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The Team3 fetal monitors are indicated for use by trained healthcare professionals in non-invasive and invasive monitoring of physiological parameters in pregnant women and fetuses, during the antepartum and intrapartum periods of pregnancy. The Team3 fetal monitors are intended for pregnant women from the 28th week of gestation, through to term and delivery. The devices are intended for use in clinical and hospital-type facilities.

Sonicaid Team3 Antepartum is suitable for use when there is a need to monitor the following physiological applications:

• Single or twin fetal heart rates by means of ultrasound
• Uterine activity externally sensed
• Fetal movement maternally sensed and externally via ultrasound
• Maternal heart rate and oxygen saturation via pulse oximetry
• Maternal non-invasive blood pressure
• CTG analysis advises whether a number of defined criteria indicative of a normal cardiograph record has been met

Sonicaid Team3 Intrapartum is suitable for use when there is a need to monitor the following physiological applications:

• Single or twin fetal heart rates by means of ultrasound and/or FECG
• Maternal heart rate via ECG electrodes
• Uterine activity externally or internally sensed
• Fetal movement maternally sensed and externally via ultrasound
• Maternal heart rate and oxygen saturation via pulse oximetry
• Maternal non-invasive blood pressure

The Sonicaid Team3, subject device, is a fetal monitoring device designed for perinatal monitoring and includes a software function, the Dawes-Redman CTG Analysis, previously cleared under K992607. The subject device provides non-invasive and invasive monitoring of physiological parameters in pregnant women and fetuses during antepartum and intrapartum periods. The subject device includes systems and accessories intended to perform perinatal monitoring as aligned with product code HGM.

Features included in the subject device are the Dawes Redman analysis, used to assess clinically indicated antepartum cardiotocographs (CTGs) in pregnancies from 26 weeks gestation onwards, assisting physicians in identifying normal and nonreassuring traces. The Dawes-Redman software is embedded in the subject device, ensuring integration with the existing hardware. The device is not intended for use in latent or established labor due to the influence of additional factors such as labor contractions and pharmacological agents.

The provided text indicates that the Sonicaid Team3 fetal monitor has incorporated the Dawes-Redman CTG Analysis software, which was previously cleared under K992607, into its hardware. The submission for K241368 aims to demonstrate substantial equivalence by addressing this integration.

However, the provided document does not contain the specific acceptance criteria or performance study details for the Dawes-Redman CTG Analysis software as requested in the prompt. The "Performance Data" section (page 10), under "Software Performance Testing," generically states: "Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, 'Guidance for the Content for the Premarket Submissions for Software Contained in Medical Devices'. The software for this device was considered as a 'major' level of concern."

This statement confirms that software testing was performed and documentation provided, and that the software was considered "major" in terms of concern, but it does not include the acceptance criteria, reported performance, sample size, ground truth establishment, expert qualifications, or MRMC study details.

Therefore, I cannot fulfill all parts of your request based on the provided text. I can only infer what was stated:

Here's what can be extracted/inferred from the provided text, and what cannot:

1. A table of acceptance criteria and the reported device performance:
* Cannot be provided. The document states software V&V was performed, but does not specify the acceptance criteria for the Dawes-Redman CTG Analysis or the performance metrics achieved against those criteria.

2. Sample size used for the test set and the data provenance:
* Cannot be provided. The document does not specify the sample size for the test set or the provenance of the data (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Cannot be provided. The document does not mention the number or qualifications of experts used for ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* Cannot be provided. The document does not describe any adjudication method.

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. The document specifically mentions the Dawes-Redman CTG Analysis assists physicians in "identifying normal and nonreassuring traces," which implies a human-in-the-loop scenario. However, it does not state whether an MRMC study was performed or any effect size related to human reader improvement with AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Cannot be explicitly confirmed or denied. While the indication for use states it "assists physicians," the document does not detail individual study types (standalone vs. human-in-the-loop).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* Cannot be provided. The document does not specify the type of ground truth used to evaluate the Dawes-Redman CTG Analysis.

8. The sample size for the training set:
* Cannot be provided. The document does not mention any details about a training set for the software.

9. How the ground truth for the training set was established:
* Cannot be provided. Since no training set details are given, how its ground truth was established is also not available.

In summary, the provided FDA premarket notification document for K241368 focuses on demonstrating substantial equivalence by integrating a previously cleared software (Dawes-Redman CTG Analysis) into new hardware. It confirms that general software verification and validation were conducted according to FDA guidance for "major" level of concern software and cybersecurity testing was performed. However, it does not include the detailed performance study results, acceptance criteria, sample sizes, ground truth methodologies, or expert qualifications for the Dawes-Redman CTG analysis itself. Such specific performance data would typically be found in more detailed test reports, which are not part of this summary document.

