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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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