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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:

1. 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.
2. Sample size used for the test set and data provenance: Not applicable as no diagnostic performance study is presented.
3. Number of experts used to establish ground truth and qualifications: Not applicable.
4. Adjudication method: Not applicable.
5. 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.
6. Standalone performance (algorithm only): Not applicable. This device is an ultrasound system operated by a human user.
7. Type of ground truth used: Not applicable for a performance study. Clinical diagnostic use implies clinicians interpret the images.
8. Sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.
9. How ground truth for the training set was established: Not applicable.

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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

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.

1. 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.

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

   • 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.

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

   • Not applicable to this submission. See point 1.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • 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.

5. 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.

6. 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.

7. 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.

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

   • Not applicable. See point 7.

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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

• 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:

1. 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.

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

   • Not applicable. No test set with ground truth established by experts is described for this 510(k) submission.

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

   • Not applicable. No test set adjudication is described.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No. This is a diagnostic ultrasound system, not an AI-assisted interpretation device. The document does not describe any MRMC study or AI components.

5. 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.

6. 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.

7. 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."

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

   • Not applicable. As above.

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