(103 days)
The LeadLiner CS lead delivery system is intended for the introduction and delivery of pacing or defibrillator leads.
The LeadLiner CS lead delivery system (LeadLiner) is used to deliver pacing or defibrillator leads and consists of the LeadLiner delivery catheter and the LeadLiner inner catheter. It is packaged with a loading tool to assist in delivery of the two-catheter system and the lead through the hemostatic valve of the introducer sheath. It also includes a retention clip to hold the delivery and inner catheters together and allow the operator to manipulate the two catheters as a single system.
The provided text describes a medical device, the LeadLiner CS lead delivery system, and its substantial equivalence to a predicate device. However, it does not contain the detailed information required to fill out all the categories in your request, particularly regarding specific acceptance criteria values and a comprehensive study report with quantitative results.
Based on the available information, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Simulated use | Met specified criteria |
| Bend radius | Met specified criteria |
| Torque | Met specified criteria |
| Tensile | Met specified criteria |
| Delivery catheter perforations | Met specified criteria |
Note: The document states that "Results of the verification tests met the specified acceptance criteria" but does not provide the specific numerical acceptance criteria or the quantitative results of the tests.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "bench tests" and "verification tests," which implies a test set was used. However, it does not specify the sample size for these tests. The data provenance is not explicitly stated, but bench tests are typically conducted in a controlled laboratory environment. There is no information on country of origin or whether the data was retrospective or prospective.
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 provided in the document. The tests described are engineering/bench tests, not clinical studies requiring expert interpretation of results in the way a diagnostic AI might.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided and is generally not applicable to the type of bench testing described for a delivery catheter.
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 was not done. This device is a lead delivery system, not an AI-powered diagnostic tool, so an MRMC study is not relevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a physical medical instrument, not an algorithm or AI.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the bench tests, the "ground truth" would be the engineering specifications and performance standards established for the device's physical and functional characteristics. For example, for "bend radius," the ground truth is likely a pre-defined maximum allowable bend before failure. This is based on engineering specifications and performance standards, rather than expert consensus, pathology, or outcomes data.
8. The sample size for the training set
This question is not applicable as the device is a physical medical instrument, not an AI or algorithm that requires a training set.
9. How the ground truth for the training set was established
This question is not applicable for the same reason as above.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).