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The Stomach (Gastric) Tube is intended for gastric decompression, gastric lavage, and administration of nutritional supplements and medication.

All Silicone Stomach (Gastric) Tube (Model 2020)

I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study that proves the device meets any specific criteria. The text is a 510(k) clearance letter from the FDA for a device called "All Silicone Stomach (Gastric) Tube (Model 2020)".

This letter primarily focuses on:

• Device Name: All Silicone Stomach (Gastric) Tube (Model 2020)
• Regulatory Information: Regulation number, name, and class.
• Substantial Equivalence: The FDA's determination that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.
• General Controls: Requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
• Indications for Use: Gastric decompression, gastric lavage, and administration of nutritional supplements and medication.

The document does not include details on:

1. Acceptance criteria and reported device performance.
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study.
6. Standalone algorithm performance study.
7. Type of ground truth used.
8. Sample size for the training set.
9. Ground truth establishment for the training set.

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The Silicone Vacuum Cup is to assist a clinician in delivery of an infant during childbirth.

Not Found

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (All Silicone Vacuum Suction) and does not contain the specific information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement. The letter simply states that the device has been found substantially equivalent to a legally marketed predicate device.

Therefore, I cannot extract the following information from the given text:

1. A table of acceptance criteria and the reported device performance: This information is not present. The letter confirms substantial equivalence, not performance against specific criteria.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not mentioned.
6. If a standalone study was done: Not mentioned.
7. The type of ground truth used: Not mentioned.
8. The sample size for the training set: Not mentioned.
9. How the ground truth for the training set was established: Not mentioned.

The document is a regulatory approval, not a clinical study report.

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To pass fluid to and from the urinary bladder after prostatectomy.

Fortune Medical Instruments Corp. All Silicone 2-Way/3-Way Hematuria Catheters Models 4861, 4862, 4863, 4864 and 4865.

I am sorry, but I cannot fulfill your request to describe the acceptance criteria and study for a device based on the provided text. The document is a 510(k) clearance letter from the FDA, which confirms that a medical device (Fortune All-Silicone 2-Way and 3-Way Hematuria Catheter Models) is substantially equivalent to a legally marketed predicate device.

This type of letter does not include information about specific acceptance criteria or an analytical study with performance metrics, sample sizes, expert qualifications, or ground truth methods. It simply states that the FDA has reviewed the premarket notification and determined substantial equivalence, allowing the device to be marketed.

Therefore, the requested information (such as a table of acceptance criteria, sample sizes, expert details, adjudication methods, MRMC study, standalone performance, or training set details) is not present in the provided text.

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The Suprapubic Catheter is intended to use for drainage of the bladder through a needle puncture or stab wound over the bladder.

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This document is a 510(k) premarket notification letter from the FDA to Fortune Medical Instrument Corp. for a Suprapubic Catheter. It indicates that the device has been found substantially equivalent to legally marketed predicate devices.

Critical information for describing acceptance criteria and a study demonstrating device performance is absent from this document. Section {0} is the FDA's acceptance letter, and Section {2} is the Indications for Use statement for the device. Neither of these sections
contain information about:

1. Acceptance criteria
2. Reported device performance
3. Details of any study (sample size, data provenance, ground truth, adjudication, MRMC, standalone performance, training set details).

This document primarily serves as regulatory clearance, not a performance study report. Therefore, I cannot provide the requested information based solely on the provided text.

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To preserve patency of the common duct and to ensure drainage of bile out of the body until edema in the common duct has subsided enough for bile to drain into the duodenum normally. The T-Y Drainage Tube is also allowed for flush in the common duct.

All Silicone T-Drainage Tube w/wo Eyes All Silicone Y-Drainage Tube All Silicone T-Y Drainage Tube

The provided text is a 510(k) premarket notification letter from the FDA. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or detailed methodologies for establishing ground truth or conducting comparative effectiveness studies.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..." This means the device was approved based on its substantial equivalence to a predicate device, rather than through a new clinical performance study demonstrating fulfillment of specific acceptance criteria.

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

To be able to answer your questions, I would need a different type of document, such as a summary of safety and effectiveness data, a clinical study report, or a detailed submission document that outlines the device's technical specifications and the studies conducted for its clearance.

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The Silicone Foley Balloon Catheter and Nelation Catheter are intended for use as urinary catheters to pass fluids to and from the urinary bladder.

All Silicone 2-Way Foley Balloon Catheter All Silicone 3-Way Foley Balloon Catheter All Silicone Nelation Catheter

The provided text is a 510(k) clearance letter from the FDA for a medical device. It does not contain information about acceptance criteria, device performance, study designs, sample sizes, expert qualifications, or ground truth methods.

Therefore, I cannot answer the questions based on the input provided. The document outlines regulatory clearance based on substantial equivalence to a predicate device, rather than detailed performance study results.

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