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Avalon Fetal/Maternal Monitor FM20:

Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, oxygen saturation, noninvasive blood pressure, pulse rate and temperature of pregnant women and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms, in antepartum testing areas, in private households and during transports in healthcare facilities.

Avalon Fetal/Maternal Monitor FM30:

Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, electrocardiography (ECG), oxygen saturation, noninvasive blood pressure, pulse rate and temperature of pregnant women and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms, in antepartum testing areas, in private households and during transports in healthcare facilities.

Avalon Fetal/Maternal Monitor FM40:

Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, oxygen saturation, noninvasive blood pressure, pulse rate and temperature of pregnant women and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms and in antepartum testing areas.

Avalon Fetal/Maternal Monitor FM50:

Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, electrocardiography (ECG), oxygen saturation, noninvasive blood pressure, pulse rate and temperature of pregnant women and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms and in antepartum testing areas.

The legally marketed Philips Avalon fetal/maternal monitors FM20. FM30. FM40. and FM50 offer monitoring of fetal and maternal heart rates, uterine activity, maternal electrocardiography (ECG) wave, maternal noninvasive blood pressure (NIBP), oxygen saturation (SpO2) with pulse rate and temperature, during antepartum testing and labor and delivery.

The Avalon Fetal/Maternal Monitor FM20 provides the following external measurement parameters:

• Up to three Fetal Heart Rates (FHR) via Ultrasound (US) -
• Fetal Movement Profile -
• Uterine activity via external Toco -
• -Maternal nulse rate
• -Maternal Heart Rate via maternal ECG
• Noninvasive blood pressure (NBP) -
• Maternal temperature -
• Pulse oximetry (maternal SpO2) -

The Avalon Fetal/Maternal Monitor FM30 shares all the features and capabilities of the Avalon FM20. In addition, the Avalon FM30 provides the following external and internal measurement parameters:

• One Fetal Heart Rate and one fetal DECG wave via direct ECG (DECG) *) -
• -Uterine activity via intrauterine pressure (IUP)
• -Maternal ECG (MECG) wave

*) Note: maximum three fetal heart rates can be monitored.

The Avalon Fetal/Maternal Monitor FM40 provides the following external measurement parameters:

• Up to three Fetal Heart Rates (FHR) via Ultrasound (US) -
• Fetal Movement Profile -
• Uterine activity via external Toco -
• -Maternal Pulse Rate
• Maternal Heart Rate via maternal ECG -
• -Noninvasive blood pressure (NBP)
• -Maternal temperature
• -Pulse oximetry (maternal SpO2)

The Avalon Fetal/Maternal Monitor FM50 shares all the features and capabilities of the Avalon FM40. In addition, the Avalon FM50 provides the following external and internal measurement parameters:

• One Fetal Heart Rate and one fetal DECG wave via direct ECG (DECG) *) -
• Uterine activity via intrauterine pressure (IUP) -
• -Maternal ECG (MECG) wave

*) Note: maximum three fetal heart rates can be monitored.

This document describes the Philips Avalon Fetal/Maternal Monitors (FM20, FM30, FM40, and FM50) with software revision J.30.

The document does not explicitly list acceptance criteria in a table format with reported device performance alongside it. Instead, it states that "Pass/Fail criteria were based on the specifications cleared for the predicate devices" and that "The test results are passed and showed substantial equivalence."

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

Based on the provided text, a specific table of acceptance criteria and reported device performance is not explicitly given. The document generally states that the device "passed" tests based on the specifications of predicate devices.

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

The document mentions "Bench testing included the use of previously recorded patient raw signals and traces." However, it does not specify the sample size for the test set or the data provenance (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:

The document does not provide information regarding the number of experts, their qualifications, or how they established ground truth for any test set.

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

The document does not describe any adjudication method used for a test set.

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 document describes a medical device for monitoring physiological parameters, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and not mentioned.

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

The document describes performance verification and validation. While software testing was performed ("Software verification and validation testing were conducted"), it primarily focuses on the device's functionality and safety in relation to its predicate devices, rather than a standalone algorithm performance in a diagnostic context. The device is a "monitor" and its modifications are related to interfaces and measuring capabilities. There is no explicit mention of a standalone algorithm-only performance study.