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WoundExpress aids in the treatment of the following clinical conditions:

• Chronic wounds including leg ulcers (venous leg ulcers and mixed aetiology leg ulcers)
• The management of lower limb pain

The WoundExpress Therapy Device is an intermittent pneumatic compression system consisting of a pump unit and a thigh garment, interconnected by a detachable three chamber tube set. It is a non-invasive mechanical system designed to enhance blood and lymph flow as a therapy to manage the clinical condition listed above. The pump is a portable, ac mains powered device, that produces a pre-set pneumatic therapy cycle delivered through a 3 port output connector, which is connected to a three chamber garment that is applied to the patient thigh. The pump operates on a 4 minute automatically timed gradient pressure sequence, consisting of a 2 minute venous emptying phase and a 2 minute rest phase. The venous emptying phase consists of six 20 second compression cycles, while no compression takes place during the rest phase. Each 20 second compression cycle is characterised by overlapping synchronous inflations and deflations of the distal (lower), central (middle) and proximal (upper) chambers.

The provided document is an FDA 510(k) Premarket Notification for the WoundExpress device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a new device's safety and efficacy through extensive clinical studies with specific performance acceptance criteria like those seen for novel drug or high-risk medical device approvals.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, as typically understood for a new and complex AI/software-as-a-medical-device (SaMD) or drug study.

Specifically:

• There is no table of acceptance criteria and reported device performance as the performance data section focuses on engineering verification and validation testing (biocompatibility, electrical safety, mechanical, functional, etc.) to ensure the device performs as intended and is safe, rather than clinical performance against specific metrics like sensitivity/specificity for a diagnostic AI.
• No sample size used for a test set (clinical data), data provenance, number of experts, adjudication methods, MRMC studies, or standalone algorithm performance are described because this is a physical medical device (compressible limb sleeve), not an AI algorithm. Its performance is related to its mechanical and physiological function, not diagnostic accuracy based on image analysis or similar AI tasks.
• There is no notion of "ground truth" establishment for a test set or training set in the context of AI. The "validation study" mentioned in the Performance Data section is likely a non-clinical/engineering validation to ensure the device meets its design specifications and intended use, not a clinical trial establishing ground truth for AI model training or evaluation.
• No sample size for a training set is applicable as this is not an AI/ML device.

The document states:

• "The WoundExpress has undergone a validation study to ensure the device can achieve its intended use. The validation concluded the device is fit for purpose and the clinical benefits of the device outweighs the overall residual risk." (Page 7)
• Under "Performance Data," various types of engineering and safety testing are listed: Biocompatibility, Electronic Hardware Testing, Mechanical Testing, Functional Testing, Performance Testing (general validation as above), Electrical Safety Testing, EMC Testing, Environmental Performance Testing. These are standard tests for physical medical devices to demonstrate safety and proper function, not clinical efficacy or diagnostic accuracy.

In summary, the provided FDA 510(k) notification for the WoundExpress device does not offer the kind of detailed information about acceptance criteria and clinical study performance (especially related to AI/ML or diagnostic accuracy) that your questions are looking for. This is because the device is a physical, mechanical system (compressible limb sleeve) cleared under the substantial equivalence pathway, which relies on demonstrating similarity to existing devices and adequate non-clinical testing, rather than novel clinical performance metrics.

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The DIOP8 surgical Doppler is indicated for use by qualified healthcare practitioners in a sterile condition in the operating theatre for the assessment of vascular blood flow by direct application to the vessel wall.

The DIOP8 is a sterile, single use, high sensitivity probe that assists in the performance of safe surgery. It is a lightweight, 8MHz ultrasound, handheld pencil probe' that has a small diameter tip that enables the detection of blood flow in vessels. The DIOP8 ultrasound probe operates in pulsed-wave mode. It has one circular piezo-electric crystal that is mounted behind the front faceplate and the crystal is used for both transmit and receive functions. The DIOP8 is manufactured at a frequency of 8MHz. The output ultrasonic parameters are fixed during the manufacturing process and cannot be adjusted by the user. A connector system at the end of the cable allows the DIOP8 to be removed from the hand held Doppler. An interconnection adapter houses the bi-directional electronics, which are specific for the device application, and is required as an interface between the main unit and DIOP8. The connector is similar to a conventional connector, but has no external conductive contacts, and is totally sealed, thus preventing the ingress of fluid and contaminants. Within the connector is a small coil that transfers electrical energy to and from a similar, but larger coil in the corresponding socket at the end of the PA8/PA8XS adapter. Transmitted and received electrical signals are passed through this connector, but there is no direct electrical connection between the probe and the PA8/PA8XS adapter. The connector provides electrical isolation between the probe and the PA8/PA8XS adapter, which optimises system electrical safety by limiting patient leakage currents to very low levels. During use, the adapter is securely held in the probe holder that is an integral part of the Doppler main unit. When connected this way, the hand held Doppler unit operates as if a normal VP8 probe is connected.

