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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal, Cardiac, Fetal (incl Obstetrics), Intraoperative, Transurethral, Neurosurgery, Pediatrics, Transrectal, Small Parts (organ

Flex Focus 1202 supports the following scanning modes and combinations thereof: B-mode (incl.Tissue Harmonic Imaging), M-mode, PWD mode, CFM mode, Amplitude (Power) Doppler mode. 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 module 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.

Here's a breakdown of the acceptance criteria and study information for the B-K Medical Ultrasound Scanner Flex Focus 1202 (K132335), based on the provided text.

Important Note: This 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device, rather than a de novo approval requiring extensive clinical validation of novel performance characteristics. The "device performance" in this context mainly refers to adherence to safety and performance standards already established for ultrasound systems, and the new features (RF wireless, Vector Flow Imaging) are discussed in terms of their safety and equivalence, not necessarily extensive clinical efficacy trials.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Acoustic Output, Thermal, Mechanical, Electrical Safety: No specific "test set" sample size in terms of patient data or image data is mentioned. The testing was likely performed on the device hardware itself following established engineering and safety standards. The provenance is internal testing and certification by a recognized body.
• RF Wireless Function: Tested at "five (5) different sites." This refers to locations, and implies device testing rather than patient data.
• Clinical Measurement Accuracy: No sample size or provenance is provided in this document; it states details are in "User Information."

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

This type of information is generally not required or provided for a 510(k) submission seeking equivalence for an existing ultrasound system with minor modifications. The "ground truth" for the performance characteristics discussed (acoustic output, safety, electrical performance) is based on engineering measurements against recognized standards, not expert clinical interpretation of images.

4. Adjudication Method for the Test Set

Not applicable. The reported tests are primarily engineering and safety evaluations against predefined standards, not diagnostic performance assessments requiring clinical adjudication.

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

No, an MRMC comparative effectiveness study was not done. This 510(k) is aimed at demonstrating substantial equivalence for an updated ultrasound system, not to prove improved clinical effectiveness with or without AI assistance for a specific diagnostic task. The description of the device as an "Ultrasound Scanner" further indicates it's a general imaging tool, not an AI-powered diagnostic aide.

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

No, a standalone algorithm performance study was not done. This device is an ultrasound scanner, which is operated by a human. There is no indication of a standalone algorithm component that performs a diagnostic task without human interaction.

7. The Type of Ground Truth Used

• Acoustic Output, Thermal, Mechanical, Electrical Safety: Ground truth is established by adherence to international and national device safety and performance standards (e.g., AIUM/NEMA UD-2, UD-3, IEC 60601 series, ISO 14971, IEC 62304, IEC 62359). This involves physical measurements and engineering validation.
• RF Wireless Function: Ground truth is implied to be actual user requirements and freedom from interference, measured through testing scenarios.
• Clinical Measurement Accuracy: Not explicitly stated, but for a diagnostic ultrasound, this would typically involve phantoms with known dimensions or comparisons to gold standard clinical measurements. The document refers to "User Information" for these details.

8. The Sample Size for the Training Set

Not applicable. This is not a submission for an AI/CADe device that requires a training set. The device is a traditional ultrasound system.

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

Not applicable, as there is no training set for this device type.

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

Pro Focus 2202 supports the following scanning modes and combinations thereof: B-mode (incl.Tissue Harmonic Imaging), M-mode, CFM mode, Amplitude (Power) Doppler mode. The system can perform simple geometric measurements, and perform calculations in the areas of Vascular, Urology, Cardiology and OB/GYN applications. An optional ECG signal can be superimposed the ultrasound information in all modes and mode combinations. The system can guide biopsy- and puncture needles. An optional 3-D module 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 purpose.

The provided text pertains to a 510(k) summary for an Ultrasound Scanner Pro Focus 2202. This document details the device's technical specifications, compared to predicate devices, and an FDA clearance letter. It is a regulatory submission for a diagnostic ultrasound system, not a study evaluating an AI device's performance.

