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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal, Cardiac, Fetal, Intraoperative, Pediatrics, Transrectal, Small Parts (organ), Transvaginal, Peripheral vascular, Muskulo-skeletal (conventional and superficial).

Mini Focus 1402 supports the following scanning modes and combinations thereof: B-mode, M-mode, PWD mode, CFM mode. B mode includes tissue harmonic imaging. The system can perform simple geometric measurements, and perform calculations in the areas of Vascular, Urology, Cardiology and OB/GYN applications. The system can guide biopsy- and puncture needles. The system can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen. (Freehand tracking). Transducers are linear and convex arrays and mechanical sector.

The provided text describes a 510(k) summary for the B-K Medical Ultrasound Scanner Mini Focus 1402. The submission focuses on demonstrating substantial equivalence to its predicate device, the B-K Medical Ultrasound Scanner Type 2400 (K024236).

The safety and performance of the new device are primarily assessed through its adherence to established standards for diagnostic ultrasound systems and comparison to the predicate device, rather than through a traditional clinical study with detailed acceptance criteria and performance metrics for a novel AI algorithm. Therefore, the information requested regarding acceptance criteria, performance tables, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as typically found in submissions for AI/ML-driven devices, is not explicitly present in the provided document. This is because the device being described is a diagnostic ultrasound system, not an AI/ML diagnostic tool in the modern context.

However, based on the information provided, we can infer some "acceptance criteria" related to device specifications and safety, and how they relate to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable in the given text. The submission relies on demonstrating substantial equivalence to a predicate device and adherence to general safety and performance standards for ultrasound systems, not a specific clinical study with a "test set" in the context of an AI/ML algorithm. The "test" mentioned relates to safety testing and potentially in-house verification of specifications.

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

• Not Applicable in the given text. There is no mention of "experts" used for establishing ground truth for a clinical "test set." The ground truth for device performance is based on adherence to established physics principles, engineering specifications, and regulatory standards for ultrasound imaging.

4. Adjudication Method for the Test Set

• Not Applicable in the given text. No "adjudication method" is described as there isn't a specific clinical test set requiring expert adjudication for AI algorithm performance.

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 in the given text. This submission is for a diagnostic ultrasound system, not an AI-assisted diagnostic tool. Therefore, no MRMC study or assessment of AI's effect on human reader performance is mentioned or relevant to this type of device clearance.

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

• Not Applicable in the given text. This device is an ultrasound scanner, a hardware and software system for medical imaging, not a standalone AI algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• For Acoustic Output: The ground truth is based on physical measurements against established regulatory limits (Ispta, MI, TI).
• For Intended Use/Modes of Operation: The ground truth is comparison against the predicate device's cleared indications and modes, and regulatory classifications (e.g., "P" for previously cleared FDA indications).
• For Safety: Adherence to recognized national/international thermal, mechanical, and electrical safety standards, verified by a Certified Body.
• For Clinical Measurement Accuracy: This is handled through documentation in the User Guide, implying that the measurements are accurate based on known physical principles and calibration, consistent with the predicate device.

8. The Sample Size for the Training Set

• Not Applicable in the given text. This is not an AI/ML device that requires a "training set."

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

• Not Applicable in the given text. As there is no training set for an AI/ML algorithm, this question is not relevant.

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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal, Cardiac, Fetal (incl Obstetrics), Intraoperative, Neurosurgery, Pediatrics, Transrectal, Small Parts (organs), Transvaginal, Peripheral vascular, Musculo-skeletal.

Pro Focus 2202 supports the following scanning modes and combinations thereof: B-mode, M-mode, PWD mode, CFM mode. An optional ECG signal can be superimposed the ultrasound information in all modes and mode combinations. The system can perform simple geometric measurements, and perform calculations in the areas of Vascular, Urology, Cardiology and OB/GYN applications. The system can guide biopsy- and puncture needles. An optional 3-D unit can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen.

The provided text is a 510(k) Pre-Market Notification for the B-K Medical Ultrasound Scanner Pro Focus 2202. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a new device meets specific acceptance criteria through a clinical study in the way AI/ML devices might.

