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The system is intended to be used by a trained/qualified healthcare professional in a hospital or clinical setting for ultrasound evaluation of fetal, abdominal, pediatric, small organ (thyroid, testes, breast), neonatal cephalic, musculoskeletal (conventional and superficial), cardiac (adult and pediatric), liver, peripheral vascular, trans-vaginal, trans-rectal, obstetrics/ gynecology applications in B-Mode(B, 2B, 4B), M-Mode, Anatomical M-mode, Color M, Color Flow Map (CFM), Power Doppler Imaging (PDI), Directional Power Doppler Imaging (DPDI), Pulsed Wave Doppler (PWD), Continuous Wave Doppler(CWD), 3D/4D, Elastography, Contrast Harmonic Imaging(CHI), S-Beam, Panoscope, Trapezoidal/Extended Sector Imaging, Tissue Doppler Imaging(TDD), Tissue Harmonic Imaging(THI), Macro Fidelity Imaging(MFI), ECG, Vector Space Flow (VS Flow), DICOM.

This system is a Track 3 device and the software used in Apogee C1, Apogee C2, Apogee C3, Apogee C5, Apogee K1, Apogee K2, Apogee K3, Apogee K5, Apogee U1, Apogee U2, Apogee U3, Apogee U5 Digital Color Ultrasound Imaging System is Ultrasound Software by SIUI and is based on the predicate device. The Document Level for the Ultrasound Software is Basic.

Here's a breakdown of the acceptance criteria and study information based on the provided text:

Important Note: The provided document is a 510(k) summary for an ultrasound system. It primarily focuses on demonstrating substantial equivalence to a predicate device based on technical characteristics, safety standards, and intended use. It explicitly states that clinical testing was not necessary to demonstrate substantial equivalence. Therefore, many of the requested items related to a clinical study (like test set sample size, expert qualifications, adjudication methods, MRMC studies, or standalone performance for an AI algorithm) are not applicable to this submission.

The document discusses non-clinical testing related to compliance with various international standards for medical electrical equipment, software, biocompatibility, and risk management. This type of testing ensures the device meets safety and performance criteria, but it's not a performance study in the sense of evaluating diagnostic accuracy against a ground truth for a specific clinical application.

1. Table of acceptance criteria and the reported device performance

Since this is a substantial equivalence claim for an ultrasound system, the acceptance criteria are primarily based on meeting safety standards and demonstrating comparable technical characteristics and intended use to the predicate device. There isn't a table of specific performance metrics for clinical accuracy as would be found in a study for an AI-powered diagnostic device.

• IEC 60601-1 (Basic safety & essential performance)
• IEC 60601-1-2 (EMC)
• IEC 60601-2-37 (Ultrasonic diagnostic & monitoring equipment)
• IEC 60601-2-25 (Electrocardiographs)
• ISO 14971 (Risk management)
• ISO 10993 (Biocompatibility parts 1, 5, 10, 23)
• IEC 62304 (Software life cycle)
• IEC 60601-1-6 (Usability)
• IEC 62366-1 (Usability engineering)
• ISO 15223-1 (Symbols for labels)
• ISO 13485 (Quality management systems)
• FDA Guidance for PMS for Software in Medical Devices
• Marketing Clearance of Diagnostic Ultrasound Systems and Transducers |
  | Software Document Level | Software documentation should meet the basic document level requirements, indicating proper development and verification processes. | "The Document Level for the Ultrasound Software is Basic." |

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

• Not Applicable. The document explicitly states: "Clinical testing is not necessary for the Apogee C2... Digital Color Doppler Ultrasound Imaging System in order to demonstrate substantial equivalence to the predicate device." Therefore, there was no clinical test set in the traditional sense of a performance study to evaluate diagnostic accuracy. The "test set" for this submission refers to the physical device being tested against safety and performance standards, and comparison of its specifications to the predicate device.

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 explained above, no clinical test set requiring expert-established ground truth was part of this 510(k) submission.

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

• Not Applicable. No clinical test set with adjudication was 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. This submission is for a general-purpose ultrasound imaging system, not an AI-assisted diagnostic tool. No MRMC study was conducted or reported.

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

• No. This submission is for an ultrasound imaging system. It states the software is "Ultrasound Software by SIUI" and is "based on the predicate device." It does not describe a standalone AI algorithm for diagnostic interpretation.

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

• Not Applicable. For the non-clinical testing performed (compliance with standards), the "ground truth" is adherence to the specifications of those standards (e.g., electrical safety limits, EMC performance, software lifecycle processes) and comparison of technical parameters to the predicate device. There was no clinical ground truth established for diagnostic performance.

