(262 days)
The proposed product, Hughes Bowel and Bladder System Model MeD-18, is an enuresis alarm, a device to detect urine and/or feces and to set off a vibratory alarm when detected, that may be used by an ambulatory adult to assist in the control of incontinence.
Hughes Bowel and Madder System model MeD-18 helps persons with incontinence manage of overcome bladder control problems by providing them with a private alarm system to detect when uncontrolled urination or excretion begins.
Hughes Bowel and Bladder System, model MeD-18, assists in controlling incontinence so that the wearer can manage their comditon promptly and with complete discretion at the first sign of bladder or bowel release day or night.
The proposed product, Hughes Bowel and Bladder System Model MeD-18, is an enuresis alarm, a device to detect urine and/or feces and to set off a vibratory alarm when detected, that may be used by an ambulatory adult to assist in the control of incontinence.
The device functions with a pager-like motor that vibrates to inform the wearer of urine / feces spillage.
The provided document is a 510(k) summary for the Hughes Bowel and Bladder System Model MeD-18. This document, primarily from 1997, is concerned with establishing substantial equivalence to a predicate device for regulatory clearance, rather than detailing a clinical study with acceptance criteria and performance metrics in the way a modern AI/ML device submission would.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and comparative effectiveness studies is not present in the provided text. The device described is a physical enuresis alarm, not an AI/ML diagnostic or predictive device.
The document states:
- The device is an "enuresis alarm, a device to detect urine and/or feces and to set off a vibratory alarm when detected..."
- It "helps persons with incontinence manage or overcome bladder control problems by providing them with a private alarm system to detect when uncontrolled urination or excretion begins."
- It "functions with a pager-like motor that vibrates to inform the wearer of urine / feces spillage."
This type of device would typically rely on engineering specifications for its components (e.g., sensor sensitivity, vibration motor reliability, battery life, material biocompatibility, electromagnetic compatibility) and perhaps user studies for usability and effectiveness in real-world scenarios. However, none of these details are available in the provided FDA 510(k) summary.
In summary, the provided text does not contain the information necessary to describe acceptance criteria and associated study details as requested for an AI/ML device.
§ 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.