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The device is indicated for use as an adjunct to mammography for B-mode ultrasonic imaging of a patient's breast when used with an automatic scanning linear array transducer.

The ABUS system, with automated ultrasound im-aging of the breast, gives the radiologist a cost effective solution for reviewing the ultrasound images with the corresponding mammogram. The FFBU Diagnostic Ultrasound System modification represents limited hardware and software changes to the Sponsor's predicate device.

The provided document is a 510(k) summary for the U-Systems ABUS Diagnostic Ultrasound System, dated September 14, 2005. This submission focuses on modifications to an already cleared predicate device (FFBU Diagnostic Ultrasound System, K032640), as well as comparing it to other legally marketed devices.

Crucially, this document only describes the device and its intended use, and affirms that its performance has been verified according to the U-Systems' Design Control process (compliant with 21 CFR Part 820.30). It does not contain specific acceptance criteria, performance data, or details of a clinical study proving the device meets acceptance criteria.

The sections on "Performance Data" ([0], E) and "Indications for Use" ([5], [6], [7], [8], [9]) indicate that the device's technical performance and clinical applications are deemed substantially equivalent or consistent with existing cleared devices for certain modes (e.g., B-mode, Harmonic Imaging, Spatial Compounding) and for specific transducers (L9-5XW, L10-5XW, L12-6XW). The "Notes" on the Indications for Use forms also point to new capabilities (Harmonic Imaging, Spatial Compounding) being added for the small organ (breast, thyroid, testes) application.

Therefore, I cannot provide the requested table or detailed study information because the provided text does not contain this information. The submission aims to demonstrate substantial equivalence based on technical specifications and intended use consistent with predicate devices, rather than a new standalone clinical efficacy study with specific acceptance criteria and performance metrics.

In summary, the provided text does not contain:

• A table of acceptance criteria and reported device performance.
• Sample sizes for a test set, data provenance, or details of a study with ground truth establishment.
• Information on the number of experts or their qualifications for ground truth.
• Adjudication methods.
• Results of a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
• Results of a standalone performance study.
• Details on the type of ground truth used for performance evaluation.
• Sample size for the training set or how ground truth was established for it.

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The device is indicated for use as an adjunct to mammography for B-mode ultrasonic imaging of a patient's breast when used with an automatic scanning linear array transducer.

U-Systems FFBU Diagnostic Ultrasound System is intended for diagnostic breast examinations.

U-Systems L. 9-5 X W MI-12 Transducer is intended for diagnostic breast examinations.

The FFBU Diagnostic Ultrasound system represents hardware and software changes to the predicate device and changes it to a Track 3 system.

The provided text for K032640 does not contain sufficiently detailed information regarding quantitative acceptance criteria and a study that proves the device meets those criteria. The submission states: "The FFBU System performance has been verified according to the FFBU System Test Plan. The FFBU Test Plan and the summary of test results to date are included in this submission." However, the actual test plan, acceptance criteria, and specific results are not included in the provided snippets. The document focuses on regulatory approval based on substantial equivalence.

Therefore, I cannot populate the table or answer most of the questions as the specific performance data, study design, and ground truth establishment methods are not present in the provided text.

Based on the limited information, here's what can be inferred:

1. Table of acceptance criteria and the reported device performance

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

• Sample size for test set: Not specified.
• Data provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

• Not specified.

4. Adjudication method

• Not specified (e.g., 2+1, 3+1, none).

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• Not specified. The document focuses on substantial equivalence to a predicate device, USI-2000 Horizon, rather than a comparative effectiveness study involving human readers.

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

• Not applicable/Not specified. This device is an ultrasound system and transducer, not an AI algorithm.

7. The type of ground truth used

• Not specified.

8. The sample size for the training set

• Not applicable/Not specified. This is a hardware/software modification of an ultrasound system, not an AI model that undergoes a training phase for image analysis.

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

• Not applicable/Not specified. As it's not an AI model, there isn't a training set with established ground truth in the context of machine learning.

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The USI-2000 Diagnostic Ultrasound System is being modified to include an accessory for use with the existing diagnostic ultrasound system. The device is indicated for use as an adjunct to mammography for B-mode ultrasonic imaging of a patient's breast when used with an automatic scanning linear array transducer. Automatic scanning obtains multiple, sequential two-dimensional images which can be compiled into a three-dimensional data set for viewing in three planes.

The modified USI-2000 includes an accessory for use with the existing diagnostic ultrasound system. The accessory is intended to provide automated data acquisition of ultrasound breast imaging is based on B-mode ultrasound technique using electronic focusing. High-gain electronics recovers the reflected ultrasound signal which is displayed on a computer screen. The accessory includes a mechanical apparatus for breast image acquisition, a video monitor to display the images, and related software. The patient stands next to system and mammography-like plates compress the breast. Tissue is electronically and mechanically scanned using linear array transducer through thin layer of water and sono-lucent film.

