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The SonoScape S9 system is a general-purpose ultrasonic intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Transrectal, Trans-vaginal, Peripheral Vascular, Cerebral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), Trans-esoph.(Cardiac), Laparoscopic, OB/Gyn and Urology.

This SonoScape S9 Portable 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 with a frequency range of 1.0 MHz to 15.0 MHz. This system consists of a portable console with touch screen and keyboard control panel, power supply module, color LCD monitor and optional probes. This system is a portable, 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 and Power Doppler, or the combination of these modes, Elastography, 3D/4D. The subject of this submission is the addition of new probes to legally marketed SonoScape S9.

The provided text is a 510(k) Summary for the SonoScape S9 Portable Digital Color Doppler Ultrasound System. It outlines the device's technical characteristics, intended use, and comparison to a predicate device to demonstrate substantial equivalence.

However, the document does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria in the context of an AI/ML medical device. It is for an ultrasound system, not an AI/ML algorithm.

Therefore, I cannot extract the requested information regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study results or effect size.
6. Standalone (algorithm only) performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document focuses on demonstrating substantial equivalence to a predicate device (SonoScape S9 Portable Digital Color Doppler Ultrasound System K142710) based on similar intended uses, technical characteristics, and compliance with safety standards for an ultrasound machine and its transducers. It explicitly states: "No clinical testing was required." and "Laboratory tests (including Phantom tests) were conducted to verify that the S9 system met all design specifications and the S9 system conformed to applicable medical device standards." This indicates a traditional medical device clearance pathway, not one typically involving the robust performance validation studies seen with AI/ML devices.

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The SonoScape S9 system is a general-purpose ultrasonic intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Transrectal, Trans-vaginal, Peripheral Vascular, Cerebral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), Trans-esoph.(Cardiac), Laparoscopic, OB/Gyn and Urology.

This SonoScape S9 Portable 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 with a frequency range of 2.0 MHz to 15.0 MHz. This system consists of a portable console with keyboard control panel, power supply module, color LCD monitor and optional probes. This system is a portable, 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 and Power Doppler, or the combination of these modes, Elastography, 3D/4D. The subject of this submission is the addition of new indications, new probes and special function to original SonoScape S9.

The provided document is a 510(k) Premarket Notification from SonoScape Company Limited for their S9 Portable Digital Color Doppler Ultrasound System. It primarily focuses on establishing substantial equivalence to previously cleared predicate devices for various indications and transducers.

Within this document, there is no specific section or study described that details acceptance criteria and device performance results in a quantitative manner (e.g., sensitivity, specificity, accuracy, precision, etc.) for AI/algorithmic components. The document predates widespread AI-driven medical devices, and the "special function" of Elastography mentioned is typically a feature of the ultrasound itself, not necessarily an AI algorithm in the modern sense.

The "study that proves the device meets the acceptance criteria" in this context refers to non-clinical tests (as described in section 7 of the 510(k) Summary) that verify the system meets design specifications and applicable medical device standards. These are typically engineering tests, phantom tests for features like elastography, and adherence to safety and compatibility standards.

Therefore, many of the requested details about acceptance criteria, test sets, ground truth, experts, and comparative effectiveness studies for AI performance are not available or applicable in this document.

However, I can extract the information that is present and indicate what is missing based on your request.

1. Table of Acceptance Criteria and Reported Device Performance

As noted, the document does not present quantitative performance metrics (like sensitivity, specificity, or accuracy) against specific acceptance criteria for an AI algorithm. The document focuses on establishing substantial equivalence to predicate devices based on intended use, technical characteristics, and probe comparisons, along with adherence to recognized safety and performance standards.

The closest to "acceptance criteria" mentioned are:

• "met all design specifications"
• "conformed to applicable medical device standards" (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-5, ISO10993-10, UD2, and UD3)
• "Elastography function was effective and Elastography performance met design specifications, including accuracy and repeatability of strain-ratio measurement and etc."

However, specific numerical performance outcomes for these are not provided in the document's summary.

Regarding the study that proves the device meets the acceptance criteria:

The study described is a series of non-clinical tests.

2. Sample size used for the test set and data provenance:

• Sample size for test set: Not specified. The document mentions "Laboratory tests" and "Phantom test" but does not give a sample size for these tests.
• Data provenance: Not explicitly stated, but typical for phantom tests and lab tests conducted by the manufacturer. No patient data provenance (country of origin, retrospective/prospective) is mentioned as it's not a clinical study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable as the tests described are technical and phantom-based, not reliant on expert review of clinical cases to establish ground truth for algorithm performance. Ground truth for phantom tests would be based on the known properties of the phantom.

4. Adjudication method for the test set:

• Not applicable for the types of non-clinical tests described.

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 MRMC comparative effectiveness study was done. This device is an ultrasound system with various imaging modes, not an AI-assisted diagnostic tool in the sense of a standalone algorithm for interpretation. The "special function" of Elastography is an imaging modality feature.

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

• No standalone algorithm performance study was described. The submission is for an ultrasound system, not a specific AI algorithm.

7. The type of ground truth used:

• For the non-clinical tests, the ground truth would be based on engineering specifications for electrical, mechanical, thermal, electromagnetic compatibility, acoustic output, and the known physical properties of phantoms used for testing features like elastography.

8. The sample size for the training set:

• Not applicable. This is not an AI algorithm submission based on machine learning from a training set of data.

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

• Not applicable.

Summary of Non-Clinical Testing (from Section 7):

• Tests Conducted: Electrical, mechanical, thermal, electromagnetic compatibility safety, biocompatibility, and acoustic output.
• Special Feature Test: Phantom test to verify strain Elastography function effectiveness and performance, including accuracy and repeatability of strain-ratio measurement.
• Standards Met: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-5, ISO10993-10, UD2, and UD3.
• Conclusion: The S9 system met all design specifications and conformed to applicable medical device standards.

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