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510(k) Data Aggregation
(20 days)
The SonoSite Edge Ultrasound System is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Ophthalmic, Fetal - OB/GYN, Abdominal, Intraoperative (abdominal organs and vascular), Intra-operative (Neuro.), Pediatric, Small Organ (breast, thyroid, testicle, prostate), Neonatal Cephalic, Adult Cephalic, Trans-Rectal, Trans-Vaginal, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Cardiac Adult, Cardiac Pediatric, Trans-esophageal (cardiac), Peripheral Vessel.
The SonoSite Edge Ultrasound System is a portable laptop style, full featured, general purpose, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. Edge is a custom fabricated digital electronic design that readily lends itself to be configured for specific ultrasound imaging applications through different system feature selections. Edge can operate on either battery or AC power.
Here's an analysis of the provided 510(k) summary regarding the SonoSite Edge™ Ultrasound System, structured to address your specific points:
Acceptance Criteria and Device Performance Study
The SonoSite Edge™ Ultrasound System is a general-purpose diagnostic ultrasound system. The provided document does not describe acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy). Instead, acceptance is implicitly tied to demonstrating substantial equivalence to a previously cleared predicate device, the SonoSite Maxx Series Ultrasound System (K071134 / K082098), and compliance with various safety and performance standards.
The "study" proving the device meets its acceptance criteria is primarily a non-clinical safety and performance evaluation, as specified in the document, rather than a clinical effectiveness study with defined performance numbers.
Here's the information requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance and Evidence |
|---|---|
| Substantial Equivalence to Predicate Device (SonoSite Maxx Series Ultrasound System K071134 / K082098) | Demonstrated via comparison of technological characteristics and intended use. The SonoSite Edge and Maxx Series Ultrasound Systems "employ the same fundamental scientific technology." The intended uses for the SonoSite Edge System and its various transducers (C8x/8-5 MHz, C11x/8-5 MHz, D2x/2 MHz, C60x/5-2 MHz, HFL38x/13-6 MHz, HFL50x/15-6 MHz, ICTx/8-5 MHz, L25x/13-6 MHz, L38xi/10-5 MHz, L38x/10-5 MHz, P10x/8-4 MHz, P21x/5-1 MHz, SLAx/13-6 MHz, TEEx/8-3 MHz) are largely shown to be "P" (previously cleared by FDA) under the predicate device K071134 and K082098, with a few "N" (new indications) for certain transducer/application/mode combinations (e.g., L38xi/10-5 MHz for Abdominal, Intra-operative, Pediatric, Small Organ, Musculo-skeletal Conventional & Superficial, and Peripheral vessel applications). The FDA's 510(k) clearance letter explicitly states: "We have determined the device is substantially equivalent... to legally marketed predicate devices." |
| Compliance with Electrical, Thermal, Mechanical, and EMC Safety Standards | Evaluated, and the device "has been found to conform to all applicable mandatory medical device safety standards." (Specific standards referenced for the Maxx series, which is the predicate, include AAMI/ANSI/ISO 10993-1, 10993-5, 10993-12 for biocompatibility, and unspecified voluntary standards detailed in tables 1.1-1 and 1.1-2, though these tables are not provided in the excerpt). |
| Compliance with Cleaning/Disinfection Requirements | Evaluated. |
| Biocompatibility of Patient Contact Materials | Evaluated. "All patient contact materials are biocompatible." |
| Acoustic Output Compliance | Evaluated. |
| Quality Assurance (System & Software Verification, Hardware Verification, Clinical Validation, Human Factors Validation) | "Assurance of quality was established by employing the following elements of product development: System and Software Verification, Hardware Verification, Safety Compliance Verification, Clinical Validation, Human Factors Validation. Reports for these product development elements are referenced in Attachment 6." However, "The SonoSite Edge Ultrasound System and transducers did not require clinical studies to support the determination of substantial equivalence." This means "Clinical Validation" in this context refers to demonstrating that the device performs as intended for its stated uses, implicitly equivalent to the predicate, rather than an independent clinical trial to establish new clinical efficacy or performance metrics. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable/Not provided. The submission explicitly states: "The SonoSite Edge Ultrasound System and transducers did not require clinical studies to support the determination of substantial equivalence." Therefore, there was no separate clinical "test set" in the context of generating new clinical performance data (like sensitivity/specificity) for this 510(k) submission. The evaluation was primarily non-clinical and a comparison to a predicate device's existing clearance.
- Data Provenance: Not applicable. As no new clinical studies were conducted for this submission, there is no new data provenance (country of origin, retrospective/prospective). The basis is primarily the regulatory clearance of the predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Not applicable. Since no new clinical studies were performed requiring new ground truth establishment, this information is not provided. The clinical indications listed as "P" (previously cleared) rely on the ground truth established for the predicate device.
4. Adjudication Method for the Test Set
- Not applicable. No clinical test set requiring adjudication was performed for this 510(k) submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with vs. without AI Assistance
- No. This is a submission for a general diagnostic ultrasound system, not an AI-enabled device. Therefore, no MRMC study or assessment of AI assistance was conducted or is relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- No. This is a diagnostic ultrasound system, not an algorithm.
7. The Type of Ground Truth Used
- For the "P" (previously cleared) indications, the ground truth was established through the original clinical validations and regulatory clearances of the predicate device (SonoSite Maxx Series, K071134 and K082098). The specific type of ground truth (e.g., pathology, outcomes data) for the predicate device is not detailed in this particular summary.
- For the "N" (new) indications, specifically for the L38xi/10-5 MHz transducer, these are new combinations of application and mode on a new transducer for which the previous system (Edge) also had "N" indications for "B+M; B+PWD; B+CD" combined modes. The basis for these "new" indications still relies on the fundamental scientific technology being equivalent to the predicate, and safety/performance evaluations rather than novel clinical ground truth data.
8. The Sample Size for the Training Set
- Not applicable. This submission is for a diagnostic imaging device, not an AI/machine learning algorithm that requires a "training set." The system's development involved "System and Software Verification, Hardware Verification, Safety Compliance Verification, Clinical Validation, Human Factors Validation," but these are engineering and validation processes, not machine learning training.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no "training set" in the machine learning sense, this question is not relevant.
