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The system is intended to be used by a trained/qualified healthcare professional in a hospital or clinical setting for ultrasound evaluation of fetal, abdominal, pediatric, small organ (thyroid, testes, breast), neonatal cephalic, musculoskeletal (conventional and superficial), cardiac (adult and pediatric), liver, peripheral vascular, trans-vaginal, trans-rectal, obstetrics/ gynecology applications in B-Mode(B, 2B, 4B), M-Mode, Anatomical M-mode, Color M, Color Flow Map (CFM), Power Doppler Imaging (PDI), Directional Power Doppler Imaging (DPDI), Pulsed Wave Doppler (PWD), Continuous Wave Doppler(CWD), 3D/4D, Elastography, Contrast Harmonic Imaging(CHI), S-Beam, Panoscope, Trapezoidal/Extended Sector Imaging, Tissue Doppler Imaging(TDD), Tissue Harmonic Imaging(THI), Macro Fidelity Imaging(MFI), ECG, Vector Space Flow (VS Flow), DICOM.

This system is a Track 3 device and the software used in Apogee C1, Apogee C2, Apogee C3, Apogee C5, Apogee K1, Apogee K2, Apogee K3, Apogee K5, Apogee U1, Apogee U2, Apogee U3, Apogee U5 Digital Color Ultrasound Imaging System is Ultrasound Software by SIUI and is based on the predicate device. The Document Level for the Ultrasound Software is Basic.

Here's a breakdown of the acceptance criteria and study information based on the provided text:

Important Note: The provided document is a 510(k) summary for an ultrasound system. It primarily focuses on demonstrating substantial equivalence to a predicate device based on technical characteristics, safety standards, and intended use. It explicitly states that clinical testing was not necessary to demonstrate substantial equivalence. Therefore, many of the requested items related to a clinical study (like test set sample size, expert qualifications, adjudication methods, MRMC studies, or standalone performance for an AI algorithm) are not applicable to this submission.

The document discusses non-clinical testing related to compliance with various international standards for medical electrical equipment, software, biocompatibility, and risk management. This type of testing ensures the device meets safety and performance criteria, but it's not a performance study in the sense of evaluating diagnostic accuracy against a ground truth for a specific clinical application.

1. Table of acceptance criteria and the reported device performance

Since this is a substantial equivalence claim for an ultrasound system, the acceptance criteria are primarily based on meeting safety standards and demonstrating comparable technical characteristics and intended use to the predicate device. There isn't a table of specific performance metrics for clinical accuracy as would be found in a study for an AI-powered diagnostic device.

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: "Clinical testing is not necessary for the Apogee C2... Digital Color Doppler Ultrasound Imaging System in order to demonstrate substantial equivalence to the predicate device." Therefore, there was no clinical test set in the traditional sense of a performance study to evaluate diagnostic accuracy. The "test set" for this submission refers to the physical device being tested against safety and performance standards, and comparison of its specifications 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. As explained above, no clinical test set requiring expert-established ground truth was part of this 510(k) submission.

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

• Not Applicable. No clinical test set with adjudication was part of this 510(k) submission.

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 submission is for a general-purpose ultrasound imaging system, not an AI-assisted diagnostic tool. No MRMC study was conducted or reported.

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

• No. This submission is for an ultrasound imaging system. It states the software is "Ultrasound Software by SIUI" and is "based on the predicate device." It does not describe a standalone AI algorithm for diagnostic interpretation.

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

• Not Applicable. For the non-clinical testing performed (compliance with standards), the "ground truth" is adherence to the specifications of those standards (e.g., electrical safety limits, EMC performance, software lifecycle processes) and comparison of technical parameters to the predicate device. There was no clinical ground truth established for diagnostic performance.

8. The sample size for the training set

• Not Applicable. This submission does not describe an AI/machine learning model that would require a training set of patient data. The "software" referred to is the operating system and imaging processing software of the ultrasound machine, not a data-driven AI algorithm in the diagnostic sense implied by this question.

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

• Not Applicable. As no training set was used, no ground truth needed to be established for it.

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Readius L15/ Readius P8/ Readius C6 Digital Color Doppler Ultrasound Imaging System is a general purpose diagnostic ultrasound system intended to be used by a trained qualified physician in a hospital or clinical setting for ultrasound evaluation of abdominal, small organ (thyroid, testes, breast), and peripheral vascular applications in B-Mode, M-mode, Color Flow Map (CFM), Vector Space Flow (VS Flow), Color Power Angio (CPA), Pulsed Wave (PW) and Panoscope.