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

The document mentions "previously recorded patient raw signals and traces" were used for bench testing. The quality and origin of these 'raw signals' as ground truth are not further specified beyond being "previously recorded."

8. The sample size for the training set:

The document does not mention a training set as this is not an AI/machine learning device in the typical sense that would require a distinct training set.

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

As no training set is discussed, information on how ground truth was established for it is not applicable and not provided.

Summary of Acceptance Criteria and Study:

The primary "acceptance criteria" appear to be meeting the specifications cleared for the predicate devices, and the "study" involved a series of non-clinical verification and validation activities.

Verification and Validation Activities Included:

• Biocompatibility testing (Cytotoxicity, Irritation, Delayed Type Hypersensitivity, Chemical characterization)
• Testing of new or impacted hazards from risk management analysis
• Software performance and regression verification and validation
• Performance and regression verification testing of wireless functionality
• Verification according to applicable EMC, safety, and performance standards (e.g., AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 60601-2-27, IEC 80601-2-30, IEC 60601-2-37, ISO 80601-2-56, ISO 80601-2-61, IEC 62304, AAMI ANSI ISO 10993-1)
• Bench testing using previously recorded patient raw signals and traces.

The conclusion states that these non-clinical tests demonstrated that the modified devices are "as safe, as effective, and perform as well or better as the predicate devices" and "do not introduce new questions concerning the safety or effectiveness." No clinical studies were deemed necessary.

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The FM20 is a Fetal Monitor for measuring and recording maternal contraction and fetal heart rate. Data is displayed on a front panel LCD(7") Display, recorded on a strip chart recorder and may be transmitted over RS232 port to a remote data receiver. Single/Twin fetal heart rates may be measured by means of Doppler Ultrasound. Uterine Activity is measured with an external TOCO transducer. The FM20 is intended to be used during the antepartum periods on pregnant woman.

FM20 is the fetal monitor that measures uterine contractions and fetal heart rate (FHR) which may be used to predict fetal status. To detect the Doppler frequency signal reflected from the heart of the fetus, FM20 irradiates ultrasound wave to the abdomen of a pregnant woman. FM20 analyzes this signal and displays the heart rate by LCD. Also, FM20 provides the sound from the heart of fetus. FM20 measures the uterine contraction of a pregnant woman by pressure sensors and displays the numerical values. And FM20 prints the heart rate of the fetus and the values of uterine contraction. FM20 records the heart rate of the fetus, the uterine contraction of a pregnant woman. and basic information of the equipment with a provided thermal orinter. FM20 is capable of Twin Monitoring with two pulsed Ultrasound Transducers. FM20 has a free voltage(100 - 240VAC input) power adaptor. FM20 has Fetal movement detection function. To extract fetal movement signal, FM20 uses a circuit and digital filter. FM20 has Event marker function so that the patient can record the time of important events. FM20 has the capability to alert the caregiver in the event a heart rate goes above or below limit for a preset time delay.

The provided text describes a 510(k) submission for the Mediana FM20 Fetal Monitor, focusing on its substantial equivalence to predicate devices. The document highlights the device's technical characteristics, indications for use, and safety testing but does not contain detailed information about specific acceptance criteria or a study proving that the device meets those criteria with quantitative performance metrics. It primarily states that "All test results were satisfactory" for safety, EMC, and performance testing according to standards EN/IEC 60601-1 and EN/IEC 60601-1-2.

Therefore, many of the requested details cannot be extracted directly from the provided text.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that the specifications and performances (FHR monitoring, UC monitoring, Transducer type, ultrasound frequency, FHR range, FHR accuracy, Detection of fetal movement via ultrasound transducer) of Mediana Model FM20 are equivalent to the predicate devices (Bistos Co.,Ltd. Model BT-300, and BiOSYS Co.,Ltd, Model IFM-500). However, it does not explicitly list numerical acceptance criteria or the specific performance values achieved by the FM20.

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

The document does not specify any sample size used for a test set or the data provenance (e.g., country of origin, retrospective or prospective) for a clinical study. The information provided heavily relies on the equivalence to predicate devices and adherence to electrical/EMC standards, rather than new clinical performance data.

