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510(k) Data Aggregation
(106 days)
TurboSEAL, L.P.
The TurboSEAL™ Nasogastric Aspiration Tube (NGAT) is intended for gastric lavage and the administration of nutritional supplements through the distal tube port. It is also indicated for the aspiration of refluxed gastric fluid from the distal esophageal aspiration areas.
The TurboSEAL™ Nasogastric Aspiration Tube (NGAT) is a typical Nasogastric Tube (NGT) allowing for enteral feeding, gastric decompression and gastric lavage. Connection of the device to standard hospital suction enables the application of suction to two separate locations (the Distal and Proximal Aspiration Areas) located at the distal end of the device. Aspiration at these sites allows for the removal of gastric fluid that has entered the esophaqus. Aspiration is limited to one aspiration site at a time, for a maximum duration of 5 hours at each site.
The provided text describes the 510(k) Summary for the TurboSEAL™ Nasogastric Aspiration Tube (NGAT). This document details device characteristics, intended use, and comparison to predicate devices, along with a summary of performance testing.
However, the text does not contain specific acceptance criteria, reported device performance metrics in a readily comparable table, sample sizes, ground truth establishment details, or information regarding expert involvement (number, qualifications, adjudication) for performance studies.
The "Summary of Performance Testing" section lists the types of tests performed, which are primarily engineering verification and validation tests rather than clinical performance studies that would typically involve human-in-the-loop or standalone algorithm performance.
Therefore, many of the requested details cannot be extracted from the provided document.
Here's an attempt to answer the questions based on the available information:
1. A table of acceptance criteria and the reported device performance
The document lists various performance tests conducted but does not explicitly state specific pass/fail acceptance criteria or quantitative performance results for the device against those criteria. It only indicates that the device "meets all of its functional requirements and intended uses" and that testing "demonstrates the substantial equivalence."
| Acceptance Criteria (Stated) | Reported Device Performance (Summary Only) |
|---|---|
| Biocompatibility | Not explicitly stated, implied to be acceptable as part of "substantial equivalence" |
| Sterilization | Not explicitly stated, implied to be acceptable as part of "substantial equivalence" |
| Packaging | Not explicitly stated, implied to be acceptable as part of "substantial equivalence" |
| Shelf Life | Not explicitly stated, implied to be acceptable as part of "substantial equivalence" |
| Dimensional Inspection | Not explicitly stated, implied to be acceptable as part of "substantial equivalence" |
| Liquid Leakage Testing | Not explicitly stated, implied to be acceptable as part of "substantial equivalence" |
| Visual Inspection | Not explicitly stated, implied to be acceptable as part of "substantial equivalence" |
| Tensile Strength Testing | Not explicitly stated, implied to be acceptable as part of "substantial equivalence" |
| Simulated Use | Not explicitly stated, implied to be acceptable as part of "substantial equivalence" |
| Gastric Fluid Compatibility | Not explicitly stated, implied to be acceptable as part of "substantial equivalence" |
| Porcine Animal Study (Visual Examination, Histology) | Not explicitly stated, implied to be acceptable as part of "substantial equivalence" |
| Human Factors/Usability | Not explicitly stated, implied to be acceptable as part of "substantial equivalence" |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document lists a "Porcine Animal Study" but does not specify the sample size for this study or any other test. It also does not mention the country of origin of the data or whether the studies were retrospective or prospective.
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)
The document mentions "Visual Examination (Gastroscopy)" and "Histology" within the Porcine Animal Study, implying expert review. However, it does not specify the number or qualifications of experts involved in establishing ground truth for any of the tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not provide any information regarding adjudication methods for establishing ground truth.
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
No MRMC comparative effectiveness study was mentioned in the document. The device described is a medical tube, not an AI-assisted diagnostic tool, so this type of study would not be applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a physical medical tube, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for engineering tests would likely be based on physical measurements and adherence to specifications. For the "Porcine Animal Study," the ground truth would involve visual examination (gastroscopy) and histology, which are expert-derived evaluations rather than outcomes data in the clinical sense for this type of device.
8. The sample size for the training set
This question is not applicable as the device is a physical medical tube and does not involve machine learning algorithms with training sets.
9. How the ground truth for the training set was established
This question is not applicable for the same reason as point 8.
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