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(91 days)
The Bio Z Cardio Profile Hemodynamic Monitor is intended to monitor and display a patient's hemodynamic parameters including: Heart Rate (HR), Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Mean Arterial Pressure (MAP), Pulse Wave Velocity (PWV), Oxygen Delivery Index (DO2l), Stroke Volume (SV), Stroke Index (SI), Cardiac Output (CO), Cardiac Index (CI), Systemic Vascular Resistance (SVR), Systemic Vascular Resistance Index (SVRI), Left Cardiac Work (LCW), Left Cardiac Work Index (LCWI), Velocity Index (VI), Acceleration Index (ACI), Heather Index (HI), Pre-Ejection Period (PEP), Left Ventricular Ejection Time (LVET), Thoracic Fluid Content (TFC), Thoracic Fluid Content Index (TFCI), Baseline Impedance (Zo), Total Arterial Compliance (TAC), Total Arterial Compliance Index (TACI), Systolic Time Ratio (STR), Systolic Time Ratio Index (STRI). The Bio Z Cardio Profile Hemodynamic Monitor is not intended to be used as a vital sign monitor.
The Bio Z Cardio Profile Hemodynamic Monitor is a data acquisition system that measures and processes ECG and impedance data. In combination with height, weight, age, and gender the hemodynamic parameters are calculated by the user software (Cardio Vascular Lab). Additional parameters are measured with the help of OEM modules (NIBP and SpO2) integrated in the device. The Bio Z Cardio Profile also allows the estimation of the Pulse Wave Velocity (PVVV). For this purpose the pressure cuff (NIBP) is placed on the upper leg. The ICG signal is used to define the opening of the aortic valve and the pressure cuff is used to determine the arrival of the pulse wave after leaving the heart. On this basis the propagation time of the pulse wave in the aorta can be estimated. Pulse Wave Velocity can be calculated when considering the distance between the heart and the pressure cuff placed on the upper leq. The Bio Z Cardio Profile measures SpO2 for the purpose of calculating Oxygen Delivery Index (DO2l). The SpO2 measurements are provided by an integrated OEM module, the Nellcor™ OxiMax™ NELL-1 ™ OEM pulse oximetry module (previously cleared on the Cheetah Reliant by the FDA (K103166)). The Nell-1 module measures functional oxygen saturation non-invasively via a light signal interacting with tissue, by utilizing the time-varying changes in tissue optical properties that occur with pulsed blood flow. The Nell-1 module receives electrical signals from the sensor, which is then run through an algorithm to provide SpO2 values. Utilizing the Nell-1 OEM module, the Bio Z Cardio Profile is capable of measuring: Blood oxygen saturation (SpO2 via finger Oximeter) for use in calculating Oxygen Delivery Index (DO2l); using Oxygen Saturation (SpO2) data from Oximeter and Cardiac Index (CI) data from the ICG function. The Nell-1 module, as part of the Bio Z Cardio Profile, is intended for spot-check measurements of arterial blood oxygen saturation. The SpO2 measurement data is not available to view by the user; it is only used in the calculation of Oxygen Delivery Index (DO2)), which requires an additional ICG Cardiac Index (CI) measurement.
The provided text describes the Bio Z Cardio Profile Hemodynamic Monitor and its intended use, but it does not contain details about a specific study or acceptance criteria with reported performance data. It primarily focuses on the device's technical characteristics, regulatory classification, and establishment of substantial equivalence to predicate devices.
Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor details about a study, sample sizes, expert involvement, or adjudication methods, as this information is not present in the provided document.
The document is a 510(k) summary, which typically outlines the device and its equivalence to legally marketed predicates, but does not always include detailed performance study results that would fulfill all the requested criteria. Such detailed study results are usually found in the full 510(k) submission or separate clinical reports, which are not included here.
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(88 days)
The SonoSite NanoMaxx Series Ultrasound System is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Fetal/OB; Abdominal; Pediatric; Small Organ (breast, thyroid, testicles, prostate); Trans-rectal; Trans-vaginal Peripheral Vessel; Intraoperative (abdominal organs, vascular); Musculoskeletal Conventional & Superficial, Cardiac Adult and Pediatric.
The SonoSite NanoMaxx Series Ultrasound System is a full featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data in 2D, Doppler, M-Mode, Color Power Doppler or in a combination of these modes. The hand-carried system weighs less than 6 pounds and has a touch screen interface with minimal controls to facilitate disinfection and cleaning. The system provides measurement capabilities for anatomical structures and fetal biometry to provide information used for clinical diagnostic purposes. The system also includes the ability to measure the intima-media thickness (IMT) of the carotid artery using digital ultrasound images, which is used in conjunction with traditional risk assessment models to assess individual cardiovascular disease risk. The system includes Digital Imaging and Communications (DICOM) capabilities as well as general computer communication capabilities, including wireless networking, to provide the acceptance, transfer, display, storage, and digital processing of ultrasound images. Security support is also provided to facilitate HIPAA compliance. The system supports the eFilm Lite™ application, which allows studies stored on a memory device in DICOMDIR format to be viewed. This viewing software can be launched on a PC when the license option is enabled. The system includes a variety of accessories including a stand, dock featuring a video in/out port, a printer port, printer, VESA mounting arm and needle guide kits. The system includes three USB host supports for peripherals and an Ethernet port for data transfer of patient data. The system also features SiteLink™ allowing an additional method for the export of patient data. Storage devices include memory sticks. The V-Universal™ stand provides a mobile work platform for the NanoMaxx, as well as a storage area for transducers and other supplies. It also provides connections for system accessories and peripherals. The PowerPark docking stand consists of two components, the dock (plugs into a power outlet and sits on the floor) and the stand module (attaches to underside of stand). An AC adapter on the stand module allows for manual connection to AC power. The PowerPack battery uses lithium-ion technology and mounts on the V Universal™ stand. LED lights on the PowerPack indicate the amount of available battery power, as well as charge status. SonoSite Workflow Solutions (SWS) is a software program for organizing exams from the NanoMaxx. SWS operates on a host server and users require a login to access the program. Patient exam information can be transferred from the ultrasound to SWS by exporting data from the ultrasound to a USB storage device, then importing it from the USB storage device. The use of a USB keyboard, barcode reader and medical grade printer is supported by the system, which allows manual entry of patient demographics, scanning entry of patient demographics and the capability to print images and/or reports. The system/transducer is capable of exceeding a TI or an MI of 1.0 in certain operating modes or mode combinations. The system monitor displays the current output level in terms of the bioeffects indices ("Mechanical Index [M]" and "Thermal Index [TI]") in accordance with the AIUM/NEMA Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment.
The provided text is a 510(k) Summary of Safety and Effectiveness for the SonoSite NanoMaxx™ Series Ultrasound System. This document outlines the device's description, intended use, and substantial equivalence to predicate devices, but it does not contain a study that proves the device meets acceptance criteria in the way a clinical performance study for an AI/CAD/software device would.