The provided documentation for K022517 (U-Systems Ultrasound System USI-2000 with automated scanning accessory) includes a 510(k) summary and FDA clearance letter. However, it does not contain detailed information regarding acceptance criteria and a study proving the device meets those criteria, as typically expected for robust clinical performance validation.

The available information indicates a "substantial equivalence" pathway for clearance, meaning the device's technical characteristics and intended use are comparable to legally marketed predicate devices. This pathway often relies on demonstrating that the new device performs similarly to existing ones without necessarily requiring extensive new clinical performance studies with predefined acceptance criteria.

Based on the provided text, here's what can be extracted and what is explicitly missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria:

• Not explicitly stated: The document does not define specific performance metrics or thresholds (e.g., sensitivity, specificity, accuracy) that the device must meet to be considered effective.

Reported Device Performance:

• The document states: "The USI-2000 accessory's performance has been validated according to the company's quality assurance procedures." This is a very general statement and does not provide specific performance results.
• The FDA clearance letter confirms that the device is "substantially equivalent" to predicate devices, implying its performance is considered acceptable based on this comparison.

2. Sample Size for the Test Set and Data Provenance

• Sample Size (Test Set): Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method

• Adjudication Method: Not specified.

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

• MRMC Study: It is not mentioned that an MRMC comparative effectiveness study was done.
• Effect size of human reader improvement: Not applicable, as no MRMC study is mentioned.

6. Standalone (Algorithm Only) Performance Study

• Standalone Study: It is not mentioned that a standalone (algorithm only) performance study was done. The device is described as an "accessory" to an existing ultrasound system, and the clearance largely hinges on its equivalence to existing technologies.

7. Type of Ground Truth Used for the Test Set

• Type of Ground Truth: Not specified.

8. Sample Size for the Training Set

• Sample Size (Training Set): Not specified. (It's unclear if a traditional "training set" in the context of machine learning was even used, given the age of the document and the nature of the device as an ultrasound system accessory relying on known B-mode technology.)

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

• Ground Truth Establishment (Training Set): Not specified.

Summary of Missing Information:

The provided 510(k) summary and FDA letter for K022517 primarily focus on demonstrating substantial equivalence to predicate devices based on intended use and technological characteristics. It lacks detailed clinical performance data, specific acceptance criteria, information about test or training sets, expert involvement, or adjudication methods that would be common in submissions for novel diagnostic algorithms or devices requiring extensive de novo clinical validation. The statement "The USI-2000 accessory's performance has been validated according to the company's quality assurance procedures" is the closest the document comes to describing performance validation, but it provides no specifics.

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The modified USI-2000 includes an accessory for use with the existing diagnostic ultrasound system. The accessory displays graphics depicting the position and future path of a rigid interventional instrument, such as a biopsy needle or an aspiration needle, on a computer monitor screen that also shows the ultrasound image of the target organs.

The accessory is intended to be used in clinical interventions and for anatomical structures where ultrasound is currently used for visualizing such procedures.

The USI Needle Guide accessory is intended for small parts use for breast biopsy.

The modified USI-2000 includes an accessory for use with the existing diagnostic ultrasound system. The accessory displays graphics depicting the position and future path of a rigid interventional instrument, such as a biopsy needle, or an aspiration needle, on a computer monitor screen that also shows the ultrasound image of the target organs.

The provided FDA 510(k) summary for the U-Systems Ultrasound System USI-2000 with Needle Guide does not contain details about acceptance criteria, a specific study proving device performance against those criteria, or information commonly found in AI/ML device studies.

The document states:

• "The USI-2000 Needle Guide performance has been validated according to the company's quality assurance procedures." This is a very generic statement and does not provide specific performance data, methodology, or results.

Therefore, I cannot extract the detailed information requested in your prompt based on the provided text. The document primarily focuses on demonstrating substantial equivalence to a predicate device and indicating new uses for the existing ultrasound system with the addition of a needle guide accessory.

The concepts of "acceptance criteria," "test set sample size," "ground truth experts," "adjudication methods," "MRMC studies," and "standalone performance" are typical for regulatory submissions of AI/ML-driven medical devices. This document predates the widespread regulatory consideration of such devices (JUN 0 5 2002).

To explicitly address your request, here's what the document shows (or, more accurately, doesn't show regarding performance studies):

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

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

• Sample size: Not specified.
• Data provenance: Not specified.

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 specified. The concept of "ground truth" as it relates to expert consensus for a test set is not discussed in this submission regarding device performance.

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

• Not specified.

