(29 days)
The Monarch™ G-Tube is to be used as a percutaneous replacement gastrostomy tube for providing a patient with nutrition, medication and allow for decompression of the stomach through an established stoma in a human patient who is unable to consume nutrition by conventional means.
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Here's an analysis of the provided text, focusing on the request to describe acceptance criteria and a study proving device performance.
Based on the provided document, the "Capsule Monarch™, Transshaping Gastrostomy Tube" received a 510(k) clearance from the FDA. However, this document does not contain information about specific acceptance criteria or an explicit study proving the device meets those criteria.
The 510(k) clearance process focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than requiring a detailed clinical study with quantifiable acceptance criteria in the same way a PMA (Pre-Market Approval) Submission would.
Therefore, many of the requested fields cannot be directly extracted from this document. I will fill in what can be inferred or stated as "Not Applicable" or "Not Provided."
Acceptance Criteria and Device Performance Study for Capsule Monarch™, Transshaping Gastrostomy Tube
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Provided | Not Provided |
| (The 510(k) clearance process for this device relies on demonstrating substantial equivalence to a predicate device, rather than specific, quantitative performance criteria being met through a dedicated study detailed in this document. The FDA letter confirms the device is substantially equivalent for its stated indications for use.) | (The document does not contain quantitative performance data or results from a study designed to meet specific acceptance criteria.) |
2. Sample size used for the test set and the data provenance
- Sample Size: Not Provided.
- Data Provenance: Not Provided. The 510(k) clearance is based on comparison to a predicate device, and the specific data used for that comparison (if any formal test set was created) is not detailed in this letter.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not Provided.
- Qualifications of Experts: Not Provided.
4. Adjudication method for the test set
- Adjudication Method: Not Applicable / Not Provided. The 510(k) summary does not describe a test set or an adjudication process for 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
- MRMC Study: No. This device is a gastrostomy tube, not an AI-assisted diagnostic tool, so an MRMC study with human readers and AI assistance is not applicable.
- Effect Size: Not Applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: No. This device is a physical medical device (gastrostomy tube), not a software algorithm.
7. The type of ground truth used
- Type of Ground Truth: Not Applicable / Not Provided. The 510(k) process for this type of device typically relies on engineering and material specifications, biocompatibility testing, and comparison to a known safe and effective predicate device rather than a "ground truth" derived from expert consensus, pathology, or outcomes data in the context of diagnostic accuracy.
8. The sample size for the training set
- Sample Size: Not Applicable / Not Provided. As this is not an AI/algorithm-based device, there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- How Ground Truth Established: Not Applicable. (See point 8).
Summary of Information from Document:
The provided document is an FDA 510(k) clearance letter for the "Capsule Monarch™, Transshaping Gastrostomy Tube." This letter confirms that the FDA found the device to be substantially equivalent to legally marketed predicate devices for its stated Indications For Use:
- To be used as a percutaneous replacement gastrostomy tube for patients with a well-established gastrostomy tract.
- Assists in providing nutrition through an established stoma in a human patient who is unable to consume nutrition by conventional means.
- Can also deliver medication and allow for decompression of the stomach.
The core of this regulatory approval is substantial equivalence, meaning the device is as safe and effective as a predicate device already on the market, not that it underwent a specific clinical trial demonstrating performance against predefined acceptance criteria outlined in this document.
§ 876.5980 Gastrointestinal tube and accessories.
(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.