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The DUS-6000 Digital Ultrasonic Diagnostic Imaging System is applicable for ultrasound evaluation in hospitals and clinics. It is intended for use in Abdominal, obstetric, gynecology, pediatrics, small parts, urology, peripheral vascular, musculoskeletal (conventional and superficial) and cardiac applications by or on the order of a physician or similarly qualified health care professional.

The DUS-6000 Digital Ultrasonic Diagnostic Imaging System is a portable diagnostic ultrasound system, which applies advanced technologies such as Phased Inversion Harmonic Compound Imaging (eHCI), Double-Beam-Forming (D Beam), Speckle Resistance Imaging (eSRI), scan receiving aperture (SRA) and Spatial Compounding Imaging. Various image parameter adjustments, 12.1 inch LCD and diverse probes are configured to provide clear and stable images. It is intended for diagnostic ultrasound imaging analysis in hospitals and clinics.

It is designed to produce ultrasound waves into body tissue and to present the returned echo information on the monitor; the resulting information is displayed in the following display modes: BB/2B/4B-Mode, M-Mode, B+M Mode or PW Mode. Supported probe types include convex, linear, micro-convex, endocavity (transvaginal, endorectal) probes. The device can detect the probe automatically.

The system consists of 7 major functional blocks, including a main unit, a display subsystem, a transducer and transceiver subsystem, digital beamformer, keyboard and power subsystem.

The provided document is a 510(k) premarket notification for the DUS-6000 Digital Ultrasonic Diagnostic Imaging System. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it explicitly states: "Clinical testing is not required."

Therefore, the document does not contain any information about an acceptance criteria table or any study that proves the device meets specific acceptance criteria related to its diagnostic performance. The filing focuses on demonstrating equivalence to a previously cleared device through non-clinical tests (safety standards, acoustic output) and comparison of technical characteristics and intended use.

This means I cannot provide the requested information for acceptance criteria and a study proving device performance, as it is explicitly stated that clinical testing was not performed or required for this 510(k) submission.

Here's a breakdown of what can be extracted or inferred from the provided text, primarily based on the absence of information:

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

• No information available. The document states "Clinical testing is not required." and does not provide any performance metrics or acceptance criteria for diagnostic accuracy or effectiveness.

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

• No test set or clinical data described. Since clinical testing was deemed "not required," there is no information about a test set, sample size, or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Not applicable. No clinical test set or ground truth establishment is described.

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

• Not applicable. No clinical test set or adjudication process 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 and no AI involved directly. This device is a diagnostic ultrasound imaging system, not an AI-assisted diagnostic tool. No MRMC study or AI performance evaluation is mentioned.

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

• Not applicable. This device is a diagnostic ultrasound imaging system, where human operation and interpretation are inherent. No standalone algorithm performance is discussed.

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

• Not applicable. No clinical test set or ground truth establishment is described.

8. The sample size for the training set

• Not applicable. This document describes a medical device (ultrasound system), not a machine learning algorithm that requires a training set.

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

• Not applicable. As above, no training set or ground truth establishment relevant to machine learning is described.

Summary of Device and Basis for Clearance (as per the document):

• Device Name: DUS-6000 Digital Ultrasonic Diagnostic Imaging System
• Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body in various clinical applications (Abdominal, obstetric, gynecology, pediatrics, small parts, urology, peripheral vascular, musculoskeletal, cardiac).
• Regulatory Clearance Basis: Substantial equivalence to the predicate device, DUS 60 ultrasound system (K131830), manufactured by EDAN Instruments Inc.
• Evidence for Equivalence:
  • Similar technology characteristics.
  • Same intended use.
  • Same design principle.
  • Same electrical classification.
  • Same accuracy (claimed, but not explicitly demonstrated through clinical performance data in this document).
  • Same needle-guide bracket material, property, and sterilization methods as the predicate.
• Non-Clinical Tests Conducted (relevant to safety and basic performance):
  • IEC 60601-1 Electrical Safety
  • IEC 60601-1-2 Electromagnetic Compatibility
  • IEC 60601-2-37 Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
  • Acoustic output testing as per FDA guidelines (September 9, 2008).
  • ISO 10993-1, ISO 10993-5, and ISO 10993-10 Biological Evaluation of medical devices.

