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Fetal & Maternal Monitor (Model: F15A, F15A Air) is intended for providing Non-Stress testing or fetal monitoring for pregnant women from the 28th week of gestation. It is intended to be used only by trained and qualified personnel in antepartum examination rooms, labor and delivery rooms.

Fetal & Maternal Monitor (Model: F15A, F15A Air) is intended for real time monitoring of fetal and maternal physiological parameters, including non-invasive monitoring and invasive monitoring:

Non-invasive physiological parameters:

• Maternal heart rates (MHR)
• Maternal ECG (MECG)
• Maternal temperature (TEMP)
• Maternal oxygen saturation (SpO2) and pulse rates (PR)
• Fetal heart rates (FHR)
• Fetal movements (FM)
• FTS-3

Note: SpO2 and PR are not available in F15A Air.

Invasive physiological parameters:

• Uterine activity
• Direct ECG (DECG)

The F15A series fetal and maternal monitor can monitor multiple physiological parameters of the fetus/mother in real time. F15A series can display, store, and print patient information and parameters, provide alarms of fetal and maternal parameters, and transmit patient data and parameters to Central Monitoring System.

F15A series fetal and maternal monitors mainly provide following primary feature:

Non-invasive physiological parameters:

• Maternal heart rates (MHR)
• Maternal ECG (MECG)
• Maternal temperature (TEMP)
• Maternal oxygen saturation (SpO2) and pulse rates (PR)
• Fetal heart rates (FHR)
• Fetal movements (FM)
• FTS-3

Note: SpO2 and PR are not available in F15A Air.

Invasive physiological parameters:

• Uterine activity
• Direct ECG (DECG)

The provided FDA 510(k) clearance letter and summary for the Fetal & Maternal Monitor (F15A, F15A Air) do not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the study that proves the device meets them.

The document focuses primarily on demonstrating substantial equivalence to a predicate device (Edan Instruments, Inc., F9 Express Fetal & Maternal Monitor, K173042) through comparison of intended use, technological characteristics, and conformance to various safety and performance standards. It mentions "functional and system level testing to validate the performance of the devices" and "results of the bench testing show that the subject device meets relevant consensus standards," but it does not specify quantitative acceptance criteria for each individual physiological parameter (e.g., FHR accuracy, SpO2 accuracy) nor the specific results of those tests beyond stating that they comply with standards.

Specifically, the document does not include information on:

• A table of acceptance criteria with specific quantitative targets for each parameter and the reported device performance values against those targets. It only states compliance with standards.
• Sample sizes used for a "test set" in the context of clinical performance evaluation (it mentions "bench testing," but this is typically laboratory-based and doesn't involve patient data in a "test set" sense for AI/algorithm performance validation).
• Data provenance for such a test set (e.g., country of origin, retrospective/prospective).
• Number or qualifications of experts used to establish ground truth.
• Adjudication methods.
• Multi-Reader Multi-Case (MRMC) studies or human reader improvement data with AI assistance.
• Standalone (algorithm-only) performance, as this is a monitoring device, not a diagnostic AI algorithm.
• Type of ground truth (beyond "bench testing" which implies engineered signals or controlled environments).
• Sample size for a training set or how ground truth for a training set was established. This device is a traditional medical device, not an AI/ML-driven diagnostic or interpretative algorithm in the way your request implies.

Therefore, based solely on the provided text, I can only address what is present or infer what is missing.

Here's a breakdown based on the available information:

Analysis of Acceptance Criteria and Performance Testing based on Provided Document

The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (F9 Express Fetal & Maternal Monitor, K173042) by showing that the new device (F15A, F15A Air) has the same intended use and fundamentally similar technological characteristics, with any differences not raising new safety or effectiveness concerns.

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

The document does not provide a specific table with quantitative acceptance criteria for each physiological parameter (e.g., FHR accuracy, SpO2 accuracy) and the corresponding reported performance values obtained in testing. Instead, it states that the device was assessed for conformity with relevant consensus standards. For example, it lists:

• IEC 60601-2-37:2015: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment (relevant for FHR).
• ISO 80601-2-61:2017+A1:2018: Particular requirements for basic safety and essential performance of pulse oximeter equipment (relevant for SpO2).
• ISO 80601-2-56:2017+A1:2018: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (relevant for TEMP).
• IEC 60601-2-27:2011: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment (relevant for MECG/DECG).

Acceptance Criteria (Inferred from standards compliance): The acceptance criteria are implicitly the performance requirements specified within these listed consensus standards. These standards set limits for accuracy, precision, response time, and other performance metrics for each type of measurement.

Reported Device Performance: The document states: "The results of the bench testing show that the subject device meets relevant consensus standards." This implies that the measured performance statistics (e.g., accuracy, bias, precision) for each parameter fell within the acceptable limits defined by the respective standards. However, the specific measured values are not provided in this summary.

