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510(k) Data Aggregation
(147 days)
11 Health Technologies Limited
SmartBag is intended for use inside and out of hospitals for any patient with a diversionary urinary or fecal stoma. It works in conjunction with 11 Health's care management platform known as Alfred. The SmartBag system uses integrated sensors to continuously monitor bag filling and drainage, providing cumulative output data to the patient and clinical team. The system also monitors skin condition, the occurrence of leaks and visual condition of the stoma.
SmartBag's intended use is to help ostomates acclimate to their lifestyle. It works in conjunction with 11 Health's care management platform known as Alfred, designed for patients and medical professionals. The SmartBag system (including the wafer and Hub), offers a continuous ostomy monitoring system, tracks the estimated volumetric filling of the bag and visual condition of the stoma using integrated sensor technology.
The SmartBag Sytem is for adult use only. (22 years and above)
The SmartBag with integrated thermistors and capacitive sensors can be used in place of a traditional ostomy bag. It notifies patients or medical professionals of any potential leaks around the peristomal skin as well as giving an estimate of the output volume within the bag.
Alfred software is a companion software suite for SmartBag. It consists of Alfred mobile app and Alfred hospital app. Alfred mobile app is a companion application for mobile phone. The application provides SmartBag user easy access to bag status, hydration tracking and restroom search functionalities. The SmartBag could operate without Alfred mobile app.
The sensors in the bag and the wafer will be able to transmit data to the hub via NFC protocol communication. The data from the hub will be transmitted to the cloud via LTE-M data transfer via secure MQTT protocol and then this data can be downloaded to web supported devices – such as an iPhone.
The provided text is a 510(k) summary for the SmartBag (SmartPouch) device. While it describes the device's indications for use, comparison to predicate devices, and non-clinical performance data, it does not contain a table of acceptance criteria or a detailed study proving the device meets such criteria in terms of performance metrics like accuracy, sensitivity, or specificity against a defined ground truth on a test set.
The document primarily focuses on demonstrating the functionality and usability of the device's volumetric and leakage detection features through a series of bench experiments and simulations. It concludes that the SmartBag prototype is "proven to be functional for volumetric measurement and leakage detection from our simulated bench tests."
Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes for test and training sets, expert involvement for ground truth, adjudication methods, MRMC studies, or standalone performance. The document does not describe a clinical study with these elements.
However, I can extract information about the types of non-clinical tests performed, which could be considered a form of "acceptance criteria demonstration" for basic functionality:
Non-Clinical Performance Data (Functionality Testing):
| Acceptance Criteria (Implied Functionality) | Reported Device Performance (Conclusion) |
|---|---|
| Volumetric Sensor Sheet Functionality: | The volumetric sensor sheet is capable of: |
| Ability to detect dynamic simulated infusions. | - Detecting dynamic simulated infusions |
| Ability to detect static volume of infused materials. | - Detecting static volume of infused materials |
| Ability to recognize different viscosities of simulated infusions. | - Recognizing different viscosities of the simulated infusions |
| Ability to measure volume in different body positions (standing/supine). | - Measure volume of the simulated infusions when user is in standing or supine positions |
| Ability to measure volume in high heat environments (close to infusion temp). | - Measure volume of the simulated infusions when the environment temperature is close to infusion temperature, with the aid of capacitors |
| Wafer Sensor Sheet Functionality: | The wafer sensor sheet is capable to: |
| Ability to detect simulated leakage with correct log interval. | - Detect simulated leakage with the correct log interval |
| Durability and functionality after saturation in water at 37°C for 7 days. | - Remain durable and functional after 7 days of saturation in 37 °C water bath |
| Overall functionality: | Consequently, the SmartBag prototype is proven to be functional for volumetric measurement and leakage detection from our simulated bench tests. (Note: These are functional conclusions, not quantitative performance metrics like accuracy or sensitivity percentages). |
Here's why the other requested information cannot be provided from this document:
- Sample size for the test set and data provenance: The document details "in-house non-clinical bench experiments" and "simulated" tests, some on "human volunteers." It doesn't specify a rigorous, statistically powered "test set" in the context of typical AI/medical device clinical studies (where cases are adjudicated against a ground truth). It refers to test reports like "028_Testing Report 3_SmartBag Prototype Water and Apple Infusion Simulation Test," suggesting a focus on engineering verification rather than clinical validation. The provenance is "in-house."
- Number of experts and qualifications, adjudication method: Not applicable as the testing described is primarily engineering bench testing and simulation, not expert-adjudicated clinical data.
- Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned or implied. The device's primary function is continuous monitoring and data collection, not an AI assisting human readers with interpreting medical images or data for diagnostic purposes in a comparative setting.
- Standalone (algorithm only) performance: While the device collects data autonomously, the "performance" described is functional operation in simulated environments rather than a quantifiable diagnostic or predictive accuracy.
- Type of ground truth used: The "ground truth" for these tests appears to be the known conditions of the simulations (e.g., specific volumes of fluid infused, presence/absence of simulated leaks, known temperatures, known viscosities). It's not a clinical ground truth like pathology or patient outcomes.
- Sample size for the training set and how ground truth for training was established: The document does not describe a machine learning model that was "trained" in the typical sense with a separate dataset. The "sensors" and "algorithms" (implicitly) seem to be based on physical principles and engineering design, not data-driven machine learning from a large training dataset.
In summary, this 510(k) summary focuses on demonstrating the engineering functionality and safety of the SmartBag device through non-clinical bench tests and simulations, rather than providing clinical performance data from a statistically designed study involving ground truth established by experts.
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