Search Results

The SonoScape S30/S40 system is a general-purpose ultrasonic instrument intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, thyroid), Cephalic (neonatal and adult), Transrectal, Trans-vaginal, Peripheral Vascular, Muscular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), Trans-esoph.(Cardiac), Laparoscopic, OB/Gyn and Urology.

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Pediatric, Small Organ (specify: breast, thyroid, testes), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Other (Ob/GYN), Other (Urology), Cardiac Adult, Cardiac Pediatric, Trans-esoph.(Cardiac), Peripheral vessel, Cerebral vascular, Laparoscopic.

This SonoScape S30/S40 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 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 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 S30 and the addition of S40 model.

This submission describes the SonoScape S30/S40 Digital Color Doppler Ultrasound System and its substantial equivalence to previously cleared predicate devices. The document does not contain information about acceptance criteria or a specific study proving the device meets those criteria, as one would typically find for a new, non-substantially equivalent device or an AI/ML product requiring performance evaluation. Instead, the submission focuses on demonstrating that the S30/S40 system is substantially equivalent to existing devices.

Therefore, many of the requested categories cannot be filled as they pertain to a performance study that was not conducted or detailed in this 510(k) summary. The submission relies on the concept of "substantial equivalence" to previously cleared devices.

Here's a breakdown of the information that can be extracted or is explicitly stated as not applicable from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document. The submission is a 510(k) for substantial equivalence, not a performance study against predefined metrics. The "performance" is implicitly deemed equivalent to the predicate devices.

2. Sample Size Used for the Test Set and Data Provenance
Not applicable. No specific test set or data provenance for a performance study is described. The submission focuses on technical comparisons and compliance with standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. Ground truth for a performance study is not established or reported.

4. Adjudication Method for the Test Set
Not applicable. No performance study is detailed that would require an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This submission does not describe an MRMC study or any AI components that would suggest one was performed. The device is an ultrasound system with various imaging modes, not an AI-powered diagnostic tool. The "AI" concept isn't mentioned in the context of improving human reader performance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This document describes an ultrasound system, not an AI algorithm.

7. Type of Ground Truth Used
Not applicable. As no clinical performance study for new capabilities is presented, no ground truth is discussed. The "clearance" is based on substantial equivalence to existing devices with established clinical use.

8. Sample Size for the Training Set
Not applicable. This document describes an ultrasound system, not an AI algorithm with a training set.

9. How the Ground Truth for the Training Set Was Established
Not applicable. This document describes an ultrasound system, not an AI algorithm with a training set.

Information that is provided in the document related to device evaluation:

The study that "proves the device meets the acceptance criteria" (in the context of a 510(k) for substantial equivalence) is the Non-Clinical Tests section, which confirms compliance with recognized standards and similarity to predicate devices.

Non-Clinical Tests (from Section 7):

• Evaluation Focus: Electrical, mechanical, thermal and electromagnetic compatibility safety, biocompatibility, and acoustic output.
• Strain Elastography Function: Laboratory tests were conducted to verify that the S30/S40 system and its strain Elastography function met all design specifications.
• Standards Conformance: The S30/S40 system was designed and manufactured to meet the following standards:
  • IEC 60601-1
  • IEC 60601-1-2
  • IEC 60601-2-37
  • ISO 10993-5
  • ISO 10993-10
  • UD2
  • UD3

Clinical Test (from Section 8):

• Requirement: "No clinical testing was required." This indicates that the FDA considered the non-clinical tests and comparison to predicate devices sufficient to demonstrate substantial equivalence, and no new clinical performance claims were being made that would necessitate a clinical study.

Substantial Equivalence Conclusion (from Section 9):

• The manufacturer concludes that the S30/S40 Digital Color Doppler Ultrasound System is substantially equivalent to the predicate devices (SonoScape S30 K132527, SonoScape S40 K131213, and SonoScape S9 K142710) with regard to safety and effectiveness, based on the non-clinical tests and comparisons.

