Search Results

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."

Ask a specific question about this device

Intended Use:
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.

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

The Ultrasound System 2300 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 which are offered in different configurations/ models intended for urology, general imaging, surgical and anesthesiology applications.
The system consists of a mobile console (engine) that provides digital acquisition, processing and display capabilities. The user interface includes a conventional keyboard or a glass touchpad, a 19" Clinical Display Monitor (CDM). In addition, a variety of system accessories are available such as baskets, foot switch, printer start-up kit, remote control, and extra holders.

Here's a breakdown of the acceptance criteria and the study details for the Prostate Volume Assist (PVA) feature, as derived from the provided document:

Acceptance Criteria and Device Performance (Prostate Volume Assist - PVA)

Study Details for Prostate Volume Assist (PVA)

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

   • Test Images Total: 975 (Healthy) + 1461 (Diseased) = 2436 images.
   • Data Provenance:
     • Czech Republic (for 9018 transducer data)
     • Amsterdam, Holland (for 9048 transducer data)
   • Retrospective/Prospective: Not explicitly stated, but the description "Data from a clinical end-user test in the Czech Republic" and "data acquired in Amsterdam, Holland" suggests retrospective use of collected data for the test set.

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 as a precise number (e.g., "3 experts"). It states "clinical experts validation testing" and "The human caliper setters scored the images individually."
   • Qualifications of Experts: "The clinical personnel had an average of about 15 years' experience in ultrasound."

3. Adjudication method for the test set:

   • The document implies individual scoring by "human caliper setters" rather than an explicit adjudication method like 2+1 or 3+1. "The human caliper setters scored the images individually." The comparison is then made against these individual manual placements.

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:

   • No MRMC comparative effectiveness study involving human readers improving with AI assistance was directly described. The study focused on validating the algorithm's performance against manual placement, indicating a standalone performance assessment of the AI. The PVA feature is described as "a workflow improvement to an existing prostate volume measurement and calculation tool" and "allows a faster and more efficient workflow," but specific effect sizes for human reader improvement with AI assistance (e.g., reduction in reading time, increase in accuracy) are not provided.

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

   • Yes, a standalone performance assessment of the algorithm was done. The acceptance criteria and reported device performance directly evaluate "the automatic initial caliper placement" and "the prostate volume calculation of PVA" against manual placement, implying the algorithm's performance without human input for the initial placement. The final verification involved visual evaluation by clinical experts comparing the initial algorithmic placement to manual placement.

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

   • Expert Manual Measurement: The ground truth for volume estimation was established by "manually placed calipers" by "clinical personnel" with extensive experience.

7. The sample size for the training set:

   • Training Images Total: 505 (Healthy) + 13447 (Diseased) + 4104 (Synthesized data) = 18056 images.

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

   • The document does not explicitly detail the method for establishing ground truth for the training set. It only mentions the types of images (healthy, diseased, synthesized) used for training. However, given that the validation uses expert manual measurements as ground truth, it is highly probable that the training data also utilized expert annotations or measurements, potentially with additional synthesized data to augment the dataset.

Ask a specific question about this device

Intended Use:
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.

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

Modes of Operation:

• 2D (B-Mode) including Tissue Harmonic Imaging
• M-Mode
• PWD Mode
• CFM Mode (C, VFI)
• Power Doppler
• Contrast Imaging
• CW Doppler
• Strain Elastography

Environment:
The Ultrasound System 2300 is intended for use in the professional healthcare environment (e.g. hospitals, physician offices)

Contraindications:
The Ultrasound System 2300 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 2300 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 which are offered in different configurations/ models intended for urology, general imaging, surgical and anesthesiology applications.

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

The Ultrasound System 2300 is available in the following marketing configurations:

• 1. bk3000 available with a conventional keyboard configuration. The bk3000 is primarily intended for applications such as urology and general imaging
• 2. bk5000 available with a conventional keyboard configuration. The bk5000 is primarily intended for surgery applications.
• 3. bkActiv is a configuration available with a glass user interface (UI). bkActiv is primarily intended for surgical and anesthesiology applications.

All configurations run on the previously cleared SW platform and HW platform (engine) (K180737). The various configurations of the Ultrasound System 2300 are intended to be used for different applications as described above with various transducers and options.

The provided text does not contain detailed information about acceptance criteria or a study that proves the device meets those criteria. The document is an FDA 510(k) summary for an ultrasound system, focusing on its substantial equivalence to a predicate device.

