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ARMADA Ureteral Dilator Set: Used for step by step dilatation of the intramural and ureter and / or for stone manipulation.
ARMADA Nottingham One Step Dilator: Used for one step dilatation of the intramural portion and ureter.
ARMADA Amplatz Renal Dilator Set: Used for progressive dilatation for tract prior to percutaneous kidney stone removal.
ARMADA Renal Dilator: Used for dilatation of Renal Tract.
Glider Amplatz Sheath: Used to maintain previously established nephrostomy tract.
Fascial Dilator: Fascial Dilators are used for dilatation of percutaneous track over the guidewire.
Introducer Sheath: Used for introducing safety wire during nephrostomy.
Introducer Catheter: Used for guiding renal dilators for establishing nephrostomy tract.

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I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for "Allwin Dilator & Sets", which specifies the device's indications for use and regulatory information. However, it does not describe any acceptance criteria or a study that proves the device meets specific performance criteria through a rigorous testing process involving AI or human reader performance.

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number of experts or their qualifications.
4. Adjudication method for the test set.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
6. Information about standalone (algorithm only) performance.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

This document is a regulatory approval letter for a medical device (dilators and sets), not a technical report or study detailing the validation or performance of an AI/ML diagnostic tool.

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Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal systems.

Cook Dilator Sets may consist of either a single dilator or a group of components that are used percutaneously to dilate puncture sites or catheter tracts, thereby facilitating the placement of other therapeutic or diagnostic devices into a natural body space (e.g., the peritoneal cavity, an artery or vein) for various vascular or non-vascular clinical applications. Some Dilator Set configurations may also include an entry needle and wire guide. The dilator component of the Dilator Sets is available in diameters ranging from 3.0 to 26.0 French and in lengths ranging from 6 to 65 cm. The broad range of dilator sizes accommodates the variation in the size of the devices that could be inserted through the initial access site. All configurations of the Dilator Sets are supplied as packaged, sterile devices, intended for single-patient use.

This document describes the premarket notification for Dilator Sets manufactured by Cook Incorporated. It's a 510(k) submission, meaning the company is demonstrating that their device is "substantially equivalent" to legally marketed predicate devices, rather than proving its safety and effectiveness from scratch like a PMA would entail.

Therefore, the information provided focuses on comparative performance and compliance with relevant standards, not on a full-scale clinical study with human-in-the-loop performance or detailed AI model training/testing.

Here's an analysis of the provided text in response to your request:

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

The document states that the device was subjected to various tests and "The pre-determined acceptance criteria were met" for all of them. However, it does not explicitly list the quantitative acceptance criteria for each test, nor does it provide the specific numerical performance results. It only confirms compliance.

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

The document does not specify the sample sizes used for any of the tests. Given this is a 510(k) submission for a physical medical device, the "data provenance" would refer to the location and conditions of the lab testing, which are not detailed here. There's no mention of specific patient data, as this is not an AI/software device or a clinical trial report.

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)

This question is not applicable to the provided document. The "ground truth" in this context is established by engineering standards and validated test methods (e.g., ISO 10993-1, ISO 11070, ASTM F640-12), not by expert consensus on clinical data interpretation. Therefore, there's no mention of experts establishing a "ground truth" for a test set in the way one would for an AI diagnostic device.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple readers assess and come to a consensus on image interpretation or diagnosis. The tests performed here are engineering and material property tests conducted under specific protocols, not expert clinical reviews.

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 (dilator sets), not an AI-assisted diagnostic tool. Therefore, no MRMC studies or human reader improvement analysis were conducted or are relevant to this submission.

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 or software. Its performance is evaluated through physical and material property tests, not through standalone algorithm performance.

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

The "ground truth" for the device's performance is based on established international and industry standards and approved study protocols for medical device testing. For example:

• Biocompatibility: ISO 10993-1:2009
• Dilator Hub to Shaft Tensile: ISO 11070:2014
• Radiopacity: ASTM F640-12
• Dilator Tip Rollback: ISO 11070:2014, Annex A.3
• Kink Radius: ISO 11070:2014, Annex A

These standards define methods and typically acceptable performance ranges or pass/fail criteria, which serve as the "ground truth" for these engineering tests.

8. The sample size for the training set

Not applicable. This device does not involve machine learning or AI, so there is no concept of a "training set."

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

Not applicable, as there is no training set.

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The Ureteral Dilator Sets are intended for the dilation of the ureter prior to ureteroscopy or stone manipulation.

The Ureteral Dilators are intended for the dilation of the ureteroscopy or stone manipulation.

The Ureteral Dilator Sets, and each individual Ureteral Dilator, are used for dilation of the ureter prior to ureteroscopy and/or stone manipulation. The Ureteral Dilator Sets are available in one of three sets: a set of 6 dilators, a set of 7 dilators and a wire guide, or a set of 9 dilators and a wire guide. The dilators are manufactured from either radiopaque ethylene vinyl acetate (EVA) or fluorinated ethylene propylene (FEP). Dilators manufactured with EVA are also available with hydrophilic coating. Dilators are also available individually. The wire guide is a stainless steel fixed core wire guide. The Ureteral Dilators and the Ureteral Dilator Sets are sterilized by ethylene oxide and intended for one-time use.

All Ureteral Dilators are manufactured with a length of 60 centimeters and range from 6.0 French to 18.0 French in diameter. The distal end of the dilators is tapered to a 0.040inch diameter endhole with the taper measuring 0.8-2.5 centimeters from the distal end, depending on the device French size. Additionally, the French size of each dilator is stamped at the proximal end.

The stainless steel fixed cored wire guide is manufactured with a diameter of 0.038 inches (0.97 millimeters) and a length of 145 centimeters.

The provided document is a 510(k) premarket notification for a medical device (Ureteral Dilator Sets and Ureteral Dilators). This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance criteria through a clinical or algorithmic study with defined acceptance criteria for a new, unproven technology.

Therefore, the document does not contain the kind of information requested in your prompt, which pertains to studies proving performance against acceptance criteria for an AI/ML or diagnostic device (e.g., sensitivity, specificity, physician improvement with AI assistance, ground truth establishment).

The "acceptance criteria" discussed in this document refer to bench testing for physical characteristics of the dilators, not clinical performance metrics or AI algorithm performance.

Here's why the document doesn't fit your prompt's requirements:

• Device Type: The device is a physical medical instrument (ureteral dilators), not an AI algorithm, diagnostic tool, or imaging system that would typically have performance metrics like sensitivity, specificity, F1-score, or require MRMC studies.
• Submission Type: A 510(k) for this type of device focuses on demonstrating substantial equivalence in terms of intended use, technological characteristics, and safety/effectiveness profiles compared to a predicate, often through bench testing and material characterization, rather than new clinical efficacy studies.
• Tests Performed: The tests listed (Tensile, Kink Resistance, Dilator Tip Rollback, Lubricity, Dimensional Verification, Radiopacity, Biocompatibility, Sterility, Packaging Integrity) are all bench tests and material/biological compatibility assessments, not performance studies involving human readers or AI output.

If I were to hypothetically interpret the "acceptance criteria" from the bench testing context within the provided document, here's how it would look, but please be aware this is not what your prompt is asking for in terms of AI/diagnostic device performance:

Hypothetical Table of "Acceptance Criteria" for Ureteral Dilators (Based on Bench Testing from Document)

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