Therefore, most of the information requested in your prompt (acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) is not present in the provided text.

The text focuses on demonstrating substantial equivalence to previously cleared devices based on:

• Technical characteristics: Modes of operation, intended use, indications for use, and features (ECG, VFI, RF wireless).
• Safety standards compliance: Acoustic output, thermal, electrical, electromagnetic, and mechanical safety, and biocompatibility of patient contact materials.

The only "testing" mentioned that marginally relates to performance is:

"Additional testing of the RF wireless function was performed at five (5) different sites representing actual user requirements. Several test scenarios was performed and no interference was measured."

This statement is very high-level and does not provide quantified acceptance criteria or performance metrics as typically expected for proving a device meets specific criteria for accuracy, sensitivity, or specificity. It merely states that "no interference was measured," which implies a pass/fail outcome for the RF wireless function's basic operational integrity, but not diagnostic performance.

In summary, as per the provided document, I cannot fulfill your request for detailed acceptance criteria and a study proving device performance because the document does not contain this information for diagnostic performance. It is a regulatory submission for a traditional medical device, not an AI/ML-driven device with performance metrics based on clinical outcomes or expert labels.

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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, Color Doppler, Vector Flow Imaging and combined mode imaging.
Signal analysis and display.
Guidance of biopsy needles, geometrical measurements and calculation of parameters.
Non monitoring ECG for superimposing the ultrasound information.
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.
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.

Flex Focus 1202 supports the following scanning modes and combinations thereof: B-mode (incl. Tissue Harmonic Imaging), M-mode. CFM mode. Amplitude (Power) Doppler mode
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.
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.
Transducers are linear arrays, convex arrays, phased arrays and mechanical sector.

The provided 510(k) summary for the B-K Medical Ultrasound Scanner Flex Focus 1202 focuses primarily on demonstrating substantial equivalence to predicate devices, rather than detailing a specific study to prove device performance against acceptance criteria. The document explicitly states:

"This submission introduces no new indications for use, modes, features or technologies relative to the predicate devices that require clinical testing. The clinical safety and effectiveness of ultrasound system with these characteristics are well accepted for both predicate and subject devices."

Therefore, it does not contain the information required to answer most of the questions about acceptance criteria and a specific study proving device performance. The submission relies on the established safety and effectiveness of the predicate devices and the fact that its technological characteristics are comparable.

However, based on the document, we can extract some information:

1. A table of acceptance criteria and the reported device performance
   The document doesn't provide a specific table of acceptance criteria with corresponding performance results from a dedicated study. Instead, it highlights that the device's technical specifications and intended use are comparable to legally marketed predicate devices.

   Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance (Implied by Comparability)
   Compliance with medical device regulations	Device is considered substantially equivalent
   Acoustic output limits	Ispta ≤ 720 mW/cm² and MI ≤ 1.9 (Track 3, non ophthalmic); TI ≤ 6.0
   Biocompatibility of patient contact materials	Complies with ISO10993-1
   Thermal, mechanical, and electrical safety	Tested according to IEC 60601-1
   Clinical measurement accuracy	Described and accuracies provided in User Guide
   Intended use and indications for clinical applications	Comparable to predicate devices, including new "Neonatal Cephalic" application considered the same as predicates for that application.

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 (N/A). The submission explicitly states that "no new indications for use, modes, features or technologies" required clinical testing. Therefore, there is no specific test set of cases or related data provenance information provided.

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)
   N/A. No specific test set requiring expert ground truth establishment was conducted.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
   N/A. No specific test set requiring adjudication was conducted.

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
   N/A. This device is a diagnostic ultrasound system and does not involve AI assistance for human readers in the context of an MRMC study. The submission focuses on the system's inherent diagnostic capabilities as comparable to predicate devices.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
   N/A. This is a diagnostic ultrasound system, not an algorithm being validated in a standalone manner. Its performance is intrinsically linked to human operation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
   N/A. No new clinical studies were performed that would require establishing a "ground truth" for novel features or diagnostic claims. The ground truth for ultrasound systems is implicitly established through long-standing clinical practice and the validation of predicate devices.

