(138 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 guidewires 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.
The IOPS system displays the position and orientation of sensor equipped guidewires and catheters utilizing electromagnetic tracking technology. The system enables mapping of the patient's vascular system utilizing previously acquired CT scan data. IOPS registers the location and orientation of the sensors in real time superimposing navigation of the catheters and guidewires to the patient's vascular map.
The provided text is a 510(k) summary for the Intra-Operative Positioning System (IOPS®). It describes the device, its intended use, technological characteristics, and non-clinical testing performed to establish substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria for performance based on a test set, expert ground truth, or MRMC studies.
Instead, the submission focuses on demonstrating substantial equivalence to a previously cleared device (IOPS 1.0, K190106) due to minor hardware changes (for obsolescence) and a software update. The non-clinical testing mentioned is primarily related to electrical safety, electromagnetic compatibility, and immunity to RFID readers, which are general safety and performance standards rather than specific acceptance criteria for the navigational accuracy or clinical effectiveness in the context of the device's indications for use.
Therefore, I cannot populate the requested table or answer most of the questions, as the information is not present in the provided document. The document confirms:
- No specific acceptance criteria table for device performance (e.g., accuracy, precision) is provided.
- No study proving the device meets clinical performance acceptance criteria is detailed.
- No information about a test set, its sample size, or data provenance for clinical performance evaluation is given.
- No mention of experts establishing ground truth, adjudication methods, or MRMC studies for clinical performance.
- No standalone algorithm performance study is described for clinical outcomes.
- No information on ground truth type (expert consensus, pathology, outcomes data) for clinical performance.
- No details are given about a training set for the software, its size, or how its ground truth was established.
The summary strongly implies that the core navigation technology (Aurora® V3 System) is an off-the-shelf, integrated component, and the submission's focus is on labeling modifications and general safety compliance for the updated IOPS system.
Therefore, the response is:
The provided document, a 510(k) summary for the Intra-Operative Positioning System (IOPS®), does not contain the specific information requested regarding acceptance criteria for device performance, the study methods used to prove these criteria, details on test sets, ground truth establishment, expert involvement, or MRMC studies.
The submission primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device (IOPS 1.0, K190106) based on minor hardware updates (for obsolescence) and a software revision. The non-clinical testing mentioned (ANSI AAMI ES60601-1, IEC 60601-1-2, AIM 7351731 Rev. 2.00) relates to general electrical safety, essential performance, electromagnetic compatibility, and RFID immunity, rather than clinical performance metrics of the device's navigation capabilities against a defined ground truth.
Specifically, the following information is not available in the provided text:
- Table of acceptance criteria and reported device performance: Not provided. The submission states the navigation system has a "high degree of accuracy" and "position error of approximately ±1 mm," which it deems "sufficient," but these are descriptive statements, not formally presented as acceptance criteria for a study.
- Sample size used for the test set and data provenance: No information on a test set used to evaluate the device's clinical performance against specific acceptance criteria.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as no such clinical performance test set or ground truth establishment process is described.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, and effect size: Not described.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No information about a standalone performance study for clinical efficacy.
- The type of ground truth used: For the device's intended use (navigation), the text implies that the Aurora® system calculates sensor positions with high accuracy. For clinical application, the IOPS uses pre-operative CT scans and correlated tracking pad data, alongside real-time sensor readings, to superimpose location on a vascular map. However, there is no explicit mention of ground truth in the context of a performance study to prove the device meets acceptance criteria. The ±1mm accuracy is stated as a system capability, not a study outcome.
- The sample size for the training set: Not provided. The document mentions "proprietary software" for image generation and processing, but no details on training data.
- How the ground truth for the training set was established: Not provided.
The key takeaway is that this 510(k) summary focuses on demonstrating substantial equivalence through standard safety and performance testing and minor modifications, rather than a de novo clinical performance study with specific acceptance criteria as might be seen for novel AI-driven diagnostic devices.
§ 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).