8. The sample size for the training set

• Not Applicable. This submission does not describe an AI/machine learning model that would require a training set of patient data. The "software" referred to is the operating system and imaging processing software of the ultrasound machine, not a data-driven AI algorithm in the diagnostic sense implied by this question.

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

• Not Applicable. As no training set was used, no ground truth needed to be established for it.

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Readius L15/ Readius P8/ Readius C6 Digital Color Doppler Ultrasound Imaging System is a general purpose diagnostic ultrasound system intended to be used by a trained qualified physician in a hospital or clinical setting for ultrasound evaluation of abdominal, small organ (thyroid, testes, breast), and peripheral vascular applications in B-Mode, M-mode, Color Flow Map (CFM), Vector Space Flow (VS Flow), Color Power Angio (CPA), Pulsed Wave (PW) and Panoscope.

Readius L15/ Readius P8/ Readius V6/ Readius C6 Digital Color Doppler Ultrasound Imaging System is a general purpose diagnostic ultrasound system intended to be used by a trained/qualified physician in a hospital or clinical setting for ultrasound evaluation of abdominal, small organs (thyroid, testes, breast), and peripheral vascular applications in B-Mode, M-mode, Color Flow Map (CFM), Vector Space Flow (VS Flow), Color Power Angio (CPA), Pulsed Wave (PW) and Panoscope.

The system is designed for use in linear, convex, phased array scanning modes and supports linear, convex and phased array transducers. The system has cine review, image zoom, measurements and calculations, image storage, review and recording capabilities.

This system is a Track 3 device and the software used in Readius L15/ Readius P8/ Readius V6/ Readius C6 Digital Color Ultrasound Imaging System is Ultrasound Software developed by SIUI and is based on the predicate device. The software documentation level is Basic Documentation Level.

The provided text does not contain information about acceptance criteria or a study proving the device meets specific performance criteria. Instead, it is an FDA 510(k) summary for a "Digital Color Doppler Ultrasound Imaging System" (Readius series), arguing for substantial equivalence to a predicate device (Apogee 2300).

Therefore, I cannot provide the requested information about acceptance criteria, reported performance, sample sizes, ground truth establishment, expert adjudication, or MRMC studies.

The document states:

• "Clinical testing is not necessary for the Readius L15/ Readius P8/ Readius V6/ Readius C6 Digital Color Doppler Ultrasound Imaging System in order to demonstrate substantial equivalence to the predicate device." This explicitly indicates that no clinical study was conducted to establish new performance metrics for this device.
• The non-clinical testing focused on compliance with various international standards (e.g., IEC 60601-1, ISO 14971, IEC 62304) to demonstrate safety and effectiveness as well as the predicate device, rather than proving specific performance against acceptance criteria for an AI algorithm.

Summary of what can be extracted, related but not directly answering the prompt:

• Device Name: Digital Color Doppler Ultrasound Imaging System (Readius L15, Readius P8, Readius V6, Readius C6)
• Intended Use: General purpose diagnostic ultrasound system for ultrasound evaluation of abdominal, small organ (thyroid, testes, breast), and peripheral vascular applications in B-Mode, M-mode, Color Flow Map (CFM), Vector Space Flow (VS Flow), Color Power Angio (CPA), Pulsed Wave (PW) and Panoscope.
• Predicate Device: Apogee 2300 Digital Color Doppler Ultrasound Imaging System (K173000) by SIUI.
• Basis for Clearance: Substantial equivalence to the predicate device, not new performance demonstration against specific acceptance criteria.
• Non-clinical Testing: Compliance with various safety, EMC, software lifecycle, usability, and risk management international standards (listed in the document).
• Clinical Testing: Not conducted as it was deemed "not necessary... to demonstrate substantial equivalence."
• AI/Algorithm Performance: The document mentions "Ultrasound Software developed by SIUI" and designates it as a "Track 3 device" with "Basic Documentation Level," but does not provide details on specific AI algorithms or their performance metrics. The comparison focuses on hardware similarity, imaging principles, and modes, but notes the current device uses WiFi for image transmission to handheld devices, unlike the predicate.

This 510(k) summary is typical for devices seeking clearance based on substantial equivalence to an already legally marketed device, often without new clinical performance studies.