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 mentions "Bench Testing" which implies laboratory-based testing using simulators, controlled signals, or phantoms, rather than a "test set" involving patient data. There is no information provided regarding:

• Sample size (e.g., number of recordings, duration of recordings, number of simulated cases) for the bench tests for each parameter.
• Data provenance (e.g., country of origin, retrospective or prospective) as this is not a study involving patient data collection for performance 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 is not applicable and not provided. For a traditional physiological monitor, ground truth for bench testing is typically established using:

• Calibrated reference equipment/simulators: e.g., ECG simulators to generate known heart rates, SpO2 simulators to generate known oxygen saturation levels.
• Physical standards/phantoms: e.g., temperature baths at known temperatures.
• Known physical properties: e.g., precise weights for pressure transducers.

Clinical experts are not involved in establishing ground truth for bench performance of these types of physiological measurements.

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

This is not applicable and not provided. Adjudication methods are relevant for human expert review of complex clinical data (e.g., medical images for AI validation) to establish a consensus ground truth. For bench testing of physiological monitors, ground truth is objectively determined by calibrated instruments or defined physical parameters.

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

This is not applicable and not provided. An MRMC study is typically performed to evaluate the diagnostic accuracy of AI-assisted human interpretations versus unassisted human interpretations for AI-driven diagnostic devices. The Fetal & Maternal Monitor is a physiological monitoring device, not an AI-assisted diagnostic imaging or interpretation system. It measures and displays physiological parameters; it does not provide AI-driven assistance for human "readers" to interpret complex clinical information.

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

The device is a monitor that directly measures physiological parameters. It is not an "algorithm only" device in the sense of an AI model providing a diagnostic output. Its performance (e.g., FHR accuracy) is its standalone performance, as it directly measures these parameters. The document states "functional and system level testing to validate the performance of the devices," which would represent this type of standalone performance for the measurement functionalities. However, specific quantitative results are not given, only compliance with standards.

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

As explained in point 3, the ground truth for bench testing of physiological monitors is established using calibrated reference equipment/simulators and physical standards.

8. The sample size for the training set

This is not applicable and not provided. This device is a traditional physiological monitor, not a machine learning model that requires a "training set." Its algorithms for parameter measurement are based on established physiological principles and signal processing techniques, not on statistical learning from large datasets.

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

This is not applicable and not provided for the same reasons as point 8.

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The monitors are intended to be used for monitoring, storing, recording, and reviewing of, and to generate alarms for, multiple physiological parameters of adults and pediatrics (including neonates). The monitors are intended for use by trained healthcare professionals in hospital environments.

The monitored physiological parameters include: ECG, respiration (RESP), temperature (TEMP), functional oxygen saturation of arterial hemoglobin (SpO₂), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), and cardiac output (C.O.).

The arrhythmia detection and ST Segment analysis are intended for adult patients.

The NIBP monitoring supports iCUFS algorithm and iFAST algorithm. The iCUFS algorithm is intended for adult, pediatric and neonatal patients. The iFAST algorithm is intended for adult and pediatric patients (≥3 years of age). Both measurement algorithms are also intended for use with pregnant women, including pre-eclamptic patients. NIBP MAP is not applicable to pregnant women.

The Spot Temp with T2A module can only measure temperature of adult and pediatric (> 1 year of age) patients.

The monitors are not intended for MRI environments.

The cardiac output (C.O.) is only intended for adult patients.

The CX&UX series Patient Monitor including CX10/CX12/CX15/UX10/UX12/UX15 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 abnormalities so that doctors and nurses can respond to the patient's situation as appropriate.

Minor differences from the predicate device are limited to some modifications of monitoring parameter specifications. These updates do not change the fundamental scientific technology of the cleared predicate device and thus do not raise any questions about the safety and effectiveness of the subject device.

The provided FDA 510(k) clearance letter details the device's technical specifications and comparisons to predicate devices, along with the non-clinical performance data and adherence to various IEC and ISO standards. However, it explicitly states: "Clinical data: The subject device did not require new clinical studies to support substantial equivalence."

This means that the submission for this Patient Monitor device (CX10, CX12, CX15, UX10, UX12, UX15) relies on demonstrating substantial equivalence to a legally marketed predicate device (Edan Instruments, Inc., Patient Monitor Model iX10, iX12, iX15, K232962) through non-clinical performance testing and software verification/validation, rather than new clinical trials or studies involving human patients.

Therefore, the requested information regarding acceptance criteria and studies that prove the device meets acceptance criteria through clinical performance (e.g., sample size for test set, expert involvement, MRMC studies, ground truth establishment for test/training sets, effect size of human reader improvement with AI) cannot be extracted from this document, as such clinical studies were explicitly not required for this 510(k) submission.

The document focuses on demonstrating that the new device's technical specifications and performance are similar to the predicate device, and that it complies with relevant safety and performance standards through bench testing.

Here's what can be extracted from the provided text regarding acceptance criteria and the type of study performed, specifically focusing on the non-clinical aspects:

Device: Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)

The acceptance criteria for this device are implicitly tied to its performance meeting the standards and accuracy specifications of the predicate device and relevant international standards. Since no new clinical studies were conducted, the "proof" comes from non-clinical bench testing and software validation.

