Search Results

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.

Ask a specific question about this device

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

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 CTS-8800 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.

The provided text is a 510(k) summary for the SIUI CTS-8800 Digital Ultrasound Imaging System. It describes the device, its intended use, and claims substantial equivalence to a predicate device (Ultrasonix Ergosonix 500 Ultrasound Scanner (K042326)).

However, this document does not contain information regarding specific acceptance criteria for device performance, nor does it describe any study (clinical or otherwise) that proves the device meets such criteria. The document focuses on regulatory compliance, safety considerations (acoustic output, electrical safety), and demonstrating substantial equivalence based on intended use, principles of operation, and technological characteristics to a predicate device.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is a breakdown of what can and cannot be answered:

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

• Cannot be answered from the text. The document does not specify any quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy, image quality metrics) or report specific performance values for the device against such criteria. The "Conclusion" states that the device is "as safe and effective as the legally marketed predicate device," implying performance equivalence, but no specific metrics are given.

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

• Cannot be answered from the text. No test set, study, or data provenance is mentioned.

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)

• Cannot be answered from the text. No ground truth establishment or expert involvement for a test set is discussed.

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

• Cannot be answered from the text. No adjudication method is mentioned as no test set study 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

• Cannot be answered from the text. The device is an ultrasound imaging system, not an AI-powered diagnostic aide for human readers. No MRMC study or AI assistance is mentioned.

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

• Cannot be answered from the text. The device is an imaging system, not a standalone algorithm. Performance claims are for the overall system.

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

• Cannot be answered from the text. No ground truth is mentioned.

8. The sample size for the training set

• Cannot be answered from the text. No "training set" is relevant or mentioned for this type of device submission. This is not an AI/ML device requiring training data.

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

• Cannot be answered from the text. Not applicable as there is no training set.

Summary:

The provided 510(k) summary for the SIUI CTS-8800 Digital Ultrasound Imaging System focuses on demonstrating substantial equivalence to a predicate device (Ultrasonix Ergosonix 500 Ultrasound Scanner, K042326) primarily through technical specifications, intended use, and compliance with general safety standards like IEC 60601-1, ISO10993-5, ISO 10993-10, and acoustic output measurements per NEMA UD 2. It does not present any clinical study data or specific performance metrics (like sensitivity, specificity, or accuracy) against predefined acceptance criteria for diagnostic performance. Therefore, almost all specific questions related to acceptance criteria and study data cannot be answered from this document.

Ask a specific question about this device

Ultrasonic pulsed echo imaging and measurement for abdominal, pediatric, small organ, cardiac, peripheral vascular and muscular-skeletal applications.

The SIUI CTS-900 is a digital diagnostic ultrasound system capable of the following operating modes: 2D (B mode) and B/M. The system is designed for use in linear and convex scanning modes and supports linear, and convex transducers. The system has cine review, image zoom, measurements and calculations, image storage and review, printing and recording capabilities. The system consists of probes, main unit, control panel and monitor.

This document, K081110, is a 510(k) Premarket Notification for the SIUI CTS-900 Digital Ultrasound Imaging System. It focuses on establishing substantial equivalence to previously cleared predicate devices (SIUI CTS-7700, K061083 and K070982) rather than conducting a de novo study with specific acceptance criteria and performance data for new clinical claims. Therefore, the information provided does not contain a study that proves the device meets specific performance acceptance criteria in the manner typically found in a clinical validation study for a new diagnostic claim or AI/CADe device.

Here's an analysis based on the provided text, addressing your points where possible, and noting where information is absent:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) for substantial equivalence of an ultrasound system, the "acceptance criteria" are implicitly met by demonstrating that the device has the same technological characteristics and intended uses as the predicate devices. The document does not specify quantitative performance acceptance criteria (e.g., sensitivity, specificity, accuracy) like those for an AI or CADe device. Instead, the performance is assumed to be equivalent to the predicate devices for the listed clinical applications.

The study that "proves" the device meets these criteria is the substantial equivalence comparison to the predicate devices, not a new clinical study with defined performance metrics. The core argument is summarized in the FDA's letter (K081110): "We have reviewed your Section 510(k) premarket notification... and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices."

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

• Sample Size for Test Set: Not applicable. This submission relies on substantial equivalence. There is no mention of a dedicated "test set" of patient data for performance evaluation in the context of a new diagnostic claim. The "data" evaluated would have been the technical specifications and clinical indications of the device itself and the predicate devices.
• Data Provenance: Not applicable. The FDA reviewed technical specifications and claims against predicate devices. If any internal testing or demonstrations were performed, their details are not included in this summary.