Specifically, the "Performance Data" section (page 19-20) only mentions non-clinical performance (bench testing) related to safety and compliance with voluntary standards (e.g., acoustic output, biocompatibility, cleaning and disinfection, thermal, electrical, electromagnetic, and mechanical safety). It explicitly states:

• "Animal Testing: Not applicable - animal testing was not required to support substantial equivalence to the predicate device."
• "Clinical Studies: Not applicable – clinical studies were not required to support substantial equivalence to the predicate device."

Therefore, I cannot extract the information required to answer your request regarding acceptance criteria and a study proving the device meets those criteria, as no such study is described in this document.

Ask a specific question about this device

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 including Obstetrics), Abdominal. Pediatric. Intra-operative, Intra-operative Neuro (also known as Neurosurgery), Laparoscopic, Small Organ (also known as Small Parts), Adult Cephalic (cephalic is also known as Adult Trans-cranial), Neonatal Cephalic, Trans-rectal, Trans-vaginal, Musculoskeletal (Conventional and Superficial), Cardiac Adult, Trans-esophageal (Cardiac) and Peripheral Vessel (also known as Peripheral Vascular).

Contraindications:

The 2300 Ultrasound System 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 Scanner System bk2300 is a multi-purpose mobile, software controlled diagnostic Ultrasound Scanner System with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms.

The transducers are all multi-frequency transducers including:

• Linear Array
• Phased Linear Array
• Convex / Curved Array

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

• Surface Contact.
• Intra-operative,
• Laparoscopic, 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.

The BK Medical ApS Ultrasound Scanner System bk2300 (K180737) did not include an AI/ML component. The provided document is a 510(k) premarket notification for an ultrasound scanner system without AI/ML functionality. Therefore, information regarding acceptance criteria and studies related to AI/ML performance (such as sample size for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details) is not applicable.

The performance data provided focuses on the safety and effectiveness of the ultrasound system itself, including its compliance with relevant international and FDA recognized standards for medical electrical equipment, acoustic output, usability engineering, laser safety, biocompatibility, sterilization, electrical safety, electromagnetic compatibility, and software verification and validation. These are standard tests for diagnostic ultrasound systems and do not involve AI/ML.

Here's a summary of the provided performance data relevant to a non-AI/ML device:

1. Acceptance Criteria and Reported Device Performance (Non-AI/ML)

2. Sample Size Used for the Test Set and Data Provenance: Not applicable as this is not an AI/ML device study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts: Not applicable as this is not an AI/ML device study.
4. Adjudication Method: Not applicable as this is not an AI/ML device study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done: Not applicable as this is not an AI/ML device study.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is not an AI/ML device study.
7. The type of ground truth used: Not applicable as this is not an AI/ML device study. The provided document does not mention the use of ground truth in the context of AI/ML performance evaluation.
8. The sample size for the training set: Not applicable as this is not an AI/ML device study.
9. How the ground truth for the training set was established: Not applicable as this is not an AI/ML device study.

Ask a specific question about this device

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.

Ask a specific question about this device

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 (also known as Adult Trans cranial), Neonatal Cephalic, Intraoperative (Neuro), Trans rectal, Trans rectal, Transvaginal, Transurethral, Musculoskeletal (Conventional and Superficial), Cardiac Adult, Trans-esophageal Cardiology, and Peripheral Vessel (also known as Peripheral Vascular).

Contraindications:

· The 2300 Ultrasound System is not intended for ophthalmic use or any use causing the acoustic beam to pass through the eve.

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

The Ultrasound Scanner System bk2300 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 transducers are all multi-frequency transducers including:

• Phased Linear Array 0
• o Convex/Curved linear array.

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

• 0 Surface contact.
• . Intra-operative, or
• 0 contact through Endocavity

when used in locations as described by the indications for use.

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.

The provided documents describe a submission for the BK Medical bk2300 ultrasound system, including various transducers and clinical applications. However, the details for acceptance criteria and specific study results proving the device meets these criteria are not explicitly provided in these particular documents.

The documents are a 510(k) premarket notification letter from the FDA and several "Indications for Use" forms for the bk2300 system and its various transducers. These documents state that "design validation testing was performed to ensure that the Ultrasound Scanner System bk2300 with modifications meets design specifications" and that "Performance, verification and validation testing was conducted to characterize performance of the proposed device and the predetermined acceptance criteria was met." However, the actual acceptance criteria values and the reported performance metrics of these tests are not included.