The requested information is not available in the provided text. The document is a 510(k) summary for a medical device (Disposable Intraoperative Probe - DIOP8) and details the device's characteristics, comparison to a predicate device, and various performance tests conducted. However, it does not include specific acceptance criteria with reported device performance values in a table, nor does it describe a study proving the device meets those criteria with a breakdown of sample sizes, ground truth establishment, expert involvement, or MRMC study results.

The document primarily focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and general performance testing (biocompatibility, mechanical, functional, electrical safety, EMC, environmental, and software).

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, sample size details for test and training sets, data provenance, number of experts, adjudication methods, MRMC study results, or standalone performance results based on the provided text.

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The Sonicaid Team3 Antepartum and Sonicaid Team3 Intrapartum fetal monitors) are indicated for use by trained healthcare professionals in non-invasive monitoring of physiological parameters in pregnant women and fetuses, during the antepartum and intrapartum periods of pregnancy. The Team3 fetal monitors are intended for pregnant women from the 28th week of gestation, through to term and delivery. The devices are intended for use in clinical and hospital-type facilities.

Sonicaid Team3 Antepartum is suitable for use when there is a need to monitor the following physiological applications:

1. Single or twin fetal heart rates by means of ultrasound
2. Uterine activity externally sensed
3. Fetal movement maternally sensed and externally via ultrasound
4. Maternal heart rate and oxygen saturation via pulse oximetry
5. Maternal non-invasive blood pressure

Sonicaid Team3 Intrapartum is suitable for use when there is a need to monitor the following physiological applications:

1. Single or twin fetal heart rates by means of ultrasound and/or FECG
2. Maternal heart rate via ECG electrodes
3. Uterine activity externally or internally sensed
4. Fetal movement maternally sensed and externally via ultrasound
5. Maternal heart rate and oxygen saturation via pulse oximetry
6. Maternal non-invasive blood pressure

The Sonicaid Team3 is a mains / battery powered multi-function fetal monitor designed for use in clinical and hospital environments during antepartum and intrapartum phases of pregnancy.

The Sonicaid Team3 is designed for use at the bedside; there is a wall mounting bracket available as well as a trolley for fixed or transportable use. The unit may also be used free-standing on a work surface.

The units are powered either from local mains electrical supply or an optional internal rechargeable battery.

The Sonicaid Team3 fetal monitors include the following:

• 8.4" Color LCD Display with LED backlighting.
• Touch screen user interface.
• Monitoring of up to two fetal heart rates via independent ultrasound transducers.
• Monitoring of maternal uterine activity via external tocodynamometer (Toco) or internal intra-uterine pressure (IUP) transducers.
• Monitoring of maternal oxygen saturation (SpO2) and heart rate via pulse oximetry sensor.
• Monitoring of maternal Non-Invasive Blood Pressure . (NIBP).
• Monitoring of fetal heart rate via ECG.
• Maternal heart rate (eMHR).
• Capture of maternally sensed fetal movements via a cabled switch.
• Chart printout via (optional) inbuilt thermal printer
• Data output via RS232.

The provided text describes the acceptance criteria and study for a medical device (Sonicaid Team3 Antepartum and Sonicaid Team3 Intrapartum fetal monitors) in the context of an FDA 510(k) submission. However, it does not contain information about acceptance criteria in terms of numerical performance thresholds (e.g., specific accuracy, sensitivity, or specificity targets for the physiological parameters being monitored). Instead, it primarily focuses on demonstrating substantial equivalence to a predicate device through adherence to recognized standards and various types of engineering and performance testing.

Therefore, the following information is extracted based on the provided text, and where specific details are not present, it will be noted.

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

The document does not explicitly present a table of numerical "acceptance criteria" and "reported device performance" in the typical sense of a clinical performance study with specific metrics like sensitivity, specificity, or accuracy targets. Instead, it demonstrates performance through compliance with recognized standards and various engineering and functional tests. The implied acceptance criterion is "demonstrating substantial equivalence to the predicate device" by meeting safety and performance standards and showing that technological differences do not raise new questions of safety or effectiveness.

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The DMX Handheld Doppler: Indicated for use by qualified healthcare practitioners in primary, acute and community healthcare environments, for the non-invasive assessment of vascular blood flow to assist in diagnosis. The SRX Handheld Doppler: Indicated for use by qualified healthcare practitioners in primary, acute and community healthcare environments, for the assessment of fetal heart rate to assist in diagnosis.