Summary of Device Performance (Implied by Substantial Equivalence):
The device is expected to perform comparably to the predicate devices mentioned (SonoScape S30 K132527, S40 K131213, and S9 K142710) for its specified indications for use across various probes and modes. The addition of new probes (C345, C613, 2P2, 3P1, 5P2, 8P1, 6V1A, CWD2.0, CWD5.0, PWD2.0, and LAP7) and the special function of Elastography were evaluated through non-clinical testing and also found to be substantially equivalent or not to raise new risks. The new indications for Cerebral Vascular and Laparoscopic use were also evaluated within this framework.

Ask a specific question about this device

The SonoScape S8 Exp/S9 Pro 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), Trans-rectal, Trans-vaginal, Peripheral Vascular, Muscular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), Trans-esoph.(Cardiac), Laparoscopic, OB/Gyn and Urology.

The SonoScape S8 Exp/S9 Pro system is a general-purpose ultrasonic imaging 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, Cerebral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), Trans-esoph.(Cardiac), Laparoscopic, OB/Gyn and Urology.

This SonoScape S8 Exp/S9 Pro 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 S8 Exp and the addition of SonoScape S9 Pro.

The provided document is a 510(k) premarket notification for the SonoScape S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound System. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a study with the detailed information requested.

Therefore, many of the requested categories cannot be directly extracted from this document, as it outlines a regulatory submission process based on comparison, not a direct performance study to meet new acceptance criteria for a novel device.

However, I can extract the following information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in the typical sense of a novel device's performance metrics. Instead, "acceptance" is implicitly tied to demonstrating substantial equivalence to existing predicate devices. Therefore, the "reported device performance" is primarily presented as its similarity and compliance with standards already met by predicate devices.

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

• Sample Size for Test Set: Not applicable. The document discusses non-clinical tests (laboratory tests, phantom tests) but does not refer to a "test set" of clinical cases or patient data with a defined sample size for performance evaluation in the context of a new acceptance criterion.
• Data Provenance: Not applicable in the context of a clinical test set. The non-clinical tests were conducted internally by SonoScape Company Limited.

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

• Not applicable. No clinical test set requiring expert ground truthing is described.

4. Adjudication method for the test set:

• Not applicable. No clinical test set requiring adjudication is 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 or mentioned. This device is an ultrasound system, not an AI-assisted diagnostic tool in the sense of improving human reader performance.

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

• Not applicable. The document describes an ultrasound system, which is inherently a human-operated device. It's not an "algorithm only" device for standalone performance.

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

• For the non-clinical tests mentioned, the "ground truth" would be established by physical measurements and expected outcomes from phantom models and engineering specifications (e.g., accuracy and repeatability of strain-ratio measurement for Elastography).

8. The sample size for the training set:

• Not applicable. This document does not describe the development of an AI algorithm requiring a training set.

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

• Not applicable. This document does not describe the development of an AI algorithm requiring a training set.

Ask a specific question about this device

The SonoScape S22 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, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), Trans-esoph.(Cardiac), OB/Gyn and Urology.

This SonoScape S22 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 mobile console with 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 and Power Doppler, or the combination of these modes, Elastography, 3D/4D.

The SonoScape S22 Digital Color Doppler Ultrasound System is a diagnostic ultrasound system. Based on the provided FDA 510(k) summary (K142815), here's an analysis of its acceptance criteria and the study that supports it:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present a table of acceptance criteria with numerical targets and corresponding device performance metrics for the S22 system in the typical sense of a novel algorithm or AI device. Instead, the "acceptance criteria" are implied by the conformity to established medical device standards and the demonstration of substantial equivalence to predicate devices, particularly regarding safety and effectiveness.

However, the document does mention "design specifications" and that the system "met all design specifications." For the specific feature of Elastography, it states that "Elastography performance met design specifications, including accuracy and repeatability of strain-ratio measurement and etc."

Based on the information, a hypothetical table reflecting the mentioned information would look like this:

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

The document explicitly states: "No clinical testing was required." Therefore, there is no test set of patient data of the type typically associated with outcome or diagnostic accuracy studies for this submission. The testing revolved around device standards and phantom studies.