Here's an analysis based on your request, highlighting what information is available and what is typically not part of a 510(k) for an ultrasound system of this nature:

Summary of Acceptance Criteria and Device Performance for this specific document:

This document focuses on demonstrating substantial equivalence to a predicate device (B-K Medical Ultrasound Scanner Type 2400, K024236), rather than establishing novel performance acceptance criteria and then proving the device meets them through a comparative study with a "test set" and "ground truth" as might be seen for an AI/ML device.

The primary "acceptance criteria" for this 510(k) are:

1. Safety: Ensuring the device's thermal, mechanical, electrical safety, and acoustic output are within established limits.
2. Effectiveness/Intended Use: Demonstrating that the new device performs its intended functions (imaging modes, clinical applications, measurements) equivalently to the predicate device.
3. Technological Characteristics: Showing that any differences in technology do not raise new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable. This 510(k) submission is for a diagnostic ultrasound system, not an AI/ML device that typically relies on test sets of patient data. The "tests" mentioned are for hardware safety, acoustic output, and comparison of functional specifications to a known predicate device. There is no mention of a "test set" of patient data in the context of an AI/ML study.

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

• Not Applicable. There is no mention of experts establishing ground truth for a test set in this kind of 510(k) submission.

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

• Not Applicable. No test set or corresponding adjudication method is discussed.

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 is not a submission for an AI-assisted device. Therefore, no MRMC study or effect size related to AI assistance would be present.

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

• Not Applicable. This is a hardware diagnostic imaging system; there is no standalone algorithm or AI component discussed.

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

• Not Applicable. Ground truth in the context of clinical data evaluation is not a concept explicitly applied in this type of 510(k) for an ultrasound system's core functional and safety performance. The "ground truth" for acoustic output would be adherence to physical standards and measurements. For clinical measurements, it would be the accuracy against physical phantoms or established reference methods.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device, so there is no concept of a "training set."

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

• Not Applicable. As there is no training set, there is no ground truth established for one.

In conclusion: The provided document is a 510(k) Pre-Market Notification for a conventional diagnostic ultrasound system. Its "study" is a demonstration of substantial equivalence to an existing legally marketed device (the predicate). This involves comparing technical specifications, safety parameters (like acoustic output), and intended uses. It does not involve clinical studies with patient data, "test sets," "ground truth," or AI/ML performance metrics as would be expected for an AI-powered medical device. The "acceptance criteria" here are largely regulatory and technical compliance points to demonstrate equivalence, rather than performance goals proven through clinical data analysis.

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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal, Cardiac, Fetal Doppler, Intraoperative, Neurosurgery, Obstetrics, Pediatrics, Transrectal, Small Parts (organ s), Transvaginal, Peripheral vascular, Musculo-skeletal.

2400 supports the following scanning modes and combinations thereof: B-mode, M-mode, PWD mode and CFM mode. An optional ECG signal can be superimposed the ultrasound information in all modes and mode combinations. The system can perform simple geometric measurements, and perform calculations in the areas of Vascular, Urology, Cardiology and OB/GYN applications. The system can guide biopsy- and puncture needles. Transducers are linear and convex arrays and mechanical sector. The patient contact materials comply with ISO10993-1 All transducers used together with 2400 are Track 3 transducers.

The provided 510(k) summary for the B-K Medical A/S Ultrasound Scanner Type 2400 (K024236) does not contain a typical clinical study with acceptance criteria and a detailed report of device performance against those criteria in the way a new diagnostic algorithm or AI system would.

Instead, this submission is for a traditional ultrasound system, and its "acceptance criteria" are related to established safety standards and demonstrating substantial equivalence to a predicate device for its intended uses. The "study" proving it meets these "criteria" primarily involves:

• Engineering and Safety Testing: Compliance with recognized international standards for medical electrical equipment and acoustic output.
• Comparison to a Predicate Device: Demonstrating that the new device's technological characteristics and intended uses are substantially equivalent to a previously cleared device.

Therefore, the requested information elements related to AI/algorithm performance (such as sample sizes for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable or extractable from this document.

