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The AMSure® Bladder Irrigation Set is intended for the infusion of fluids to evacuate the bladder. It is also indicated for use in such procedures as cystoscopies and transurethral-resections as a means of continuous bladder irrigation.

The AMSure™ Bladder Irrigation Set is comprised of tubing with a catheter adapter at one end and “spikes” with protectors on the other end. The device is available in a single-lead (single spike), or multiple-lead (2 or 4 spikes) configuration. All configurations have a drip chamber and directly below the drip chamber is a roller clamp. There is a flexible, non-latex, synthetic rubber connecting tube, attached to the catheter adapter.

The provided 510(k) submission for the AMSure® Bladder Irrigation Set (K070873) describes a medical device and its non-clinical testing for safety and effectiveness. However, it does not contain the specific information required to complete a table of acceptance criteria and reported device performance related to an AI/algorithm-driven device, nor does it detail a study that proves the device meets such criteria in the context of AI.

The information provided confirms that the AMSure® Bladder Irrigation Set is a urological irrigation system, and its submission indicates performance and biocompatibility testing were conducted. However, these tests are typical for a physical medical device and do not involve AI, machine learning, or software-driven diagnostic capabilities. Therefore, many of the questions regarding AI/algorithm performance, ground truth, expert review, and reader studies are not applicable to this submission.

Here's a breakdown of the requested information based on the provided document and why certain sections are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states: "Performance and biocompatibility testing have demonstrated that the AMSure® Bladder Irrigation System is safe and effective for its intended use." However, it does not provide a table of specific acceptance criteria (e.g., fluid flow rates, pressure limits, material strength, sterility, etc.) or the quantitative results of these performance tests.

2. Sample size used for the test set and the data provenance

Not applicable. This is a physical medical device, not an AI/algorithm. Performance testing would involve physical samples of the irrigation sets, not a "test set" of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth, in the context of AI, refers to expert-validated labels for data. This device does not generate diagnostic outputs that require expert ground truth labeling.

4. Adjudication method for the test set

Not applicable. Adjudication methods are used in AI performance studies to resolve discrepancies in expert labeling or model outputs, 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

Not applicable. This is a physical medical device, not an AI-assisted diagnostic tool. There are no "human readers" interpreting data with or without AI assistance for this product.

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

Not applicable. There is no algorithm for this physical device that operates in a standalone capacity.

7. The type of ground truth used

Not applicable. As there's no AI/algorithm generating outputs to be evaluated against a ground truth, this concept doesn't apply. The "truth" for this device would be its physical properties and function meeting predefined engineering specifications and biological safety standards (e.g., non-toxic materials, sterile packaging).

8. The sample size for the training set

Not applicable. This is a physical medical device. There is no "training set" in the AI sense.

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

Not applicable. No AI training set.

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AMSure Enteral Delivery Pump Set with Spike is a device intended to deliver, through an enteral feeding pump, liquid nutrition formulas from a container to an enteral access device (a feeding tube).

AMSure™ Enteral Delivery Pump Set with Spike

The provided text is a 510(k) premarket notification letter from the FDA to Amsino International, Inc. regarding their AMSure™ Enteral Delivery Pump Set with Spike. This document confirms the device's substantial equivalence to a legally marketed predicate device and grants permission to market it.

This letter, typical for medical device regulatory approval, does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or specific ground truth methodologies. These details are usually found in the original 510(k) submission document, which is not provided here.

Therefore, I cannot fulfill your request for:

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

The provided document is a regulatory approval letter and not a technical study report.

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AMSure CLEANSING ENEMA SET IS A DEVICE INTENDED TO INSTILL WATER INTO COLON THROUGH A NOZZLE INSERTED INTO THE RECTUM TO PROMOTE EVACUATION OF THE CONTENTS OF THE LOWER COLON.

AMSure® Cleansing Enema Set

This document, K974042, is a 510(k) premarket notification decision letter for the AMSure® Cleansing Enema Set. It declares the device substantially equivalent to legally marketed predicate devices.

