(139 days)
SIM™ (Smart Incontinence Management) is indicated for use by healthcare professionals to remotely monitor wetness events, and collect, transmit and report wetness events and other medical information from multiple patients within a clinical setting (e.g., hospitals, skilled nursing facilities, residential care facilities), to establish effective management care plans for continence events.
SIM™ consists of disposable incontinence pads with embedded sensors, a wireless transceiver, hardware, and software.
The provided text does not contain information regarding specific acceptance criteria for device performance or a detailed study proving the device meets said criteria in the format requested. The document is a 510(k) summary for the Simavita SIM™ System, which outlines the device's substantial equivalence to a predicate device and its intended use, but does not provide quantitative performance metrics or a detailed study description with ground truth and expert involvement.
Here's a breakdown of what is and is not available in the provided text, based on your request:
1. Table of Acceptance Criteria and Reported Device Performance:
- Not available. The document states that "SIM™ was subjected to biocompatibility testing, electrical safety and electromagnetic safety testing, standard testing for electrical equipment intended for measurement purposes, safety testing for information technology equipment, and other relevant performance testing. In all instances, SIM™ functioned as intended and the results observed were as expected." However, it does not provide specific acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or quantitative performance results for the device's primary function of monitoring wetness events.
2. Sample size used for the test set and the data provenance:
- Not available. The document states "SIM™ functioned as intended and the results observed were as expected" for various tests, but it does not specify any sample sizes for these tests, nor does it mention data provenance (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not available. There is no mention of a test set requiring expert-established ground truth for performance evaluation of the wetness monitoring function. The reported testing focuses on safety and general functionality.
4. Adjudication method for the test set:
- Not available. This information is typically relevant when multiple experts are involved in establishing ground truth or reviewing cases, which is not described here.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size:
- Not available. The document does not describe any MRMC study or an assessment of human reader improvement with or without AI assistance. This device is an "Enuresis Alarm" for remote monitoring of wetness, not a diagnostic imaging AI system that typically involves human readers in an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not available in the sense of a detailed performance study. The device's function is standalone in terms of detecting wetness events, but the document doesn't provide a rigorous, quantitative standalone performance study with metrics like sensitivity, specificity, etc. It only states that the device "functioned as intended."
7. The type of ground truth used:
- Not explicitly stated for the core function of wetness detection. For the safety and electrical performance tests, the "ground truth" would be established by the adherence to regulatory standards and expected performance. However, for the primary function of wetness detection, no specific ground truth methodology (e.g., actual wetness measured by a different method, expert observation) is described in the provided text.
8. The sample size for the training set:
- Not applicable/Not available. The document describes a medical device for wetness monitoring, not an AI/machine learning system that typically requires a training set of data.
9. How the ground truth for the training set was established:
- Not applicable/Not available. As above, this is not relevant for the type of device and information provided in the 510(k) summary.
In summary, the provided 510(k) summary for the Simavita SIM™ System focuses on establishing substantial equivalence to a predicate device based on intended use, technological characteristics, and general safety/performance testing that "functioned as intended." It does not include the detailed quantitative performance metrics, study designs (e.g., sample sizes, expert involvement, ground truth methodologies), or comparative effectiveness studies that your request pertains to.
§ 876.2040 Enuresis alarm.
(a)
Identification. An enuresis alarm is a device intended for use in treatment of bedwetting. Through an electrical trigger mechanism, the device sounds an alarm when a small quantity of urine is detected on a sensing pad. This generic type of device includes conditioned response enuresis alarms.(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 § 876.9.