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510(k) Data Aggregation
(168 days)
ULTRASOUND SCANNER FLEX FOCUS 1202
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
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Acoustic Output | Ispta ≤ 720 mW/cm² and M1 ≤ 1.9 (Track 3, non-ophthalmic); Thermal Index (TI) ≤ 6.0 | The system in the modified Flex Focus 1202 is the same as the Flex Focus 1200 and "will assure that the acoustic output always will stay below the pre-amendments upper limits i.e. Ispta ≤ 720 mW/cm² and M1 ≤ 1.9 (Track 3, non ophthalmic). The Thermal Index values are maximum 6.0, i.e. TI ≤ 6.0." It also adheres to AIUM/NEMA UD-2 and UD-3. |
| Clinical Measurement Accuracy | Not explicitly stated as a numerical criterion in the provided text. Implied expectation is that accuracy is maintained consistent with previously cleared devices. | "Clinical measurements and calculations are described and accuracies are provided in the User Information." (No specific values or studies are provided in this document, but implied to be acceptable). |
| Thermal, Mechanical, and Electrical Safety | Conformance to applicable medical device safety standards, including IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-37, ISO 14971, IEC 62304, IEC 62359. Biocompatibility of patient contact materials. | "The scanner Flex Focus 1202 has been tested by a recognized Certified Body." and "has been found to conform with applicable medical device safety standards." "Cleared patient contact materials, electrical and mechanical safety are unchanged." |
| RF Wireless Function (New Feature) | No interference with other devices or the ultrasound system itself. Performance to meet "actual user requirements." | "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." |
| Technological Equivalence (Overall System) | The device should demonstrate "substantial equivalence" to the identified predicate devices (K081154, K123254) in terms of intended use, modes of operation, indications for use, and technological characteristics. Only minor non-safety/efficacy impacting differences are acceptable. | The document repeatedly asserts substantial equivalence, stating the predicate device has "the same major technological characteristics as the subject device." Minor differences are limited to the optional RF wireless function. |
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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(132 days)
ULTRASOUND SCANNER FLEX FOCUS 1202
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:
-
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. -
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. -
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. -
Adjudication method (e.g., 2+1, 3+1, none) for the test set
N/A. No specific test set requiring adjudication was conducted. -
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. -
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. -
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. -
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. -
How the ground truth for the training set was established
N/A. See explanation for point 8.
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(118 days)
ULTRASOUND SCANNER FLEX FOCUS
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.
| Acceptance Criteria (Stated or Implied) | Reported Device Performance / Compliance |
|---|---|
| Acoustic Output: | |
| Ispta ≤ 720 mW/cm² | Stated to stay below this limit |
| MI ≤ 1.9 (Track 3, non-ophthalmic) | Stated to stay below this limit |
| TI ≤ 6.0 | Maximum 6.0 |
| Clinical Measurement Accuracy: | Described and accuracies provided in User Information (details not provided in this document) |
| Safety: | |
| Thermal, mechanical, electrical safety | Tested by a recognized Certified Body |
| Acoustic Output Reporting: | Made according to FDA standards |
| Modes of Operation: | B, M, PWD, CFM, Tissue Harmonic Imaging, and combinations (including optional VFI module) |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body |
| Indications For Use: | Abdominal, Cardiac, Fetal, Intraoperative, Transurethral, Neurosurgery, Pediatrics, Transrectal, Small Parts, Transvaginal, Peripheral vascular, Musculoskeletal |
| Biocompatibility: | Patient contact materials are biocompatible |
| Substantial Equivalence: | Determined by FDA to be substantially equivalent to predicate devices K081154 and K100919 |
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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(30 days)
ULTRASOUND SCANNER FLEX FOCUS, MODEL 1202
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.
| Feature/Criterion | Acceptance Criteria (Implied by Predicate Equivalence & Standards) | Reported Device Performance (Flex Focus 1202) |
|---|---|---|
| Modes of Operation | Must support B, M, PWD, CFM (Color Flow Mapping/Color Doppler and Amplitude Doppler), and combinations, including Tissue Harmonic Imaging. (Based on predicate device Pro Focus 2202) | Supports B-mode (incl. Tissue Harmonic Imaging), M-mode, PWD mode, CFM mode, Amplitude (Power) Doppler mode. The table on page 2 explicitly lists these modes for various clinical applications, indicating previous FDA clearance (P) for these modes and applications. |
| Clinical Applications | Must support Abdominal, Cardiac, Fetal (incl Obstetrics), Intraoperative, Transurethral, Neurosurgery, Pediatrics, Transrectal, Small Parts (organs), Transvaginal, Peripheral vascular, Musculo-skeletal. (Based on predicate device Pro Focus 2202) | Supports all listed clinical applications. The table on page 2 explicitly states "1202 intended uses are contained within 2202-intended uses" and details P-status for all these clinical applications and modes. |
| Simple Geometric Measurements & Calculations | Ability to perform simple geometric measurements and calculations in areas like Vascular, Urology, Cardiology, OB/GYN. (Standard for diagnostic ultrasound) | The system can perform simple geometric measurements, and perform calculations in the areas of Vascular, Urology, Cardiology and OB/GYN applications. Clinical measurement accuracy is stated to be described in the User Guide. |
| Biopsy/Puncture Guidance | Ability to guide biopsy- and puncture needles. (Standard for diagnostic ultrasound) | The system can guide biopsy- and puncture needles. |
| 3-D Reconstruction (Optional) | Ability to reconstruct 2-D images into a 3-D volume and display. (Optional feature, likely assessed for function) | 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. |
| Transducers | Must use linear arrays, convex arrays, phased arrays, and mechanical sector transducers with biocompatible patient contact materials. Track 3 transducers. (Standard for safety/performance) | 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. Specific transducers (1850, 8661, 8662, 8811, 8820e, 4.00) are listed as cleared with the system. |
| Acoustic Output Safety | Acoustic output must stay below pre-amendments upper limits; Ispta ≤ 720 mW/cm², MI ≤ 1.9 (Track 3, non-ophthalmic), TI ≤ 6.0. (FDA standard "Information for Manufacturers...") | The system controlling the Acoustic Output in Flex Focus 1202 is the same as the system in Pro Focus 2200. The system will assure that the acoustic output always will stay below the pre-amendments upper limits i.e. Ispta ≤ 720 mW/cm² and MI ≤ 1.9 (Track 3, non ophthalmic). The Thermal Index values are maximum 6.0, i.e. TI ≤ 6.0. |
| Safety Testing (Thermal, Mechanical, Electrical) | Must be tested by a recognized Certified Body to ensure safety. (Regulatory requirement) | The scanner Flex Focus 1202 has been tested by a recognized Certified Body. |
| Substantial Equivalence | The device must have the same intended use and similar technological characteristics to a legally marketed predicate device, or differences must not raise new questions of safety/effectiveness. | The device's intended uses are contained within the predicate device's (Pro Focus 2202, K043524). Major technological characteristics are the same. Minor differences (modified scanconverter, transmitter, beamformer, mechanical outline) are considered not to raise new questions of safety or effectiveness. |
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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