Therefore, I cannot provide the requested information for the following points based on the provided text:

• A table of acceptance criteria and the reported device performance
• Sample sized used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts
• Adjudication method for the test set
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size
• If a standalone performance (i.e., algorithm only without human-in-the-loop performance) was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

The documents primarily focus on:

1. FDA clearance for the device (bk2300) and its various transducers for specific indications.
2. Listing of the clinical applications and exam types for which the ultrasound system is intended.
3. Contraindications for the device.
4. Mention of the device's technological characteristics and its similarity to predicate devices.
5. A list of voluntary standards with which the system complies (e.g., IEC 60601-1, IEC 60601-2-37, IEC 62359).

To address your request fully, the actual test reports, validation studies, and performance data from BK Medical ApS would be needed, which are not present in this set of FDA clearance documents.

Ask a specific question about this device

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Ultrasound scanner and transducers for B, Tissue and Contrast Harmonic Imaging, M, PWD, CWD, Color Doppler, Vector Flow Imaging and combined mode imaging and Elastography.
Signal Analysis.
Guidance of biopsy needles, geometrical measurements and calculation of parameters. And optimal 3-D unit can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen.
An optional Vector Flow Imaging (VFI) module: Color Flow Mapping (CFM) imaging mode with the ability to visualize both the axial and the transverse velocity.
An optional RF wireless function with the ability to wireless transmit for printing and archive connectivity purpose.

Ultrasound scanner and transducers for B, Tissue and Contrast Harmonic Imaging, M, PWD, CWD, Color Doppler, Vector Flow Imaging and combined mode imaging and Elastography.
Signal Analysis.
Guidance of biopsy needles, geometrical measurements and calculation of parameters. And optimal 3-D unit can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen.
An optional Vector Flow Imaging (VFI) module: Color Flow Mapping (CFM) imaging mode with the ability to visualize both the axial and the transverse velocity.
An optional RF wireless function with the ability to wireless transmit for printing and archive connectivity purpose.

This is a 510(k) premarket notification for the BK Medical Ultrasound Scanner System bk2300, which is an ultrasound device. The information provided is typical for a 510(k) submission, focusing on establishing substantial equivalence to a legally marketed predicate device rather than detailing specific clinical study results for novel performance claims.

Based on the provided document, here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are primarily related to safety and performance specifications that demonstrate equivalence to predicate devices, rather than specific diagnostic accuracy metrics for AI. Since this is an ultrasound system, the performance is about its various imaging modes, clinical applications, and safety.

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

The document does not explicitly describe a "test set" in the context of a clinical performance study using patient data for specific diagnostic claims for AI. For an ultrasound system, "testing" primarily refers to technical verification and validation, and acoustic output measurements.

• The section on Acoustic Output Reporting states it's "made according to the standards required by 'Information for Manufacturers Seeking Clearance of Diagnostic Ultrasound Systems and Transducers, FDA, CDRH, September 9, 2008'". These standards define measurement procedures and reporting requirements, but not a patient-based test set size.
• The document also notes that "All transducers in this submission have previous been cleared," simplifying the current submission to changes to the system rather than the transducers themselves.
• Data Provenance: Not applicable in the context of a clinical test set for AI, as this submission focuses on the safety and functional equivalence of an ultrasound system, not AI performance.

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

Not applicable. This FDA 510(k) submission is for a general diagnostic ultrasound system (bk2300) and its various transducers. It does not describe an AI/CADe (Computer-Aided Detection/Diagnosis) system that requires expert-established ground truth on a clinical test set. The "performance" claims are about physical parameters and safety limits, not diagnostic accuracy in interpreting images.

4. Adjudication Method for the Test Set

Not applicable. As there is no clinical test set for diagnostic performance evaluation or AI, no adjudication method would have been used.

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

Not applicable. This submission is for an ultrasound imaging system, not an AI or CADe product. MRMC studies are typically used for evaluating the effectiveness of AI/CADe systems in improving human reader performance.

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

Not applicable. This is not an AI algorithm being submitted for standalone performance evaluation. It is a diagnostic ultrasound system.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance claims (e.g., acoustic output, electrical safety, biocompatibility, measurement capabilities) is established through adherence to recognized national and international standards (e.g., IEC, ISO, AIUM/NEMA standards) and technical specifications. It's not clinical "ground truth" derived from expert consensus, pathology, or outcomes data in the context of diagnostic accuracy for AI.

8. The Sample Size for the Training Set

Not applicable. This submission does not describe an AI system, therefore, there is no training set for an algorithm.

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

Not applicable. As there is no AI algorithm or training set, this information is not relevant to this submission.