The document explicitly states that "Clinical testing is not required," which means the submission relies on non-clinical data, comparison to the predicate device, and adherence to recognized standards to demonstrate safety and substantial equivalence, rather than new clinical performance studies or specific diagnostic acceptance criteria.

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The FM-3000 Fetal Monitor is intended for non-invasive and invasive monitoring of fetus during antepartum examination, labor and delivery. It is intended to be used only by trained and qualified personnel in antepartum examination rooms, labor and delivery rooms.

It provides Non-stress testing for pregnant women from the 28th week of gestation. It can externally monitor the fetal heart rate using ultrasound and uterine activity via a pressure sensing transducer. Alternatively, it can internally monitor one of the fetal heart rates with an electrocardiograph and uterine activity with an intrauterine pressure catheter.

With non-invasive ultrasound Doppler, external pressure sensing transducer and direct fetal electrocardiograph technique, the FM-3000 Fetal Monitor provides Non-Stress testing for pregnant women from the 28th week of gestation. It can externally monitor the fetal heart rate using ultrasound and uterine activity. Alternatively, it can internally monitor one of the fetal heart rate with direct fetal electrocardiograph technique and uterine activity with an Intrauterine Pressure Catheter.

The Fetal monitor can be connected with Central Monitoring System via a RJ45 interface. Also it can be connected to wireless network module via a DB9 interface, and the wireless network module will complete the data switch of the monitor and the Obstetrical Central Monitoring System.

The FM-300 is not intended for use in intensive care units, operating rooms or for home use.

This document describes a 510(k) premarket notification for the FM-3000 Fetal Monitor. The core of this submission is to demonstrate substantial equivalence to a predicate device, the F3 Fetal Monitor (K102140) from EDAN Instruments.

Based on the provided information, the device relies entirely on the demonstration of substantial equivalence to a predicate device, with no new performance data or studies conducted specifically for the FM-3000. Therefore, it does not contain the detailed acceptance criteria and study data as one might expect for a novel device.

Here's a breakdown of the requested information based solely on the provided text:

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

The document explicitly states: "The FM-3000 Fetal Monitor is identical to the predicate device in terms of design, materials, specifications, and manufacturing. Therefore, no new testing was needed to support substantial equivalence."

This means there are no new acceptance criteria or reported device performance metrics specifically for the FM-3000 Fetal Monitor because it claims to be identical to its predicate. The acceptance criteria and performance data would have been established and met by the predicate device (F3 Fetal Monitor K102140) to obtain its clearance.

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. No new test set or data was used for the FM-3000 Fetal Monitor. The device claims substantial equivalence to a predicate, implying that previous studies on the predicate device would have established its performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. No new test set or ground truth establishment was performed for the FM-3000 Fetal Monitor.

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

Not applicable. No new test set or adjudication was performed for the FM-3000 Fetal Monitor.

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. The FM-3000 Fetal Monitor is not an AI-assisted device, and no MRMC study was conducted.

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

Not applicable. The FM-3000 Fetal Monitor is not an algorithm-only device. It is a physical monitoring system for fetal vital signs.

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

Not applicable. No new ground truth establishment was performed for the FM-3000 Fetal Monitor. For the predicate device, it would likely have been clinical validation against established fetal monitoring practices and potentially comparison to other validated monitoring systems, though the document does not provide details on the predicate's original ground truth.

8. The sample size for the training set

Not applicable. The FM-3000 Fetal Monitor is not a machine learning or AI device that requires a training set.

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

Not applicable. The FM-3000 Fetal Monitor is not a machine learning or AI device that requires a training set.

Summary of the K141194 submission for FM-3000 Fetal Monitor:

The manufacturer, Advanced Instrumentations, Inc., successfully argued for 510(k) clearance by demonstrating substantial equivalence to an existing predicate device, the EDAN Instruments F3 Fetal Monitor (K102140). The key argument is that:

• "The FM-3000 Fetal Monitor is identical to the predicate device in terms of design, materials, specifications, and manufacturing."
• "There are no differences in technological characteristics between the two devices."
• "The only difference between the predicate device and the FM-3000 Fetal Monitor is the device name and branding in the labeling."

Therefore, the performance of the FM-3000 Fetal Monitor is asserted to be the same as the predicate device, and no new studies or data were deemed necessary to support this claim. The safety and effectiveness of the FM-3000 are directly linked to the established safety and effectiveness of the predicate.