8. The sample size for the training set
   N/A. As this submission describes a diagnostic ultrasound system and not an AI/ML algorithm, there is no concept of a "training set" for the device's core functionality.

9. How the ground truth for the training set was established
   N/A. See explanation for point 8.

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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.
Signal analysis and display.
Guidance of biopsy needles, geometrical measurements and calculation of parameters.
Non monitoring ECG for superimposing the ultrasound information. 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.
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.

Clinical applications:
Ultrasound Scanner Pro Focus 2202:
Fetal, Obstetrics, Abdominal, Intraoperative, Neurosurgery, Small organ, Pediatric, Neonatal Cephalic, Adult Cephalic, Cardiac, Transrectal, Transvaginal, Transurethral. Peripheral Vascular, Musculoskeletal.
Ultrasound Transducer N13C5, Type 8862: Neonatal Cephalic.

2202 supports the following scanning modes and combinations thereof:
B-mode. M-mode. CWD-mode, PWD mode and CFM mode. Tissue harmonic imaging. Contrast harmonic imaging.
An optional ECG signal can be superimposed the ultrasound information in all modes and mode combinations.
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 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 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 a breakdown of the acceptance criteria and study information based on the provided text, using the requested format:

Acceptance Criteria and Device Performance

Study Information

The provided document describes a 510(k) Pre-market Notification for an Ultrasound Scanner (Pro Focus 2202) and a specific transducer (N13C5 Type 8862). This submission primarily focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than conducting new clinical studies to prove device performance against specific novel acceptance criteria.

Therefore, many of the requested study details (e.g., sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies) are not applicable (N/A) because the core of this submission is a comparison to established devices and their existing performance and safety profiles.

Here's a breakdown of what can be gleaned:

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

   • N/A. The submission states: "This submission introduces no new indications for use, modes, features or technologies relative to the predicate devices that require clinical testing." This indicates that no new clinical test sets were generated or utilized to prove performance in the traditional sense of a clinical trial for a novel device. The "test set" in this context is implicitly the historical data and established clinical performance of the predicate devices.

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

   • N/A. As no new explicit clinical test set was used for this submission, there was no need for a new "ground truth" establishment by experts specifically for this device's performance claims. The substantial equivalence relies on the established ground truth and clinical acceptance of the predicate devices.

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

   • N/A. No new clinical test set requiring adjudication was performed as part of this substantial equivalence submission.

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. The device is a diagnostic ultrasound system. There is no mention of AI or machine learning components, nor any MRMC study.

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

   • No. This is a diagnostic ultrasound system with human-in-the-loop operation. No standalone algorithm performance is reported.

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

   • N/A. For this substantial equivalence submission, the "ground truth" for the device's acceptable performance and safety is implicitly tied to the established and accepted clinical performance, safety profiles, and regulatory clearances of the predicate devices. New ground truth for a novel claim was not established as part of this submission.

7. The sample size for the training set:

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

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

   • N/A. As above, not an AI/ML device.

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Diagnostic ultrasound imaging or fluid flow analysis of the human body.

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

Signal analysis and display.

Guidance of biopsy needles, geometrical measurements and calculation of parameters.

Non monitoring ECG for superimposing the ultrasound information.

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.

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.

Clinical applications: Abdominal, Cardiac, Fetal, Intraoperative, Neurosurgery, Obstetrics, Transrectal, Small organs, Transvaginal, Musculoskeletal.

Flex Focus 1202 supports the following scanning modes and combinations thereof: B-mode (incl.Tissue Harmonic Imaging), M-mode, PWD mode, CFM mode, Amplitude (Power) Doppler mode.

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 module 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.

Transducers are linear arrays, convex arrays, phased arrays and mechanical sector. The patient contact materials are biocompatible.

All transducers used together with Flex Focus 1202 are Track 3 transducers.

