.

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

Not applicable/Not provided. This document describes an ultrasound system, not a device trained on a dataset.

Summary of what is provided from the text:

The submission for the Esaote 6400 Ultrasound System (MyLabX6, MyLabX7) is a 510(k) Premarket Notification, which aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This type of submission generally relies on demonstrating similar technological characteristics and indications for use, and adherence to recognized performance and safety standards, rather than conducting new, elaborate clinical performance studies with specific acceptance criteria and ground truth validation for novel claims.

The document explicitly states: "No clinical tests were performed." This clarifies that the submission did not include studies with acceptance criteria related to clinical performance, a test set, expert ground truth, or MRMC studies.

The justification for substantial equivalence relies on:

• Predicate Devices: Primary predicate K161359 (6400 – MyLabSeven), and reference predicates K183191 (6420 - MyLabX5) and K173291 (6440 – MyLab9).
• Technological Characteristics: The updated devices (MyLabX6 and MyLabX7) employ the "same fundamental technological characteristics" as the predicate device (Esaote 6400 model cleared via K142008 and K161359). New capabilities (Auto NT, MicroV, QPack, 4D STIC, management of new probes, full screen option, Windows 10 OS) are stated to be "identical" to those already cleared in other Esaote models (6440 and 6420 via K173291 and K183191).
• Non-Clinical Tests: Evaluation for acoustic output, biocompatibility, cleaning and disinfection effectiveness, thermal, electrical, electromagnetic, and mechanical safety, conforming to standards such as IEC 60601-1, IEC 60601-2-37, NEMA UD-2, and NEMA UD-3, among others.
• Indications for Use: The indications for use are consistent with those of previously cleared devices.

Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context are interpreted as the regulatory requirement to demonstrate substantial equivalence to legally marketed predicate devices, primarily through engineering and safety testing, and showing that any new features are identical to those already cleared.

Ask a specific question about this device

Esaote 7400, MyLabOmega, is a compact portable system intended to perform diagnostic general ultrasound studies including: Fetal, Abdominal, Intraoperative (Abdominal), Laparoscopic, Pediatric, Small organs, Neonatal, Neonatal Cephalic, Adult Cephalic, Transvaginal, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Urological, Cardiovascular Adult, Cardiovascular Pediatric, Transoesophageal (cardiac), Peripheral Vessel.

The equipment provides imaging for guidance of biopsy and imaging to assist in the placement of needles and catheters in vascular, or other anatomical structures, as well as peripheral nerve blocks in Musculoskeletal applications.

The ultrasonic medical diagnostic equipment is intended to be connected to mechanical and electronic ultrasound probes (convex array, linear array and phased array) and Doppler probes.

The upgraded 7400 system (MyLabOmega) is portable systems equipped with a handle. The system sizes and weights allow them to be carried using its handle. The primary modes of operation are for both models: B-Mode, M-Mode, Tissue Enhancement Imaging (TEI), Multi View (MView), Doppler, Color Flow Mapping (CFM), Amplitude Doppler (AD), Tissue Velocity Mapping (TVM), 3D and 4D. Model 7400 manages Qualitative Elastosonography. 7400 is equipped with a LCD color display where acquired images and advanced image features are shown. 7400 can drive Phased, Convex, Linear array, Doppler probes and Volumetric probes (Bi-Scan probes). On both models the touchscreen has an emulation of the Qwerty alphanumeric keyboard that allows data entry. 7400 model is equipped with wireless capability and has been designed to be powered by battery.

The upgraded 7400 system, defined herein, combines the cleared features of both the 6440 and 7400 systems with new capabilities, listed below:

• 1. Addition of Auto NT option.
• 2. Addition of MicroV option.
• 3. Addition of Qpack option.
• 4. Management of probe P 1-5.
• 5. Management of probe L 4-15
• 6. Addition of 4D Stic option.
• 7. Addition of Full screen option.
• 8. Operative system Windows 10

The provided text details a 510(k) premarket notification for the Esaote 7400 Ultrasound System, not an AI/ML medical device. Therefore, the traditional acceptance criteria and study designs typically associated with proving the performance of AI/ML devices (e.g., specific metrics like sensitivity/specificity, sample sizes for test/training sets, expert ground truth establishment, MRMC studies) are not applicable here.