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The system is intended to be used by a trained/qualified physician in a hospital or clinical setting for ultrasound evaluation of fetal, abdominal, pediatric, small organ (thyroid, testes, breast), neonatal cephalic, musculoskeletal (conventional and superficial), cardiac (adult and pediatric), peripheral vascular, trans-rectal, obstetrics/ gynecology and urology applications in B-Mode (B, 2B, 4B), M-Mode, CFM, CPA, DPA, PWD, CWD, Combined (B, M, CFM, CPA, DPA, PWD, XBeam, Panoscope), and others (3D, Trapezoidal /Extended Sector Imaging, Elastography, Anatomical M-mode, TDI, THI, MFI, ECG, VS Flow, Color M, DICOM).

The SIUI Apogee 1000 series (Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W/ Apogee 1 series (Apogee 1T/ Apogee 1T/ Apogee 1G) Digital Color Ultrasound Imaging System is capable of the following operating modes: B-Mode (B, 2B, 4B), M-Mode, CFM, CPA, DPA, PWD, CWD, Combined(B, M, CFM, CPA, DPA, PWD, CWD, XBeam, Panoscope), and others (3D, Trapezoidal /Extended Sector Imaging, Elastography, Anatomical M-mode, THI, TDI, DPA, MFI, ECG, VS Flow, Color M, DICOM). The system is designed for use in linear, convex, phased array scanning modes and supports linear, convex, phased array and endocavity (trans-vaginal and trans-rectal) transducers. The system has cine review, image zoom, measurements and calculations, image storage and review, printing and recording capabilities. This system is a Track 3 device and the software used in Apogee 1000 series / Apogee 1 series Digital Color Ultrasound Imaging System is Ultrasound Software by SIUI and is based on the predicate device. The Level of Concern for the Ultrasound Software is Moderate.

The provided document is a 510(k) summary for the SIUI Apogee 1000 series/Apogee 1 series Digital Color Doppler Ultrasound Imaging System. It describes the device, its intended use, and its comparison to a predicate device (SIUI Apogee 2300, K173000) to demonstrate substantial equivalence.

Based on the content, here's an analysis of the acceptance criteria and study information:

Description of Acceptance Criteria and Device Performance

The document does not explicitly state specific, quantifiable acceptance criteria (e.g., minimum sensitivity, specificity, or image quality metrics) for the device's performance. Instead, it relies on demonstrating substantial equivalence to a legally marketed predicate device (Apogee 2300, K173000) through compliance with recognized standards and a comparison of technological characteristics.

The "device performance" reported is the demonstration that the subject device (Apogee 1000 series/Apogee 1 series) is comparable to the predicate device in terms of:

• Intended Use: Both devices have the same intended use.
• Technological Characteristics: They share the same PC module, digital signal processing module, and ultrasound front-end module. The overall user interface is substantially unchanged.
• Functions: While some models of the subject device may lack the 4D imaging mode present in the predicate, they are similar in "other ultrasonic diagnostic functions, imaging modes, file storage management, compatible peripherals, measurement and calculation functions."
• Safety and Effectiveness: Non-clinical tests demonstrate that the subject device performs as well as, and is substantially equivalent with respect to safety and effectiveness of the predicate device.

Table of Acceptance Criteria and Reported Device Performance

Given the nature of the 510(k) submission for a diagnostic ultrasound system based on substantial equivalence, specific numerical acceptance criteria (like those for AI/CADe devices) are not typically presented in this format. The "acceptance criteria" here are implicitly meeting the regulatory requirements for substantial equivalence by demonstrating comparable technical characteristics and complying with relevant standards.

Study Details

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

   • The document describes non-clinical testing to demonstrate compliance with various international standards (e.g., electrical safety, EMC, software lifecycle, biological evaluation).
   • It does not mention a "test set" in the context of clinical image data or patient data. The evaluation is primarily based on engineering and performance standards applied to the device itself, rather than testing its diagnostic output against a specific dataset.
   • Data provenance is not applicable as this is not a study involving clinical data.

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

   • Not applicable. There is no mention of an external "test set" with ground truth established by experts. The "ground truth" implicitly comes from adherence to established engineering and medical device standards.

3. Adjudication method for the test set:

   • Not applicable. No "test set" or adjudication process described.

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

   • No, an MRMC comparative effectiveness study was not done.
   • This submission is for a general-purpose ultrasound imaging system, not an AI/CADe (Computer-Aided Detection/Diagnosis) device designed to assist human readers or perform automated analysis. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not relevant to this submission.

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

   • No, a standalone algorithm performance study was not done.
   • This device is an imaging system, not an algorithm, and is intended for use by a "trained/qualified physician" (human-in-the-loop).