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

• Not applicable. There was no "ground truth" to establish for a test set in the context of this 510(k) submission. The FDA's determination is based on the comparison of the device's design, technology, and intended use to that of already cleared devices.

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

• Not applicable. No test set requiring expert adjudication 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. This is not an AI/CADe device, and no MRMC study was conducted or referenced in this 510(k) summary.

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 an algorithm, and no standalone performance study in this context was performed.

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

• Not applicable in the sense of a clinical validation study. The "ground truth" for the FDA's decision is the established safety and effectiveness of the legally marketed predicate devices to which the SIUI CTS-900 is compared.

8. The sample size for the training set

• Not applicable. This device is an imaging system and does not involve AI or machine learning that would require a "training set" of data in the manner you're describing.

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

• Not applicable, for the same reasons as point 8.

Ask a specific question about this device

Ultrasonic pulsed echo imaging and measurement for abdominal, pediatric, small organ, cardiac, peripheral vascular applications. Muscular-Skeletal Conventional and Superficial applications. Small organs include: thyroid, testes, breast. Other uses include: Uterus, Ovary, and Prostate.

The SIUI CTS-7700 is a digital diagnostic ultrasound system capable of the following operating modes: 2D (B mode) and B/M. The system is designed for use in linear and convex scanning modes and supports linear, and convex transducers. The system has cine review, image zoom, measurements and calculations, image storage and review, printing and recording capabilities. The system consists of probes, main unit, control panel and monitor.

The SIUI CTS-7700 Digital Ultrasound System is an ultrasonic pulsed echo imaging system intended for diagnostic use. The relevant submission K070982 specifically adds Muscular-Skeletal Conventional and Superficial applications to the system.

1. Acceptance Criteria and Reported Device Performance:

The provided documents do not detail specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy) for the addition of Muscular-Skeletal Conventional and Superficial applications. Instead, the "acceptance criteria" appear to be based on demonstrating substantial equivalence to a predicate device (SonoAce 6000, K981510) for these expanded indications.

The device's performance is not presented in quantitative metrics but rather by the FDA's determination of substantial equivalence, which implies that its technological characteristics and intended use for the new applications are comparable to those of the predicate device and meet safety and effectiveness standards.

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

The provided documents do not describe any specific test set, clinical study, or patient data used to demonstrate the performance of the device for the new Muscular-Skeletal Conventional and Superficial applications. The submission primarily focuses on technological characteristics and comparison to a predicate device to establish substantial equivalence.

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

Since no specific test set or clinical study is described, there is no information available regarding experts used for establishing ground truth.

4. Adjudication Method for the Test Set:

As no specific test set or clinical study is described, there is no information available regarding any adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No MRMC comparative effectiveness study is mentioned or appears to have been conducted as part of this submission. The submission relies on substantial equivalence to a predicate device rather than a direct comparison of human reader performance with and without AI assistance (which is not applicable here as it's an ultrasound system, not an AI-assisted diagnostic tool).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This device is a digital ultrasound system, not an AI algorithm. Therefore, a "standalone" performance study in the context of an algorithm would not be applicable and is not mentioned. Its performance is inherent to its imaging capabilities, which are assessed for safety and effectiveness in comparison to predicate devices.

7. The Type of Ground Truth Used:

Given the nature of the submission (510(k) for an ultrasound system expansion based on substantial equivalence), the "ground truth" implicitly relies on:

• Engineering and technical specifications: Ensuring the system's output (image quality, measurements, modes) meets industry standards and is comparable to the predicate device.
• Clinical experience and predicate device history: The understanding that similar ultrasound systems with comparable specifications are safe and effective for the stated indications through prior regulatory clearances and medical practice.

There is no mention of specific pathology, expert consensus on case reads, or outcomes data being used to establish a "ground truth" for the clearance of these new indications.

8. The Sample Size for the Training Set:

This device is a hardware/software system, not a machine learning model. Therefore, the concept of a "training set" in the context of AI is not applicable and no training set size is mentioned.

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

As there is no training set for an AI model, this question is not applicable. The "ground truth" for the system's design and engineering would be based on established ultrasound physics, medical imaging principles, and technical performance standards.

