(241 days)
The Detrusan 500 Incontinence Treatment System is indicated for acute, ongoing or chronic treatment of Urge. Stress, or Mixed Urinary Incontinence. The System is indicated to improve urethral sphincter closure, strengthen of the pelvic floor and inhibition of the detruser muscle through reflexive mechanisms.
Detrusan 500 incontinence Therapy system comes with the external electric stimulator unit and vaginal and anal electrodes (Probes made by "Laborie Medical Technologies") Vaginal Probes K 990041 Anal Probes K 993721 Approved by FDA. Detrusan 500 is a Main net powered electrical stimulator, which provides output stimulus to the probes. The Device can be adjusted to deliver AC voltages in the range up to 30 Volts. The current is depended on the resistor of the patient as standard measuring level at 500 Ohm- 60 mA limited by hardware and software up to 80 mA. Frequencies are adjustable 1 to 100 Hz The pulse width is adjustable 10 to 400 us. 12 preprogrammed follow-ups and frequencies as well as pulse width adjustments are available by calling program number. The Device is constant Voltage stabilized.
The provided text does not contain information about acceptance criteria for a device, nor does it describe a study proving the device meets acceptance criteria in the manner typically expected for medical device evaluations involving performance metrics, clinical trials, or expert assessments.
Instead, the document is a 510(k) premarket notification for the "DETRUSAN 500 Incontinence Therapy System." It focuses on demonstrating substantial equivalence to a predicate device (K994109) rather than presenting new clinical study data with specific acceptance criteria and performance outcomes.
Here's a breakdown of why the requested information cannot be extracted from this document:
- No Acceptance Criteria or Reported Device Performance Table: The document compares the technological characteristics of the Detrusan 500 to a predicate device. This comparison focuses on technical specifications (e.g., voltage, frequency, pulse width) and intended use, not on predefined acceptance criteria for clinical efficacy or diagnostic accuracy, which would typically involve metrics like sensitivity, specificity, accuracy, or symptom improvement rates.
- No Sample Sizes, Data Provenance, Expert Information, or Adjudication Method for a Test Set: Since there is no described study to prove efficacy against acceptance criteria, there's no mention of a test set, its sample size, data origin, the number or qualifications of experts, or any adjudication method. The document is a technical comparison for regulatory submission.
- No Multi-Reader Multi-Case (MRMC) or Standalone Study: The document does not describe either a MRMC comparative effectiveness study or a standalone algorithm-only study. It's a premarket notification for a physical therapeutic device, not an AI or diagnostic imaging device that would typically undergo such studies.
- No Ground Truth Type: As there's no study described for performance evaluation, there's no mention of the type of ground truth used (e.g., pathology, outcomes data). The "ground truth" in this context would generally refer to a physician's diagnosis of incontinence, which the device treats, but the document doesn't detail how the device's effectiveness is measured against such a truth.
- No Training Set Sample Size or Ground Truth Establishment for Training Set: The Detrusan 500 is an electrical stimulator, not a machine learning model. Therefore, there is no "training set" in the sense of data used to train an algorithm. The device has preprogrammed follow-ups and frequencies, which are likely based on established physiological principles and previous clinical experience with similar devices, rather than a machine learning training process.
In summary, this document is a regulatory submission demonstrating substantial equivalence based on technological characteristics and intended use. It does not provide the details of a study that establishes acceptance criteria and proves device performance against those criteria in the way your request describes for a typical performance evaluation study.
§ 876.5320 Nonimplanted electrical continence device.
(a)
Identification. A nonimplanted electrical continence device is a device that consists of a pair of electrodes on a plug or a pessary that are connected by an electrical cable to a battery-powered pulse source. The plug or pessary is inserted into the rectum or into the vagina and used to stimulate the muscles of the pelvic floor to maintain urinary or fecal continence. When necessary, the plug or pessary may be removed by the user. This device excludes an AC-powered nonimplanted electrical continence device and the powered vaginal muscle stimulator for therapeutic use (§ 884.5940).(b)
Classification. Class II (performance standards).