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The VPan (View Panoramic) Module is being added to the Technos™ ultrasound imaging system to provide panoramic, wide field-of-view images for easier orientation of anatomy and pathology.

The Technos™ ultrasound imaging system is intended to be used by a physician for diagnostic imaging in cardiac, abdominal, peripheral vascular, fetal, pediatric, small organ, neonatal cephalic, transrectal, transvaginal, intraoperative abdominal, intraoperative peripheral vascular, laparoscopic, adult cephalic, other-urological and musculoskeletal applications.

The VPan (View Panoramic) Module is being added to the Technos™ ultrasound imaging system to provide panoramic, wide field-of-view images for easier orientation of anatomy and pathology.

The provided 510(k) summary for the VPan Module to the TechnosMP Ultrasound Imaging System does not contain a detailed study proving the device meets specific acceptance criteria in the manner of a clinical trial with performance metrics. Instead, the submission focuses on demonstrating substantial equivalence to a previously cleared predicate device.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy, or quantitative image quality scores). It relies on a comparison to a predicate device.

The "Comparison Chart for Substantial Equivalence" serves as the primary "acceptance criteria" by showing the new device functions similarly to the predicate.

Reported Device Performance: The document states that the VPan Module (the subject device) "provides panoramic, wide field-of-view images for easier orientation of anatomy and pathology." The implicit performance is that it performs these functions equivalently to the predicate device. No quantitative performance metrics are provided.

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

The document does not describe a test set or data provenance for a performance study. Clinical data is not typically required for 510(k) submissions that demonstrate substantial equivalence through comparison to predicate devices, especially for devices like this that are modifications or additions to existing ultrasound systems. The focus is on technical characteristics and intended use.

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

Not applicable. No ground truth establishment for a test set is described as there isn't a performance study evaluating diagnostic capabilities against a reference standard.

4. Adjudication Method for the Test Set

Not applicable. No test set or independent adjudication is described.

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 device is an ultrasound imaging module, not an AI or CAD (Computer-Aided Detection) system. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this submission.

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

Not applicable. This is an imaging module, not an algorithm, so standalone performance is not relevant in this context.

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

Not applicable. There is no performance study described that would require establishing a ground truth. The submission relies on demonstrating the new module's technical similarity and equivalent intended use to the predicate device.

8. The Sample Size for the Training Set

Not applicable. This is an ultrasound imaging module, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI/ML.

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

Not applicable, as there is no training set mentioned or implied.

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The AU6 (Technos/TechnosMP) ultrasound imaging system is intended to be used by a physician for diagnostic imaging in pediatric, small organ, neonatal cephalic, transrectal, transvaginal, intraoperative abdominal, intraoperative peripheral vascular, laparoscopic, adult cephalic and musculoskeletal applications.

Not Found

This is a 510(k) premarket notification for an ultrasound imaging system. Such notifications typically focus on establishing substantial equivalence to a legally marketed predicate device rather than presenting detailed standalone performance studies with specific acceptance criteria and outcome metrics like accuracy, sensitivity, or specificity.

Based on the provided document, here's what can be extracted and what cannot be determined:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria for image quality or diagnostic accuracy/performance. The "reported device performance" is essentially that it is substantially equivalent to the predicate devices and supports the specified imaging modes and clinical applications.

The tables within the document (e.g., "Comparison Chart for Substantial Equivalence", and tables for individual transducers) indicate capabilities and modes of operation for various clinical applications, rather than quantifiable performance metrics against acceptance criteria.

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

The document does not provide any information about a specific "test set" in the context of an accuracy study. This submission is a 510(k) for an ultrasound imaging system, which primarily demonstrates substantial equivalence through technical comparison and compliance with performance standards (e.g., electrical safety, acoustic output), rather than clinical performance studies against a gold standard for specific diagnostic tasks. The "data provenance" for a clinical test set is therefore unstated.

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

This information is not provided as there is no mention of a clinical performance study with a test set requiring expert-established ground truth.

4. Adjudication Method for the Test Set:

This information is not provided as there is no mention of a clinical performance study with a test set requiring adjudication.

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

The document does not report on an MRMC comparative effectiveness study, nor does it mention any effect size of human readers improving with AI vs. without AI assistance. This device is an ultrasound imaging system, not an AI-powered diagnostic aide in the context of this submission.