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical/Bench Testing)

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

• Sample Size: Not applicable in terms of human subjects or patient data test sets, as "new clinical studies" were not required. The "test set" refers to bench testing and functional system-level validation. The specific number of test cycles or a detailed breakdown of test cases for bench testing is not provided in this summary.
• Data Provenance: The data primarily originates from Edan Instruments Inc. (Shenzhen, Guangdong, China) through internal engineering and quality assurance processes for non-clinical bench testing and software validation. It is not patient data, so concepts like "retrospective or prospective" do not apply.

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

• Not applicable for clinical ground truth: Since no clinical studies were performed requiring human interpretation or diagnosis for a test set, no medical experts (e.g., radiologists) were used to establish ground truth in this context.
• Internal experts: Bench testing and software validation would have involved engineers and quality assurance professionals, whose qualifications are implicit in the quality system (21 CFR Part 820) but not specified in detail here.

4. Adjudication Method for the Test Set:

• Not applicable: Adjudication methods (e.g., 2+1, 3+1) are relevant for clinical studies involving multiple readers. This was not a clinical study. Bench testing relies on established technical specifications and standard compliance.

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

• No: No MRMC study was performed as no new clinical studies were required or conducted. Therefore, there's no effect size of human readers improving with AI assistance. The device is a patient monitor, not an AI-assisted diagnostic tool.

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

• Yes (for the technical components): The "performance testing-Bench" effectively represents a standalone evaluation of the device's functional components (ECG, NIBP, SpO2, etc.) and software against defined technical specifications and standards. The "software verification and validation testing" also represents a standalone evaluation of the algorithm and software functions. The specific algorithms (e.g., iCUFS, iFAST for NIBP, arrhythmia analysis logic) are tested independently for their accuracy against known inputs or reference standards as part of bench testing.

7. The Type of Ground Truth Used:

• Technical/Reference Standards: For the bench testing, the "ground truth" would be derived from:
  • Reference standards/simulators: Calibrated medical equipment, physiological simulators, and test signals (e.g., known ECG waveforms, simulated blood pressure readings, temperature standards) are used to provide the "true" values against which the device's measurements are compared.
  • Defined specifications: The device's internal design specifications and the requirements of the referenced IEC/ISO standards serve as the "ground truth" for compliance testing.
• Not clinical ground truth: No expert consensus, pathology, or outcomes data from real patients were used for establishing ground truth for this submission.

8. The Sample Size for the Training Set:

• Not applicable: The device is a patient monitor, not a machine learning/AI algorithm that typically undergoes a distinct "training" phase with a large dataset. Its functionality is based on established physiological measurement principles and programmed algorithms. Any internal calibration or algorithm refinement would be part of the product development process, not a dedicated "training set" in the AI/ML sense.

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

• Not applicable: As there was no "training set" in the context of an AI/ML model, the concept of establishing ground truth for it does not apply to this 510(k) submission.

In summary, this 510(k) clearance relies on demonstrating that the new Patient Monitor is substantially equivalent to a previously cleared predicate device, primarily through robust non-clinical bench testing and software validation, proving compliance with established medical device standards and functional specifications. No new clinical studies with patient data were required or conducted for this specific submission.

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The Acclarix AX8 Series Diagnostic Ultrasound System is intended for use by a qualified physician or allied health professional for ultrasound evaluations in hospitals and clinics.
The Acclarix AX8 Series Diagnostic Ultrasound System clinical applications include Abdominal, Gynecology, Obstetric, Cardiac, Small parts, Urology, Peripheral vascular, Musculoskeletal, Pediatric, Neonatal, Adult Cephalic, Thoracic/Pleural and Trans-esophageal Cardiac.
The Modes of Operation for Acclarix AX8 Series include B mode, M mode, Doppler mode, Harmonic Imaging, Elastography Imaging, Contrast imaging and their combination modes.
The Acclarix AX9 Series Diagnostic Ultrasound System is intended for use by a qualified physician or allied health professional for ultrasound evaluations in hospitals and clinics.
The Acclarix AX9 Series Diagnostic Ultrasound System clinical applications include Abdominal. Gynecology, Obstetric, Cardiac, Small parts, Urology, Peripheral vascular, Musculoskeletal, Pediatric, Neonatal, Adult Cephalic, Thoracic/Pleural and Trans-esophageal Cardiac.
The Modes of Operation for Acclarix AX9 Series include B mode, M mode, Doppler mode, Harmonic Imaging, Elastography Imaging, Contrast imaging and their combination modes.

The Acclarix AX8 Series & Acclarix AX9 Series Diagnostic Ultrasound System is a software controlled Diagnostic Ultrasound System, which consists of a main unit along with associated transducers. It is intended for use by a qualified physician or allied health professional for ultrasound evaluations in hospitals and clinics. This system is a Track 3 device to acquire and display ultrasound data in various imaging modes.

The provided text focuses on the 510(k) summary for the Edan Instruments Inc. Acclarix AX8 and AX9 Series Diagnostic Ultrasound Systems. It primarily addresses the substantial equivalence to a predicate device and outlines non-clinical performance data. It explicitly states "Clinical data: Not applicable," which means that no clinical studies were performed to establish acceptance criteria or demonstrate device performance against clinical metrics.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them because such a study involving clinical data and performance metrics is explicitly stated as "Not applicable" in the document.

