Search Results

The Seager Model Electroejaculator (EE) is intended to induce seminal emission in patients for whom prior or present illness precludes their ability to spontaneously ejaculate. The EE device is indicated for use in neurologically impaired males who are 18 yrs. and anejaculatory due to the following conditions:

Spinal Cord Injury (paralysis)

Retroperitoneal Lymph Node Dissection (RPLND) [surgical therapy post testicular cancer]

Idiopathic (neuropsychosis/psychogenic)

Diabetes

Spina Bifida

Pelvic Surgery Complications

Multiple Sclerosis (MS)

Neurological Impairments

The EE device is contraindicated in the following individuals:

Chron's Disease

Ulcerative Colitis

Rectal cancer or other significant rectal pathology

Patients with pacemakers or other artificial heart device

The Seager EE device consists of a power unit and rectal probe which is designed to provide low level (5-10 volts) electrical stimulation. The rectal probes vary in diameter from 1 inch to 1 5/16 inches. Prior to the procedure, a rectal exam is performed to determine the correct probe size and assure that the rectal mucosa are not compromised. For spinal cord injured patients with lesions at T-6 or above, or patients at risk of dysreflexia (elevated blood pressure), this may be controlled with appropriate medication (e.g. Procardia; nitrogylcerine). For non spinal cord injured patients whose lesion may be Incomplete, short general anesthesia (GA) may be administered.

The rectal probe is inserted into the rectum and a series of low level electrical stimulations are delivered to the prostate gland and seminal vesicles. Once the patient begins to ejaculate (usually after 5 to 10 stimulations), additional stimulations (10 to 12) are applied to obtain the entire ejaculate volume. During the procedure, patient comfort and blood pressure are monitored. If blood pressure increases above 180 systolic and/or 120 diastolic, the procedure is halted until pressures return to normal and the patient wishes to continue. After discontinuation of rectal stimulation, blood pressure is monitored until it returns to normal physiological levels. Following the procedure, the rectal mucosa is re-examined to assess any changes from pre-stimulation.

The rectal probe, which comes into short-term (3-5 minutes) contact with the rectal mucosa, is manufactured from medical grade (306) stainless steel electrodes embedded in a polyvinylchloride (grade 6 PVC) substrate.

Acceptance Criteria and Study for Seager Electroejaculator

This document outlines the acceptance criteria for the Seager Electroejaculator (EE) and details the clinical study performed to demonstrate its safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for the Test Set

• Sample Size: A total of 403 subjects participated in the clinical investigation.
  • 346 (85.9%) were spinal cord injured (SCI).
  • 57 (14.1%) were non-spinal cord injured (non-SCI).
• Data Provenance: The study was a multi-center clinical investigation conducted at 13 sites in the US. It was a prospective, single-arm non-randomized study.

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly state the exact number or specific qualifications of experts involved in establishing the ground truth for the test set beyond the general oversight of medical professionals at the 13 clinical sites. However, the study involved monitoring patient comfort, blood pressure, and conducting rectal exams by presumably qualified medical professionals. "Clinically significant changes" and "medical complications" would have been determined by these professionals.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method (e.g., 2+1, 3+1). The "ground truth" for effectiveness (successful ejaculation) was an objective observation (production of ejaculate). For safety, "clinically significant changes" and "no adverse events" were reported, suggesting assessment by the attending medical staff at each site. There is no mention of an independent, centralized adjudication committee.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study focuses on the standalone performance of the device in eliciting ejaculation, not on comparing human readers' performance with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone study was conducted. The clinical investigation directly assessed the performance of the Seager EE device in inducing ejaculation in anejaculatory males, without the implication of human interpretation being part of the algorithmic output or a human-in-the-loop interaction for the device to function. The "algorithm" here is the device's electrical stimulation process.

7. Type of Ground Truth Used

The ground truth used was primarily objective clinical observation and diagnostic assessment:

• Effectiveness: Direct observation of the production of ejaculate.
• Safety:
  • Measurement of blood pressure compared to physiological ranges.
  • Visual assessment through rectal examinations for changes from baseline.
  • Reporting of any adverse events or medical complications.

8. Sample Size for the Training Set

The document does not specify a separate training set for the device. The "training" or development of the electroejaculation technique was based on extensive historical research and animal studies:

• Studies in animals (e.g., Francois et al., 1975; Seager et al., 1984 with 12 monkeys).
• Prior research with over 100 species of animals (Seager, Wildt & Platz, 1980; Seager, 1983).
• Human studies (e.g., Horne et al., 1948; Brindley, 1980-1984) contributing to the refinement of the technique.

The 403 subjects in the multi-center clinical investigation appear to be the primary dataset for validating the final device. This suggests a traditional medical device validation paradigm rather than a machine learning approach with distinct training and test sets from the same population.

9. How the Ground Truth for the Training Set Was Established

As noted above, a distinct "training set" in the machine learning sense is not explicitly described. However, the development and refinement of the electroejaculation technique (analogous to "training" a methodology) relied on observed outcomes from historical studies and animal models:

• Successful ejaculation in animals and early human trials.
• Observations of electrode positioning, stimulation parameters, equipment, and safety issues from Brindley's work and other researchers.
• Assessment of rectal mucosa effects and overall safety in animal models (e.g., Seager et al., 1984, in monkeys, through autopsy studies and examination of tissue samples for abnormalities).

The "ground truth" for refining the technique involved direct observation of ejaculation, physiological responses, and pathological examination in pre-clinical and early clinical investigations.

Ask a specific question about this device