The DMX Doppler provides the clinician with the ability to perform vascular investigations. It is powered from two internal replaceable AA format 1.5 volt alkaline or 1.2 volt NiMH rechargeable batteries. The DMX hand unit is used with a Doppler or Arterial Photoplethysmography (APPG) probe, selected to suit the nature of the investigation to be performed. The device includes a colour liquid crystal display and three soft keys for user input. Doppler audio sounds are reproduced by the integral loudspeaker; the audio level can be adjusted by two buttons. Doppler Mode: The probes emit low energy ultrasonic waves into the body which are reflected back into the probe. The reflected ultrasonic waves contain information about the blood flow, which can be heard as audio sounds from the loudspeaker and waveforms presented on the display. There is a range of compatible Doppler probes; the choice of probe is determined by the type of vascular assessment being performed and depth of vessel. APPG Mode: The APPG sensor emits low energy infra-red light into the body, some of which is reflected by blood within the tissue back into the sensor. The variation of this reflected light is related to the blood volume within the tissue. The APPG probe is used with an inflatable cuff and sphygmomanometer gauge to measure toe / finger blood pressures. Dopplex Reporter 5 (DR5) Software Package: The DR5 software is a medical device data system (MDDS) and is an optional accessory to the dopplex® DMX bidirectional Doppler. It can display bidirectional velocity/time waveforms obtained from various vessels. Data can be archived and a printout can be obtained for patients notes. The DR5 is not a standalone medical device – it can only be used with the DMX Doppler to display, archive and print Doppler waveforms and PPG pressures produced by the DMX. The SRX Doppler range is intended to be used by qualified healthcare practitioners for the detection and presentation of the fetal heart rate to assist in the assessment of fetal well-being during pregnancy. Each model is powered from two internal replaceable AA format 1.5 volt alkaline or 1.2 volt NiMH rechargeable batteries. The SRX hand unit is used with a choice of either a 2MHz (OP2XS) or 3MHz (OP3XS) obstetric Doppler probe. The SR2 and SR3 have fixed probes (2MHz and 3MHz respectively). All models include a colour liquid crystal display and three soft keys for user input. Doppler audio sounds are reproduced by the integral loudspeaker; the audio level can be adjusted by two buttons. The probes emit low energy ultrasonic waves into the body some of which are reflected back into the probe. The reflected ultrasonic waves contain information about the fetal heart, which can be heard as audio sounds from the loudspeaker and heart rate values presented on the display.

This document describes the Huntleigh Healthcare Ltd DMX/SRX Handheld Doppler and Probes, and its substantial equivalence to predicate devices. It focuses on engineering and performance verification, rather than clinical studies with acceptance criteria in the context of device performance metrics like sensitivity or specificity.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of acceptance criteria for specific performance metrics (e.g., accuracy, sensitivity, specificity) of the DMX/SRX Handheld Doppler, especially in comparison to clinical outcomes. Instead, it details various engineering and regulatory compliance testing.

The document states that "The data detailed within this submission demonstrates that the device is as safe and effective and performs as well as the predicate devices identified in this summary, which are currently marketed for the same intended use." This implies that the acceptance criteria are met if the new device demonstrates similar performance and safety characteristics as the legally marketed predicate devices through the conducted verification and validation tests.

Below is a table summarizing the types of testing performed, which serve as the basis for demonstrating equivalence and meeting "acceptance criteria" in a broad sense for a 510(k) submission:

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To enhance fluid flow into and along the vascular and lymphatic vessels. As a treatment for venous and lymphatic disorders. As an effective in the treatment of the following clinical conditions, when combined with an individualized monitoring programme: - Lymphedema. - · Primary and secondary (including post-surgery, radio or chemotherapy). - . Chronic Edema of Venous Origin - Chronic venous insufficiency. . - Acute and chronic wounds including venous leg ulcers and post- surgical wounds. . IPC may also be beneficial in the management of: - . Lipoedema. - Varicose veins . - Postoperative Venous Ligation or Stripping . - . Sports injuries - Post Traumatic Edema . - . Lymphatic Filariasis

The Hydroven 12 system comprises of a range of inflatable sleeves. inserts and a compatible air pump. The sleeves fit around patients' upper and lower limbs. The sleeves contain separate but overlapping air chambers that intermittently compress the limbs in a specific sequence. The resultant pressure on the patient's limb tissues promotes the transport of fluids and proteins. The inflatable inserts can be added to allow large circumference limbs to be treated. The pump provides the compressed air to the sleeves with user selected pressures and sequence of operation.

The provided text is a 510(k) summary for the Hydroven 12 Pump and Garments, a medical device for intermittent pneumatic compression therapy. This document aims to demonstrate substantial equivalence to a predicate device, not to prove the device meets specific performance acceptance criteria through clinical studies. Therefore, much of the requested information regarding acceptance criteria, study details, ground truth, and expert involvement is not available in the provided text.

