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The Digital Color Doppler Ultrasound System is a general-purpose ultrasonic imaging instrument intended for use by appropriately trained healthcare professionals in hospital for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Transrectal, Trans-vaginal, Peripheral Vascular, Cerebral Vasculoskeletal (Conventional and Superficial), Cardiac (pediatric and adult), Trans-esoph (Cardiac), Laparoscopic, OB/Gyn and Urology.

This SonoScape P60 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 phased array and etc.

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, Direct Power Doppler, or the combination of these modes, Compound, 3D/4D, Elastography and Contrast.

Here's a breakdown of the acceptance criteria and the study details for the S-FetusAI feature of the Sonoscape Digital Color Doppler Ultrasound System (P60 Series), based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Clinical Performance:

• Precision of Sp (spinal cord cone end positioning). | S-FetusAI has a good consistency with the manual measurement.
  The Sp (spinal cone end positioning) precision was basically equal between the trial group and control group. |

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

• S-Fetus-Recognition Test Set:
  • More than 200 images for each of the 14 standard sections.
  • Total: 3717 images.
• S-Fetus-Measure Test Set:
  • More than 250 images for each of the 9 standard sections.
  • Total: 2929 images.
• Data Provenance: A mix of retrospective and prospective data collection in clinical practice. The test sets were collected at three hospitals in China.

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

• Initial Ground Truth Drawing: Five OB/GYN experts with more than 3 years' experience.
• Cross-checking: Two experts with more than 20 years' experience.
• Re-checking: Four experts with more than 30 years' experience.
• Clinical Performance Study (Adjudication of results): Two Readers from an independent evaluation group, consisting of qualified professionals (senior experts who had been involved in prenatal ultrasound examination).

4. Adjudication Method for the Test Set

The ground truth was established through a multi-level expert consensus process:

1. Initial Drawing: 5 OB/GYN experts.
2. Cross-checking: 2 senior experts.
3. Re-checking: 4 very senior experts.
   This indicates a robust, multi-stage consensus-based adjudication, effectively a form of "expert consensus with multiple layers of review."

For the clinical performance testing, a separate "independent evaluation group" with 2 senior experts evaluated the section recognition results and precision of Sp from both the trial (AI-assisted) and contrast (manual) groups.

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

• A clinical performance testing was conducted, which involved comparing the S-FetusAI function (Trial group) with manual recognition and measurement by investigators (Contrast group). This can be considered a comparative effectiveness study.
• Research Group Composition (Contrast Group): Investigators (physicians with more than 3 years of specialized training in obstetric ultrasound examination; total 7 investigators) performing manual recognition and measurement.
• Effect Size: The study focused on demonstrating non-inferiority rather than a specific improvement percentage for human readers with AI assistance. The conclusion states that "the recognition precision of the standard sections of S-FetusAI was not inferior to that of the manual scan." This implies that the AI-assisted system performs at least as well as, or comparably to, manual recognition. It does not explicitly quantify how much human readers improve when using AI, but rather that the AI's standalone performance (for recognition) and consistency/precision (for measurement) are comparable to manual methods.

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

Yes, a standalone performance testing was done for the S-FetusAI feature for both S-Fetus-Recognition and S-Fetus-Measure. The results (90.01% accuracy for recognition and 85% accuracy for measurement) are reported as entirely algorithmic performance against established ground truth.

7. The Type of Ground Truth Used

The ground truth used was expert consensus. It was established by multiple OB/GYN experts with varying levels of experience, going through a process of initial drawing, cross-checking, and re-checking. Any images not meeting inclusion/exclusion criteria were excluded from the ground truth set.

8. The Sample Size for the Training Set

The document explicitly states: "The test set used to test the standalone performance of S-FetusAI are independent of the training data set and tuning data set". However, the sample size for the training set is not provided in the given text.

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

While the document implies that training and tuning datasets were used, the specific method for establishing their ground truth is not mentioned in the provided text. It only details the ground truth establishment for the test set.

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The ultrasonic gastrovideoscope (hereinafter called endoscope) is intended to provide endoscopic images for the examination and diagnosis of the upper gastrointestinal tract and to perform the ultrasound examination and diagnosis of the upper gastrointestinal sub-mucosa and the surrounding organs.

The endoscope should be used in the medical institution. The operator of the endoscope should be a physician or a medical staff supervised by a physician, both of whom have received sufficient training in clinical endoscopy technology.