The 510(k) submission for the Esaote 7400 Ultrasound System (K190447) focuses on demonstrating substantial equivalence to previously cleared predicate devices, primarily through technological characteristics and adherence to established medical device safety and performance standards.

Here's how the provided information relates to the request, reinterpreting "acceptance criteria" and "study" in the context of a traditional medical device 510(k):

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

In the context of a 510(k) for a conventional ultrasound system, the "acceptance criteria" are compliance with relevant safety and performance standards, and demonstrating that the new device's technological characteristics are substantially equivalent to the predicate. Device performance is typically proven through a suite of non-clinical tests.

• Acoustic output
• Biocompatibility
• Cleaning and disinfection effectiveness
• Thermal, electrical, electromagnetic, and mechanical safety
  And found to conform to:
• IEC 60601-1
• IEC 60601-1-2
• IEC 60601-2-37
• NEMA UD-3 (Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment)
• NEMA UD-2 (Acoustic Output Measurement Standard for Diagnostic Ultrasound) |
  | Technological Equivalence to Predicate Devices: | The 7400 upgrade employs the same fundamental technological characteristics as its predicate devices.
• The upgraded system is substantially equivalent to Esaote 7400 (cleared via K111302 and K161359).
• Clinical uses from Esaote 7400 (K142008) and Esaote 6440 (K173291) are unchanged.
• Specific new features (Auto NT, Auto EF, Qpack, probes L 4-15 and P 1-5 management, Full screen mode, Windows 10 OS) are identical to those already cleared on the Esaote 6440 (K173291). |
  | Manufacturing Quality System: | The 7400 new version is manufactured under an ISO 9001 and ISO 13485 certified quality system. |

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

For this type of device (ultrasound system), the "test set" is not a dataset of images for an algorithm, but rather the device itself undergoing a series of engineering and performance verification tests. The document does not specify a "sample size" in the conventional sense of patient data.

• Test Sample Size: Not applicable in the context of an AI/ML algorithm. The "sample" is the physical device being tested against engineering specifications and regulatory standards.
• Data Provenance: Not applicable for an AI/ML algorithm test set. The data presented are engineering test results and compliance assessments. The document mentions previous clearances (K111302, K132231, K132466, K142008, K161359, K173291), indicating an iterative development and clearance process, but not specifically data provenance for an algorithm. This is a submission for a hardware system update.

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

• Number of Experts/Qualifications for Ground Truth: Not applicable. Ground truth, in the context of AI/ML, refers to expert-labeled data used to train and validate models. For a conventional ultrasound system, performance is assessed through objective engineering measurements and compliance testing, not through expert reading of images in a studies designed for AI model evaluation.

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

• Adjudication Method: Not applicable. This concept belongs to the evaluation of AI/ML algorithms where multiple readers might disagree on a diagnosis, requiring an adjudication process to establish definitive ground truth. For an ultrasound system, performance is assessed against technical specifications and established standards, which don't typically involve reader adjudication.

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:

• MRMC Study: No, an MRMC study was not done, and it's not relevant for this type of device submission. This study design is specifically for evaluating the impact of AI on human reader performance. This submission is for the ultrasound system itself, not an integrated AI-powered diagnostic tool requiring such a study for its regulatory clearance.

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

• Standalone Performance: Not applicable. The device is an ultrasound system, which is inherently a human-in-the-loop diagnostic tool. The document does not describe any "algorithm only" component being evaluated in a standalone manner. The "options" mentioned (Auto NT, MicroV, Qpack, 4D Stic) are features of the ultrasound system, not independent AI algorithms with their own performance metrics being evaluated in isolation.

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

• Type of Ground Truth: Not applicable in the AI/ML sense. The "ground truth" for this device's performance is compliance with international and national safety and performance standards (e.g., IEC, NEMA) and demonstrating that its technological changes do not raise new questions of safety or effectiveness compared to predicate devices. This involves objective engineering measurements and verification, not diagnostic ground truth from medical cases.

8. The sample size for the training set:

• Training Set Sample Size: Not applicable. This refers to the data used to train an AI/ML model, which is not the subject of this 510(k) submission.

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

• Training Set Ground Truth Establishment: Not applicable, as there is no mention of an AI/ML training set in the provided document.

