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The system is a diagnostic ultrasound imaging system used by qualified and trained healthcare professionals for ultrasound imaging, human body fluid flow analysis and puncture and biopsy guidance.

The clinical applications and exam types include: Fetal (including Obstetrics), Abdominal, Pediatric, Small Organ (also known as Small Parts), Adult Cephalic is also known as Adult trans-cranial), Neonatal Cephalic, Intra-operative, Intra-operative Neuro (also known as Neurosurgery). Trans-raginal. Musculo-skeletal (Conventional and Superficial), Cardiac Adult, and Peripheral Vessel (also known as Peripheral Vascular).

Modes of Operation:

• · 2D (B-Mode) (including Tissue Harmonic imaging)
• · M-Mode
• · Vector Flow Imaging (VFI)
• Strain Elastography
• · CW Doppler
• · Contrast Imaging
• · PWD Mode
• · CFM Mode (Includes Color Doppler and Amplitude (Power) Doppler)

The Ultrasound System 1300 is a multi-purpose mobile, software-controlled diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms.

The system consists of a mobile console (engine) that provides digital acquisition, processing and display capabilities. The user interface includes a glass touchpad, a 19" Clinical display monitor (CDM). In addition to this a variety of system accessories are available such as baskets, foot switch, printer start-up kit, and extra holders.

Here's a breakdown of the acceptance criteria and study details for the Prostate Volume Assist (PVA) AI feature, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set (Clinical Validation):
  • Healthy Images: 975
  • Diseased Images: 1461 (includes images from the Holland dataset specifically used for testing)
  • Total Test Images: 2436
• Data Provenance: Czech Republic, Holland.
• Retrospective/Prospective: The text does not explicitly state retrospective or prospective, but as it's referred to as "data acquired in Amsterdam, Holland" and "data from curved and linear arrays," it implies retrospective use of existing data for a test set. The use of a "Holland dataset that are only used as Test images" further supports a retrospective approach.

3. Number of Experts and Qualifications for Ground Truth Establishment

• Number of Experts: Not explicitly stated as a single number, but referred to as "clinical personnel" who had "an average of about 15 years' experience in ultrasound." This suggests multiple experts.
• Qualifications: Clinical personnel with "an average of about 15 years' experience in ultrasound." (Specific roles like radiologist or sonographer are not mentioned, but the context implies experienced ultrasound practitioners).

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly stated as a formal adjudication process like 2+1 or 3+1. However, the "human caliper setters scored the images individually," and the comparison was made between the "automatic initial placement" and "manual placement by clinical personnel." This indicates a direct comparison to individual expert measurements, rather than a consensus-driven ground truth process for each image.

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

• Was an MRMC study done? A formal MRMC study, as typically understood for comparative effectiveness of AI vs. human readers, was not explicitly detailed. The study focused on comparing the AI's initial caliper placement and volume calculation against manual placement by clinical personnel, framed as a "workflow improvement."
• Effect Size of Human Reader Improvement: Not applicable, as the study design was not an MRMC to measure human reader improvement with AI assistance. The AI's performance (initial caliper placement deviation) was measured against human manual placement.

6. Standalone (Algorithm Only) Performance Study

• Was a standalone study done? Yes, the "segmentation part of the algorithm is tested using a standard metric of similarity," which represents a standalone performance test. The numerical result for this specific metric is not provided beyond "The test passed."
• The comparison of "automatic initial placement" to "manual placement by clinical personnel" also evaluates the standalone performance of the AI's caliper placement, even though it's compared against human input.

7. Type of Ground Truth Used

• Ground Truth Type: Expert consensus for the training data (implied, see point 9) and individual expert manual measurements for the test data ("The validator used 2 distance measurements (using 4 calipers) on the transverse image and one distance measurement (using 2 calipers) on the sagittal image."). The purpose was to compare the prostate volume calculation of PVA with volume measurement performed by clinical personnel. So the ground truth for volume measurement is based on clinical personnel's manual calculations.

8. Sample Size for the Training Set

• Healthy Images: 505
• Diseased Images: 13447
• Synthesized Data: 4104
• Total Training Images: 18056

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

• The document implies that the ground truth for the training set was established through expert annotation/labeling, as it refers to the test volumes being "completely distinct from the ones used during training process" and mentions that the algorithm uses both "segmentation and caliper placement." The process of generating synthesized data also suggests a controlled method for creating labeled examples, but the specifics of human involvement in training data ground truth are not detailed beyond inferring that it must have been expert-derived to train an algorithm providing "initial caliper placement."

