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The Digital Color Doppler Ultrasound System is a general-purpose ultrasonic instrument intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (pediatric and adult), Trans-esoph (Cardiac), Laparoscopic, OB/Gyn and Urology. The Modes of Operation include B, M, PW Doppler, CW Doppler, Color M Doppler, Power Doppler, Tissue Harmonic Imaging, Power Doppler Imaging, Directional Power Doppler Imaging, Tissues Doppler Imaging, Pulse Inversion Harmonic Imaging, 3D/4D Imaging mode, Elastography Imaging, Contrast imaging, Panoramic Imaging, Trapezoid Imaging and their combination modes, and the system is intended to be used in a hospital or medical clinic.

This SonoScape S60 Elite Series Digital Color Doppler Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The basic principle is that system transmits ultrasonic energy into patient body and implements post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body. This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array. This system consists of a mobile console with touch screen and keyboard control panel, power supply module, color LCD monitor and optional probes. This system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound data and to display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Wave Doppler, Continued Wave Doppler, Power Doppler and Directional Power Doppler Imaging, or the combination of these modes, Contrast lmaging, Elastography, 3D/4D.

The medical device in question is the Sonoscape S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System (K201059).

Based on the provided document, here's the information regarding its acceptance criteria and supporting study:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• The document states that non-clinical tests (electrical safety, EMC, acoustic, biocompatibility, software verification/validation) were performed.
• No clinical testing was required for this 510(k) submission.
• Therefore, there is no specific "test set" in terms of patient data for an AI algorithm as typically understood in such studies. The evaluation focused on engineering and performance parameters against established standards.
• Data provenance: Not applicable as no clinical data test set was used.

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

• Not applicable. Since no clinical test set was utilized and no AI algorithm with independent ground truth establishment was conducted, there were no experts needed to establish ground truth for a clinical test set. The device is an ultrasound system, not an AI diagnostic tool requiring clinical ground truth for performance evaluation in this submission.

4. Adjudication Method for the Test Set:

• Not applicable. No clinical test set or subjective interpretations requiring adjudication were part of this 510(k) submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

• No. An MRMC comparative effectiveness study was not performed. This submission is for a general-purpose ultrasound system, not an AI-assisted diagnostic tool that would typically undergo such a study to evaluate reader performance with and without AI.

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

• No. This is not an AI algorithm. It is a digital color Doppler ultrasound system. The evaluation was of the system's compliance with safety and performance standards.

7. The Type of Ground Truth Used:

• For the non-clinical tests, the "ground truth" was based on the requirements and methodologies outlined in the specified international medical device standards (IEC, ISO, AIUM/NEMA). These standards define objective parameters and testing procedures for assessing the safety and performance of ultrasound systems.

8. The Sample Size for the Training Set:

• Not applicable. This submission does not pertain to an AI algorithm that requires a training set.

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

• Not applicable. As there is no AI algorithm training set, no ground truth needed to be established for it.

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The Diagnostic Ultrasound Systems Aplio i900 Model TUS-AI900, Aplio i800 Model TUS-AI800, Aplio i700 Model TUS-AI700 and Aplio i600 Model TUS-AI600 are indication of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, intra-operative (abdominal), pediatric, small organs, trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediat, transesophageal, musculo-skeletal (both conventional and superficial) and laparoscopic.

The Aplio i900 Model TUS-AI900, Aplio i800 Model TUS-AI800, Aplio i700 Model TUS-AI700 and Aplio i600 Model TUS-AI600, V3.1 are mobile diagnostic ultrasound systems. These systems are Track 3 devices that employ a wide array of probes including flat linear array, convex linear array, and sector array with frequency ranges between approximately 2 MHz to 30 MHz.

The provided text is a 510(k) summary for the Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1. It describes the device's indications for use, its substantial equivalence to predicate devices, and the performance testing conducted. However, the document does not describe a study involving human readers or AI assistance to improve human reader performance. It focuses solely on the device's technical capabilities and its equivalence to other cleared devices. Therefore, I cannot provide details on MRMC studies or human reader improvement with AI assistance based on this document.