The subject device, Ultrasonic Gastrovideoscope, is consisting of insertion, control section and connector section. The insertion is consisting of a distal end, a bending section and an insertion tube. This Ultrasonic Gastrovideoscope is intended to use in conjunction with Endoscopic Image Processor (HD-550Exp, HD-550, HD-550Pro, HD-550S, HD-510 and HD-500Plus), light source (VLS-55Q, VLS-55T, VLS-51D and VLS-51T), ultrasound system (P60 Exp, P60, P60 Pro, P60 CV, P60S and P60 VO) and monitor to provide endoscopic images for the examination and diagnosis of the upper gastrointestinal tract and to perform the ultrasound examination and diagnosis of the upper gastrointestinal sub-mucosa and the surrounding organs.

The Ultrasonic Gastrovideoscope is a reusable device. The Ultrasonic Gastrovideoscope has only one model EG-UR5.

The prospective clinical value of the enhanced imaging modes (EWL, SFI, and VIST) has not been demonstrated, and no clinical claims are made.

The provided text describes the acceptance criteria and the study conducted for the Sonoscape Medical Corp. Ultrasonic Gastrovideoscope (EG-UR5).

Here's the information broken down as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by testing against recognized standards and comparing performance to a predicate device. The document repeatedly states that the device's performance is "similar" to or "meets the requirements" of the predicate device and relevant standards.

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

The document does not explicitly state the sample size for test sets (e.g., number of devices tested for each non-clinical test). The studies appear to be non-clinical bench testing rather than clinical studies on human subjects.

• Data Provenance: The tests were conducted by the manufacturer, Sonoscape Medical Corp., in China, as indicated by their address. The data is retrospective in the sense that it was collected as part of the device development and verification process before submission for FDA clearance.

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

• Not Applicable. As this was a non-clinical submission, the "test set" refers to physical device testing against standards and predicate devices, not clinical data requiring expert human interpretation for ground truth.

4. Adjudication Method for the Test Set

• None. Since there was no clinical test set requiring human interpretation, no adjudication method was used. The evaluation involved technical measurements and comparisons to established standards and the predicate device's specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. The document explicitly states: "No clinical study is included in this submission." Therefore, no MRMC study was performed.

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

• Not Applicable. The device is an endoscope, a hardware medical device that directly captures images and performs ultrasound. It is not an AI algorithm or software-only device, so the concept of "standalone algorithm performance" does not apply in this context. Its performance is intrinsically tied to human operation and interpretation.

7. The Type of Ground Truth Used

The ground truth for the non-clinical tests was established by:

• Technical Specifications and Performance of the Predicate Device (K130206): The subject device's performance was compared directly to that of the PENTAX EG-3670URK Ultrasound Video Gastroscope.
• International Standards: Compliance with standards such as ISO 10993 (biocompatibility), IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 60601-2-18, IEC 60601-2-37 (particular requirements), and ISO 8600 (endoscope performance).
• FDA Guidance Documents: For example, "Mitigating the risk of Cross-Contamination from valves and Accessories Used for irrigation through Flexible Gastrointestinal Endoscopes" for backflow prevention.

8. The Sample Size for the Training Set

• Not Applicable. This device is a hardware endoscope, not an AI or machine learning system. Therefore, there is no "training set" in the context of algorithm development.

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

• Not Applicable. See point 8.

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The S90 Exp Series Digital Color Doppler Ultrasound System (S90 Exp, S80 Exp, S80 Exp, S80 Plus, S80 Elite, S80 Senior, S80 Super, S70i, S100 Exp, P90i, P80, P80 Exp, P80 Plus, P80 Elite, P80 Senior, P80 Super, P70i, I80-Endo, I80-Surg, 175-Endo, 170-Endo) is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician or sonographer with sufficient clinical ultrasound training for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic. The system is applicable for people who need clinical ultrasound examination.

The system is intended for use in the following clinical applications: Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Trans-vaginal, Peripheral Vascular, Cerebral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (pediatric and adult), Trans-esophageal (Cardiac), Laparoscopic, OB/Gyn and Urology.

Modes of operation include: B, M, PW Doppler, CW Doppler, Color M Doppler, Power Doppler, Power Doppler, Directional Power Doppler, Tissue Harmonic Imaging, Tissue Doppler Imaging, 3D/4D Imaging mode, Strain Elastography, Shear Wave Elastography, Contrast and Combined modes: B/M, B/PWD, B/THI, M/Color M, B/Color Doppler, B/Color Doppler/PWD, B/Power Doppler/PWD.