However, I can extract information about the non-clinical testing performed:

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

Since no clinical acceptance criteria or performance metrics were reported, this table cannot be created as requested in the context of clinical performance. The document only states that the device complies with certain electrical safety, EMC, and performance standards.

Regarding the other requested information, the document states "Clinical data: Not applicable." Therefore, the following points cannot be addressed from the given text:

• 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable due to lack of clinical data.
• 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 due to lack of clinical data.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable due to lack of clinical data.
• 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 the document doesn't mention AI assistance or MRMC studies.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is an ultrasound system, not an AI algorithm intended for standalone performance.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable due to lack of clinical data.
• 8. The sample size for the training set: Not applicable as no clinical training data is mentioned.
• 9. How the ground truth for the training set was established: Not applicable as no clinical training data is mentioned.

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The SD1 is a pocket Doppler device used for detecting the fetal heartbeat from the 10th week of gestation. It is intended to be used by medical professionals only.

SD1 Ultrasonic Pocket Doppler is a device prescribed by a licensed physician for use by professional healthcare providers. It is a hand-held, battery powered audio Doppler device integrated with 3 MHz probe and with optional use of Bluetooth/app, used for detecting fetal heart beats. The device is for prescription use and is intended for use at or after 10 weeks gestation.

The provided text describes the SD1 Ultrasonic Pocket Doppler, a device intended for detecting fetal heartbeats from the 10th week of gestation. While the document outlines performance data and its substantial equivalence to predicate devices, it does not detail specific acceptance criteria for performance metrics like sensitivity, specificity, or predictive values that would typically be associated with AI/ML diagnostic devices. The acceptance criteria mentioned primarily relate to regulatory compliance, electrical safety, electromagnetic compatibility, and general performance standards for ultrasonic equipment.

Therefore, I cannot provide an acceptance criteria table or information related to AI/ML specific aspects such as sample size for test sets/training sets, expert adjudication methods, MRMC studies, or standalone algorithm performance, as these details are not present in the provided document.

However, I can extract the information relevant to the performance evaluation that was conducted:

Here's a summary of the available information:

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

Based on the document, specific, quantitative clinical performance acceptance criteria (e.g., minimum sensitivity/specificity thresholds) and their corresponding reported values are not explicitly stated for the SD1 Ultrasonic Pocket Doppler in the context of fetal heart rate detection accuracy. The document focuses on demonstrating substantial equivalence to predicate devices by ensuring the SD1 performs comparably and meets relevant safety and performance standards.

The closest to "acceptance criteria" for clinical performance is the conclusion that:
"The results showed that it did not take more time to find the fetal heart rate in pregnant patients, from 10 weeks of gestation onward, using the SD1 Pocket Doppler in comparison to the predicate SD3 Ultrasonic Pocket Doppler." This implies an acceptance criterion related to the time taken to detect FHR, with the performance meeting this criterion by being comparable to the predicate.

General performance characteristics (like FHR Accuracy) are listed in the predicate comparison table, and the SD1 matches the predicate for these:

Other acceptance criteria are regulatory and non-clinical in nature:

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "clinical testing was conducted at a Chinese hospital" with "pregnant patients, from 10 weeks of gestation onward." The exact number of patients or cases is not provided.
• Data Provenance: Prospective, from a "Chinese hospital."

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

Not applicable. The clinical study focused on comparing the time taken to detect fetal heart rate between the subject device (SD1) and a predicate device (SD3). The "ground truth" here would likely be the confirmed presence of a fetal heartbeat, assessed by medical professionals, but the number and qualifications of experts involved in this specific assessment are not detailed.

4. Adjudication method for the test set

Not applicable. The study design described does not involve a multi-reader adjudication process for establishing ground truth, as it's a comparative performance study of two Doppler devices in detecting FHR.

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 fetal Doppler, not an AI-assisted diagnostic tool for image interpretation. Therefore, an MRMC study comparing human readers with and without AI assistance was not performed.

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

Not applicable. The device is a hardware-based fetal Doppler, not an AI algorithm. Its performance inherently involves a human operator to locate the fetal heartbeat.

7. The type of ground truth used

The clinical study compared the SD1 to a legally marketed predicate device (SD3 Ultrasonic Pocket Doppler). The "ground truth" for the clinical performance aspect would be the successful detection of the fetal heart rate by a medical professional during the clinical test, effectively using the predicate device as a reference for comparison of detection time. There is no mention of pathology or other advanced outcomes data for ground truth in this context.

8. The sample size for the training set

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

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

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

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The diagnostic ultrasound system (U2) 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, musculosketal (conventional and superficial), endovaginal and cardiac clinical applications, by or on the order of a physician or similarly qualified health care professional.

U2 is a cart based diagnostic ultrasound system. U2 has the same intended use, similar product design, same performance effectiveness as the previous cleared U50 (K142511).

This is a 510(k) premarket notification for the U2 Diagnostic Ultrasound System. It asserts that the U2 system is substantially equivalent to the previously cleared U50 Diagnostic Ultrasound System (K142511).

