(133 days)
The GISH arterial filters are indicated for use in the extracorporeal bypass circuit for the removal of microemboli. It is designed to operate at flow rates of one (1.0) to six (6.0) liters per minute for periods up to six (6.0) hours.
The Gish Arterial Filter with GBS™ 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 nonpyrogenic.
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 GBS™ Coating may be purchased separately or pre-connected with tubing and other components of an extracorporeal circuit.
The provided text does not contain specific acceptance criteria or a detailed study description with performance metrics for the Gish Arterial Filter with GBS™ Coating. It states that "Final testing for the systems includes various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications" and "Safety tests have further been performed to ensure the device complies with applicable industry and safety standards." However, it does not elaborate on what these specific "functional requirements," "performance specifications," or "applicable industry and safety standards" are, nor does it provide the results of these tests in a quantifiable manner against acceptance criteria.
The submission is for a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a predicate device. The core of the argument is that the new device (Gish Arterial Filter with GBS™ Coating) has "the same device characteristics as the predicate devices" and is "equivalent in safety and efficacy to its predicate device."
Therefore, based solely on the provided text, I cannot complete most of the requested fields as the information is not present.
Here's an attempt to fill in what can be inferred or directly stated:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document. The general criteria seem to be meeting "functional requirements and performance specifications" and complying with "applicable industry and safety standards." | Not explicitly quantified in the document beyond a general statement that the device meets these requirements. The document concludes "that Gish Arterial Filter with GBS™ Coating is equivalent in safety and efficacy to its predicate device." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size Used for Test Set: Not specified. The document mentions "extensive safety, performance, and validations prior to release" and "Final testing," but no specific sample sizes for these tests are provided.
- Data Provenance: Not specified.
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. This device is an arterial filter, not an AI/imaging device requiring expert ground truth for image interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This device is an arterial filter, not an AI/imaging device requiring adjudication for ambiguous cases.
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 device is an arterial filter. The document does not describe MRMC studies or AI involvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device (arterial filter), not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not explicitly stated. For an arterial filter, "ground truth" would likely relate to objective performance measures like filtration efficiency, flow rates, pressure drops, biocompatibility, and mechanical integrity, rather than expert consensus on diagnostic interpretations. The document states that the testing ensured the device meets "functional requirements and performance specifications" and "complies with applicable industry and safety standards."
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device.
§ 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.”