Ask a specific question about this device

Ultrasonic pulsed echo imaging and measurement for abdominal, pediatric, small organ, cardiac, peripheral vascular applications

The SIUI CTS-7700 is a digital diagnostic ultrasound system capable of the following operating modes: 2D (B mode) and B/M. The system is designed for use in linear and convex scanning modes and supports linear, and convex transducers. The system has cine review, image zoom, measurements and calculations, image storage and review, printing and recording capabilities. The system consists of probes, main unit, control panel and monitor.

Here's an analysis of the provided text regarding the SIUI CTS-7700 Digital Ultrasound Imaging System, focusing on acceptance criteria and supporting studies.

Important Note: The provided document is a 510(k) summary, which is a premarket notification to the FDA. This type of document primarily focuses on demonstrating substantial equivalence to a previously cleared device, not necessarily providing a detailed study report with specific acceptance criteria and performance metrics as one might find in a clinical trial. Therefore, much of the requested information about formal acceptance criteria, specific studies, sample sizes, and ground truth establishment will not be explicitly present in this type of regulatory submission. The goal of a 510(k) is to show the new device is as safe and effective as a predicate device, often by comparing technical characteristics and intended uses.

Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) summary, the "acceptance criteria" are implicitly tied to demonstrating that the new device (CTS-7700) is "substantially equivalent" to its predicate device (SIUI CTS-485, K012772) and meets the general controls and classifications for an ultrasonic pulsed echo imaging system (21 CFR 892.1560) and diagnostic ultrasonic transducer (21 CFR 892.1570).

The "performance" isn't reported in quantitative metrics against specific thresholds but rather as a list of features and capabilities that are comparable to or an evolution of the predicate device.

Study Information (Based on 510(k) Summary's Limitations)

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 does not provide information on a specific test set, its sample size, or data provenance. 510(k) submissions typically rely on technical comparisons and performance testing to standards rather than clinical study data from a "test set" in the context of AI/diagnostic accuracy.

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)

• No information is provided regarding experts or ground truth establishment for a test set, as no dedicated clinical study with such a methodology is described.

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

• No information is provided on an adjudication method, as no formal "test set" requiring expert adjudication is discussed in this summary.

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, an MRMC comparative effectiveness study was not done or reported. This device is an analog/digital ultrasound imaging system, not an AI-powered diagnostic tool. The concept of human readers improving with AI assistance is not applicable to this type of device.

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

• No. This is a hardware imaging system, not an algorithm. Therefore, "standalone" algorithm performance is not relevant.

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

• For an ultrasound imaging system, the "ground truth" for demonstrating performance would typically involve phantom studies (to assess image quality metrics like resolution, penetration, contrast, etc.), biocompatibility testing, electrical safety testing, and comparison of technical specifications to a predicate device, confirming that the images produced are diagnostically acceptable and comparable. Clinical efficacy (diagnostic accuracy) is often implied by demonstrating similar technical performance to a legally marketed equivalent device, rather than a de novo clinical trial with pathology or outcomes-based ground truth. The document does not explicitly describe these ground truth methods.

8. The sample size for the training set

• This device is an ultrasound imaging system, not a machine learning model. Therefore, the concept of a "training set" in the AI sense is not applicable.

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

• As explained above, the concept of a "training set" (for an AI model) is not applicable to this device.

Ask a specific question about this device

Diagnostic Ultrasound System Indications for Use Form Device Name: CTS-415
Clinical Application: Fetal, Abdominal, Pediatric, Small Organ (specify), Cardiac, Peripheral Vascular
Mode of Operation: B, M, Combined (specify)
Small organs includes: thyroid, parathyroid, parotid, submaxillary gland testes and breast
Pediatric Comments: Pediatric Intended Uses include: Cardiology. Abdomen. Peripheral Vasa

Scanhead Indications for Use Form Device Name: Convex Array C3I40
Clinical Application: Fetal, Abdominal, Pediatric, Cardiac
Mode of Operation: B, M, Combined (specify)
Pediatric Comments: Pediatric Intended Uses include: Cardiology, Abdomen

Scanhead Indications for Use Form Device Name: Linear Array L7I50
Clinical Application: Pediatric, Small Organ (specify), Peripheral Vascular
Mode of Operation: B, M, Combined (specify)
Small organs includes: thyroid, parotid, submaxillary gland. testes and breast Pediatric Intended Uses include: Peripheral Vasa Pediatric Comments:

Model CTS-415 is a linear/convex electronic scanning ultrasonotomograph with a built-in digital scan converter (DSC) and main CPU module. The unit allows heart, abdominal organic and fetal tomographic images to be observable on a video monitor. The main unit is portable and is separable from other equipment to be carried for its use at another place as well as being usable in combination with a 9inch video monitor and a special photographic unit.

