Search Results

For percutaneous placement of a long-term initial-placement feeding and/or decompression device.

The EnTake PEG Standard and Safety System contains a gastrostomy feeding tube, external retention bolster, two-port feeding adapter, feeding tube clamp packaged sterile in a kit containing procedural aides. The EnTake PEG System consist of both standard and safety kits in both push and pull versions. Standard kits contain the components that are typically used in the procedure. Safety kits contain alternative safety versions of the scalpel, the needle introducer and the 5 cc syringe.

The EnTake PEG System will be offered in a variety of sizes and variations that allow for installation via guidewire (push) or pull wire, placement in a new gastrostomy.

The provided text describes a 510(k) submission for the "EnTake™ PEG Standard and Safety System." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than independent performance studies with detailed acceptance criteria and expert reviews often seen for AI/ML devices.

Therefore, much of the requested information regarding acceptance criteria derived from a study, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, and ground truth establishment will not be present in this document.

However, I can extract the information that is available and clarify what is missing based on the nature of this submission.

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable/Not provided in the document. This document describes a 510(k) submission based on substantial equivalence, which primarily relies on comparison to existing legally marketed devices, biocompatibility, and bench testing, rather than clinical efficacy studies requiring large test sets of patient data.

3. 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/Not provided in the document. Ground truth establishment by experts for a test set is not part of this 510(k) summary, as it does not involve the evaluation of an algorithm's performance on medical images or diagnostic data.

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

• Not applicable/Not provided in the document. Adjudication methods are not relevant to this type of device submission.

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

• No, an MRMC comparative effectiveness study was not done. This is not an AI/ML device, and such a study is not required for a PEG tube system.

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

• Not applicable/No. This device is a medical instrument (PEG tube system), not an algorithm, so standalone performance testing in this context is irrelevant.

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

• The "ground truth" for this device's performance is established through biocompatibility and bench testing standards, and the characteristics of the predicate devices. The device passed predetermined performance specifications based on these tests and demonstrated substantial equivalence to the predicate devices in terms of intended use, technological characteristics, and materials.

8. The sample size for the training set

• Not applicable/Not provided in the document. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

• Not applicable/Not provided in the document. As above, this is not an AI/ML device and does not utilize a training set in the conventional sense.

Ask a specific question about this device