(203 days)
The Quantitative Sentinel (QS) System is a software application that is intended for use as clinical data management system (also referred to as a clinical information system - CIS). The primary function of the system is the management of clinical data (whether manually or automatically acquired) for the purpose of providing integrated, ready and organized access to patient and/or clinical data that would normally be provided on paper records and/or separate clinical systems/devices. The QS System serves as a decision support tool as well as an electronic medical record. The device is intended for use in a hospital/clinical environment.
The Quantitative Sentinel (QS) System is a software application that is intended for use as clinical data management system (also referred to as a clinical information system - CIS). The primary function of the system is the management of clinical data (whether manually or automatically acquired) for the purpose of providing integrated, ready and organized access to patient and/or clinical data that would normally be provided on paper records and/or separate clinical systems/devices. The QS System serves as a decision support tool as well as an electronic medical record. The QS System operates on off-the-shelf software and hardware. The device is intended for use in a hospital/clinical environment.
The provided text describes a clinical data management system called the Quantitative Sentinel System. However, it explicitly states that "No clinical testing was necessary to demonstrate conformity to performance requirements." This means that there is no study described in this document that proves the device meets acceptance criteria based on clinical performance.
Therefore, I cannot fulfill your request for information related to acceptance criteria and a study proving the device meets them, as typically understood in the context of device performance evaluation. The document focuses on technological characteristics and substantial equivalence to predicate devices, not on clinical performance metrics or studies.
However, I can extract information about what was tested to demonstrate conformity to requirements, which substitutes for what would be "acceptance criteria" in the absence of clinical performance standards:
1. A table of acceptance criteria and the reported device performance:
Since no clinical performance criteria are stated, the "acceptance criteria" here relate to software functionality and environmental performance.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Software Requirements | Extensively tested to meet its requirements and design. |
| Design Requirements | Extensively tested to meet its requirements and design. |
| Environmental Performance | Extensively tested to meet its requirements and design (referring to the software's operating environment). |
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 states "No clinical testing was necessary." The testing mentioned is internal software and environmental testing, not testing with patient data.
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. No clinical ground truth was established as no clinical testing was performed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No clinical test set or adjudication process 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. No MRMC study was done, and the device is a data management system, not one that directly assists in reader interpretation in a diagnostic sense.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. No standalone performance study was done in the clinical sense. The device's "performance" is its ability to manage data as a software application.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. No clinical ground truth was established. The "ground truth" for the software testing would be the predefined functional and design specifications.
8. The sample size for the training set:
Not applicable. This device is a software application for data management, not an AI/ML algorithm that requires a training set of data in the typical sense.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set mentioned for an AI/ML algorithm.
In summary, the provided 510(k) summary for the Quantitative Sentinel System clarifies that its conformity was demonstrated through extensive internal software and environmental testing to meet its requirements and design, and not through clinical performance studies.
§ 884.2740 Perinatal monitoring system and accessories.
(a)
Identification. A perinatal monitoring system is a device used to show graphically the relationship between maternal labor and the fetal heart rate by means of combining and coordinating uterine contraction and fetal heart monitors with appropriate displays of the well-being of the fetus during pregnancy, labor, and delivery. This generic type of device may include any of the devices subject to §§ 884.2600, 884.2640, 884.2660, 884.2675, 884.2700, and 884.2720. This generic type of device may include the following accessories: Central monitoring system and remote repeaters, signal analysis and display equipment, patient and equipment supports, and component parts.(b)
Classification. Class II (performance standards).