The document primarily focuses on:
- Device Description: What the device is and its capabilities (e.g., 2D, Doppler, M-Mode imaging, measurement capabilities).
- Intended Use: The specific clinical applications for which the ultrasound system is designed (e.g., Fetal/OB, Abdominal, Cardiac).
- Technological Characteristics: Technical specifications like frequency range and acoustic output limits, and compliance with various standards (e.g., IEC 60601-1, NEMA UD 2-2004).
- Substantial Equivalence: The claim that the NanoMaxx system is substantially equivalent to previously cleared SonoSite ultrasound systems (K092058, K071134, K082098). This is the basis for its clearance, rather than a new clinical study demonstrating specific performance metrics against acceptance criteria for a diagnostic aid.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them because the provided text does not contain such a study or performance metrics for acceptance criteria related to a diagnostic algorithm or AI.
The tables detailing the "Indications for Use Form" (Tables 1.3-1 through 1.3-8) simply list clinical applications and the modes of operation available for the main system and each transducer. The "P" indicates "previously cleared by FDA," and "N" indicates a "new indication" for this specific device as compared to its predicate (which means the new indication is covered by the substantial equivalence argument, not necessarily by a new clinical performance study for this specific 510k submission).
Here's a breakdown of why the requested information cannot be extracted from this document:
- Table of acceptance criteria and reported device performance: Not present. The document lists technical specifications (e.g., acoustic output) and intended uses, but not performance metrics (e.g., sensitivity, specificity, accuracy) against specific acceptance criteria for a diagnostic outcome.
- Sample size used for the test set and data provenance: Not applicable as no diagnostic performance study is presented.
- Number of experts used to establish ground truth and qualifications: Not applicable.
- Adjudication method: Not applicable.
- Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable. This document is for a diagnostic ultrasound system, not an AI/CAD/software device designed to assist human readers.
- Standalone performance (algorithm only): Not applicable. This device is an ultrasound system operated by a human user.
- Type of ground truth used: Not applicable for a performance study. Clinical diagnostic use implies clinicians interpret the images.
- Sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.
- How ground truth for the training set was established: Not applicable.
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(284 days)
The LumenVu™ Catheter Guidance System is intended to aid in the placement of peripherally inserted central catheters (PICC) by providing real-time visual navigation of the catheter tip. The system may be used by trained caregivers in hospitals or other healthcare facilities.
The SonoSite LumenVu™ Catheter Guidance System consists of a control box, a display screen, a camera, and a sterile optical stylet. The system uses a near-infrared light source to provide immediate visual feedback to the user on the location of a peripherally inserted central catheter tip. The optical stylet replaces traditional stiffening wire and provides a path for NIR light to its tip.
This document describes the SonoSite LumenVu™ Catheter Guidance System, which is intended to aid in the placement of peripherally inserted central catheters (PICC) by providing real-time visual navigation of the catheter tip.
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not contain a specific table of detailed acceptance criteria with numerical targets and the device's corresponding performance metrics for its primary intended use (catheter tip navigation performance). However, it does state that the system demonstrated compliance with general safety and performance standards.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Device Functionality | "Test results demonstrated that the LumenVu™ System functioned as intended." |
| Safety and Effectiveness | "The observed test results demonstrate that the Lumen Vu™ System is as safe and effective as the predicate devices." |
| Electrical Safety | "Testing demonstrated that the system meets the requirements of IEC 60601-1 for electrical safety." |
| Electromagnetic Compatibility (EMC) | "Testing demonstrated that the system meets the requirements of IEC 60601-1-2 for electromagnetic compatibility." |
| Laser Safety | "Testing demonstrated that the system meets the requirements of IEC 60825-1 for laser safety." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for specific performance tests related to the catheter guidance functionality. It broadly refers to "Performance testing and engineering analysis."
The data provenance (e.g., country of origin, retrospective or prospective) is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The study described appears to be an engineering performance and safety study rather than a clinical study requiring expert-established ground truth for diagnostic accuracy.
4. Adjudication Method for the Test Set
This information is not provided in the document. It is not relevant given the type of performance testing described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned in the provided text. The submission focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and general performance, not on direct comparison of human reader performance with and without AI assistance.
6. If a Standalone Study Was Done
Yes, safety and performance testing was done on the "algorithm only" in the sense that the LumenVu™ System itself (the device) underwent testing to ensure it functioned as intended and met safety standards in a standalone capacity, independent of clinical human-in-the-loop performance measurement. The described "Performance testing and engineering analysis" supports this.
7. The Type of Ground Truth Used
The "ground truth" for the performance claims appears to be based on:
- Engineering specifications and standards conformance: For electrical, EMC, and laser safety (IEC 60601-1, IEC 60601-1-2, IEC 60825-1).
- Intended functionality: The system's ability to "function as intended" for real-time visual navigation, likely assessed against pre-defined engineering criteria.
- Comparison to predicate devices: The assertion that the system is "as safe and effective as the predicate devices" implies a comparison against the established performance of existing devices.
8. The Sample Size for the Training Set
This information is not applicable and is not provided in the document. The LumenVu™ Catheter Guidance System, as described, uses a light-based visual navigation system rather than a machine learning or AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and is not provided. No training set for an AI/ML algorithm is mentioned.
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(50 days)
The SonoSite Series Ultrasound Systems are a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Ophthalmic, Fetal/OB; Abdominal; Intra-operative (abdominal organs and vascular); Laparoscopic; Pediatric; Small Organ (breast, thyroid, testicles, prostate); Neonatal Cephalic; Adult Cephalic; Trans-recta;, Trans-vaginal; Musculo-skeletal (Conventional); Musculo-skeletal (Superficial); Cardiac Adult; Cardiac Pediatric; Trans-esophageal (cardiac); Peripheral Vessel.
Cardiac Imaging Applications: This system allows the clinician to perform focused cardiac studies. This system transmits ultrasound energy into the thorax of adult and pediatric patients to obtain 2D, PowerMap, DCPD, M-mode (where available), Tissue Harmonic Imaging, or PW and CW Doppler images of the heart, great vessels, and anatomic or pathologic structure. This system can be used to assess overall cardiac performance and size, determine the presence and location of fluid around the heart and lungs, aid in pericardialcentesis and pleuralcentesis procedures, and visualize blood flow through cardiac valves. Also the system can be used to access the presence and extent of some injuries and diseases. The ECG (where available) is used for accurate timing of diastolic and systolic function. The ECG trace is not used to diagnose cardiac rhythms and is not designed for long term cardiac rhythm monitoring.
SonoSite ultrasound systems are highly portable, software-controlled ultrasound systems used to acquire and display high resolution, real-time ultrasound data in a variety of modes and clinical settings.