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This monitor is intended to be used for monitoring, storing, reviewing, recording, and generating alarms for multiple physiological parameters including ECG, respiration (RESP), temperature (TEMP), functional arterial oxygen saturation (Sp02), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), expired C02, cardiac output (C.O.) and anesthetic gas (AG)of adults, pediatrics and neonates in hospital environments. The monitor is equipped with alarms that indicate system faults (such as loose or defective electrodes), physiologic parameters that have exceeded the limits set by the operator, or both.

This monitor is suitable for use in hospital environments including but not limited to OR, PACU, ICU and neonate intensive care room.

The PM-2000M Patient Monitor can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormities happen.

The PM-2000M realizes the monitoring of physiological parameters by configuration with different parameter modules which include Sp02 (pulse oxygen saturation, pulse rate and Sp02 plethysmogram) with EDAN Sp02 module or Nellcor SP02 module, NIBP (systolic pressure, diastolic pressure, mean pressure and pulse rate), TEMP, ECG, RESP, C02, IBP, C.O. and AG.

The above is the maximum configuration for elite VB, the user may select different monitoring parameters in according with the requirement.

The PM-2000M is configured with a 17-inch touch screen and build-in Lithium-ion battery, Besides, and supports software upgrade online and networking

This document is a 510(k) summary for the PM-2000M Patient Monitor. It focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study report as typically seen for novel devices that require extensive performance validation against a defined set of criteria.

Therefore, the requested information, particularly regarding specific acceptance criteria, detailed study designs (sample size, data provenance, expert ground truth, adjudication, MRMC, or standalone performance), and ground truth establishment for novel algorithms, is not explicitly available in the provided text.

Here's an analysis based on the information provided and what can be inferred:

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

The document does not provide a table of
specific, quantitative acceptance criteria for each physiological parameter (ECG, SpO2, NIBP, etc.) or a corresponding reported performance from a study. The "Test Summary" lists general categories of testing:

• Software testing
• Hardware testing
• Safety testing
• Environment testing
• Risk analysis
• Final validation

This implies that the device underwent validation to ensure it meets general performance and safety standards for patient monitors, likely including accuracy and reliability benchmarks commonly applied to such devices (e.g., ISO or AAMI standards for specific physiological measurements). However, the specific metrics and thresholds are not detailed.

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. The general nature of the "Test Summary" does not include details about specific test sets, their size, or the provenance of any data used for validation.

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. The document does not describe studies that would require expert-established ground truth in the way a diagnostic AI device would (e.g., for image interpretation). Patient monitors typically rely on physical measurement standards or highly accurate reference devices for ground truth during testing.

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

This information is not provided. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which are not detailed here for this patient monitor.

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

No, an MRMC comparative effectiveness study was not done or at least not reported in this document. This type of study is usually conducted for AI-powered diagnostic aids where human readers interact with the AI. The PM-2000M is a patient monitor, and its primary function is direct physiological measurement, not aiding human readers in interpretation tasks in the same way an AI diagnostic tool would.

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

The document implies that standalone testing of the device's functions (measurements, alarms) was performed as part of "Software testing," "Hardware testing," and "Final validation." However, explicit details of these standalone performance metrics (e.g., accuracy of ECG measurement compared to a reference, alarm detection rates) are not provided. The focus is on substantial equivalence to a predicate device, suggesting performance was assessed against established standards for patient monitors rather than novel algorithm-specific benchmarks.

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

The document does not explicitly state the type of ground truth used. For patient monitors, ground truth typically involves:

• Reference devices: Highly accurate, calibrated medical devices (e.g., a reference ECG machine, a calibrated blood pressure simulator, a SpO2 simulator) that provide the true physiological values.
• Physical standards: For environmental and safety testing, compliance with relevant industry standards (e.g., for electromagnetic compatibility, temperature ranges).

8. The sample size for the training set

This information is not applicable / not provided. Patient monitors like the PM-2000M typically rely on established physics-based algorithms and signal processing techniques for physiological parameter measurement, rather than machine learning algorithms that require a "training set" of data in the common sense of AI/ML devices. Therefore, the concept of a training set of data for a "novel" algorithm is not relevant here based on the device description.