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

Since no clinical testing involving patient data was required or performed, there were no experts used to establish ground truth for a test set in the context of diagnostic performance.

4. Adjudication Method for the Test Set

As there was no clinical test set requiring human interpretation, no adjudication method was used.

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

No MRMC comparative effectiveness study was done. The submission demonstrates substantial equivalence primarily through technical comparisons and compliance with established standards, not through studies showing human reader improvement with or without AI assistance.

6. If a Standalone Performance Study Was Done

While not a "standalone performance study" in the context of AI algorithm only without human-in-the-loop, the document describes laboratory tests and a phantom test for the S22 system's functions and performance.

• Laboratory tests: These were conducted to verify that the system met all design specifications and 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). This essentially acts as a rigorous standalone check against engineering and safety criteria.
• Phantom Test for Elastography: A specific phantom test was performed "to verify that the strain Elastography function was effective and Elastography performance met design specifications, including accuracy and repeatability of strain-ratio measurement and etc." This is a standalone evaluation of the Elastography feature's technical performance using a controlled phantom.

7. The Type of Ground Truth Used

• For regulatory compliance and safety/performance standards (electrical, mechanical, thermal, EMC, biocompatibility, acoustic output), the "ground truth" is defined by the specifications within the cited international and national standards (e.g., IEC, ISO, UD2/UD3). The device's output and performance are measured against these established quantitative and qualitative criteria.
• For the Elastography phantom test, the "ground truth" would be the known physical properties of the phantom material and the expected strain-ratio measurements, as defined by the phantom's design and engineering specifications.

8. The Sample Size for the Training Set

The S22 Digital Color Doppler Ultrasound System is described as an "integrated preprogrammed color ultrasound imaging system" and a "software controlled" system. While it uses complex algorithms for image processing and display (B-Mode, M-Mode, Color-Flow Doppler, etc., and features like Elastography), the document does not indicate that this specific device underwent a machine learning or AI training process that would require a "training set" of data to develop its core functionality. These systems typically rely on pre-programmed algorithms based on physics and signal processing, often optimized through extensive engineering rather than data-driven machine learning. Therefore, a "training set" of the kind used for AI development is not mentioned and likely not applicable to how this device's algorithms were developed or validated for this 510(k) submission.

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

As no "training set" in the context of machine learning/AI development is indicated, the concept of establishing ground truth for such a set is not applicable to this 510(k) summary. The "ground truth" for the device's development and validation would instead stem from fundamental physics, engineering principles, and the specifications of the standards it adheres to.

Ask a specific question about this device

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.

Ask a specific question about this device

The SonoScape S12 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, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.

This SonoScape S12 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 mobile console with 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 and Power Doppler, or the combination of these modes, Elastography, 3D/4D.

This document describes the safety and performance evaluations for the SonoScape S12 Digital Color Doppler Ultrasound System (K142474) and its transducers, in comparison to predicate devices, to establish substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the SonoScape S12 Digital Color Doppler Ultrasound System are primarily demonstrated through conformance to established international and national standards, and by showing substantial equivalence to predicate devices for its intended uses and technological characteristics. The document doesn't present a specific table of numerical performance acceptance criteria and reported performance values in a typical AI/software context. Instead, it relies on a comparison of technical specifications and functionalities with predicate devices.

However, based on the provided text, we can infer some "acceptance criteria" through comparison to predicate devices and adherence to standards. Since direct numerical performance metrics are not given, the "Reported Device Performance" for equivalence is qualitative, stating "Same" or "Substantially Equivalent (SE) with detailed analysis".

Here's a summarized view of the comparisons:

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 states, "Laboratory tests were conducted to verify that the S12 system met all design specifications... Phantom test was conducted to verify that the strain Elastography function was effective and Elastography performance met design specifications, including accuracy and repeatability of strain ratio measurement and etc."