Here's a breakdown of the acceptance criteria and the study information based on the provided document.
Acceptance Criteria and Device Performance
The provided document doesn't explicitly state quantitative acceptance criteria for device performance in the traditional sense of a study testing performance metrics against predefined thresholds. Instead, the "acceptance criteria" are implied by the device's conformance to established industry standards and its substantial equivalence to previously cleared devices. The study detailed is a demonstration of conformance to these standards, not a performance study with numerical criteria.
Note: The tables in the document (Tables 1.3-1 to 1.3-6) list "Clinical Application" and "Mode of Operation" and indicate whether these were "previously cleared by FDA" ("P"). This signifies that the intended uses and technological characteristics were already deemed acceptable based on prior 510(k) clearances. This submission is for an expansion of marketing claims for existing cleared devices, not for a new device requiring novel performance testing.
Therefore, the "acceptance criteria" for this specific 510(k) submission are that the device (with its expanded indications for use) still conforms to the safety and performance standards demonstrated in previous clearances, and that the expanded indications do not introduce new technology, software, or hardware changes that would necessitate new performance studies.
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Effectiveness Standards Conformance: Device develops and operates in compliance with recognized regulatory and industry standards. | "SonoSite performs testing in order to verify compliance with the standards." (Refers to AAMI/ANSI/ISO 10993 series, IEC 60601-1, IEC 60601-2-37, NEMA UD 2-2004, NEMA UD 3-2004, ISO 9001:2008, 21 CFR Part 820, EN ISO 13485:2003, EN ISO 14971:2000, RTCA D160E). "SonoSite development records demonstrate compliance and are maintained in the Device History Record, in compliance with 21 CFR 820." "The device conforms to applicable electromedical device safety standards with compliance verified through independent evaluation and ongoing factory audits." |
| New Technology/Software/Hardware: Expanded indications do not introduce new technologies, software, or hardware that would require new performance studies. | "This 510(k) premarket notification includes no changes, including no new system functions or technology changes, to the ultrasound systems, transducers, or accessories that were the subjects of the above-referenced submissions." "This update required no new technology, no new software, and no new instructions for use." "As this submission is in support of expanding marketing claims only, there have been no changes to technology, software or hardware. As such no additional testing was performed in support of this submission." |
| Substantial Equivalence: The device remains substantially equivalent to previously cleared predicate devices. | "SonoSite, Inc., believes that the SonoSite Ultrasound Systems described in this Submission, and previously cleared on 510(k)'s K071134, K082098 and K092058 are substantially equivalent to the SonoSite 180 Hand Carried Ultrasound System (K014116)." "It is the opinion of SonoSite, Inc. that the SonoSite Series Ultrasound System is substantially equivalent with regard to safety and effectiveness to other devices already cleared for marketing." |
| Clinical Application Extension: The expanded clinical applications (specifically identifying "Presence and location of fluid around the heart and lungs, aid in pericardialcentesis and pleuralcentesis and visualize bloodflow through cardiac valves") are consistent with current clinical practice and FDA guidelines. | "This clinical application and intended use is consistent with current clinical practice and FDA guidelines. Ultrasound is commonly used to visualize existing landmarks in the anatomy, and the use of diagnostic ultrasound for the evaluation of fluid flow in the cardiac system, including lung is well established. Specific clinical application to the discrimination of Lung anatomy, including other types of anatomical detail, adds no significant risk to the general indication for use." |
Study Information
The document explicitly states that no new testing was performed for this specific 510(k) submission. This submission solely focuses on expanding marketing claims for already cleared devices without any changes to the technology, software, or hardware. Therefore, information regarding sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth for new studies is not applicable to this 510(k) submission.
The "study" referenced in the document is the prior verification and validation performed during the original clearances of the predicate devices (K071134, K082098, K092058, and ultimately K014116 as the base predicate). The current submission relies on the established safety and effectiveness of those prior clearances and the fact that no changes have been made that would invalidate those prior assessments.
Below is a breakdown based on the general nature of such a submission when relying on previous clearances, noting that specific details for those prior clearances are not provided in this document.
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable to this submission. The document states, "As this submission is in support of expanding marketing claims only, there have been no changes to technology, software or hardware. As such no additional testing was performed in support of this submission." The clinical applications ("P" for previously cleared) were established in prior 510(k)s (K092058, K071134, K082098, K014116). The specific details of the test sets for those prior submissions are not described here.
-
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 to this submission. See point 1. The document does not describe any new clinical studies requiring ground truth establishment by experts for this submission.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable to this submission. See point 1.
-
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 a diagnostic ultrasound system, not an AI-based interpretation or diagnostic aid. No MRMC study is described. The submission extends indications for a human-operated imaging device.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a diagnostic ultrasound system intended for human operation, not a standalone algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable to this submission. For the prior clearances that established the "P" (previously cleared) indications, it's generally understood that diagnostic ultrasound systems are evaluated based on their ability to produce clinically acceptable images that allow trained clinicians (experts) to make diagnoses. The ground truth for such systems typically relies on established clinical evaluation by medical professionals, potentially corroborated by other diagnostic modalities or pathology where relevant. However, this specific document does not detail how ground truth was established for the prior clearances.
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The sample size for the training set:
- Not applicable. This is a hardware/software diagnostic ultrasound system, not an AI model that requires a "training set" in the machine learning sense. The "development records" mentioned refer to product design and testing, not AI model training.
-
How the ground truth for the training set was established:
- Not applicable. See point 7.
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(86 days)
The SonoSite NanoMaxx Series Ultrasound System is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Fetal/OB; Abdominal; Pediatric; Small Organ (breast, thyroid, testicles, prostate); Peripheral Vessel; Intra-operative (abdominal organs, vascular); Musculoskeletal Conventional & Superficial, Cardiac Adult and Pediatric.
The SonoSite NanoMaxx Series Ultrasound System is a full featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data in 2D, Doppler, Color Power Doppler or in a combination of these modes. The hand-carried system weighs less than 6 pounds and has a touch screen interface with minimal controls to facilitate disinfection and cleaning. The System provides measurement capabilities for anatomical structures and fetal biometry that provide information used for clinical diagnostic purposes. The system also includes the ability to measure the intima-media thickness (IMT) of the carotid artery using digital ultrasound images, which is used in conjunction with traditional risk assessment models to assess individual cardiovascular disease risk. The system includes security support to facilitate HIPAA compliance. The system includes a variety of accessories including a stand, dock featuring a video in/out port, a printer port, printer, VESA mounting arm and needle guide kits. The system includes two USB host supports for peripherals such as input devices and storage devices. Input devices include wired and wireless devices such as keyboard, and mouse. Storage devices include devices such as memory sticks, hard drives, and CDs. The system also features SiteLink™ allowing an additional method for the export of patient data. The System/Transducer is capable of exceeding a TI or an MI of 1.0 in certain operating modes or mode combinations. The System monitor displays the current output level in terms of the bioeffects indices ("Mechanical Index [MI]" and "Thermal Index [TI]") in accordance with the AIUM/NEMA Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment.
