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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.

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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, 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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Intended for use by a qualified/trained physician or technician for the purpose of acquiring X-ray images of the desired parts of patient's anatomy (including head, cervical spine, chest, abdomen, lumbar spine, pelvis and extremities).This device is not intended for mammography.

This SR-1000/SR-1000S Portable DR Imaging System is a portable digital device developed, designed and manufactured by SIUI. The device consists of the following major components: a portable X-ray unit, a flat panel detector, and workstation. The difference between SR-1000 and SR-1000S is the operation interface of the portable X-ray Unit only, while the flat panel detector and the workstation are the same for SR-1000 and SR-1000S. The SR-1000S has the display interface with button-operation digital tube, while the SR-1000 has the display interface with touch screen operation. Except for the difference above, the 2 models (SR-1000 and SR-1000S) are completely the same in all the other mechanical and circuit design.

I am sorry, but based on the provided text, there is no information about acceptance criteria, reported device performance, sample size, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or training set details.

The document is a 510(k) summary for a portable DR imaging system, focusing on demonstrating substantial equivalence to a predicate device based on non-clinical testing and comparison of technical characteristics. It explicitly states that "Clinical testing is not necessary for the SR-1000/SR-1000S Portable DR Imaging System in order to demonstrate substantial equivalence to the predicate device." Therefore, there would not be a study proving device performance against specific acceptance criteria in the way you've outlined for a clinical performance study.

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Intended for use by a qualified/trained physician or technician for the purpose of acquiring X-ray images of the desired parts of patient's anatomy (including head, cervical spine, chest, abdomen, lumbar spine, pelvis and extremities).This device is not intended for mammography.

This SR-2300/SR-2300S Portable DR Imaging System is a portable digital device developed, designed and manufactured by SIUI. The device consists of the following major components: a portable X-ray unit, a flat panel detector, and workstation. The difference between SR-2300 and SR-2300S is the operation interface of the portable X-ray Unit only, while the flat panel detector and the workstation are the same for SR-2300 and SR-2300S. The SR-2300S has the display interface with button-operation digital tube, while the SR-2300 has the display interface with touch screen operation.

The provided text describes a 510(k) premarket notification for the SR-2300/SR-2300S Portable DR Imaging System. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical performance study for an AI/ML-enabled medical device.

Therefore, many of the requested details about acceptance criteria, study design (sample size, ground truth, experts, adjudication, MRMC), and training set information for an AI/ML device are not present in this document. This submission is for a traditional medical device (portable X-ray system), not an AI/ML diagnostic software.

Here's a breakdown of the available information based on your request, highlighting what is not applicable (N/A) or not provided in this type of submission:

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

• Acceptance Criteria: N/A. This submission focuses on demonstrating substantial equivalence to a predicate device through technical specifications and compliance with established performance standards for X-ray systems, rather than meeting specific performance metrics for a diagnostic or AI algorithm.
• Reported Device Performance: The document provides a comparison of technical characteristics between the subject device and the predicate device (Table 1 on page 6-7). This table serves to show that the new device's specifications meet or exceed those of the predicate, or that any differences do not impact safety or efficacy. For example:
  • X-ray Generator Peak Power: Predicate: 2kW; Subject: 3.2kW (implied from "Tube voltage 40-125kV, Tube current 10-100mA")
  • Tube Voltage Adjustable Range: Predicate: 40-100kV; Subject: 40-125kV
  • mAs Range: Predicate: 0.4mAs-50mAs; Subject: 0.4mAs-200mAs
  • DQE: Predicate: 25% at 1.0 lp/mm, 5% at 3.0 lp/mm; Subject: 36% at 1.0 lp/mm, 13% at 3.0 lp/mm
  • MTF: Predicate: 35% at 2.0 lp/mm; Subject: 38% at 2.0 lp/mm

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

• Sample Size for Test Set: N/A. No clinical test set data is reported as "Clinical testing is not necessary for the SR-2300/SR-2300S Portable DR Imaging System in order to demonstrate substantial equivalence to the predicate device." (Page 10, Section 5.9).
• Data Provenance: N/A for clinical performance. The document states "Clinical images were provided; these images were not necessary to establish substantial equivalence based on the modifications to the predicate device, but they provide further evidence in addition to bench testing data to show that the complete system works as intended." (Page 10, Section 5.7). No details on the number or origin of these "clinical images" are given.

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

• N/A. No clinical test set with expert-established ground truth was required or performed for this 510(k) submission.

4. Adjudication method for the test set

• N/A. No clinical test set.

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

• N/A. This is not an AI/ML-enabled device, and no MRMC study was conducted.

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

• N/A. This is a hardware device (portable X-ray system), not a standalone algorithm.

7. The type of ground truth used

• N/A. No clinical performance study requiring ground truth was conducted. The "ground truth" for this type of device is typically established through engineering specifications, phantom testing, and comparisons to established performance standards for X-ray imaging, as well as the predicate device's characteristics.

