(276 days)
The Arterial Filter with HA Coating is indicated for use for up to 6 hours in the extracorporeal bypass circuit for the removal of microemboli.
The Gish Arterial Filter with HA Coating is designed for use as the final filtration product in the arterial line of the extracorporeal bypass circuit. The top of the filter housing contains a vent port to assist in the priming and removal of air from the arterial filter. The components of this system which have contact with the fluid path are sterile and nonpyogenic. A filter bypass line may be used to enable blood to bypass the arterial filter should higher than normal pressures be observed on the inlet side of the arterial filter. A four way stopcock is also provided for placement on the vent port of the arterial filter. All materials of the arterial filter are biocompatible and coated with a proprietary coating. The Gish Arterial Filter with HA Coating may be purchased separately or pre-connected with tubing and other components of an extracorporeal circuit.
The provided text describes a 510(k) premarket notification for a medical device, the Gish Arterial Filter with HA Coating. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive details on novel performance studies with acceptance criteria, ground truth, or expert involvement as would be typical for AI/ML device submissions.
Therefore, many of the requested categories for AI/ML device studies are not applicable to this traditional medical device submission.
Here's an analysis based on the information provided:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicit in the 510(k) summary. The submission focuses on demonstrating substantial equivalence to predicate devices (K914791 and K023833). | The device has been "subjected to extensive safety, performance, and validations prior to release." "Final testing for the systems includes various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications." "Safety tests have further been performed to ensure the device complies with applicable industry and safety standards." |
| Functional Requirements (Implicit) | Met |
| Performance Specifications (Implicit) | Met |
| Applicable Industry and Safety Standards (Implicit) | Complies |
| Equivalence to Predicate Devices (Implicit) | Deemed equivalent in safety and efficacy. |
Explanation: In a 510(k) for a non-AI/ML device, explicit numerically defined acceptance criteria for a novel clinical study are often not presented in the summary if the primary pathway is substantial equivalence to a predicate device through non-clinical bench testing and adherence to existing recognized standards. The "acceptance criteria" here are implicitly that the new device performs comparably to the predicate devices and meets relevant safety and performance standards.
Regarding AI/ML specific study information (2-9):
The provided 510(k) submission does not describe an AI/ML device or an AI/ML study. It's for a physical medical device (an arterial filter). Therefore, the following points are not applicable to this document.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This is not an AI/ML device requiring a test set of data. The submission refers to "final testing" and "safety tests" which would typically involve bench testing of the physical filter devices.
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)
- Not Applicable. No ground truth determination by experts is mentioned, as this is not an AI/ML diagnostic or prognostic device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No expert adjudication process is described.
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. This is not an AI/ML device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a physical filter, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable. No ground truth for data is mentioned. The "ground truth" for a physical device would be its ability to physically perform its intended function (e.g., filter microemboli, maintain flow, biocompatibility), typically assessed via engineering and laboratory tests against specifications, not by clinical ground truth data from cases.
8. The sample size for the training set
- Not Applicable. No training set is mentioned as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not Applicable. No training set or associated ground truth establishment is described.
Summary of the Device Study:
The study described is a traditional medical device verification and validation process for a physical device (Gish Arterial Filter with HA Coating). The 510(k) submission states that the device:
- "has been subjected to extensive safety, performance, and validations prior to release."
- Includes "various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications."
- Has undergone "Safety tests... to ensure the device complies with applicable industry and safety standards."
- A literature review was conducted.
- The conclusion is that the device is equivalent in safety and efficacy to its legally marketed predicate devices (Gish Arterial Filter, K914791 and Gish Arterial Filter with GBS™ Coating, K023833).
This submission pathway (510(k)) relies on demonstrating substantial equivalence, often through non-clinical testing (bench and biocompatibility) that shows the new device performs as intended and is as safe and effective as a previously cleared predicate device, rather than detailed clinical trials or studies involving expert performance metrics as would be seen with AI/ML devices.
§ 870.4260 Cardiopulmonary bypass arterial line blood filter.
(a)
Identification. A cardiopulmonary bypass arterial line blood filter is a device used as part of a gas exchange (oxygenator) system to filter nonbiologic particles and emboli (blood clots or pieces of foreign material flowing in the bloodstream which will obstruct circulation by blocking a vessel) out of the blood. It is used in the arterial return line.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submissions.”