The provided text is a 510(k) Summary for the SonoSite NanoMaxx™ Series Ultrasound System. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed studies demonstrating novel performance against defined acceptance criteria. Therefore, the document does not contain explicit acceptance criteria or detailed study information of the type requested.
The document primarily focuses on:
- Substantial Equivalence: Stating that the device is substantially equivalent to existing SonoSite Maxx Series Ultrasound Systems and Philips Medical Systems HDP 5000 Ultrasound System.
- Device Description: A general overview of the SonoSite NanoMaxx system's features, modes of operation (2D, Doppler, Color Power Doppler), measurement capabilities, and compliance with various medical device standards.
- Intended Use/Indications for Use: Listing the clinical applications for which the device is intended (e.g., Fetal/OB, Abdominal, Cardiac, Vascular, etc.) for the system as a whole and for specific transducers.
- Technological Characteristics: Highlighting acoustic output limits and adherence to bioeffects indices standards.
Therefore, many sections of your requested output table cannot be filled from the provided text. The information below reflects what can be extracted.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from document) | Reported Device Performance (from document) |
|---|---|
| Acoustic Output Limits: | Met: |
| - ISPTA (d) Maximum: 720 mW/cm² | - ISPTA (d): 720 mW/cm² (Maximum) |
| - Tis/Tib/Tic Range: 0.0 - 4.0 | - Tis/Tib/Tic: 0.0 - 4.0 (Range) |
| - Mechanical Index (MI) Maximum: 1.9 | - Mechanical Index (MI): 1.9 (Maximum) |
| - ISPPA (d) Range: 0 - 700 W/cm² | - ISPPA (d): 0 - 700 W/cm² (Range) |
| Compliance with Standards: | Met (Implicitly stated by compliance with standards): The system is designed to comply with a range of standards including: - AAMI/ANSI/ISO 10993 (Biological evaluation of medical devices)- IEC 60601-1 (General requirements for safety)- IEC 60601-2-37 (Safety of ultrasonic medical diagnostic and monitoring equipment)- NEMA UD 2-2004 (Acoustic Output Measurement Standard)- NEMA UD 3-2004 (Real-Time Display of Thermal and Mechanical Acoustic Output Indices, explicitly stating adherence to on-screen display feature)- ISO 9001:2008 (Quality management systems)- 21 CFR Part 820 (Quality System Regulation)- EN ISO 13485:2003 (Quality management systems for regulatory purposes)- EN ISO 14971:2000 (Application of risk management)- RTCA D160E (Emission of Radio Frequency Energy) |
| Intended Use: (as defined by FDA guidance documents and listed clinical applications; functional equivalence to predicate devices) | Met (Implicitly stated through substantial equivalence to predicate devices and listed indications): The device functions to "acquire and display high-resolution, real-time ultrasound data in 2D, Doppler, Color Power Doppler or in a combination of these modes." It provides "measurement capabilities for anatomical structures and fetal biometry." The listed indications for use are extensive, covering: Fetal/OB, Abdominal, Pediatric, Small Organ, Peripheral Vessel, Musculo-skeletal (Conventional & Superficial), Cardiac (Adult & Pediatric), and Intra-operative (abdominal organs, vascular, spinal cord for nerve blocks). |
| Functional Equivalence: (to predicate devices, meaning it operates in the same way and produces similar diagnostic information capabilities) | Met (Explicitly stated): "This device operates identically to the predicate devices in that piezoelectric material in the transducer is used as an ultrasound source to transmit sound waves into the body. Sound waves are reflected back to the transducer and converted to electrical signals that are processed and displayed as 2D mages. Doppler shift caused by blood flow is displayed as Color Flow, or as spectrum analysis. The modes of this device (2D, velocity color) are the same as a combination of the predicate devices identified in item 3." It also claims the limits for acoustic output are "the same as predicate Track 3 devices." |
Regarding a "study that proves the device meets the acceptance criteria":
For a 510(k) submission, the "study" is often a comparison to a predicate device, focusing on functional, technological, and safety equivalence rather than a new clinical trial demonstrating efficacy or performance against novel criteria. The document states:
"SonoSite, Inc. believes that the System described in this Submission is substantially equivalent to a combination of the SonoSite Maxx Series Ultrasound System (K071134 and K082098), and the Philips Medical Systems (formerly Advanced Technology Laboratories) HDP 5000 Ultrasound System (K034003 and K011224)."
This implies that the "proof" is based on demonstrating that the NanoMaxx system has the same technological characteristics, intended use, and similar performance to these legally marketed predicate devices, and that any differences do not raise new questions of safety or effectiveness. The document itself does not describe a specific clinical performance study designed to test specific acceptance criteria on a patient cohort for the purpose of this 510(k). The "studies" primarily referenced are compliance with various engineering, safety, and quality standards.
Filling the additional information points:
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not provided. The document does not describe a test set or clinical study with a specified sample size.
- The "study" here is essentially the comparison of technical specifications and intended uses to predicate devices.
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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 test set with ground truth established by experts is described for this 510(k) submission.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No test set adjudication is described.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is a diagnostic ultrasound system, not an AI-assisted interpretation device. The document does not describe any MRMC study or AI components.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This is a diagnostic ultrasound system requiring a human operator to perform imaging and interpretation.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. No specific ground truth establishment is described for performance evaluation beyond general functional equivalence to predicate devices and compliance with technical standards.
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The sample size for the training set:
- Not applicable. This document is for a conventional ultrasound system and does not mention machine learning or AI models requiring a "training set."
-
How the ground truth for the training set was established:
- Not applicable. As above.
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(31 days)
The device is intended for prescription use (Per 21 CFR 801.109) for diagnostic ultrasound imaging or fluid flow analysis of the human body in the following clinical applications: Ophthalmic, Fetal - OB/GYN, Abdominal, Intra-operative (Abdominal organs and vascular), Intra-operative (Neuro.), Laparoscopic, Pediatric, Small Organ (breast, thyroid, testicles, prostate), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-skel. (Conventional), Musculo-skel. (Superficial), Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card.), Peripheral vessel.
