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Goldtrace FSE is indicated for patients requiring continuous electronic intrapartum monitoring of the fetal heart rate during labor and delivery.

Goldtrace FSE is a sterile, single use device transmitting the fetal ECG signal for continuous electronic intrapartum monitoring. The device consists of gold-plated stainless steel spiral needle electrode that attaches to the fetal presenting part. The device includes a reference plate to measure the reference voltage level in the amniotic fluid. A guide tube and drive tube are used for application to the fetal presenting part. The subject device is connected to a compatible monitor (e.g., Philips Avalon FM30) via Philips DECG Reusable Legplate adaptor cable to provide a fetal ECG signal to the monitor. The subject device does not perform any conversion, analysis, quantification, or modifications to the fetal ECG.

This document is a 510(k) Summary for the Goldtrace Fetal Spiral Electrode (FSE), which is a medical device. The summary outlines the device's indications for use, its comparison to a predicate device, and the non-clinical performance data provided to support its substantial equivalence.

Here's an analysis to answer your questions:

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

The document does not explicitly state "acceptance criteria" with numerical targets for the comparative performance testing. Instead, it states that the devices are "equivalent" and "perform equally."

For other performance areas, the acceptance criteria are implied by adherence to recognized standards and successful completion of tests.

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

The document is a 510(k) summary for non-clinical performance data. It does not provide details about clinical studies, test set sample sizes, or data provenance in terms of patient data. The "test sets" for the non-clinical tests would refer to the number of device units tested for each specific test (e.g., how many devices were tested for biocompatibility, electrical safety, mechanical strength), which is not specified in this summary. The data provenance is from non-clinical testing, likely conducted by the manufacturer or accredited labs on their behalf. The country of origin for the data is not explicitly stated, but the manufacturer is Neoventa Medical AB in Sweden.

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 document is about a hardware medical device (fetal spiral electrode) and its non-clinical performance. It does not involve interpretation of medical images or data by human experts for establishing ground truth in the way an AI algorithm for diagnostics would. Therefore, this question is not applicable to the information provided. The ground truth for the device's function is its ability to transmit fetal ECG signals accurately, which is assessed through instrumental measurements rather than expert consensus on medical findings.

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

As this document describes non-clinical performance testing of a hardware device, there is no adjudication method involving multiple human readers as would be typical for clinical studies or AI diagnostic algorithms. Performance is assessed against technical standards and comparisons to a predicate device via instrumental measurements.

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

No, an MRMC comparative effectiveness study was not done. This is a 510(k) summary for a hardware medical device (fetal spiral electrode), not an AI-powered diagnostic tool. The document focuses on the device's physical and electrical performance, and its equivalence to a predicate device, not on human reader performance with or without AI assistance.

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

This question is not applicable. The Goldtrace Fetal Spiral Electrode is a hardware device described as transmitting a fetal ECG signal to a monitor. The document explicitly states: "The subject device does not perform any conversion, analysis, quantification, or modifications to the fetal ECG." It does not contain an algorithm for standalone performance.

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

For this device, the "ground truth" for its performance is established by:

• Adherence to recognized technical standards: This includes biocompatibility, electrical safety, sterility, and mechanical integrity standards (e.g., ISO, IEC, ASTM, USP). The "truth" is whether the device meets the specifications and limits defined by these standards.
• Functional equivalence to a predicate device: For the comparative performance testing, the ground truth is that the device should achieve the "same" or "equivalent" performance in transmitting fetal ECG signals as the legally marketed predicate device (K030691) when used with a compatible monitor. This equivalence is assessed through direct electrical and signal integrity measurements, not a human-derived ground truth.

8. The sample size for the training set

This question is not applicable. This device is a hardware medical device and does not involve AI algorithms that require a "training set."

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

This question is not applicable, as there is no training set for this hardware device.

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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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For patients requiring fetal heart rate monitoring during labor.

The device consists of a stainless steel spiral needle electrode. It is fixed to the fetal scalp by penetration of the skin by the spiral needle and thereby obtains the fetal ECG signal. A guide tube and a drive tube are required to place the electrode and are then removed before monitoring is begun. A stainless steel reference electrode is included close to the body housing the spiral electrode. The electrode is connected to the fetal monitor using a reusable adapter cable. A disposable maternal reference electrode connection is built into the adapter cable.

The provided text is a 510(k) summary for a Fetal Spiral Electrode. While it mentions safety and effectiveness, it does not contain a detailed study report that proves the device meets specific acceptance criteria.

The document primarily focuses on establishing substantial equivalence to previously marketed devices based on shared intended use, basic technological characteristics, and material biocompatibility. It states that "The laboratory testing verified the performance," but it does not provide details of this testing, specific performance metrics, or acceptance criteria.

Therefore, many of the requested details about acceptance criteria, study specifics, ground truth, and expert involvement cannot be extracted from this document.

Here's a breakdown of what can be inferred or directly stated from the provided text, and what is missing:

1. Table of acceptance criteria and the reported device performance:

   • Acceptance Criteria: Not explicitly stated in terms of measurable performance parameters. The general acceptance criterion is "safety and effectiveness are similar to existing devices" and "performance verified by laboratory testing."
   • Reported Device Performance: Not provided with specific metrics or results. The document states "Effectiveness is the same as the predicate devices" and "The laboratory testing verified the performance," but without any quantitative data to support this.

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

   • Sample Size (Test Set): Not mentioned. "Laboratory testing" is referenced, but no details about participants or test cases.
   • Data Provenance: Not mentioned (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 (e.g. radiologist with 10 years of experience):

   • Not mentioned, as no specific clinical study with ground truth establishment is detailed.

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

   • Not mentioned.

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. This is a physical medical device (Fetal Spiral Electrode), not an AI/software device. Therefore, MRMC studies or AI assistance are not relevant to this submission.

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

   • No. Not applicable to this type of physical device.

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

   • Not mentioned, as no detailed clinical study with ground truth is provided. The evaluation appears to be based on "laboratory testing" for performance and biocompatibility.

8. The sample size for the training set:

   • Not applicable, as this is not an algorithm/AI device that requires a training set. The device's "effectiveness" is stated as being "the same as the predicate devices."

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

   • Not applicable.

In summary, the provided 510(k) notification focuses on demonstrating substantial equivalence to predicate devices through similarities in intended use, technological characteristics, materials, and general safety/effectiveness claims based on internal laboratory testing (the details of which are not disclosed in this summary). It does not present a detailed clinical study with specific acceptance criteria, performance metrics, ground truth establishment, or expert involvement in the way an AI/software medical device submission might.

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