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

This information is not applicable / not provided for the same reason as point 8.

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The diagnostic ultrasound system (DUS-5000) is applicable for adults, pregnant women, pediatric patients' ultrasound evaluation in hospitals and clinics. It is intended for use in abdominal, obstetrics, gynecology, pediatric, small parts, urology, peripheral vascular, musculoskeletal (conventional and superficial), transvaginal and cardiac clinical applications, by or on the order of a physician or similarly qualified health care professional.

The DUS-5000 Diagnostic Ultrasound System, which applies advanced technologies such as Phased Inversion Harmonic Compound Imaging (eHCI), Multi-Beam-Forming (mBeam), Speckle Resistance Imaging (eSRI), and Spatial Compounding Imaging, etc. Various image parameter adjustments, 12.1 inch LCD and diverse probes are configured to provide clear and stable images. Its function is to acquire and display Ultrasound images in B-mode, M-mode, PW-mode, Color-mode, PDI/DPDI mode. This system provides a series of probes that include linear array, convex array, micro-convex array with a frequency range of approximately 2.5 MHz to11 MHz.

The DUS-5000 Diagnostic Ultrasound System is a medical device intended for diagnostic ultrasound imaging and fluid flow analysis. The acceptance criteria and the study proving the device meets these criteria are outlined below, derived from parts {0} through {15} of the provided text.

Based on the provided information, clinical testing was not required for this device, as stated in section {2}. This implies that the device's performance was evaluated through non-clinical means and comparison to a predicate device. Therefore, details regarding test sets, ground truth establishment, expert adjudication, or MRMC studies for clinical performance are not available in this document. The "acceptance criteria" in this context refer to the successful completion of non-clinical safety and performance standards and demonstrating substantial equivalence to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Given that clinical testing was not required, the acceptance criteria are primarily related to non-clinical safety and performance standards, and comparison to the predicate device. The performance is assessed by confirming the device meets these standards and functions identically or equivalently to the predicate.

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

Since clinical testing was not required (section {2}), there is no mention of a clinical "test set" in terms of patient data or provenance. The "test set" in this context refers to the device itself undergoing non-clinical technical evaluations and comparisons to the predicate device.

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

Not applicable, as clinical testing was not required (section {2)} and no expert-based ground truth establishment for clinical performance is reported. The "ground truth" for the non-clinical evaluations would be the established engineering and biocompatibility standards themselves.

4. Adjudication method for the test set

Not applicable, as clinical testing was not required (section {2)} and no clinical test set requiring adjudication is described.

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

Not applicable. The device is a diagnostic ultrasound system and not explicitly stated to be an AI-assisted device. Furthermore, clinical testing was not required (section {2}), so no MRMC study or AI assistance evaluation was conducted or reported.

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

Not applicable, as the device is a diagnostic ultrasound system, not an algorithm-only device. Additionally, clinical testing was not required (section {2)}.

7. The type of ground truth used

For non-clinical evaluation, the "ground truth" is established through adherence to national and international safety standards (e.g., IEC 60601-1, IEC 60601-1-2, Acoustic Output Guidelines, ISO 10993 series) and by demonstrating identical or equivalent performance to the legally marketed predicate device (Model U50 Diagnostic Ultrasound System, K123249).

8. The sample size for the training set

Not applicable, as clinical testing was not required (section {2}). This device is a diagnostic ultrasound system, and the submission does not mention machine learning or AI components that would typically require a training set of data.

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

Not applicable, as clinical testing was not required (section {2}), and no training set is mentioned.

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The monitor monitors parameters such as ECG (3-lead or 5-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood pressure (dual-IBP, NIBP), Temperature (dual-TEMP), Expired C02.

The monitor is intended to be used only under regular supervision of clinical personnel. It is applicable to adult, pediatric, and neonatal usage in a hospital environment and during patient transport inside a healthcare facility. The monitor is equipped with alarms that indicate system faults (such as loose or defective electrodes), physiologic parameters that have exceeded the limits set by the operator, or both.

The Patient Monitor Models PM-2000A, PM-2000A+ & PM-2000A Pro can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormity so that doctors and nurses can deal with them in time. The patient monitor supports software upgrade online and networking and build-in battery power is available for all the models.