SiteLink™ Image Manager is a software accessory for SonoSite Maxx Series medical diagnostic ultrasound systems. SiteLink enables image download, in full resolution .bmp format or compressed .jpg format, from SonoSite systems to a Windows-based PC.
The SonoSite® DICOM/Clips Bundle is a software option available on SonoSite Maxx Series™ medical diagnostic uitrasound systems. It is intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation.
The SonoSite Maxx Series Ultrasound System is a full featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data in 2D, 2D Chroma, THI, M-Mode, Pulsed Wave (PW) Doppler, Continuous Wave (CW) Doppler, Color Power Doppler, Velocity Color Doppler, Anatomical M-Mode, Color M-Mode, Pulsed Wave Tissue Doppler Imaging (PW-TDI), Color Tissue Doppler Imaging (Color-TDI), Elastography (Strain), Strain Rate Imaging, tissue 4D and flow 3D imaging or in a combination of these modes. The SonoSite Maxx Series is a design that readily lends itself to be configured to specific ultrasound imaging applications through physical packaging and system feature selections.
The provided document is a 510(k) Summary of Safety and Effectiveness for the SonoSite Maxx™ Series Ultrasound System and its associated transducers. This type of document is used to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove specific performance metrics against acceptance criteria in the way a clinical study report would for a new feature or algorithm.
Therefore, the document does not contain acceptance criteria or a study that proves the device meets specific acceptance criteria in terms of accuracy, sensitivity, or other quantitative performance measures for an AI/algorithm.
Instead, the document focuses on demonstrating substantial equivalence by stating that the device is compliant with existing standards and has comparable technological characteristics, safety, and effectiveness to its predicate devices.
Here's a breakdown of why the requested information is absent:
-
A table of acceptance criteria and the reported device performance: This is not present in the document. The tables (4.3-1 through 4.3-34) list "Indications for Use" for the main system and various transducers, detailing the clinical applications and available modes of operation (B-mode, M-mode, Pulsed Wave Doppler, Continuous Wave Doppler, Color Doppler, and combined modes). They indicate whether these indications were "previously cleared by FDA" (P) or are "new indications" (N). This is a statement of intended use and cleared functionalities, not a performance report against acceptance criteria.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): The document does not describe any specific test set or data used to evaluate the performance of a new algorithm or feature. It mentions "The device is verified and validated according to the company's design control process," but details of such testing (including sample size or data provenance) are not provided in this summary.
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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): Since no specific performance study against a test set is described, there is no mention of experts or their qualifications for establishing ground truth.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: As no test set performance is detailed, there is no information on an adjudication method.
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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: This document predates widespread AI integration in medical devices. There is no mention of AI, human readers, or MRMC studies. The device is a diagnostic ultrasound system, and the clearance is for its functionalities as an imaging system and associated accessories (SiteLink Image Manager, DICOM/Clips Bundle).
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No standalone algorithm performance is discussed, as the device is an ultrasound system with various imaging modes, not an AI algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as detailed performance validation against an established ground truth is not provided in this summary.
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The sample size for the training set: Not applicable, as there is no indication of an AI/machine learning algorithm that would require a training set.
-
How the ground truth for the training set was established: Not applicable, for the same reason as point 8.
In summary, the provided document is a regulatory submission demonstrating substantial equivalence for a diagnostic ultrasound system and its transducers to existing predicate devices. It confirms compliance with design control processes and safety standards but does not include specific performance data or studies that would typically be required to prove an AI/algorithm meets detailed acceptance criteria.
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(15 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Ophthalmic, Fetal - OB/GYN, Abdominal, Intra-operative (Abdominal organs and vascular), Intra-operative (Neuro.), Laparoscopic, Pediatric, Small Organ (breast, thyroid, testicles, prostate), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-skel. (Conventional), Musculo-skel. (Superficial), Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card.), Peripheral vessel.
The SonoSite Maxx Series Ultrasound System is a full featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data in 2D, M-Mode, Pulsed Wave (PW) Doppler, Continuous Wave (CW) Doppler, Color Power Doppler, and Velocity Color Doppler or in a combination of these modes. The SonoSite Maxx Series is a design that readily lends itself to be configured to specific ultrasound imaging applications through physical packaging and system feature selections. The System has an electrocardiography (ECG) display feature and supports a 3-lead ECG cable assembly to collect data for M-mode and Doppler measurements. The System provides measurement capabilities for anatomical structures and fetal biometry that provide information used for clinical diagnostic purposes. The System has a PW and CW Doppler audio output feature and cine review, image zoom, labeling, bionsy, measurements and calculations, image storage and review, printing, and recording capabilities. The system includes the ability to measure the intima-media thickness (IMT) of the carotid artery using digital ultrasound images. The IMT measurement of the carotid artery may be used adjunctively with other medical data obtained by a physician to help assess the cardiovascular health of a patient. The system includes Digital Imaging and Communications (DICOM) capabilities as well as general computer communication capabilities to provide the acceptance, transfer, display, storage, and digital processing of ultrasound images and loops. Security support is also provided to facilitate HIPAA compliance. The system includes a variety of accessories including a mobile docking system, external monitor, bar code reader, digital video disk recorder, printer, VCR, and biopsy/needle guide kits. The system includes USB host support for peripherals such as input devices and storage devices include wired and wired and wireless devices such as keyboard, mouse, remote. Storage devices include wired and wireless devices such as memory sticks, hard drives, CDs, 802.11 devices. The SonoSite Maxx Series Ultrasound System is designed to accept curved or linear transducers of the types and frequency listed in the table below. All actions affecting the performance of the transducer are activated from the main system control panel.
The provided text describes the SonoSite Maxx™ Series Ultrasound System and its various transducers, along with their intended uses and compliance with regulatory standards. It does not contain information about acceptance criteria or a specific study proving the device meets those criteria, as typically found in a performance study section.
Therefore, most of the requested information cannot be extracted from the given text. The document is primarily a 510(k) Summary of Safety and Effectiveness for the SonoSite Maxx™ Series Ultrasound System, focusing on its description, intended uses, and substantial equivalence to predicate devices, along with compliance with recognized standards.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Cannot be answered from the text. The document lists acoustic output limits as therapeutic safety limits, not as performance acceptance criteria for clinical efficacy. It does not provide detailed performance metrics for specific medical imaging tasks or a comparison against predefined acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be answered from the text. The document does not describe any clinical or technical performance studies that would involve a "test set" in the context of algorithm or device performance evaluation.
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)
- Cannot be answered from the text. No "test set" and corresponding ground truth establishment is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be answered from the text. No "test set" 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
- Cannot be answered from the text. This document is for an ultrasound system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be answered from the text. This document is for an ultrasound system, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Cannot be answered from the text. No ground truth for performance evaluation is mentioned.