6. The type of ground truth used:

   • For the non-clinical testing, the "ground truth" is implied by the technical specifications outlined in the international standards (e.g., electrical parameters, mechanical safety, software functionality, biocompatibility). It's not a clinical ground truth like pathology or patient outcomes.

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device that requires a "training set."

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

   • Not applicable. No training set is mentioned.

Ask a specific question about this device

The system is intended to be used by a trained qualified physician in a hospital or clinical setting for ultrasound evaluation of fetal, abdominal, pediatric, small organ (thyroid, testes, breast), neonatal cephalic, musculoskeletal (conventional and superficial), cardiac (adult and pediatric), peripheral vascular, trans-rectal, obstetrics/ gynecology and urology applications in B-Mode (B, 2B, 4B), M-Mode, CFM, CPA, CWD, CWD, Combined (B, M, CFM, CPA, DPA, PWD, CWD, XBeam, Panoscope), and others (3D/4D, Trapezoidal /Extended Sector Imaging, Elastography, Anatomical M-mode, TDI, THI, MFI, ECG, VS Flow, Color M, DICOM).

The SIUI Apogee 6500/ Apogee 6300/ Apogee 6200 Digital Color Ultrasound Imaging System capable of the following operating modes: B-Mode (B, 2B, 4B), M-Mode, CFM, CPA, DPA, PWD, CWD, Combined (B, M, CFM, CPA, DPA, PWD, CWD, XBeam, Panoscope), and others (3D/4D, Trapezoidal /Extended Sector Imaging, Elastography, Anatomical M-mode, TDI, THI, MFI, ECG, VS Flow, Color M, DICOM).

The system is designed for use in linear, convex, phased array scanning modes and supports linear, convex, phased array and endocavity (trans-vaginal and trans-rectal) transducers. The system has cine review, image zoom, measurements and calculations, image storage and review, printing and recording capabilities.

This system is a Track 3 device and the software used in Apogee 6500 / Apogee 6300/Apogee 6200 Digital Color Ultrasound Imaging System is Ultrasound Software by SIUI and is based on the predicate device. The Level of Concern for the Ultrasound Software is Moderate.

The provided text is a 510(k) summary for the Apogee 6500, Apogee 6300, and Apogee 6200 Digital Color Doppler Ultrasound Imaging Systems. This document aims to demonstrate substantial equivalence to a legally marketed predicate device (Apogee 5500).

Based on the provided information, the device is an ultrasound imaging system, not an AI/ML-driven device, and therefore the majority of the requested information (acceptance criteria, specific study details for AI/ML performance, ground truth, expert adjudication, MRMC studies) is not applicable or not provided in this type of regulatory document.

Here's an breakdown of the available information in response to your request, and why some parts cannot be answered from this document:

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

This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific performance metrics against pre-defined acceptance criteria for a novel AI/ML algorithm. The performance is assessed by comparison to the predicate device and compliance with relevant international standards.

• Acceptance Criteria (Implied for Substantial Equivalence): The device is substantially equivalent if it has the same intended use, similar technological characteristics, and does not raise new questions of safety or effectiveness compared to the predicate device.
• Reported Device Performance:
  • Intended Use: Same as the predicate device (Apogee 5500, K160853).
  • Technical Characteristics: Basic and key technical features (Operation Principle, Operation Controls, System Setup, Operation Modes, Measurement, Calculation and Report item Cine and File Management) are the same as the predicate.
  • Acoustic Power Levels: Meet FDA limits, same as the predicate device.
  • Materials of Probes: Same as the predicate device.
  • Probes: Similar probes as the predicate, with two new transducers (P5FC and V6LF) whose applications fall within the predicate's indications for use.
  • Safety and Efficacy: Differences between the new device and the predicate have no impact on safety or efficacy and do not raise new potential or increased safety risks. The new device is equivalent in performance to existing legally marketed devices.

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

• Not applicable / Not provided. As this is an ultrasound imaging system (not an AI/ML diagnostic algorithm), the performance is assessed through engineering tests, compliance with safety standards, and comparison of technical specifications to the predicate device. There is no "test set" in the context of image classification or detection algorithms with associated ground truth labels to be tested.

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

• Not applicable / Not provided. Ground truth establishment using expert review is relevant for AI/ML performance studies, which are not described in this 510(k) summary for an ultrasound imaging system.