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

Not applicable. The document does not describe a study involving expert-established ground truth for a test set.

4. Adjudication Method for the Test Set:

Not applicable. The document does not describe a study with an adjudication method.

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

No, an MRMC comparative effectiveness study is not mentioned. The submission focuses on substantial equivalence based on technical characteristics and safety standards, not on direct comparison of human reader performance with or without AI assistance.

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

The document describes the device as a "Fetal Monitor," implying it's a standalone monitoring device. However, it doesn't detail performance studies for the algorithm in isolation. Its performance is stated as "equivalent" to predicate devices, which are also standalone fetal monitors. The device does have features like "Fetal movement detection function. To extract fetal movement signal, FM20 uses a circuit and digital filter" and "capability to alert the caregiver in the event a heart rate goes above or below limit for a preset time delay," which represent algorithm-driven functions. However, quantitative standalone performance metrics for these functions are not provided.

7. The Type of Ground Truth Used:

Ground truth, in the context of clinical performance evaluation (e.g., pathology, outcomes data, expert consensus), is not explicitly mentioned or used in this submission. The "ground truth" for the device's acceptable performance appears to be its adherence to established electrical, mechanical, and environmental safety standards (EN/IEC 60601-1, EN/IEC 60601-1-2) and its technical equivalence to previously cleared predicate devices.

8. The Sample Size for the Training Set:

Not applicable. The document does not describe a machine learning algorithm that would require a training set in the conventional sense. The device's "Fetal movement detection function" uses a "circuit and digital filter," suggesting a more traditional signal processing approach rather than a machine learning model requiring a large training dataset.

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

Not applicable, as a training set for a machine learning algorithm is not described.

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Avalon Fetal/Maternal Monitor FM20: Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, oxygen saturation, non-invasive blood pressure, pulse rate of pregnant women and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms, in antepartum testing areas, in private households and during transports in healthcare facilities.

Avalon Fetal/Maternal Monitor FM30: Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, ECG, oxygen saturation, non-invasive blood pressure, and pulse rate of pregnant women and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms, in antepartum testing areas, in private households and during transports in healthcare facilities.

Avalon Fetal/Maternal Monitor FM40: Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, oxygen saturation, non-invasive blood pressure, and pulse rate of pregnant women and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms and in antepartum testing areas.

Avalon Fetal/Maternal Monitor FM50: Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, ECG, oxygen saturation, non-invasive blood pressure, and pulse rate of pregnant women and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms and in antepartum testing areas.

The legally marketed Philips Avalon Fetal/Maternal Monitors FM20, FM30, FM40, and FM50 offer monitoring of fetal and maternal heart rates, uterine activity, maternal ECG wave, maternal non-invasive blood pressure (NIBP) and oxygen saturation (SpO2) with pulse rate, during antepartum testing and labor and delivery.

The Avalon Fetal/Maternal Monitor FM20 provides the following external measurement parameters: Up to three Fetal Heart Rates (FHR) via ultrasound (US), Fetal Movement Profile, Uterine activity via external Toco, Maternal pulse rate, Maternal Heart Rate via maternal ECG, Non-invasive blood pressure (NIBP), Pulse oximetry (maternal SpO2).

The Avalon Fetal/Maternal Monitor FM30 shares all the features and capabilities of the Avalon FM20. In addition, the Avalon FM30 provides the following external and internal measurement parameters: One Fetal Heart Rate and one fetal DECG wave via direct ECG (DECG), Uterine activity via intrauterine pressure (IUP), Maternal ECG (MECG) wave. Note: maximum three fetal heart rates can be monitored.

The Avalon Fetal/Maternal Monitor FM40 provides the following external measurement parameters: Up to three Fetal Heart Rates (FHR) via ultrasound (US), Fetal Movement Profile, Uterine activity via external Toco, Maternal Pulse Rate, Maternal Heart Rate via maternal ECG, Non-invasive blood pressure (NIBP), Pulse oximetry (maternal SpO2).

The Avalon Fetal/Maternal Monitor FM50 shares all the features and capabilities of the Avalon FM40. In addition, the Avalon FM50 provides the following external and internal measurement parameters: One Fetal Heart Rate and one fetal DECG wave via direct ECG (DECG), Uterine activity via intrauterine pressure (IUP), Maternal ECG (MECG) wave. Note: maximum three fetal heart rates can be monitored.