Summary of the Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is primarily a non-clinical technical verification and validation study. This involves:

• Acoustic Output Measurements: The system controlling acoustic output (same as predicate Pro Focus 2202) was verified to ensure that the device's acoustic output remains below regulatory limits (Ispta ≤ 720 mW/cm² and MI ≤ 1.9, TI ≤ 6.0). This is done through standard phantom and hydrophone measurements as per AIUM/NEMA UD-2 and UD-3.
• Safety Testing: The device was tested by a recognized Certified Body to confirm compliance with a comprehensive set of safety standards, including IEC 60601-1 (general safety), IEC 60601-1-2 (EMC), IEC 60601-2-37 (ultrasonic equipment specific safety), ISO 14971 (risk management), IEC 62304 (software lifecycle), and IEC 62359 (field characterization). These tests ensure thermal, mechanical, and electrical safety, as well as software integrity.
• Biocompatibility Testing: Patient contact materials were assessed for biocompatibility according to EN ISO 10993-1.
• Clinical Measurements and Calculations: The accuracy of clinical measurements and calculations is stated to be "described and accuracies are provided in the User Information," indicating that these were verified against established performance benchmarks, although specific metrics are not in the 510(k) summary itself.
• Technological Equivalence Comparison: The core of the 510(k) submission relies on demonstrating that the bk2300 system, including its new optional RF wireless function and the addition of Elastography (for some transducers compared to the oldest reference device, though it's present in the direct predicate), has "the same major technological characteristics" and intended use as the previously cleared predicate device (bk2300, K143298) or the reference device (ProFocus 2202, K132346). This comparison inherently "proves" that the device meets acceptance criteria by establishing its substantial equivalence to a device already deemed safe and effective by the FDA.

In essence, the "study" is a collection of engineering and regulatory compliance tests rather than a clinical trial assessing diagnostic performance.

Ask a specific question about this device

Ultrasound scanner and transducers for B, Tissue and Contrast Harmonic Imaging, M, PWD, Color Doppler, Vector Flow Imaging and combined mode imaging and Elastography.

Signal Analysis.

Guidance of biopsy needles, geometrical measurements and calculation of parameters. And optimal 3-D unit can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen.

An optional Vector Flow Imaging (VFI) module: Color Flow Mapping (CFM) imaging mode with the ability to visualize both the axial and the transverse velocity.

Ultrasound Scanner System bk2300 with the addition of an optional system with an alternate power source (battery) solution is intended for the diagnostic ultrasound imaging or fluid flow analysis of the human body and includes the following: ultrasound scanner and transducers for B. Tissue and Contrast Harmonic Imaging, M. PWD, CWD, Color Doppler, Vector Flow Imaging and combined mode imaging and Elastography.

Signal Analysis.

Guidance of biopsy needles, geometrical measurements and calculation of parameters. An optimal 3-D unit can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen.

An optional Vector Flow Imaging (VFI) module: Color Flow Mapping (CFM) imaging mode with the ability to visualize both the axial and the transverse velocity.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies for the BK Medical Ultrasound Scanner System bk2300:

Based on the provided FDA 510(k) summary (K152052), there is no specific table of acceptance criteria and reported device performance defined in terms of diagnostic accuracy metrics (e.g., sensitivity, specificity, accuracy) for a particular clinical application (e.g., detecting a disease) as would be typical for an AI/CADe device.

Instead, this submission is for a general-purpose ultrasound scanner system. The "acceptance criteria" discussed are primarily related to engineering performance, safety, and substantial equivalence to a predicate device as required for a 510(k) clearance, rather than a clinical study evaluating diagnostic performance against specific benchmarks.

Here's a breakdown of the requested information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, the document does not present "acceptance criteria" in the context of diagnostic performance metrics for a specific clinical task. The "performance" described is largely about meeting safety standards and functional capabilities.

Ask a specific question about this device

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Applications:

• Fetal (Sometimes called Obstetrics) .
• Abdominal ●
• Intra-operative ●
• Intra-operative (Neuro) (sometimes called Neuro Surgical) ●
• Pediatrics .
• Small Organ (Sometimes called Small Parts) .
• . Neonatal Cephalic (Cephalic is sometimes called trans-cranial)
• Adult Cephalic (Cephalic is sometimes called trans-cranial) ●
• Trans-rectal
• . Trans-vaqinal
• . Trans-urethral
• Musculo-skeletal (Conventional)
• Musculo-skeletal (Superficial)
• Cardiac Adult
• Peripheral Vessel (Sometimes called Peripheral Vascular) .