Readius L15/ Readius P8/ Readius V6/ Readius C6 Digital Color Doppler Ultrasound Imaging System is a general purpose diagnostic ultrasound system intended to be used by a trained/qualified physician in a hospital or clinical setting for ultrasound evaluation of abdominal, small organs (thyroid, testes, breast), and peripheral vascular applications in B-Mode, M-mode, Color Flow Map (CFM), Vector Space Flow (VS Flow), Color Power Angio (CPA), Pulsed Wave (PW) and Panoscope.

The system is designed for use in linear, convex, phased array scanning modes and supports linear, convex and phased array transducers. The system has cine review, image zoom, measurements and calculations, image storage, review and recording capabilities.

This system is a Track 3 device and the software used in Readius L15/ Readius P8/ Readius V6/ Readius C6 Digital Color Ultrasound Imaging System is Ultrasound Software developed by SIUI and is based on the predicate device. The software documentation level is Basic Documentation Level.

The provided text does not contain information about acceptance criteria or a study proving the device meets specific performance criteria. Instead, it is an FDA 510(k) summary for a "Digital Color Doppler Ultrasound Imaging System" (Readius series), arguing for substantial equivalence to a predicate device (Apogee 2300).

Therefore, I cannot provide the requested information about acceptance criteria, reported performance, sample sizes, ground truth establishment, expert adjudication, or MRMC studies.

The document states:

• "Clinical testing is not necessary for the Readius L15/ Readius P8/ Readius V6/ Readius C6 Digital Color Doppler Ultrasound Imaging System in order to demonstrate substantial equivalence to the predicate device." This explicitly indicates that no clinical study was conducted to establish new performance metrics for this device.
• The non-clinical testing focused on compliance with various international standards (e.g., IEC 60601-1, ISO 14971, IEC 62304) to demonstrate safety and effectiveness as well as the predicate device, rather than proving specific performance against acceptance criteria for an AI algorithm.

Summary of what can be extracted, related but not directly answering the prompt:

• Device Name: Digital Color Doppler Ultrasound Imaging System (Readius L15, Readius P8, Readius V6, Readius C6)
• Intended Use: General purpose diagnostic ultrasound system for ultrasound evaluation of abdominal, small organ (thyroid, testes, breast), and peripheral vascular applications in B-Mode, M-mode, Color Flow Map (CFM), Vector Space Flow (VS Flow), Color Power Angio (CPA), Pulsed Wave (PW) and Panoscope.
• Predicate Device: Apogee 2300 Digital Color Doppler Ultrasound Imaging System (K173000) by SIUI.
• Basis for Clearance: Substantial equivalence to the predicate device, not new performance demonstration against specific acceptance criteria.
• Non-clinical Testing: Compliance with various safety, EMC, software lifecycle, usability, and risk management international standards (listed in the document).
• Clinical Testing: Not conducted as it was deemed "not necessary... to demonstrate substantial equivalence."
• AI/Algorithm Performance: The document mentions "Ultrasound Software developed by SIUI" and designates it as a "Track 3 device" with "Basic Documentation Level," but does not provide details on specific AI algorithms or their performance metrics. The comparison focuses on hardware similarity, imaging principles, and modes, but notes the current device uses WiFi for image transmission to handheld devices, unlike the predicate.

This 510(k) summary is typical for devices seeking clearance based on substantial equivalence to an already legally marketed device, often without new clinical performance studies.

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The device is intended for ultrasonic pulsed echo imaging and measurement for abdominal, pediatric, small organs, musculo-skeletal, cardiac, trans-vaginal, trans-rectal and peripheral vascular applications.

Diagnostic ultrasonic imaging for abdominal, pediatric, small organ, musculo-skeletal, cardiac, peripheral vascular, trans-vaginal and trans-rectal applications in B, M, PWD, CWD, Color Doppler and 3D imaging modes.

The SIUI Apogee 1200 is a Digital Ultrasound Imaging System capable of the following operating modes: 2D (B mode), M, Doppler (PWD/CWD mode), Color (CFM mode) and 3D. The system is designed for use in linear, convex, phased array and 3D scanning modes and supports linear, convex, phased array, 3D and endocavity (trans-vaginal and trans-rectal) transducers. The system has cine review, image zoom, measurements and calculations, image storage and review, printing and recording capabilities.

The provided document is a 510(k) Summary for the SIUI Apogee 1200 Digital Color Doppler Ultrasound Imaging System. This type of document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study against specific acceptance criteria for a new device.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, specifically:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set and data provenance.
• Number and qualifications of experts for ground truth.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study findings.
• Standalone (algorithm only) performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

Instead, the document states:

Acceptance Criteria & Study:
The "study" presented here is a demonstration of substantial equivalence to a legally marketed predicate device, the Ultrasonix Ergononix 500 Ultrasound Scanner (K042326). The core "acceptance criteria" for a 510(k) submission are that the new device is as safe and effective as the predicate device.