Device Modifications: Operation of the models FM20 (M2702A) and FM30 (M2703A) with an internal rechargeable power source (optional) to support fetal/maternal monitoring during transport within healthcare facilities. Modification of the existing Toco transducer M2734A to include maternal pulse measurement, using plethysmography at an alternative body location (abdomen). The modified transducer is labeled M2734B 'Toco MP'. Automated antepartum fetal/maternal trace interpretation and printout the resulting non-stress test (NST) report. The new software G.02.xx, which is a modification of the software F.01.xx (cleared with K102958) to support the before listed modifications / additions. Additionally, the option to equip the Avalon Fetal/Maternal Monitors with maternal SpO2 measurement is enabled now also for the model FM20 (M2702A).

This submission describes the Philips Avalon Fetal/Maternal Monitor FM20/30, FM40/50, Release G.0. The primary focus of the provided text regarding new functionalities is on the M2734B 'Toco MP' transducer, which measures maternal pulse rate via plethysmography at the abdomen, and automated antepartum fetal/maternal trace interpretation and NST report generation.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a table format for the modified device functionalities. Instead, it states that "Pass/Fail criteria were based on the specifications cleared for the predicate devices and test results showed substantial equivalence." For the new Toco MP transducer, the performance is reported as meeting the requirements through comparison with ECG-derived maternal heart rate.

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

• M2734B Toco MP Transducer Clinical Study: The document states, "For the clinical validation of the M2734B 'Toco MP' transducer a clinical study has been performed. The patient population was covering a variety of body mass indices (BMI) and skin colors."
  • Sample Size: The exact numerical sample size for this clinical study is not specified in the provided text.
  • Data Provenance: The country of origin is not specified. The study is described as a "clinical study," implying it was prospective, gathering new data for the validation.
• Non-clinical Testing: "Some tests included the use of previously recorded patient raw signals and traces." This suggests some retrospective data was used in the non-clinical testing phase. The origin is not specified.

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

This information is not provided in the document. The document describes clinical studies and comparative tests but does not detail the process of establishing ground truth with expert involvement for the test set, nor the number or qualifications of such experts.

4. Adjudication Method for the Test Set

This information is not provided in the document. The text mentions "compared and evaluated" for the Toco MP transducer data, but no specific adjudication method (e.g., 2+1, 3+1, none) is described.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If so, What Was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

• No MRMC study was mentioned. The device involves "automated antepartum fetal/maternal trace interpretation and printout the resulting non-stress test (NST) report." This implies an algorithmic interpretation. While the NST report might assist human readers, no study comparing human readers with and without this AI assistance, or quantifying an effect size, is described. The comparison was for the algorithm's output against a predicate algorithm (OB TraceVue G.00).

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

• Yes, a standalone performance test for the antepartum trace interpretation algorithm was done. The document states: "Comparative test of antepartum fetal/maternal trace interpretation and NST report against the implementation in OB TraceVue G.00 (K100420)." This testing evaluates the algorithm's output independently by comparing it to an existing cleared algorithm, which is a form of standalone performance evaluation against a defined standard.

7. The Type of Ground Truth Used

• For the M2734B Toco MP Transducer: The ground truth for maternal pulse rate was "ECG derived maternal heart rate (MECG)." This is a well-established and highly accurate physiological measurement, serving as a reliable reference standard.
• For the Automated Antepartum Trace Interpretation/NST Report: The ground truth was the "implementation in OB TraceVue G.00 (K100420)." This means the new algorithm's output was compared to the output of a previously cleared, predicate software. This isn't a direct "pathology" or "outcomes data" ground truth, but rather a comparative standard against a known, accepted performance of another device.

8. The Sample Size for the Training Set

• The document does not specify a training set nor its sample size. The description of modifications primarily concerns new hardware (Toco MP transducer) and software features (NST report, internal power source). While the NST report would likely involve some form of algorithmic development, no details about its training data are provided.

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

• As no training set is described, information on how its ground truth was established is not provided.

