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SRF618B5 Fetal Monitor detects and displays single or twin (optional) Fetal Heart Rate (FHR), Fetal Movement (FM) and Uterine Activity (UA) in a real time on the color LCD viewer, and also provides the fetal heart beat sound with internal speaker. Ten hours of tracing may be stored and later retrieved for printing. It is intended for antepartum use by trained healthcare personnel. It is not intended for home use.

Diagnostic ultrasound imaging or fluid flow analysis of the human body for antepartum use as follows: Fetal / Obstetrics, Mode of Operation: PWD (N)

SRF618B5 is a fetal monitor, providing continuous monitoring, displaying, printing and recording of single or twin (optional) Fetal Heart Rate (FHR), Fetal Movement (FM) and Uterine Activity (UA) for antepartum testing and monitoring. SRF618B5 irradiates the ultrasound wave to maternal abdomen, and detects the Doppler effect signal reflected from the heart of the fetus. SRF618B5 extracts FHR and FM from this signal and provides the fetal heart beat sound with internal speaker.

SRF618B5 measures the UA of a pregnant woman using TOCO sensor. SRF618B5 displays FHR, UA and FM with waveforms and numbers on the color LCD screen, saves them in internal flash memory and prints parts of them to review in details.

The provided document is a 510(k) summary for the Sunray Medical Apparatus Co., Ltd. Fetal Monitor, model SRF618B5. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a clinical study to prove the device meets specific acceptance criteria in the way a novel medical device might.

Therefore, the document does not contain information about a study designed to prove the device meets specific performance acceptance criteria in terms of accuracy or efficacy against a defined ground truth. Instead, it relies on demonstrating compliance with safety standards and similarity to predicate devices.

Here's an analysis based on the information available:

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

No explicit acceptance criteria for performance (e.g., accuracy, sensitivity, specificity) and corresponding device performance results are provided within this 510(k) summary. The summary focuses on compliance with established safety standards and comparison to predicate devices, rather than a clinical performance study.

The document mentions that the device has been evaluated for safety and performance by lab bench testing according to various standards (IEC 60601-1, IEC 60601-2-37, IEC 60601-1-2, ISO 10993-1, ISO 10993-5, ISO 10993-10). These standards cover general safety, essential performance of ultrasonic medical diagnostic and monitoring equipment, electromagnetic compatibility, and biological evaluation (biocompatibility). The "reported device performance" in this context refers to compliance with these standards, not a specific clinical performance metric against a gold standard.

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

Not applicable. The document does not describe a clinical study with a test set of patient data to evaluate performance against ground truth. The evaluation was primarily through lab bench testing against engineering standards.

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 applicable. As no clinical study with a test set is described, there's no mention of experts establishing ground truth.

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

Not applicable. No clinical study with a test set requiring expert adjudication is described.

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 device is a Fetal Monitor, not an AI-powered diagnostic imaging device that would typically undergo an MRMC study. The document does not mention any AI component or human reader assistance.

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

Not applicable. This device is a Fetal Monitor that provides real-time monitoring. Its performance is inherent in its ability to detect and display FHR, FM, and UA, not in an independent algorithm's performance on a dataset. The evaluation cited is lab bench testing.

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

For the lab bench testing, the "ground truth" would be the specifications and requirements defined in the international standards (e.g., accuracy of FHR measurement within a certain range as tested with a simulator, electromagnetic compatibility within limits). It's not clinical "ground truth" like pathology or expert consensus on patient data.

8. The sample size for the training set

Not applicable. This device is a Fetal Monitor, not a machine learning or AI-based device that would require a training set.

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

Not applicable. As there's no training set, there's no ground truth establishment for it.

Summary of what the document does indicate about acceptance criteria:

The acceptance criteria for this device appear to be primarily based on:

1. Compliance with recognized international standards: IEC 60601-1, IEC 60601-2-37, IEC 60601-1-2, ISO 10993 (various parts). These standards cover electrical safety, essential performance, electromagnetic compatibility, and biocompatibility.
2. Substantial Equivalence: The primary "study" proving the device "meets the acceptance criteria" in the context of a 510(k) is the demonstration of substantial equivalence to predicate devices (Bionet FC-700 and FC-1400) without raising new questions of safety or effectiveness. The manufacturer states that "the subject device is very similar in design principle, intended use, indication for use, functions, material and the applicable standards" to the predicate devices. The differences are noted as not affecting safety or effectiveness.

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