This SonoScape S90 Exp 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 Imaging, Strain Elastography, Shear Wave Elastography (S-SWE, P-SWE), SonoFusion, 3D/4D.

The provided text describes the Sonoscape Medical Corp.'s S90 Exp Series Digital Color Doppler Ultrasound System and its substantial equivalence to predicate devices, but does not contain information about specific acceptance criteria related to a performance study for the device's clinical or algorithmic performance, nor does it detail a study that proves the device meets such criteria.

The document primarily focuses on:

• Indications for Use: What the device is intended for (various clinical applications and modes of operation).
• Comparison to Predicate Devices: Explaining how the S90 Exp Series is similar to previously cleared devices in terms of intended use, regulations, safety standards, acoustic output, probes, biopsy brackets, and technical characteristics.
• Non-Clinical Tests: Listing compliance with electrical safety, EMC, acoustic, and software verification standards.

Therefore, I cannot provide the requested information. The text explicitly states:

"No clinical testing was required."

This indicates that, for the purpose of this 510(k) submission, a clinical study demonstrating the device's performance against specific clinical acceptance criteria was not performed or submitted. The substantial equivalence argument is based on the device's similarity to predicate devices and compliance with non-clinical technical standards.

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The P12 Elite Series Digital Color Doppler Utrasound System (P12 Exp, P12 Elite, P12 Pro, R12, P12N, P11 Exp, P11 Elite, P11 Pro, R11, P11N, P10 Eirte, P10N, R10, P9 Eirte, M11,R9) is a general-purpose ultrasonic imaging instrument intended for use by a qualified and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic. The system is applicable for people who need clinical ultrasound examination. Age, weight, health condition and race are unlimited. The system is intended for use in the following clinical applications: Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Cerebral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (pediatric and adult), Trans-esoph (Cardiac), Laparoscopic, OB/ Gyn and Urology.

This SonoScape P12 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 Imaging, Elastography, 3D/4D.

The provided text details the P12 Elite Series Digital Color Doppler Ultrasound System and its substantial equivalence to predicate devices, but it does not include a study that proves the device meets specific performance acceptance criteria related to efficacy beyond general safety and electrical standards. The document states "No clinical testing was required" (Section 8).

Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, and comparative/standalone effectiveness studies is not available in the provided text.

However, the document does list non-clinical performance test results:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable/not specified for performance criteria beyond standards compliance. The document explicitly states "No clinical testing was required." The "test set" in this context refers to the device and its components undergoing engineering and safety evaluations rather than a clinical dataset.
• Data Provenance: Not specified, but likely internal laboratory testing by Sonoscape Medical Corp. (manufacturer's non-clinical testing).

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

• Not applicable/not specified, as no clinical ground truth was established from expert consensus for device performance. The "ground truth" for the non-clinical tests was the compliance with established engineering and safety standards.

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

• Not applicable/not specified, as individual case-level adjudication by experts was not performed for these non-clinical tests. Compliance was assessed against defined technical standards.

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. The document explicitly states "No clinical testing was required." The device is a general-purpose ultrasound system, not an AI-assisted diagnostic tool discussed in the context of improving human reader performance.

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

• Not applicable. The device is a diagnostic ultrasound system, not an algorithm being tested in a standalone capacity without a human operator. Its performance is assessed through its ability to provide images and measurements for human interpretation.

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

• For the non-clinical tests described, the "ground truth" was compliance with established international and national engineering, electrical, electromagnetic, acoustic output, software, and biocompatibility standards (e.g., IEC 60601 series, ISO 10993, AIUM/NEMA UD 2).

8. The sample size for the training set:

• Not applicable. This document describes the regulatory clearance of a medical device (ultrasound system), not the development or validation of a machine learning model that requires a training set.

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

• Not applicable. As above, this document does not concern a machine learning model with a training set.

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The P20 Elite Series Digital Color Doppler Ultrasound System (P25 Exp, P20 Exp, P20 Elite, P22 Elite, P22 Exp, P15 Exp and P15 Elite) is a general-purpose ultrasonic imaging instrument intended for use by a qualified and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital clinic. The system is applicable for people who need clinical ultrasound examination. Age, weight, health condition and race are unlimited.