The provided text describes a 510(k) summary for the B-K Medical Ultrasound Scanner Flex Focus 1202. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study to prove a device meets specific clinical performance acceptance criteria.

The information primarily discusses the device's technical specifications, modes of operation, intended use, indications for use, and safety aspects (thermal, mechanical, electrical, and acoustic output). It leverages existing standards and prior clearances for similar devices.

Therefore, many of the requested details regarding acceptance criteria for device performance and an accompanying study or analysis are not present in the provided text.

Here's a breakdown of what can and cannot be extracted:

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

The document does not specify quantitative clinical performance acceptance criteria for the device in terms of accuracy, sensitivity, or specificity. Instead, it relies on technical and safety compliance.

No information is provided for the following points related to a performance study:

• 2. Sample size used for the test set and the data provenance: Not applicable as no clinical performance study is detailed.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: 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. This device is an ultrasound scanner, not an AI-assisted diagnostic tool.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for clinical performance as described in the prompt. For technical and safety aspects, the ground truth is often established by adherence to recognized standards and validated testing procedures.
• 8. The sample size for the training set: Not applicable as it's not a machine learning/AI device.
• 9. How the ground truth for the training set was established: Not applicable.

In summary, this document is a regulatory submission for premarket clearance (510(k)) based on substantial equivalence, not a clinical trial report detailing performance criteria and a study to meet them. The "acceptance criteria" here largely pertain to technical specifications, safety limits, and intended/indicated uses matching those of previously cleared devices, rather than quantitative clinical efficacy metrics.

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

Pro Focus 2202 supports the following scanning modes and combinations thereof: B-mode (incl.Tissue Harmonic Imaging), M-mode, PWD mode, CFM mode, Amplitude (Power) Doppler mode. 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 ECG signal can be superimposed the ultrasound information in all modes and mode combinations. An optional 3-D module 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. Transducers are linear arrays, convex arrays, phased arrays and mechanical sector. The patient contact materials are biocompatible. All transducers used together with Pro Focus 2202 are Track 3 transducers.

The provided document is a 510(k) Summary for an Ultrasound Scanner Pro Focus 2202. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain information about acceptance criteria or a specific study proving the device meets acceptance criteria in the way a clinical performance study would.

Instead, the document details the device's technical specifications, intended use, and substantial equivalence to a previously cleared device (K043524). The "acceptance criteria" discussed are largely related to regulatory compliance and safety standards, rather than clinical performance metrics for a novel algorithm or feature.

Here's a breakdown of the available information based on your requested points:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the document, the "acceptance criteria" are primarily related to safety, acoustic output, and functional equivalence to the predicate device. There isn't a table of clinical performance metrics with pre-defined acceptance thresholds and observed values in the provided text. The document states:

"Clinical measurements and calculations are described and accuracies are provided in the User Information."

This suggests that accuracy specifications for measurements are available but not provided within this 510(k) summary. The document focuses on regulatory compliance:

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

Not applicable as this document does not describe a clinical performance study with a distinct "test set" in the context of algorithm evaluation. The document discusses regulatory validation against predicate devices and safety standards.

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

Not applicable. Ground truth, in the context of clinical studies, is not mentioned for this submission. The "ground truth" for regulatory clearance is essentially compliance with standards and equivalence to a predicate device.

4. Adjudication Method

Not applicable for a clinical performance study.

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

No. This document does not mention an MRMC study or any comparison of human readers with vs. without AI assistance. The device is a diagnostic ultrasound system, and the AI component (if any) is not explicitly detailed as a reader assistance tool from this summary. The "Vector Flow Imaging (VFI)" is a new imaging mode, not an AI interpretation aid.

6. Standalone (Algorithm Only) Performance Study

No. The document describes a diagnostic ultrasound system, not a standalone algorithm. The VFI module is an integrated imaging mode.

7. Type of Ground Truth Used

Not applicable for a clinical performance study. For regulatory purposes, the "ground truth" is that the device meets safety standards and is substantially equivalent to a previously cleared device.