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

• Not applicable / Not provided. Adjudication is relevant for resolving discrepancies in expert labeling of imaging data for AI/ML algorithm development/testing, which is not the subject of this document.

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: "Clinical testing is not necessary for the Apogee 6500/ Apogee 6300/ Apogee 6200 Digital Color Doppler Ultrasound Imaging System in order to demonstrate substantial equivalence to the predicate device." MRMC studies evaluating human reader performance with and without AI are not mentioned or required for this type of device clearance.

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

• Not applicable / Not provided in the context of diagnostic performance. This device is an imaging system, not a diagnostic algorithm. Its "performance" is assessed by its imaging capabilities, safety, and compliance with standards, not a standalone diagnostic accuracy.

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

• Not applicable / Not provided. The concept of "ground truth" as used in AI development is not relevant to the substantial equivalence demonstration for this general-purpose ultrasound system. Its performance evaluation relies on engineering verification, compliance with safety standards (e.g., IEC 60601 series), and direct comparison of specifications and intended use to the predicate device.

8. The sample size for the training set:

• Not applicable / Not provided. This is not an AI/ML algorithm requiring a training set. The "software" mentioned (Ultrasound Software by SIUI) is based on the predicate device's software and its "Level of Concern" is Moderate, implying it was developed and validated through standard software engineering practices for medical devices (e.g., IEC 62304), not through machine learning training on a dataset.

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

• Not applicable / Not provided. As there is no AI/ML training set, the establishment of ground truth for such a set is not relevant.

In summary, this 510(k) pertains to a new generation of an existing ultrasound imaging system, demonstrating its substantial equivalence to a previously cleared model. The evaluation focuses on hardware, software (system-level, not AI/ML), safety standards, and technical specifications, rather than clinical performance metrics typically associated with AI/ML-driven diagnostic aids.

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Diagnostic ultrasonic imaging for abdominal, pediatric, small organ, musculoskeletal, cardiac, peripheral vascular, transvaginal and trans-rectal applications in B-Mode (B, 2B, 4B), M-Mode, CFM, CPA, PWD, CWD, Combined (B, M, CFM, CPA, PWD, CWD, XBeam, Panoscope, and others (3D, 4D, Trapezoidal /Extended Sector Imaging, Elastography, Anatomical M-mode, TDI, MFI, ECG , VS Flow, Color M and DICOM).

The SIUI Apogee 2100/ Apogee 2300 is a Digital Ultrasound Imaging System capable of the following operating modes: B-Mode (B, 2B, 4B), M-Mode, CFM, CPA, PWD, CWD, Combined (B, M, CFM, CPA, PWD, CWD, XBeam, Panoscope), others (3D, 4D, Trapezoidal /Extended Sector Imaging, Elastography, Anatomical M-mode, TDI, MFI, ECG, VS Flow, Color M, DICOM). The system is designed for use in linear, convex, phased array and 3D scanning modes and supports linear, convex, phased array, 3D and endocavity (trans-vaginal and trans-rectal) transducers. The system has cine review, image zoom, measurements and calculations, image storage and review, printing and recording capabilities.

Here's a breakdown of the acceptance criteria and study information, based on the provided text, with a crucial caveat: The document describes a 510(k) submission for an ultrasound imaging system, which primarily focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific clinical performance acceptance criteria through the types of studies you've listed (e.g., MRMC, standalone AI performance).

Therefore, many of your requested points about clinical studies, ground truth establishment, sample sizes for training/test sets, expert qualifications, and adjudication methods are not present in this type of regulatory document because they are not typically required for a 510(k) clearance of an ultrasound imaging system. The information provided heavily emphasizes hardware and software feature equivalence and safety standards.

Acceptance Criteria and Device Performance

The document doesn't explicitly state "acceptance criteria" in terms of clinical performance metrics like sensitivity, specificity, accuracy, or reader agreement. Instead, the acceptance criteria for this 510(k) submission are implied through demonstrating substantial equivalence to predicate devices in terms of:

1. Indications for Use: The new device's intended clinical applications must be substantially equivalent to or within the scope of the predicate devices.
2. Technological Characteristics: The new device's core technology, operating modes, and transducers must be substantially equivalent.
3. Safety and Effectiveness: Compliance with recognized medical device safety standards and acoustic output limits substituted for direct clinical evidence of safety and effectiveness for a new device.

