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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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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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