8. The sample size for the training set

• N/A. This is a traditional medical device, not an AI/ML device that requires a training set.

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

• N/A. No training set for an AI/ML algorithm.

Summary of what the document does provide regarding device performance proof:

The document primarily relies on non-clinical testing and compliance with established standards to demonstrate substantial equivalence and ensure safety and effectiveness.

• Non-clinical Testing Summary (pages 8-10, Section 5.7):
  • The device complies with and was tested in accordance with numerous international standards for medical electrical equipment, X-ray equipment, electromagnetic compatibility, radiation protection, risk management, biological evaluation, software life cycle processes, usability, and symbols.
  • Examples of standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-54, IEC 60601-1-3, ISO 14971, ISO 10993 (various parts), IEC 62304, IEC 60601-1-6, IEC 62366-1, ISO 15223-1, ISO 13485.
  • Proof: "The test results showed compliance with the above standards. Validation was performed for overall operation by taking and reviewing test images. Clinical images were provided; these images were not necessary to establish substantial equivalence based on the modifications to the predicate device, but they provide further evidence in addition to bench testing data to show that the complete system works as intended. The non-clinical tests demonstrate that the device is as safe, as effective, and performs as well as the predicate." (Page 10, Section 5.7).
• Comparison to Predicate Device (Table 1, pages 6-7): Shows that the subject device's technical specifications are comparable or superior to the predicate, and any differences do not raise new safety or effectiveness concerns.

In conclusion, this 510(k) submission is for a conventional X-ray system, and therefore, the detailed criteria for an AI/ML device performance study are not applicable or provided. The "proof" of meeting acceptance criteria for this device rests on demonstrating adherence to recognized performance standards for X-ray equipment and showing substantial equivalence to a legally marketed predicate device through technical comparisons and non-clinical bench testing.

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The SR-8100 Portable X-ray Unit is a portable X-ray device, intended for use by a qualified/trained physician or technician for the purpose of acquiring X-ray images of the desired parts of patient's anatomy (including head, cervical spine, chest, abdomen, lumbar spine, pelvis and extremities). The device may be used for handheld diagnostic imaging of body extremities.

The system is subject to the following limitations of use when stand-mounted: The device may be used for diagnostic imaging of head, cervical spine, lumbar spine, pelvis or extremities. The device may be used for imaging of the chest when used without a grid.

This device is not to be used on bariatric patients, unless imaging body extremities. This device is not intended for mammography.

This SR-8100 Portable X-ray Unit is a portable digital device developed, designed and manufactured by SIUI. Its high-definition imaging and low-dose X-ray significantly minimize harm to patients and practitioners. The device consists of the following major components: an X-ray main unit, an exposure hand switch and a charger. The X-ray main unit is mainly for emitting X-rays required for X-ray exams; the hand switch is for output control of X-ray emitting, and the charger is for charging the built-in battery in the X-ray main unit.

The device can be used with an X-ray detector (see the table below for the basic requirements), a computer for receiving and detecting signal results and image processing software.

The major components of the X-ray main unit include: handle, enclosure, control panel, system control (SYS) board, high-voltage tank, collimator (beam limiter), lithium-ion battery and system control software running on the SYS board.

The system control software is for real-time interaction and control with various circuit modules inside the portable X-ray unit. The software responds to user operations on the control panel. The user can adjust and control the kV and mAs parameters, and the software will display the parameters or directly load the APR parameters. The software loads the control data from X-ray output into the high-voltage generation control circuit of the system control board, and control the high-voltage tank to generate high-voltage to excite the X-ray tube inside to emit X-rays, control the switch of the collimator indicator, and monitor the working status of the device, the battery power status, and control the display of the status indicators.

The system is for X-ray imaging and diagnosis in facilities with mobile or fixing sites. Since the kV range of this device is 40~100kVp, which is not suitable for breast exams, the device is not intended for mammography.

The provided text is a 510(k) summary for the SIUI SR-8100 Portable X-ray Unit. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing and comparison of technical characteristics. Crucially, it explicitly states that "Clinical testing is not necessary for the SR-8100 Portable X-ray unit in order to demonstrate substantial equivalence to the predicate device."

This means the document does not contain information about a clinical study involving human subjects or AI algorithms that would require acceptance criteria, sample sizes for test sets, expert ground truth establishment, or MRMC studies. The device described is a traditional X-ray unit, not an AI-powered diagnostic tool. Therefore, I cannot extract the requested information as it is not present in the provided text.