Based on the available information, here's what can be extracted and what cannot:

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

The document does not explicitly state quantitative acceptance criteria in the typical sense (e.g., sensitivity, specificity, accuracy thresholds) for clinical performance. Instead, it relies on demonstrating substantial equivalence to a predicate device (Lympha Press Plus and compression Garments, K013331) through various engineering and performance tests. The "acceptance criteria" are implied to be "compliance with standard" or "Passed" for functional and safety tests.

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 tests mentioned (software/hardware validation, pressure cyclic test, electrical, EMC, environmental) are typically engineering and bench tests, not clinical studies with human subjects that would have a "test set" in the context of AI or diagnostic device evaluation.

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. As explained above, this document is focused on engineering testing and substantial equivalence, not clinical validation requiring expert-established ground truth.

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

This information is not provided.

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. The Hydroven 12 is a physical therapy device (intermittent pneumatic compression pump and garments), not an AI-powered diagnostic or interpretive device that would involve human "readers" or AI assistance in that sense.

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

This is not applicable and not provided. The device is an electro-mechanical system, not an algorithm in the AI sense. Its standalone performance is assessed by the "Passed" or "Complies with Standard" results for its functional and safety tests.

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

The "ground truth" for the engineering tests would be the established specifications, performance requirements, and regulatory standards (e.g., pressure output accuracy, electrical safety limits, EMC compliance). It is not expert consensus, pathology, or outcomes data in the clinical sense because it's not a diagnostic device.

8. The sample size for the training set

This information is not provided. There is no mention of a "training set" in the context of machine learning or AI, as this is not an AI device.

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

This information is not provided and is not applicable for the reasons stated above.

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The Sonicaid™ Freedom Wireless Fetal Monitoring System ('Freedom') is a wireless transducer system for monitoring fetal heart movement and maternal contractions during intrapartum and antepartum periods of pregnancy.

It is an optional accessory for use with Huntleigh Healthcare Limited's Sonicaid™ FM820 and FM830 Encore Fetal Monitors ('FM800E Monitors') as an alternative to their wired transducers. When connected to an FM800E Monitor, the system monitors:

• Uterine activity by using an external, pressure-sensitive TOCO transducer, and

• Fetal Heart Rate (FHR) by pulsed Doppler ultrasound using an external Ultrasound transducer.

Freedom is suitable for use with pregnant women in clinical and hospital facilities. The transducers are water tight allowing pregnant women to be monitored while they are mobile, stationary or in a bath or shower environment.

This system should only be used by, or under the supervision of, a licensed physician or other health practitioner who is trained in the use of FHR monitors.

The Sonicaid™ Freedom is intended to monitor fetal heart movement and uterine activity by using wireless, non-invasive transducers on pregnant women during antepartum and intrapartum phases of pregnancy. This system is an optional accessory that must be connected to, and used with, a Sonicaid™ FM800E Monitor when a woman wishes to be mobile or in a water environment when being monitored or giving birth.

The Freedom has three major components; the Receiver and Ultrasound ('US') and Tocograph ('TOCO') transducers. The wireless transducers are powered by internal batteries that are recharged when docked on the Receiver.

The Sonicaid ™Freedom operates in the WMTS frequency bandwidth. There are 100 selectable channels available for use. If there is interference when installing the system, then the channel may be changed to achieve clear transmission.

The Huntleigh Healthcare Ltd. Sonicaid™ Freedom Wireless Fetal Monitoring System (K132650) did not report specific acceptance criteria or a dedicated clinical study to demonstrate its performance relative to specific metrics. Instead, the submission relies on demonstrating substantially equivalent performance to a predicate device through bench tests.

Here’s a breakdown of the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy) are not explicitly stated for the device's main function of fetal monitoring. The performance is indirectly demonstrated by showing comparability to the predicate device through bench tests.

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

• Test Set Sample Size: Not applicable/not reported. The submission did not involve a clinical test set with patient data for performance evaluation. Performance was assessed through simulated bench tests.
• Data Provenance: Not applicable, as there were no clinical test sets or patient data involved. The tests were simulated bench tests.

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

• Not applicable. No expert-established ground truth was reported for a clinical test set, as no clinical tests were performed.

4. Adjudication Method for the Test Set

• Not applicable. No clinical test set or adjudication method was reported.

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

• No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "No clinical tests were required to determine substantial equivalence between the Freedom and the predicate device."

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

• The device itself is a fetal monitoring system that collects data, not an algorithm that interprets data. While the performance of the transducers (the "standalone" components for data acquisition) was assessed through bench tests, it's not a "standalone algorithm" in the typical sense of AI. The system is designed to be used by trained health practitioners.

7. The Type of Ground Truth Used

• For the technical and safety aspects, the "ground truth" was established by compliance with recognized standards (e.g., IEC, ISO, EN, FCC) and by comparison to the established performance of existing Sonicaid™ FM800E transducers (for FHR and UA detection) and the predicate device (Avalon CTS Cordless Fetal Transducer System) for overall system functionality and design. There was no clinical ground truth (e.g., pathology, outcomes data) based on patient results provided.

