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InnoSight Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), M-Mode, PW and CW Spectral Doppler, CPA, Tissue Harnonic imaging and Color Doppler modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Fetal, Abdominal, Pediatric, Small Organ (breast, thyroid, testes), Adult Cephalic, Trans-rectal, Musculo-skel. (Conventional), Other (Ob/GYN, Urology, Nerve), Cardiac Adult, Cardiac Pediatic, Peripheral Vessel and Carotid. The clinical environments where the used include physician offices, clinics, hospitals, and clinical point-of-care for diagnosis of patients except environments where the intensity of electromagnetic disturbances is high.

The system is intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the system user information, and only for the purposes for which it was designed. The system should only be operated by someone who has received proper training in the use and operation of an ultrasound system. This system produces images derived from sound echoes; those images must be interpreted by a qualified medical professional. This system in no way interprets these images or provides a medical diagnosis of the patient being examined.

InnoSight diagnostic ultrasound system is a compact and portable diagnostic ultrasound device, have integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The user interface is touch screen with 11.6" display. The all-digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows cost-effective system integration to a variety of upgrade-able options and features.

The major features of the InnoSight diagnostic ultrasound:

• 64 Channel all digital beam former
• Progressive dynamic receive focusing
• Wide band all digital demodulation
• Native frequency digital scan converter
• . InnoSight diagnostic ultrasound can be hand carried for portable use
• . Full patient database solutions: DICOM3.0, MP4 /PNG, USB, SSD, PDF report
• Supports B (2-D), M, CFM, DPI, PW, Tissue Harmonic Image and combine . mode

Here's a breakdown of the acceptance criteria and the study information for the InnoSight Diagnostic Ultrasound System based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document, a 510(k) Premarket Notification, primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific numerical acceptance criteria and performance metrics for the InnoSight system itself from an independent study.

Instead, the "acceptance criteria" are implied by compliance with various international and FDA-recognized consensus standards for medical electrical equipment, including safety, electromagnetic compatibility, and acoustic output. The "reported device performance" is essentially the statement of compliance with these standards and the demonstration of equivalent functionality to the predicate device.

Specific Numerical Performance Targets (Acceptance Criteria) are not provided in detail in this document. The submission hinges on substantial equivalence to a predicate device, supported by compliance with recognized standards.

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

• Sample Size for Test Set: The document does not specify a distinct "test set" sample size in terms of patient cases or images for evaluating clinical performance. The non-clinical testing involved various engineering tests (e.g., electrical safety, EMC, acoustic output, biocompatibility) conducted on the device itself.
• Data Provenance: The data described is primarily from non-clinical performance testing conducted on the device. There is no mention of clinical data (patient data) provenance (e.g., country of origin, retrospective or prospective) because the document explicitly states: "The InnoSight did not require clinical data since substantial equivalence to the primary currently marketed predicate CX50 Diagnostic Ultrasound System demonstrated with indication for use, technological characteristics, Non-clinical performance testing; and Safety and effectiveness."

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

• This information is not applicable as there was no clinical test set requiring expert ground truth establishment for a diagnostic performance study. The evaluation focused on engineering performance and substantial equivalence.

4. Adjudication Method for the Test Set

• This information is not applicable as there was no clinical test set requiring adjudication.

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

• No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not conducted or described in this document. The submission explicitly states that clinical data was not required.

6. Standalone (Algorithm Only) Performance Study

• No, a standalone (algorithm only) performance study was not conducted or described in this document. The InnoSight system is a diagnostic ultrasound device designed to be operated by a trained medical professional, not an AI algorithm performing diagnostic tasks without human interaction.

7. Type of Ground Truth Used

• Not directly applicable in the context of a clinical diagnostic performance study. For the non-clinical tests, the "ground truth" would be established by the specifications of the standards (e.g., a device must operate within specific acoustic output limits as defined by NEMA UD 2).

8. Sample Size for the Training Set

• This information is not applicable. The InnoSight Diagnostic Ultrasound System is a hardware-based imaging system, not an AI/ML algorithm that requires a "training set" in the conventional sense. Its "training" involves engineering design, calibration, and adherence to established physical and electrical principles of ultrasound.

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

• This information is not applicable for the reason stated in point 8.

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The system is a general-purpose ultrasonic intended for use by a qualified physician for ultrasound evaluation/clinical analysis etc. It can be used in non-intrusive applications, including Abdomen, Cardiology, Gynecology, Obstetric, Breast, Thyroid, Musculoskeletal, Venous, Arterial), Nerve, Renal, and Urology. The clinical environments where the system can be used include clinics, hospitals, and clinical point of care for diagnosis of patients.

The system is intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the system user information, and only for the purposes for which it was designed. The system should only be operated by someone who has received proper training in the use and operation of an ultrasound system. This system produces images derived from sound echoes; those images must be interpreted by a qualified medical professional. This system in no way interprets these images or provides a medical diagnosis of the patient being examined.