The document claims:
"The conclusions drawn from testing of the Apogee 1200 Digital Color Doppler Ultrasound Imaging System demonstrates that the device is as safe and effective as the legally marketed predicate device."

No specific quantitative performance metrics or studies against predefined acceptance criteria for the device's diagnostic capabilities are provided in this summary. Instead, the justification for safety and effectiveness relies on:

• Intended Use: The intended uses for the Apogee 1200 are compared and found to be substantially equivalent to the predicate device.
• Principles of Operation: Both devices operate on similar principles of ultrasound imaging.
• Technological Characteristics: The Apogee 1200's various operating modes (2D, M, Doppler, Color, 3D) and transducer types are presented as comparable to modern ultrasound systems, implying equivalence.
• Safety Considerations: The device was tested per "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" (September 2008 FDA Guidance document) and conforms to applicable medical device safety standards (IEC 60601-1, ISO10993-5, ISO 10993-10). Acoustic output measurements were done per NEMA UD 2. These are standard safety and performance tests for ultrasound devices, but they do not report diagnostic accuracy performance.

In summary, this 510(k) document is a declaration of substantial equivalence based on technical specifications and adherence to general safety standards, rather than a clinical performance study with predefined acceptance criteria for diagnostic accuracy. Such detailed performance data showing how well the device performs clinically (e.g., sensitivity, specificity for a particular pathology) is typically not required or provided in a 510(k) summary if substantial equivalence can be demonstrated through other means.

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Diagnostic ultrasonic imaging for abdominal, pediatric, small organ, musculo-skeletal, cardiac, peripheral vascular applications in B, M, PWD, Color Doppler and 3D imaging modes.

The SIUI Apogee 3800 is a Digital Ultrasound Imaging System capable of the following operating modes: 2D (B mode), M, Doppler (PWD mode), Color (CFM mode) and 3D. The system is designed for use in linear, convex, phased array and 3D scanning modes and supports linear, convex, phased array and 3D transducers. The system has cine review, image zoom, measurements and calculations, image storage and review, printing and recording capabilities.

This document is a 510(k) summary for the SIUI Apogee 3800 Digital Color Doppler Ultrasound Imaging System. It describes the device, its intended use, and its substantial equivalence to a predicate device (Apogee 3500, K102023).

The summary does not contain any information about acceptance criteria or a study proving that the device meets those criteria, nor does it provide details about reported device performance metrics.

The document primarily focuses on:

• Identification of the device and manufacturer.
• Identification of the predicate device.
• Description of the device's operating modes and capabilities.
• Stated intended uses and clinical applications (abdominal, pediatric, small organs, musculo-skeletal, cardiac, and peripheral vascular, in B, M, PWD, Color Doppler, and 3D modes).
• Safety considerations and compliance with relevant medical device safety standards (NEMA UD 2, UD 3, IEC 60601-1, ISO10993-5, ISO 10993-10).
• FDA's substantial equivalence determination letter.
• Detailed Indications for Use forms for the system and each associated transducer (C3L60C, L8L38C, C5L40C, P3F14C), specifying which clinical applications are "new indications" (denoted by "N") for various modes of operation.

Therefore, I cannot populate the requested table or answer most of the specific questions about the study design, sample sizes, ground truth, or MRMC studies, as this information is not present in the provided text.

The closest information provided is the "Safety Considerations" section, which states: "The Apogee 3800 Digital Color Doppler Ultrasound Imaging System has been tested per the FDA Guidance document Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers issued in September 2008. The device conforms to applicable medical device safety standards. It has been designed to meet the following standards: NEMA UD 2, UD 3, IEC 60601-1, ISO10993-5 and ISO 10993-10." This indicates that the device underwent testing for safety and compliance with general performance standards for ultrasound systems, but it does not detail any specific performance acceptance criteria or the results of such testing related to diagnostic accuracy or effectiveness.

In summary, the provided text does not contain the requested information regarding acceptance criteria, device performance metrics, or details of a study assessing such performance.

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Diagnostic ultrasonic imaging for abdominal, pediatric, small organ, musculo-skeletal, cardiac, peripheral vascular applications in B, M, PWD, Color Doppler and 3D imaging modes.

Apogee 1100 Digital Color Doppler Ultrasound Imaging System with Convex Array Transducer C3L60C, Linear Array Transducer L8L38C, Convex Array Transducer C5L40C, Phased Array Transducer P3F14C

The provided document is a 510(k) clearance letter from the FDA for an ultrasound imaging system. It primarily lists the approved indications for use for the system and its various transducers. Crucially, it does not contain information about acceptance criteria or specific studies demonstrating the device meets those criteria.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as these are not present in the provided text.

The document essentially states what the device is cleared for, not how its performance was evaluated against specific metrics.

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