For the aspects that are covered, here is the information:

1. Table of Acceptance Criteria & Reported Device Performance:

The document describes performance testing for several features, primarily focusing on proving substantial equivalence to predicate devices and meeting specifications. Specific numerical acceptance criteria are not explicitly detailed in this summary, but the reported device performance implies that the features met specifications and performed as intended.

2. Correct quantitative measurement results (Velocity and Direction). | 1. Color mapping image depicted correctly in terms of spatial distribution of moving bubbles using a wire phantom and test data.
3. Quantitative measurement results (Velocity and Direction) obtained correctly using a string phantom, a flow phantom, and test data. |
   | Breast Scan Guide | Correct display of locational information of an object of interest in the X-ray image (matching breast body mark location in ultrasound with lines calculated from X-ray image locational data). | Correctly displays the locational information of an object of interest in the X-ray image, specifically, the location information of the breast body mark in the ultrasound system matches with the lines calculated using the locational data directly obtained from the X-ray image. |
   | 3D Wall Motion Tracking | Meeting specifications and performing as intended. | Met specifications and performed as intended. |
   | 2D Wall Motion Tracking | Meeting specifications and performing as intended. | Met specifications and performed as intended. |
   | Smart Fusion | Meeting specifications and performing as intended. | Met specifications and performed as intended. |
   | 2nd Console | Meeting specifications and performing as intended. | Met specifications and performed as intended. |

2. Sample Sizes Used for the Test Set and Data Provenance:

The document mentions "test data phantom and in a clinical evaluation" for Limb Volume Measurement, and "a wire phantom and test data" or "a string phantom, a flow phantom and test data" for Contrast Vector Imaging. However, specific sample sizes for these test sets are not provided. The provenance of the "clinical data" / "test data" and "volunteer studies" is not specified (e.g., country of origin, retrospective or prospective).

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

The document does not mention the use of experts to establish ground truth for the described performance tests. The testing appears to rely on physical phantoms and "test data" which would likely have inherent or pre-defined ground truth based on their construction or known properties, or clinical data where the "truth" is established by the device's calculations or outputs being compared against an expected outcome or another measurement method.

4. Adjudication Method for the Test Set:

No information regarding adjudication methods (e.g., 2+1, 3+1, none) is provided. This type of information is usually relevant for studies involving human readers or subjective interpretations, which are not detailed here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, a MRMC comparative effectiveness study was not done according to the provided text. The document describes technical performance testing and "clinical evaluation" but no studies involving human readers evaluating the device's impact on their performance, either with or without AI assistance. The submission focuses on device functionality and substantial equivalence.

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

The performance testing described ("correctly calculated", "depicted correctly", "obtained correctly") relates to the device's algorithmic performance in specific modes and features using phantom and possibly clinical data. This would fall under standalone performance assessment, as it's evaluating the device's output directly against a known or expected result, rather than a human's interpretation.

7. The Type of Ground Truth Used:

The ground truth for the tests described appears to be:

• Physical Phantoms: For Limb Volume Measurement (test data phantom), Contrast Vector Imaging (wire phantom, string phantom, flow phantom). These phantoms are designed with known properties or simulated conditions that serve as ground truth.
• Expected Results/Specifications: For the calculations and depictions, and for the improvements to existing features, the "ground truth" is implied to be that the device's output matches its design specifications and performs as intended.
• Clinical Data: Used in conjunction with phantoms for Limb Volume Measurement. The nature of the ground truth within this clinical data (e.g., pathology, clinical outcomes, or another validated measurement method) is not explicitly stated, but it would logically be a reference standard for the values being calculated (fractional limb volume, EFW).
• X-ray Image Data: For Breast Scan Guide, the locational information from the X-ray image serves as the ground truth against which the ultrasound system's display of the breast body mark is compared.

8. The Sample Size for the Training Set:

The document is a 510(k) summary for an ultrasound system, not explicitly an AI/ML device per se, although it does mention "Smart Navigation" and "Smart 3D". It outlines performance testing for new and improved features and transducer models rather than a specific AI algorithm. As such, the document does not provide information on the sample size of a training set as it is not discussing the development of an AI model.

