Search Results

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

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal (includes infertility monitoring of follicle development), Abdominal, Intra-operative (abdominal organs and peripheral vessel, neurological), Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac, Trans-Rectal, Trans-Vaginal, Peripheral-Vascular, Muscular-Skeletal (conventional, superficial). Typical examinations performed using the system are: General abdominal and pelvic studies including organ surveys, assessment, and retro-peritoneal cavity studies. Study of small parts including breasts, shoulders, thyroid, and the abdominal wall. Pediatric scans of organs and bony structures. Peripheral vascular applications including carotid arteries, legs, arms, feet, and penile artery. Monitoring procedures for infertility studies (other than in vitro fertilization). First, second and third trimester pregnancy studies. Prostate, prostate biopsy guidance, and rectal wall studies. Neonatal head studies. Transcranial studies of middle cerebral arteries, internal carotid artery, and vertebral arteries. Cardiac studies in adults and children. Biopsy guidance for tissue or fluid sampling. Conventional podiatry scans. Intraoperative application including soft tissue structures.

The UM 400C/SA 6000C system is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B-mode, M-mode, Color-Flow Doppler, Pulsed (PW) Doppler, Power Doppler, 3D, Tissue Harmonic Imaging or in a combination of these modes. M-mode uses the sweep display method which has its images flow from the left to the right on the monitor The UM 400C/SA 6000C also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The system has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed. Nine different models of transducers are available and any two may be connected at the same time. In addition to the initial operational settings for each transducer preprogrammed in the system, user-customized parameter settings for each transducer may be inserted by the operator and stored for recall as needed via the system control panel. Customization includes transmit focusing, filtering, image enhancement processing, dynamic window curve selection. Controls are also provided to select display format (single and various combinations), to activate zoom features, and to utilize the cine loop function. The UM 400C/SA 6000C system uses digital beamforming technology, and supports a variety of Linear and Convex probes for a wide variety of applications. It is a diagnostic ultrasound scanner, which provides high resolution, high penetration performance, and various measurement functions. Probes are supported in frequencies from 2.0 MHz to 9.0 MHz. The system can be used to measure distances and calculate areas, circumferences and volumes, as well as calculate the date of delivery by using BPD (biparietal diameter), OFD (occipitofrontal diameter), HC (head circumference), AC (abdominal circumference), AD (abdominal diameter), FL (femur length), CRL (crown rump length), APTD (anteroposterior trunk diameter), TTD (transverse trunk diameter), GS (gestational sac), LMP (last menstural period.), Cardiac Analysis and Vascular Analysis. Biopsy guidelines are provided on screen to assist in the collection of tissue samples, using biopsy guide adapters offered as an optional accessory. The UM 400C/SA 6000C supports the Cine function (capable of storing up to 64 sequential images) and real-time zoom function to the region-of-interest. The system provides the ability to perform remote viewing of images, without compression, via a Dicom 3.0 compatible output. Management of patient history is possible by image-filing function. High-resolution images are provided by utilizing a technology called digital dynamic receive focusing.

The provided text does not contain information about acceptance criteria for a device, nor does it describe a study proving the device meets acceptance criteria.

The document is a 510(k) summary for the UM 400C/SA 6000C Ultrasound System, which is a premarket notification to the FDA. It details:

• Submitter's information
• Device name and classification
• Predicate device identification
• Device description: General purpose, mobile, software-controlled diagnostic ultrasound system with various display modes (B-mode, M-mode, Color-Flow Doppler, Pulsed (PW) Doppler, Power Doppler, 3D, Tissue Harmonic Imaging). It also mentions measurement capabilities and analysis packages.
• Intended Use: Lists a wide range of clinical applications (Fetal, Abdominal, Intra-operative, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac, Trans-Rectal, Trans-Vaginal, Peripheral-Vascular, Muscular-Skeletal).
• Technological Characteristics: Describes the device's operational principle (piezoelectric material to transmit and receive sound waves) and acoustic output limits (TIS/TIB/TIC, ISPTA, MI). It states that these limits are the same as predicate Track 3 devices.
• FDA Clearance Letter: Confirms substantial equivalence to legally marketed predicate devices and mentions the C3-7 Curved Linear Array 4.5 MHz/60R/60D/128 elements transducer is included in this determination. It also requests a post-clearance special report with acoustic output measurements based on production line devices.
• Indications for Use Statement: Lists clinical applications and modes of operation, differentiating between previously cleared (P) and new (N) indications for the overall system and specifically for the C3-7 transducer with Tissue Harmonic Imaging (THI).

There is no mention of a clinical study, test set, ground truth establishers, adjudication methods, MRMC studies, or standalone algorithm performance. The "acceptance criteria" discussed are limited to the device's acoustic output limits, which are stated to be "the same as predicate Track 3 devices," implying adherence to established safety standards rather than performance metrics from a comparative study.

