Search Results

The Q LAB Quantification software is a Windows 2000/Windows XP software application package. It is designed to view and quantify image data acquired on Philips Medical Systems ultrasound products.

The O LAB software provides a means of opening and displaying image files. The O LAB software provides a means of creating AVI and BMP files from the image data displayed by the software. The Q LAB software provides a means of quantifying the image data using a plugin module designed to operate with the core engine of the software. The O LAB software provides a means for performing an automatic distance measurement of the intima media thickness of an artery represented in the image file data. The Q LAB software provides a means of creating region of interest figures overlaid on the image data displayed by the software. The Q LAB software provides a means of analyzing the content of the image data contained within the ROI figure. The Q LAB software provides a means of presenting the ROI data in an XY graphic format. The O LAB software provides a means to perform a curve fit operation on a data set generated by the ROI analysis software. The O LAB software provides a means of exporting the data generated by the plugin modules in a form accessible to the end user.

The provided K021966 510(k) summary does not contain the detailed information necessary to fully address all aspects of your request regarding acceptance criteria and study data. This submission is for Q LAB Quantification Software, which is described as a Picture Archiving and Communications Systems (PACS) Workstation with quantification capabilities.

Here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The 510(k) summary does not explicitly state specific quantitative acceptance criteria or corresponding reported device performance metrics for the Q LAB Quantification Software, beyond general statements about safety and effectiveness. The document primarily focuses on establishing substantial equivalence to predicate devices and adherence to software development processes.

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

The 510(k) summary does not mention any specific test set sample size or data provenance (e.g., country of origin, retrospective/prospective). The document describes software verification and validation but doesn't provide details on the data used for these activities.

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

The 510(k) summary does not provide information on the number of experts, their qualifications, or how ground truth was established for any test set.

4. Adjudication Method for the Test Set:

Given the absence of information on a test set and ground truth establishment, the 510(k) summary does not describe any adjudication method.

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

The 510(k) summary does not mention any MRMC comparative effectiveness study. The focus is on the software's functionality and its substantial equivalence to predicate devices for image viewing and quantification. There is no discussion of human reader improvement with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study:

While the device is a software application and performs quantification, the 510(k) summary does not present a formal standalone performance study with specific metrics (e.g., sensitivity, specificity, accuracy) for its algorithms. It describes the software's capabilities (e.g., automatic distance measurement of intima media thickness, ROI analysis) but without quantified performance data.

7. Type of Ground Truth Used:

The 510(k) summary does not specify the type of ground truth used for any evaluations, as detailed performance studies are not described.

8. Sample Size for the Training Set:

The 510(k) summary does not provide any information regarding the sample size used for a training set. This filing appears to be for a software product that, while performing "quantification," is primarily described in terms of its ability to display, analyze, and export data, rather than a novel AI/ML algorithm requiring extensive training data.

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

Given the absence of information on a training set, the 510(k) summary does not describe how ground truth for a training set was established.

Summary of Available Information:

The K021966 510(k) summary describes a software device (Q LAB Quantification Software) that provides image viewing, creation of AVI/BMP files, quantification using plug-in modules, automatic intima media thickness measurement, region of interest (ROI) creation and analysis, graphic presentation of ROI data, curve fitting, and data export.

The submission focuses heavily on:

• Substantial Equivalence: Comparing the Q LAB software's image viewing capabilities to the MedLink Workstation and its ROI quantification capabilities to the Hewlett Packard Acoustic Densitometry Option.
• Software Design Controls: Stating that software development follows documented processes for design, verification, and validation testing, and that a risk assessment was completed.
• Compliance with Standards: Mentioning compliance with Microsoft Developer's Network (MSDN) and ISO Joint Photographic Experts Group (JPEG) standards.

In conclusion, this 510(k) filing provides a high-level overview of the software's functionalities and its adherence to regulatory processes, but it does not contain the specific, quantitative performance data or detailed study descriptions that your request specifies for demonstrating acceptance criteria. This level of detail is often not included in the public 510(k) summaries for devices cleared under substantial equivalence, especially for software applications of this nature from this era. Device performance data, if collected, would typically be part of the full 510(k) submission reviewed by the FDA but often not made public in the summary.

Ask a specific question about this device

Ask a specific question about this device

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

The HDI 5000 system is intended for ophthalmic, fetal, abdominal, intraoperative, pediatric, small organ, adult and neonatal cephalic, cardiac, transesophageal, transrectal, transvaginal, peripheral vessel, laparoscopic, and musculoskeletal (conventional and superficial) intended uses as defined in the FDA guidance document.

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Ophthalmic, Fetal, Abdominal, Intra-operative (Abdominal, vascular), Intra-operative (Neuro.), Laparoscopic, Pediatric, Small Organ (breast, thyroid, testicles), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Trans-esoph. (non-Card.), Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Intra-luminal, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card.), Peripheral vessel.

