(90 days)
The Quantitative Sentinel (QS) System's is intended for automatic patient data management. It does this by:
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(a) providing the user the ability to create and use electronic forms for entering, viewing and storing patient and facility related data (e.g. charts, forms, graphs, chalkboards, care plans, user reference manual).
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(b) interfacing with other hospital information systems and medical devices for automatic data acquisition, viewing and storage with the electronic patient record.
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(c) providing visual notification of when acquired fetal monitor heart rate values exceed the user defined limits for high and low fetal heart rate and poor signal quality.
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(d) providing Spectra Alerts capabilities for fetal monitoring (surveillance).
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(e) providing automatic computations of physiologic indexes (e.g. nutrition).
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(f) providing calculations from user defined formulas (i.e. index calculator).
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(g) providing the ability to record, with the patient record, fluid input and oulput information that is defined by the user.
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(h) providing the ability to export patient data to relational databases for research and Quality Assurance purposes.
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(i) providing the ability to archive files to a secondary or tertiary storage medium (i.e. optical disk).
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(i) providing the ability to print (locally or remotely) patient records and QS database definition (e.g. item names)
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(k) providing the ability to review fetal monitor data (OB-Link) remotely over the internet.
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 Quantitative Sentinel System 7.0 is a software application intended for use as a clinical data management system. According to the provided 510(k) summary, "No clinical testing was necessary to demonstrate conformity to performance requirements." Therefore, there is no study described that proves the device meets specific acceptance criteria related to its clinical performance.
The submission focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and extensive software testing to meet its requirements and design.
However, based on the provided text, we can infer some "acceptance criteria" related to functionality and system capabilities, and the "reported device performance" is the statement that these functions are met or enabled.
Here's an attempt to structure the information based on your request, acknowledging the limitations due to the absence of clinical study data:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied from Intended Use/Features) | Reported Device Performance (as stated in 510(k) Summary) |
|---|---|
| Ability to create and use electronic forms for entering, viewing, and storing patient and facility related data. | Yes (stated in Indications for Use) |
| Interface with other hospital information systems and medical devices for automatic data acquisition, viewing, and storage. | Yes (stated in Indications for Use & comparison table) |
| Provide visual notification when acquired fetal monitor heart rate values exceed user-defined limits and for poor signal quality. | Yes (stated in Indications for Use - "Spectra Alerts capabilities for fetal monitoring (surveillance)" and comparison table) |
| Provide automatic computations of physiologic indexes. | Yes (stated in Indications for Use) |
| Provide calculations from user-defined formulas. | Yes (stated in Indications for Use) |
| Provide ability to record fluid input and output information with the patient record. | Yes (stated in Indications for Use) |
| Provide ability to export patient data to relational databases for research and Quality Assurance purposes. | Yes (stated in Indications for Use) |
| Provide ability to archive files to a secondary or tertiary storage medium. | Yes (stated in Indications for Use) |
| Provide ability to print (locally or remotely) patient records and QS database definitions. | Yes (stated in Indications for Use) |
| Provide ability to review fetal monitor data remotely over the internet. | Yes (stated in Indications for Use & comparison table) |
| Operate on off-the-shelf software and hardware. | Yes (stated in Device Description & comparison table) |
| Utilize Network architecture (Ethernet, Token Ring, IBM Wireless LAN). | Yes (stated in comparison table) |
2. Sample size used for the test set and the data provenance:
The document explicitly states, "No clinical testing was necessary to demonstrate conformity to performance requirements." Therefore, there is no information provided regarding a clinical "test set" in the context of patient data. The testing mentioned refers to software and environmental testing. The provenance of any data used for internal software testing is not detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as no clinical test set with expert-established ground truth was reported.
4. Adjudication method for the test set:
Not applicable, as no clinical test set was reported.
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:
No MRMC study was reported. This device is a data management system, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device is a software application intended as a clinical data management system and decision support tool. It is inherently designed to manage and present data for human use. The "performance" described refers to its functional capabilities (e.g., data acquisition, display, calculation, remote access) rather than a standalone diagnostic or interpretive algorithm. The document states "The QS software and its environment have been extensively tested to meet its requirements and design," which implies standalone software functionality testing, but not in the context of a standalone clinical performance without human involvement in interpretation or decision-making.
7. The type of ground truth used:
Not applicable. For software and environmental testing, the "ground truth" would be the predefined functional and performance requirements of the software, verified through testing scenarios. No clinical ground truth (e.g., pathology, outcomes data, expert consensus on patient conditions) was used or reported in the context of clinical performance evaluation.
8. The sample size for the training set:
Not applicable, as no clinical training set was reported. This device does not appear to involve machine learning models that require a training set in the conventional sense.
9. How the ground truth for the training set was established:
Not applicable.
§ 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).