Ask a specific question about this device

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal (includes infertility monitoring of follicle development), Abdominal, Intra-Operative (abdominal organs and peripheral vessel, neurological), Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac, Trans-Rectal, Trans-Vaginal, Peripheral-Vascular, Muscular-Skeletal (conventional, superficial). Includes imaging for guidance of biopsy and 3D Imaging.

The SA 6000C/UM 400C System is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B-mode. M-mode, Color-Flow Doppler, Pulsed (PW) Doppler, Power Doppler, 3D or in a combination of these modes. M-mode uses the sweep display method which has its images flow from the left to the right on the monitor The SA 6000C/UM 400C also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The system has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed. Eight different models of transducers are available and any two may be connected at the same time. In addition to the initial operational settings for each transducer preprogrammed in the system, user-customized parameter settings for each transducer may be inserted by the operator and stored for recall as needed via the system control panel. Customization includes transmit focusing, filtering, image enhancement processing, dynamic window curve selection. Controls are also provided to select display format (single and various combinations), to activate zoom features, and to utilize the cine loop function. Patient contact materials are the same as those previously cleared in the predicate device, SA 8800/HDI 1500 and SA 6000C/UM 400C ultrasound systems and transducers (K974267 and K981510). The SA 6000C/UM 400C uses digital beamforming technology, and supports a variety of Linear and Convex probes for a wide variety of applications. It is an ultrasound scanner, which provides high resolution, high penetration performance, and various measurement functions. Probes are supported in frequencies from 2.0 MHz to 9.0 MHz. The system can be used to measure distances and calculate areas, circumferences and volumes, as well as calculate the date of delivery by using BPD (biparietal diameter), OFD (occipito-frontal diameter), HC (head circumference), AC (abdominal circumference), AD (abdominal diameter), FL (femur length), CRL (crown rump length), APTD (anteroposterior trunk diameter), TTD (transverse trunk diameter), GS (gestational sac), LMP (last menstural period.), Cardiac Analysis and Vascular Analysis. Biopsy guidelines are provided on screen to assist in the collection of tissue samples, using biopsy guide adapters offered as an optional accessory. The SA 6000C/UM 400C supports the Cine function (capable of storing up to 64 sequential images) and real-time zoom function to the region-of-interest. The system provides the ability to perform remote viewing of images, without compression, via a Dicom 3.0 compatible output. Management of patient history is possible by image-filing function. High-resolution images are provided by utilizing a technology called digital dynamic receive focusing.

The provided text does not contain information about acceptance criteria for a specific device performance study, nor does it describe a study proving a device meets such criteria. Instead, it is a 510(k) Premarket Notification for the SonoAce 6000C/Ultramark 400C Diagnostic Ultrasound System and its transducers.

This submission focuses on demonstrating substantial equivalence to previously marketed predicate devices (SA 8800/HDI 1500 and SA 6000/UM 400 systems). Substantial equivalence in the context of 510(k) means that the new device is as safe and effective as a legally marketed device and does not raise new questions of safety or effectiveness. This is typically achieved by showing that the device has the same intended use and similar technological characteristics as the predicate device(s), or if there are differences, that those differences do not raise new questions of safety or effectiveness.

The document primarily outlines:

• Device Description: What the SonoAce 6000C/UM 400C does (general purpose, mobile, software-controlled, diagnostic ultrasound system, displaying B-mode, M-mode, Color-Flow Doppler, Pulsed (PW) Doppler, Power Doppler, 3D, and various measurement functions).
• Intended Use: A comprehensive list of clinical applications for which the device is intended (e.g., Fetal, Abdominal, Cardiac, Peripheral-Vascular, Small Organ, etc.).
• Technological Characteristics: Details on how it operates (piezoelectric material in transducer, sound wave transmission/reflection, conversion to electrical signals for display), biocompatibility of patient contact materials, and acoustic output limits (I SPTA 720 mW/cm2, MI 1.9), stating these are the same as predicate Track 3 devices.
• Safety Standards Compliance: A list of electromechanical safety standards the device has been designed to meet (e.g., EN 60601-1, UL 2601-1).
• Transducers: A list of eight different transducer models available with the system, along with their specific indications for use.

No information is provided regarding:

• Acceptance criteria for performance metrics.
• Specific device performance data against acceptance criteria.
• Details of a study proving performance, including sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance.

The FDA's letter mentions that a post-clearance special report containing "acoustic output measurements based on production line devices" will be required, indicating that some performance verification related to acoustic output happens after the initial 510(k) clearance, but the primary submission itself does not include performance study results in the context of acceptance criteria as you've requested.

Therefore, I cannot populate the table or provide the requested study details based on the provided text. The document serves as a substantial equivalence claim, not a performance study report with specific acceptance criteria and results.

Ask a specific question about this device