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The Moss Gastrostomy Tube is used for gastric and proximal duodenal decompression plus duodenal feeding in adult populations.

The Moss Nasal Tube is used for decompression and simultaneous feeding in adult populations.

The 18", triple-lumen, 18FR Moss Gastrostomy Tube provides decompression while simultaneously feeding enterally. The suction channel supplements the gastric site with aspiration within the proximal duodenum. Multiple holes in the suction lumen are designed to prevent mucosal occlusion. The second bore delivers an elemental diet three inches farther downstream into the distal duodenum, utilizing an industry standard ENFit connector. Refluxing excess is automatically removed while still within the proximal duodenum. The third lumen inflates a gastric retention balloon. Each device is individually packaged, and sterilized by Ethylene Oxide.

The 44", triple-lumen, 18FR Moss® Nasal Tube provides decompression while simultaneously feeding enterally. The suction channel supplements the aspiration within the distal esophagus and proximal duodenum. Multiple holes in the suction lumen prevent mucosal occlusion. The second bore delivers an elemental diet three inches farther downstream into the distal duodenum, utilizing an industry standard ENFit connector. Refluxing excess is automatically removed while still within the proximal duodenum. The third lumen inflates a gastric retention balloon at the esophagogastric junction. Each device is individually packaged, and sterilized by Ethylene Oxide.

I am sorry, but the provided text does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is an FDA 510(k) clearance letter and summary for a medical device (Moss Gastrostomy Tube and Moss Nasal Tube - Mark IV).

It primarily discusses:

• The FDA's decision of substantial equivalence to predicate devices.
• Regulatory information (e.g., product codes, classification, general controls).
• Device descriptions and intended uses.
• A limited device modification (change in ENFit connector and cap material from ABS to Nylon).
• Mention of compliance with design controls and design verification activities (e.g., ISO 80369-3 conformance, chemical/mechanical stress test, biocompatibility, sterilization, shelf life).

However, it does not include:

• A table of specific acceptance criteria (performance metrics with pass/fail thresholds).
• Detailed study results proving the device meets these criteria.
• Information on sample sizes for test or training sets.
• Data provenance (country, retrospective/prospective).
• Details about expert involvement (number, qualifications, adjudication methods).
• Any multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance.
• The type of ground truth used or how it was established for training and testing.

Therefore, I cannot populate the table or answer the specific questions you posed based on the provided text. The document confirms that design verification activities were completed, and that the device meets the requirements for "substantial equivalence" based on these activities, but it does not detail the nature or results of those activities in the way your request specifies.

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Used for gastric and proximal duodenal decompression plus duodenal feeding.

Moss Gastrostomy Tube

The provided text does not contain information about the acceptance criteria or a study proving the device meets them. The document is a 510(k) clearance letter from the FDA for a device called "Moss Gastrostomy Tube," dated March 22, 1999. It states that the device is substantially equivalent to legally marketed predicate devices.

The letter mentions:

• Device Name: Moss Gastrostomy Tube
• Indications for Use: Used for gastric and proximal duodenal decompression plus duodenal feeding.
• Regulatory Class: II, 21 CFR 876.5980
• Procode: 78 KNT

However, it does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for test sets, data provenance, or retrospective/prospective study details.
3. Number of experts or their qualifications for establishing ground truth.
4. Adjudication methods.
5. Information about multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes for human readers with/without AI assistance.
6. Results of a standalone algorithm-only performance study.
7. The type of ground truth used (e.g., expert consensus, pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document serves as a regulatory clearance document based on substantial equivalence, not a detailed study report with performance metrics.

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The Moss P. E. G. Tray is used to place a tube through the abdominal wall and into the lumen of the stomach (and/or beyond) without open surgery. The procedure provides a channel for providing nourishment directly into the digestive system for patients who cannot swallow (e.g. after stroke). An independent channel can be suctioned to remove excess feedings, swallowed air, or other fluids that might distend the stomach and lead to vomiting.

Not Found

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria. The document is an FDA 510(k) clearance letter for the Moss P.E.G. Tray, indicating substantial equivalence to a predicate device.

It includes:

• Device Name: Moss P.E.G. Tray (Percutaneous Endoscopic Gastrostomy Tray)
• Regulatory Class: II, 21 CFR 876.5980/Procode: 78 KNT
• Indications for Use: To place a tube through the abdominal wall into the stomach for nourishment, and to remove excess feedings, air, or fluids.
• Date of Clearance: March 17, 1999

However, it does not provide details about:

1. A table of acceptance criteria and reported device performance.
2. Sample size, data provenance, or details of a test set.
3. Number or qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study or effect size.
6. Standalone performance study.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document is a regulatory approval notice, not a study report or clinical trial summary.

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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

1. Table of Acceptance Criteria and Reported Device Performance: This information is not present in the provided document.

2. 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.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.

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 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.

6. 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.

7. 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.

8. 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.

9. 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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Used to feed nutrients directly into the stomach through a stoma in the abdomen. The tubes are intended as a replacement device and are labeled as such.

Moss Tubes, Inc. All Silicone Gastrostomy Tube

The provided document is a 510(k) clearance letter from the FDA for the Moss Tubes All Silicone Gastrostomy Tube. It states that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information regarding acceptance criteria, study details, performance metrics, sample sizes, ground truth establishment, expert qualifications, or adjudication methods.

The 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a predicate device, not necessarily on novel performance studies with detailed acceptance criteria as one might find for a new, high-risk device or an AI/ML-based device.

Therefore, I cannot provide the requested table and information based solely on the text provided. The document confirms the device's clearance but does not elaborate on the specific studies and acceptance criteria that would typically be detailed for performance evaluation.

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