However, the specific "sample size" for these laboratory and phantom tests (e.g., number of phantom measurements, specific dataset sizes) is not provided. The data provenance (country of origin, retrospective/prospective) is also not specified/mentioned for these tests.

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)

The document does not mention the use of experts to establish ground truth for testing. The evaluation appears to be based on technical specifications, direct comparison to predicate devices, and phantom testing, rather than human expert interpretation of images. The "phantom test" mentioned for Elastography implies a physical standard or controlled environment rather than expert-labeled cases.

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

Since the document does not describe the use of human experts or clinical data for a test set that would require ground truth adjudication, there is no adjudication method mentioned or applicable in the context presented.

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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study being done. The device is a diagnostic ultrasound system, and the submission focuses on establishing substantial equivalence based on technical characteristics and safety standards, not on AI-assisted diagnostic improvement.

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

The document describes a diagnostic ultrasound system and its transducers, which are hardware devices with embedded software for image acquisition and processing. It is not an AI-based standalone diagnostic algorithm. The phrase "algorithm only without human-in-the-loop performance" is not applicable in this submission. The system produces images for human interpretation.

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

For the Elastography function (the only feature specifically mentioned with a "test"), the ground truth was established using phantom tests. This suggests a physical phantom with known properties (e.g., stiffness) was used as the reference, rather than expert consensus on clinical cases, pathology, or outcomes data. For other aspects of the ultrasound system, the "ground truth" seems to be adherence to engineering specifications and performance matching that of the predicate devices.

8. The sample size for the training set

The document is for a traditional diagnostic ultrasound system and does not mention machine learning or AI algorithms requiring a "training set." Therefore, no training set size is provided or applicable.

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

As there is no mention of a training set (see point 8), the method for establishing its ground truth is also not applicable.

Ask a specific question about this device

The SonoScape S30 device is a general-purpose ultrasonic imaging 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, Trans-esoph (Cardiac), Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), Urology and OB/Gyn.

The SonoScape S30 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 all digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in-depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows cost-effective system integration to a variety of upgrade-able options and features. This SonoScape system is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound data and display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Doppler and Power Doppler, or a combination of these modes. 3D/4D.

This 510(k) submission (K132527 for the SonoScape S30 Digital Color Doppler Ultrasound System) does not contain a study comparing the device's performance to specific acceptance criteria. Instead, it relies on a substantial equivalence (SE) comparison to a legally marketed predicate device (SonoScape SSI-8000, K102642).

The document explicitly states: "No clinical testing was required" (Section 8, page 2). This indicates that a study demonstrating the device meets quantified acceptance criteria through clinical performance was not performed for this submission.

The acceptance criteria are implicitly defined by the parameters and performance of the predicate device, with the claim that the proposed device either matches or is "better" in certain aspects without raising new safety or effectiveness concerns.

Here's the breakdown of the requested information based on the provided text, while acknowledging the lack of a traditional performance study:

1. Table of Acceptance Criteria and Reported Device Performance

Since there isn't a direct "acceptance criteria" table with specific thresholds, the comparison table from the 510(k) summary (Table 4: Specifications Comparison, page 7-8) serves as the de facto acceptance target, with the predicate device's performance being the benchmark. "Acceptance" here means demonstrating equivalence or superiority without introducing new risks.

Other differences noted in the "General Comparison" and "Functions Comparison" tables (pages 3-6) include:

• Probe Type & Connectors (ID 7): The proposed device has different or additional probe types/frequencies. SE Analysis 1 states these comply with IEC 60601-2-37 and raise no new risks.
• Design (ID 9):
  • User Interface: Proposed device has a touch panel, predicate has a full keyboard. SE Analysis 2 deems this equivalent based on compliance with IEC 60601-1 and IEC 60601-1-2.
  • Image Sector Size: Proposed device: 32 lines to full B (512 lines); Predicate: 32 lines to full B (256 lines). SE Analysis 3 states the proposed device is "better."
  • Focal Number: Proposed device: 12 focal zone setting; Predicate: 9 focal zone setting. SE Analysis 3 states the proposed device is "better."
• Controls (ID 10):
  • PW angle correction: Proposed device: 0 to 80 degree user control; Predicate: 0 to 72 degree user control. SE Analysis 3 states the proposed device is "better."

