(88 days)
The Recovery Filter System is indicated for use in the prevention of recurrent pulmonary embolism via permanent placement in the vena cava in the following situations:
- -Pulmonary thromboembolism when anticoagulants are contraindicated.
- -Failure of anticoagulant therapy for thromboembolic disease
- Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced.
- -Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated.
- -Recovery filter may be removed according to the instructions supplied in the Section labeled: Optional Procedure for Filter Removal. Data from removals in a 58 patient study suggests that the device can be safely removed (mean of 60 days; range 1-161 days).
The Recovery Filter System consists of a nitinol vena cava filter and a delivery system. The filter has two levels of filtration and is prepackaged in a storage tube. The delivery system consists of a 7 Fr ID introducer sheath and dilator and a pusher system. Both components of the system are packaged in Tyvek/film pouches.
The provided text indicates that the Recovery Filter System is "identical to the cited predicate device with the exception of the removal of labeling limitations and the addition of specific instructions to allow for safe removal of the device." Therefore, the primary acceptance criterion is safe removal of the device.
Here's the information about the study that proves the device meets this acceptance criterion, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safe removal of the device | Demonstrated in a series of animal and clinical testing. |
| Confirmatory experience of 58 patients showing the filter "may be safely retrieved." | |
| Mean retrieval time of 60 days (range 1-161 days). | |
| Conclusion that "the benefit of this procedure outweighs the potential associated risks." |
2. Sample size used for the test set and the data provenance:
- Sample Size: 58 patients.
- Data Provenance: Clinical testing. The document doesn't specify the country of origin, but it's presented in a US FDA submission, implying compliance with US regulatory standards. It's a prospective study as it involves the removal of the device in these patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The study focuses on the "confirmatory experience" of patients regarding the safety of removal, implying observational data rather than a judgment based on a specific ground truth as would be established by experts for diagnostic performance.
4. Adjudication method for the test set:
This information is not provided in the document. Given the nature of the study (safety of device removal), an adjudication method in the form of multiple expert reviews might not have been directly applicable. The "safety" would likely be assessed through clinical outcomes and adverse events.
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 was not a MRMC comparative effectiveness study. The device is an intravascular filter, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This was not a standalone performance study. The device is a physical medical implant, not an algorithm.
7. The type of ground truth used:
The ground truth for the safety of removal was based on clinical outcomes and observations in patients, specifically the successful and safe retrieval of the filter, as well as the absence of unacceptable risks. Animal testing (including histology) also contributed to the safety assessment.
8. The sample size for the training set:
This information is not applicable/not provided. The study described is a clinical validation of device safety, not a machine learning model, and therefore does not have a "training set" in that context. There were "animal and clinical testing" which would have informed the device design and instructions for removal, but these wouldn't be referred to as a "training set" in this context.
9. How the ground truth for the training set was established:
This information is not applicable/not provided as there is no "training set" in the context of device approval for an intravascular filter. Safety was established through a combination of animal and clinical testing.
§ 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.”