The system is intended for use in the following clinical applications: Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Cerebral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (pediatric and adult), Trans-esoph (Cardiac), Laparoscopic, OB/ Gyn and Urology.

Modes of operation include: B, M, PW Doppler, CW Doppler, Color M Doppler, Power Doppler, Directional Power Doppler, Tissue Harmonic Imaging, Tissue Doppler Imaging mode, Elastography, Contrast and Combined modes: B/M, B/PWD, B/THI, M/Color Doppler, B/Color Doppler/PWD, B/Power Doppler/PWD.

This SonoScape P20 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 Imaging, Elastography, 3D/4D.

The provided FDA 510(k) summary (K221140) describes the Sonoscape P20 Elite Series Digital Color Doppler Ultrasound System. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study for software performance and acceptance criteria for an AI/ML powered device.

Therefore, the information required to answer your request (acceptance criteria, study details, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth details, and training set information) is not available in the provided text.

The document discusses general performance tests related to electrical safety, EMC, acoustic testing, and software verification/validation, but these are for the overall ultrasound system's hardware and embedded software, not for an AI/ML algorithm within the system.

The "P20 Elite Series" system includes some "newly added features in Function" such as "contrast imaging, Color 3D, S-Live/S-Live Silhouette/S-Live Contour, S-Depth, STIC, 3D/4D HyCoSy, SPI, Micro F, SR Flow, Auto Face, VCI and etc." and "new features (Measurement Items), including AVC Follicle, Auto OB, Auto NT, Auto EF, Auto bladder, Auto IMT and etc."

For these new functions, the summary states:

• They are "the same as or similar with the imaging functions of the reference device S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System (K201059)" for imaging functions.
• They are "the same as or equivalent with the measurement functions of the reference S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System (K201059)" for measurement items.
• "The differences in function and measurement items will not raise new risk and different questions of safety and effectiveness."
• "The end user can edit, accept, or reject the measurements and can modify the measurement results at any point. The final output and its accuracy is controlled by the end user."

This indicates that these functions are either manual or assisted measurement tools where the final decision rests with the user, and their performance is deemed similar to existing cleared devices, not necessarily validated through specific AI/ML performance studies with acceptance criteria as you've requested.

Conclusion: The provided text does not contain the detailed information regarding acceptance criteria and performance studies for an AI/ML powered device as outlined in your request. The submission focuses on demonstrating substantial equivalence of a general-purpose ultrasound system to a predicate device based on technical characteristics and safety standards.

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The HD-550 video endoscope system, which includes a video colonoscope, image processor, light source, monitor, accessories and other peripheral devices, is intended for endoscopic examination, diagnosis and treatment of the upper and lower gastrointestinal tract.

The EG-550 Series Video Gastroscope has been designed to be used with the image processor. Iight source, monitor and other peripheral devices for endoscopic observation, diagnosis and treatment of the upper digestive tract (including the esophagus, stomach and duodenum).

The EC-550 Series Video Colonoscope has been designed to be used with the image processor, light source, monitor and other peripheral devices for endoscopic observation, diagnosis and treatment of the lower digestive tract (including the anus, rectum, colon and ileocecal segment).

The HD-550 Series Image Processor has been designed to be used with the endoscope, light source, monitor and other peripheral devices for endoscopic observation, diagnosis, treatment, and video recording.

The VLS-55 Series Light Source has been designed to be used with the endoscope, image processor and other peripheral devices for endoscopic observation, diagnosis and treatment.

The proposed device, HD-550 Video Endoscope System, which includes a video gastroscope /video colonoscope, image processor, light source, monitor, accessories and other peripheral devices.

HD-550 Video Endoscope System can be offered in several configurations with the options of different models of primary components.

The EG-550 Series Video Gastroscope/ EC-550 Series Video Colonoscope is the hand-held, direct-viewing flexible endoscope used for endoscopy and endoscopic surgery within the upper and lower gastrointestinal tract.

The HD-550 Series Image Processor is a video processing system which is designed to be used with endoscopes, light source, monitor of the proposed system. Apart from the image processing functions, it also provides power supply for the endoscopes.

The VLS-55 Series Light Source provides illumination for endoscopic diagnosis, treatment and video observation.

The SonoScape Medical Corp. HD-550 Video Endoscope System (K222020) is found to be substantially equivalent to its predicate device (K211882) based on non-clinical performance data. No clinical study was performed.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence determination based on an identical predicate device, the "acceptance criteria" are effectively the specifications and performance of the predicate device, and the "reported device performance" is the claim that the proposed device is identical to the predicate device in these aspects.

