(182 days)
ELA Medical endocardial leads are designed to be used with implantable cardiac pacemakers. J-shaped leads are intended for permanent pacing and sensing of the atrium.
The Stela™ Model UJ45 is a silicone rubber, tined, J-shaped, unipolar transvenous lead that provides a permanent electrical pathway between a pacemaker and the atrium. It is similar in design and construction to other such leads in commercial distribution.
The provided document is a 510(k) submission for a medical device (Stela™ Model UJ45 Pacing Lead) and its associated FDA clearance letter from 1998. This type of submission relies on demonstrating substantial equivalence to a predicate device rather than conducting new clinical trials for safety and effectiveness.
Therefore, the document does not contain the detailed information typically found in a study demonstrating device performance against specific acceptance criteria for AI/diagnostic devices. Specifically, it does not include:
- A table of acceptance criteria and reported device performance metrics in the way you've requested (e.g., sensitivity, specificity, AUROC).
- Details about a test set (sample size, data provenance), ground truth establishment, or expert adjudication for performance evaluation.
- Information about multi-reader multi-case (MRMC) studies or standalone algorithm performance.
- Training set details.
Instead, the document states:
- "No clinical study was required to demonstrate safety and effectiveness since the Stela™ Model UJ45 presents no new feature." (Section 2.1.7)
- The device's safety and effectiveness are supported by its substantial equivalence to predicate devices (ELA Medical Focus® Model J43F and Stela™ Model BJ45), which have a history of successful use.
- The primary "studies" mentioned are in-vitro functional testing to ensure the new model met basic engineering specifications, consistent with existing lead products.
Here's a breakdown of the available information in the context of your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Functional/In-Vitro) | Reported Device Performance (Implied "Meets") |
|---|---|
| Stylet insertion/removal | Passed (Functional) |
| Stylet bottoming | Passed (Functional) |
| Electrical resistance | Passed (Functional) |
| IS-1 connector conformity | Passed (Functional) |
| Leak resistance | Passed (Functional) |
| Insulation integrity | Passed (Functional) |
| Tensile strength test | Passed (Functional) |
Note: The document implicitly states that these tests were "performed" and contributed to the conclusion that the device would "perform in a safe and effective manner," suggesting that it met internal specifications for these functional tests. Specific quantitative performance values or defined acceptance thresholds are not provided in this public summary.
2. Sample size used for the test set and the data provenance
- No specific "test set" in the diagnostic/AI sense was used. The evaluation relied on in-vitro functional testing of the device itself and comparison to predicate devices, not on a dataset of clinical cases for diagnostic performance.
- The in-vitro tests were conducted on the Stela™ Model UJ45 leads. The sample size for these specific in-vitro tests is not specified in the document.
- Data provenance: Not applicable in the context of clinical data for performance evaluation. The data is from in-vitro engineering tests of the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable as there was no clinical "test set" requiring ground truth established by experts for performance evaluation. The functional tests likely had engineering specifications as their "ground truth" and were evaluated by engineers/technicians.
4. Adjudication method for the test set
- This is not applicable as there was no clinical "test set" requiring expert adjudication for performance evaluation.
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 such study was performed. This device is a pacing lead, not an AI-assisted diagnostic tool or an imaging analysis system. The concept of human readers improving with AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a hardware medical device (a pacing lead), not an algorithm or AI system.
7. The type of ground truth used
- For the in-vitro functional testing, the "ground truth" would be established engineering specifications and performance standards for each test (e.g., a certain electrical resistance range, a minimum tensile strength).
8. The sample size for the training set
- Not applicable. This device is a pacing lead, not an AI system that requires a "training set."
9. How the ground truth for the training set was established
- Not applicable.
Summary Rationale from the Document:
The FDA 510(k) clearance for the Stela™ Model UJ45 Pacing Lead was based on demonstrating "substantial equivalence" to legally marketed predicate devices, not on new clinical trials or performance studies as would be required for novel diagnostic algorithms. The manufacturer explicitly states: "No clinical study was required to demonstrate safety and effectiveness since the Stela™ Model UJ45 presents no new feature." The in-vitro functional tests were performed to confirm that the new model met established engineering standards consistent with its predicate devices.
§ 870.3680 Cardiovascular permanent or temporary pacemaker electrode.
(a)
Temporary pacemaker electrode —(1)Identification. A temporary pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to anexternal pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.(2)
Classification. Class II (performance standards).(b)
Permanent pacemaker electrode —(1)Identification. A permanent pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to an implantable pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before October 4, 2012, for any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976, or that has, on or before October 4, 2012, been found to be substantially equivalent to any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976. Any other pacemaker repair or replacement material device shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.