The BenQ Diagnostic Ultrasound System (hereinafter called "system") is an easy-to-use, portable ultrasound imaging instrument intended for use by a qualified operator for ultrasound evaluation and clinical analysis. The user interface is touch screen with 13.3" display. The all-digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows cost-effective system integration to a variety of upgrade-able options and features.

The major features of the BenQ diagnostic ultrasound:

• Compact size with 1 transducer sockets. Convertible cart-based svstem design.
• . 2D (B&M mode) with harmonic imaging
• Color Flow Imaging, Pulsed Wave Spectral Doppler, Steerable Continuous Wave Doppler, Power Doppler
• 13.3″ LCD supporting wide-viewing angle with multi-touch
• Support 64 channels, support up to 128 elements probes, and easy maintenance.
• High density transducers with frequency range from 2 to 15 MHz
• Full patient database solutions: DICOM3.0, MP4 /PNG, USB3.0, SSD, PDF report, etc.

The provided document is a 510(k) Premarket Notification from the FDA for a diagnostic ultrasound system. It details the device's indications for use, comparison to a predicate device, and summarization of non-clinical tests.

The document explicitly states: "The subject of this premarket submission, T3300, is not required clinical studies to support substantial equivalence." This means that the device was not evaluated through clinical studies with human subjects, and therefore, it does not contain the information requested in points 1-7 and 9 of your prompt.

The acceptance criteria mentioned in the document are primarily related to non-clinical performance and safety standards, not diagnostic accuracy derived from a test set of patient data with expert ground truth.

Here's an attempt to answer your questions based on the available information:

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

Since this is a 510(k) submission and clinical studies were not required, the "acceptance criteria" are compliance with recognized safety and performance standards for medical electrical equipment and diagnostic ultrasound systems. The "reported device performance" is its demonstration of conformance to these standards.

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, as no clinical test set was required or used for this 510(k) substantial equivalence determination.

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.

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 device is a diagnostic ultrasound system itself, not an AI-assisted interpretation tool. The document explicitly states, "This system in no way interprets these images or provides a medical diagnosis of the patient being examined."

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

Not applicable. This is a medical device (ultrasound system), not a standalone algorithm.

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

Not applicable. The ground truth for this submission was based on engineering and safety standard compliance, not clinical diagnostic accuracy.

8. The sample size for the training set

Not applicable, as no clinical training set was used for this 510(k) submission. The "training" in this context would refer to the engineering and design validation process against specified requirements and standards.

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

Not applicable for a clinical training set. For the non-clinical and engineering validation, "ground truth" was established based on internationally recognized standards and specifications for medical device performance and safety (e.g., IEC standards, ISO standards, AIUM guidelines). The manufacturer's design, development, and quality processes (conforming to 21 CFR 820 and ISO 13485) ensure that the device meets these established engineering and safety "ground truths."

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InnoSight Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), M-Mode, PW Doppler, CPA, Tissue Harmonic imaging and Color Doppler modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Fetal, Abdominal, Small Organ (Breast, Thyroid, testes), trans-rectal, trans-vaginal, Other (OB/GYN, Urology, Nerve), Cardiac Adult and Peripheral Vessel. The clinical environments where the system can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients. The system is intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the system user information, and only for the purposes for which it was designed.

InnoSight diagnostic ultrasound system is a compact and portable diagnostic ultrasound device, have integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The user interface is touch screen with 11.6" display. The all-digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows cost-effective system integration to a variety of upgrade-able options and features.

The major features of the InnoSight diagnostic ultrasound:

• 64 Channel all digital beam former .
• Progressive dynamic receive focusing
• Wide band all digital demodulation
• Native frequency digital scan converter
• InnoSight diagnostic ultrasound can be hand carried for portable use
• Remote access image management through LAN port
• Supports B (2-D), M, CFM, DPI, PW, Tissue Harmonic Image and combine mode

The provided text does not contain information about specific acceptance criteria or a study that proves the device meets those criteria from an AI/algorithm performance perspective. The document primarily focuses on regulatory approval (510(k) clearance) based on substantial equivalence to predicate devices, safety considerations, and general technical specifications of an ultrasound system.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details as they are not present in the given text.

The "Predicate Device Comparison" table lists various technical specifications and operating controls for the submitted device (InnoSight Diagnostic Ultrasound System) and two predicate devices (BenQ UP600 and Philips CX50 and Sparq). This comparison is used to demonstrate substantial equivalence to existing legally marketed devices, rather than establishing or proving specific performance acceptance criteria for a new, AI-driven functionality.

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The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Abdomen, Cardiac, Small Organ (breast, testes, thvroid), heart soft tissue, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Pediatric, Fetal, Cephalic, and Ob/Gyn.

The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal/QB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Cardiac (adult & pediatric); Peripheral Vascular, Musculo-skeletal Conventional & Superficial, Transrectal and Transvaginal.