The provided 510(k) Premarket Notification for the CTS-415 with C3I40 and L7I50 Transducers focuses on demonstrating substantial equivalence to a predicate device (Hitachi Medical Corporation EUB-310, K862867). This type of submission relies on showing that the new device has similar technological characteristics and performs comparably to a device already cleared by the FDA, rather than proving novel effectiveness through clinical trials with specific acceptance criteria and outcome measurements.

Therefore, the document does not contain the detailed information requested about acceptance criteria, study design, sample sizes, expert ground truth establishment, or specific performance metrics in the way one would find for a de novo submission or a device claiming superiority.

Specifically, the document does not include:

• A table of specific acceptance criteria or reported device performance against such criteria.
• Information on a "test set" sample size, data provenance, number or qualifications of experts, or adjudication methods for ground truth because such a study design is not described.
• A multi-reader multi-case (MRMC) comparative effectiveness study or any effect size for human readers with/without AI assistance, as AI functionality is not mentioned for this device.
• A standalone (algorithm only) performance study.
• The type of ground truth used (e.g., pathology, outcomes data) for a study, as no such study is detailed.
• Sample size for a training set or how ground truth for a training set was established, as machine learning or AI models requiring such sets are not described.

Summary based on the provided document:

The device, "CTS-415 with C3I40 and L7I50 Transducers," is a Diagnostic Ultrasound System. Its acceptance for marketing by the FDA (K013327) is based on demonstrating substantial equivalence to the predicate device, Hitachi Medical Corporation EUB-310 (K862867).

The document lists the device's technological characteristics (e.g., scanning methods, display modes, frequency of probes, image adjustments, measuring functions) and its intended uses for various clinical applications (Fetal, Abdominal, Pediatric, Small Organ, Cardiac, Peripheral Vascular) in B and M modes, with the C3I40 and L7I50 transducers supporting specific subsets of these applications.

The "acceptance criteria" in this context are implicitly met by demonstrating that the device's technological characteristics and stated intended uses are substantially equivalent to a legally marketed predicate device. The FDA's letter explicitly states that the determination of substantial equivalence means the device can be marketed, subject to general controls and requirements for a post-clearance special report on acoustic output measurements. This process does not involve setting quantitative performance metrics like sensitivity, specificity, or accuracy against a pre-defined threshold in a clinical study as typically seen with de novo submissions for novel devices or AI/ML-enabled devices.

Ask a specific question about this device

Ultrasonic pulsed echo imaging and measurement for fetal imaging and other abdominal as well as pediatric, small organ cardiac.
Small organs includes: thyroid, parathyroid, parotid, submaxillary gland, testes and breast.
Pediatric Intended Uses include: Cardiology, Abdomen, Peripheral Vasa.

Model CTS-485 is a linear/convex electronic scanning ultrasonotomograph with a built-in digital scan converter (DSC) and main CPU module. The unit allows heart, abdominal organic and fetal tomographic images to be observable on a video monitor. The main unit is portable and is separable from other equipment to be carried for its use at another place as well as being usable in combination with a 9-inch video monitor and a special photographic unit.

The provided document is a 510(k) Premarket Notification Summary for the SIUI CTS-485 Ultrasound Imaging System. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific acceptance criteria through a study with performance metrics. As such, the document does not contain the acceptance criteria or a study proving the device meets acceptance criteria in the way typically expected for an AI/ML device or a device with new performance claims.

Instead, the document details the device's technical specifications and intended uses, and asserts its substantial equivalence to a predicate device (MEDISON Co. SONOACE 600, K000030). The FDA's letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and find the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976...". This means the device is considered safe and effective because its characteristics are similar enough to a device already on the market, not because it has met specific, novel performance benchmarks.

Therefore, I cannot populate the requested table and sections as the information is not present in the provided text.

Here's why and what information is available:

• Acceptance Criteria and Reported Device Performance: This document does not list specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or corresponding reported device performance values from a clinical study. It focuses on technical specifications (e.g., display modes, grey scale, frequency of probe, depth, gain) and intended uses.
• Study Information (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set): No such study is described or referenced in this 510(k) summary. The submission relies on demonstrating substantial equivalence through comparison of technological characteristics and intended use to a predicate device. The only "test" mentioned is a future "postclearance special report" for acoustic output measurements based on production line devices, which is a safety/engineering test, not a performance study as typically understood for AI/ML or new clinical claims.

