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The gi 4000 Electrosurgical Generator is intended to deliver electrosurgical outputs to perform cutting and/or coagulation and coagulation with or without delivery of argon gas in flexible endoscopic applications. The integrated lavage pump is intended to was tissue or mucosa within the gut when used in conjunction with washing catheters or bipolar endoscopic probes, endoscope water jet channels, or endoscope working channels. The Genii ArConnect™ Conducting Adapter is intended for use with the gi 4000 during argon assisted coagulation.

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This is an FDA clearance letter for a medical device (gi-4000 Electrosurgical Generator), not a study report. Therefore, it does not contain information about acceptance criteria, device performance tables, sample sizes, expert qualifications, or study methodologies. The document's purpose is to confirm that the FDA has reviewed the device and determined it is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.

While the document references "Indications for Use," it does not provide data from studies to support these indications or detail how the device's performance meets specific acceptance criteria.

Therefore, I cannot provide the requested information from this document.

To answer your request, I would need a clinical study report or a technical performance report for the gi-4000 Electrosurgical Generator.

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The Lariat snare is an electrosurgical device designed to endoscopically grasp, dissect and transect tissue during Gastrointestinal (GI) endoscopic procedures. The device can be used with or without monopolar diathermic energy.

The Lariat snare is an electrosurgical device designed to endoscopically grasp, dissect and transect tissue during Gastrointestinal (GI) endoscopic procedures.

This document is a 510(k) K200745 Premarket Notification for the Lariat Hot/Cold Snare, which is an electrosurgical device. It outlines the FDA's decision regarding substantial equivalence. However, this document does NOT contain information about acceptance criteria or a study proving the device meets those criteria.

The 510(k) clearance process primarily demonstrates substantial equivalence to a predicate device, rather than requiring extensive clinical trials with strict performance criteria and ground truth validation as would be the case for novel AI/Software as a Medical Device (SaMD) products.

Therefore, I cannot fulfill your request for the following information based on the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present.
2. Sample sizes used for the test set and data provenance: Not present.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable/present.
4. Adjudication method for the test set: Not applicable/present.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable/present.
6. If a standalone (algorithm only) performance was done: Not applicable/present (this is a physical device, not an algorithm).
7. The type of ground truth used: Not applicable/present.
8. The sample size for the training set: Not applicable/present.
9. How the ground truth for the training set was established: Not applicable/present.

The document is a regulatory clearance letter, not a clinical study report or a technical performance description for an AI/SaMD product. The "Lariat, Hot/Cold Snare" is a physical medical device.

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The BioGuard Air/Water Valve is intended to be used to control the air/water function on and endoscope during a Gl endoscopic procedure.

The BioGuard Suction Valve is intended to be used to control the suction function on and endoscope during a GI endoscopic procedure.

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The provided document is a 510(k) clearance letter from the FDA for the "Bio Guard Air/Water & Suction Valves." This document primarily focuses on the regulatory clearance for a physical medical device (valves for endoscopes) and confirms its substantial equivalence to predicate devices. It does not contain information about the performance of an AI/ML powered medical device, nor does it describe an acceptance criteria study for such a device.

Therefore, I cannot extract the requested information using this document. It does not provide:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets or data provenance.
3. Number of experts or their qualifications for ground truth.
4. Adjudication method.
5. Multi-reader multi-case (MRMC) comparative effectiveness study results.
6. Standalone performance details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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The AquaShield CO2 System is intended to be used with an air or carbon dioxide (CO2) source with the purpose of supplying sterile water to the endoscope procedures. It is compatible with U.S. commercially available water bottles.

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I apologize, but the provided text from the FDA 510(k) clearance letters and "Indications for Use" document does not contain the specific information required to describe the acceptance criteria and the study proving the device meets those criteria.

The documents primarily focus on:

• Administrative corrections to trade names (Document 0).
• Substantial equivalence determination for the AquaShield System (Document 1).
• General regulatory information and compliance requirements for medical devices (Document 1 & 2).
• Indications for Use of the AquaShield System (Document 3), which states its purpose is to supply sterile water to endoscope procedures and its compatibility with US commercially available water bottles.

There is no mention of:

• A table of acceptance criteria or reported device performance.
• Sample sizes for test sets, data provenance, or details on training sets.
• Number or qualifications of experts, establishment of ground truth, or adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.

Therefore, I cannot fulfill your request using the provided text. 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.

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The Roth Net Retriever Product Line is intended to be used to retrieve excised polyps, tissue samples, foreign bodies and calculi during flexible and rigid endoscopy procedures.

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The provided text is a 510(k) clearance letter from the FDA for the Roth Net Retriever Product Line. It is a regulatory document and does not contain any information about acceptance criteria, device performance studies, or AI-related metrics (such as effect size of human readers with/without AI assistance).

Therefore, I cannot fulfill your request for the following sections based on the provided text:

• A table of acceptance criteria and the reported device performance
• Sample sized used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts
• Adjudication method for the test set
• 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
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

The document primarily focuses on:

• Confirming the substantial equivalence of the Roth Net Retriever Product Line to legally marketed predicate devices.
• Outlining regulatory requirements the manufacturer must adhere to.
• Stating the intended use of the device.

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The AquaShield CO2 System is intended to be used with an air or carbon dioxide (CO2) source with the purpose of supplying sterile water to the endoscopic procedures. It is compatible with U.S. commercially available water bottles.

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I am sorry, but the provided text only contains an FDA clearance letter for a medical device called "AquaShield System CO2." It specifies the device's intended use and regulatory classification but does not include information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, or training set details.

Therefore, I cannot provide the requested information based on the input text.

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For endoscopic ultrasound applications using the balloon method in the upper or lower gastrointestinal tract.