This device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Abdomen; Pediatric; Small Organ (breast, testes, thyroid); heart soft tissue; Peripheral Vascular; Musculo-skeletal; Ob/Gyn and Urology.

The device is a general-purpose ultrasonic intended for use by a qualified physician for evaluation of Abdomen, Cardlac, Small Organ (breast, thyroid), heart soft tissue, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Pediatric, Fetal, Cephalic, Ob/Gyn, Trans-rectal, Trans-vaginal, Urology.

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Pediatric, Small Organ (Breast, Thyroid, Testes), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Ob/GYN, Cardiac Adult, Cardiac Pediatric, Peripheral vessel.

The UP600 diagnostic doppler ultrasound system is a compact and portable diagnostic ultrasound device, have integrated preprogrammed color ultrasound imaging system, capable of producing a resolution intended for clinical diagnostic imaging applications. The user interface includes a specialized control kevboard and color 15-inch LCD display. The digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the in depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows system integration to a variety of upgrade-able options and features.

The provided text is a 510(k) Premarket Notification Summary for the BenQ Medical Technology UP600 Diagnostic Doppler Ultrasound System. This document does not describe specific acceptance criteria and a study proving the device meets those criteria in the typical format expected for AI/ML device evaluations. Instead, it focuses on demonstrating substantial equivalence to predicate devices, which is a different regulatory pathway.

Therefore, many of the requested elements (sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable or extractable from this specific document, as it predates the widespread regulatory expectations for AI/ML device evaluations.

Here's a breakdown of what can be extracted, along with explanations for what cannot:

1. Table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria (e.g., specific sensitivity, specificity, or image quality metrics) or report performance against such criteria. Instead, it relies on demonstrating comparable technological characteristics and intended uses to legally marketed predicate devices. The "performance" aspect is implicitly shown by comparison to these predicate devices rather than through specific quantitative metrics presented for the UP600 itself.

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

This information is not provided in the document. As a premarket notification for a general ultrasound system based on substantial equivalence, the submission primarily focuses on technical specifications, safety standards, and comparison to existing devices rather than clinical study data with specific test sets.

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)

This information is not provided in the document. No specific clinical test set requiring expert ground truth is described.

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

This information is not provided in the document. No specific clinical test set requiring adjudication is described.

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

A Multi-Reader, Multi-Case (MRMC) comparative effectiveness study was not performed, nor is it applicable for this type of device submission. The UP600 is a diagnostic ultrasound system, a hardware device, and does not incorporate AI/ML functionality that would assist human readers in image interpretation. Therefore, there is no "AI vs without AI assistance" comparison.

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

A standalone performance evaluation of an algorithm was not performed, nor is it applicable. The UP600 is a diagnostic ultrasound system, not an algorithm, and is intended for use by a qualified physician (human-in-the-loop).

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

This information is not provided in the document. No specific ground truth for performance evaluation is mentioned, as the focus is on substantial equivalence.

8. The sample size for the training set

This information is not provided in the document. This device is a hardware system, not an AI/ML algorithm that would typically have a training set.

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

This information is not provided in the document. Not applicable for this hardware device.

Summary of the Study (or lack thereof, in the context of AI/ML evaluation):

The BenQ Medical Technology UP600 Diagnostic Doppler Ultrasound System's acceptance was based on a demonstration of substantial equivalence to legally marketed predicate devices (BenQ Medical Technology UP600 K121983, GE Healthcare Voluson i K053435, and CGMC OPUS 5000 K102989). This is the primary "study" or justification presented in the 510(k) summary.

The document highlights the following to support substantial equivalence:

• Comparable Indications for Use: The UP600 and its transducers are intended for the same clinical applications as the predicate devices.
• Similar Technological Characteristics: The UP600 shares core operational principles (applying high voltage burst to piezoelectric material, detecting reflected echoes, constructing 2D B-mode, Doppler color, and Doppler spectrum images) and many features (display modes, measurements, transducer types) with the predicate devices. Some features, like the 128-channel digital beam former, are even identical to one predicate (GE Voluson I) and an improvement over another (CGMC OPUS 5000).
• Compliance with Safety Standards: The device meets recognized national and international safety standards (NEMA UD 2, NEMA UD 3, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 10993-1).
• Equivalent Acoustic Output: The acoustic output levels are identical to the predicate devices and stated to be below applicable FDA limits ("Track 3; MI, TIS, TIC, TIB. Derated Ispta: 720mW/cm2 maximum," etc.).
• Biocompatible Patient Contact Materials: Materials used for patient contact are compliant with ISO10993-5 (a standard for biological evaluation of medical devices).

The 510(k) summary concludes that "The UP600 is substantially equivalent in safety and effectiveness to the predicate systems." This implies that by meeting the technical and safety specifications and having comparable intended uses to already cleared devices, it is deemed safe and effective without the need for extensive clinical performance studies that would typically involve test sets, expert ground truth, or AI-specific evaluations.

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