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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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Application of non-thermal radio frequency for relief of minor muscle aches and pains, relief of muscle spasm, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite.

The Ultimate Contour is a body sculpting device that combines the technologies of radio-frequency in one convenient unit. The Ultimate Contour utilizes a single power source and control circuitry that directs the emission of energy based on which operating screen is selected and which applicator handpiece is attached to the unit's delivery cable. Based on the attached handpiece, the Ultimate Contour delivers to the handpiece the appropriate energy intensity based on the settings selected. Delivered radio frequency energy is accomplished with the multi-nodal RF handpiece that contains RF energy to the treatment area and works to gently heat the tissue to induce collagen contraction and increase local circulation. The elevated temperature further works to provide temporary relief from pain and muscle spasms. The unit features an interactive color LCD touchscreen for adjusting device settings, as well as for viewing onboard tutorial videos. The device is presented as two model (005-00035) is an integrated free-standing system. The second model (005-00036) is a portable, table-top style units feature exactly the same internal electronics and components, the exact same software, the exact same attachments and accessories, and the exact same environment of use. The models differ only in the shape and dimensions of the mechanical enclosure of the control unit.

This document is a 510(k) Summary for a medical device called "Ultimate Contour" and "Ultimate Contour Mini." It does not describe an AI/algorithm-based device, but rather a physical device that uses radio frequency for therapeutic purposes.

Therefore, many of the requested criteria for AI/algorithm acceptance and study details (such as sample size for test/training sets, ground truth establishment for AI, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this document.

However, I can extract information related to the device's performance testing and general acceptance criteria as described in the document.

Here's the closest interpretation of the requested information based on the provided document, with notes indicating why certain points are not applicable:

Device Name: Ultimate Contour, Ultimate Contour Mini
Regulation Number: 21 CFR 878.4400 (Electrosurgical Cutting and Coagulation Device and Accessories)
Regulatory Class: Class II
Product Code: PBX
Indications for Use: Application of non-thermal radio frequency for relief of minor muscle aches and pains, relief of muscle spasm, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite.

Acceptance Criteria and Reported Device Performance

The document describes performance testing rather than explicitly stating acceptance criteria in a quantitative sense for each indication. However, it implicitly aims to demonstrate the device's ability to achieve the stated therapeutic effects or safety parameters.

Table of Acceptance Criteria (Inferred from Performance Testing) and Reported Device Performance:

Study Details

Many of these points are not applicable as this is not an AI/algorithm-based device being submitted for a clinical study to prove algorithmic accuracy. It's a physical device seeking substantial equivalence based on technical characteristics and limited clinical performance testing.

1. Sample size used for the test set and the data provenance:

   • For Clinical Performance Testing (heating skin tissues): "a single-site study on 5 human patients with varying skin pigmentation".
   • Data Provenance: Not explicitly stated, but clinical testing implies prospective data collection from human subjects. The document is part of a US FDA submission, so the study would likely have been conducted, or data collected, in North America, but this is not specified.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • N/A. This document describes a physical medical device. The "ground truth" for the clinical performance testing was the direct measurement of skin tissue temperature, not an expert assessment of an image or diagnostic output for an algorithm. There is no indication of experts establishing a "ground truth" label in the sense of an AI model's training or testing.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • N/A. This concept applies to human reader studies often used to establish ground truth for AI algorithms or assess reader performance. The testing for this device involved direct physical measurements (temperature) and engineering verification (electrical safety, RF power), not qualitative assessments requiring adjudication.

4. 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:

   • N/A. This device does not involve AI or human-in-the-loop assistance for interpretation. It's a direct therapeutic device.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • N/A. This is not an algorithm/AI device. The "standalone" performance here would refer to the device itself operating as intended. Bench testing and the limited clinical performance testing (heating tissues to a specific temperature range) serve this purpose for the physical device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For the Clinical Performance Testing: The ground truth was direct physiological measurement (skin tissue temperature, measured to be within 40-45°C). It was not based on expert consensus, pathology, or broader outcomes data for the described study.
   • For other tests (electrical safety, RF power), the "truth" was compliance with engineering standards and design specifications.

7. The sample size for the training set:

   • N/A. This refers to AI/machine learning models. There is no mention of an AI training set for this device.

8. How the ground truth for the training set was established:

   • N/A. As there is no AI training set, this question is not applicable.

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