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the performance specifications of the predicate device (U50 Diagnostic Ultrasound System, K142511). The document states that the U2 has "the same performance effectiveness as the previous cleared U50 (K142511)". Therefore, the performance criteria for the U2 are identical to those of the U50.

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

The document does not provide information on a specific test set sample size or data provenance (country of origin, retrospective/prospective) for a study of the U2's diagnostic performance. The submission relies on demonstrating substantial equivalence to a predicate device through non-clinical testing and comparison of technical specifications.

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

This information is not applicable as the document explicitly states: "Clinical testing is not required." Therefore, there was no test set requiring expert ground truth establishment for diagnostic performance.

4. Adjudication Method for the Test Set

This information is not applicable as no clinical test set requiring expert ground truth or adjudication was conducted.

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

No MRMC comparative effectiveness study is mentioned or appears to have been conducted, as the basis for clearance is substantial equivalence without clinical testing. Therefore, there is no reported effect size for human readers improving with AI vs. without AI assistance.

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

This information is not applicable. The U2 Diagnostic Ultrasound System is a medical imaging device operated by a human, not an AI algorithm performing diagnostic tasks in a standalone capacity. The claim is for the system itself, not a specific AI diagnostic feature within it.

7. Type of Ground Truth Used

As per point 3, no clinical ground truth (expert consensus, pathology, outcomes data, etc.) was explicitly established for a test set to prove diagnostic performance. The clearance relies on equivalence to a predicate and compliance with performance and safety standards.

8. Sample Size for the Training Set

This information is not applicable. The document does not describe the development or evaluation of an AI algorithm, and therefore no training set for such an algorithm is mentioned. The U2 is a diagnostic ultrasound system, not an AI-powered diagnostic tool in the sense of requiring a training set for model development.

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

This information is not applicable for the same reasons as point 8.

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The Acclarix AX8 Diagnostic Ultrasound system Acclarix LX8 Diagnostic Ultrasound system is intended for use by a qualified physician or allied health professional for ultrasound evaluations. Specific clinical applications include:

• Abdominal
• Gynecology (including endovaginal)
• Obstetric
• Cardiac
• Small parts (Breast, Testes, Thyroid, etc.)
• Urology
• Musculoskeletal
• Peripheral vascular
• Intra-operative
• Pediatric
• Neonatal (including abdominal and cephalic)
• Adult Cephalic

The Acclarix series contains the Acclarix AX8 and Acclarix LX8 Diagnostic Ultrasound Systems sharing a software platform (Edan Ultrasound Software Platform, also abbreviated as EUP) and the most parts of hardware platform from Edan Instruments. The Acclarix AX8 is a portable laptop diagnostic ultrasound system. A simple way to summarize the difference is that the Acclarix LX8 is a cart based version of the Acclarix AX8.

The provided text describes the Acclarix AX8 and Acclarix LX8 Diagnostic Ultrasound Systems. However, it does not explicitly state acceptance criteria in the typical sense of quantitative thresholds for performance metrics. Instead, it outlines the scope of the device's intended use and compares its features and compliance with standards to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

As noted above, explicit quantitative acceptance criteria are not presented. The document focuses on demonstrating substantial equivalence to predicate devices by comparing intended use, design features, safety standards compliance, and modes of operation.

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

The document states: "Clinical testing is not required." This implies that the device's performance was not evaluated through a clinical study with a "test set" of patient data in the typical sense that would involve a sample size and data provenance (country of origin, retrospective/prospective). The assessment is based on non-clinical tests (e.g., engineering benchmarks, compliance with standards) and comparison to legally marketed predicate devices.

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

Not applicable, as "Clinical testing is not required." Therefore, there was no "ground truth" for a test set established by experts in this context.

4. Adjudication Method:

Not applicable, as "Clinical testing is not required."

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

Not applicable. The document does not describe any MRMC studies or the use of AI. The devices are diagnostic ultrasound systems, not AI-powered diagnostic aids, and the submission is for an updated version of existing devices, primarily focusing on hardware and software updates and expanded indications.

6. Standalone (Algorithm Only) Performance:

Not applicable. The device is an ultrasound system, not an AI algorithm intended for standalone performance evaluation without human-in-the-loop.

7. Type of Ground Truth Used:

Not directly applicable in the context of clinical performance evaluation (e.g., pathology, outcomes data). For the purpose of regulatory submission, the "ground truth" for demonstrating substantial equivalence is compliance with established safety and performance standards for diagnostic ultrasound equipment (e.g., acoustic output, electrical safety, biocompatibility) and functional equivalence to predicate devices.

8. Sample Size for the Training Set:

Not applicable. This document is for a medical device regulatory submission for an ultrasound system, not for an AI/machine learning algorithm that would require a "training set."

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

Not applicable, as there is no "training set" for this device in the context of an AI algorithm.

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The Edan Acclarix LX8 Ultrasound system is intended for use by a qualified physician or allied health professional for ultrasound evaluations. Specific clinical applications include:

• Abdominal
• Gynecology (including endovaginal)
• Obstetric
• Cardiac
• Small parts (Breast, Testes, Thyroid, etc.)
• Urology
• Musculoskeletal
• Peripheral vascular
• Intra-operative
• Pediatric
• Neonatal (including abdominal and cephalic).