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The provided text is a U.S. FDA 510(k) clearance letter for a medical device called the "Ultramatrix EUS Balloon." This document is a regulatory communication and does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria.

The letter confirms that the device is substantially equivalent to a legally marketed predicate device, allowing the manufacturer to market it. It outlines regulatory requirements the manufacturer must adhere to but does not include any performance data, study designs, or ground truth establishment details.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size, data provenance, number of experts, qualifications of experts, or adjudication methods for a test set.
3. Information on a multi-reader multi-case (MRMC) comparative effectiveness study or human reader improvement with AI.
4. Information on a standalone algorithm performance study.
5. Type of ground truth used.
6. Sample size for the training set.
7. How ground truth for the training set was established.

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The AquaShield CO2 System is intended to be used with an air or carbon dioxide (CO2) source with the purpose of supplying sterile water to the endoscope procedures. It is compatible with U.S. commercially available water bottles.

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The provided document is an FDA 510(k) clearance letter for the "AquaShield System CO2- Fujifilm." This letter indicates that the device has been cleared for marketing based on substantial equivalence to a predicate device. However, this document does not contain information about acceptance criteria, a specific study proving those criteria, or details regarding performance metrics for a diagnostic or AI-driven device.

The AquaShield System CO2- Fujifilm is described as a system "intended to be used with an air or carbon dioxide (CO2) source with the purpose of supplying sterile water to the endoscope procedures." This suggests it is an accessory for endoscopy procedures, likely for irrigation or insufflation, rather than a diagnostic device with performance metrics typically associated with AI or imaging analyses.

Therefore, I cannot extract the requested information as it is not present in the provided text. The questions regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details are relevant for AI/ML-driven diagnostic devices, but not for the type of device described in this 510(k) clearance.

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The gi 4000 Electrosurgical Generator is intended to deliver electrosurgical outputs to perform cutting and/or coagulation and coagulation with or without delivery of argon gas in flexible endoscopic applications. The integrated layage pump is intended to was tissue or mucosa within the gut when used in conjunction with washing catheters or bipolar endoscopic probes, endoscope water jet channels, or endoscope working channels. The Genii ArConnect™ Conducting Adapter is intended for use with the gi 4000 during argon assisted coagulation.

Not Found

This document is an FDA 510(k) clearance letter for the gi-4000 Electrosurgical Generator. It confirms that the device has been found substantially equivalent to existing legally marketed predicate devices.

However, this document does not contain the acceptance criteria or a study demonstrating that the device meets acceptance criteria.

The 510(k) clearance process primarily evaluates substantial equivalence to a predicate device, focusing on safety and effectiveness. While testing is certainly conducted by the manufacturer, the detailed results and acceptance criteria are typically part of the manufacturer's submission to the FDA, which is not publicly available in this clearance letter.

Therefore, I cannot provide the requested information based on the given text.

To give you an idea of what that typically looks like for a medical device cleared via 510(k), here's a general outline of the information you've requested, and why it's not present in this specific document:

1. A table of acceptance criteria and the reported device performance: This would typically involve specific quantifiable metrics for the device's performance (e.g., power output accuracy, coagulation time, safety parameters) and the pre-defined thresholds for acceptable performance. This is part of the manufacturer's test report.
2. Sample size used for the test set and the data provenance: This refers to the number of units tested, conditions, and origin of the data. Again, internal testing by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Less applicable to an electrosurgical generator in terms of "ground truth" like in AI/imaging; more relevant to clinical evaluation if human assessment was part of performance testing (e.g., assessment of tissue effects).
4. Adjudication method: Not directly applicable to the type of device or information found in this letter.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: This type of study is primarily relevant for diagnostic imaging devices or AI algorithms that assist human interpretation, not electrosurgical generators.
6. Standalone performance (algorithm only without human-in-the-loop performance): This is specific to AI algorithms. The gi-4000 is a physical electrosurgical generator, so this concept doesn't apply.
7. Type of ground truth used: For an electrosurgical device, "ground truth" would relate to objective measurements of its physical output and effects, often against a gold standard instrument or validated test methods, not expert consensus or pathology in the same way as an imaging diagnostic.
8. Sample size for the training set: Not applicable for this type of device, as it's not an AI/machine learning product that requires training data.
9. How the ground truth for the training set was established: Not applicable for this type of device.

In summary, the provided FDA clearance letter confirms the regulatory status of the gi-4000 Electrosurgical Generator but does not contain the detailed technical performance data, acceptance criteria, or study results that would typically be part of the manufacturer's 510(k) submission.

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The disposable AdvanCE® capsule endoscope delivery device is a 2.5 mm single sheathed device indicated for transendoscopic delivery of Capsules (with the dimensions of 10.5mm - 11.5mm in diameter and 23.5mm in length), to the stomach or duodenum. This device is intended for patients who are either unable to swallow the capsule, or unable to pass the capsule beyond the pylorus in sufficient time to complete the desired diagnostic evaluation.

The disposable AdvanCE® capsule endoscope delivery device is a 2.5 mm single sheathed device.

I am sorry, but based on the text provided, I cannot fulfill your request. The document is a 510(k) clearance letter for a medical device called "Advance - Capsule Endoscope Delivery Device." This letter grants clearance for the device based on substantial equivalence to a predicate device but does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies.

The document discusses:

• The device name and regulation number.
• The indication for use of the device.
• General regulatory requirements for marketing the device.

It explicitly states that the FDA "reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...". This means the device was found to be as safe and effective as a legally marketed predicate device, but the details of how that safety and effectiveness were demonstrated through performance studies are not included in this particular document.

Therefore, I cannot extract the specific information you requested, such as:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets or their provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC study details or effect sizes.
6. Standalone performance details.
7. Type of ground truth used.
8. Training set sample size.
9. Ground truth establishment for the training set.

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