8. The Sample Size for the Training Set

• Not applicable. This device is a hardware system for signal acquisition, not an AI/machine learning algorithm requiring a "training set" for model development.

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

• Not applicable, as no training set was used.

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Dopplex Ability is indicated for use on adult subjects at risk of having or developing peripheral arterial disease (PAD).

Dopplex Ability is intended for rapid measurement of ankle-brachial pressure index (ABPI) or ankle-brachial index (ABI) in adults and pulse volume recording (PVR) / volume plethysmography.

It is suitable for use in woundcare assessment, for assessing symptomatic PAD, and as a screening device for PAD. It may also be used on patients with venous or arterial ulcers prior to the application of compression therapy. Dopplex Ability can be used on patients with unilateral lower limb amputation.

Dopplex Ability is intended to measure a patient's Ankle Brachial Index (ABI) and provide PVR. This is done through an automated process.

The operator places the four colour coded cuffs on each of the patient's limbs as described in the instruction for use and connect to the device.

When connected the operator pushes soft touch button to start measurement, the device then will automatically control the inflation / deflation of the cuffs on each limb and monitor minute variations in individual pressures to determine values to be used for the calculation of the ABI values for both the left and right hand of the patient.

Dopplex Ability uses pneumo-plethysmography uses obtain physiological measurements from patient's limbs. Measurements are conducted as a single occurrence on all four limbs, eliminating any requirement to rest the patient between measurements.

The test period takes approximately 3 minutes. The ABI indices are calculated using an in house algorithm.

ABI values are displayed on the LCD and can also be printed. In addition, records are generated of the Pulse Volume Waveforms (PVR), which may also be displayed on the LCD and can be printed.

Here's an analysis of the acceptance criteria and study information for the "Dopplex Ability" device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state numerical acceptance criteria in a dedicated table format. Instead, it describes the study design and concludes that the device performs as well as the predicate. The performance is demonstrated through a comparison with a predicate device.

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

The document states:

• "The predicate device has been used in comparison bench testing and clinical assessment to evaluate and demonstrate the equal capability of both devices to measure ABI."
• "Clinical data submitted demonstrates the submission device to provide the performance as indicated for use by a comparison of measured indices using both devices."

However, the specific sample size for the test set (number of patients or measurements) is not explicitly mentioned in the provided 510(k) summary.

Data Provenance: The document does not specify the country of origin for the clinical data. It also does not explicitly state if the study was retrospective or prospective. Given the nature of a 510(k) submission and the description of "clinical assessment" to demonstrate "equal capability," it is most likely a prospective clinical study designed for this comparison.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth for the test set. The study design described is a comparison of the new device (Dopplex Ability) to a predicate device (Vascular Assist), rather than a comparison to expert-derived ground truth as such. The predicate device's measurements are effectively treated as the "reference standard" for comparison.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method. Since the study focuses on quantitative measurement agreement between two devices rather than subjective interpretation, a formal adjudication process for "ground truth" might not have been applicable in the traditional sense. The comparison likely involved statistical methods to assess agreement (e.g., Bland-Altman analysis, correlation).

5. If an MRMC Comparative Effectiveness Study Was Done, and Effect Size

The provided text does not indicate a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The study described is a comparison of two devices (Dopplex Ability vs. Vascular Assist) rather than comparing human readers with and without AI assistance. Therefore, there is no mention of an effect size for human reader improvement with AI.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the study primarily describes standalone performance of the Dopplex Ability device itself, comparing its measurements to those of the predicate device. The device is described as an "automated process" where "the device then will automatically control the inflation / deflation of the cuffs on each limb and monitor minute variations in individual pressures to determine values to be used for the calculation of the ABI values." The "in house algorithm" calculates the ABI values. While a human initiates the test and places cuffs, the core measurement and calculation are automated.

7. The Type of Ground Truth Used

The "ground truth" for the test was the measurements obtained by the legally marketed predicate device (Vascular Assist). The study's objective was to demonstrate that the Dopplex Ability device's measurements of ABI and PVR were "equal" or provided "the performance as indicated for use by a comparison of measured indices using both devices."

8. The Sample Size for the Training Set

The document does not specify a sample size for a training set. The device performs quantitative measurements based on pneumo-plethysmography and an "in house algorithm" for ABI calculation. While such algorithms might be developed and "trained," the summary only describes the clinical validation against the predicate, not the internal development or training process.

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

Since a training set sample size is not provided, the method for establishing its ground truth is also not described in this document.

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The Huntleigh Healthcare Ltd Sonicaid FM820 and FM830 Encore fetal monitors are indicated for use by trained healthcare professionals in non-invasive monitoring of physiological parameters in pregnant adult human females, and fetuses, during the intrapartum and antepartum periods of pregnancy. The devices are intended for use in clinical and hospital-type facilities. They are not intended for use in intensive care units, operating rooms or in transport monitoring applications.