Ultrasound scanner and transducers for B, Tissue and Contrast Harmonic Imaging, M, PWD, CWD, Color Doppler, Vector Flow Imaging and combined mode imaging and Elastography.
Signal Analysis.
Guidance of biopsy needles, geometrical measurements and calculation of parameters. And optimal 3-D unit can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen.
An optional Vector Flow Imaging (VFI) module: Color Flow Mapping (CFM) imaging mode with the ability to visualize both the axial and the transverse velocity.

This document is an FDA 510(k) premarket notification for the BK Medical Ultrasound Scanner System bk2300, dated January 16, 2015. It primarily details the device's indications for use, its substantial equivalence to predicate devices, and summaries of non-clinical tests. The document does not contain information about acceptance criteria or a study proving the device meets those criteria, specifically concerning clinical performance metrics. It focuses on safety and technological equivalence.

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

Here is a summary of the available information:

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

• Not provided in the document. The document discusses regulatory compliance, safety standards, and intended uses, but does not specify performance acceptance criteria or report specific performance metrics from clinical studies.

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

• Not provided in the document. The document exclusively mentions "non-clinical tests" and does not refer to clinical studies or test sets.

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. No clinical test set or ground truth establishment by experts is mentioned.

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

• Not applicable. No clinical test set or adjudication method is mentioned.

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. The device is an ultrasound scanner system, not an AI assistance tool for human readers. No MRMC study is mentioned.

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

• Not applicable. This document describes a diagnostic ultrasound system, not a standalone algorithm.

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

• Not applicable. No clinical ground truth is mentioned. The document primarily relies on non-clinical testing for safety and technical characteristics.

8. The sample size for the training set

• Not applicable. No training set is mentioned as this document does not describe an AI/ML device relying on trained models.

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

• Not applicable. No training set or ground truth for it is mentioned.

General Information from the Document (Relevant to Device and Regulatory Approval):

• Device Name: Ultrasound Scanner System bk2300

• Regulation Number: 21 CFR 892.1550

• Regulation Name: Ultrasonic pulsed doppler imaging system

• Regulatory Class: II

• Key Features/Modes: B, Tissue and Contrast Harmonic Imaging, M, PWD, CWD, Color Doppler, Vector Flow Imaging, combined mode imaging, and Elastography.

• New Modes (in this submission): Elastography, Vector Flow Imaging (VFI), Continuous Wave Doppler (CWD/CW).

• Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body.

• Clinical Applications (Indications for Use): Fetal, Abdominal, Intra-operative (Neuro), Pediatrics, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Musculo-skeletal (Conventional & Superficial), Cardiac Adult, Peripheral Vessel.

• Predicate Devices:

  • B-K Medical Ultrasound Scanner Pro Focus 2202 (K043524, K100919)
  • BK Medical Ultrasound Scanner bk2300 (K140428)
  • Siemens Ultrasound Scanner System Acuson S1000 (K130619)

Non-Clinical Test Summaries (Relied upon for Substantial Equivalence):

• Acoustic Output: Evaluated according to AIUM/NEMA UD-2 and UD-3 standards, and FDA guidance "Information for Manufacturers Seeking Clearance of Diagnostic Ultrasound Systems and Transducers, FDA, CDRH, September 9, 2008". Output stays below pre-amendments upper limits (Ispta ≤ 720 mW/cm², MI ≤ 1.9, TI ≤ 6.0).
• Thermal, mechanical, and electrical safety: Tested by a recognized Certified Body and complies with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-37.
• Biocompatibility: Complies with EN ISO 10993-1.
• Software Lifecycle: Complies with IEC 62304.
• Specific Transducers mentioned with new indications:
  • System bk2300 (general): Elastography, Vector Flow Imaging (VFI).
  • Transducer 9018: New indication for Elastography (N24) for Trans-rectal and Trans-vaginal applications.
  • Transducer 9051: New indication for Elastography (N24) and Vector Flow Imaging (N23) for Pediatric, Small Organ, Musculo-skeletal (Conventional), Musculo-skel. (Superficial), and Peripheral vessel applications.
  • Transducer 9062: New indication for Elastography (N24) for Intra-operative, Intra-operative (Neuro), Pediatric, and Neonatal Cephalic applications.
  • Transducer 9077: New indication for Continuous Wave Doppler (CWD) for Abdominal, Adult Cephalic, and Cardiac Adult applications. Also, CWD has been added as a "new mode" for these applications ("N" in the CWD column).

The document's purpose is to demonstrate substantial equivalence to existing legally marketed devices, primarily focusing on safety and technological characteristics rather than providing new clinical performance data against specific acceptance criteria.

Ask a specific question about this device