(81 days)
The IOPS (Intra-Operative Positioning System) is intended for the evaluation of vascular anatomy as captured via 3D modeling from previously acquired scan data. It is intended for real time tip positioning and navigation using sensor-equipped compatible catheters and quidewires used in endovascular interventions in the descending aorta. The system is indicated for use as an adjunct to fluoroscopy. The IOPS does not make a diagnosis.
IOPS Fiducial Tracking Pad is a sterile, single use tracking pad intended for use with the Intra-Operative Positioning System (IOPS), manufactured by Centerline Biomedical. It is equipped with a single tracking sensor allowing IOPS to track gross patient motion to allow maintenance of patient registration during a procedure. It will not track minor patient motion such as breathing or cardiac movement. The tracking pad is equipped with radiopaque beads which allow registration of a conebeam CT scan of the patient in their current position to a previously acquired CT scan.
IOPS Guidewire Handle is a sterile, single use, non-sensorized device intended for use with the Intra-Operative Positioning System (OPS) and its sensorized 0.035″ guidewire, manufactured by Centerline Biomedical. It is meant to be connected to an IOPS sensorized guidewire to allow detection and visualization of the guidewire tip position, in real time, on a 3D rendering of the patient's vascular map.
The provided text is an FDA 510(k) summary for the Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad) and Intra-Operative Positioning System (IOPS®) (Guidewire Handle). It describes the device, its intended use, comparison to predicate devices, and a summary of non-clinical testing.
However, the document does not contain information regarding detailed acceptance criteria, specific device performance metrics against those criteria, or a study that proves the device meets the acceptance criteria with quantitative results. It primarily focuses on demonstrating substantial equivalence to predicate devices through a comparison of technological characteristics and a list of conducted non-clinical tests.
Therefore, many of the requested fields cannot be directly extracted from the provided text. I will answer based on the information available and indicate where information is not present.
1. A table of acceptance criteria and the reported device performance
The document lists "Accuracy Testing with IOPS per ASTM F2554" as a conducted test, implying accuracy is an acceptance criterion. However, specific acceptance criteria values (e.g., "accuracy shall be less than X mm") and the reported device performance against these criteria are not provided in this summary.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Accuracy (per ASTM F2554) | Not specified in the provided text. The document states "Accuracy Testing with IOPS per ASTM F2554" was conducted, but does not provide the specific acceptance criteria or the measured performance. |
| Dimensional Analysis | Not specified in the provided text. Stated as conducted, but no criteria or results are detailed. |
| Device Functionality and Essential Performance | Not specified in the provided text. Stated as conducted, but no criteria or results are detailed. |
| Tensile Strength | Not specified in the provided text. Stated as conducted, but no criteria or results are detailed. |
| Radiopacity | Not specified in the provided text. Stated as conducted, but no criteria or results are detailed. |
| Electrical Safety (IEC 60601 and Applied Part Testing) | Not specified in the provided text. Stated as conducted, but no criteria or results are detailed. |
| Biocompatibility (ISO 10993) | Not specified in the provided text. Stated as conducted, but no criteria or results are detailed. Concluded to be equivalent. |
| Sterilization (ISO 14937 and TIR56) | Not specified in the provided text. Stated as conducted, but no criteria or results are detailed. |
| EO/ECH Residuals (ISO 10993-7) | Not specified in the provided text. Stated as conducted, but no criteria or results are detailed. |
| Packaging Integrity (ISO 11607) | Not specified in the provided text. Stated as conducted, but no criteria or results are detailed. |
| Design Validation | Not specified in the provided text. Stated as conducted, but no criteria or results are detailed. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the given text. The document only lists the types of non-clinical tests performed.
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)
This information is not provided in the given text. The device is a positioning system, and the "ground truth" would likely be based on physical measurements or established anatomical references, not expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the given text. This type of adjudication is typically relevant for studies involving human interpretation or clinical outcomes, which are not detailed here for the non-clinical tests.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not performed or described in the provided text, as this is a non-clinical evaluation for device substantial equivalence. The device is a "Programmable Diagnostic Computer" for positioning and is indicated "as an adjunct to fluoroscopy," but the submission focuses on hardware components (Fiducial Tracking Pad, Guidewire Handle) and their non-clinical validation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance evaluation of the algorithm and system was implicitly done through the "Non-Clinical Testing" which included "Accuracy Testing with IOPS per ASTM F2554" and "Device Functionality and Essential Performance." However, specific details of the standalone performance are not provided in the given text, such as quantitative metrics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests listed, the ground truth would likely be established through physical measurements against known standards or validated instruments (e.g., for accuracy, tensile strength, dimensions). The exact methods for establishing this ground truth for each test are not specified in the provided text.
8. The sample size for the training set
This information is not provided in the given text. The document describes a non-clinical evaluation for substantial equivalence, not a machine learning model development process requiring a distinct training set.
9. How the ground truth for the training set was established
This information is not provided in the given text, as no training set for an AI/ML model is mentioned.
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).