(102 days)
The intended use for the Hill-Rom Wireless Connectivity Module is to assist clinical staff to monitor bed parameters on specific Hill-Rom beds. The Hill-Rom Wireless Connectivity Module is intended to be used only with specifically enabled Hill-Rom beds that have been verified and validated with the Hill-Rom Wireless Connectivity Module, and is not intended to provide bed status information for non-Hill-Rom beds. The Hill- Rom Wireless Connectivity Module is not intended to permanently store any type of data. The Hill-Rom Wireless Connectivity Module is not intended to provide automated treatment decisions or as a substitute for professional healthcare judgment. The Hill- Rom Wireless Connectivity Module is not a replacement or substitute for existing alert equipment. All patient medical diagnosis and treatment are to be performed under direct supervision and oversight of an appropriate health care professional.
The Hill-Rom Wireless Connectivity Module is a wireless module installed on specific Hill-Rom bed models. The Hill-Rom Wireless Connectivity Module is integrated into existing bed platforms via a USB connection to the bed's electrical system and provides connectivity to a remote server application.
The Hill-Rom Wireless Connectivity Module is used to assist staff to monitor hospital bed status and to assist the healthcare provider in providing patient care. The optional feature is mounted onto Hill-Rom hospital beds to wirelessly transmit bed information such as: bed exit status, bed side rail status, bed brake status, head of bed angle, and patient weight from bed scale. The Hill-Rom Wireless Connectivity Module is a tool that facilitates the wireless transmission of the bed status data using a wireless hardware and software device which communicates with a remote server in the hospital. The bed status data may be displayed at user-defined locations, such as nursing stations. It may also be shared with EMR (Electronic Medical Record) Systems through integration with 3rd party systems.
This document describes regulatory approval for a medical device called the "Hill-Rom Wireless Connectivity Module," which is a wireless module installed on specific Hill-Rom bed models to transmit bed parameters to a remote server. The information provided is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with acceptance criteria for device performance in a diagnostic or clinical decision-making context.
Therefore, the requested information cannot be fully provided as the device is not an AI/ML algorithm or a diagnostic tool that would typically undergo such a rigorous performance study. The submission focuses on regulatory compliance, safety, and functionality.
Here's an attempt to answer the questions based on the provided document, highlighting where the requested information is not applicable or not explicitly stated:
1. A table of acceptance criteria and the reported device performance
This document does not provide acceptance criteria and reported performance in the typical sense for a diagnostic device or AI algorithm (e.g., sensitivity, specificity, AUC). Instead, the "performance" is assessed against compliance with international standards for electromagnetic compatibility and usability engineering.
| Acceptance Criteria Category (Implied) | Reported Device Performance |
|---|---|
| Functional & Performance | Meets specifications |
| Safety | Meets specifications |
| Efficacy | Meets specifications |
| Electromagnetic Immunity | Compliant with EN 55024:2010 |
| Radio Disturbance | Compliant with EN 55022:2010 |
| Usability Engineering | Compliant with IEC 62366:2007/(R)2013 |
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. This device is a hardware module for transmitting existing bed data, not a diagnostic or AI algorithm requiring a test set of patient data. The testing mentioned refers to hardware and software verification and validation, and compliance with standards. No information regarding patient-specific data provenance or sample size for a test set is provided as it's not relevant to this type of device submission.
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 explained above, there is no "test set" in the context of diagnostic performance requiring ground truth established by medical experts for this device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no test set requiring ground truth adjudication by experts for this device.
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 wireless connectivity module for monitoring bed parameters, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance would not be relevant or performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a hardware module that transmits data. It does not perform an "algorithm only" task in the sense of an AI model making diagnostic predictions. Its function is to communicate existing bed status data wirelessly.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the typical sense for a diagnostic device. The "ground truth" for this device would be the actual state of the bed parameters (e.g., bed exit status, side rail status, brake status, head of bed angle, patient weight) as measured inherently by the bed's sensors. The device's performance would be validated by ensuring it accurately transmits these existing bed status data points. The document states "The Wireless Connectivity Module communicates existing bed status data. Clinical testing was therefore not required for determination of substantial equivalence as there is no new data involved in the wireless communication..." This implies the "ground truth" is the direct measurement from the bed itself.
8. The sample size for the training set
Not applicable. This device is not an AI/ML algorithm that is "trained" on a dataset.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI/ML algorithm requiring a training set with established ground truth.
§ 890.5170 Powered flotation therapy bed.
(a)
Identification. A powered flotation therapy bed is a device that is equipped with a mattress that contains a large volume of constantly moving water, air, mud, or sand. It is intended for medical purposes to treat or prevent a patient's bedsores, to treat severe or extensive burns, or to aid circulation. The mattress may be electrically heated.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.