(550 days)
Molecular Flow Simulations is designed as a planning system for pre- and intra-operative planning of stereotactic or image-guided surgeries. It is specially designed to display anatomical images of a patient acquired with magnetic resonance (MR) or computed tomography (CT) scanners as well as images derived from diffusion tensor imaging (DTI) data acquired with MR. Molecular Flow Simulations is a dedicated tool for planning trajectories of intracranial catheters. Guidelines for the catheter placement, such as from catheter suppliers, can be visualized and displayed to support the surgeon in improving catheter placement planning. The guidelines, in combination with anatomical information, can be used to suggest areas that are compliant with the guidelines. Molecular Flow Simulations does not generate or create rules for the placement of intracranial catheters by any means. Molecular Flow Simulations uses MR-DTI and T2- weighted MR images to suggest likely volumes of fluid distribution.
The primary mode of action for Molecular Flow Simulations is a device for creating stereotactic or image-guided surgical plans, especially for the creation of plans for the placement of intracranial catheters.
Molecular Flow Simulations is a software tool running on a standard, standalone computer (PC or Laptop), or being accessible via the intranet connection, that can be used by surgeons for pre- or intraoperative planning of treatments based on stereotactic systems or image guided surgery systems. The system is a software-only medical device to be installed on common IT hardware.
The provided text does not contain detailed acceptance criteria or a study proving the device meets those criteria. It focuses on the substantial equivalence determination for the "Molecular Flow Simulations" device to a predicate device ("iPlan Flow").
Here's a breakdown of what is available and what is missing based on your request:
1. A table of acceptance criteria and the reported device performance
- Missing. The document states that "Verification testing that product meets product performance and functional specifications" was performed, but it does not list those specifications/acceptance criteria or the specific performance results against them.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Partially Available. The document mentions "several tests were performed, in concordance with Duke University, using synthetic, animal and human imaging."
- Sample Size: Not specified for any of the synthetic, animal, or human imaging test sets.
- Provenance: Duke University (USA), for synthetic, animal, and human imaging.
- Retrospective/Prospective: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Missing. The document does not provide any information about experts used for establishing ground truth or their qualifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Missing. No adjudication method is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Missing. The document does not describe an MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The device is described as a "planning system" used by surgeons, not one directly assisting image readers in diagnosis.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Partially Available. The device, "Molecular Flow Simulations," is a "software-only medical device" designed for "pre- or intraoperative planning." It "uses MR-DTI and T2-weighted MR images to suggest likely volumes of fluid distribution" and "does not generate or create rules for the placement of intracranial catheters by any means." It calculates "likely fluid distribution from the planned catheter positions." This implies that the software performs its simulations and suggestions as an algorithm without direct human input during the simulation process itself, though the output is used by a human (surgeon) for planning. However, no specific "standalone performance study" with metrics like sensitivity, specificity, accuracy, etc., is provided for these "suggestions" or "calculations."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Missing. The document states that testing used "synthetic, animal and human imaging" but does not elaborate on how ground truth was established for any of these data types for performance evaluation.
8. The sample size for the training set
- Missing. There is no information provided about a training set since the document describes performance testing rather than model development. Given it's a "planning system" that uses "mathematical modeling," it might not have a traditional "training set" in the context of deep learning, but rather relies on established physical/mathematical principles.
9. How the ground truth for the training set was established
- Missing. As no training set information is available, no ground truth establishment method for it is mentioned.
In summary, the provided FDA 510(k) summary focuses primarily on demonstrating substantial equivalence to a predicate device based on intended use, technological characteristics, and general verification testing, rather than detailed performance study results against specific acceptance criteria for an AI/CAD-type device.
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).