Table of Acceptance Criteria and Reported Device Performance (as implied by the 510(k) process):

• Operating Modes: B-Mode (B, 2B, 4B), M-Mode, CFM, CPA, PWD, CWD, Combined (B, M, CFM, CPA, PWD, CWD, XBeam, Panoscope), others (3D, 4D, Trapezoidal /Extended Sector Imaging, Elastography, Anatomical M-mode, TDI, MFI, ECG, VS Flow, Color M, DICOM).
• Comparison to Predicate: "All the Indications for Use of the Apogee 2100/ Apogee 2300 are included in the indications for use of predicate SIUI Apogee 1200." and "The Apogee 2100/ Apogee 2300 have three more imaging functions than the predicate SIUI Apogee 5500, namely VS Flow, Color M and DICOM." Additional new configurable transducers (L10LN, C6LN, U5LN) and 5 additional exams (Neonatal Cephalic, Trans-vaginal and Trans-rectal, Gynecology and Urology) are identical to Apogee 5500. |
  | 2. Technological Characteristics Equivalence | - Apogee 2100/2300 vs. Apogee 1200: "mainly have cosmetic changes," "same in their working principle and internal modules," "use the same PC module, digital signal processing module, and ultrasound front-end module." Control panel and display adjusted for ergonomics.
• Apogee 2100/2300 vs. Apogee 5500: "similar imaging modes," "similar diagnostic ultrasound applications," "similar technical parameters and hardware implementation principle" for transducers. |
  | 3. Safety (Acoustic Output & General Safety Standards Compliance) | - Tested per FDA Guidance (Sept 2008) for Diagnostic Ultrasound Systems and Transducers.
• Acoustic output measured and calculated per NEMA UD 2:2004.
• Conforms to IEC 60601-1, ISO10993-5, ISO 10993-10, and IEC 60601-1-2. |

Study Information (Based on the 510(k) document):

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

   • Test Set Sample Size: Not applicable/not provided. This document describes a 510(k) submission based on technical and performance equivalence and safety standards, not a clinical study with a specific test set of patient data with ground truth.
   • Data Provenance: Not applicable/not provided for a clinical test set. The submission relies on engineering tests, compliance with standards, and comparison to existing cleared devices.

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

   • Not applicable. No ground truth establishment by clinical experts is described for a test set of patient data.

3. Adjudication method for the test set:

   • Not applicable. No clinical test set requiring adjudication is described.

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

   • No. An MRMC study was not done, as this is an ultrasound imaging system regulatory submission, not an AI diagnostic algorithm for which such studies are commonly required. The device itself is the imaging system, not an AI feature providing interpretive assistance.

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

   • Not applicable. This is not an AI algorithm. Its performance is inherent to its imaging capabilities, which are assessed against technical specifications and predicate device equivalence.

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

   • Not applicable for clinical ground truth. The "ground truth" in this context is adherence to engineering specifications, safety standards, and functional equivalence to predicate devices, verified through technical testing.

7. The sample size for the training set:

   • Not applicable. There is no mention of an algorithm being trained on a dataset.

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

   • Not applicable. No training set is mentioned.

In summary: The provided document is a 510(k) premarket notification for an ultrasound imaging system. The "study" referenced is largely a technical and engineering comparison study to predicate devices and a compliance assessment against recognized safety and performance standards. It does not involve a clinical study with patients, expert readers, or AI performance metrics as would be seen for a diagnostic AI device submission.

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The device is intended for use by a qualified physician for ultrasound evaluation of Fetal, Abdominal, Pediatric, Small Organ (Thyroid, Testes, Breast), Neonatal Cephalic, Musculoskeletal (Conventional and Superficial), Cardiac (Adult and Pediatric), Peripheral Vascular, Trans-rectal, Obstetrics/ Gynecology and Urology applications.

The SIUI Apogee 5500/ Apogee 5300 /Apogee 5800 is a Digital Ultrasound Imaging System capable of the following operating modes: B-Mode(B, 2B, 4B), M-Mode, CFM, CPA, PWD, CWD, Combined(B, M, CFM, CPA, PWD, CWD, XBeam, Panoscope), and other(3D, 4D, Trapezoidal /Extended Sector Imaging, Elastography, Anatomical M-mode, TDI, MFI, ECG).The system is designed for use in linear, convex, phased array and 3D scanning modes and supports linear, convex, phased array, 3D and endocavity (trans-vaginal and trans-rectal) transducers. The system has cine review, image zoom, measurements and calculations, image storage and review, printing and recording capabilities.