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 MRMC study was mentioned. The device is an ultrasound system with a needle guide accessory, not an AI-driven interpretation tool.

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

• This is not an AI/ML algorithm; it's a physical accessory that displays graphics on an ultrasound screen. Thus, the concept of "standalone performance" for an algorithm isn't applicable or discussed.

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

• Not specified in the context of a performance study for the needle guide.

8. The sample size for the training set

• Not applicable/not specified. This submission is for a physical ultrasound accessory, not a machine learning model requiring a training set.

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

• Not applicable/not specified.

Summary of what is available:

• Device: U-Systems Ultrasound System USI-2000 with Needle Guide accessory.
• Purpose of Accessory: Displays graphics depicting the position and future path of a rigid interventional instrument (e.g., biopsy needle, aspiration needle) on a computer monitor screen alongside the ultrasound image.
• Intended Use: Clinical interventions and anatomical structures where ultrasound is currently used for visualizing such procedures, specifically for small parts use (breast biopsy).
• Predicate Device: UltraGuide 1000 System.
• Performance Claim: "The USI-2000 Needle Guide performance has been validated according to the company's quality assurance procedures," but no specific data or metrics are provided in the public summary. The FDA granted clearance based on substantial equivalence and a required post-clearance special report on acoustic output measurements.

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The modified U-2000 is indicated for acquisition of related sets of 2D ultrasound images and 3 dimensional reconstruction of diagnostic ultrasound images. It is intended to acquire, analyze, store, and retrieve digital ultrasound images for computerized 3 dimensional image processing.

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal, Small Organ (breast, thyroid, testes), Peripheral Vascular, Musculo-skeletal Conventional.

The modified U-2000 software provides the capability for the acquisition, analysis, storage and retrieval of digital 3D ultrasound image data sets and multiplaner reformatting capabilities.

The U-Systems Inc. 510(k) Notification for the U-2000 Ultrasound System with modified software (K013848) does not contain detailed acceptance criteria or a specific study proving the device meets quantitative performance metrics. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device, the Echotech 3D Freescan, and adherence to internal software quality assurance procedures.

Therefore, many of the requested fields cannot be directly extracted from the provided text.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

No specific, measurable acceptance criteria (e.g., minimum accuracy, sensitivity, or specificity values) or numerical performance metrics for the modified software are provided in the document. The document primarily attests to functional capabilities and intended use.

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

No information is provided regarding a specific "test set" for performance evaluation, its sample size, or data provenance (e.g., country of origin, retrospective or prospective). The validation mentioned is related to software quality assurance procedures.

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

No information is provided regarding experts, ground truth establishment, or their qualifications, as no specific performance study with a test set is detailed.

4. Adjudication method for the test set

Not applicable, as no specific test set or adjudication process is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a diagnostic ultrasound system with modified software for 3D reconstruction and analysis, not an AI-assisted diagnostic tool as understood in the context of MRMC studies for AI.

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

This is a diagnostic ultrasound system. While it has software for image acquisition, analysis, storage, and retrieval, the primary performance would inherently involve a human operator and interpretation. No "standalone algorithm" performance is described in the context of diagnostic accuracy. The "standalone" performance here refers to the software's ability to perform its specified functions (acquisition, reconstruction, analysis, storage, retrieval) which are implicitly covered by the software validation.

7. The type of ground truth used

No specific ground truth (expert consensus, pathology, outcomes data) is mentioned as a benchmark for evaluating the modified software's performance, as the submission focuses on functional equivalence and software validation rather than a diagnostic accuracy study.

8. The sample size for the training set

Not applicable. The document describes a software modification to an existing ultrasound system, not a machine learning or AI model that would require a "training set" in the conventional sense.

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

Not applicable, as no training set is discussed.

Summary of the Study Discussed in the Document:

The provided documents indicate that the "study" for the modified U-2000 software primarily consisted of software validation according to the company's software quality assurance procedures, as certified in the original 510(k) Notification. This validation ensures that the software correctly performs its intended functions (acquisition, analysis, storage, and retrieval of digital 3D ultrasound image data sets and multiplaner reformatting capabilities).

The basis for regulatory clearance (510(k)) is substantial equivalence to an existing legally marketed predicate device (Echotech 3D Freescan) regarding features, specifications, and intended use, rather than a de novo performance study against explicit effectiveness criteria. The FDA's letter confirms this substantial equivalence determination based on the provided information. The new indications listed for the USI-2000 system and its transducers (7.5 MHz and 10 MHz) relate to expanded clinical applications for various modes of operation (B, M, PWD, Color Doppler, Amplitude Doppler, and combined modes) in areas like Abdominal, Small Organ, Peripheral Vascular, and Musculoskeletal imaging.

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