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The Optilume Basic Urological Balloon Dilation Catheter is indicated for the dilation of urethral strictures.

The Optilume Basic Urological Balloon Dilation Catheter (Optilume Basic) is a 0.038" (0.97 mm) guidewire and flexible cystoscope compatible over-the-wire (OTW) catheter with a dual lumen design with a tapered atraumatic tip. The Optilume Basic is used to exert radial force to dilate narrow urethral segments (strictures). The distal end of the catheter is a semi-compliant inflatable balloon. The usable length is 75 cm and allows the device to be compatible with the working channel of a standard flexible cystoscope. The device has two radiopaque marker bands that indicate the working length of the balloon.

The device is sterilized using ethylene oxide in a Tyvek pouch. Post sterilization the pouched catheter is sealed in a foil pouch with desiccant and contained within a single unit carton.

The provided text describes the regulatory clearance of the Optilume Basic Urological Balloon Dilation Catheter (K191061) as substantially equivalent to a predicate device. It includes performance data for various engineering and biocompatibility tests, but it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of diagnostic accuracy, which would typically involve human readers and assessment of performance metrics like sensitivity, specificity, or AUC.

The document focuses on the physical and biological performance of the device itself, rather than evaluating an AI algorithm's diagnostic performance. Therefore, most of the requested information regarding acceptance criteria for diagnostic performance, sample sizes for test/training sets, expert involvement for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance cannot be extracted from this text.

Here's a breakdown of what can and cannot be extracted based on the provided document:

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

The document lists performance tests but does not provide explicit acceptance criteria values (e.g., "burst pressure > X atm") alongside the reported results. It only states that the device "underwent extensive testing" and "performed as intended."

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: Not applicable in the context of diagnostic "test set" as this is a medical device for dilation, not a diagnostic algorithm. For the GLP animal study, the sample size is not specified beyond "canines."
• Data Provenance: The GLP animal study was performed in "canines." No country of origin is mentioned for the animal study.

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):

Not applicable. The performance data relates to the physical and biological characteristics of the device, not the interpretation of diagnostic images requiring expert ground truth.

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

Not applicable.

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 not an AI-assisted diagnostic device.

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

Not applicable. This is not an algorithm.

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

For the engineering tests (e.g., balloon burst, tensile testing), the "ground truth" would be the established engineering specifications and physical properties of the materials. For biocompatibility, the ground truth is compliance with ISO 10993-1 standards. For the animal study, the "ground truth" refers to observation of device performance and absence of adverse events in living subjects.

8. The sample size for the training set:

Not applicable. This is not a machine learning algorithm.

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

Not applicable. This is not a machine learning algorithm.

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The Inflation Device is recommended for use with balloon dilatation catheters to create and monitor the pressure in the balloon and to deflate the balloon.

The Athor Modiour & Locking palm grip that control that control the plunger, a manometer to measure pressure and a connecting tube.

The provided text describes a 510(k) premarket notification for the "Atrion Medical QL® Inflation Device". It is a submission for a medical device, and as such, the concept of "acceptance criteria" and "study proving the device meets acceptance criteria" as typically understood in the context of clinical trials for diagnostic algorithms or AI models does not directly apply here.

Instead, the document focuses on demonstrating substantial equivalence to legally marketed predicate devices, which is the primary regulatory pathway for devices like this. Substantial equivalence means that the new device is as safe and effective as a legally marketed device that is not subject to PMA (Premarket Approval).

Here's an analysis based on the provided text, addressing the points you requested where applicable, and highlighting why some points are not relevant to this type of device and submission:

Analysis of Acceptance Criteria and Device Performance for Atrion Medical QL® Inflation Device (K032840)

1. Table of Acceptance Criteria and Reported Device Performance:

For a device like the Atrion Medical QL® Inflation Device, the "acceptance criteria" are primarily based on demonstrating that it performs equivalently to predicate devices in its fundamental functions and does not raise new questions of safety or effectiveness. The document states:

2. Sample Size Used for the Test Set and Data Provenance:

This information is not applicable to this type of 510(k) submission. The "test set" and "data provenance" as described in the context of AI/diagnostic algorithm validation (e.g., country of origin, retrospective/prospective) are not relevant here. This submission relies on engineering testing and comparison to predicate device specifications, rather than clinical data sets in that sense.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

This information is not applicable. The "ground truth" for a device like an inflation device is based on objective engineering specifications (pressure, material safety, leak integrity, etc.) and its functional equivalence to predicate devices, not expert consensus on medical images or diagnoses.

4. Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods (e.g., 2+1, 3+1) are for resolving discrepancies in expert interpretations, typically in diagnostic studies. This is not how the performance of an inflation device is evaluated.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

This information is not applicable. MRMC studies are used to assess the impact of a diagnostic tool on human reader performance. The Atrion Medical QL® Inflation Device is a surgical accessory, not a diagnostic tool requiring such a study.

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

This information is not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

The "ground truth" for this device's safety and effectiveness determination is primarily based on:

• Engineering Specifications and Performance Testing: Demonstrating the device meets its functional requirements (e.g., pressure range, leak-free operation, material integrity).
• Predicate Device Equivalence: Showing that its design, materials, and intended use are substantially equivalent to previously cleared devices.
• Biocompatibility Testing: Ensuring materials in contact with body fluids are safe.