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The Philips Avalon FM20, FM30, FM40 and FM50 Fetal/Maternal Monitors are intended for non-invasive monitoring of the physiological parameters of pregnant women during antepartum testing and labor and delivery. All monitors are intended for monitoring fetal heart rates, fetal movement profiles, maternal heart rates, uterine activity, maternal noninvasive blood pressure, and additionally for the FM30, FM40 and FM50 maternal oxygen saturation (Sp02). The FM30 and FM50 are additionally intended for maternal ECG and for invasive monitoring of fetal Direct ECG and intrauterine pressure. All monitors are intended for generating alarms from fetal and maternal parameters, for displaying, storing and recording patient data and related waves, transmitting patient data to a patient information and surveillance system on a network, and for postpartum monitoring of the mother. All monitors are intended for use by trained health care professionals. They are intended for use in labor and delivery rooms, antepartum testing areas and during postpartum recovery in the hospital environment. They are not intended for use in intensive care units or operating rooms. The FM20 and FM30 are additionally intended for use in healthcare and for example in doctors' offices, and in private households.

The subject devices Philips Avalon Fetal Monitors FM20, FM30, FM40 and FM50 are a modification of the legally marketed Philips Avalon Fetal Monitors FM20, FM30, FM40 and FM50 and offer monitoring of fetal heart rates, fetal movement profiles, fetal Direct ECG, maternal uterine activity, maternal heart rates, maternal pulse rates, maternal ECG, maternal non-invasive blood pressure (NIBP) and maternal oxygen saturation (Sp02) during antepartum testing and labor and delivery. The modification of the Philips Avalon Fetal Monitors FM20, FM30, FM40 and FM50 only permits specific Sp02 sensors, which are already cleared for the Philips picoSATIIplus SpO2 pulse oximetry module, the Philips Intellivue X2 (M3002A) multi measurement module and the Philips M1020B Sp02 plug-in module, to be also used with the Philips Avalon Fetal monitors FM30, FM40 and FM50.

The Philips Avalon Fetal Monitors (FM20, FM30, FM40, and FM50) are a modification of previously cleared devices, primarily to permit the use of specific SpO2 sensors already cleared for other Philips modules. The submission focuses on demonstrating substantial equivalence to these predicate devices.

Acceptance Criteria and Device Performance:

The document explicitly states that "hazard criteria were based on the Pass/Fail analysis. specifications cleared for the predicate devices and test results showed substantial equivalence." This implies that the acceptance criteria for the modified devices were the same performance specifications as those established for the predicate devices. The study concludes that the "results demonstrate that the Philips Avalon Fetal Monitors meet all reliability requirements and performance claims."

Study Details:

1. Sample Size and Data Provenance (Test Set):

   • The document does not specify the sample size used for the test set.
   • The data provenance (country of origin, retrospective/prospective) is not mentioned.

2. Number of Experts and Qualifications (Ground Truth for Test Set):

   • The document does not provide information on the number of experts or their qualifications used to establish ground truth for the test set.

3. Adjudication Method (Test Set):

   • The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set.

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

   • No MRMC comparative effectiveness study is mentioned. The submission focuses on device performance and substantial equivalence, not human reader improvement with AI assistance.

5. Standalone Performance Study:

   • A standalone performance study was implicitly done, as "Verification and Validation testing activities" were conducted to "establish the performance, functionality, and reliability characteristics of the modified devices." This testing was against predefined specifications, indicating an algorithm-only (device-only) performance assessment.

6. Type of Ground Truth Used:

   • The document does not explicitly state the type of ground truth used (e.g., expert consensus, pathology, outcomes data). The ground truth for the verification and validation appears to be the "specifications cleared for the predicate devices."

7. Sample Size for Training Set:

   • The document does not mention a training set, as the evaluation method described is primarily focused on verification and validation against pre-established specifications for the modified device, rather than training a new algorithm from data.

8. How Ground Truth for Training Set was Established:

   • Not applicable, as no training set is mentioned in the context of this submission. The device is a modification of an existing, cleared device, implying its core algorithms were already established and validated. The current submission focuses on verifying continued performance after a component modification.

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Avalon Fetal Monitor FM20:
Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, non-invasive blood pressure, pulse rate of pregnant women and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms, in antepartum testing areas and in private households.

