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Found 4 results
510(k) Data Aggregation
(106 days)
BSS
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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(131 days)
BSS
Indications for use would be when the patient cannot feed him/herself and cannot be fed by another person. This catheter would be placed Nasogastrically and nutrients supplied through catheter to the patient.
Nasogastric Feeding Tube (4Fr, 6Fr, 10Fr and 12Fr; sterile and non-sterile)
The provided document is a 510(k) premarket notification approval letter for a Nasogastric Feeding Tube. It does not contain any information about acceptance criteria, device performance studies, or AI/software validation.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance
- Sample sizes or data provenance for a test set
- Number and qualifications of experts for ground truth
- Adjudication method
- MRMC comparative effectiveness study or effect size
- Standalone performance study
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
The document is a regulatory approval notice, confirming that the FDA found the device (a physical medical device, not a software or AI product) substantially equivalent to a predicate device. It focuses on regulatory compliance rather than detailed performance study results.
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(62 days)
BSS
Used for decompression and simultaneous internal feeding.
Moss Tubes, Inc. Nasal Tube - Mark IV
The provided text is a 510(k) clearance letter from the FDA for a medical device: "Moss Tubes, Inc. Nasal Tube - Mark IV". This type of document does not typically contain detailed information about acceptance criteria or specific study results. It primarily states that the device has been found substantially equivalent to a legally marketed predicate device.
Therefore, most of the requested information cannot be extracted from the provided text. I will indicate where information is missing.
Here's what can be inferred and what is explicitly stated:
Acceptance Criteria and Device Performance
- Acceptance Criteria: Not explicitly stated in the document. A 510(k) clearance is based on substantial equivalence to a predicate device, meaning the new device is as safe and effective as a device already on the market. The acceptance criteria would likely relate to demonstrating this equivalence through performance testing, material biocompatibility, and sterilization validation, but the specific metrics are not detailed here.
- Reported Device Performance: Not explicitly stated. The document affirms the device's substantial equivalence to a predicate device based on its intended use (decompression and simultaneous internal feeding). No specific performance metrics (e.g., accuracy, sensitivity, specificity, flow rates, durability) are provided.
Study Details
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Table of Acceptance Criteria and Reported Device Performance: This information is not present in the provided document.
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Sample size used for the test set and the data provenance: Not mentioned. 510(k) submissions often include bench testing and sometimes limited clinical data, but the specifics of any test set (e.g., sample size, country of origin, retrospective/prospective) are not provided in this clearance letter.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
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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 a "Nasal Tube," which is a physical medical device, not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance would not be relevant.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned. For a physical device like a nasal tube, "ground truth" might relate to physical properties, biocompatibility, or functional performance, but the specifics are not detailed.
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The sample size for the training set: Not applicable and not mentioned. This is not an AI device that typically involves a "training set." Any "training" would be related to user training or manufacturing processes.
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How the ground truth for the training set was established: Not applicable and not mentioned.
In summary, the provided FDA 510(k) clearance letter confirms that the Moss Tubes, Inc. Nasal Tube - Mark IV has been reviewed and found substantially equivalent to predicate devices for its stated indications for use. However, it does not contain the detailed study design, acceptance criteria, or performance data that would typically be required to answer most of your specific questions, as these details are usually part of the full 510(k) submission, not the clearance letter itself.
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(405 days)
BSS
The intended use is for the prophylaxis of pulmonary aspirations during induction and termination of general anesthesia.
The Aspisafe Gastric Tube is designed to be used for the prophylaxis of pulmonary aspiration during induction and termination of general anesthesia.
The provided text describes a 510(k) premarket notification for the Aspisafe Gastric Tube. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical trial data or detailed performance studies with acceptance criteria in the way a novel therapeutic device might.
Based on the provided text, the device Aspisafe Gastric Tube is a Class II medical device intended for the prophylaxis of pulmonary aspiration during induction and termination of general anesthesia. The submission seeks to prove substantial equivalence to Gastric Sump Tubes (K935688) by Andersen Products.
Here's an analysis of the provided information against your requested points:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reported Device Performance (from text) |
|---|---|
| Material Composition | "Composed of materials that have been tested in accordance with Tripartite Guidance for biocompatibility and determined to be suitable for the intended use of this product." |
| Physical Performance | "All finished products are tested and must meet all required release specifications before distribution. The array of testing required for release include, but are not limited to: physical testing, visual examination (in process and to: finished product). The physical testing is defined by Quality Control Test Procedure documents. These tests are established testing procedures and parameters which conform to the product design specifications." |
| Intended Use | "Identical... to the Gastric Sump Tubes currently... There are no new issues of safety or effectiveness raised by Aspisafe Gastric Tube." (Demonstration of substantial equivalence to predicate) |
| Safety and Effectiveness | "NO new issues of safety or effectiveness raised by Aspisafe Gastric Tube" (vs. predicate) |
Note: The document does not provide specific numerical acceptance criteria (e.g., tensile strength minimums, flow rate ranges, specific biocompatibility thresholds) or quantitative performance data. Instead, it refers to internal quality control procedures and adherence to existing guidance documents, which is common for 510(k) submissions focusing on substantial equivalence.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a sample size for any test set or provide details on data provenance (country of origin, retrospective/prospective). The "testing" mentioned refers to internal manufacturing quality control and material biocompatibility, not clinical or comparative performance studies in a "test set" in the sense of a clinical trial.
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 and not provided in the document. The submission is for a medical device (a gastric tube), not an AI or diagnostic algorithm requiring expert-established ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided in the document, as no clinical test set adjudication 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
This information is not applicable and not provided in the document. The device is a physical medical device (gastric tube), not an AI or imaging diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided in the document, as the device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable and not provided in the document. The concept of "ground truth" as used in algorithm validation is not relevant to this type of device submission. The "truth" here is compliance with material safety, manufacturing specifications, and functional equivalence to the predicate device.
8. The sample size for the training set
This information is not applicable and not provided in the document. There is no mention of a "training set" as this is not an AI/algorithm submission.
9. How the ground truth for the training set was established
This information is not applicable and not provided in the document, as there is no training set described.
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