(42 days)
EndoVive™ Initial Placement PEG Kit is indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional means.
The EndoVive™ Initial Placement Direct PEJ Kit is indicated for use for enteral nutritional support and decompression directly into the jejunum when feeding via the upper gastrointestinal tract is contraindicated.
The EndoVive™ Initial Placement PEG Safety Kit is indicated for providing nutrition directly into the stomach in patients who are unable to consume nutrition by conventional means. The safety components of the kit are designed to reduce the potential for inadvertent sharps injury to medical personnel during and after the procedure.
The proposed EndoVive™ Initial Placement PEG Kit, the proposed EndoVive™ Initial Placement Direct PEJ Kit, and the EndoVive™ Initial Placement PEG Safety Kit are used during initial placement for direct feeding.
The provided text is a 510(k) summary for medical devices (gastrostomy and jejunostomy tubes). This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive clinical performance data or AI model evaluation.
Therefore, the document does not contain the kind of information typically requested for AI/ML device studies, such as:
- Acceptance criteria and reported device performance in a numerical format.
- Sample sizes for test sets, data provenance, or details about training sets.
- Information on expert ground truth establishment (number of experts, qualifications, adjudication methods).
- MRMC comparative effectiveness studies or standalone algorithm performance.
- Specific types of ground truth (e.g., pathology, outcomes data).
Instead, the document states:
"The proposed devices are substantially equivalent to currently marketed devices, as they are identical with the exception of the proposed domed PEG/PEJ material. The proposed devices are substantially equivalent to currently marketed devices in terms of performance characteristics and were tested for biocompatibility."
This indicates that the primary "study" for this submission was a comparison of characteristics to predicate devices and biocompatibility testing, not a clinical trial with performance metrics against a defined acceptance criterion.
Therefore, I cannot populate the table or answer most of the questions as the information is not present in the provided text.
Here's what can be extracted based on the document's nature:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Substantial equivalence to predicate devices (K030855, K030852) in terms of intended use, technological characteristics (except for the proposed domed PEG/PEJ material), and performance characteristics. Biocompatibility testing was also performed.
- Reported Device Performance: The device was determined to be substantially equivalent to the predicate devices and passed biocompatibility testing. No specific numerical performance metrics are provided in this summary.
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable for this type of submission. Performance was based on a comparison of characteristics and biocompatibility, not a clinical test set.
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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): Not applicable. "Ground truth" in the context of clinical performance data is not established or reported for this submission.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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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 is not an AI/ML device.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI/ML device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of clinical performance data. The "ground truth" for this submission is the established performance and safety of the predicate devices.
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The sample size for the training set: Not applicable. This is not an AI/ML device.
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How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
§ 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.