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The SonoSite Maxx™ 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 include: Ophthalmic, Fetal - OB/GYN, Abdominal, Intraoperative (abdominal organs and vascular), Intra-operative (Neuro.), Pediatric, Small Organ (breast, thyroid, testicle, prostate), Neonatal Cephalic, Trans-Rectal, Trans-Vaginal, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Cardiac Pediatric, Trans-esophageal (cardiac), 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 a number of exam types and clinical applications. The SonoSite Maxx Series is a design that readily lends itself to be configured to specific ultrasound imaging applications through physical packaging adaptations and system feature selections. Maxx Series can operate on either battery or AC power.

The provided document is a 510(k) summary for the FUJIFILM SonoSite Maxx™ Series Ultrasound System and its associated transducers. This submission focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than performing novel clinical studies to establish new acceptance criteria. Therefore, the document primarily lists the features and performance of the device and compares them to the predicate devices, rather than defining specific acceptance criteria for performance metrics and studies to prove they are met.

Based on the document, here's the information that can be extracted or inferred:

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

The document does not define specific quantitative "acceptance criteria" for the device's imaging performance (e.g., sensitivity, specificity, accuracy). Instead, it establishes substantial equivalence by demonstrating that the device's technological characteristics, intended use, and indications for use are comparable to legally marketed predicate devices and that it complies with relevant safety and performance standards.

The "reported device performance" is implicitly that it performs equivalently to the predicate devices for the listed applications and modes. The tables provided (Table 1.3-1 to 1.3-17) list the clinical applications and modes of operation for the main system and each transducer. "P" indicates that these indications and modes were "previously cleared" for the predicate devices, which implies the current device meets existing performance expectations for these.

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

The document explicitly states: "The SonoSite Maxx Series Ultrasound System and transducers did not require clinical studies to support the determination of substantial equivalence." This means there was no specific "test set" of patient data used for clinical performance validation as would be the case for a new or significantly modified device. The data provenance is therefore not applicable in the context of clinical performance testing.

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)

Since no clinical studies were performed, there was no "test set" or explicit "ground truth" establishment by experts for performance metrics.

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

Not applicable, as no clinical studies with test sets were performed.

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

Not applicable. This device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool, and no MRMC studies are mentioned.

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

Not applicable. This is a medical imaging device, not an algorithm.

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

Not applicable, as no clinical studies with specific performance endpoints requiring ground truth were performed. The "ground truth" for this 510(k) submission relies on demonstrating substantial equivalence to predicate devices that have an established history of safety and effectiveness, meaning their performance was already accepted by regulatory bodies.

8. The sample size for the training set

Not applicable, as this is not an AI/ML device that requires a training set.

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

Not applicable, as this is not an AI/ML device that requires a training set and ground truth for it.

In summary:

The submission for the SonoSite Maxx™ Series Ultrasound System is a 510(k) premarket notification. This type of submission aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. For such submissions, extensive new clinical performance studies are often not required if the device is sufficiently similar to existing ones.

In this case, the manufacturer has established substantial equivalence by:

• Comparing the Intended Use and Indications for Use of the new device and its transducers to those of predicate devices (K082098, K101757, K113156, K112953). The tables indicate that almost all applications and modes ("P" for previously cleared) are identical or highly similar to those cleared for the predicate devices.
• Detailing the Technological Characteristics (e.g., transducer types, frequency, modes of operation, system specifications) and showing they are equivalent to or improve upon predicate devices without introducing new safety or effectiveness concerns.
• Demonstrating compliance with a comprehensive list of national and international safety and performance standards (e.g., IEC 60601 series for electrical safety, ISO 10993 series for biocompatibility, NEMA UD series for acoustic output). These standards define a baseline of acceptable performance and safety for such devices.
• Explicitly stating that clinical studies were not required, as the equivalence was demonstrated through non-clinical testing and comparison to predicates.

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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 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:

1. 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.

2. 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.

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): Since no specific performance study against a test set is described, there is no mention of experts or their qualifications for establishing ground truth.

4. 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.

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: 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).

6. 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.

7. 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.

8. 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.

9. 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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