(235 days)
The device is indicated for percutaneous placement of a long term initial feeding and/or decompression gastrostomy device.
The device is described as a Percutaneous Endoscopic Gastrostomy tube. The device may be life supporting in tha it can be the primary source of nutrition for the patient. The indications, complications and contra-indications are identical to those of the predicate Bard device. The actual insertion and placement techniques are also identical. The bolster and connector systems perform the same functions as those performed by the Bard unit. The dilator tip is composed of the same medical grade polyethylene material that is used by Bard and is identical in design. The external bolster is a silicone friction fit as is the Bard. The internal bolster system is comparable to the Bard system in both retention and removal characteristics.
The provided text is a 510(k) summary for the "Radius Pull Percutaneous Endoscopic Gastrostomy Kit". This document describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not include information about acceptance criteria or a study proving the device meets those criteria, as typically found in a clinical study report or a more detailed technical submission.
The 510(k) summary is focused on establishing substantial equivalence, primarily by comparing the new device's design, materials, and intended use to a legally marketed predicate device (Bard Ponsky-Gauderer Silicone Peg Tray). This process generally doesn't require new clinical studies for devices similar in design and function to existing ones, especially for a relatively mature technology like gastrostomy tubes.
Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, MRMC study, or standalone algorithm performance) from the provided text because it simply isn't present in this type of regulatory document for this kind of device.
To answer your request based solely on the provided text, I must state that the information is not available.
Here's a breakdown of why each specific point cannot be addressed from the given text:
- A table of acceptance criteria and the reported device performance: Not present. The 510(k) focuses on equivalence of design and function, not on specific performance metrics with acceptance criteria.
- Sample size used for the test set and the data provenance: Not present. No "test set" or clinical study data is detailed. The comparison is based on device features and intended use.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. No clinical data requiring expert review is mentioned.
- Adjudication method for the test set: Not present. No clinical data or test set requiring adjudication is mentioned.
- 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 present. This device is a medical instrument (gastrostomy tube kit), not an AI/imaging diagnostic device. Therefore, MRMC studies and AI assistance are not applicable.
- If a standalone (i.e., algorithm only without human-in-the loop performance) was done: Not present. This is not an algorithm or AI-driven device.
- The type of ground truth used: Not present. No clinical data requiring ground truth is detailed.
- The sample size for the training set: Not present. The device is not an AI/machine learning model, so there is no "training set."
- How the ground truth for the training set was established: Not present. Not applicable to this device.
In summary, the provided 510(k) document is a declaration of substantial equivalence for a medical device (a gastrostomy tube kit) based on comparison to a predicate device. It does not contain the kind of detailed study data, acceptance criteria, or performance metrics that would be found in a submission for a novel, higher-risk device, or an AI/software-as-a-medical-device (SaMD) product.
§ 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.