Sonicaid FM820E is suitable for use when there is a need to monitor the following physiological parameters:

• . Single or twin fetal heart rates by means of ultrasound
• ◆ Fetal or maternal heart rate via ECG
• Uterine activity externally or internally sensed .
• . Fetal movement - maternally sensed.

Sonicaid FM830E is suitable for use when there is a need to monitor the following physiological parameters:

• . Single or twin fetal heart rates by means of ultrasound
• . Fetal or maternal heart rate via ECG
• Uterine activity externally or internally sensed .
• Fetal movement - maternally sensed.
• . Maternal heart rate and oxygen saturation via pulse oximetry
• . Maternal non-invasive blood pressure

The FM820E and FM830E are fetal/maternal monitors designed for use in clinical and hospital environments during the ante-partum and intra-partum phases of pregnancy.

Both units are designed for use at the bedside and the range includes a wall mounting bracket and a trolley for fixed or transportable use. The units may also be used free-standing on a work surface.

The FM820E and FM830E are powered from the local mains electrical supply.

The FM820E includes the following facilities:

• Monitoring of one or two fetal heart rates via two independent ultrasound transducers. .
• Monitoring of maternal uterine activity either via external (Toco) or internal (IUP) transducers. .
• Monitoring of maternal or fetal heart rate via ECG.
• . Capture of maternally sensed fetal movements via cabled switch.
• Display of vital signs parameters via colour LCD screen. .
• t Control interface via combination of dedicated and "soft" function buttons in conjunction with on-screen prompts.
• . Chart printout via inbuilt thermal printer.
• Connection to Central Monitoring System possible via RS232 or Ethernet. .
• Audio and visual alerts (user set limits).

The following facilities are provided on the FM830E model in addition to the above:

• . Monitoring of maternal oxygen saturation and heart rate via pulse oximetry sensor.
• Monitoring of maternal Non-Invasive Blood Pressure (NIBP) via inflatable cuff. .

The connections for the additional facilities are incorporated in a "side pod", which extends the area of the front panel. Field upgrade of the FM820E to FM830E specification is not allowed.

The provided text describes the Sonicaid FM800, a fetal/maternal monitor, and its comparison to predicate devices, but it does not include detailed acceptance criteria or a dedicated study definitively proving the device meets specific performance criteria in the format requested.

Instead, the document focuses on demonstrating substantial equivalence to existing legally marketed devices (Sonicaid FM830 (K002150) and RDT Limited Tempus IC™ Patient Monitor (K082718)) for FDA 510(k) premarket notification. This means the manufacturer is asserting their new device is as safe and effective as a device already on the market, rather than conducting a de novo study against pre-defined acceptance criteria for a novel device.

However, I can extract the relevant information and present what is available in a structured manner, highlighting the limitations.

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

Acceptance Criteria and Device Performance Study for Sonicaid FM800

Based on the provided FDA 510(k) summary for the Sonicaid FM800, the device aims to demonstrate substantial equivalence to predicate devices rather than meeting specific, explicitly stated acceptance criteria from a de novo study. Therefore, the "acceptance criteria" are implied by the performance of the predicate devices. The study conducted to support this is primarily comparative bench testing and reliance on OEM-provided clinical data.

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

Since specific, quantitative acceptance criteria are not explicitly defined in the document for general device performance (like sensitivity/specificity for a diagnostic device), I will use the comparison to the predicate device's characteristics and the documented performance improvements as a proxy.

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

• Test Set Sample Size:
  • For non-clinical bench testing: The document does not specify a "sample size" in terms of number of cases or patients for the comparative bench testing (document 7515101 - FM800E Comparative Bench Test Summary) or the MsP02 verification protocol (document 7514502), although these would involve laboratory tests on the device itself.
  • For clinical tests: "No specific clinical tests were carried out to determine substantial equivalence." The submission references clinical trials carried out by the OEM providers of the SpO2 technology, but the sample size for these external OEM trials is not provided within this document. User evaluation trials are proposed but not yet completed at the time of submission.
• Data Provenance:
  • Bench Testing: Conducted internally by Huntleigh Healthcare Ltd. (United Kingdom). This would be prospective for the submitted device, comparing it against the predicate.
  • OEM SpO2 Clinical Trials: Conducted by BCI (Smiths Medical). The country of origin and whether these were retrospective or prospective are not specified in this document.

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)

• The document does not mention using experts to establish ground truth for the test set as part of its own substantial equivalence testing. The primary test method was comparative bench testing against a predicate device.
• For the OEM SpO2 clinical trials, details about expert involvement for ground truth are not provided in this submission.