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The system is a diagnostic ultrasound imaging system used by qualified and trained healthcare professionals for ultrasound imaging, human body fluid flow analysis and puncture and biopsy guidance.

The clinical applications and exam types include: Fetal (including Obstetrics), Abdominal, Pediatric, Small Organ (also known as Small Parts), Adult Cephalic (cephalic is also known as Adult trans-cranial), Neonatal Cephalic, Intra-operative, Intra-operative Neuro (also known as Neurosurgery), Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional and Superficial), Cardiac Adult, and Peripheral Vessel (also known as Peripheral Vascular).

Contraindications:

The Ultrasound System 1300 is not intended for ophthalmic use or any use causing the acoustic beam to pass through the eye.

The Cardiac Adult application is not intended for direct use on the heart.

The Ultrasound System 1300 is a multi-purpose mobile, software controlled diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms.

The initial release of the 1300 system will include the BK1500 marketing configuration model.

The transducers are all multi-frequency transducers including:

• Phased Linear Array
• Convex / Curved Array .
• Linear Array. ●

The interaction with the patients is dependent upon the transducer type which may be:

• Surface Contact, ●
• Intra-operative, or ●
• Endocavity .

The function of the ultrasound scanner system and its transducers is to acquire primary or secondary harmonic ultrasound echo data and display it in the scanning modes.

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance for BK Medical Ultrasound System 1300 (K173569)

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes the BK Medical Ultrasound System 1300 as being substantially equivalent to its predicate device, the BK2300 Ultrasound Scanner System (K161960). Substantial equivalence means the device is as safe and effective as a legally marketed device. The acceptance criteria are therefore tied to meeting relevant standards and demonstrating comparable performance to the predicate device.

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

The document does not specify a "test set" in terms of patient data or images for evaluating the clinical performance of the device itself. The primary method for demonstrating substantial equivalence relies on bench testing against recognized standards for diagnostic ultrasound systems and transducers.

The data provenance for the non-clinical performance data is therefore from bench testing conducted by BK Medical ApS. The country of origin of this data would be Denmark, where BK Medical ApS is located. The nature of the data is retrospective in the sense that it refers to established standard tests.

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

The concept of "experts" establishing ground truth in the context of this submission is not applicable in the typical sense of evaluating AI models. Since clinical studies or evaluations using a test set of patient data were not deemed necessary for this 510(k) submission, there are no details provided about experts establishing ground truth for such a test set.

4. Adjudication Method

As there was no "test set" of clinical cases requiring expert interpretation and adjudication for this 510(k) submission, no adjudication method is mentioned or relevant.

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

No. The document explicitly states: "Clinical Studies: Not applicable - clinical studies were not required to support substantial equivalence to the predicate device." Therefore, an MRMC comparative effectiveness study was not performed, and no effect size for human readers improving with or without AI assistance is provided.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop) Performance Was Done

No. The device is an ultrasound system with various imaging modes and functions; it is not described as an AI algorithm in the context of this submission. Its performance is evaluated as a diagnostic tool used by "qualified and trained healthcare professionals."

7. The Type of Ground Truth Used

For the purpose of this 510(k) submission, the "ground truth" for the device's performance is established by its conformance to recognized industry standards (IEC, NEMA, AAMI/ANSI/ISO) for diagnostic ultrasound systems and transducers. This includes:

• Engineering specifications and technical performance metrics related to image quality, acoustic output, electrical safety, EMC, and software functionality.
• Established safety and effectiveness profiles of the predicate device (BK2300 Ultrasound Scanner System – K161960).

There is no mention of pathology, expert consensus on clinical cases, or outcomes data being used as ground truth for this submission, as clinical studies were not required.

8. The Sample Size for the Training Set

This question is not applicable. The device is a diagnostic ultrasound system, not an AI/ML algorithm that requires a training set of data in the sense typically understood for machine learning models.

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

This question is not applicable, as there is no mention of a training set or AI/ML components for which ground truth would need to be established in this 510(k) summary. The submission focuses on demonstrating substantial equivalence to a predicate ultrasound device through engineering and performance testing.

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