The HDI 5000 system is a general purpose, mobile, software-controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and display it on a monitor in 2D, M-mode, 2D Color Doppler, M-mode Color Doppler, Continuous Wave Doppler (CW), Pulsed (PW) Doppler, Color Power Angio (CPA), 3D, or in a combination of modes. The HDI 5000 system 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 HDI 5000 has an output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

Advanced Image Processing is a feature upgrade to the HDI 5000 Ultrasound System that adds enhanced DSP image processing hardware and proprietary software algorithms to improve 2D image quality. The sub-systems affected by the software algorithms include the beamformer, signal processing, and image processing modules. The enhanced DSP hardware approximately doubles the image processing power of the HDI 5000 system, allowing processed images to be generated in real time with no loss of frame rate. The benefits of Advanced Image Processing include enhanced contrast resolution, improved tissue texture definition, clutter reduction, and better definition and continuity of tissue interfaces.

The provided document is a 510(k) summary for the HDI® 5000 Ultrasound System with Advanced Image Processing. It focuses on the substantial equivalence to a predicate device and safety standards, rather than detailing specific acceptance criteria and a performance study in the way a clinical study report would.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be fully extracted from the provided text.

Here's an attempt to answer based on the available information, highlighting what is missing:

Acceptance Criteria and Device Performance

The document does not specify quantitative acceptance criteria for image quality improvements due to "Advanced Image Processing." Instead, it describes the benefits of the feature.

Table of Acceptance Criteria and Reported Device Performance (Based on descriptive claims, no quantitative metrics provided):

Acoustic Output Limits (Specific acceptance criteria, but not directly related to image quality performance of the "Advanced Image Processing" feature):

Study Information (Based on available text, much of this is not detailed):

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

   • Sample Size: Not specified. The document describes a feature upgrade and states "The HDI 5000 system is a general purpose, mobile, software-controlled, diagnostic ultrasound system." The "Advanced Image Processing" feature "adds enhanced DSP image processing hardware and proprietary software algorithms to improve 2D image quality." No specific test set to evaluate this improvement is described in terms of cases or images.
   • Data Provenance: Not specified.

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

   • Number of Experts: Not specified. Given the nature of a 510(k) for an ultrasound system feature upgrade focusing on image quality, it's possible qualitative comparisons were made by internal experts, but this is not documented here.
   • Qualifications of Experts: Not specified.

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

   • Adjudication Method: Not specified.

4. 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 MRMC comparative effectiveness study is described in this document. The "Advanced Image Processing" is presented as a general improvement to image quality, not as an AI assistance tool requiring a human-in-the-loop performance evaluation.

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

   • Standalone Performance: The document describes the technical enhancements (enhanced DSP hardware and proprietary software algorithms) that improve 2D image quality. This enhancement is the "standalone" operation of the feature, as it processes the acquired ultrasound data to produce a better image. However, no quantitative standalone performance metrics (e.g., specific image quality scores, SNR improvements, contrast-to-noise ratio measurements, etc.) are provided for the "Advanced Image Processing" feature itself. The safety and effectiveness are established through substantial equivalence to a predicate device and adherence to safety standards.

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

   • Type of Ground Truth: Not specified. For improvements in "contrast resolution, tissue texture definition, clutter reduction, and better definition and continuity of tissue interfaces," ground truth would typically refer to a reference standard against which image quality improvements are objectively measured. This could involve phantom studies with known properties or expert qualitative assessment of images. Neither is detailed here.

7. The sample size for the training set:

   • Sample Size: Not specified. Given that "proprietary software algorithms" are mentioned, implying some level of algorithm development, a training set might have been used if machine learning/AI was involved. However, the document predates widespread terminology like "AI" in medical devices, and the description focuses on DSP and algorithms rather than explicit machine learning. Therefore, a "training set" in the modern sense might not have been applicable or documented as such.

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

   • Ground Truth Establishment: Not specified. See point 7 regarding the nature of the "algorithms."

Summary of what's provided for acceptance criteria and study:

The 510(k) summary focuses on establishing substantial equivalence to a predicate device (General Electric System Five) and adherence to electromechanical and acoustic output safety standards (IEC 601-1, UL 2601-1, C22.2 No. 601.1, CEI/IEC 1157:1992, IEC 601-1-2, AIUM/NEMA 1992). The "Advanced Image Processing" feature is described in terms of its technical components (DSP hardware, software algorithms) and the perceived benefits it offers to image quality, such as "enhanced contrast resolution" and "improved tissue texture definition." However, the document does not present a formal study with quantitative acceptance criteria and detailed performance metrics specifically for the image quality improvements of this feature. The clearance implies that the FDA found the claims of effectiveness and safety to be sufficiently supported for substantial equivalence, without requiring a detailed clinical performance study report as would be expected for a novel device or AI algorithm today.