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

As no training set is discussed or implied to exist for a specific AI algorithm in this Preamarket Notification summary, no information on how ground truth for a training set was established is provided.

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The TEECAD System is intended to provide visualization during the placement of a Transesophageal Echocardiogram (TEE) probe in adults. Do not use this system for any purpose other than the intended use.

The Visura TEE Camera Assist Device (TEECAD) is an accessory that provides visualization for the physician during TEE probe placement. It consists of a very simple design that has two main components:

• Disposable Carrier a single-use carrier with an integrated camera .
• Viewing System a physician interface display unit .
  The TEECAD System is not a diagnostic or therapeutic device. The TEECAD Disposable Carrier acts as an accessory that attaches to the commercially available Philips X7-2t TEE transducer probe and is removed once the probe reaches its target location in the patient's esophagus to allow for normal ultrasound imaging of the heart.
  The TEECAD Disposable Carrier is a single use device, and is designed to be manufactured with commonly used medical device materials that are considered safe for body contact.
  The Viewing System includes software that allows the operator to view the endoscopic images during TEE probe placement. The software is installed by the manufacturer and cannot be accessed, modified or installed by the user.

The provided text does not contain specific acceptance criteria or details of a study that proves the device meets such criteria. It is an FDA 510(k) clearance letter and summary, which confirms the device's substantial equivalence to a predicate device based on non-clinical testing.

Here's what can be extracted based on the provided text, and what information is not available:

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

The document does not provide a table of acceptance criteria or specific reported device performance metrics in detail. It mentions that "the collective results of the non-clinical tests demonstrate that the TEECAD System meets the established specifications necessary for consistent performance for its intended use" and that "the TEECAD System is a safe and effective device." However, the 'established specifications' are not detailed, nor are the specific performance results in a quantifiable manner.

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 refers to "non-clinical tests" including "TEECAD Design Verification and Validation Studies," "Packaging Testing," "Biocompatibility Testing," "Cleaning Validation," "Software Verification and Validation," "Electrical safety, electromagnetic compatibility, and laser safety testing," and "TEECAD System GLP Animal Safety and Performance Report."

• Sample Size for Test Set: Not specified for any of the tests.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
  • The "GLP Animal Safety and Performance Report" implies animal testing, but specifics of the animal model, location, and study design are not given.

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)

This information is not provided. The testing described is "non-clinical" and appears to involve engineering, material science, and animal studies rather than human clinical studies requiring expert ground truth establishment in the traditional sense of diagnostic accuracy.

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

Not applicable or not provided. The described tests are non-clinical and do not involve adjudication by experts for diagnostic or similar outcomes.

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

• MRMC Study: No, an MRMC study was not described. The device, TEECAD System, is an accessory for visualization during TEE probe placement, not an AI diagnostic tool requiring human reader improvement comparison.
• Effect Size: Not applicable.

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

• Standalone Performance: The TEECAD System's "Viewing System includes software that allows the operator to view the endoscopic images during TEE probe placement." The software is not described as an AI algorithm providing diagnostic or analytical output; rather, it facilitates live image viewing. Therefore, a standalone algorithm performance in the context of AI is not relevant or described. The non-clinical tests assess the device's functional and safety performance, which would include the performance of the imaging system itself.

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

Given the non-clinical nature of the studies (design verification, biocompatibility, animal safety), the concept of "ground truth" as typically applied in diagnostic imaging (e.g., pathology, expert consensus) is not directly applicable. The "ground truth" for these tests would be defined by the specified engineering standards, material properties, safety parameters, and physiological responses observed in animal models.

8. The sample size for the training set

Not applicable. The TEECAD System is described as a "very simple design" with hardware components (disposable carrier with integrated camera, viewing system) and software for image viewing. There is no mention of machine learning or an AI algorithm that would require a "training set."

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

Not applicable, as no training set for an AI algorithm appears to be involved.

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