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

• Sample Size for Test Set: Not applicable. The submission explicitly states, "No clinical testing was required" (Section 8, page 2). The device's performance was evaluated through laboratory testing and comparison to an existing predicate device's specifications.
• Data Provenance: Not applicable, as no clinical test data was generated for this submission. The comparison relies on the verified specifications of the predicate device (SonoScape SSI-8000, K102642) and the proposed device's compliance with general safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 2-2004, NEMA UD3: 2004).

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

• Not applicable. There was no clinical test set that required ground truth established by experts.

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

• Not applicable. There was no clinical test set requiring adjudication.

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 submission is for a general-purpose ultrasound system, not an AI-assisted diagnostic device, and no MRMC study was performed.

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

• Not applicable. This device is not an algorithm for standalone performance evaluation. Its performance is evaluated as an integrated hardware and software ultrasound system under the guidance of a qualified physician.

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

• Not applicable. No clinical ground truth was established as no clinical testing was required. The "truth" for this submission are the established safety and performance specifications and standards for diagnostic ultrasound systems, to which both the proposed and predicate devices are demonstrated to conform.

8. The sample size for the training set

• Not applicable. This device is a preprogrammed ultrasound system, not an AI/machine learning model that typically requires a training set.

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

• Not applicable. As there is no training set for an AI/machine learning model.

Ask a specific question about this device

Digital Electrocardiographs, IE3/ IE12/ IE12P/ IE15, are intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease. Digital Electrocardiographs shall be used in healthcare facilities by doctors and/or trained healthcare professionals.

Digital Electrocardiographs, IE3/ IE12/ IE12/ IE15, are designed to acquire, analyze, display and record ECG signals from patient body surface by ECG electrodes. After been amplified, filtered and analyzed, the ECG signals waveforms and analysis results are displayed in the LCD and recorded in the paper through thermal printer. ECG data, analysis result and patient information could be stored in the memory of the device.
The device consists of three modules, which are power supply module, amplification module, and control module.
The device has three recording mode, AUTO mode, MAN mode and RHY mode,
They are standard twelve leads, including bipolar limb leads, augmented unipolar limb leads and unipolar chest leads.

The provided 510(k) summary for K131262 does not contain information related to a clinical study or performance data against specific acceptance criteria for the device's diagnostic capabilities. Instead, it focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing and technical specifications.

Therefore, many of the requested sections regarding acceptance criteria, study details, and performance metrics cannot be directly addressed from the provided document.

Here's a breakdown of what can be extracted and what is missing:

Description of Acceptance Criteria and Device Performance

The submission focuses on establishing substantial equivalence to predicate devices (K122712 and K123816) based on technical specifications and compliance with international standards, rather than defining specific diagnostic acceptance criteria for the device's analytical function.

The non-clinical tests were conducted to verify that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate devices. The test results demonstrated compliance with the following standards:

• IEC 60601-1:1990+ A1:1993+ A11:1993+ A12:1993+ A13:1996, Medical electrical equipment, Part 1: General requirements for safety.
• IEC 60601-2-25:1993+A1:1999. Medical electrical equipment, Part 2-25: Particular requirements for the safety of electrocardiographs.
• IEC 60601-1-2: 2007, Medical electrical equipment, Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility- Requirements and tests.

Table of Acceptance Criteria and Reported Device Performance (Based on Technical Specifications and Compliance to Standards):

Ask a specific question about this device

The SonoScape S8 Exp device is a general-purpose ultrasonic imaging 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 (neonatal and adult), OB/Gyn and Urology.

The SonoScape S8 Exp 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 all digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in-depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows cost-effective system integration to a variety of upgrade-able options and features. This SonoScape system is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound data and display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Doppler and Power Doppler, or a combination of these modes, 3D/4D.