8. Sample Size for the Training Set

Not applicable. This document does not describe the development or training of a specific algorithm that would require a "training set."

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

Not applicable.

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Needle guide(s) provides guidance for needles or other interventional devices during an ultrasound-guided procedure. It positions the needle relative to the transducer, so that the needle image is in a specified position in the ultrasound image during procedures. that require precise needle placement or biopsy.

The BK Medical Needle Guides described are designed to be used with BK Medical' Ultrasound system to provide alignment with an ultrasound intra-operative transducer, in order to guide a needle (biopsy device, or other interventional device) in relation to the ultrasound image. The components for the Needle Guides are all single use disposable, and delivered sterile. Note! The needle guides are delivered without needles.

The provided text describes a 510(k) premarket notification for a medical device (Needle Guide for BK Medical ultrasound transducers) and its comparison to a predicate device. The information is presented in the context of demonstrating substantial equivalence, not a study proving specific performance metrics against acceptance criteria.

Specifically, the document does not contain a study with acceptance criteria and reported device performance as typically understood for a detailed clinical or analytical validation study for an AI/ML device. The provided text is a summary of a regulatory submission (510(k)) that focuses on showing the new device is "substantially equivalent" to an already approved device. This process primarily relies on comparing technological characteristics and intended use.

Therefore, many of your requested points cannot be answered from the provided text. I will indicate where the information is missing or not applicable based on the nature of the document.

1. Table of Acceptance Criteria and Reported Device Performance

This table cannot be fully generated as the document does not specify formal acceptance criteria for device performance or report specific performance metrics in a study. The comparison table focuses on technological characteristics and intended use for substantial equivalence.

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

• Sample Size: Not applicable. This document is not a report of a performance study that uses a test set of data. It is a regulatory submission for substantial equivalence.
• Data Provenance: Not applicable.

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

• Not applicable. No ground truth establishment from experts for a test set is described in this regulatory submission.

4. Adjudication method for the test set

• Not applicable. No adjudication method for a test set 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

• No, an MRMC comparative effectiveness study was not done. This device is a physical needle guide, not an AI-assisted diagnostic tool.

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

• No, a standalone algorithm performance study was not done. This device is a physical needle guide.

7. The type of ground truth used

• Not applicable. No ground truth in the context of a performance study is mentioned. The "ground truth" for the 510(k) submission is the existence and characteristics of the legally marketed predicate device.

8. The sample size for the training set

• Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

• Not applicable.

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Purpose: Performing ultrasound guided biopsies of the prostate.
Indications for Use: Performing ultrasound guided biopsies of the prostate

The biopsy guides are designed to be used with B-K Medical's ultrasound systems to guide needles for taking biopsies of the prostate and similar soft tissue. The biopsy guides are fixed to the ultrasonic probe, and provide a predetermined path for a biopsy needle. The biopsy guides are similar to previously used biopsy guides delivered non sterile. The new biopsy guides are delivered sterile.

This appears to be a 510(k) summary and FDA clearance letter for a medical device, specifically biopsy needle guides. This type of document is about regulatory clearance based on substantial equivalence to a predicate device, not typically a detailed study proving performance against acceptance criteria in the way an AI/software as a medical device (SaMD) study would.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set, ground truth for training set) are not applicable to this type of submission. This submission primarily focuses on comparing the technological characteristics of the new device to a legally marketed predicate device to demonstrate substantial equivalence, particularly regarding a change in delivery (from non-sterile to sterile).

However, I can extract information related to the device's characteristics and intended use, and frame the "acceptance criteria" based on the comparison to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The document describes a 510(k) premarket notification submission. The "study" in this context is a comparison of the subject device (new biopsy guides) to a legally marketed predicate device (Targetscan biopsy kit, Targetscan biopsy needle guide - K073399) to establish substantial equivalence.

