Search Results
Found 1 results
510(k) Data Aggregation
(29 days)
BEHAVIORAL TECHNOLOGY, INC.
The MONARCH 21 system's intended use is to measure sexual response to visual and auditory stimuli in male sexual offenders as an important part of evaluating individual treatment need and determining risk for recidivism.
MONARCH 21 Penile Plethysmograph consists of attached sensors, which measure penile tumescence. A laptop computer is used to store, tabulate, display and print out the acquired data.
The MONARCH 21 Penile Plethysmograph's acceptance criteria and the study proving it meets these criteria are described below:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state numerical acceptance criteria for the MONARCH 21 Penile Plethysmograph. Instead, it focuses on demonstrating substantial equivalence to a predicate device (CAT-600 Penile Plethysmograph, K936115) through functional testing. The "acceptance criterion" in this context is implicitly the successful mimicry of the predicate device's examination results, ensuring that differences do not diminish safety and effectiveness.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Mechanical, electrical safety, software testing demonstrates no diminution of safety and effectiveness compared to predicate. | Differences between MONARCH 21 and predicate devices were subjected to mechanical, electrical safety, software testing to demonstrate that they do not diminish safety and effectiveness. (General statement without specific metrics provided) |
| Penile sensors accurately measure full range of values. | A precision machined aluminum calibration cone with graduated circumference sizes was used to measure the penile sensors' full range of values. (Specific measurement results are not provided, only the method.) |
| Secondary agents tested using simulated equivalent values. | Secondary agents were tested using simulated equivalent values. (Specific results for these tests are not provided.) |
| All testing mimics prior predicate device examination, resulting in substantial equivalence. | All testing mimicked prior predicate device examination resulting in substantial equivalence. (This is the overarching conclusion of the non-clinical tests rather than specific performance metrics.) |
2. Sample Size Used for the Test Set and Data Provenance
The study described is a non-clinical, in-vitro validation for functional equivalence, not a clinical study involving human subjects or patient data.
- Sample Size: Not applicable. The "test set" consists of a precision machined aluminum calibration cone and "secondary agents" for in-vitro testing. No human data or patient samples were used.
- Data Provenance: Not applicable. The data is generated from laboratory testing of the device components (sensors, system functionality) using physical calibration tools and simulated values.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This was a non-clinical engineering and functional validation study. Ground truth was established by physical measurements and comparison to known values, not expert consensus.
4. Adjudication Method for the Test Set
Not applicable. As a non-clinical, in-vitro validation, there was no need for expert adjudication. The comparison was against expected physical measurements and the performance of the predicate device.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Affect Size of How Much Human Readers Improve with AI vs Without AI Assistance
No. An MRMC comparative effectiveness study was not done. The MONARCH 21 is a device to measure sexual response, not an AI-assisted diagnostic tool for human readers. It provides data for human interpretation but does not involve AI or "human readers" in the context of diagnostic image or signal interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the loop performance) Was Done
Yes, in essence. The "non-clinical test results" section describes standalone testing of the device's components and system functionality. This involved measuring the penile sensors' range of values using a calibration cone and testing secondary agents with simulated values. This testing assessed the device's intrinsic mechanical and electrical performance without human interpretation as part of the assessment.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, Etc.)
The ground truth used was based on physical measurement standards and simulated equivalent values.
- For sensor calibration: Known circumferences of a precision machined aluminum calibration cone.
- For secondary agents: Simulated equivalent values, implying comparison against predefined or calculated values.
- Overall: The performance of the predicate device (CAT-600 Penile Plethysmograph) served as a benchmark for demonstrating substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. The MONARCH 21 is a medical measurement device, not an AI or machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
Ask a specific question about this device
Page 1 of 1