In summary: The provided document is a 510(k) premarket notification for a diagnostic ultrasound system, not an AI/ML medical device. Therefore, the criteria and study types requested in the prompt, which are standard for AI/ML device evaluations (e.g., test sets, training sets, ground truth, MRMC studies), are not present or applicable here. The focus of this 510(k) is on demonstrating substantial equivalence to predicate devices and adherence to established safety and performance standards for ultrasound equipment through non-clinical (engineering) testing.

Ask a specific question about this device

Esaote's 6420 is intended to perform diagnostic general ultrasound studies including: Fetal, Abdominal, Intraoperative (Abdominal), Laparoscopic, Pediatric, Small organs, Neonatal, Neonatal Cephalic, Adult Cephalic, Transvaginal, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Urological, Cardiovascular Adult, Cardiovascular Pediatric, Transoesophageal (cardiac), Peripheral Vessel.

The equipment provides imaging for guidance of biopsy and imaging to assist in the placement of needles and catheters in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

The ultrasonic medical diagnostic equipment is intended to be connected to mechanical and electronic ultrasound probes (convex array, linear array and phase array) and Doppler probes.

The upgraded 6420 system (MyLabX5) is compact mainframe system equipped with wheels allowing to move the system. The system sizes and weights allow them to be carried using the handle.

The primary modes of operation are: 2D, M-Mode, Continuous Wave Doppler (CW), Tisue Enhancement Imaging (TEI), Multi View (MView), Doppler, Pulse Wave (PW) Doppler, Color Flow Mapping (CFM), Amplitude Doppler (AD), Tissue Velocity Mapping (TVM), 3D and 4D.

6420 is equipped with a LCD color display where acquired images and advanced image features are shown. 6420 can drive Phased array, Convex array, Linear array, Doppler probes and Volumetric probes (Bi-Scan probes). Model 6420 control panel is equipped with a pull-out Qwerty alphanumeric keyboard that allows data entry.

6420 is equipped with wireless capability.

Model 6420 was previously cleared via K161168.

The upgraded 6420 system, defined herein, combines the cleared features of both the 6440 and 6420 systems with new capabilities, listed below:

• 1. Management of Strain 2D.
• 2. Addition of Auto NT option.
• 3. Addition Auto EF option
• 4. Management of probe L 4-15.
• 5. Addition of Full screen option.
• 6. Operative system Windows 10

The 6420 new version is manufactured under an ISO 9001 and ISO 13485 certified quality system.

The provided document is a 510(k) summary for the Esaote 6420 Ultrasound System. It details an upgrade to an existing device, establishing substantial equivalence to previously cleared predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present acceptance criteria in terms of quantitative performance metrics, such as sensitivity, specificity, or accuracy, for the device's diagnostic capabilities. Instead, the "acceptance criteria" are implied through establishing substantial equivalence to predicate devices and conformance to recognized safety standards. The reported device performance is therefore based on its similarity to the cleared predicates and its adherence to non-clinical safety requirements.

Acceptance Criteria (Implied by Substantial Equivalence and Standards Conformance)

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

The document explicitly states: "No clinical tests were performed." Therefore, there is no sample size for a test set and no data provenance from clinical studies. The demonstration of performance relies on substantial equivalence to existing devices and non-clinical evaluations.

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

Since "No clinical tests were performed," there were no experts used to establish ground truth for a clinical test set.

4. Adjudication Method for the Test Set:

Not applicable, as "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, as "No clinical tests were performed" and this device is an ultrasound system, not an AI-assisted diagnostic tool as described. The document does not mention any AI components or human-in-the-loop performance studies.

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

Not applicable, as this is an ultrasound imaging system, not a standalone algorithm. The performance evaluation is based on the characteristics of the hardware and software features being substantially equivalent to predicates.

7. The type of ground truth used:

Given the statement "No clinical tests were performed," there was no clinical ground truth established through expert consensus, pathology, or outcomes data. The "ground truth" for this 510(k) submission is effectively the established performance and safety profiles of the predicate devices. The submission asserts that the upgraded device's features and overall performance are analogous to these already cleared devices, and non-clinical testing confirms adherence to relevant technical standards.

8. The sample size for the training set:

Not applicable. As "No clinical tests were performed" and the device is not an AI/ML algorithm that requires a training set in the conventional sense, there is no mention of a training set or its size. The upgrades primarily involve hardware and software features already present in other cleared devices.

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

Not applicable for the same reasons as #8.

Ask a specific question about this device