This document describes the premarket notification for the SIUI Apogee 5500, Apogee 5300, and Apogee 5800 Digital Color Doppler Ultrasound Imaging Systems. It focuses on demonstrating substantial equivalence to predicate devices rather than providing specific acceptance criteria and performance data for a novel AI device or software. Therefore, much of the requested information regarding acceptance criteria, sample sizes for test and training sets, expert qualifications, and adjudication methods is not directly available in the provided text.

Here is an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly those required to demonstrate substantial equivalence to previously cleared predicate devices, as per FDA's 510(k) pathway. The reported performance is primarily functional similarity and adherence to safety standards, rather than specific quantitative metrics.

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

The document does not explicitly mention a "test set" in the context of an AI/algorithm performance study. The evaluation appears to be based on engineering validation and verification testing of the ultrasound system's performance characteristics (e.g., acoustic output, image quality checks) and comparison to predicate devices, rather than a clinical study with a defined patient test set for an algorithm.

• Sample Size: Not specified for any performance testing beyond general system validation.
• Data Provenance: Not applicable from the provided text, as it doesn't describe a study with patient data for algorithm evaluation. The company (SIUI) is based in China.

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

This information is not provided because the submission is for an ultrasound imaging system, not an AI algorithm that would typically require expert-established ground truth on a test set of medical images. The "ground truth" for an ultrasound system typically relates to its physical performance characteristics, image quality, and diagnostic accuracy as determined by established medical principles and comparison to predicate devices.

4. Adjudication Method

Not applicable, as there is no mention of a study involving human reader interpretation or ground truth establishment that would require an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This type of study would be relevant for evaluating the impact of AI assistance on human reader performance, which is not the subject of this 510(k) submission.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. This submission is for a full ultrasound imaging system, not a standalone AI algorithm. While the system incorporates "new imaging modes" such as XBeam, Panoscope, 3D, 4D, Elastography, etc., these are features of the imaging system itself, not separate AI algorithms. The document states these new modes "were tested and proved no impact on device safety and effectiveness," which implies technical validation rather than a standalone clinical performance study typically associated with AI.

7. Type of Ground Truth Used

The ground truth for the device's performance is implicitly based on:

• Engineering specifications and measurements: Adherence to established standards for acoustic output (NEMA UD 2), electrical safety (IEC 60601-1), and biocompatibility (ISO 10993-5, ISO 10993-10).
• Comparison to predicate devices: The "ground truth" for substantial equivalence is the validated performance and safety profile of the legally marketed predicate devices (SIUI Apogee 3800 and SIEMENS Acuson X700).
• Qualitative assessment: Clinical utility and image quality are likely assessed by medical professionals during internal validation, but no specific study details are provided.

8. Sample Size for the Training Set

Not applicable. This is not a submission for an AI algorithm that involves a training set.

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

Not applicable for the same reason as point 8.

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The device is intended for ultrasonic pulsed echo imaging and measurement for abdominal, pediatric, small organs, musculo-skeletal, cardiac, trans-vaginal, trans-rectal and peripheral vascular applications.

Diagnostic ultrasonic imaging for abdominal, pediatric, small organ, musculo-skeletal, cardiac, peripheral vascular, trans-vaginal and trans-rectal applications in B, M, PWD, CWD, Color Doppler and 3D imaging modes.

The SIUI Apogee 1200 is a Digital Ultrasound Imaging System capable of the following operating modes: 2D (B mode), M, Doppler (PWD/CWD mode), Color (CFM mode) and 3D. The system is designed for use in linear, convex, phased array and 3D scanning modes and supports linear, convex, phased array, 3D and endocavity (trans-vaginal and trans-rectal) transducers. The system has cine review, image zoom, measurements and calculations, image storage and review, printing and recording capabilities.

The provided document is a 510(k) Summary for the SIUI Apogee 1200 Digital Color Doppler Ultrasound Imaging System. This type of document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study against specific acceptance criteria for a new device.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, specifically:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set and data provenance.
• Number and qualifications of experts for ground truth.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study findings.
• Standalone (algorithm only) performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

Instead, the document states:

Acceptance Criteria & Study:
The "study" presented here is a demonstration of substantial equivalence to a legally marketed predicate device, the Ultrasonix Ergononix 500 Ultrasound Scanner (K042326). The core "acceptance criteria" for a 510(k) submission are that the new device is as safe and effective as the predicate device.

The document claims:
"The conclusions drawn from testing of the Apogee 1200 Digital Color Doppler Ultrasound Imaging System demonstrates that the device is as safe and effective as the legally marketed predicate device."