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

The Edan Acclarix LX8 Diagnostic Ultrasound system consists of a main system along with associated transducers. The system circuitry generates an electronic voltage pulse, which is transmitted to the transducer. In the transducer, a piezo electric array converts the electronic pulse into an ultrasonic pressure wave. When coupled to the body, the pressure wave transmits through body tissues. The waves are then reflected within the body and detected by the transducer, which then converts back to an electrical signal. The Acclarix LX8 Diagnostic Ultrasound system then analyzes the returned signal to generate an image or conduct Doppler processing. The Acclarix LX8 Diagnostic Ultrasound system gives the operator the ability to measure anatomical structures, and offers analysis packages that provide information used by competent health care professionals to make a diagnosis. The system provides both touch screen and hard buttons for the User Interface.

This document is a 510(k) Premarket Notification for the Acclarix LX8 Diagnostic Ultrasound System. It aims to demonstrate that the device is substantially equivalent to legally marketed predicate devices. The document does not describe acceptance criteria or a study that proves the device meets specific performance acceptance criteria beyond regulatory safety and performance standards. It primarily focuses on comparing the new device's features and safety compliance with predicate devices to establish substantial equivalence.

Based on the provided text, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a specific table of quantitative acceptance criteria for device performance (e.g., sensitivity, specificity, accuracy for a diagnostic task) or clinical performance metrics. Instead, it outlines regulatory compliance and feature equivalence as the basis for substantial equivalence.

The "reported device performance" is essentially that the device complies with various safety and performance standards and offers similar or expanded features compared to its predicates.

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

The document explicitly states: "Clinical test: Clinical testing is not required."
Therefore, there is no test set of patient data, nor is there information on data provenance (country of origin, retrospective/prospective). The assessment for substantial equivalence relies on non-clinical tests and comparisons to predicate devices.

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

Since no clinical testing was performed, there was no test set requiring ground truth established by experts.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set was used.

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

No, an MRMC comparative effectiveness study was not done. The document states "Clinical test: Clinical testing is not required."

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

Not applicable. The device is a diagnostic ultrasound system, not an AI algorithm for standalone performance evaluation in the context of this submission. The "algorithm" here refers to the internal signal processing of the ultrasound system itself, which is evaluated through technical performance standards rather than clinical algorithm performance studies.

7. The Type of Ground Truth Used:

For the demonstration of substantial equivalence, the "ground truth" primarily refers to:

• Compliance with recognized consensus standards (e.g., IEC 60601 series for electrical safety and electromagnetic compatibility, ISO 10993 series for biocompatibility, NEMA UD for acoustic output). These standards define technical performance requirements.
• Equivalence to predicate devices based on their previously cleared performance and safety profiles.

8. The Sample Size for the Training Set:

Not applicable. This document describes a traditional medical device (ultrasound system) submission, not an AI/Machine Learning device that undergoes a training phase with a specific dataset.

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

Not applicable, as there is no training set mentioned.

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The Edan Acclarix AX8 Ultrasound system is intended for use by a qualified physician or allied health professional for ultrasound evaluations. Specific clinical applications include: Abdominal Gynecology (including endovaginal) Obstetric Cardiac Small parts (Breast, Testes, Thyroid, etc.) Urology Musculoskeletal Peripheral vascular Intra-operative

The Acclarix AX8 is a portable laptop diagnostic ultrasound system, intended for use by a qualified physician or sonographer for ultrasound evaluation in Point of Care environments such as Emergency Departments, Interventional procedures and mobile imaging centers, which applies advanced technologies such as HPRF, Dual screen display, Panorama, Spatial Compounding Imaging, Frequency Compounding Imaging, Multi-Beam-Forming, Speckle Resistance Imaging (eSRI), One-Key Optimization, B-Steer, Digital Zoom, Needle Visualization, etc. Various image parameter adjustments, 15 inch LCD display with 10 inch touch screen and 5 inch track pad and diverse probes are configured to acquire and display clear and stable ultrasound images.

The provided document is a 510(k) premarket notification for the Edan Instruments Acclarix AX8 Diagnostic Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving effectiveness through clinical studies against specific acceptance criteria for diagnostic performance.

Therefore, the document does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning advanced diagnostic performance (e.g., sensitivity, specificity, accuracy) for a given clinical task.

Instead, the document highlights:

• Substantial equivalence: The device is claimed to be substantially equivalent to predicate devices (Acclarix AX8 r.10 Diagnostic Ultrasound System/K150999 and U50 Diagnostic Ultrasound System/K142511).
• Compliance with safety and technical standards: The device complies with standards like IEC 60601-1 (Electrical Safety), IEC 60601-1-2 (Electromagnetic Compatibility), and acoustic output testing guidelines, as well as biocompatibility standards (ISO 10993 series).
• Intended Use and Clinical Applications: The document lists the intended use as "Diagnostic ultrasound imaging or fluid flow analysis of the human body" and specifies various clinical applications (e.g., Abdominal, Gynecology, Obstetric, Cardiac, Small parts, Urology, Musculoskeletal, Peripheral vascular, Intra-operative).