Ask a specific question about this device

Ultrasonic pulsed echo imaging, measurement, color Doppler, and color velocity imaging for Fetal, Abdominal, Pediatric, Small Organ, and Peripheral Vascular.

Apoqee 800 PLUS transmits ultrasound waves. receives the echoes, and generates images based on information contained in the echoes. The format in which the information is displayed depends on the imaging mode or modes that you select. The system is capable of real-time two-dimensional (2D) imaging, motion mode (M-mode) imaging, Doppler imaging, Power imaging, and color imaging. The system supports application and exam type presets, which means that the system is automatically optimized for the scanhead and application you have selected. Additionally, analysis protocols are made available so that you can store measurements in the patient's report. Physically the system consists of the monitor module, the control module, the main chassis, and transducers.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the SIUI Apogee 800 PLUS Ultrasound Imaging System, structured according to your request.

Please note: The provided document is a 510(k) Premarket Notification Summary from 1999. These types of documents are primarily concerned with demonstrating "substantial equivalence" to a predicate device, rather than providing detailed clinical study results and statistically derived acceptance criteria as might be expected for novel AI/ML-driven devices today. Therefore, much of the requested information (like specific sample sizes for test and training sets, expert qualifications, and adjudication methods for AI performance studies) is not present in this document. The "acceptance criteria" here are essentially the features and performance specifications of the device being compared directly to a predicate.

Acceptance Criteria and Device Performance for SIUI Apogee 800 PLUS Ultrasound Imaging System

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, "acceptance criteria" are effectively whether the new device's specifications and performance fall within a comparable range to the predicate device, demonstrating substantial equivalence. The document doesn't provide explicit statistical acceptance criteria for performance metrics in the way a clinical trial for a new diagnostic might. Instead, it presents a direct comparison of features and specifications.

Study Details:

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

• Not Applicable. This document pre-dates modern AI/ML device evaluations. The "test set" in this context is the physical device and its performance against technical specifications and clinical uses, primarily through comparison to a predicate device. There is no mention of a separate "test set" of diagnostic images or patient data to evaluate algorithmic performance.
• Data Provenance: The manufacturer is Shantou Institute of Ultrasonic Instruments, China. The device and its specifications are presented by the manufacturer for FDA review.

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

• Not Applicable. No explicit "ground truth" establishment by experts for a test set of data is described. The comparison is based on the declared technical specifications and intended uses, which are implicitly validated by general medical consensus and the established performance of the predicate device.

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

• Not Applicable. No adjudication method for a test set 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:

• No. This document does not describe an MRMC study, nor does the device involve AI assistance for human readers. It is a standalone ultrasound imaging system.

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

• Yes, in concept, but not as an "algorithm." The "standalone performance" is the performance of the ultrasound system itself, as described by its technical specifications and capabilities, independent of a specific human operator’s interpretive skill. This is the core of what the comparison tables are trying to establish – that the system on its own can perform the stated functions. However, it's not an "algorithm-only" performance study in the modern sense of AI/ML evaluation.

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

• Not explicitly stated in terms of a study. The "ground truth" for this submission is an implicit one: the established performance and safety of the predicate devices (ATL Ultramark 9 HDI system, K903603 and Interspec Inc Apogee RX 400, K924231) and the general understanding of what constitutes a safe and effective ultrasound imaging system for the stated intended uses. The clinical applications and modes of operation are standard for these devices and are understood to provide diagnostically useful information.

8. The sample size for the training set:

• Not Applicable. This is not a submission for an AI/ML device that requires a training set of data. The device is hardware-based.

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

• Not Applicable. As above, no training set is relevant for this type of device submission.

Ask a specific question about this device

Ultrasonic pulsed echo imaging and measurement for fetal imaging and other abdominal as well as pediatric, small organ, neonatal cephalic, adult cephalic, and heart.

Model CTS-310B is a linear/convex electronic scanning ultrasonotomograph with a built-in digital scan converter (DSC). The unit allows heart, abdominal organic and fetal tomographic images to be observable on a video monitor. The main unit is portable and is separable from other equipment to be carried for its use at another place as well as being usable in combination with a 9-inch video monitor and a special photographic unit.

Here's an analysis of the provided text regarding the acceptance criteria and study for the SIUI CTS-310B Ultrasound Imaging System, structured according to your request.