The SonoScape S8 Exp Portable Digital Color Doppler Ultrasound System is a general-purpose integrated, preprogrammed color ultrasound imaging system intended for diagnostic imaging.
The device's performance aligns with the predicate device, SonoScape S9 Portable Digital Color Doppler Ultrasound System (K131088).

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states that "No clinical testing was required." Therefore, there is no information on a test set, sample size, or data provenance from clinical data. The testing mentioned in the submission focuses on laboratory testing to verify design specifications and compliance with safety standards.

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

Since no clinical testing was required, there is no mention of experts being used to establish a ground truth for a test set.

4. Adjudication Method for the Test Set

As no clinical testing was required, there is no adjudication method described.

5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study Was Done

No MRMC comparative effectiveness study was mentioned in this submission. The submission focuses on comparing the proposed device to a predicate device based on technical specifications and compliance with standards, not on human reader performance.

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

This device is an ultrasound system and not an AI algorithm. Therefore, the concept of standalone performance of an algorithm without human-in-the-loop is not applicable in the context of this submission. The performance assessment is related to the imaging capabilities of the hardware and software as a complete diagnostic tool used by a physician.

7. The Type of Ground Truth Used

Given that no clinical testing was required, the "ground truth" for demonstrating device performance relied on:

• Compliance with Industry Standards: NEMA UID 2: 2004, NEMA UD3: 2004, IEC 60601-1: 2005, IEC 60601-1-2: 2007, IEC 60601-2-37: 2008, ISO 10993-5, ISO 10993-10.
• Comparison to Predicate Device Specifications: The primary method for proving substantial equivalence was a direct comparison of technical specifications, intended use, and performance parameters (e.g., measurement accuracy, acoustic output) against the previously cleared predicate device (SonoScape S9, K131088).

8. The Sample Size for the Training Set

There is no mention of a "training set" in the context of this device, as it is a diagnostic ultrasound system and not an AI/machine learning algorithm requiring a training phase with a dataset.

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

Not applicable, as no training set for an AI/machine learning algorithm was involved.

Ask a specific question about this device

The SonoScape S40 device is a general-purpose ultrasonic imaging 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 (neonatal and adult), OB/Gyn and Urology.

The SonoScape S40 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 all digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in-depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows cost-effective system integration to a variety of upgrade-able options and features. This SonoScape system is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound data and display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Doppler and Power Doppler, or a combination of these modes, 3D/4D.

This document describes the SonoScape S40 Digital Color Doppler Ultrasound System and its substantial equivalence to a predicate device (SonoScape S6). The information provided is primarily for regulatory submission and does not detail a clinical study with an acceptance criterion for device performance in the way a clinical trial for an AI algorithm would. Instead, it focuses on technical specifications and compliance with safety standards to demonstrate substantial equivalence.

Based on the provided text, a "study" in the sense of a clinical performance study with human readers or standalone algorithm performance, as typically found in AI/ML device submissions, was not conducted. The study supporting this device's acceptance is a bench testing and comparison study against a predicate device and relevant safety standards.

Here's a breakdown of the requested information based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily defined by the performance characteristics of the predicate device (SonoScape S6) and compliance with international safety and performance standards. The "reported device performance" is the comparison of the SonoScape S40 against the S6.

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

• Sample Size: Not explicitly stated as a "test set" in the context of a clinical performance study on patients. The testing involved laboratory testing to verify design specifications and compliance with standards. It's implied that various transducers were tested for their acoustic output and safety characteristics.
• Data Provenance: The testing was conducted internally by SonoScape Company Limited ("Laboratory testing was conducted to verify that the S40 system with added transducer met all design specification..."). The country of origin for the data would be China, where SonoScape is based.
• Retrospective or Prospective: This was likely prospective bench testing and engineering validation against predefined specifications and standards, rather than retrospective or prospective clinical data collection from patients.

