(29 days)
The LAA Exclusion System is indicated for the exclusion of the heart's left atrial appendage, performed under direct visualization and in conjunction with other cardiac surgical procedures.
Direct visualization, in this context, requires that the surgeon is able to see the heart directly, with or without assistance from a camera, endoscope, etc., or any other appropriate viewing technology.
The LAA Exclusion System consists of a single use, sterile, self-closing, implantable Clip preloaded on a single use delivery system. When closed, the implant applies pressure to ensure exclusion of the left atrial appendage (LAA). Once the clip is deployed, it remains as a permanent implant. The implantable clip is available in lengths of 35mm, 40mm, 45mm to accommodate different sizes of LAA. The LAA Selection Guide is a sterile, single use, disposable surgical accessory device to assist the physician in selecting the appropriately sized clip implant for each individual patient.
The provided text describes a 510(k) premarket notification for a medical device called the "LAA Exclusion System." This document is a submission to the FDA demonstrating that the modified device is substantially equivalent to a previously cleared predicate device.
The essential information related to acceptance criteria and performance data is found under the "Performance Data" section. However, it's crucial to understand that this document does not contain the detailed study results, specific numerical acceptance criteria, or the methodology (like sample size, number of experts, ground truth establishment) for proving the device meets these criteria in the way one would expect for an AI/ML medical device submission.
This document describes a mechanical device (an implantable clip and delivery system), not an AI/ML diagnostic or prognostic tool. Therefore, the questions related to MRMC studies, training/test set sample sizes for algorithms, number of experts for ground truth, and adjudication methods for AI models are not applicable to this type of device submission.
The "acceptance criteria" for this mechanical device are performance specifications met through engineering verification tests, not clinical performance metrics based on diagnostic accuracy.
Here's an attempt to answer the questions based on the provided text, acknowledging the limitations due to the nature of the device:
1. A table of acceptance criteria and the reported device performance
The document states that "All pre-determined acceptance criteria were met" for the following tests, indicating successful performance. The specific numerical acceptance criteria themselves are not detailed in this summary document, only the types of tests performed.
| Acceptance Criteria Category (Test Performed) | Reported Device Performance |
|---|---|
| Bent Shaft Functional Check | Met acceptance criteria |
| Trigger Actuation Force | Met acceptance criteria |
| Deployment/Recapture | Met acceptance criteria |
| Clip Orientation | Met acceptance criteria |
| One Pin Mis-Capture | Met acceptance criteria |
| Recapture Indicator | Met acceptance criteria |
| Implant Tip Opening | Met acceptance criteria |
| Implant Root Opening | Met acceptance criteria |
| Implant Deployment Force | Met acceptance criteria |
| Implant Recapture Force | Met acceptance criteria |
| Implant Retention Strength | Met acceptance criteria |
| Implant Forced Pull-Off | Met acceptance criteria |
| Max Dose Sterilization | Met acceptance criteria (implicitly, as part of "All pre-determined...") |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for each of these engineering verification tests, nor does it explicitly state the data provenance (e.g., country) or whether the testing was retrospective or prospective. These are typically internal design verification tests conducted by the manufacturer.
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 question is not applicable to this type of mechanical device verification. Ground truth in this context is based on engineering specifications and measurements, not expert clinical interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical imaging studies, typically for AI/ML performance evaluation, not for mechanical device testing.
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, an MRMC study was not done. This device is a mechanical implantable clip and delivery system, not an AI-assisted diagnostic tool. Therefore, effects on human reader performance are not relevant or measured here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance evaluation was not done. This is a mechanical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance demonstration relies on engineering specifications and physical measurements validated against those specifications. For example, "Implant Tip Opening" would be measured directly and compared to a pre-defined minimum opening distance. It's not based on expert consensus, pathology, or outcomes data in the clinical diagnostic sense.
8. The sample size for the training set
This question is not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This question is not applicable, as there is no training set for an AI/ML model for this mechanical device.
Summary of Inapplicability due to Device Type:
The provided document describes a 510(k) submission for a mechanical medical device (LAA Exclusion System), focused on demonstrating substantial equivalence to a predicate device based on engineering performance specifications and biocompatibility. The framework of your questions (e.g., sample size for AI test/training sets, expert readers, ground truth for AI models, MRMC studies) is primarily relevant to the FDA's evaluation of Artificial Intelligence/Machine Learning (AI/ML) based medical devices. Since the device in question is not an AI/ML product, many of your specific inquiries are not addressed in this type of submission document.
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.