Search Results

To provide nutrition directly into the stomach through an established stoma in a patient who is unable to consume nutrition by conventional means.

Not Found

This FDA letter is a 510(k) clearance for a medical device (AMT G-Tube Balloon Replacement Gastrostomy Tube), not a study report. Therefore, it does not contain information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, or other details typically found in a study proving a device meets acceptance criteria.

The letter primarily states that the FDA has reviewed the manufacturer's notification and determined the device is substantially equivalent to legally marketed predicate devices. This means it has similar indications for use and technological characteristics to a device already on the market and does not raise new questions of safety and effectiveness.

To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness data (SSED) or a clinical study report. This 510(k) clearance letter does not provide the requested information.

Ask a specific question about this device

The Pre-Loaded Replacement G-Tube Device is to be used as a percutaneous replacement gastrostomy tube for a patient with a well established gastrostomy tract. This device will assist in providing nutrition directly into the stomach through an established stoma in a human patient who is unable to consume nutrition by conventional means. The Pre-Loaded Replacement G-Tube Device can also deliver medication and allow for decompression of the stomach.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device, the "AMT Pre-Loaded Replacement Gastrostomy Tube." This document is a regulatory approval letter and an "Indications for Use Statement."

Unfortunately, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methods.

The letter from the FDA (Pages {0} and {1}) is primarily concerned with:

• Confirming that the device is substantially equivalent to legally marketed predicate devices.
• Outlining the regulatory classification (Class II).
• Mentioning general controls provisions, manufacturing practice requirements, and other Federal Laws or Regulations.
• Granting permission to market the device.

The "Indications for Use Statement" (Page {2}) describes what the device is intended for (e.g., replacement gastrostomy tube for nutrition, medication delivery, stomach decompression) but does not provide any performance metrics or study details.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The requested information (Table of acceptance criteria, sample sizes, data provenance, expert qualifications, adjudication method, MRMC study, standalone performance, ground truth types, training set sample size, and ground truth establishment for training set) is not present in this regulatory correspondence.

Ask a specific question about this device

The AMT Balloon Stoma Measuring Devices are to be used by medical professionals and home health givers in association with replacement gastrostomy feeding devices. The purpose of the AMT Balloon Stoma Measuring Devices is to aid in determining the depth (length) of an established stoma tract in order to assist in determining the proper length replacement gastrostomy feeding device to be used.

Not Found

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (AMT Balloon Stoma Measuring Devices). This document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as requested in your prompt.

The letter explicitly states that the FDA has determined the device is "substantially equivalent" to predicate devices, which is the basis for its clearance, not a detailed performance study as you've outlined.

Therefore, I cannot extract the requested information from the given text.

Ask a specific question about this device

The A.M.T. Low Profile Feeding Set Accessories are to be used with the Mic-Key Skin Level (low profile) feeding system gastrostomy devices in place of the Mic-Key" Secure-Lok feeding accessories. The purpose of the AMT Low Profile Feeding Accessory Feeding Devices are for administering feeding, medications, and when indicated, decompression.

Not Found

This document is a 510(k) clearance letter from the FDA for a medical device called the "Low Profile Feeding Set Accessory" and its accompanying "Indications For Use Statement." It does not contain information about acceptance criteria or a study proving that the device meets those criteria. Medical devices like this typically undergo laboratory testing and performance evaluations, but the details of such studies are not present in these FDA documents.

Therefore, I cannot provide the requested information from the given input. The document is primarily an administrative letter confirming the device's substantial equivalence to a predicate device and its regulatory classification.

Ask a specific question about this device

The Cauterization Smoke Evacuator is an accessory device used to provide an air suction path for the reduction of gasses, body fluids, and smoke associated with the use of most electro-cauterization systems. The Cauterization Smoke Evacuator is meant to be an accessory add-on device to currently designed and distributed electro-cauterization systems, and most standard operating room suction systems.

The Cauterization Smoke Evacuator is an accessory device used to provide an air suction path for the reduction of gasses, body fluids, and smoke associated with the use of most electro-cauterization systems. The Cauterization Smoke Evacuator is meant to be an accessory add-on device to currently designed and distributed electro-cauterization systems, and most standard operating room suction systems.

This document does not contain information regarding acceptance criteria, device performance, or a study proving that the device meets acceptance criteria. The document is a 510(k) clearance letter from the FDA for a Cauterization Smoke Evacuator, indicating that the device is substantially equivalent to legally marketed predicate devices. It primarily details regulatory information, product classification, and contact information for further inquiries.

Ask a specific question about this device

The Domed Percutaneous Endoscopic Gastrostomy (P.E.G.) Feeding Tube is a percutaneously placed gastrostomy feeding device used to administer nutrition directly into the stomach.

