(174 days)
The CrossPoint TransAccess Catheter is intended to facilitate the placement and positioning of catheters within the peripheral vasculature. The CrossPoint TransAccess Catheter also provides an intraluminal, cross-sectional ultrasound image of the area of interest. The CrossPoint TransAccess Catheter is not indicated for use in the coronary or cerebral vasculature.
The CrossPoint TransAccess Catheter is intended to facilitate the placement and positioning of catheters within the peripheral vasculature. The CrossPoint TransAccess Catheter also provides an intraluminal, cross-sectional ultrasound image of the area of interest.
Here's an analysis of the provided text, focusing on acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state numerical acceptance criteria in the typical sense (e.g., minimum sensitivity or specificity thresholds). Instead, the performance claims are qualitative and relate to the device's intended function and safety.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functionality: Facilitate placement and positioning of catheters within the peripheral vasculature. | "Results of in-vitro testing and animal studies demonstrate that the CrossPoint TransAccess Catheter is safe and effective to allow the positioning and placement of catheters within the peripheral vasculature." |
| Imaging: Provide an intraluminal, cross-sectional ultrasound image of the area of interest. | "The CrossPoint TransAccess Catheter also provides an intraluminal, cross-sectional ultrasound image of the area of interest." (This is a statement of capability, not a performance metric like image quality or resolution.) |
| Biocompatibility: Materials must be safe for use in the body. | "The materials used in the manufacture of the CrossPoint TransAccesss Catheter have been shown to be biocompatible when tested in accordance with ISO 10993-1 requirements." |
| Safety: Device must be safe for its intended use. | "Results of in-vitro testing and animal studies demonstrate that the CrossPoint TransAccess Catheter is safe and effective..." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a numerical sample size for the "in-vitro testing and animal studies." It only refers to "results of in-vitro testing and animal studies."
- Data Provenance: The studies mentioned are "in-vitro testing" and "animal studies." No country of origin is specified, and the studies are inherently prospective in nature (designed and conducted to gather specific data).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not provide any information about the number or qualifications of experts used to establish ground truth for the test set. Given the nature of "in-vitro testing and animal studies," ground truth would likely be established through direct observation, physiological measurements, or histological analysis, rather than by human expert interpretation in the same way it would be for a diagnostic AI.
4. Adjudication Method for the Test Set
No information is provided regarding an adjudication method. This type of method (e.g., 2+1, 3+1) is typically relevant for studies involving human interpretation of medical images where disagreements need to be resolved. For in-vitro and animal studies, objective measurements or observations form the "ground truth."
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No MRMC comparative effectiveness study was done. The device described (CrossPoint TransAccess Catheter) is a physical medical device (catheter with ultrasound imaging capability), not an AI algorithm intended for diagnostic interpretation to be used with or without human assistance. Therefore, a study comparing human readers with and without AI assistance is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No standalone algorithm performance study was done. As noted above, this device is not an AI algorithm. Its performance is related to its physical function and the quality of the ultrasound images it provides, not algorithmic interpretation.
7. The Type of Ground Truth Used
Based on the description of "in-vitro testing and animal studies," the ground truth would likely be established through:
- Direct Observation: For catheter placement and manipulation.
- Physiological Measurements: To assess efficacy and safety in animal models.
- Histological Analysis or Other Pathology: For evaluating tissue effects or confirming findings in animal studies.
- Engineering Measurements/Specifications: For in-vitro performance (e.g., image resolution, catheter flexibility).
8. The Sample Size for the Training Set
The document does not mention a training set. This is because the device is a physical medical device, not a machine learning or AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.