Missing Information:

The document explicitly states: "Clinical testing is not required." This means there is no study presented in this document that would provide acceptance criteria for diagnostic accuracy, sensitivity, specificity, etc., nor a study proving the device meets such criteria for a specific clinical task.

Therefore, I cannot provide the following information based on the given text:

1. A table of acceptance criteria and the reported device performance: No such criteria or performance metrics for diagnostic effectiveness are detailed.
2. Sample size used for the test set and the data provenance: No clinical test set or data provenance is mentioned as clinical testing was not required.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical test set is described.
4. Adjudication method: Not applicable.
5. MRMC comparative effectiveness study: Not conducted. The focus is on substantial equivalence to existing devices.
6. Standalone performance (algorithm only without human-in-the-loop performance): This is not an AI-driven diagnostic algorithm but a general-purpose ultrasound imaging system, so this concept does not apply in the context of this document.
7. Type of ground truth used: Not applicable as diagnostic performance metrics (which require ground truth) are not provided.
8. Sample size for the training set: Not applicable as this is not an AI algorithm requiring a training set in the sense of machine learning for diagnostic tasks.
9. How the ground truth for the training set was established: Not applicable.

Summary of available information:

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

• Acceptance Criteria for Substantial Equivalence: Demonstrated "same intended use, similar product design, same performance effectiveness, performance safety as the predicate device" (K150999 and K142511).
• Reported Device Performance:
  • Safety Standards Compliance: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, -5, -10, -12, AIUM, NEMA UD 2, UD 3.
  • Acoustic Output: Track 3: MI, TIS, TIC, TIB (TI Range 0-6.0), Derated ISPTA: 720W/cm2 maximum, Mechanic Index ≤ 1.9 maximum or Derated ISPPA 190 W/cm2 max. Ophthalmic use: TI = Max (TIS_as, TIC) ≤1; ISPTA.3 ≤ 50m/W/cm2; and MI < 0.23. (Same as predicate)
  • Patient Contact Materials: Complies with ISO 10993. (Same as predicate)
  • Modes of Operation: B-Mode, M-Mode, Color, PDI/DPDI, PW, CW. (Same as predicate)
  • Measurements: B-Mode: Distance, Circ/Area, Angle, Volume, Stenosis ratio; M-Mode: Distance, Time, Slope and Heart Rate; D-Mode: Velocity, RI, Time, PI, Heart Rate, Auto Trace PG, S/D, ΔV, Acceleration, PHT, VTI. (Same as predicate)
  • Transducer Types: Convex Array, Linear Array, Endocavity-Micro Convex Array, Phased Array. (Same as predicate)
  • Transducer Frequency: 2.5-15.0 MHz. (Same as predicate)
  • Physical Specifications: 407mm (W) x 388mm (L) x 77mm (H), Weight: 9.1Kg (with rechargeable battery, without power adaptor or transducers). (Same as predicate)
  • Power Requirements: 100-240V, 50/60Hz. (Same as predicate)
  • Rechargeable Battery: Yes. (Same as predicate)

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

• None provided for diagnostic performance as "Clinical testing is not required."
• "Non-clinical test" references compliance with electrical safety, EMC, acoustic output, and biocompatibility standards. The document does not specify sample sizes or data provenance for these technical tests in detail.

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

• Not applicable, as no clinical test set for diagnostic performance requiring expert ground truth is described.

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

• Not applicable, as no clinical test set for diagnostic performance is described.

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

• No MRMC study was done. This is a general ultrasound system, not an AI-assisted diagnostic device.

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

• Not applicable. This defines the capabilities of the ultrasound system itself, not an algorithm's standalone performance.

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

• Not applicable. Diagnostic performance metrics requiring ground truth are not provided.

8. The sample size for the training set:

• Not applicable. This is not an AI algorithm in the machine learning sense that requires a training set for diagnostic image analysis.

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

• Not applicable.

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The Acclarix LX8 Diagnostic Ultrasound System is intended for use by a qualified physician or sonographer for ultrasound evaluation. Clinical applications include: Abdominal, Gynecology (including endovaginal), Obstetic, Cardiac, Small parts (Breast, Testes, Thyroid, etc.), Urology, Musculoskeletal, and Peripheral vascular, and Intra-operative.

The Edan Acclarix LX8 Ultrasound system consists of a main system along with associated transducers. The system circuitry generates an electronic voltage pulse, which is transmitted to the transducer. In the transducer, a piezo electric array converts the electronic pulse into an ultrasonic pressure wave. When coupled to the body, the pressure wave transmits through body tissues. The waves are then reflected within the body and detected by the transducer, which then converts back to an electrical signal. The Acclarix LX8 system then analyzes the returned signal to generate an image or conduct Doppler processing. The Acclarix LX8 system gives the operator the ability to measure anatomical structures, and offers analysis packages that provide information used by competent health care professionals to make a diagnosis. The system provides both touch screen and hard buttons for the User Interface.