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

• No adjudication method is mentioned for any test set within this submission. The tests performed are primarily engineering bench tests or rely on external OEM 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

• No MRMC study was done. This device is a medical monitor, not an AI-powered diagnostic imaging tool that would typically involve human readers. The document states that user evaluation trials are proposed to verify effectiveness in clinical situations, but these are not described as MRMC studies and were not completed at the time of submission.

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

• The device is a monitor that provides physiological parameters. Its performance is inherent in its measurement accuracy and display, which can be evaluated in a standalone manner (e.g., how accurately it measures heart rate or blood pressure compared to a reference). The "Comparative bench tests" confirm this standalone performance. No specific standalone performance metrics (e.g., algorithm only) as might be seen in an AI context are provided, but the device itself has standalone performance.

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

• For the bench tests, the "ground truth" is typically established by using calibrated reference equipment or standards to ensure the new device's readings are accurate and comparable to the predicate device.
• For the OEM SpO2 clinical trials, the type of ground truth for oxygen saturation would likely involve co-oximetry, the gold standard for blood oxygen measurement. However, this is not detailed in the provided text.

8. The sample size for the training set

• The device is a traditional medical monitor; it is not described as utilizing machine learning or artificial intelligence that would require a "training set" in the computational sense. The "improved signal processing" or "enhanced" algorithms refer to conventional digital signal processing, not AI model training. Therefore, this question is not applicable.

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

• This question is not applicable as there is no "training set" for an AI model mentioned for this device.

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The Smartsigns MP1 and MP1R handheld pulse oximeter is intended for noninvasive continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate. It is intended for use by healthcare professionals for monitoring adult and pediatric patients in hospitals and hospital-type facilities. The specific medical indications for the use of this device is : - This device is a prescription device - . This device is re-useable and is intended for spot or continuous measurement - 트 This device is intended to display oxygen saturation, heart rate and pulse strength or pulsatile signal. - This device is intended to indicate an alarm if the measured saturation or 트 heart rate are outside user-set alarm limits.

The Smartsigns Minipulse MP1 is a hand held, battery powered pulse oximeter used for monitoring pulse rate and saturated oxygen in arterial blood. It is also available as a rechargeable unit (MP1R). The MP1R is supplied with four rechargeable batteries, a Deskstand charger unit and power supply. The MP1R is recharged by docking it on the Deskstand charger unit. The Smartsigns MP1 and MP1R provide audible alarms, a membrane keypad and LED displays to display digital values of heart rate and saturation. Pulse amplitude is displayed by means of a bargraph LED array. The keypad allows the unit to be switched ON and OFF, it also allows the user to set alarm limits for saturation and heart rate.

Here's a breakdown of the acceptance criteria and the study information for the Huntleigh Healthcare Ltd Smartsigns Minipulse MP1-MP1R, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document doesn't explicitly state quantitative acceptance criteria for SpO2 and pulse rate accuracy (e.g., "within +/- 2% for SpO2"). It broadly states "within specification" and "verified".

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

• Sample Size: Not specified for the desaturation trial. "In-house testing" is mentioned, likely referring to further tests, but no sample size is given.
• Data Provenance: The desaturation trial was "conducted by the oximeter OEM." No specific country of origin is mentioned, but the manufacturer is based in the United Kingdom. It is implied to be a prospective study, as it was conducted for the purpose of testing this device.

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

• This information is not provided in the document. The desaturation trial is mentioned, which typically involves comparing the device's readings to laboratory co-oximeter reference values, but no details about human experts or their qualifications for establishing ground truth are given.

4. Adjudication Method for the Test Set

• This information is not provided in the document.

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

• No, an MRMC comparative effectiveness study was not explicitly mentioned or performed. The study focused on the device's technical performance and equivalence to a predicate device, not on human reader improvement with or without AI assistance.

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

• Yes, a standalone performance assessment was done. The entire study described assesses the performance of the Smartsigns Minipulse MP1 and MP1R device itself (which includes its internal algorithms and hardware) without direct human intervention in the measurement process for the SpO2 and pulse rate. The device is a diagnostic tool, and its accuracy is evaluated on its own.

7. The Type of Ground Truth Used

• For SpO2 accuracy, the ground truth for the desaturation trial would typically be laboratory co-oximetry measurements, which are considered the gold standard for arterial oxygen saturation. While not explicitly stated, this is the standard method for such trials.
• For pulse rate accuracy, the ground truth would likely be an ECG reference or a precise heart rate monitor.
• The document also mentions "comparison to the legally marketed predicate device BCI 3303," implying the predicate device's readings served as a comparative reference.

8. The Sample Size for the Training Set

• This information is not applicable as the document describes a hardware medical device with embedded algorithms, not a machine learning model that requires a discrete training set. The "oximeter OEM" would have developed and validated the underlying oximetry technology, but details of their internal development or validation datasets are not provided.

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

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

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