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510(k) Data Aggregation
(132 days)
The EMBOL-X Intra-aortic Filter is indicated for use with the EMBOL-X Aortic Cannula in first time, nonemergent cardiac surgery procedures to capture and remove particulate emboli from the ascending aorta and heart during and following cross clamp removal in patients aged 18 years and older.
The EMBOL•X® Intra-aortic Filter device consists of three primary components: (1) a distal heparin-coated mesh filter, mounted onto a flexible frame to form a filter basket for particulate emboli capture and retention; (2) a locking cartridge housing for attachment to the EMBOL•X Aortic Cannula side port, permitting access to the aorta and to ensure correct orientation of the filter during use; and (3) a proximal syringe-like plunger mechanism to deploy and withdraw the distal basket into and from the aorta, via the cannula, during surgery. The filter is introduced surgically into the aorta via the previously placed cannula, and particulates are captured and removed as blood passes through the filter basket. The filter may remain in situ for up to 60 minutes. The EMBOL•X Intra-aortic Filter utilizes conventional medical grade materials and processes, and is provided packaged, labeled, and sterile, intended for single-use.
I am sorry, but the provided text is for a 510(k) summary for a medical device (EMBOL•X® Intra-Aortic Filter), which is a physical device, not an AI/ML device. Therefore, the questions related to AI/ML device performance, such as sample size for test/training sets, ground truth establishment, expert adjudication, or MRMC studies, are not applicable.
The document discusses the device's technical characteristics, non-clinical test results (biocompatibility, in-vitro, pre-clinical), and clinical study results from a post-market European Registry to support its safety and effectiveness for expanded indications. These studies confirm the device meets established internal performance specifications and satisfies relevant external standards and FDA guidance.
Here's the relevant information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a tabular format with specific numerical targets. However, the performance is described in terms of safety and effectiveness, drawing comparisons to a predicate device study.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: No additional risk compared to predicate/expected. | - Composite Safety Endpoint: Comparable between IDE Eligible Registry patients and the Filter arm of the US IDE Study (K022071). |
| - No increases in the composite safety endpoint between IDE Eligible Registry patients and Non-IDE Eligible Registry patients (combination CABG/Valve or re-operations). | |
| - Patients undergoing emergent cardiac surgery had higher event rates, and patients < 60 yrs had lower event rates, both considered "expected given the preoperative risk factors." | |
| - Adjustment for preoperative risk factors indicated observed odds ratio was less than expected compared to published, validated univariate analyses of morbidity. | |
| - Observed mortality was comparable to the expected mortality rate seen in European Registry patients. | |
| Effectiveness: Captures and removes particulate emboli. | - A total of 98.2% of the EMBOL-X® Aortic Filters used in the Registry captured one or more particulates. |
| - "The EMBOL-X Intra-aortic Filter is compatible with cardiac surgery procedures." | |
| Biocompatibility: | - Demonstrated through non-clinical (animal) tests from K022071. |
| Sterility: | - Demonstrated through non-clinical tests from K022071. |
| Internal Performance Specifications: | - Meets established internal performance specifications based on non-clinical (bench) tests from K022071. |
| External Standards/FDA Guidance: | - Satisfies requirements of relevant external standards and applicable FDA guidance based on non-clinical tests from K022071. |
| Overall Conclusion: | - "The EMBOL-X Intra-aortic Filter is safe and effective when used as indicated in the instructions for use." |
| - "Provides valid clinical evidence and reasonable assurance that the EMBOL-X Intra-aortic Filter is safe and effective for its intended use in a larger cardiac surgery patient population, namely first time, non-emergent cardiac surgery procedures in patients aged 18 years and older." |
2. Sample size used for the test set and the data provenance:
- Sample Size: 1645 patients for the European ICEM Registry.
- Data Provenance: Prospective, consecutive enrollment registry from 17 centers in Europe. Retrospective analysis of the registry data for comparison.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is a physical medical device. The "ground truth" for its performance is derived from clinical outcomes and the physical capture of particulates, not expert interpretation of outputs.
4. Adjudication method for the test set:
- Not applicable as this is a physical medical device. Clinical outcomes were assessed, and comparisons were made to a composite safety endpoint defined in a previous US IDE Study.
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:
- Not applicable as this is a physical medical device, not an AI/ML device involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable as this is a physical medical device, not an AI/ML algorithm.
7. The type of ground truth used:
- Clinical Outcomes/Events: Specifically, a "Composite Safety endpoint" (as defined in the US IDE Study K022071) which likely includes adverse events and complications.
- Physical Observation: Confirmation that the filter "captured one or more particulates."
- Mortality Rates: Compared to expected mortality rates.
- Morbidity Rates: Compared to expected morbidity rates.
8. The sample size for the training set:
- Not applicable as this is a physical medical device, there is no "training set" in the AI/ML sense. The device's design and initial validation (biocompatibility, in-vitro, pre-clinical tests) would be analogous to development phases, but not a data-driven training set.
9. How the ground truth for the training set was established:
- Not applicable as this is a physical medical device. The "ground truth" for the device's development and design would be based on engineering principles, material science, and pre-clinical testing outcomes, rather than a "training set" with established ground truth labels.
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