Specifically, the following requested information cannot be found or is not applicable:

1. A table of acceptance criteria and the reported device performance: This is typically for clinical performance or AI algorithm performance. The document only discusses performance in terms of technical specifications (kV, mA, etc.) comparable to a predicate.
2. Sample sized used for the test set and the data provenance: No clinical test set is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment for a test set is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as no test set 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: Not applicable, as this is solely an X-ray imaging device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable as no clinical study with ground truth is mentioned.
8. The sample size for the training set: Not applicable, as this is not an AI algorithm.
9. How the ground truth for the training set was established: Not applicable, as this is not an AI algorithm.

The document states that the "performance tests of the device shows that the performance specifications of the device comply with the requirements of mobile X-ray system." and "As confirmed by the radiologist, the results of the image quality test show that the clinical diagnostic requirements of the image quality of each part meet the criteria requirements." However, these are general statements about the device's image quality meeting clinical needs, not a structured clinical study with specific acceptance criteria and detailed performance metrics as would be required for an AI device.

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The SR-8230/SR-8230S Portable X-ray Unit is a portable X-ray device, intended for use by a qualified/trained physician or technician for the purpose of acquiring X-ray images of the desired parts of patient's anatomy (including head, cervical spine, chest, abdomen, lumbar spine, pelvis and extremities).

The device may be used for handheld diagnostic imaging of body extremities.

The system is subject to the following limitations of use when stand-mounted:

• -The device may be used for diagnostic imaging of head, cervical spine, abdomen, lumbar spine, pelvis or extremities.
• -The device may be used for imaging of the chest when used without a grid.

This device is not intended for mammography.

This SR-8230/SR-8230S Portable X-ray Unit is a portable digital device developed, designed and manufactured by SIUI. The device consists of the following major components: an X-ray main unit, an exposure hand switch and a charger. The X-ray main unit is mainly for emitting X-rays required for X-ray exams; the hand switch is for output control of X-ray emitting, and the charger is for charging the built-in battery in the X-ray main unit. The difference between SR-8230 and SR-8230S is the operation interface of the device only. The SR-8230 has the display interface with button-operation digital tube, while the SR-8230S has the display interface with touch screen operation. Except for the difference above, the 2 models (SR-8230 and SR-8230S) are completely the same in all the other mechanical and circuit design. The major components of the X-ray main unit include: handle, enclosure, control panel, system control (SYS) board, high-voltage tank, collimator (beam limiter), lithium-ion battery and system control software running on the SYS board. The system control software is for real-time interaction and control with various circuit modules inside the portable X-ray unit. The software responds to user operations on the control panel. The user can adjust and control the kV and mAs parameters, and the software will display the parameters or directly load the APR parameters. The software loads the control data from X-ray output into the high-voltage generation control circuit of the system control board, and control the high-voltage tank to generate high-voltage to excite the X-ray tube inside to emit X-rays, control the switch of the collimator indicator, and monitor the working status of the device, the battery power status, and control the display of the status indicators. The system is for X-ray imaging and diagnosis in facilities with mobile or fixing sites. Since the kV range of this device is 40~125kVp, which is not suitable for breast exams, the device is not intended for mammography. The device can be used with an X-ray flat panel detector, a computer for receiving and detecting signal results and an image processing software. The portable X-ray unit SR-8230 /SR-8230S is designed for handheld or stand-mounted imaging. The portable X-ray unit SR-8230 / SR-8230S can be configured to an optional portable stand/rack or use a stand that complies with IEC 60601- 1 safety standard.

This document is a 510(k) summary for the SR-8230/SR-8230S Portable X-ray Unit. It appears to focus on demonstrating substantial equivalence to a predicate device rather than providing specific acceptance criteria for AI performance or a study demonstrating such.

Therefore, the following information you requested regarding acceptance criteria and performance study for an AI device is largely not applicable to this document, as it describes a conventional X-ray unit, not an AI-powered diagnostic device.

However, I can extract the general acceptance criteria for the device itself (not AI performance) and how it met those, primarily through compliance with medical device standards and comparison to predicate devices.

General Acceptance Criteria and Reported Device Performance (Non-AI)

Information Not Applicable to this Document (as it is not an AI device submission):

2. Sample size used for the test set and the data provenance: Not applicable. This document does not describe a clinical performance study with a test set of patient data for an AI algorithm. The "test results" mentioned pertain to engineering and electrical safety standards.
3. 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 for an AI algorithm is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable. This document describes a physical X-ray unit, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

Summary of Device Nature:

This 510(k) submission is for a conventional portable X-ray unit (SR-8230/SR-8230S). The primary method for demonstrating its safety and effectiveness is through compliance with recognized electrical and medical device standards (e.g., IEC 60601 series, ISO 14971) and by showing substantial equivalence to existing legally marketed predicate X-ray devices. The document explicitly states that "Clinical testing is not necessary for the SR-8230/SR-8230S Portable X-ray unit in order to demonstrate substantial equivalence to the predicate device." Therefore, there are no AI-specific acceptance criteria or performance studies mentioned within this submission.

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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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