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510(k) Data Aggregation
(134 days)
ProBx Software is intended for use as follows:
· ProBx Software is a computer-based image-guidance accessory intended for use in conjunction with commercially available Magnetic Resonance Imaging (MRI) systems and interventional devices.
· ProBx Software helps physicians guide biopsy instrumentation to targets that have been defined by the physician in MRI. The Software provides the clinician with image analysis and display of pre-procedural MRI images of tracked accessory hardware and the target organs, along with the projected path to the Software displays an MRI image of the current location of the interventional instrument for positioning confirmation.
· ProBx Software is intended to be used by physicians in a clinical setting for treatment planning and guidance for clinical, interventional, and/or diagnostic procedures of the prostate.
ProBx Software along with ProBx Hardware accessories is used for in-bore Magnetic Resonance Imaging (MRI) guided interventional and diagnostic procedures of the prostate. The ProBx Software is intended to be loaded onto a commercially available workstation and used as an accessory to commercially available MRI systems. The software receives pre-procedural and intra-procedural DICOM images and provides 2D and 3D visualization for treatment planning. The Software performs calculations on user-selected target locations to assist the clinician in manually utilizing the tracked accessory hardware to reach targets. The Software also provides MRI scan confirmation of positioning during the procedure.
Here's a breakdown of the acceptance criteria and study information for the ProBx Software, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Metric | Reported Device Performance | Notes |
|---|---|---|
| Needle Placement Accuracy (End-to-End) | 1.88 mm | This was demonstrated in a simulated clinical use phantom study. It was compared against the published accuracy of the predicate device (DynaCAD). |
| Non-inferiority to predicate device (DynaCAD) in needle placement accuracy | Demonstrated non-inferiority | The reported 1.88 mm accuracy for ProBx Software was considered non-inferior to the published end-to-end needle placement accuracy of DynaCAD. Specific numerical value for DynaCAD's published accuracy is not provided in this document, but the statement implies ProBx met or exceeded a benchmark set by the predicate. |
| Fiducial Registration Technique Validation | Validated | Bench testing was performed using "acceptable scientific methods" for this validation. No specific quantitative metric or target is provided beyond "validated." |
| Software Verification and Validation Testing | Successful (functions as intended) | This general criterion is stated to have supported the proposed indications for use and that the software functions as intended when used with ProBx Hardware accessories for prostate interventional procedures. No specific quantitative metrics for V&V tests are detailed in this summary, beyond the needle placement accuracy. |
| Compliance with referenced standards: |
- ISO 15223-1:2016
- ISO 14971:2007
- IEC 62304:2006 | Device designed and developed in accordance with these standards | The device was developed referencing these standards, indicating compliance with general medical device and software development best practices. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Bench testing" and a "simulated clinical use phantom study."
- Test Set Description: Phantom study.
- Sample Size: Not explicitly stated. The number of phantom procedures or measurements taken during the "simulated clinical use phantom study" is not provided.
- Data Provenance: This was an internal "preclinical software verification and validation testing" using a phantom. It is therefore retrospective in the sense that it's based on controlled lab testing, not real patient data. The country of origin for the data is not specified but is implied to be within the company's testing facilities (Harmonus, Inc., likely in Massachusetts, USA).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
It is common for phantom studies to use pre-defined, known values (ground truth) established by engineering or physics principles, rather than human expert consensus for a test set. In this case, the ground truth for needle placement accuracy would likely be the precisely known target location within the phantom as defined during its design. The process of setting up and performing the phantom study would be conducted by trained technical personnel, but these are not "experts" in the clinical sense of establishing a medical ground truth.
4. Adjudication Method for the Test Set
Not applicable. As a phantom study, ground truth is based on known physical parameters, not human interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The study described is a preclinical phantom study focused on technical accuracy. The comparison to the predicate device (DynaCAD) is based on "published end-to-end needle placement accuracy" of DynaCAD, not a direct comparative clinical study involving human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the described "simulated clinical use phantom study" that validated end-to-end needle placement accuracy of 1.88 mm is a form of standalone performance evaluation. While a human operator would manipulate the interventional hardware, the performance metric (accuracy) is a direct measure of the system's ability (software + hardware) to guide to a target, effectively evaluating the algorithm's guidance without comparing it to unassisted human performance or analyzing human interpretation.
7. The Type of Ground Truth Used
The ground truth used for the phantom study assessing needle placement accuracy would be the known physical coordinates of the target within the phantom. This is an objective, precisely defined ground truth.
8. The Sample Size for the Training Set
The document does not mention a training set or any deep learning/machine learning components that would typically require one. The ProBx Software is described as an "image-guidance accessory" that "performs calculations on user-selected target locations." This suggests a rule-based or calculational software rather than one heavily relying on machine learning that would necessitate a large training dataset.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned or implied, this question is not applicable.
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