The core of the "proof" is the declaration that: "The predicate device has the same major technological characteristics as the subject device, see comparison below." The only mentioned difference is that the new biopsy guides are delivered sterile, whereas the predicate was delivered non sterile. This sterility change would typically involve validation studies (e.g., sterilization validation) which are part of the overall submission but not detailed in this summary.

Further Requested Information (Not Applicable to this type of 510(k) Summary):

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

• N/A. This is a substantial equivalence submission for a physical medical device, not an AI/SaMD performance study using a test set of data.

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)

• N/A. Ground truth for image interpretation or diagnosis is not relevant to this device's regulatory review.

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

• N/A. Not an AI/SaMD performance study.

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

• N/A. This device is a biopsy guide, not an AI/software product that assists human readers.

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

• N/A. This device is a physical medical device, not an algorithm.

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

• N/A. Ground truth in the context of diagnostic accuracy is not relevant here. The "ground truth" for this submission is that the predicate device is legally marketed and safe/effective for its intended use, and the new device is functionally identical with an added sterility benefit.

8. The sample size for the training set

• N/A. Not an AI/SaMD.

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

• N/A. Not an AI/SaMD.

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

Flex Focus 1202 supports the following scanning modes and combinations thereof: B-mode (incl.Tissue Harmonic Imaging), M-mode, PWD mode, CFM mode, Amplitude (Power) Doppler mode. 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.

Here's an analysis of the provided text regarding acceptance criteria and the study:

The provided 510(k) summary for the B-K Medical Ultrasound Scanner Flex Focus 1202 (K081154) does not contain information about a diagnostic study for AI/algorithm performance against acceptance criteria.

Instead, this submission is for a traditional ultrasound system and focuses on demonstrating substantial equivalence to a predicate device (B-K Medical Ultrasound Scanner Pro Focus 2202, K043524) based on technological characteristics and intended use. The "acceptance criteria" mentioned implicitly refer to safety and performance standards for diagnostic ultrasound systems as per FDA guidelines at the time (e.g., "Information for Manufacturers Seeking Clearance of Diagnostic Ultrasound Systems and Transducers, FDA, CDRH, September 30, 1997").

Let's break down the information available and what is missing, based on your requested categories:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is not a submission for an AI/CAD/algorithmic device, there are no specific diagnostic performance metrics (e.g., sensitivity, specificity, AUC) or acceptance criteria (e.g., "sensitivity must be >X%") against which the device performance is measured in a clinical study.

The primary "performance" discussed relates to technological characteristics and acoustic output safety.

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

This information is not provided as there is no diagnostic study with a "test set" in the context of an AI/algorithm. The submission is for an ultrasound system, and its "performance" is primarily demonstrated through engineering specifications, comparison to a predicate device, and compliance with general safety and performance standards for ultrasound equipment.

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

This information is not applicable/not provided. There is no "test set" requiring ground truth established by experts for a diagnostic algorithm in this submission.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. There is no "test set" or adjudication process described as part of this traditional ultrasound system 510(k).

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a standalone ultrasound system, not an AI or CAD (Computer-Aided Detection/Diagnosis) system designed to assist human readers.

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

This information is not applicable/not provided. The device itself is an ultrasound imaging system, not a standalone diagnostic algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

This information is not applicable/not provided. "Ground truth" in the context of a diagnostic dataset is not discussed here, as this is a submission for an ultrasound imaging device itself, not an AI/algorithmic device requiring such a validation.

8. The Sample Size for the Training Set

This information is not applicable/not provided. There is no "training set" for an AI algorithm discussed in this submission.

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

This information is not applicable/not provided. There is no "training set" or establishment of "ground truth" for it in this submission.

In summary:

The provided document is a 510(k) summary for a traditional diagnostic ultrasound system. It demonstrates substantial equivalence to a predicate device by comparing intended uses and technological characteristics, and by declaring compliance with relevant safety and performance standards for ultrasound (e.g., acoustic output limits). It does not involve any AI/CAD algorithms, and therefore, the specific types of studies, acceptance criteria, and ground truth methodologies relevant to AI/algorithmic performance are not present in this submission.

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