8. The sample size for the training set:

This information is not applicable. This is not an AI/ML device, so there is no "training set" in the computational sense. The design and testing are based on engineering principles and regulatory standards.

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

This information is not applicable for the same reasons as point 8.

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The inflation device is intended for single use while performing gastrointestinal (GI), gastrouterine (GU) and lacrimal duct balloon catheter dilation procedures to inflate the balloon, monitor the pressure within the balloon and deflate the balloon.

The Atrion Medical Balloon Catheter Inflation Device consists of a plastic syringe with a screw-type plunger and a locking lever and rotating palm grip that control the plunger. a manometer to measure pressure and a connecting tube. The Device has a fluid capacity of 20 cc and an operating pressure range of vacuum to between 10 and 20 atm, depending on the manometer attached.

The provided text describes a medical device, the Atrion Medical Balloon Catheter Inflation Device, and its clearance through the 510(k) pathway. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies.

This document is a "Summary of Safety and Effectiveness" and a subsequent FDA Letter, both primarily focused on establishing substantial equivalence to a predicate device (Ryder International Urological Balloon Catheter Inflation Device). The safety testing mentioned refers to material compatibility with contrast solution, not the functional performance of the inflation device itself in a clinical or simulated clinical setting.

Therefore, I cannot populate the requested table or answer most of the questions using the provided text.

Here's what can be extracted based on the limitations:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:
Not provided in the document. The "safety testing" mentioned refers only to material tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No clinical or performance testing requiring expert ground truth is described.

4. Adjudication method for the test set:
Not applicable. No clinical or performance testing requiring adjudication is described.

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 device is a mechanical inflation device, not an AI-assisted diagnostic tool, and no MRMC studies are mentioned.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a mechanical device, not an algorithm.

7. The type of ground truth used:
For the "Summary of Safety Testing," the ground truth used was compliance with "USP guidelines" for material testing with contrast solution. No clinical ground truth is mentioned.

8. The sample size for the training set:
Not applicable. This is a medical device, not an AI model, and no training set is mentioned.

9. How the ground truth for the training set was established:
Not applicable. This is a medical device, not an AI model.

In summary: The provided FDA submission documents focus on comparing the Atrion Medical Balloon Catheter Inflation Device to a predicate device for substantial equivalence, with an emphasis on technological characteristics and material safety. They do not contain the type of performance study data, acceptance criteria, or ground truth information typical for diagnostic or AI-driven medical devices.

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The inflation device is intended for single use while performing urological balloon dilation procedures to inflate the balloon, monitor the pressure within the balloon and deflate the balloon.

The Ryder Urological Balloon Catheter Inflation Device consists of a plastic syringe with a screw-type plunger and a locking lever and rotating palm grip that control the plunger, a manometer to measure pressure and a high pressure connecting tube. The Device has a fluid capacity of 20 cc and an operating pressure range of vacuum to 20 atm.

This document is a 510(k) summary for a medical device (Ryder Urological Balloon Catheter Inflation Device) and does not contain detailed information about a clinical study with acceptance criteria, sample sizes, expert involvement, or adjudication methods in the way a diagnostic AI study would. Instead, it focuses on demonstrating substantial equivalence to a predicate device through technological characteristics and safety testing.

Therefore, many of the requested fields cannot be directly extracted from the provided text.

Based on the information given, here's what can be inferred and what cannot:

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

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

• Sample Size for Test Set: Not applicable. This document describes a new device submission, not a study involving a "test set" in the context of clinical performance data. The device's safety was assessed through materials testing and comparison to a predicate.
• Data Provenance: Not applicable.

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)

• Not applicable. No "ground truth" establishment in a diagnostic sense is described.

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

• Not applicable.

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 device is not an AI-assisted diagnostic tool.

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

• Not applicable. This is a physical medical device, not an algorithm.

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

• For the safety testing, the "ground truth" was adherence to USP guidelines for biocompatibility of materials.

8. The sample size for the training set

• Not applicable. No "training set" in the context of machine learning or clinical trials is mentioned.

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

• Not applicable.

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The AQ Hydrophilic Dilators are intended to dilate the suprapubic and/or nepluostomy fascial tract, urethra and ureters.

The AQ Hydrophilic Dilators are intended to dilate the suprapubic and/or nepluostomy fascial tract, urethra and ureters. The constructions of the materials are polyethylcuse and vinyl. The lydrophilic coating will allow the catheters to become lubricious which will reduce friction.

This document is a 510(k) summary for a medical device called "AQ Hydrophilic Dilators." It is a premarket notification to the FDA. The document focuses on establishing substantial equivalence to predicate devices based on indications for use, design, and materials, rather than providing a performance study with acceptance criteria.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available in the provided text.

The document primarily describes:

• Device Name: AQ Hydrophilic Dilators
• Intended Use: To dilate the suprapubic and/or nephrostomy fascial tract, urethra, and ureters.
• Materials: Polyethylene and vinyl with a hydrophilic coating for lubricity.
• Predicate Devices: Ureteral Dilators with Hydro Plus™ (Microvasive) and uncoated dilators (Cook Urological).
• Substantial Equivalence Argument: Based on similar indications, design, materials, manufacturing processes, packaging, and sterilization to predicate devices.

There is no mention of a clinical study or performance data against specific acceptance criteria in this 510(k) summary.

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