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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:

1. 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.
2. 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.
3. 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.
4. Adjudication method for the test set: Not present. No clinical data or test set requiring adjudication is mentioned.
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: 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.
6. 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.
7. The type of ground truth used: Not present. No clinical data requiring ground truth is detailed.
8. The sample size for the training set: Not present. The device is not an AI/machine learning model, so there is no "training set."
9. 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.

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The device is indicated for percutaneous placement of a long term initial placement feeding and/or decompression gastrostomy device.

The device is described as a Percutaneous Endoscopic Gastrostomy tube. The device may be life supporting in that 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 portion of the over-the-guidewire peg is composed of the same medical grade polyethylene material that is used by Bard and is identical in design. 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 a medical device called the "Radius Push Over the Guide Wire Percutaneous Endoscopic Gastrostomy Kit". It outlines the device's description, intended use, and its comparison to a predicate device for the purpose of demonstrating substantial equivalence to the FDA.

However, the document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. It focuses solely on the regulatory submission process and the determination of substantial equivalence based on comparison to an existing predicate device, rather than performance testing against specific criteria.

Therefore, I cannot fulfill your request for the detailed table and study information as the necessary data is absent from the provided text.

Here's why and what's missing:

• Acceptance Criteria & Reported Performance: These are usually quantitative metrics (e.g., tensile strength, flow rate, biocompatibility testing results, shelf-life stability) with defined pass/fail thresholds. The document mainly describes the device and its intended function, stating that its components perform "the same functions" and are "comparable" to the predicate. This is a descriptive comparison, not a report of specific test results against pre-defined acceptance criteria.
• Sample Sizes, Data Provenance, Expert Information, Adjudication, MRMC/Standalone Studies, Ground Truth: These details are typical for clinical performance studies or rigorous engineering verification/validation studies. The 510(k) summary provided here does not include any such study results. It's a regulatory document demonstrating equivalence, not a scientific publication presenting study data.
• Training Set Information: This would be relevant if the device incorporated a machine learning or AI component that required training. This device is a mechanical medical kit (a gastrostomy tube kit), and therefore, a "training set" in the AI context is not applicable.

In summary, the provided K97210Z document is a regulatory submission for a medical device that relies on substantial equivalence to a predicate device, and it does not include the details of performance studies or acceptance criteria that you've requested.

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The device is a low profile replacement gastrostomy tube kit designed for percutaneous insertion through an established stoma tract.
The device is indicated for percutaneous placement of a low-profile long term gastrostomy feeding and decompression device through an established stoma.

The Low Profile Gastrostomy Tube Kit is a collection of medical devices that are assembled for the convenience of the health care professional for the purpose of creating a percutaneous gastrostomy through which an enteral feeding tube is placed. The Kit contains items that are commonly used in this type of procedure and which otherwise would be procured through the facility's central supply system. The units are packaged in a kit form with related feeding components and is ethylene oxide sterilized. It is packaged in a preformed plastic tray, and is sealed with a 1073B tyvek lid containing a description of the kit components. This packaging is similar to the predicate unit and is a system commonly used in the medical device industry.

The provided text describes a 510(k) summary for the "Radius Low Profile Gastrostomy Tube Kit." This document explains the device, its intended use, and its comparison to a predicate device for regulatory purposes. However, it does not contain any information regarding specific acceptance criteria, performance studies, sample sizes, expert ground truth establishment, or any of the detailed analytical performance metrics typically associated with a medical device study.

The document is a regulatory submission for premarket clearance based on substantial equivalence, not a clinical or performance study report.

Therefore, I cannot fulfill your request with the provided input text. To answer your questions, I would need a different document, such as a clinical study report or a detailed performance verification and validation report for the device.

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