The Patient Monitor Models PM-2000A, PM-2000A+ & PM-2000A Pro can monitor physiological parameters including SpO2, NIBP, ECG, RESP, TEMP, C02, IBP. The above is the maximum configuration; the user may select different monitoring parameters in according with specific requirements. The main difference between Patient Monitor models is the screen size as it is illustrated in the table below:

The provided document is a 510(k) summary for patient monitors (PM-2000A, PM-2000A+, and PM-2000A Pro). It describes the device, its intended use, and its classification, but does not contain any information about acceptance criteria or a study proving performance against such criteria.

The document states:

• "Verification and Validation testing was done on the Patient Monitor."
• "This premarket notification submission demonstrates that the Patient Monitor Models PM-2000A, PM-2000A+ & PM-2000A Pro is substantially equivalent to the predicate device."

However, no details about the specific tests performed (e.g., performance metrics, acceptance thresholds, methodology, or results) are included in this summary. It lists general test categories like "Software Testing," "Hardware Testing," "Electrical Testing," and "Safety Testing" but provides no further specifics that would allow answering the prompt's questions about acceptance criteria or study details.

Therefore,Based on the provided information, I cannot answer your request as the document does not contain the necessary details regarding acceptance criteria, device performance results, sample sizes, ground truth establishment, or study methodologies.

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The AM-6000 Anesthesia machine is intended for general anesthesia use. The AM-6000 Anesthesia machine will delivery operator set concentrations of oxygen and anesthesia gases as well as deliver controlled breaths to the patient with either a constant or a deceleration flow pattern. AM-6000 Anesthesia machine is also intended to allow for the provision of manual ventilation.

The AM-6000 Anesthesia Machine is a continuous flow Anesthesia Machine which offers manual or automatic vehtilation, easily adjustable fresh gas delivery, anesthetic agent delivery, ventilation monitoring, convenient ergonomics, and state-of-the-art safety systems. The AM-6000 is designed to decrease the risk of hypoxic mixtures and the inadvertent movement of the air flow control knobs. Additionally, the AM-6000 provides battery power in the event of an AC power outage. Multiple ventilation modes, i.e., CMV, PCV, SIMV and PSV, are offered by the AM-6000 with electronic PEEP available in each of the modes. The fresh gas dosing subsystem offers features of a traditional Anesthesia Machine along with dual flow tubes which display the gas flows at all times. The AM-6000 contains two vaporizers and a heated breathing system to minimize condensation and return moisture to the patient.

I am sorry, but the provided text does not contain the necessary information to construct a table of acceptance criteria and reported device performance, nor does it detail a study proving the device meets acceptance criteria. The document is a 510(k) summary for an anesthesia machine and primarily focuses on its description, indications for use, comparison to a predicate device, and the FDA's substantial equivalence determination.

Specifically, there is no mention of:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test or training sets.
• Data provenance.
• Number or qualifications of experts.
• Adjudication methods.
• MRMC comparative effectiveness studies or effect sizes.
• Standalone algorithm performance.
• Type of ground truth used for testing or training sets.

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The FM-9000 Plus Fetal and Maternal Monitor is intended for monitoring physiological parameters of pregnant women during antepartumn examination, labor and delivery. It is intended to be used only by trained and qualified personnel in antepartumn examination rooms, labor and delivery rooms. The FM-9000 Plus Fetal and Maternal Monitor is intended for providing Non-Stress testing or fetal monitoring for pregnant women from the 28th week of gestation. In addition, it provides a solution for maternal vital signs monitoring.

The Fetal & Maternal Monitor provides the following primary features that can be available for the multiple configurations:

• Basic parameters: FHR, TOCO, Event Mark, AFM .
• Dual FHR monitoring .
• Internal parameters: UIP, DECG .
• FHR limit alarm .
  Following facilities are also provided in addition to the above:
• Maternal ECG monitoring ●
• Maternal SP02 monitoring ●
• Maternal NIBP .
• Maternal temperature monitoring ●

