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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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