(385 days)
The ALN Optional Vena Cava Filter and the ALN Optional Vena Cava Filter with Hook is indicated for the prevention of recurrent pulmonary embolism via placement in the vena cava in the following situations:
- Pulmonary thromboembolism when anticoagulants are contraindicated; -
- Failure of anticoagulant therapy in thromboembolic diseases; -
- Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced; and
- Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated.
The ALN Optional Vena Cava Filter and the ALN Optional Vena Cava Filter with Hook may be retrieved according to the instructions supplied in the Instruction For Use of the ALN Extraction Kit.
The ALN Optional Vena Cava Filter with Hook may be retrieved with a standard GooseNeck Snare according to the instructions supplied in the Instruction For Use of this medical device.
Extraction kit: The ALN Optional Vena Cava Filter Extraction Kit has been designed for the removal of an implanted ALN Optional Vena Cava Filter or ALN Optional Vena Cava Filter with Hook in patients who no longer require a filter. The retrieval of the filter can be performed only by jugular approach.
The ALN Optional Vena Cava Filter and Extraction Kit consists of a 9 legs 316L stainless steel vena cava filter with or without a retrieval hook sold with a delivery kit, and an extraction kit with an 8 arms 316L stainless steel forceps. The filter is prepackaged in a filter holder designed to facilitate the insertion of the filter in the introducer catheter. The filter and the delivery kit are packaged together in Tyvel/film pouches and the extraction kit is packaged alone in the same type of pouches.
The ALN Optional Vena Cava Filter is designed to stop free thrombus in the vena cava in high risk patients. The insertion of the filter can be made by jugular, brachial or femoral approach and are very little traumatic, as the sheath has a 7F diameter. The extraction can be made only by jugular approach.
The provided document is a 510(k) Summary for the ALN Optional Vena Cava Filter and Extraction Kit. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a novel AI/ML medical device. Therefore, much of the requested information regarding acceptance criteria and study details for an AI/ML device is not applicable or cannot be extracted from this document.
However, I can provide information on the non-clinical and clinical performances presented to support the device's safety and effectiveness, which serve a similar purpose to demonstrating acceptance criteria.
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria in a table format. Instead, it describes general categories of non-clinical tests and highlights that the device "passed all the tests required to demonstrate its non clinical performances." For clinical performance, it discusses "low rates of complication" and successful retrieval.
Here's a summary of the reported performance categories:
| Acceptance Criteria Category (Implied) | Reported Device Performance |
|---|---|
| Non-Clinical Performances | |
| Simulated deployment | Passed all required tests. |
| Introducer / sheath suitability | Passed all required tests. |
| Clot trapping ability | Passed all required tests. Bench test comparison with a predicate device showed similar results. |
| Filter fracture | Passed all required tests. |
| Caval perforation / filter migration | Passed all required tests. |
| Thrombogenicity | Passed all required tests. |
| MRI compatibility | Passed all required tests. |
| Clinical Performances | |
| Safety and Effectiveness | Demonstrated via clinical data collected for 14 years. "In conformance with the FDA guidance for cardiovascular intravascular filter." Similar to predicate device clinical performances. "Low rates of complication" reported in a 2006 study. |
| Filter Retrieval Safety and Success | In a clinical study of 220 patients, 55 filters were retrieved "without any complication" after a mean period of 51 days (range: 6 - 352 days). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
For clinical performance, a study involving 220 patients was cited. The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It mentions the study was published in "Chest in 2006."
For non-clinical performance, specific sample sizes are not provided for each test, but it states "passed all the tests required."
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 to this type of device and study. The clinical data involves patient outcomes and complications, which are typically established through medical records and clinical assessments by treating physicians, not by a panel of experts creating "ground truth" in the context of an AI/ML device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable to the type of safety and effectiveness study described for this medical device. Clinical outcomes and complications are generally recorded by treating clinicians and are not subjected to a multi-reader adjudication process as would be common in an imaging-based AI/ML 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
There is no indication that a multi-reader multi-case (MRMC) comparative effectiveness study was performed for this device, nor is there any mention of AI assistance. This document describes a traditional medical device, not an AI/ML diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is a physical medical implant (vena cava filter) and extraction kit, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For clinical performance, the "ground truth" was based on outcomes data (e.g., complication rates, successful retrieval rates) from the 220-patient clinical investigation. These outcomes would have been observed and recorded by medical professionals.
8. The sample size for the training set
This information is not applicable as this isn't an AI/ML device requiring a training set. The clinical data referenced is to demonstrate the device's performance in real-world use.
9. How the ground truth for the training set was established
This information is not applicable as this isn't an AI/ML device.
§ 870.3375 Cardiovascular intravascular filter.
(a)
Identification. A cardiovascular intravascular filter is an implant that is placed in the inferior vena cava for the purpose of preventing pulmonary thromboemboli (blood clots generated in the lower limbs and broken loose into the blood stream) from flowing into the right side of the heart and the pulmonary circulation.(b)
Classification. Class II. The special controls for this device are:(1) “Use of International Standards Organization's ISO 10993 ‘Biological Evaluation of Medical Devices Part I: Evaluation and Testing,’ ” and
(2) FDA's:
(i) “510(k) Sterility Review Guidance and Revision of 2/12/90 (K90-1)” and
(ii) “Guidance for Cardiovascular Intravascular Filter 510(k) Submissions.”