6. Standalone (Algorithm Only) Performance Study:

The document does not report on a standalone performance study. The device is an ultrasound imaging system, where its "performance" for 510(k) purposes is largely demonstrated through technical specifications and adherence to safety and performance standards.

7. Type of Ground Truth Used:

As no clinical performance study with a "test set" is described, there is no mention of the type of ground truth used (e.g., expert consensus, pathology, outcomes data).

8. Sample Size for the Training Set:

The document does not provide any information about a training set. This is not an AI/machine learning device in the context of this 510(k) submission.

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

This information is not provided as no training set is mentioned.

Summary of the Study (Based on the 510(k) provided):

The "study" presented in this 510(k) is a substantial equivalence comparison. The manufacturer, Biosound Esaote, sought clearance for the AU6 (Technos/Technos MP) Ultrasound Imaging System with the addition of 3D Imaging Mode and Musculoskeletal Indication.

The study primarily involves a technical comparison of the proposed device (AU6 Technos/Technos MP with 3D/Musculoskeletal additions) against predicate devices: the Esaote AU5 3D (K000931) for 3D capabilities and the Esaote AU6 Digital (Technos K990360) for general ultrasound capabilities.

The "acceptance criteria" are implicitly met if the new device demonstrates similar technological characteristics and performance specifications for the modes and applications it claims, and meets relevant electrical and ultrasound safety standards (IEC 60601-1 and Track 3 for Ultrasound safety). The performance is "reported" by affirming the device's capabilities match or are comparable to the predicates for the cleared indications and modes, while explicitly highlighting the new applications (Musculoskeletal Conventional, Musculoskeletal Superficial, and 3D imaging in certain contexts) as additions with these capabilities. The FDA's letter of clearance confirms that the device is "substantially equivalent" for the stated indications for use.

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The E-scan XQ is intended for diagnostic nuclear magnetic resonance imaging of the hip, knee, ankle, foot, shoulder, elbow, wrist, hand, calf, thigh, arm and forearm. The device produces transverse, sagittal, coral and oblique cross-sectional images, displaying the internal structure of the limbs and joints being imaged. The images that are produced correspond to the spatial distribution of protons (hydrogen nuclei) that check the magnetic resonance properties and depend upon the MR parameters (spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and chemical shift). If interpreted by a medical expert, these images can provide diagnostically useful information.

The E-Scan MRI system is substantially equivalent to the currently available E-Scan system cleared via K012728.

The provided 510(k) summary for the E-Scan XQ Magnetic Resonance Diagnostic Device does not contain information regarding acceptance criteria or a study proving the device meets specific performance criteria beyond substantial equivalence to predicate devices.

The document focuses on:

• Submitter Information: Details of the manufacturer and contact person.
• Device Identification: Trade name, common name, classification, and product code.
• Predicate Devices: Lists similar devices previously cleared by the FDA.
• Intended Use: Description of the device's diagnostic purpose and areas of the body it images.
• Technological Characteristics: States that the device is "substantially equivalent" to an existing cleared E-Scan system.
• FDA Clearance Letter: Confirms substantial equivalence to predicate devices.

Therefore, it is not possible to fill out the requested table or provide details about a performance study, sample sizes, expert qualifications, or ground truth based solely on the provided text.

Explanation for the absence of requested information:

510(k) submissions primarily focus on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through extensive clinical performance studies. While the device's output (images) is intended to be interpreted by a medical expert for diagnostically useful information, the 510(k) summary itself does not detail a specific study proving the device's diagnostic accuracy or performance against pre-defined acceptance criteria. The FDA's clearance is based on the device being "substantially equivalent" in terms of intended use, technological characteristics, and safety and effectiveness to existing predicate devices.

To obtain the requested information, one would typically need to review a more detailed technical file, design validation reports, or clinical study reports that might have been submitted to the FDA as part of the overall 510(k) submission, but this information is not present in the provided summary.