8. The sample size for the training set
- Cannot be answered from the text. This information is relevant for AI/ML device submissions, which this is not.
9. How the ground truth for the training set was established
- Cannot be answered from the text. This information is relevant for AI/ML device submissions, which this is not.
Information that can be extracted related to device specifications and safety limits:
Acoustic Output Limits (acting as safety limits, not performance acceptance criteria):
| Parameter | General Use Max/Range | Ophthalmic Use Max/Range |
|---|---|---|
| ISPTA (d) | 720 mW/cm² (Maximum) | 50 mW/cm² (Maximum) |
| Tis/Tlb/Tlc | 0.0 - 4.0 (Range) | 0.0 - 1.0 (Range) |
| Mechanical Index (MI) | 1.9 (Maximum) | 0.23 (Maximum) |
| ISPPA (d) | 0 - 700 W/cm² (Range) | Not specified |
The document states these limits are "the same as predicate Track 3 devices," indicating that meeting these safety limits is part of demonstrating substantial equivalence to previously cleared devices. Compliance with these limits is typically verified through engineering testing and measurements, not a clinical study to establish performance against acceptance criteria. The document explicitly states that the determination of substantial equivalence is granted "on the condition that prior to shipping the first device, you submit a postclearance special report... including acoustic output measurements based on production line devices."
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(15 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Ophthalmic, Fetal - OB/GYN, Abdominal, Intra-operative (Abdominal organs and vascular), Intra-operative (Neuro.), Laparoscopic, Pediatric, Small Organ (breast, thyroid, testicles.), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Musculo-skel. (Conventional), Musculo-skel. (Superficial), Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card.), Peripheral vessel.
The MicroMaxx™ High-Resolution Ultrasound System (C3 Series) is a full featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display highresolution, real-time ultrasound data in 2D, M-Mode, Pulsed Wave (PW) Doppler, Continuous Wave (CW) Doppler, Color Power Doppler, and Velocity Color Doppler or in a combination of these modes. The System has an electrocardiography (ECG) display feature and supports a 3-lead ECG cable assembly to collect data for M-mode and Doppler measurements. The System provides measurement capabilities for anatomical structures and fetal biometry that provide information used for clinical diagnostic purposes. The System has a PW and CW Doppler audio output feature and cine review, image zoom, labeling, biopsy, measurements and calculations, image storage and review, printing, and recording capabilities. The system includes the ability to measure the intima-media thickness (IMT) of the carolid artery using digital ultrasound images. The IMT measurement of the carotid artery may be used adjunctively with other medical data obtained by a physician to help assess the cardiovascular health of a patient. The system includes Digital Imaging and Communications (DICOM) capabilities as well as general computer communication capabilities to provide the acceptance, transfer, display, storage, and digital processing of ultrasound images and loops. Security support is also provided to facilitate HIPAA compliance. The MicroMaxx™ High-Resolution Ultrasound System (C3 Series) is designed to accept curved or linear transducers of the types and frequency listed in the table below. All actions affecting the performance of the transducer are activated from the main system control panel.
The provided document is a 510(k) Premarket Notification for the Sonosite MicroMaxx High-Resolution Ultrasound System (C3 Series) and its associated transducers. This type of document is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific, quantitative acceptance criteria through a study with a dedicated test set and ground truth.
Therefore, the information typically requested in your prompt regarding acceptance criteria, specific study designs (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance), and details about training sets and ground truth methodologies for AI/ML devices is not applicable to this 510(k) submission for a diagnostic ultrasound system.
This document focuses on demonstrating that the new device has the same intended use and similar technological characteristics as predicate devices, and that any differences do not raise new questions of safety or effectiveness.
However, I can extract the relevant information presented in the document pertaining to the device's characteristics and its compliance with recognized standards, which serve as a form of "acceptance criteria" for regulatory clearance based on substantial equivalence.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and the Reported Device Performance:
Since this is a 510(k) submission for an ultrasound system, the "acceptance criteria" are not reported as performance metrics like accuracy, sensitivity, or specificity against a clinical ground truth, but rather as compliance with regulatory standards and alignment with the capabilities of predicate devices. The "reported device performance" is essentially the device's specifications and features.
| Acceptance Criteria (Regulatory Compliance / Predicate Equivalence) | Reported Device Performance (Device Specifications) |
|---|---|
| Intended Use: Device performs diagnostic ultrasound imaging or fluid flow analysis for various clinical applications as specified by FDA guidance documents. | Clinical Applications Supported: Ophthalmic, Fetal (OB/GYN), Abdominal, Intra-operative (Abdominal organs and vascular), Intra-operative (Neuro.), Laparoscopic, Pediatric, Small Organ (breast, thyroid, testicles), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Musculo-skel. (Conventional), Musculo-skel. (Superficial), Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card.), Peripheral vessel. (Tables 4.3-1 to 4.3-8 and section 5 of the 510(k) Summary). |
| Imaging Modes: Device supports standard diagnostic ultrasound imaging modes. | Supported Modes: 2D, M-Mode, Pulsed Wave (PW) Doppler, Continuous Wave (CW) Doppler, Color Power Doppler, Velocity Color Doppler, or combinations thereof. Electrocardiography (ECG) display feature for M-mode and Doppler measurements. (Section 4 of 510(k) Summary) |
| Measurement Capabilities: Device provides standard measurement capabilities. | Measurement Capabilities: Anatomical structures and fetal biometry. Intima-media thickness (IMT) of the carotid artery. (Section 4 of 510(k) Summary) |
| Connectivity and Data Handling: Device integrates with standard medical imaging and communication systems. | Connectivity: Digital Imaging and Communications (DICOM) capabilities, general computer communication capabilities for acceptance, transfer, display, storage, and digital processing of ultrasound images and loops. Security support for HIPAA compliance. (Section 4 of 510(k) Summary) |
| Frequency Range of Transducers: Capable of operating within a specified frequency range. | Frequency Range: 2.0 - 12.0 MHz. (Section 4 of 510(k) Summary) |
| Transducer Types Supported: Compatible with various transducer types. | Transducer Types: Linear array, Curved array, Intracavitary array, Phased array, Static probes. Specific cleared transducers listed include: D2/2 2.0 MHz Dual Element Circular Array; C60e/5-2 5.0-2.0 MHz Curved Array; HFL38/13-6 13.0-6.0 MHz Linear Array; SLA/13-6 13.0-6.0 MHz Linear Array; LAP/12-5 12.0-5.0 MHz Linear Array Laparoscopic; L38e/10-5 10.0-5.0 MHz Linear Array; TEE/8-3 8.0-3.0 MHz Trans-esophageal Echocardiography; SLT/10-5 10.0-5.0 MHz Linear Array; P10/8-4 8.0-4.0 MHz Phased Array; P17/5-1 5.0-1.0 MHz Phased Array. (Page 1 of the letter & Section 4 of 510(k) Summary) |