No specific quantitative performance metrics or studies against predefined acceptance criteria for the device's diagnostic capabilities are provided in this summary. Instead, the justification for safety and effectiveness relies on:

• Intended Use: The intended uses for the Apogee 1200 are compared and found to be substantially equivalent to the predicate device.
• Principles of Operation: Both devices operate on similar principles of ultrasound imaging.
• Technological Characteristics: The Apogee 1200's various operating modes (2D, M, Doppler, Color, 3D) and transducer types are presented as comparable to modern ultrasound systems, implying equivalence.
• Safety Considerations: The device was tested per "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" (September 2008 FDA Guidance document) and conforms to applicable medical device safety standards (IEC 60601-1, ISO10993-5, ISO 10993-10). Acoustic output measurements were done per NEMA UD 2. These are standard safety and performance tests for ultrasound devices, but they do not report diagnostic accuracy performance.

In summary, this 510(k) document is a declaration of substantial equivalence based on technical specifications and adherence to general safety standards, rather than a clinical performance study with predefined acceptance criteria for diagnostic accuracy. Such detailed performance data showing how well the device performs clinically (e.g., sensitivity, specificity for a particular pathology) is typically not required or provided in a 510(k) summary if substantial equivalence can be demonstrated through other means.

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Diagnostic ultrasonic imaging for abdominal, pediatric, small organ, musculo-skeletal, cardiac, peripheral vascular applications in B, M, PWD, Color Doppler and 3D imaging modes.

The SIUI Apogee 3800 is a Digital Ultrasound Imaging System capable of the following operating modes: 2D (B mode), M, Doppler (PWD mode), Color (CFM mode) and 3D. The system is designed for use in linear, convex, phased array and 3D scanning modes and supports linear, convex, phased array and 3D transducers. The system has cine review, image zoom, measurements and calculations, image storage and review, printing and recording capabilities.

This document is a 510(k) summary for the SIUI Apogee 3800 Digital Color Doppler Ultrasound Imaging System. It describes the device, its intended use, and its substantial equivalence to a predicate device (Apogee 3500, K102023).

The summary does not contain any information about acceptance criteria or a study proving that the device meets those criteria, nor does it provide details about reported device performance metrics.

The document primarily focuses on:

• Identification of the device and manufacturer.
• Identification of the predicate device.
• Description of the device's operating modes and capabilities.
• Stated intended uses and clinical applications (abdominal, pediatric, small organs, musculo-skeletal, cardiac, and peripheral vascular, in B, M, PWD, Color Doppler, and 3D modes).
• Safety considerations and compliance with relevant medical device safety standards (NEMA UD 2, UD 3, IEC 60601-1, ISO10993-5, ISO 10993-10).
• FDA's substantial equivalence determination letter.
• Detailed Indications for Use forms for the system and each associated transducer (C3L60C, L8L38C, C5L40C, P3F14C), specifying which clinical applications are "new indications" (denoted by "N") for various modes of operation.

Therefore, I cannot populate the requested table or answer most of the specific questions about the study design, sample sizes, ground truth, or MRMC studies, as this information is not present in the provided text.

The closest information provided is the "Safety Considerations" section, which states: "The Apogee 3800 Digital Color Doppler Ultrasound Imaging System has been tested per the FDA Guidance document Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers issued in September 2008. The device conforms to applicable medical device safety standards. It has been designed to meet the following standards: NEMA UD 2, UD 3, IEC 60601-1, ISO10993-5 and ISO 10993-10." This indicates that the device underwent testing for safety and compliance with general performance standards for ultrasound systems, but it does not detail any specific performance acceptance criteria or the results of such testing related to diagnostic accuracy or effectiveness.

In summary, the provided text does not contain the requested information regarding acceptance criteria, device performance metrics, or details of a study assessing such performance.

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Diagnostic ultrasonic imaging for abdominal, pediatric, small organ, musculo-skeletal, cardiac, peripheral vascular applications in B, M, PWD, Color Doppler and 3D imaging modes.

Apogee 1100 Digital Color Doppler Ultrasound Imaging System with Convex Array Transducer C3L60C, Linear Array Transducer L8L38C, Convex Array Transducer C5L40C, Phased Array Transducer P3F14C

The provided document is a 510(k) clearance letter from the FDA for an ultrasound imaging system. It primarily lists the approved indications for use for the system and its various transducers. Crucially, it does not contain information about acceptance criteria or specific studies demonstrating the device meets those criteria.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as these are not present in the provided text.

The document essentially states what the device is cleared for, not how its performance was evaluated against specific metrics.

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