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

• Sample size for the test set: Not applicable. The submission states, "No clinical study is included in this submission." The evaluation relies on the equivalence of the proposed device to the predicate device, which itself would have had its performance demonstrated through testing. The current submission focuses on non-clinical tests to demonstrate that the proposed device is identical to the predicate device in all relevant aspects, except for a reprocessing change.
• Data provenance: Not explicitly stated for the non-clinical tests. However, the manufacturer is Sonoscape Medical Corp. in Shenzhen, Guangdong, China. The non-clinical tests (electrical safety, EMC, performance, biocompatibility) are typically performed by the manufacturer or accredited labs on their behalf. The liquid chemical sterilization test reports were submitted to support the reprocessing change.

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. No clinical study with a "test set" requiring expert ground truth was conducted for this specific submission. The submission is based on substantial equivalence to a predicate device.

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

Not applicable. No clinical study requiring adjudication of a test set was conducted for this 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

Not applicable. This device is an endoscope system, not an AI-assisted diagnostic tool for interpretation of images by human readers. The document makes a note that "The prospective clinical value of the enhanced imaging modes has not been demonstrated, and no clinical claims are made" regarding the enhanced imaging modes (EWL, SFI, VIST).

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

Not applicable. This is not an algorithm-only device. It is a medical device system (endoscope, image processor, light source) used by a human operator.

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

Not applicable. No clinical study with a "ground truth" was conducted for this submission. The demonstration of performance relies on compliance with recognized standards (IEC, ISO) and comparison of specifications with a legally marketed predicate device.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI-driven submission that would involve a "training set."

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

Not applicable. As above, no training set was used.

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The HD-550 video endoscope system, which includes a video colonoscope, image processor, light source, monitor, accessories and other peripheral devices, is intended for endoscopic examination, diagnosis and treatment of the upper and lower gastrointestinal tract.

The EG-550 Series Video Gastroscope has been designed to be used with the image processor. Iight source, monitor and other peripheral devices for endoscopic observation, diagnosis and treatment of the upper digestive tract (including the esophagus, stomach and duodenum).

The EC-550 Series Video Colonoscope has been designed to be used with the image processor, light source, monitor and other peripheral devices for endoscopic observation, diagnosis and treatment of the lower digestive tract (including the anus, rectum, colon and ileocecal segment).

The HD-550 Series Image Processor has been designed to be used with the endoscope, light source, monitor and other peripheral devices for endoscopic observation, diagnosis, treatment, and video recording.

The VLS-55 Series Light Source has been designed to be used with the endoscope, image processor and other peripheral devices for endoscopic observation, diagnosis and treatment.

The proposed device, HD-550 Video Endoscope System, which includes a video gastroscope /video colonoscope, image processor, light source, monitor, accessories and other peripheral devices.

HD-550 Video Endoscope System can be offered in several configurations with the options of different models of primary components

The EG-550 Series Video Gastroscope/ EC-550 Series Video Colonoscope is the hand-held, direct-viewing flexible endoscope used for endoscopy and endoscopic surgery within the upper and lower gastrointestinal tract.

The HD-550 Series Image Processor is a video processing system which is designed to be used with endoscopes, light source, monitor of the proposed system. Apart from the image processing functions, it also provides power supply for the endoscopes.

The VLS-55 Series Light Source provides illumination for endoscopic diagnosis, treatment and video observation.

The provided text is a 510(k) Summary for the Sonoscape Medical Corp. HD-550 Video Endoscope System. It outlines the regulatory process for demonstrating substantial equivalence to a predicate device, as opposed to proving novel performance criteria. Therefore, the document does not contain the information required to answer the prompt for acceptance criteria and a study proving the device meets those criteria, specifically concerning an AI component or complex performance metrics beyond equivalence.

The document states:

• "No clinical study is included in this submission." (Page 7)
• The non-clinical tests were conducted to "verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device." (Page 6)
• The comparison focuses on "same intended use, comparable product specification and optical performance" with the predicate device. (Page 14)

The "acceptance criteria" discussed are largely about meeting established safety and performance standards relevant to Class II endoscopes and demonstrating equivalence to a previously cleared device (K173921 HD-500 Video Endoscope System). The performance metrics tested (e.g., color reproduction, resolution, depth of field) are for comparison with the predicate device, not against specific pre-defined acceptance thresholds for a novel AI or diagnostic capability.

