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Intended Use: To provide an access port into the peritoneal cavity.

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This appears to be a 510(k) clearance letter from the FDA for a Peritoneal Catheter. This document does not include information about acceptance criteria or a study proving device performance against such criteria.

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 letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market."

This indicates that the device received marketing clearance based on a demonstration of substantial equivalence to a predicate device, not necessarily on a performance study against specific acceptance criteria. While the manufacturer would have performed testing to support the 510(k) submission, the details of that testing, acceptance criteria, and study results are not contained within this FDA clearance letter.

Therefore, I cannot provide the requested information based on the input document. The document is an FDA clearance letter, not a study report or a summary of acceptance criteria and performance data.

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For use as an abdominal access port during a laparoscopic procedure and the 1-way stopcock for attaching insufflation tubing to maintain pneumoperitoneal pressure.

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The provided text is a 510(k) clearance letter for a Peritoneal Catheter. It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria, device performance studies, or clinical trial data.

The letter is a regulatory approval document and not a scientific or clinical study report. Therefore, I cannot extract the requested information as it is not present in the provided text.

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THE DEVICE IS INTENDED FOR USE AS AN ABDOMINAL ACCESS PORT DURING LAPARASCOPIC PROCEDURE AND THE VALVE FOR ATTACHING INSUFFLATION TUBING TO MAINTAIN PNEUMOPERITONEAL PRESSURE.

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I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance testing, or any studies conducted on the device "Introducer Port SC" (K972112). The document is solely an FDA 510(k) clearance letter, which states that the device is substantially equivalent to a predicate device and can be marketed. It does not contain details regarding performance studies, clinical trials, or any specific acceptance criteria that the device had to meet.

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Catheter for drainage of blood and fluid from mediastinum after chest surgery and/or trauma; for use with suction apparatus

Silicone perforated tubing, flattened profile, blue radiopaque stripe; surface treated to reduce friction and Antimicrobial; perforations ("eyes") on both flattened surfaces of tubing; external end has cutaway adapter; imprinted with drain size

This document describes a 510(k) submission for an "Antimicrobial Mediastinal Silicone Drain." However, it is not a study involving AI or a medical imaging device.

Therefore, I cannot provide the information requested in your prompt as it pertains to AI/ML device studies. The prompt asks for details like:

• Acceptance criteria and reported device performance in the context of AI/ML metrics.
• Sample size and provenance for test sets for AI/ML models.
• Number of experts and their qualifications for establishing AI/ML ground truth.
• Adjudication methods for AI/ML ground truth.
• Multi-reader multi-case comparative effectiveness studies for AI/ML assistance.
• Standalone performance of an algorithm.
• Type of ground truth used for AI/ML training/testing.
• Sample size and ground truth establishment for AI/ML training sets.

The provided text describes a catheter with an antimicrobial coating. The "study" mentioned is a microbiological challenge test to prove the effectiveness of the antimicrobial surface against specific organisms.

Here's what I can extract from the provided text, re-framed to directly answer the specific questions where applicable, and noting where the information is not present or irrelevant to AI/ML:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria & Reported Performance (for Antimicrobial Efficacy):

(Note: The document doesn't explicitly state quantitative acceptance criteria like "X% reduction in bacterial count." It only states the device "proved effective" against the listed organisms through a challenge.)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size (for Antimicrobial Challenge Test): Not specified in the document. This would typically refer to the number of device samples tested in the lab.
• Data Provenance: Not specified, but generally, these are laboratory-based studies, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Number of Experts & Qualifications: Not applicable. Ground truth for an antimicrobial challenge test is established in a microbiology laboratory by testing the device against bacterial cultures, not by human experts interpreting medical images.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Adjudication Method: Not applicable. This concept pertains to resolving discrepancies in expert interpretations of medical images, which is not relevant here.

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

• MRMC Study: No. This is not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Standalone Performance: No. This is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Type of Ground Truth: The "ground truth" (or outcome measure) for this device is the inhibition or killing of specific microorganisms when they are exposed to the device's surface in a controlled laboratory setting (microbiological culture results).

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. There is no AI model or training set involved.

9. How the ground truth for the training set was established

• Ground Truth for Training Set Establishment: Not applicable. There is no AI model or training set involved.

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Ask a specific question about this device

Ask a specific question about this device