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Cadence series Fetal monitor is intended for monitoring physiological parameters of pregnant women during antepartum examination, labor and delivery. It is intended to be used only by trained and qualified personnel in antepartum examination rooms, labor and delivery rooms. It is not intended for use in intensive care units, operating rooms or for home use.

There are four models included in Cadence series Fetal monitor: Cadence, Cadence Dual, Cadence Pro and Cadence II.

The Fetal Monitor can provide different configurations according to different user requirements, FHR1 (Fetal Heart Rate 1), FHR2 (Fetal Heart Rate 2), TOCO, FM (remote marker), AFM (automatic fetal movement mark), FS (fetal stimulator, optional). The user can select the monitors according to requirements.

The Fetal monitor can be connected with Central Monitoring System via RJ45 interface. Also it can be connected to wireless network module via a DB9 interface, and the wireless network module will complete the data switch of the monitor and the Obstetrical Central Monitoring System.

Cadence II adopts 5.7"LCD, and the collected data, trends, and monitoring parameters are displayed at the same screen. A built-in thermal recorder is used to record the monitoring information.

The data collected and stored by Fetal Monitor can be real-time transferred to PC or Obstetrical Central Monitoring System and can be managed and printed by the Insight software.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Edan Instruments Fetal Monitor:

Based on the provided text, the submission is a 510(k) premarket notification for a Fetal Monitor, which primarily focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo performance criteria through rigorous clinical studies for a new technology. Therefore, many of the typical acceptance criteria and study elements you've requested are not explicitly detailed in this type of submission.

Here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission for substantial equivalence, the "acceptance criteria" are primarily based on equivalence to the predicate devices in terms of intended use, design, principle of operations, performance, and fundamental scientific technology. There are no explicit quantitative performance metrics or acceptance criteria stated in the document in the format of a clinical study endpoint.

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

The document does not describe a clinical "test set" in the context of a performance study to establish new acceptance criteria. The activities mentioned are "verification and validation activities" related to design control, which are typically engineering and functional tests rather than human-subject clinical trials for performance endpoints.

• Sample Size for Test Set: Not applicable/Not specified in the provided text, as this is a substantial equivalence submission, not a de novo performance study.
• Data Provenance: Not applicable/Not specified.

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

Not applicable. The document does not describe a clinical study that involved experts establishing ground truth for a test set. This type of submission relies on established safety and efficacy of predicate devices.

4. Adjudication Method for the Test Set

Not applicable. No clinical study for performance evaluation involving adjudication is described.

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

No. The document makes no mention of an MRMC study or any comparative effectiveness study with human readers, with or without AI assistance. The Fetal Monitor is a monitoring device, not an interpretative AI algorithm for image analysis.

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

Not applicable. The device is a traditional fetal monitor, not an AI algorithm. Its function is to collect and display physiological data, not to perform standalone diagnostic interpretations without human involvement.

7. The Type of Ground Truth Used

Not applicable in the context of a clinical performance study. The "ground truth" here is effectively the accepted performance and safety of the legally marketed predicate devices to which the new device is compared for substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. The device described is a hardware medical device (Fetal Monitor) and does not inherently involve machine learning algorithms that require a "training set" in the conventional sense.

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

Not applicable. See #8.

Summary of Device and Regulatory Context:

The submission for the Edan Instruments Fetal Monitor (models Cadence, Cadence Dual, Cadence Pro, Cadence II) is a 510(k) premarket notification. This regulatory pathway means the manufacturer is claiming that their new device is "substantially equivalent" to one or more legally marketed predicate devices and therefore does not require a new premarket approval (PMA) application, which would necessitate extensive clinical trials to establish de novo safety and effectiveness.

The "study" that proves the device meets the "acceptance criteria" (which are fundamentally criteria for substantial equivalence) consisted of:

• Verification and validation activities related to design control and risk analysis. These are typically engineering tests to ensure the device performs according to its specifications and is safe.
• Demonstrating equivalence in intended use, technological characteristics (no new safety/effectiveness questions), design, principle of operations, performance, and fundamental scientific technology to the predicate devices (Cadence [K040903] and Cadence II [K073221]).

The FDA's letter states that "We have reviewed your Section 510(k) premarket notification... and we have determined the device is substantially equivalent... You may, therefore, market the device, subject to the general controls provisions of the Act." This confirms that the device met the criteria for substantial equivalence based on the provided information, rather than specific performance metrics from a large-scale clinical study.

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The CADENCE II fetal monitor is used to monitor fetal well being during the antepartum period what is commonly called the non stress test. It is to be used by trained medical personnel in hospitals, clinics, physicians offices and in the patients home by prescription or doctors orders.

The CADENCE II Fetal Monitor can provide different configurations according to different user requirements, FHR1 (US1), FHR2 (US2), TOCO, FM (remote marker), AFM (automatic fetal movement mark), fetal stimulator (optional), DECG (direct fetal ECG, optional), and IUP (Intra-uterine Pressure, optional). The user can select the monitors according to requirements.

CADENCE II adopts 5.7" LCD, and the collected data, trends, and monitoring parameters are displayed at the same screen. A built-in thermal recorder is used to record the monitoring information.

The provided text is a 510(k) summary for the CADENCE II Fetal Monitor. This document describes the device and its intended use, but it does not contain specific acceptance criteria or a study proving the device meets those criteria from an objective performance standpoint. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, and study methodologies cannot be extracted from this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Cannot be provided from the text. The document does not define specific performance acceptance criteria for the CADENCE II, nor does it present a table of reported performance against such criteria. It focuses on demonstrating substantial equivalence to a predicate device based on design, principle of operations, and overall performance, rather than specific quantitative performance metrics from a new study.

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

• Cannot be provided from the text. The document does not describe a performance study with a test set, sample sizes, or data provenance information.

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)

• Cannot be provided from the text. No information about experts or ground truth establishment for a test set is included.

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

• Cannot be provided from the text. No details about test set adjudication are present.

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 from the text. This device is a fetal monitor, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study or AI-assistance effect size is not applicable and not mentioned.

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

• Cannot be provided from the text. The document does not describe performance studies for the device as a standalone algorithm. The CADENCE II is a monitoring system intended for use by trained medical personnel.

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

• Cannot be provided from the text. No information about ground truth for any performance evaluation is given.

8. The sample size for the training set

• Cannot be provided from the text. This document does not describe an AI or machine learning model that would require a training set.

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

• Cannot be provided from the text. As there's no mention of a training set, there's no information on how its ground truth would be established.

Summary of what the document does provide:

• Device Name: CADENCE II
• Intended Use: To monitor fetal well-being during the antepartum period (non-stress test). To be used by trained medical personnel in hospitals, clinics, physician's offices, and in the patient's home by prescription.
• Predicate Device: Cadence [K040903]
• Purpose of Submission: To demonstrate substantial equivalence to the predicate device.
• Basis for Equivalence: The submitter states that the CADENCE II is substantially equivalent to the predicate device in intended use, design, principle of operations, performance, and contains the same fundamental scientific technology. Modifications were made to the predicate device, and "All design control activities including safety risk analysis and the verification and validation activities conducted as related to the risks proved that the modified CADENCE II is substantially equivalent." This implies that the 'study' to prove equivalence was a comprehensive set of design control activities, risk analysis, and verification/validation, rather than a specific comparative performance study with defined acceptance criteria and a test set against a ground truth.

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