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The Quantitative Sentinel (QS) System's is intended for automatic patient data management. It does this by:

• (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).

• (b) interfacing with other hospital information systems and medical devices for automatic data acquisition, viewing and storage with the electronic patient record.

• (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.

• (d) providing Spectra Alerts capabilities for fetal monitoring (surveillance).

• (e) providing automatic computations of physiologic indexes (e.g. nutrition).

• (f) providing calculations from user defined formulas (i.e. index calculator).

• (g) providing the ability to record, with the patient record, fluid input and oulput information that is defined by the user.

• (h) providing the ability to export patient data to relational databases for research and Quality Assurance purposes.

• (i) providing the ability to archive files to a secondary or tertiary storage medium (i.e. optical disk).

• (i) providing the ability to print (locally or remotely) patient records and QS database definition (e.g. item names)

• (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

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.

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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 OS System serves as a decision support tool as well as an electronic medical record.

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 OS 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.

This document does not contain the requested information regarding acceptance criteria and a study proving the device meets those criteria.

Instead, the provided text is a 510(k) summary for the Quantitative Sentinel System 7.0, describing its intended use, comparison to predicate devices, and asserting that no clinical testing was necessary to demonstrate conformity to performance requirements.

Therefore, I cannot populate the table or answer the specific questions about sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, or ground truth establishment.

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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.

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.

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