(30 days)
The ONE Snare endovascular snare system is intended for use in the coronary and peripheral vascular system or hollow viscous to retneve and manipulate foreign objects. Retrieval and manipulation procedures include indivelling venous catheter repositioning, indwelling venous catheter fibrin sheath stripping, and central venous access veripouncture procedure assistance.
The ONE Snare Endovascular Snare System is a snare system that is designed for use in the coronary and peripheral vascular system or hollow viscous to retrieve and manipulate foreign objects. The One Snare wire consists of a Nitinol core with a ground tapered distal section, a formed nitinol cable covered with a gold-plated tungsten coil. The formed cable with coil is attached to the core wire and then covered with a PTFE polymer sleeve. The wires are packaged with an introducer, torque device and guiding catheter – this makes up the “One Snare Endovascular Snare System”.
The provided text describes the regulatory clearance for the ONE Snare™ endovascular snare system (K193507) and references its substantial equivalence to a predicate device (K122088). However, it does not contain information about a study that proves the device meets acceptance criteria in the context of an Artificial Intelligence (AI) or machine learning product.
The document details the physical characteristics and performance testing of a medical device (an endovascular snare system), focused on demonstrating its mechanical and functional equivalence to a previously cleared device. The "acceptance criteria" and "device performance" described are related to physical specifications and mechanical testing, not algorithm performance.
Therefore, many of the requested items (e.g., sample size for test/training sets, data provenance, ground truth establishment, expert adjudication, MRMC studies, standalone algorithm performance) are not applicable to the information provided.
Here's the relevant information that can be extracted, interpreted within the context of a physical medical device:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists several performance attributes that were tested. The general statement is that "All test results were comparable to the predicate devices and the subject One Snare Endovascular Snare System met the predetermined acceptance criteria." Specific, quantitative acceptance criteria are not explicitly detailed in the provided text.
| Acceptance Criterion (General Concept) | Reported Device Performance |
|---|---|
| Snare Size Designation | Met predetermined acceptance criteria; comparable to predicate device |
| Catheter Size Designation | Met predetermined acceptance criteria; comparable to predicate device |
| Catheter Surface Inspection | Met predetermined acceptance criteria; comparable to predicate device |
| Catheter OD Inspection | Met predetermined acceptance criteria; comparable to predicate device |
| Catheter Tip Length of Angle | Met predetermined acceptance criteria; comparable to predicate device |
| Catheter Angle | Met predetermined acceptance criteria; comparable to predicate device |
| Catheter Tip ID Inspection | Met predetermined acceptance criteria; comparable to predicate device |
| Simulated Use (design validation) | Met predetermined acceptance criteria; comparable to predicate device |
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 as the tests are for physical device performance, not AI/ML model performance on data. The tests performed are listed as:
- Snare Size Designation
- Catheter Size Designation
- Catheter Surface Inspection
- Catheter OD Inspection
- Catheter Tip Length of Angle
- Catheter Angle
- Catheter Tip ID Inspection
- Simulated Use (design validation)
The provenance of this testing data (e.g., country of origin, retrospective/prospective) is not specified.
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 applicable as the tests relate to the physical properties and simulated performance of a medical device, not to the interpretation of medical images or data requiring expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the reasons stated in item 3.
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 comparative effectiveness study is not applicable as this is not an AI/ML device for diagnostic or assistive interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as this is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the physical tests conducted (e.g., Catheter OD Inspection, Catheter Angle), the "ground truth" would be the engineering specifications and tolerances of the device. This is inherent to the manufacturing and design process and not explicitly detailed in terms of "expert consensus," "pathology," or "outcomes data."
8. The sample size for the training set
This information is not applicable as this is not an AI/ML device.
9. How the ground truth for the training set was established
This information is not applicable as this is not an AI/ML device.
In summary, the provided document describes a 510(k) clearance for a physical medical device and its performance testing to demonstrate substantial equivalence, not an AI/ML product's validation study. Therefore, most of the requested information related to AI/ML evaluation criteria is not present.
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).