Avalon Fetal Monitor FM30:
Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, ECG, oxygen saturation, non-invasive blood pressure, and pulse rate of pregnant women and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms, in antepartum testing areas and in private households.

The Philips Avalon Fetal Monitors FM20 and FM30 are intended for noninvasive monitoring of parameters of pregnant women during antepartum testing and labor and delivery. The FM30 is additionally intended for invasive monitoring. All monitors are intended for monitoring fetal and maternal heart rates, uterine activity, maternal noninvasive blood pressure, and additionally for the FM30, oxygen saturation (SpO2). All monitors are intended for generating alarms for displaying, storing and recording patient data and related waves, transmitting patient data to a patient information and surveillance system on a network, and for postpartum monitoring of the mother.

The provided 510(k) summary (K071800) for the Philips Avalon Fetal Monitors FM20 and FM30 does not contain information related to specific acceptance criteria or details of a study proving device performance against such criteria.

This 510(k) is a premarket notification for a modification to an already cleared device: the Philips Avalon Fetal Monitors FM20 and FM30 (cleared under K052795 and K062137). The modification only introduces the capability for healthcare professionals to monitor pregnant women in private households.

Therefore, the submission relies on the substantial equivalence to the previously cleared devices and does not present new performance study data. The document focuses on regulatory classification, intended use, and substantial equivalence, rather than detailed performance metrics.

Based on the provided text, I cannot complete the requested information for the acceptance criteria and the study that proves the device meets them. The pertinent sections of the request that cannot be addressed due to the lack of information in the document are:

1. A table of acceptance criteria and the reported device performance: Not available.
2. Sample sized used for the test set and the data provenance: Not available.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
4. Adjudication method for the test set: Not available.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable/Available. (The device is not AI-assisted).
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable/Available. (The device does not involve a standalone algorithm for diagnostic performance).
7. The type of ground truth used: Not available.
8. The sample size for the training set: Not available.
9. How the ground truth for the training set was established: Not available.

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Avalon Fetal Monitor FM30: Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, ECG, oxygen saturation, non-invasive blood pressure, and pulse rate of pregnant women and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms and in antepartum testing areas.

Avalon Fetal Monitor FM20: Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, non-invasive blood pressure, pulse rate of pregnant women and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms and in antepartum testing areas.

The modified devices Philips Avalon Fetal Monitors FM20 and FM30 are intended for non-invasive and invasive monitoring of the physiological parameters of pregnant women during antepartum testing and labor and delivery. The Avalon FM20 and FM30 are intended for monitoring fetal and maternal heart rates, uterine activity, maternal non-invasive blood pressure (NIBP) and maternal oxygen saturation (SpO2). The Avalon FM20 and FM30 are intended for generating alarms, for displaying, storing and recording patient data and related waves.

The provided text describes a 510(k) summary for the Philips Avalon Fetal Monitors FM20 and FM30, specifically for a modification that introduces the capability of monitoring fetal heart rates of triplets. However, the text does not include detailed acceptance criteria or a specific study that quantitatively proves the device meets such criteria.

The information mainly focuses on establishing substantial equivalence to a predicate device, regulatory classifications, and the general scope of the device's intended use and functionality.

Here's a breakdown of what is and is not available in the provided text regarding your request:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not Available. The document states that "Pass/Fail criteria were based on the specifications cleared for the predicate devices" but does not provide details of these criteria nor specific reported performance metrics against them. It only states that "test results showed substantial equivalence" and "the results demonstrate that the Philips Avalon Fetal Monitors FM20 and FM30 meet all reliability requirements and performance claims." There are no quantitative performance numbers (e.g., sensitivity, specificity, accuracy, error rates) reported for the device, especially concerning the triplet monitoring capability.

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

• Not Available. The document mentions "performance tests, regression tests, and testing from hazard analysis" but does not specify the sample size (number of patients, records, or fetal heart rate traces) used for any of these tests. There is no information regarding the provenance of the data (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not Applicable/Not Available. Since no specific performance study with a 'ground truth' is described (such as for diagnostic accuracy), there's no mention of experts establishing ground truth or their qualifications. The device is a physiological monitor, not typically one that requires expert-established ground truth for its core function in the same way an AI diagnostic tool would.

