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510(k) Data Aggregation
(268 days)
The Syntheon 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 Syntheon 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, and 50mm to accommodate different sizes of LAA. The Syntheon 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.
This document describes the Syntheon LAA Exclusion System and its substantial equivalence to a predicate device, focusing on various performance and safety aspects rather than an AI/ML component. Therefore, several of the requested categories for AI/ML device studies are not applicable.
Here's the summary of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Clip Opening | Proximal opening >4 mm for all implant sizes (specifically, "Same as PROV, design verification testing for the Syntheon LAA Exclusion system has demonstrated a proximal opening >4 mm for all implant sizes. The implant functions as intended.") | Met (implied by "All pre-determined acceptance criteria were met.") |
| Mechanical Testing | Not explicitly stated what the specific acceptance criteria were, but the general goal was to ensure the device meets performance specifications and demonstrates substantial equivalence to the predicate device. | Met (implied by "All pre-determined acceptance criteria were met. The data demonstrate that the Syntheon LAA Exclusion System is substantially equivalent to the predicate device.") |
| Packaging Testing | Not explicitly stated. | Met (implied by "All pre-determined acceptance criteria were met.") |
| Shelf-life Testing | Not explicitly stated. | Met (implied by "All pre-determined acceptance criteria were met.") |
| Bench-top Validation Testing | Not explicitly stated. | Met (implied by "All pre-determined acceptance criteria were met.") |
| Animal Validation Testing | Not explicitly stated. | Met (implied by "All pre-determined acceptance criteria were met.") |
| Biocompatibility (various tests) | Met requirements of ISO 10993-1:2018 for implantable devices (>30 days contact) and delivery system (<24 hours contact). Specific tests include Chemical Characterization, Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity, Sub-Acute/Sub-Chronic Toxicity, Genotoxicity (Ames Mutagenicity, In Vitro Mouse Lymphoma Mutagenesis for implant), Implantation (1-, 4-, and 13-weeks for implant). | Met (explicitly stated: "The Syntheon LAA Exclusion System biocompatibility testing met all requirements.") |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the given document. The document refers to "design verification and validation" and "animal validation testing" but does not detail sample sizes or data provenance for these tests.
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 applicable as the document describes a medical device (implantable clip) and its related performance testing, not an AI/ML algorithm that requires expert-established ground truth from interpretative data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the document describes a medical device (implantable clip) and its related performance testing, not an AI/ML algorithm that undergoes adjudication for interpretative data.
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
This information is not applicable as the document describes a medical device (implantable clip) and its related performance testing, not an AI/ML algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the document describes a medical device (implantable clip) and its related performance testing, not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the performance and validation tests mentioned (e.g., mechanical testing, biocompatibility, animal studies), the "ground truth" would be established by physical measurements, biological responses, and observed clinical outcomes in the animal models, rather than expert consensus on interpretative data or pathology in the context of an AI/ML algorithm.
8. The sample size for the training set
This information is not applicable as the document describes a medical device (implantable clip) and its related performance testing, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as the document describes a medical device (implantable clip) and its related performance testing, not an AI/ML algorithm that requires a training set.
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