| Regulatory Standards Compliance: Device complies with relevant FDA-recognized consensus standards and miscellaneous design standards for medical electrical equipment, safety, biological evaluation, acoustic output, and electromagnetic compatibility. | Compliance List (Examples): AAMI/ANSI/ISO 10993-1, AIUM Medical Ultrasound Safety, ANSI/AAMI EC53, EN 980 A1, IEC 60601-1 (and amendments), IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-25, IEC 60601-2-37, NEMA UD 2-2004, NEMA UD 3-2004, ASTM D5276-98, ASTM D999-96, CISPR 11, EN 60529, JIS standards, RTCA/DO160D, UL 60601-1, UL 94, EN ISO 13485, EN ISO 14971, ACR-NEMA DICOM version 3.0 - 2003. (Section 4 of 510(k) Summary) |
| Acoustic Output Limits: Device's acoustic output remains within specified safe limits. | Acoustic Output Limits (Non-Ophthalmic): ISPTA(d) max=720 mW/cm², Tis/Tlb/Tlc range=0.0-4.0, Mechanical Index (MI) max=1.9, ISPPA(d) range=0-700 W/cm². Acoustic Output Limits (Ophthalmic): ISPTA(d) max=50 mW/cm², Tls/Tlb/Tic range=0.0-1.0, Mechanical Index (MI) max=0.23. These limits are stated to be the same as predicate Track 3 devices. (Section 6 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)
- This 510(k) submission does not describe a clinical study in the typical sense with a "test set" of images or patient data for performance evaluation against a ground truth. Instead, it demonstrates substantial equivalence to predicate devices, which means it fulfills the same intended uses with similar technological characteristics without raising new questions of safety or effectiveness.
- The document primarily references engineering and safety standards compliance.
- Data provenance for clinical performance is not applicable or 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)
- Not applicable. This submission doesn't detail a study involving expert-established ground truth for performance evaluation of a new algorithm.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This submission doesn't detail a study with adjudicated ground truth.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is not an AI/ML device and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a diagnostic ultrasound system, not an algorithm being evaluated for standalone performance. Its performance is inherent to the imaging technology and operator use.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. The clearance is based on substantial equivalence, not a direct clinical performance study with a specific ground truth.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device, so there is no training set in the context of machine learning model development.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set for an AI/ML model.
In summary: The provided document is a regulatory submission demonstrating substantial equivalence for a diagnostic ultrasound system. It focuses on comparing the device's intended use and technical specifications with existing, legally marketed predicate devices, and on compliance with recognized safety and performance standards. It does not contain information about clinical performance studies with specific acceptance criteria, test sets, or ground truth methodologies that would be typical for an AI/ML device or a novel clinical diagnostic tool requiring such rigorous validation.
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(7 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Small Organ (breast, thyroid, testicles, prostate)
The device referenced in this Submission is a highly portable, software-controlled, diagnostic ultrasound system with accessories. This Submission does not include any technological or feature changes from the previously cleared SonoSite devices or transducers.
The provided text is a 510(k) Summary of Safety and Effectiveness for a diagnostic ultrasound system. It addresses an application to add a new clinical application ("Small Organ") to an existing device.
Here's an analysis of the acceptance criteria and study information, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes the device's compliance with various safety and performance standards for ultrasound systems and medical devices. However, it does not specify quantitative performance acceptance criteria (e.g., sensitivity, specificity, resolution) for the imaging quality relevant to the new "Small Organ" application, nor does it provide a table of reported device performance against such criteria.
Instead, the acceptance criteria are implicitly that the device continues to meet the safety and effectiveness standards of its predicate device and applicable recognized consensus standards, with the new clinical application being demonstrated as substantially equivalent.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Conformance to applicable medical device safety standards (acoustic output, biocompatibility, cleaning/disinfection, thermal, electrical, mechanical safety). | The SonoSite Hand-Carried Ultrasound System (C1 Series) was evaluated for academic output, biocompatibility, cleaning and disinfection effectiveness, as well as thermal, electrical, and mechanical safety, and was found to conform to applicable medical device safety standards (listed in Section 4). These reports were included in previous predicate submissions. |
| Substantial equivalence in safety and effectiveness to the predicate device (Advanced Technology Laboratories HDI 5000 Ultrasound System (K011224)) for the "Small Organ" application. | The applicant believes that the testing and analysis (referencing previously submitted reports and the fact that the added indication is not novel) demonstrates that the SonoSite Hand-Carried Ultrasound System (C1 Series) and the "Small Organ" indication on the C60/5-2 5.0-2.0 MHz Curved Array transducer are substantially equivalent with respect to safety and effectiveness to the identified predicate device. No new clinical testing was required as the added indication is not a novel indication and the anatomical site is amenable to current transducer and post-processing ultrasound technology. |
2. Sample Size Used for the Test Set and Data Provenance:
The document explicitly states: "No additional clinical testing is required, as the added indication for use is not a novel indication as shown by the predicate devices in Section 3."
This indicates there was no specific clinical test set used for this particular submission to evaluate the "Small Organ" application. The data provenance is effectively based on the previously cleared predicate device and the existing SonoSite system.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Since no new clinical test set was required and no clinical study was performed for this submission, there were no experts specifically engaged to establish ground truth for a test set related to the "Small Organ" application. The determination of substantial equivalence relies on existing regulatory clearances and technical specifications.
4. Adjudication Method for the Test Set:
Not applicable, as no new clinical test set was used for this submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:
Not applicable. This submission is for an ultrasound system, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This is for a diagnostic ultrasound system, not a standalone algorithm.
7. The Type of Ground Truth Used:
The ground truth for this submission is based on the established safety and effectiveness of the predicate device (Advanced Technology Laboratories HDI 5000 Ultrasound System (K011224)) which already included "Small Organ" as a clinical application. The argument is that the SonoSite system, with its existing cleared technologies, is capable of performing this application equivalently. The document implies that the "anatomical site is amenable to current transducer and post-processing ultrasound technology available with the SonoSite Hand-Carried Ultrasound System (C1 Series) and predicate devices."
8. The Sample Size for the Training Set:
Not applicable. This submission does not involve a machine learning or AI model 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.
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