(90 days)
The ViaOne Epicardial Access System is intended to access the epicardial surface of the heart via a subxiphoid approach to deliver diagnostic and therapeutic interventions for ventricular tachycardia.
ViaOne Epicardial Access System is a sterile, single-use access tool consisting of a concealed needle within a leading channel to facilitate guidewire access into the pericardium through a subxiphoid incision. The device consists of a radiopaque distal tip designed to retract a portion of the pericardial tissue into the device, and away from the heart muscle, where it is punctured by the concealed needle and a guidewire is introduced into the pericardial space.
The provided text describes the 510(k) premarket notification for the ViaOne Epicardial Access System. However, it does not contain the detailed acceptance criteria and the specific study results in a format that would allow for a complete table of acceptance criteria and reported device performance.
The text generally states that the device "met the predetermined acceptance criteria" and "All tests were successfully completed and passed, and the device met the defined acceptance criteria." but does not quantify these criteria or results.
Here's a breakdown of what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document. The document lists performance tests but does not state the specific acceptance criteria (e.g., "tensile strength > X N") nor the quantitative results from those tests (e.g., "tensile strength Y N").
2. Sample size used for the test set and the data provenance
- Biocompatibility: Not specified.
- Sterilization, Packaging and Shelf Life Testing: Not specified.
- Performance Testing: Not specified for individual tests.
- Animal Study: Not specified (e.g., number and type of animals).
- Clinical Information: "multi-central clinical trial which included VT subjects." The exact number of subjects is not specified. Data provenance (country of origin, retrospective/prospective) explicitly is not specified, though "multi-central" implies a prospective clinical trial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided for any of the studies mentioned.
4. Adjudication method for the test set
This information is not provided for any of the studies mentioned.
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
An MRMC study is not applicable to this device. The ViaOne Epicardial Access System is an access tool, not an AI-powered diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
A standalone performance study of an algorithm is not applicable to this device as it is a physical medical device, not an AI algorithm.
7. The type of ground truth used
- Biocompatibility: Established by ISO 10993-1 standards.
- Sterilization, Packaging and Shelf Life Testing: Established by ISO 11135-1 standards and internal performance criteria.
- Performance Testing: Established by internal design specifications and ISO 11070:2014 standards.
- Animal Study: Ground truth was based on observation of device performance, malfunction, and Histopathology evaluation and pathological examination.
- Clinical Information: Ground truth for adverse events would be clinical observation and diagnosis by medical professionals. Ground truth for pericardial space access success would be confirmed during the procedure.
8. The sample size for the training set
This information is not applicable as this is a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable as this is a physical medical device.
Summary of available and missing information:
| Information Category | Status in Document |
|---|---|
| 1. Table of Acceptance Criteria and Reported Device Performance | Missing (Qualitative statements only) |
| 2. Sample size for test set | Missing (Not specified for any study type) |
| 2. Data Provenance (country, retrospective/prospective) | "multi-central clinical trial" implies prospective; country not specified for clinical or animal studies |
| 3. Number of experts & qualifications for ground truth | Missing |
| 4. Adjudication method | Missing |
| 5. MRMC comparative effectiveness study? Effect size? | Not Applicable (Not an AI device) |
| 6. Standalone (algorithm only) performance? | Not Applicable (Not an AI device) |
| 7. Type of Ground Truth Used | ISO standards, pathological examination (animal), clinical observation (human trials) |
| 8. Sample size for training set | Not Applicable (Not an AI device) |
| 9. How ground truth for training set was established | Not Applicable (Not an AI device) |
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).