The information provided does not contain the details typically sought when describing acceptance criteria and a study to prove a device meets those criteria in the context of a new, potentially AI-driven, medical device. This is largely because the document pertains to a Class I medical device (a cleansing enema set) cleared in 1997, which would not involve the complex performance studies, statistical analysis, or AI-specific criteria requested in the prompt.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria development, study design, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth establishment, or sample sizes related to a performance study for this device based on the given text.

The closest information provided is:

• Device Name: AMSure® Cleansing Enema Set
• Indications For Use: "AMSure CLEANSING ENEMA SET IS A DEVICE INTENDED TO INSTILL WATER INTO COLON THROUGH A NOZZLE INSERTED INTO THE RECTUM TO PROMOTE EVACUATION OF THE CONTENTS OF THE LOWER COLON."
• Regulatory Class: I (21 CFR §876.5210/Product Code: 78 FCE)

For Class I devices like this, substantial equivalence is often based on fundamental design, materials, and intended use being similar to existing legally marketed devices, rather than extensive clinical performance studies as would be required for higher-risk devices or novel AI/software as a medical device. The "acceptance criteria" here implicitly refer to meeting the general controls provisions of the Act and demonstrating substantial equivalence to a predicate device, which would involve showing that the device is as safe and effective as the predicate.

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AMSINO INTRAVASCULAR ADMINISTRATION SET IS A DEVICE INTENDED TO ADMINISTER FLUIDS FROM A CONTAINER TO A PATIENT'S VASCULAR SYSTEM THROUGH A CATHETER INSERTED INTO A VEIN.

Not Found

This document is a 510(k) premarket notification decision letter from the FDA for the Amsino I.V. Administration Set. It states that the device is substantially equivalent to legally marketed predicate devices.

This document describes a regulatory approval for an I.V. administration set, not a software device or an AI/ML medical device. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not applicable to this submission.

The letter is a notification of the FDA's finding of substantial equivalence, which allows the company to market the device. It does not contain performance study data or acceptance criteria in the format typically provided for novel medical devices or AI/ML technologies.

The "Indications For Use" provided in the enclosure merely describes the intended purpose of the device: "AMSINO INTRAVASCULAR ADMINISTRATION SET IS A DEVICE INTENDED TO ADMINISTER FLUIDS FROM A CONTAINER TO A PATIENT'S VASCULAR SYSTEM THROUGH A CATHETER INSERTED INTO A VEIN."

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Amsino Suction Catheter, tracheobronchial, is to be used to aspirate liquids or semisolids from a patient's upper airway.

AMSINO® Suction Catheter

The provided text is a 510(k) clearance letter from the FDA for a device called "AMSINO® Suction Catheter." This letter indicates that the device has been found substantially equivalent to a predicate device, allowing it to be marketed.

However, the letter does not contain any information regarding acceptance criteria or a study proving the device meets those criteria. The content is purely administrative, focusing on the regulatory clearance process.

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

To be clear:

1. Table of acceptance criteria and reported device performance: Not available.
2. Sample size and data provenance: Not available.
3. Number and qualifications of experts for ground truth: Not available.
4. Adjudication method for test set: Not available.
5. MRMC comparative effectiveness study: Not available.
6. Standalone performance study: Not available.
7. Type of ground truth used: Not available.
8. Sample size for training set: Not available.
9. How ground truth for training set was established: Not available.

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Amsino Urinary Leg Bag is a device intended to collect urine.

Not Found

The provided text is a legally binding letter from the FDA to AMSINO International, Inc. regarding their Urinary Leg Bag, confirming its substantial equivalence to previously marketed devices. This document does not contain any information regarding acceptance criteria, device performance, sample sizes, expert qualifications, or study methodologies that you've requested.

Therefore, I cannot extract the requested information from the provided text. The document is a regulatory approval letter, not a technical report or study summary.

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Ask a specific question about this device