Please Note: The provided document is a 510(k) Premarket Notification Summary from 1999. In this type of submission, the primary goal is to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than to prove safety and effectiveness through extensive, de novo clinical trials. Therefore, the information typically available for newer AI/SaMD devices (e.g., detailed study designs, sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance metrics like AUC, sensitivity, specificity, etc.) is generally not present. The "acceptance criteria" here are mainly a demonstration that the new device's technical specifications match or are similar to the predicate device.

Acceptance Criteria and Device Performance Study for SIUI CTS-310B Ultrasound Imaging System

The acceptance criteria for the SIUI CTS-310B Ultrasound Imaging System and its associated transducers (EZU-PL12 and EZU-PC3A) are based on demonstrating substantial equivalence to a predicate device, the Hitachi Medical Corporation EUB-310 (K862867). The "study" proving this equivalence is a direct technical comparison.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the specifications of the predicate device (Hitachi EUB-310A). The SIUI CTS-310B is deemed to meet these criteria by demonstrating identical or comparable performance across various technical characteristics.

2. Sample Size for the Test Set and Data Provenance

• Sample Size: This submission does not describe a clinical test set in the way a modern AI/SaMD submission would. The "test" for substantial equivalence is primarily a technical comparison of specifications and intended use against a legally marketed predicate device. No patient data or image datasets are mentioned as being used for testing.
• Data Provenance: Not applicable, as no clinical test set data is described. The comparison is based on the published technical specifications of the predicate device (Hitachi EUB-310A) and the manufacturer's own specifications for the SIUI CTS-310B, along with a demonstration of compliance with relevant electrical safety standards (IEC 601-1).

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

• Not applicable. No "ground truth" establishment using experts or patient data for a test set is described in this 510(k) submission. Substantial equivalence relies on comparing technical specifications and intended use.

4. Adjudication Method for the Test Set

• Not applicable. No clinical test set requiring adjudication is described.

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

• No. This is a 1999 510(k) for a conventional ultrasound system, not an AI/SaMD. Such studies are not part of the substantial equivalence pathway for this type of device.

6. Standalone (i.e. algorithm only without human-in-the loop performance) Study

• Not applicable. This device is a diagnostic ultrasound system operated by a human, not an algorithm providing standalone interpretations.

7. Type of Ground Truth Used

• Not applicable in the context of an AI/SaMD. For this ultrasound system, the "ground truth" for demonstrating substantial equivalence is the set of established technical specifications and performance characteristics of the predicate device. The SIUI CTS-310B's own technical specifications were compared against these.

8. Sample Size for the Training Set

• Not applicable. This is not an AI/SaMD. No machine learning training set is involved.

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

• Not applicable, as no training set is described.

Summary of the "Study" for Substantial Equivalence:

The "study" conducted for the SIUI CTS-310B Ultrasound Imaging System to meet acceptance criteria was a technical comparison against a predicate device, the Hitachi EUB-310A. The manufacturer presented detailed technical specifications for their device and demonstrated that these specifications were either identical or acceptably comparable to those of the predicate. This comparison supported the claim that the new device has the same fundamental scientific technology, materials, design, safety features, and performance characteristics, and the same intended use as the predicate device, thus establishing "substantial equivalence" as required for 510(k) clearance by the FDA. The "acceptance criteria" were met by showing that the proposed device performed within the operational and technical parameters established by the predicate. Regulatory compliance for electrical safety (IEC 601-1) was also a critical component.

Ask a specific question about this device

Diagnostic ultrasound imaging of the human body as follows: Fetal, Abdominal, Cardiac Adult (B mode, M mode)

Model CTS-285 is a compact-type linear/convex electronic scanning ultrasound system with a built-in digital scan converter (DSC). The unit allows adult heart, abdominal organ and fetal tomographic images to be observable on a video monitor. The main unit is portable and is separable from other equipment to be carried for its use at another place as well as being usable in combination with a full keyboard, 9-inch video monitor and a special photographic unit.

This 510(k) premarket notification describes the CTS-285 Diagnostic Ultrasound System. The primary method for proving substantial equivalence to the predicate device, Hitachi Medical Corporation EUB-310 (K862867), is through a comparison of technological characteristics. There are no direct performance studies with acceptance criteria in the document that would be typical for AI/ML devices. Therefore, I will create a table to compare the reported specifications of the new device (SIUI CTS-285) against its predicate (Hitachi EUB-310A) to infer "acceptance criteria" based on the predicate's established performance, and then note the new device's "performance" based on its characteristics.

1. Table of Acceptance Criteria (Inferred from Predicate) and Reported Device Performance

Ask a specific question about this device