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The E-scan is intended for diagnostic nuclear magnetic resonance imaging of the hip, knee, ankle, foot, shoulder, elbow, wrist, hand, calf, thigh, arm and forearm. The device produces transverse, sagittal, coronal and oblique cross-sectional images, displaying the internal structure of the limbs and joints being imaged. The images that are produced correspond to the spatial distribution of protons (hydrogen nuclei) that check the magnetic resonance properties and depend upon the MR parameters (spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and chemical shift). If interpreted by a medical expert, these images can provide diagnostically useful information.

The E-scan is a magnetic resonance diagnostic device. The Multipurpose Flexible Receiving Coil improves the system performance and does not alter the fundamental scientific technology of the cleared device.

The provided 510(k) summary does not contain the detailed information typically required to describe acceptance criteria and a study proving a device meets them in the context of an AI/ML medical device submission. This document pertains to an MRI system (E-Scan) and a new receiving coil, filed in 2001, long before the widespread use and regulatory frameworks for AI/ML in medical devices.

Therefore, many of the requested fields cannot be directly extracted from the provided text. I will address what information is available and explain why other fields are missing or not applicable.

Here's an analysis based on the provided text:

Acceptance Criteria and Study for E-Scan MRI System (Receiving Coil)

The submission focuses on establishing substantial equivalence to a predicate device, primarily through demonstrating that the addition of a "Multipurpose Flexible Receiving Coil" does not alter the fundamental scientific technology of the cleared device (Esaote E-Scan K001894). The acceptance criteria are implicitly tied to maintaining the safety and effectiveness profile of the predicate device.

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

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

• Sample Size: Not specified. The document does not describe a clinical study or test set in the way an AI/ML validation would. It primarily focuses on the technical characteristics of the new coil and its intended use.
• Data Provenance: Not applicable. There's no mention of specific data used for a test set that would have provenance like country of origin or whether it was retrospective/prospective.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The submission states that images, "If interpreted by a medical expert, these images can provide diagnostically useful information," but doesn't detail their role in a specific test for the coil.

4. Adjudication method for the test set:

• Adjudication method: Not applicable. No specific test set or adjudication process is described.

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.
• Effect Size of AI assistance: Not applicable. This submission is for an MRI system and a mechanical coil, not an AI/ML algorithm.

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

• Standalone Performance: Not applicable. This is not an AI/ML algorithm. The device produces images that "If interpreted by a medical expert, these images can provide diagnostically useful information," clearly indicating human interpretation is part of its intended use.

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

• Type of Ground Truth: Not explicitly stated as part of a formal validation study. For an MRI system, the "ground truth" for image quality and diagnostic utility is typically established by comparing the images produced to established anatomical knowledge, clinical expectations, and the ability of human experts to make diagnoses from them. No specific methodology for establishing such ground truth in the context of this specific submission (for the new coil) is detailed beyond its intended use for diagnostic imaging.

8. The sample size for the training set:

• Sample Size: Not applicable. This is not an AI/ML algorithm that required a training set.

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

• Ground Truth Establishment: Not applicable. This is not an AI/ML algorithm that required a training set.

Summary of what can be gleaned about the "study" for this device:

The "study" for this 510(k) submission primarily involved demonstrating that the new Multipurpose Flexible Receiving Coil is consistent with the established safety and effectiveness of the predicate E-Scan MRI system (K001894). The key "performance" claim is that the new coil "improves the system performance and does not alter the fundamental scientific technology of the cleared device," and that it can be used for various anatomical regions, including those that might be challenging with other coils (e.g., painful or plastered limbs). This substantial equivalence argument is based on technical specifications and comparison to existing devices rather than a formal clinical trial or AI/ML validation study.

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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Pediatric, Small Organ (Thyroid, Breast and Testicles), Neonatal Cephalic, Adult Cephalic, Cardiac, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular. Applicable combined modes: B+M+PW+CW+CFM+PD. New indication: Tissue Harmonic Imaging for Cardiac.