{
"1. A table of acceptance criteria and the reported device performance": "The provided text does not contain a table of acceptance criteria or reported device performance for clinical endpoints. It primarily discusses the device's technical aspects and regulatory classification.",
"2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": "The document explicitly states: "Clinical testing is not required." Therefore, no test set sample size or data provenance is available for clinical performance.",
"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)": "As clinical testing was not required, there is no mention of experts or ground truth establishment for a clinical test set.",
"4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": "Clinical testing was not required, so no adjudication method for a test set is discussed.",
"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 Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The device is a Fetal and Maternal Monitor, not an AI-assisted diagnostic tool for human readers.",
"6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "The document states "Clinical testing is not required." Therefore, no standalone performance study was conducted or reported.",
"7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": "Since clinical testing was not required, no specific type of ground truth was used for clinical performance evaluation.",
"8. The sample size for the training set": "The document does not mention a training set or its sample size. The device is a medical monitoring instrument, and the regulatory submission indicates that clinical testing was not required for its approval.",
"9. How the ground truth for the training set was established": "As no training set is mentioned and clinical testing was not required, there is no information on how ground truth for a training set was established."
}

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The Ultrasonic Tabletop Doppler is intended to be used by health care professionals including registered nurses, practical nurses, midwives, ultrasound technicians, and physician assistants, by prescription from licensed physicians in hospitals, clinics and private offices.

The 2 MHz and/or 3 MHz probes are indicated for the detection of fetal heart rate from early gestation thru delivery and as a general indication of fetal well being. They can also be used to verify fetal heart viability following patient trauma.

Ultrasonic Tabletop Doppler provides the following primary features:

• Basic parameters: FHR
• 240 seconds fetal heart sound record and playback
• Infrared communication (for TD-6000 only)
• Ni-MU1 battery for 20 hours continuous working of main unit
• Li-ion battery for 2.5 hours continuous working of TD-6000 probe
• Charge the TD-6000 probe battery by main unit
• Continuous wave Doppler transducer for FUR detection

The provided 510(k) summary for the TD-5000 & TD-6000 Ultrasonic Tabletop Doppler explicitly states: "Clinical testing is not required" (Page 2).

Therefore, there is no clinical study that proves the device meets specific acceptance criteria based on human performance or diagnostic accuracy. The substantial equivalence determination is based on non-clinical tests and comparison to a predicate device.

Given this, I cannot provide the requested information regarding acceptance criteria and performance based on a clinical study, as such a study was not performed or reported in this submission.

However, I can extract information about the non-clinical tests that were performed:

Non-Clinical Tests Performed:

The following quality assurance measures were applied to the development of the Ultrasonic Doppler (Page 2):

• Software testing
• Hardware testing
• Safety testing
• Environment test
• Risk analysis
• Final validation

The submission states that "Verification and validation testing was done on the TD-5000 & TD-6000 Ultrasonic Tabletop Doppler" (Page 2), and that the device "has similar technology characteristics and has the same intended use, same design principle, same electrical classification, same measurement mode and same accuracy as the predicate device" (Page 2).

Since no clinical study was conducted, the following requested information points cannot be answered:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and their qualifications
• Adjudication method for the test set
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size
• If a standalone performance (algorithm only) was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

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The PD-100 series Ultrasonic Pocket Doppler are intended for use by health care professionals including registered nurses, practical nurses, midwives, ultrasound technicians, and physicians' assistants, by prescription from licensed physicians in hospitals, clinics and private offices. The 2 MHz and 3 MHz obstetrical probes are indicated for the detection of fetal heart rate from early gestation thru delivery and as a general indication of fetal well being. They can also be used to verify fetal heart viability following patient trauma. The 4 MHz, 5 MHz and/or 8 MHz vascular probes are indicated for the detection of blood flow in veins and arteries for assisting in the detection of peripheral vascular disease.

Not Found

This is most likely a 510(k) premarket notification letter for the PD-100 Series Ultrasonic Doppler. This type of document generally does not contain acceptance criteria or study results in the detail you are requesting.

Instead, 510(k) submissions demonstrate substantial equivalence to a legally marketed predicate device, often relying on existing validated technology and established performance characteristics rather than novel clinical studies with specific acceptance criteria as you've outlined.

Therefore, many of your questions cannot be answered from the provided text.

Here is what can be inferred or stated about the provided document:

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

• Cannot be provided. This document is a clearance letter, not a detailed technical report or study submission. It does not list specific acceptance criteria or reported device performance metrics in the format requested. The FDA's determination is based on the submission demonstrating substantial equivalence to a predicate device, which inherently means performance is considered "equivalent" to the predicate, but specific performance values are not typically part of the clearance letter itself.