Thus, I cannot extract the requested information regarding:

1. A table of acceptance criteria and reported device performance (in the context of an AI/diagnostic study).
2. Sample sizes used for a test set or data provenance for an AI study.
3. Number and qualifications of experts for ground truth establishment.
4. Adjudication method for a test set.
5. MRMC comparative effectiveness study or human reader improvement with AI.
6. Standalone (algorithm-only) performance.
7. Type of ground truth used (expert consensus, pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document pertains to a traditional medical device (endoscope system) seeking 510(k) clearance based on substantial equivalence, not a device incorporating AI or requiring a new clinical performance study to establish specific diagnostic or therapeutic efficacy.

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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 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, Muscular, Musculo-skeletal (Conventional and Superficial), Cardiac (pediatric and adult), Trans-esoph.(Cardiac), OB/Gyn and Urology.

This SonoScape X5 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 X5 Series system utilizes the ultrasound echo characteristics, transmits ultrasonic energy into patient body, sweeps in a certain direction, processes the signals according to the delay time and the echo strength, and images the organs by using the electronic circuits and backend controller to process, then analyzes the distance and the status of organs; and at the same time, this system utilizes Doppler and auto-correlation technology to image the blood flow and add the color-coding information to the grayscale image of B mode, then displays the image in real time. The probes provided with this system are electrical-acoustical and acoustical-electrical transducers. The probes firstly convert the electric excitation signal to the acoustic signal and transmit the signal into the patient body, then converts the echo signals from the patient body to electric signal. The echo signal is processed and converted by DSC to image signal to output to the LCD display.

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 keyboard control panel, power supply module, color LCD monitor and optional probes.

This system (X5 Series Digital Color Doppler Ultrasound System) are additional models (X5 Exp, X5 Pro, X6, X6 Exp, X6 Pro), additional transducers (C1-6, 12L-B, 9L-A, 18L-A, 13L-A, L746, 10L-I, 1012, 6V7, 6V3, 6V3A, C361, VC6-2, C542, C322, 12LT-A, 12LI-A, 6CT-A, 6CI-A, BCC9-5, S1-5, 2P1, CWD5.0, CWD2.0, MPTEE and MPTEE min probes), additional functions (Elastography, Contrast imaging) and updated intended use (Trans-esoph.(Cardiac)) to legally marketed SonoScape X5 (K160258).

The provided document describes the Sonoscape Medical Corp.'s X5 Series Digital Color Doppler Ultrasound System (K182648) and its substantial equivalence to predicate devices, rather than detailing a study that proves the device meets specific performance acceptance criteria for a diagnostic AI algorithm.

The document primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices by comparing intended use, technical characteristics, and probes, as well as adherence to recognized safety and performance standards. No information regarding an AI algorithm's performance or study details (like sample size for test sets, ground truth establishment, expert qualifications, or MRMC studies) is present.

Therefore, I cannot extract the requested information regarding acceptance criteria and the study that proves an AI device meets these criteria, as the provided text pertains to a general diagnostic ultrasound system and its transducers, not an AI-powered diagnostic tool.

The "Performance test" section under "Non-Clinical Tests" lists compliance with electrical safety, EMC, acoustic testing, and software verification/validation standards, indicating the device meets these standards. However, these are general device safety and performance criteria, not specific diagnostic performance criteria for an AI algorithm.

Disclaimer: The provided document is a 510(k) summary for a medical device and does not contain details about the performance of an AI algorithm or a study testing such an algorithm. The information below is based solely on the content available in the provided text, which primarily addresses the substantial equivalence of a physical ultrasound system to predicate devices. As such, many of the requested fields are not applicable or cannot be extracted from this document because it does not describe an AI medical device or its validation study.

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HD-500 Video Endoscope System
The HD-500 Video Endoscope System, which includes a video colonoscope, image processor, light source, monitor, accessories and other peripheral devices, is intended for endoscopies examination, diagnosis and treatment of the disease of the upper and lower gastrointestinal tract.

HDL-500 Series Light Source, HDL-500E, HDL-500X
The HDL-500 Series Light Source has been designed to be used with the endoscope, image processor and other peripheral devices for endoscopic observation, diagnosis and treatment.