The device is available in either the guidewire or pullwire method. The domed shaped internal bolster is injection molded onto clear medical grade silicone tubing. The tubing has graduated markings which allows for verification of tube positioning. The internal bolster is also composed of medical grade silicone but which has been pigmented with barium sulfate which provides radiopacity. The internal bolsters' shape allows for ease of passage during placement and is advantages because it permits passage of a jeujenostomy tube if jeujenal feeding is required.

The provided 510(k) summary for the Domed Percutaneous Endoscopic Gastrostomy (P.E.G.) Feeding Tube does not contain any information related to acceptance criteria or a study proving the device meets said criteria in the context of an AI/ML-based device.

The summary describes a traditional medical device (a PEG feeding tube) and focuses on its substantial equivalence to existing devices based on its design, materials, and intended use.

Therefore, I cannot provide the requested information. The document does not discuss:

• Acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy).
• Any study involving a test set, ground truth, or expert evaluation.
• Multi-reader multi-case studies or standalone algorithm performance.
• Training sets for an AI/ML model.

This is a traditional medical device submission, not an AI/ML device submission.

Ask a specific question about this device

The Endoscopic Access Device is an instrument access portal for use during endoscopic surgery.

The Endoscopic Access Device is an instrument access portal for use during endoscopic surgery. It is designed to be substantially equivalent to the presently marketed AMT Esophageal Overtube. The devices' internal flange is inserted into the incision site and allowed to expand freely. Once in place, the internal flange retains the device in place and allows for the access of a variety of surgical instruments. The shaft is angulated at 30° but can range from 20° to 90°, depending on the specific application. The external flange reduces site contamination and trauma. It also easily defines the access into the region. The Endoscopic Access Device is injection molded from the same biocompatible Dow Corning silicone (Q7-4840) as the AMT Button (K943392). The Endoscopic Access Deivce is sold sterile for single use.

This 510(k) summary for K960232 provides very limited information about performance criteria and studies. It describes a medical device, an Endoscopic Access Device, and states its intended use. However, it does not include the detailed information requested in the prompt regarding acceptance criteria, specific study results, sample sizes, ground truth establishment, or expert involvement.

Here's a breakdown of why it's not possible to answer the prompt with the provided text, and what can be inferred:

Inference from the Provided Text:

The document is a 510(k) summary for a relatively simple medical device (an access portal for endoscopic surgery), not a diagnostic AI/ML device. This type of device typically relies on simpler performance tests like bench testing for mechanical integrity and biocompatibility, rather than complex clinical studies involving human readers, AI algorithms, or extensive ground truth adjudication.

Specific to the Prompt's Requirements:

1. A table of acceptance criteria and the reported device performance
* Not provided. The text only mentions "Bench testing has been performed on the minimum pull out force versus the the strength of the device to ensure mechanical integrity for functional performance (see Exhibit VIa)." It does not state specific acceptance criteria (e.g., "minimum pull-out force must be > X Newtons") nor does it report the tested performance values (e.g., "device demonstrated a pull-out force of Y Newtons").

2. Sample size used for the test set and the data provenance
* Not provided. The term "bench testing" implies laboratory testing of physical samples, but the number of samples tested is not mentioned. Data provenance (country of origin, retrospective/prospective) is irrelevant for this type of mechanical bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
* Not applicable/Not provided. This device does not have "ground truth" in the diagnostic sense. Its performance is assessed through objective physical measurements (e.g., force, strength), not expert interpretation of outputs.

4. Adjudication method for the test set
* Not applicable/Not provided. No adjudication method would be used for bench testing of mechanical properties.

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, and not applicable. This is not an AI/ML device, nor is it a diagnostic device that would involve human readers interpreting data.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
* No, and not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
* Not applicable. The "ground truth" for this device's performance would be the objectively measured physical properties (e.g., actual tensile strength, actual biocompatibility).

8. The sample size for the training set
* Not applicable/Not provided. This device doesn't have a "training set" in the machine learning sense. The design and manufacturing process would involve internal testing and iterations, but this isn't reported as a formal "training set."

9. How the ground truth for the training set was established
* Not applicable.

Summary of available information regarding performance:

• Test Performed: Bench testing on "minimum pull out force versus the strength of the device."
• Purpose of Test: To "ensure mechanical integrity for functional performance."
• Reference: "see Exhibit VIa" (which is not provided)
• Biocompatibility: Stated to be "injection molded from the same biocompatible Dow Corning silicone (Q7-4840) as the AMT Button (K943392)," implying equivalence in material biocompatibility based on a previously cleared device. This acts as a form of "data provenance" for the material's safety.

Ask a specific question about this device