4. Adjudication Method for the Test Set:

• Not Applicable/Not Available. As no detailed performance study requiring adjudication is described, this information is not present.

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

• Not Available. The document does not describe any MRMC comparative effectiveness study, nor does it mention any AI component or the effect size of AI assistance on human readers. The device is a monitor, not an AI-assisted diagnostic tool in the sense of image analysis.

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

• Not Applicable/Not Available. This device is a monitor, not a standalone algorithm in the typical sense of AI/ML. Its function is to acquire and display physiological parameters. While it processes signals, the "algorithm only" performance metric as described for AI is not relevant here.

7. The Type of Ground Truth Used:

• Not Available. As no specific performance study requiring ground truth is described, this information is not present. For a physiological monitor, "ground truth" typically refers to the accuracy of the measurements against a gold standard instrument, but details of such testing are not provided beyond a general statement of meeting specifications.

8. The Sample Size for the Training Set:

• Not Applicable/Not Available. The document describes a traditional medical device (fetal monitor) and a modification for triplet monitoring. It does not indicate the use of machine learning or AI that would require a "training set."

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

• Not Applicable/Not Available. Since no training set for an AI/ML algorithm is mentioned, the method for establishing its ground truth is not applicable.

In summary, the provided 510(k) summary focuses on regulatory compliance through substantial equivalence, indicating that the device's modification (triplet monitoring) was verified through "performance tests, regression tests, and testing from hazard analysis" against existing predicate specifications. However, it does not provide the detailed, quantitative performance data, sample sizes, or specifics of ground truth establishment that you requested for a comprehensive understanding of the device's acceptance criteria and the study proving it.

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Avalon Fetal Monitor FM30: Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, ECG, oxygen saturation, non-invasive blood pressure, and pulse rate of pregnant women and the fetal heart rate in labor and delivery rooms and in antepartum testing areas.

Avalon Fetal Monitor FM20: Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, non-invasive blood pressure, pulse rate of pregnant women and the fetal heart rate in labor and delivery rooms and in antepartum testing areas.

The subject devices Philips Avalon Fetal Monitors FM20 and FM30 are modification of the legally marketed Philips Series 50XM (M1350B) Fetal/Maternal Monitor (K954351) and offer monitoring of fetal and maternal heart rates, uterine activity, maternal ECG, maternal non-invasive blood pressure (NIBP) and oxygen saturation (Sp02) during antepartum testing and labor and delivery. The Avalon FM20 and FM30 are intended for non-invasive and invasive monitoring of the physiological parameters of pregnant women during antepartum testing and labor and delivery. The Avalon FM20 and FM30 are intended for monitoring fetal and maternal heart rates, uterine activity, maternal non-invasive blood pressure (NIBP) and oxygen saturation (SpO2). The Avalon FM20 and FM30 are intended for generating alarms, for displaying, storing and recording patient data and related waves.

Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them:

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

The provided text does not explicitly list specific quantitative acceptance criteria or detailed performance metrics. Instead, it makes a general statement:

Explanation: The submission is for a modified device (Philips Avalon Fetal Monitors FM20 and FM30) that is stated to have the "same technological characteristics" and "same intended use" as legally marketed predicate devices. The "acceptance criteria" here are implicitly tied to demonstrating that the modified device performs equivalently to the predicate devices and meets their established specifications. The text confirms that this equivalence was met.

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

• Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

Not applicable. The submission describes verification, validation, and testing activities against predicate device specifications, not a clinical study involving experts establishing ground truth for diagnostic accuracy.

4. Adjudication method for the test set

Not applicable. The submission describes engineering and system-level testing, not a clinical study requiring adjudication of expert interpretations.

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

Not applicable. This is not an AI-powered diagnostic device, and no MRMC comparative effectiveness study is mentioned. The device is a fetal monitor.

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

The device itself is a standalone fetal monitor designed to provide physiological data. Its "standalone" performance was assessed through system-level, performance, and safety tests against predicate device specifications. There is no "algorithm only" performance reported in the context of AI.

7. The type of ground truth used

The "ground truth" for the device's performance was established by the specifications cleared for the predicate device. The testing demonstrated that the modified device met these existing specifications.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable, as there is no training set for this type of device.

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