(174 days)
The lead delivery system, consisting of Selectra catheters in conjunction with the Selectra Accessory Kit, is used to facilitate implantation of leads in the heart chambers or in the coronary veins via the coronary sinus.
Selectra 3D catheters are also indicated to facilitate Solia S lead implantation in the left bundle branch area to achieve left bundle area pacing (LBBAP).
BIOTRONIK's Selectra 3D lead introducer system is a combination of guiding catheters and implantation accessories used to facilitate access to the heart for suitable leads and catheters. The Selectra 3D lead introducer system consists of several individually available quiding catheters with various curve shapes and the Selectra accessory kit.
The Selectra Accessory Kit includes the following components in a single sterile package:
- 1 Selectra Slitter Tool .
- . 1 quide wire
- 2 7F Transvalvular Insertion Tools (TVI)
- 1 syringe
- 1 torque tool ●
- 2 check valves ●
- 2 stopcocks
- 1 Tuohy Borst Adapter (TBA) ●
The catheters facilitate implantation of leads into the heart. The Selectra catheters are compatible with one another as well as the Selectra Accessory Kit.
The provided FDA 510(k) summary describes the acceptance criteria and study for the Selectra 3D Lead Delivery System. However, it's important to note that this document is for a medical device (lead delivery system), not an AI/software device. Therefore, many of the typical acceptance criteria and study design elements requested for AI/software (e.g., test set sample size, data provenance, number of experts for ground truth, MRMC studies, standalone performance) are not applicable in this context.
The study presented focuses on the physical device's safety and effectiveness for lead implantation, particularly for left bundle branch area pacing (LBBAP).
Here's a breakdown based on the provided text, highlighting what is applicable and what is not for an AI/software device:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Safety (Primary Endpoint) | SADE-free rate > 90% (Serious Adverse Device Effect-free rate by 7 days post-implant) | 100% SADE-free rate (95% CI: 97.7, 100) by 7 days post-implant |
| Effectiveness (Secondary Endpoint) | Not explicitly defined as an acceptance criterion with a specific threshold. | Successful conduction system pacing implants with Selectra 3D: 93.6% (95% CI: 88.6, 96.9) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: 157 patients were enrolled. This serves as the study population for evaluating the device's safety and effectiveness.
- Data Provenance:
- Country of Origin: "ten investigational sites across Europe, Asia, and Australia."
- Retrospective or Prospective: Prospective study.
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)
- Number of Experts: An "Endpoint Adjudication Committee" determined the relatedness of SADEs to the Selectra 3D catheter. The exact number of experts and their qualifications beyond being part of this committee are not specified in the provided text.
- Ground Truth for Effectiveness: "Successful His bundle or left bundle branch area pacing was determined by the implanting physician." The qualifications of these physicians are not detailed, but they are implied to be specialists performing these cardiac procedures.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: For the primary safety endpoint, an "Endpoint Adjudication Committee" assessed the relatedness of SADEs. The specific method (e.g., consensus, majority vote) is not detailed in this summary. For effectiveness, the implanting physician made the determination, which does not involve a multi-expert adjudication among different readers of an image, for example.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This study is for a physical medical device, not an AI/software product, so the concept of "human readers improve with AI vs without AI assistance" is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: No, a standalone performance study (in the context of an algorithm) was not done. This device is a tool used by a human implanter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Ground Truth for Safety: Expert consensus/adjudication by an "Endpoint Adjudication Committee" for SADE relatedness.
- Ground Truth for Effectiveness: Clinical determination by the "implanting investigator" regarding the success and stability of lead implantation for conduction system pacing. This is an outcome evaluated by the treating physician in real-time or soon after implantation.
8. The sample size for the training set
- Training Set Sample Size: This study describes the evaluation of a physical medical device. There is no concept of a training set in the context of this type of clinical study for a traditional device. The study uses a prospective cohort to gather safety and effectiveness data.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable, as there is no training set for this type of device study.
§ 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).