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Indicated for coagulation of tissue
These devices are intended for use by qualified medical personnel trained in the use of electrosurgery.

Model A 4000 Tubular Electrode, 4 Needle, No Irrigation or Aspiration
Model A 4000 Tubular Electrode, 4 Needle, With Irrigation or Aspiration
Model A 4400 Tubular Electrode, 8 Needle (2 rows of 4), No Irrigation or Aspiration
Model A 4400 Tubular Electrode, 8 Needle (2 rows of 4), With Irrigation or Aspiration
Model A 8000 Tubular Electrode, 8 Needle, No Irrigation or Aspiration
Model A 8000 Tubular Electrode, 8 Needle, With Irrigation or Aspiration

I apologize, but the provided text from the FDA 510(k) premarket notification for the Conway Stuart Medical Tubular Electrode series (Model A 4000, A 4400, A 8000) does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or any details typically found in such studies.

The document is a letter from the FDA acknowledging the review of the 510(k) submission and determining substantial equivalence for the device. It focuses on regulatory aspects such as:

• Trade Names and Regulatory Class: Listing the different models and their classification.
• Substantial Equivalence Determination: Stating that the device is substantially equivalent to predicate devices marketed before May 28, 1976.
• Regulatory Compliance: Reminding the applicant of general controls, Good Manufacturing Practice (GMP) requirements, and other federal laws.
• Marketing Authorization: Allowing the device to be marketed.
• Indications for Use: Stating that the devices are "Indicated for coagulation of tissue" and "intended for use by qualified medical personnel trained in the use of electrosurgery."

Therefore, I cannot provide the requested table or information because the document does not contain the study details.

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The Stretta Control Module Model S400 RF electrosurgical generator with pump, in combination with CSM electrodes, is indicated for coagulation of tissue. This device is intended for use by qualified medical personnel, trained in the use of electrosurgery.

The Stretta Control Module Model S400 is an electrosurgical generator that is designed to deliver controlled low level radiofrequency energy for localized tissue coagulation. The Stretta generator has controls for maximum temperature, power delivered, energy delivered and time of energy delivered. The unit has readout for total energy delivered, impedance, maximum power and temperature for up to six channels. Connectors located on the front panel include electrode connectors and a foot pedal. A fluid pump is integrated into the Stretta generator to deliver cooling fluid to the surrounding tissue adjacent to the electrode.

System accessories include an AC power cord, a single-pedal footswitch and a connecting cable.

This document does not contain the requested information regarding acceptance criteria, device performance, or study details. It is a 510(k) premarket notification summary for a medical device (Stretta Control Module Model S400 RF Generator) and includes its intended use, description, comparison to a predicate device, and the FDA's clearance letter. It does not provide data from performance studies or specify acceptance criteria for such studies.

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The Conway Stuart Medical Model 100 Irrigation Pump and Accessories is indicated for irrigation of tissue.

Model 100 Irrigation Pump and Accessories

This document is a 510(k) premarket notification decision letter from the FDA for the Conway Stuart Medical Model 100 Irrigation Pump and Accessories. It does not contain any information about acceptance criteria or a study proving the device meets those criteria.

The letter merely states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices and therefore allows Conway Stuart Medical, Inc. to market the device.

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

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Indicated for coagulation of tissue
These devices are intended for use by qualified medical personnel trained in the use of electrosurgery.

Conway Stuart Medical Model C8 Needle Inflatable Basket Catheter Electrode with Aspiration

I'm sorry, but without further input, I cannot furnish an answer. The provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device called the "Stretta Model C8 Needle Inflatable Basket Catheter Electrode with Aspiration." This letter confirms the device's substantial equivalence to previously marketed devices and outlines regulatory responsibilities. However, it does not contain information about acceptance criteria, device performance, study details, or ground truth establishment. Therefore, I cannot construct an answer based on the provided text.

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The Conway-Stuart Medical Model C4 RF Generator, in combination with Conway Stuart Medical electrodes, is indicated for coagulation of tissue. This device is intended for use by qualified medical personnel, trained in the use of electrosurgery.

Model C4 Radiofrequency Electrosurgical Generator

I am sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter from the FDA for a Model C4 Radiofrequency Electrosurgical Generator. It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory information and indications for use.

It does not include:

1. A table of acceptance criteria and reported device performance.
2. Information on sample sizes, data provenance, or details about test sets.
3. The number or qualifications of experts used for ground truth.
4. Adjudication methods.
5. Details about multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
6. Information about standalone algorithm performance.
7. The type of ground truth used (e.g., pathology, outcomes data).
8. The sample size for the training set or how its ground truth was established.

Therefore, I cannot fulfill your request based on the provided input.

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Indicated for coagulation of tissue These devices are intended for use by qualified medical personnel trained in the use of electrosurgery.

Not Found

The provided text describes an FDA 510(k) clearance letter for an electrosurgical device. It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot fulfill your request for that specific information based on the given text.

The document states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its clearance. Substantial equivalence generally means that the new device has the same intended use and the same technological characteristics as the predicate device, or if it has different technological characteristics, it does not raise different questions of safety and effectiveness, and the data submitted show that the device is as safe and effective as the predicate device. However, the details of how this substantial equivalence was demonstrated through specific studies or acceptance criteria are not present in this clearance letter.

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To be used with an endoscope or other medical instrument when repeated insertion and removal of the instrument is anticipated.

Not Found

I am sorry, but the provided text describes a 510(k) clearance letter for a medical device (Conway Stuart Medical Delivery Sheath). It only contains information about the device's regulatory classification, its intended use, and the FDA's determination of substantial equivalence to a predicate device.

The document does not contain any information about:

• Acceptance criteria for performance.
• Any study performed to demonstrate device performance.
• Sample sizes, data provenance, ground truth establishment, or expert qualifications.
• Adjudication methods.
• Multi-reader multi-case (MRMC) studies or standalone algorithm performance.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.

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Indicated for coagulation of tissue

These devices are intended for use by qualified medical personnel trained in the use of electrosurgery.

Electrosurgical Basket Electrodes

I am sorry, but the provided text is a 510(k) clearance letter for "Electrosurgical Basket Electrodes" and an associated "Indications for Use" document. This type of document is an FDA clearance and does not contain any information about acceptance criteria or a study proving that a device meets such criteria.

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

To answer your request, I would need a document that describes:

• A specific device that uses AI or has performance criteria requiring a study.
• The acceptance criteria for that device.
• Details of a study performed to demonstrate conformance to those acceptance criteria.

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