HD-500 Series Image Processor, HD-500, HD-500S, HD-330Plus
The HD-500 Series Image Processor has been designed to be used with the endoscope, light source, monitor and other peripheral devices for endoscopic observation, diagnosis, treatment, and video recording.

EG-500 Series Video Gastroscope, EG-500, EG-500L
The EG-500 Series Video Gastroscope has been designed to be used with the image processor, light source, monitor and other peripheral devices for endoscopic observation, diagnosis and treatment of the upper digestive tract (including the esophagus, stomach and duodenum).

EC-500 Series Video Colonoscope, EC-500, EC-500T, EC-500L, EC-500L/T
The EC-500 Series Video Colonoscope has been designed to be used with the image processor, light source, monitor and other peripheral devices for endoscopic observation, diagnosis and treatment of the lower digestive tract (including the anus, rectum, colon and ileocecal segment).

The proposed device, HD-500 Video Endoscope System, which includes a video gastroscope /video colonoscope, image processor, light source, monitor, accessories and other peripheral devices.
HD-500 Video Endoscope System can be offered in several configurations with the options of different models of primary components
The EG-500 Series Video Gastroscope/ EC-500 Series Video Colonoscope is the hand-held, direct-viewing flexible endoscope used for endoscopy and endoscopic surgery within the upper and lower gastrointestinal tract.
The HD-500 Series Image Processor is a video processing system which is designed to be used with endoscopes, light source, monitor of the proposed system. Apart from the image processing functions, it also provides power supply for the endoscopes.
The HDL-500 Series Light Source provides illumination for endoscopic diagnosis, treatment and video observation.

The provided text is a 510(k) summary for the HD-500 Video Endoscope System. It describes the device, its intended use, and a comparison to a predicate device (EVIS EXERA II 180 System) to demonstrate substantial equivalence.

However, this document does not describe a study that proves the device meets specific acceptance criteria related to AI or a "human-in-the-loop" performance study. The entire document focuses on non-clinical tests and a comparison to a predicate device to establish substantial equivalence for a medical endoscope system, which is a hardware device, not an AI/software as a medical device (SaMD).

Here's a breakdown of why the requested information cannot be fully provided from the given document:

• No AI Component: The document clearly describes a traditional video endoscope system, including gastroscopes, colonoscopes, image processors, and light sources. There is no mention of any artificial intelligence, machine learning, or software for diagnosis/analysis.
• No Clinical Study for Performance Benchmarking: The document explicitly states: "No clinical study is included in this submission." (Page 6, Section 7). This means there is no data on human-in-the-loop performance, MRMC studies, or standalone algorithm performance.
• Focus on Substantial Equivalence: The entire submission is built around demonstrating that the new device is "substantially equivalent" to an existing, legally marketed predicate device. This is primarily done through feature-by-feature comparison and non-clinical engineering tests (electrical safety, EMC, optical performance, physical/functional performance, imaging performance) against established standards (IEC, ISO).

Therefore, I cannot populate the table or answer most of your specific questions related to AI acceptance criteria, data provenance, expert ground truth establishment, MRMC studies, or training sets. The document simply doesn't contain that information.

What the document does provide in terms of "acceptance criteria" and "performance" (though not AI-related):

The "acceptance criteria" in this context are the standards and benchmarks the device needs to meet to be considered safe and effective and "substantially equivalent" to predicate devices. These are primarily engineering and technical specifications.

1. Table of Acceptance Criteria and Reported Device Performance (Non-AI/Traditional Device Focus)

2. Sample size used for the test set and the data provenance: Not applicable. This is a non-clinical submission. The "test set" refers to the specific units of the device that underwent engineering tests (e.g., optical performance, physical performance). The data provenance is these lab tests themselves, conducted by the manufacturer (Sonoscape Medical Corp.) likely in China.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the AI/clinical context, is not established for this type of non-clinical device test. The "ground truth" for these tests would be the established engineering standards and specifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This is not a clinical study involving human readers or interpretation.

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, explicitly stated "No clinical study is included in this submission." (Page 6, Section 7). No AI component.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, explicitly stated "No clinical study is included in this submission." (Page 6, Section 7). No AI component.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the AI/clinical sense. The "ground truth" for engineering tests are the industry standards (IEC, ISO) and the specifications of the predicate device for comparison.

8. The sample size for the training set: Not applicable. No AI/ML model.

9. How the ground truth for the training set was established: Not applicable. No AI/ML model.

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