(24 days)
The MediGuide Technology System is intended for the evaluation of vascular and cardiac anatomy. It is intended to enable real time tip positioning and navigation of a MediGuide enabled (equipped with a MediGuide sensor) diagnostic or therapeutic invasive device used in vascular or cardiac interventions in the Cath Lab environment, on both live fluoroscopy or recorded background. The System is indicated for use as an adjunct to fluoroscopy.
The MediGuide Technology System, used in conjunction with an X-ray System, employs magnetic positioning technology to track a MediGuide enabled diagnostic or therapeutic invasive device for the 3D position relative to any X-Ray image, in real-time or previously recorded cine-loop. The MediGuide Technology System includes two optional software packages. The Coronary package includes the Coronary application, and it supports coronary procedures. The Cardiac package includes the Cardiac Navigation and the Cardiac Navigation with Angio Survey™ application, both support cardiac procedures. The most fundamental capability of the MediGuide Technology is the positioning and navigation of MediGuide enabled devices. This feature enables projection of the real time position of a MediGuide sensor (and thus of the MediGuide enabled device) on real time 2D X-Ray images (live mode) or in a recorded mode (the MediGuide enabled device tip real time position is superimposed on a previously recorded cine loop or still image). The MediGuide Technology enables simultaneous tracking of up to three MediGuide enabled devices.
The provided text describes the MediGuide Technology system, its intended use, and substantial equivalence to a predicate device. However, it does not contain the specific details required to fully address your request regarding acceptance criteria and a study proving the device meets them.
Here's a breakdown of what is and is not available in the provided text:
Information Present:
- Device Name: MediGuide Technology
- Intended Use/Indications for Use: Evaluation of vascular and cardiac anatomy; real-time tip positioning and navigation of MediGuide enabled devices in vascular or cardiac interventions in the Cath Lab, as an adjunct to fluoroscopy.
- Device Description: Uses magnetic positioning technology to track MediGuide enabled diagnostic or therapeutic invasive devices for 3D position relative to X-Ray image (real-time or recorded). Supports up to three devices simultaneously.
- Features: Landmarking, 3D reconstruction, trace rendering, 2D fusion, 3D measurements, Quantitative Coronary Angiography.
- Substantial Equivalence: Claimed based on identical intended use/indications for use, similar technological characteristics, and principles of operation to the gMPS™ II system (K 102905).
- General Performance Statement: "Performance testing was conducted in order to demonstrate the performance and accuracy of the MediGuide Technology and to verify that all the modifications introduced in the device as compared to its predicate device did not raise any new safety and effectiveness issues. Test results indicated that the MediGuide Technology is as safe and effective as its predicate device for its intended use and is substantially equivalent to its predicate device without raising any new safety and/or effectiveness issues."
Information NOT Present (and therefore cannot be included in the table or detailed answers):
- Specific Acceptance Criteria: The document mentions "performance and accuracy" but does not define what those quantitative or qualitative criteria were (e.g., specific error margins for positioning, success rates for navigation, etc.).
- Reported Device Performance: While it states "Test results indicated that the MediGuide Technology is as safe and effective," no specific performance metrics are reported.
- Sample Size for Test Set: Not mentioned.
- Data Provenance (country, retrospective/prospective): Not mentioned.
- Number of Experts for Ground Truth: Not mentioned.
- Qualifications of Experts: Not mentioned.
- Adjudication Method: Not mentioned.
- MRMC Comparative Effectiveness Study: No mention of a study comparing human readers with and without AI assistance, nor any effect sizes.
- Standalone Performance Study: The document focuses on the system as an adjunct to fluoroscopy and comparing it to a predicate; it doesn't describe a standalone algorithm-only performance assessment clearly.
- Type of Ground Truth: Not specified (e.g., reference standard from pathology, clinical outcomes, expert consensus with defined criteria).
- Sample Size for Training Set: Not mentioned.
- How Ground Truth for Training Set was Established: Not mentioned.
Based on the provided text, here is what can be inferred and what remains unknown:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from general statements) | Reported Device Performance (General Statement in document) |
|---|---|
| Demonstrate performance and accuracy | Test results indicated the device is "as safe and effective as its predicate device" and "substantially equivalent" |
| Verify modifications did not raise new safety/effectiveness issues | Modifications did not raise new safety and/or effectiveness issues |
Note: Specific, quantifiable acceptance criteria (e.g., positioning accuracy within X mm, navigation success rate > Y%) and corresponding measured performance values are not provided in the document.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified in the provided text.
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified in the provided text.
- Qualifications of Experts: Not specified in the provided text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not specified in the provided text.
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:
- MRMC Study: No mention of a multi-reader multi-case (MRMC) comparative effectiveness study. The document focuses on the device's performance relative to a predicate, not enhancement of human reader performance.
- Effect Size: Not applicable, as no such study is described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The document implies the system is an "adjunct to fluoroscopy" and provides "real time tip positioning and navigation." While the core technology tracks the device, the description does not explicitly detail a "standalone algorithm-only" performance study in isolation from the clinical environment or human interaction. The focus is on the integrated system's function alongside existing procedures.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: Not specified in the provided text. The "performance testing" is mentioned, but the reference standard against which performance was measured is not detailed.
8. The sample size for the training set:
- Sample Size for Training Set: Not specified in the provided text. The document refers to "performance testing" but does not distinguish between training and test sets or provide sizes for either.
9. How the ground truth for the training set was established:
- Ground Truth Establishment for Training Set: Not specified in the provided text.
§ 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).