Ask a specific question about this device

Level 10 HDI is intended for cardiac, peripheral vascular, fetal imaging and other, and ophthalmic intended uses as defined FDA guidance documents.

Typical examinations using Level 10 HDI are:

• General abdominal and pelvic studies including organ surveys, blood flow assessment, and retroperitoneal cavity studies.
• Study of small parts and superficial structures including breasts, shoulders, thyroid/parathyroid, and the abdominal wall.
• Pediatric scans of organs, superficial, 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.
• Monitoring of cardiac function during procedures using transesophageal echocardiography.
• Biopsy guidance for tissue or fluid sampling.
• Assessment of cardiac muscle, coronary arteries and great vessels during cardiac surgery
• Study of myocardial function in adults
• Study of eye anatomy including blood flow in retinal vessels and branches
• Study of the esophagus, stomach, biliary sytem, pancreas and gastrointestinal tract using endoscopic probe
• Study of abdominal and pelvic organs and masses using laparoscopic probe
• Examination of organs, masses and vessels during surgical procedures
• Study of muscles, ligaments, nerve bundles and connective tissue

Level 10 HDI is a general purpose, mobile, software-controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and display it on a monitor in 2D, M-mode, 2D Color Doppler, Mmode Color Doppler, Continuous Wave Doppler (CW), Pulsed (PW) Doppler, Color Power Angio (CPA) or in a combination of modes. Level 10 HDI also gives the opertor 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. Level 10 HDI has an output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

The Level 10 HDI system is designed to accept a large selection of scanheads with up to three array scanheads and one static probe being connected to the system at any one time. The operator may select among the scanheads by means of a control located on the system control panel. All actions affecting the performance of the scanhead are activated from the main system control panel.

The Level 10 HDI system is designed to accept scanheads of the following types and frequency:

frequency range: 2.0 - 10.0 MHz

scanhead types: Linear array Curved linear array Phased array Static probes

Specific operating conditions (frame rate, line density, center frequency, number of active elements etc.) are automatically optimized by the system software in response to user inputs such as field of view, focal depth, image quality, power etc.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Level 10 HDI Ultrasound System:

Summary of Acceptance Criteria and Device Performance:

The provided document does not explicitly state specific acceptance criteria (e.g., in terms of sensitivity, specificity, accuracy, or other quantitative performance metrics for disease detection or measurement). Instead, it focuses on the device's adherence to intended uses, technological characteristics matching predicate devices, and compliance with electromechanical safety and acoustic output standards.

The "device performance" reported is primarily in terms of its capabilities and specifications, rather than quantitative clinical outcomes against predefined targets.

Table of Acceptance Criteria and Reported Device Performance:

Detailed Information Regarding Study and Ground Truth:

The provided 510(k) summary does not appear to describe a formal clinical study with a test set, ground truth established by experts, or quantitative performance metrics in the way typically expected for AI/ML device submissions. This is largely because the document is from 1996, a time before AI/ML diagnostic devices were common and regulatory requirements for their validation were established. This submission focuses on substantial equivalence to predicate devices.

Therefore, for aspects related to clinical performance studies (items 2-7), the answer is that the information is not provided or not applicable based on the content.

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

   • Not provided. The document focuses on technological equivalence and safety standards, not a specific clinical performance study with a test set.

2. 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 provided. No explicit ground truth establishment for a test set is described.

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

   • Not provided. No adjudication method is mentioned as a clinical performance test set is not described.

4. 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 done/Not applicable. This document predates the widespread use of AI in medical imaging, and no such study is described. The device itself is a diagnostic ultrasound system, not typically an AI-assisted diagnostic tool in the modern sense.

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

   • Not applicable. As the device is an ultrasound system intended to be operated by a human, the concept of "standalone algorithm only" performance as distinct from a human-in-the-loop system doesn't apply in the context of this submission. The device's function is to acquire and display data for human interpretation.

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

   • Not provided/Not applicable. As no specific clinical performance study based on a test set is described, no ground truth type for such a study is mentioned. The implicit "ground truth" for this submission's regulatory approval is the established performance and safety profiles of the predicate devices and general knowledge of ultrasound technology.

7. The sample size for the training set:

   • Not applicable. This document describes a diagnostic ultrasound system whose underlying principles are well-established physics and signal processing. It is not an AI/ML device that requires a "training set" in the contemporary sense. Any software optimization is likely based on engineering principles and general data, not a specific, labeled "training set" for an AI model.

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

   • Not applicable. See point above regarding the nature of the device and the submission.

Ask a specific question about this device