(138 days)
The EarlySense Central Display System is intended to provide remote central monitoring and display of information as recorded by multiple EarlySense bedside units, on a central remote screen. The system can be used in hospital type and clinic environment.
The EarlySense Central Display System (CDS) is a system which includes EarlySense developed application software, installed on standard off-the-shelf PC computer with a computer screen. The system also uses standard off-the shelf communication and IT hardware.
The CDS is intended to communicate with multiple EarlySense Bedside monitoring devices (cleared as K131379 and K120465), in order to display the information as it is monitored on the bedside units on a central remote screen. The users can access the user interface of the individual bedside units via the CDS's screen and view or adjust bedside units' parameters, e.g. change settable parameters, such as alert thresholds.
The communication is performed through TCP/IP protocol, either via standard wired or via wireless LAN communication. The transmitted information from Bedside Unit to CDS and backwards includes alert information and physiological parameters (such as patient in / out of bed status, heart rate, respiration rate, motion rate and Sp02, if monitored at bedside unit, as well as room and bed number, etc.). The CDS can also format the alert information as obtained from Bedside units into a message that can be transmitted to external devices that can communicate with the CDS via standard TCP/IP port. In addition, a possibility to remotely view the CDS screen from a tablet or additional PC computer exists.
The accessories that can be possibly used with CDS system include:
- . Computer Screen
- . Keyboard and mouse
- Additional hallway LCD/LED screen .
- . External communication devices, like: pagers, etc.
- Tablet or additional PC computer (to remotely view the CDS computer . screen)
The provided text describes the EarlySense Central Display System (CDS) and its substantial equivalence to predicate devices, but it does not contain the detailed information necessary to answer most of the questions about acceptance criteria and a specific study proving the device meets those criteria.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than a detailed report of a performance study with specific acceptance criteria.
Here's what can be extracted and what is missing:
1. Table of acceptance criteria and the reported device performance:
This information is not provided in the document. The document states that the modified EarlySense CDS System was subject to "the whole range of verification and validation tests," including:
- Risk analysis
- Software Verification and Validation
- Performance Bench Testing
However, it does not specify what the acceptance criteria for these tests were, nor does it present the actual performance results in relation to such criteria. The conclusion simply states that the non-clinical tests demonstrate the device is "as safe, as effective, and performs as well as or better than the predicate devices."
Regarding a specific study proving the device meets acceptance criteria:
The document mentions "Performance Bench Testing" but provides no details on its methodology, sample size, or specific outcomes.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The document mentions "Performance Bench Testing" but does not detail the sample size or data provenance.
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)
This information is not provided. The mention of "Performance Bench Testing" does not include details on how ground truth was established or by whom. The device is a central display system for physiological parameters, not an AI diagnostic device that typically requires expert-established ground truth in the same way.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
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
This information is not provided. The device is a central display system for monitoring, not an AI for interpretation or assisting human readers in a diagnostic task that would typically warrant a MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document implies "Performance Bench Testing" was done for the software algorithm as part of the system. The device itself is essentially a standalone software application displaying data from other bedside units. However, specific details of this testing (e.g., how "standalone" was measured) are not provided. The comparison is made against predicate devices which are also central display systems, implying a functional comparison rather than a human-in-the-loop versus algorithm-only comparison.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not provided. For a central display system, the "ground truth" for performance testing would likely involve ensuring accurate transmission and display of physiological parameters from the bedside units. This would typically be verified against the direct output of the bedside units or simulated data, rather than expert consensus or pathology.
8. The sample size for the training set
This information is not provided. The device is described as a software application that displays data from other units and allows for parameter adjustment. It does not appear to be an AI/ML device that requires a "training set" in the conventional sense for learning patterns or making predictions. It's a display and control interface.
9. How the ground truth for the training set was established
This information is not provided and is likely not applicable, as the device is not described as an AI/ML system requiring a training set with established ground truth.
Summary of what is present:
- Device Description: The EarlySense Central Display System (CDS) is a software application installed on standard off-the-shelf PC hardware. It communicates with multiple EarlySense Bedside monitoring devices to remotely display physiological information (heart rate, respiration rate, motion rate, SpO2, in/out of bed status, etc.) and allows remote adjustment of bedside unit parameters.
- Purpose of Review: This is a 510(k) premarket notification for an updated software version (1.1.2.2) of the CDS, demonstrating substantial equivalence to predicate devices (EarlySense Central Display Station, K121885, and Connex Central Station, K132807).
- Performance Data Mentioned: The system underwent Risk analysis, Software Verification and Validation, and Performance Bench Testing.
- Conclusion: Non-clinical tests demonstrate the device is "as safe, as effective, and performs as well as or better than the predicate devices."
The document focuses on the regulatory pathway of substantial equivalence rather than a detailed scientific and clinical performance study report.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).