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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 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 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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Dopplex Centrale (DCII) is a software package that collects and manages real-time data from a maximum of 48 individual fetal monitors which are connected to a central server by means communication links.

Dopplex Centrale is indicated for use in healthcare facilities by healthcare professionals whenever there is a need for comprehensive and centralised obstetrical surveillance of those maternal patients who are being monitored by otherwise autonomous CTG devices. Fetal heart rate information can be concurrently viewed on up to 50 conveniently sited computers including a central station, patient bedsides, nurses' lounges and physicians' offices.

Dopplex Centrale provides an easy to use means of patient surveillance within a perinatal environment within a hospital. A Dopplex Centrale system is specified, supplied, commissioned and maintained exclusively by the manufacturer, Huntleigh Healthcare, or its appointed agents. It provides storage and archiving of FHR traces together with the associated patient details.

The specific medical indications for the use of this device is :

• This device is a prescription device
• This device is not intended to contact the patient
• This device is used continuously in Obstetrical Departments
• Basic fetal trace alerting for antepartum and intrapartum applications
• The physiological purpose is indirect. The device is intended to gather and store fetal and maternal information provided by the attached fetal monitors which constitute the primary care sources.

The Dopplex Centrale (DCII) monitoring system provides a powerful flexible solution to satisfy current and future central monitoring requirements for perinatal care wards. Various makes of fetal monitor can be linked to Dopplex Centrale which collects data from up to 48 beds in real time. This data is displayed graphically to the user at conveniently sited client workstations. The CTG information is saved using a secure database for subsequent review and patient management. Dopplex Centrale is customisable at manufacturer to cater for disparate needs of particular antenatal clinic or labour ward sites. Dopplex Centrale can be configured to suit the operating protocols of individual customers.

The provided documentation is a 510(k) summary for the Dopplex Centrale (DCII) device, primarily focusing on demonstrating substantial equivalence to a predicate device (Philips OB TraceVue). It describes the device's features and intended use but does not contain explicit acceptance criteria or a detailed study section with performance metrics and statistical analyses typically associated with proving a device meets acceptance criteria.

Therefore, I cannot fulfill all parts of your request with the provided information.

Here's what I can extract and what is missing:

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

Summary: The Dopplex Centrale (DCII) system is presented as substantially equivalent to the Philips OB TraceVue system for centralized perinatal monitoring. The evidence for this equivalence relies on a "comprehensive review of the features" of the predicate device as defined in its labeling and marketing information, rather than a quantifiable performance study against predefined acceptance criteria. This means the acceptance criteria are implicitly tied to matching the functionality and safety profile of the predicate device.

Missing Information: The document does not explicitly state specific, quantifiable acceptance criteria for performance metrics (e.g., accuracy, sensitivity, specificity, data transfer speed, reliability in terms of uptime) or provide a dedicated study section with data to prove the device quantitatively meets such criteria. The focus is on functional equivalence and safety compliance.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable. The document does not describe a test set in the context of a performance study with patient data. The "review" for substantial equivalence was based on product labeling and marketing information of the predicate device, not primary data from a test set.
• Data Provenance: Not applicable, as no test set data is described. The comparison is based on publicly available documentation of the predicate device.

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

• Not applicable. There was no test set involving human experts establishing ground truth for performance metrics in this 510(k) submission.

4. Adjudication Method for the Test Set

• Not applicable. No test set requiring adjudication is described.

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

• No. The document does not mention any MRMC study or any study involving human readers' performance with or without AI assistance. The device is a "monitoring system," not primarily an AI diagnostic or interpretive tool that directly assists human readers in a comparative effectiveness study as typically understood in this context.

6. Standalone (Algorithm Only) Performance Study

• Not applicable. The document focuses on the system's functionality and its substantial equivalence to a predicate monitoring system. It does not describe a standalone performance study in terms of quantifiable algorithm output (e.g., accuracy of automatic FHR interpretation). While it mentions "Basic fetal trace alerting," it does not provide performance metrics for these alerts.

7. Type of Ground Truth Used

• Not applicable in the context of a performance study. The "ground truth" for the substantial equivalence claim was the features, functions, and intended use as described in the product labeling and marketing information of the predicate device (Philips OB TraceVue).

8. Sample Size for the Training Set

• Not applicable. The document does not describe the use of machine learning or AI models that would require a training set in the conventional sense. The device is a data collection, display, and management system.

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

• Not applicable, as no training set is described.

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