ESAOTE's 7250 is a compact ultrasound system used to perform non-invasive diagnostic general ultrasound studies. Its primary modes of operation are the following: B-Mode, M-Mode, Doppler, Color Flow Mapping, Harmonic Imaging (TEI) and Amplitude Doppler. The 7250 can be equipped with an LCD Color Display (Portable Configuration) or with a 15" Color Monitor and a cart (Mainframe Configuration). The full alphanumeric keyboard allows complete on-screen data entry of patient information and on-screen annotations. The 7250 can drive annular array, phased, convex and linear array probes. In addition, the 7250 is equipped with a volumetric scan converter and the ability to control simultaneously two independent scan planes. This technological characteristic allows to manage Bi-Scan Probes, to obtain volumetric datasets; these datasets can then be used to display "omni-directional" 2D images (anyplane sectioning) as well as multiple parallel equidistant sections (paraplane sectioning). This Bi-Scan approach is ideal for volume computations through the Simpson rule; specifically, it can be used to measure volumes of irregular structures since it does not require a geometrical assumption. The 7250 is designed for ease of use. The user interface allows the operator to perform an examination quickly and efficiently. Clearly labeled mode selection keys are easily accessed, and the system's "pop-up" menus allow the operator to change parameters with ease. The user may also access special function menus and perform calculations with a minimal number of kev strokes. The 7250 offers a vast selection of calculations and measurements which can be performed quickly and easily. The MOD.7250 is equipped with a 3.5" floppy disk drive to simplify software modifications and provide fast, cost effective system upgrades. This drive (or an optional Optical Disk Drive) can also be used for image storage. Moreover, this unit can store data directly to a Personal Computer via a LAN (Network) port. In addition, the 7250 can be equipped with recording devices, including a S-VHS video recorder and a black-and-white or color printer, which are controlled through the keyboard.

This submission, K994369, appears to be for a 7250 Ultrasound Imaging System with the addition of a new imaging mode: Tissue Enhancement Imaging (TEI) or 2nd Harmonic Imaging Mode. The provided text is a 510(k) summary, formal FDA correspondence, and Indications for Use forms.

It is important to note that the provided document does NOT contain a study or data proving the device meets specific acceptance criteria related to its diagnostic performance (e.g., sensitivity, specificity, accuracy) for the new Tissue Enhancement Imaging mode. Instead, this document focuses on demonstrating substantial equivalence to a predicate device, primarily through technical and safety comparisons, and specifying the intended uses for the added mode.

Therefore, many of the requested sections about specific performance criteria, study design, sample sizes, and ground truth establishment cannot be extracted directly from the provided text. The submission relies on the established safety and efficacy of the predicate device and the general understanding of ultrasound technology, along with safety testing for the new mode.

Here's an attempt to answer the questions based on the available information, noting when information is absent:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided K994369 summary, there are no specific performance-based acceptance criteria (e.g., sensitivity, specificity, image quality metrics) or corresponding reported performance data for the new Tissue Enhancement Imaging mode from a diagnostic study.

The acceptance criteria implicitly referred to in this 510(k) revolve around substantial equivalence to the predicate device (Esaote 7250, K982444), particularly in terms of:

• Safety: Meeting electrical (EN60601-1) and ultrasound safety standards (Track 3 Acoustic Output Display).
• Technical Specifications: Matching or being comparable to the predicate for imaging frequencies, CFM/Doppler frequencies, biopsy guidance features, display type, digital archival capabilities, and measurement capabilities.
• Intended Use: The new mode expanding the indications for use for Cardiac applications.

While no explicit performance table is available, here's how the general comparison is presented:

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

Not specified in the provided document.

The document details a 510(k) submission for adding a new imaging mode (Tissue Enhancement Imaging) to an existing ultrasound system. It does not describe a clinical performance study with a "test set" in the sense of patient data used to evaluate diagnostic accuracy. The evaluation is focused on technical and safety equivalence to the predicate device.

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.

No ground truth establishment by experts is described, as no clinical performance study for diagnostic accuracy is detailed in this 510(k) summary.

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

Not applicable.

No clinical performance study requiring adjudication is detailed.

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.

This is an ultrasound imaging device, not an AI-powered diagnostic tool, and no MRMC study is mentioned.

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

Not applicable.

This is an ultrasound imaging device, not an algorithm, and no standalone performance study is detailed.

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

Not applicable.

No clinical performance study requiring a ground truth is detailed. The submission is focused on demonstrating the safety and technical comparability of the new imaging mode to the predicate device and general ultrasound standards.

8. The sample size for the training set

Not applicable.

This submission does not describe an AI or machine learning model that would require a training set.

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

Not applicable.

This submission does not describe an AI or machine learning model that would require a training set with established ground truth.

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