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

• Cannot be provided. This information is not present in the clearance letter.

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)

• Cannot be provided. This information is not present in the clearance letter.

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

• Cannot be provided. This information is not present in the clearance letter.

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

• Cannot be provided. This device is an ultrasonic Doppler, not an AI-assisted diagnostic tool for interpretation by human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and would not have been performed.

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

• N/A. This device is a hardware device (ultrasonic Doppler) that produces signals (fetal heart rate, blood flow). It is not an algorithm that performs standalone diagnoses. Its performance is related to its ability to detect these physiological signals, which is then interpreted by a healthcare professional.

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

• Cannot be provided. This information is not present in the clearance letter. For Doppler devices, ground truth often involves comparison to established clinical methods or other validated Doppler devices, but the specific details are not here.

8. The sample size for the training set

• Cannot be provided. This information is not present in the clearance letter and is typically more relevant for machine learning/AI models.

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

• Cannot be provided. Same as above.

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The DUS-3000/DUS-3000Plus Digital Ultrasonic Diagnostic Imaging System is intended for diagnostic ultrasound imaging analysis in gynecology rooms, obstetrics rooms, examination rooms, intensive care units, and emergency rooms. The DUS-3000/DUS-3000Plus is intended for use by or on the order of a physician or similarly qualified health care professional for ultrasound evaluation of Fetus; Abdomen; Pediatrics; Small Organ; Neonatal Cephalic; Cardiology; Peripheral Vessel; Musculo-skeleton (both Conventional and Superficial); Urology (including prostate); Transrectal and Transvaginal.

The DUS-3000/DUS-3000Plus Digital Ultrasound Diagnostic Imaging System is a portable digital ultrasonic diagnostic BMV system applied in ultrasound diagnostic examination of abdominal, obstetrical, small parts, gynecological, orthopedic, cardiac, and urological applications.

It is designed to produce ultrasound waves into the body tissue and to present the returned echo information on the monitor. The resulting information is displayed in five display modes: B-Mode, 2B-Mode, 4B-Mode, M-Mode or the combined mode (i.e. B/M-Mode). This system controlled by software is a Track 1 device that employs an array of probes that include linear array, convex linear array, micro convex linear array, transrectal and transvaginal with a frequency range of approximately 2.5MHz-10MHz. The system consists of a main unit, a display and transducers.

This document is a 510(k) summary for the DUS-3000/DUS-3000Plus Digital Ultrasound Diagnostic Imaging System. It primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing and outlining the intended uses.

Based on the provided text, there is no detailed information regarding acceptance criteria, specific device performance metrics for a study, or a study that proves the device meets specific acceptance criteria related to diagnostic accuracy.

The summary states: "Clinical testing is not required" and focuses on non-clinical tests for safety standards and comparison to a predicate device to establish substantial equivalence. Therefore, many of the requested details about a performance study with acceptance criteria cannot be extracted from this document.

However, I can extract the following based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

No specific quantitative or qualitative acceptance criteria related to diagnostic performance (e.g., sensitivity, specificity, accuracy) are mentioned for the device. The document states that "clinical testing is not required" and instead relies on non-clinical testing for safety and demonstrating substantial equivalence to a predicate device.

The reported device "performance" is implicitly its adherence to various safety and general characteristics, as it is found substantially equivalent to the predicate.

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

• Sample Size (Test Set): Not applicable, as no clinical performance study was conducted.
• Data Provenance: Not applicable.

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

• Not applicable, as no clinical performance study was conducted.

4. Adjudication Method for the Test Set

• Not applicable, as no clinical performance study was conducted.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states "Clinical testing is not required."

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

• Not applicable, as this device is a diagnostic ultrasound system, not an AI algorithm. It is a "Track 1 device" meaning it's a conventional medical device, not an AI/ML software as a medical device.

7. The Type of Ground Truth Used

• Not applicable, as no clinical performance study was conducted. The "ground truth" for the submission's claims is adherence to safety standards and demonstration of substantial equivalence to a predicate device.

8. The Sample Size for the Training Set

• Not applicable, as this device is a conventional diagnostic ultrasound system, not an AI/ML algorithm that requires a training set.

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

• Not applicable, as this device is a conventional diagnostic ultrasound system, not an AI/ML algorithm that requires a training set.

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