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

• This type of information is not provided in the 510(k) summary. The submission does not describe a clinical study requiring human expert ground truth for interpretation of images. The ground truth for the technical measurements and safety compliance would be established by validated test equipment and calibration standards, assessed by qualified engineers and technicians, not clinical experts for diagnostic accuracy.

4. Adjudication Method for the Test Set

• Not applicable. Given that no clinical test with human experts interpreting results was conducted, an adjudication method like 2+1 or 3+1 is not relevant to this submission.

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

• No, an MRMC comparative effectiveness study was not done. The summary explicitly states: "No clinical testing was required." (Section 8). The comparison was primarily technical specifications against a predicate device.

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

• Not applicable / No. This device is a diagnostic ultrasound system, not an AI algorithm intended for standalone diagnostic interpretation. Its performance is evaluated based on its ability to acquire and display ultrasound data accurately and safely, matching or improving upon the predicate device's technical specifications.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• The "ground truth" for the acceptance of this device relies on:
  • Predicate Device Performance: The established performance characteristics and safety profile of the legally marketed SonoScape S6 ultrasound system.
  • International Safety and Performance Standards: Compliance with standards like IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 2, NEMA UD3, ISO 10993-5, and ISO 10993-10.
  • Bench Test Results: Direct measurements of technical parameters (e.g., measurement accuracy for distance, area, velocity, acoustic output) using calibrated equipment.

8. The Sample Size for the Training Set

• Not applicable. This device is a hardware and software system, not an AI/ML algorithm that is "trained" on a specific dataset. Its development involves standard engineering design, testing, and validation processes.

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

• Not applicable. As there is no "training set" in the AI/ML sense, there is no ground truth established for one. The device's functionality is based on established ultrasound physics and engineering principles.

Ask a specific question about this device

The SonoScape S11 device is a general-purpose ultrasonic imaging 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 (neonatal and adult), OB/Gyn and Urology.

The SonoScape S11 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 all digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in-depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows cost-effective system integration to a variety of upgrade-able options and features. This SonoScape system is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound data and display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Doppler and Power Doppler, or a combination of these modes, 4D.

The provided 510(k) summary is for a diagnostic ultrasound system, which is a hardware device. These types of submissions typically focus on demonstrating substantial equivalence to a predicate device based on technical specifications and adherence to recognized safety standards, rather than clinical performance metrics often associated with AI/ML-enabled devices.

Therefore, many of the requested criteria (acceptance criteria related to clinical performance, specific study types like MRMC, sample sizes for test/training sets, ground truth establishment, or expert qualifications) are not applicable or detailed in this document. The submission asserts substantial equivalence based on comparisons of design, function, and safety characteristics with a predicate device.

Here's a breakdown of what can be extracted and what is not provided based on the input:

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

The document does not specify quantitative acceptance criteria for device performance in terms of diagnostic accuracy, sensitivity, or specificity, as it's an ultrasound hardware device submission focused on substantial equivalence rather than a new clinical claim. Its "performance" is implicitly deemed acceptable if it meets the technical specifications and safety standards, and is substantially equivalent to the predicate.

The table below summarizes the comparison items where "SE" (Substantially Equivalent) is indicated, implying the proposed device meets the predicate's performance in those aspects.

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 "No clinical testing was required." Therefore, there is no information on sample size for a test set or data provenance related to clinical data. The testing mentioned in Section 7 refers to "Laboratory testing" to verify design specifications and compliance with safety standards, which is not a clinical test set.

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, as no clinical testing or test set requiring ground truth was conducted for this submission.

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

Not applicable, as no clinical testing or test set requiring adjudication 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 a diagnostic ultrasound system, not an AI-enabled device designed to assist human readers. No MRMC study was mentioned.

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

Not applicable. This is a hardware device; it does not perform as a standalone algorithm in the sense of AI/ML.

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

Not applicable, as no clinical testing or test set requiring ground truth was conducted for this submission.

8. The sample size for the training set

Not applicable. This is a hardware device; there is no "training set" in the context of AI/ML algorithms.

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

Not applicable, as there is no training set for this hardware device.

Ask a specific question about this device