(707 days)
The Prostate Mechanical Imager (PMI) is indicated for the production of an elasticity image of the prostate as an aid in documenting prostate abnormalities that were previously identified by digital rectal examination (DRE). The device utilizes a transrectal probe with pressure sensor arrays and a motion tracking system and provides real-time elasticity images of the prostate. This device is limited to use as a documentation tool and therefore is not to be used for cancer diagnosis or for any other diagnostic purpose. This device is only to be used to image and document an abnormality that was already identified by DRE. Clinical management decisions are not to be made on the basis of information from the PMI device, but rather on the basis of the DRE. If there is disagreement between the DRE and the recorded image produced by the device, patient management decisions are to be based on the DRE and other available clinical and diagnostic information (e.g., prostate-specific antigen (PSA) levels) in accordance with standard medical practice.
The Prostate Mechanical Imager (PMI) is an electronic palpation device that is meant to mimic the digital rectal examination (DRE) by generating images of pressure patterns of the palpated prostate. The information provided by the device is characterized as being similar in nature to the information obtained from a standard DRE (i.e., determination of regions of relative tissue hardness within the prostate) with the utility being that the results are visually displayed and can be electronically saved, transmitted, and/or printed out for documenting in patient's medical records.
Here's a breakdown of the acceptance criteria and the study information for the Prostate Mechanical Imager (PMI), based on the provided text:
Prostate Mechanical Imager (PMI) Acceptance Criteria and Study Details
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical "acceptance criteria" for the device's imaging performance. Instead, it describes capabilities and outcomes. The primary acceptance criteria for this device, based on the Special Controls and Risks to Health sections, are related to its ability to consistently produce an accurate image, and its reproducibility, while ensuring safety and proper use.
| Acceptance Criteria Category | Specific Criterion (from Special Controls/Risks) | Reported Device Performance |
|---|---|---|
| Imaging Performance, Accuracy & Reproducibility | Accuracy of the constructed image | Bench Testing: |
- Initially designed and evaluated using soft tissue phantoms with hard inclusions, demonstrating detection of hard nodules.
- Comparison against manual palpation and pathology on 9 excised prostates showed PMI abnormalities correlated closely with palpated nodules and pathologyfindings.
- Performance testing on 24 prostate models (720 examinations across 5 operators/systems) demonstrated reliable visualization of abnormalities and production of nodule images in prostate models.
Clinical Study (Earlier Generation - 2006): - Sufficient for image reconstruction in 84% (141/168) of study cases.
Clinical Study (Latest Generation - 2009): - Capable of visualizing the prostate in 98% (55/56) of patients.
- Agreement between DRE and PMI determinations regarding the presence of an abnormality in 89% of cases. |
| | Reproducibility of the constructed image | Bench Testing: - Demonstrated reproducibility over time, inter-system reproducibility, and inter-operator reproducibility for generating a real-time digital image. |
| Safety and Usability (Indirectly related to imaging) | Electromagnetic Compatibility | Complies with IEC 60601-1-2 (edition 2.1, Amendment 1: 2004) and related immunity standards. |
| | Electrical Safety | Complies with IEC 60601-1 (1998: Amendment 1 and Amendment 2). |
| | Thermal Safety | Complies with IEC 60601-1 (1998: Amendment 1 and Amendment 2). |
| | Mechanical Safety | Complies with IEC 60601-1 (1998: Amendment 1 and Amendment 2). |
| | Biocompatibility | Probe sheath and lubricant are 510(k)-cleared; direct mucosal contact (
§ 876.2050 Prostate lesion documentation system.
(a)
Identification. A prostate lesion documentation system is a prescription device intended for use in producing an image of the prostate as an aid in documenting prostate abnormalities previously identified during a digital rectal examination. The device uses pressure sensors and image reconstruction software to produce a prostate image that highlights regional differences in intraprostatic tissue elasticity or stiffness. The device is limited to use as a documentation tool and is not intended for diagnostic purposes or for influencing any clinical decisions.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Non-clinical and clinical performance testing must demonstrate the accuracy and reproducibility of the constructed image.
(2) Appropriate analysis/testing must validate electromagnetic compatibility, electrical safety, thermal safety, and mechanical safety.
(3) Appropriate software verification, validation, and hazard analysis must be performed.
(4) All elements of the device that may contact the patient must be demonstrated to be biocompatible.
(5) Methods and instructions for reprocessing of any reusable components must be properly validated.
(6) The labeling must include specific information needed to ensure proper use of the device.