Here's an attempt to structure the available information per your request, with significant caveats that much of it either doesn't apply or can't be found in this specific document:

1. Table of Acceptance Criteria and Reported Device Performance

Regarding items specific to AI/algorithmic performance (which are NOT in this submission):

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This is not an AI/algorithm submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. Performance is inherent to the physical device and its integrated software, not a separate algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of an AI/algorithm. Ground truth for a diagnostic ultrasound system refers to its ability to produce diagnostically useful images and accurate measurements, usually validated through engineering measurements, phantom studies, and comparison to established clinical standards and the predicate device's performance.
8. The sample size for the training set: Not applicable. (There might be internal software development and testing data, but it's not described as a "training set" in the AI sense for regulatory submission.)
9. How the ground truth for the training set was established: Not applicable.

Summary of the "study" proving the device meets acceptance criteria:

The "study" in this context is a combination of engineering testing, adherence to recognized standards, and a direct comparison to a legally marketed predicate device.

• Acoustic Output, Electrical, and Biocompatibility Safety: Compliance was demonstrated through testing by a recognized, certified body (IEC 60601-1) and adherence to specific FDA guidance and NEMA standards for acoustic output and ISO standards for biocompatibility. The system's acoustic output control mechanism is stated to be identical to the predicate device, which had already been cleared.
• Clinical Measurement Accuracy: The document states that accuracies are provided in the User Guide, implying that these have been established through internal validation and characterization of the device's measurement capabilities.
• Substantial Equivalence: The core of the regulatory submission is demonstrating that the new Type 2400 Ultrasound Scanner is substantially equivalent to the predicate device (Type 2102). This involves showing that the intended uses and technological characteristics are either identical or that any differences do not raise new questions of safety or effectiveness. The detailed tables listing modes of operation and clinical applications for the system and its various transducers, marked as "previously cleared (P)" or "added under Appendix E (E)" or "new (N)", serve as the evidence for this comparison. The FDA's clearance letter confirms their agreement that the device is substantially equivalent for the stated indications for use. This means its performance is considered comparable to the predicate device, which is already accepted as safe and effective.

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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Intraoperative, Intraoperative Neurological, Pediatrics, Small Organ, Cardiac, Transrectal, Transvaginal, Musculo-skeletal Conventional, Musculo-skeletal Superficial.

1101 supports the following scanning modes and combinations thereof: B-mode M-mode. The system can perform simple geometric measurements, and perform calculations in the areas of Urology, Cardiology and OB/GYN applications. The system can guide biopsy- and puncture needles. Transducers are linear and convex arrays and mechanical sector. The patient contact materials comply with ISO10993-1 All transducers used together with 1101 are Track 3 transducers.

The provided text describes a 510(k) premarket notification for an Ultrasound Scanner Type 1101, comparing it to a predicate device (Siemens Sonoline Elegra) to establish substantial equivalence. The majority of the document focuses on regulatory compliance, safety, and intended uses rather than specific performance studies against acceptance criteria in a clinical setting.

Here's an analysis of the acceptance criteria and study information present, noting where information is explicitly stated as not provided in the text:

1. Table of acceptance criteria and 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):

• The document describes a regulatory submission for substantial equivalence based on technical specifications and safety standards. It does not contain information about a clinical study with a "test set" in the context of device performance in patient cases. The evaluation is primarily against engineering and safety standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not applicable. The document does not describe a study involving expert readers to establish ground truth for a test set of images.

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

• Not applicable. There is no mention of a test set with an adjudication method.

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 a diagnostic ultrasound system without AI assistance. The document does not describe an MRMC study.

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

• Not applicable. This device is a diagnostic ultrasound system, not an AI algorithm.

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

• The "ground truth" for this submission appears to be regulatory compliance with established standards (IEC 60601-1, AIUM 1998, ISO10993-1, etc.) and demonstrating technical characteristics and intended uses similar to a predicate device. There is no mention of clinical ground truth (e.g., pathology) in this submission.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device, so there is no training set in that context.

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

• Not applicable. No training set for an AI/ML model is mentioned.

In summary:

This 510(k) submission focuses on demonstrating the safety and effectiveness of the Ultrasound Scanner Type 1101 by showing its compliance with recognized standards and its technological characteristics and intended uses are substantially equivalent to a previously cleared predicate device. It does not describe a clinical performance study involving a test set, expert readers, or AI integration. The "acceptance criteria" are predominantly technical and regulatory compliance benchmarks.

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Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device