(90 days)
The Medtronic Model 10626 Myocardial Implant Tool is used to facilitate myocardial pacing lead placement. It is designed to assist in the placement and manipulation of the Model 5071 myocardial pacing lead.
The implant tool consists of a handle, malleable shaft and lead hub fixation assembly (tongs) which grab and release a Model 5071 lead when the springloaded button actuator is depressed and released. The handle assembly includes a rotable, thumbwheel. Rotation of this thumbwheel in a clockwise direction results in equivalent rotation of a lead hub fixation assembly located at the distal end of the tool. Depression of the actuator allows fixation to the Model 5071 lead and also activates the fixation release upon completion of implant. Release of the actuator activates the fixation of the tool to the Model 5071 lead.
The provided text describes the Medtronic Model 10626 Myocardial Implant Tool, a Class I accessory device intended to facilitate myocardial pacing lead placement. It is a mechanical tool, not an AI/ML powered device, and therefore the majority of the requested information (related to AI/ML specific studies, ground truth, expert consensus, etc.) is not applicable.
However, I can extract the acceptance criteria and the study performed for this device based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Defined by Medtronic Product Specification) | Reported Device Performance |
|---|---|
| Visual Examination Pass | Meets Requirements |
| Grabber Insertion/Removal Pass | Meets Requirements |
| Grabber Rotation Pass | Meets Requirements |
| Lead Fixation/Removal Pass | Meets Requirements |
| Shaft Rotation Pass | Meets Requirements |
| Shaft Flexibility Pass | Meets Requirements |
| Mechanical testing of tong retention Pass | Meets Requirements |
| Mechanical testing of actuator button Pass | Meets Requirements |
| Mechanical testing of retainer retention Pass | Meets Requirements |
| Overall: Meets all requirements of the product specification as defined by Medtronic. | The Model 10626 meets the requirements of the product specification as defined by Medtronic. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The text mentions "Testing was performed on tools built according to a documented process and subjected to environmental conditioning." This suggests some number of physical devices were manufactured and tested, but the exact number is not provided.
- Data Provenance: Not applicable in the context of typical AI/ML data provenance (e.g., country of origin of patient data). The testing was an in vitro (benchtop/laboratory) evaluation of the physical device's mechanical and functional properties. The tests were performed by Medtronic.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a mechanical implant tool, not a diagnostic or AI/ML device that requires expert-established ground truth for its performance evaluation. The "ground truth" for this device's performance is its ability to meet documented engineering and functional specifications.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. As a mechanical device, performance testing involves objective measurements against engineering specifications, not subjective interpretation requiring adjudication among experts.
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:
- No. This is not an AI/ML device and therefore no MRMC study or assessment of human reader improvement with AI assistance was performed or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a mechanical tool operated by a human, not an algorithm. Its performance is always tied to human use, though the in vitro tests assess its standalone functional integrity.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is adherence to predefined product specifications and engineering requirements for its mechanical and functional attributes (e.g., grabber insertion, rotation, lead fixation, shaft flexibility).
8. The sample size for the training set:
- Not Applicable. This device is not an AI/ML model, so there is no "training set."
9. How the ground truth for the training set was established:
- Not Applicable. There is no training set for this mechanical device.
§ 870.4500 Cardiovascular surgical instruments.
(a)
Identification. Cardiovascular surgical instruments are surgical instruments that have special features for use in cardiovascular surgery. These devices include, e.g., forceps, retractors, and scissors.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.