The provided document is a 510(k) summary for the EDAN INSTRUMENTS, INC. Acclarix LX8 Diagnostic Ultrasound System. It outlines the device's indications for use and compares it to predicate devices to establish substantial equivalence. However, the document explicitly states that clinical testing was not required for this submission (Page 15, "Clinical test: Clinical testing is not required."). Therefore, the detailed information requested regarding acceptance criteria and studies proving the device meets those criteria for clinical performance is not available within this document.

The document focuses on non-clinical testing and benchmarking against predicate devices to demonstrate safety and effectiveness.

Here's a breakdown of the available information based on your request:

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

Since no clinical studies were performed, there are no specific clinical performance acceptance criteria or reported clinical performance metrics in this document. The "acceptance criteria" appear to be compliance with relevant safety and performance standards for ultrasound devices, which are met through non-clinical testing.

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

• Test set sample size: Not applicable, as no clinical test set was used.
• Data provenance: Not applicable, as no clinical data was generated for the purpose of this submission. The testing was non-clinical (electrical safety, electromagnetic compatibility, acoustic output, biocompatibility) and based on engineering validation.

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

Not applicable, as no clinical test set with human-established ground truth was used.

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

Not applicable, as no clinical test set requiring adjudication was used.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and 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, not an AI-powered image interpretation device, and no MRMC study was performed or required for this 510(k) submission.

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

Not applicable. The device is a diagnostic imaging system, not a standalone algorithm.

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

Not applicable. For the non-clinical tests conducted, the "ground truth" would be established by reference standards or engineering specifications.

8. The sample size for the training set:

Not applicable, as this is not an AI/Machine Learning device requiring a training set.

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

Not applicable, as this is not an AI/Machine Learning device requiring a training set.

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The Maternal Fetal Monitoring – Central Nurse System (hereinafter called "MFM-CNS") is a clinical data managing software application and is indicated for antepartum and intrapartum monitoring of pregnant women in a healthcare setting.

The MFM-CNS is intended to manage perinatal monitoring data acquired from bedside monitors or manual input for viewing at the central nursing station. The system also produces an electronic medical record.

The MFM-CNS has display fields for the following obstetric data:

• patient demographics
• provider notes
• fetal heart rate (FHR)
• uterine activity (via tocodynamometry or IUP)
• fetal movement
• maternal heart rate
• SpO2
• non-invasive blood pressure (NIBP)
• respiratory rate
• temperature
• pulse

The Maternal Fetal Monitoring – Central Nurse System (hereinafter called "MFM-CNS") is a clinical data managing software application. Its function is to manage clinical data of fetal heart and maternal vital signs (CTG - Cardiotocography), which is automatically acquired from bedside monitors, for the purpose of collecting, processing and saving the patient and/or clinical data that is normally provided on record papers and/or separate bedside monitors. It provides electronic medical records and operates with off-the-shelf software and hardware.

The MFM-CNS is intended to be used in hospital clinical areas such as monitor units, delivery room, etc. It is intended to be operated by or under guidance of qualified healthcare professionals, not intended for home healthcare environment. During monitoring, the user should check the results on the bedside monitor in person, even though they could observe the results on the MFM-CNS system interface. The user cannot only depend on the MFM-CNS system to obtain monitoring data, because whether the data provided by the system is accurate depends on the stability of the operating system, the performance of PC station and the network. Although the software has its independent alarm system, the alarm information provided by the system is just for reference.

The provided document is a 510(k) premarket notification for the Edan Instruments Inc. "Central Monitoring System" (MFM-CNS). It outlines the device's description, indications for use, comparison to predicate devices, and non-clinical testing for safety and effectiveness.

However, the document explicitly states:

• "Clinical test: Clinical testing is not required." (Page 8)
• The non-clinical tests relate to software validation, risk analysis, usability analysis, and software life cycle management, not direct performance criteria against a ground truth.

Therefore,Based on the provided document, the following information regarding acceptance criteria and a study proving the device meets them cannot be provided:

1. A table of acceptance criteria and the reported device performance: The document states no clinical testing was required, and the non-clinical tests focused on software quality assurance (validation, risk, usability, lifecycle management) rather than performance metrics against specific acceptance criteria.
2. Sample size used for the test set and the data provenance: No clinical test set was used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there was no clinical test set.
4. Adjudication method 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 described as a "clinical data managing software application" for viewing perinatal monitoring data, not an AI-assisted diagnostic tool that would enhance human reader performance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as there's no indication of an algorithm performing diagnoses or analyses independently that would require standalone performance testing against a ground truth.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth was established or used for performance evaluation since no clinical testing was deemed necessary.
8. The sample size for the training set: Not applicable, as there's no mention of Machine Learning/AI training in the document.
9. How the ground truth for the training set was established: Not applicable.

Summary from the document:

The device, MFM-CNS, is a "clinical data managing software application." Its purpose is to facilitate the management, viewing, and electronic record-keeping of perinatal monitoring data (FHR, uterine activity, maternal vital signs, etc.) acquired from bedside monitors or manual input. The substantial equivalence determination was based on non-clinical software quality assurance measures and a comparison to predicate devices, noting that the differences do not affect safety and effectiveness.

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