(305 days)
The PROcedure Rehearsal Studio software is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a CT scanner to an output file. It is also intended as pre-operative software for simulating/evaluating surgical treatment options.
The Simbionix PROcedure Rehearsal Studio software allows clinicians to create a patient specific 3D anatomical model based on a patient's CT for the purpose of simulating, analyzing and evaluating for preoperative surgical treatment options. Once the 3D segmentation model has been exported to the Simbionix ANGIO Mentor Simulator Practice Environment, the physician can use it to create a library of modules for training and post operative debriefing.
Here's an analysis of the provided text regarding the acceptance criteria and study for the PROcedure Rehearsal Studio™ device, presented in the requested format:
It's important to note that the provided text is a 510(k) summary, which is a regulatory document. These summaries typically focus on demonstrating substantial equivalence to a predicate device rather than providing extensive details on a comprehensive clinical study with specific acceptance criteria and detailed performance metrics. As such, several requested pieces of information are not available in the provided document.
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
Summary: The PROcedure Rehearsal Studio™ device performance was validated through bench tests and phantom studies, demonstrating substantial equivalence to its predicate device, Mimics® by Materiallise N.V. (K073468). The primary claim is substantial equivalence, not a specific performance metric against a predefined numerical acceptance criterion.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (Mimics® K073468) | Device was found substantially equivalent to the Mimics® predicate device based on bench tests and phantom studies. |
| No new safety and/or effectiveness issues raised. | Simbionix Ltd. believes no new safety and/or effectiveness issues are raised. |
Note: The document does not specify quantitative acceptance criteria (e.g., specific accuracy, sensitivity, specificity thresholds) that the device had to meet. The acceptance was based on demonstrating equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): Not specified. The document only mentions "bench tests and phantom studies."
- Data Provenance: Not specified. "Bench tests and phantom studies" typically imply engineered test scenarios and physical models, not patient data from a specific country or retrospective/prospective collection.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not mentioned.
- Qualifications of Experts: Not mentioned.
4. Adjudication Method for the Test Set
- Adjudication Method: Not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No, an MRMC comparative effectiveness study is not mentioned. The validation involves comparison to a predicate device, not human reader performance.
- Effect Size of Human Readers with vs. without AI: Not applicable, as no MRMC study was performed.
6. Standalone Performance Study
- Was a standalone study done? Yes, the device's performance was evaluated independently through "bench tests and phantom studies" in comparison to the predicate device. This implies an algorithm-only (standalone) assessment of the software's ability to perform its intended functions (image segmentation, 3D model creation). The comparison to the predicate device itself is a form of standalone performance evaluation against an established benchmark.
7. Type of Ground Truth Used for the Test Set
- Type of Ground Truth: Implied to be engineered "ground truth" models within "bench tests and phantom studies." This would likely involve phantoms with known anatomical structures and precise measurements against which the device's segmentation and 3D model generation capabilities could be compared. It is not expert consensus, pathology, or outcomes data in the traditional clinical sense.
8. Sample Size for the Training Set
- Sample Size (Training Set): Not mentioned. The document primarily focuses on validation for regulatory clearance, not detailed algorithm development.
9. How Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not mentioned. The document does not provide details on the algorithm's training process or how ground truth for any potential training data was established.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).