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The Well Lead Ureteral Access Sheath is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract.

The Well Lead Ureteral Access Sheath is a single use sterile device, provides ureteral dilation and a continuous working channel for the introduction of endoscopes and instruments during ureteral access procedures. The Ureteral Access Sheath is comprised of three components: sheath, dilator and connector. The outer surface of the sheath has a hydrophilic coating. When activated, the hydrophilic feature allows for easier insertion and removal of the sheath. The sheath is offered in three French sizes: 10Fr, 12Fr and 14Fr, and range in length from 13cm (shortest) to 55cm (longest).

I am sorry, but the provided text is a 510(k) summary for a medical device (Well Lead Ureteral Access Sheath) and does not contain the specific information requested regarding an AI device's acceptance criteria and the study proving it meets those criteria.

The document focuses on the regulatory clearance process for a physical medical device, outlining its specifications, intended use, and substantial equivalence to predicate devices. It refers to performance testing for the physical device characteristics (e.g., attachment security, bending resistance, coefficients of friction, dimensions, biocompatibility), but not AI performance metrics like sensitivity, specificity, or reader improvement.

Therefore, I cannot fulfill your request based on the provided input.

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The Well Lead Hydrophilic Silicone Foley Catheter is intended for use for bladder management including urine drainage, collection and measurement. The Catheter is passed through the urethra during urinary catheterization and into the bladder to drain urine. The Three-way Catheter provides a lumen that is used for bladder irrigation.

The Well Lead Hydrophilic Silicone Foley Catheter is sterile, single patient use, urinary drainage catheter that is made from silicone and with a hydrophilic coating. The Catheter is available in two types, Two-way and Three-way Silicone Foley Catheter, it is supplied in French size ranging from 6 to 26 and balloon size 1.5cc to 30cc. The 6Fr, 8Fr and 10Fr catheters are for pediatric, and others are for adult.

The provided text describes the 510(k) premarket notification for the "Well Lead Hydrophilic Silicone Foley Catheter." It details the device, its intended use, and substantial equivalence to predicate devices. Crucially, it outlines the performance requirements and testing conducted to demonstrate compliance.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

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

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

The document does not specify the exact sample sizes used for each of the performance tests. It states that "Testing datas and results are included in this submission," but doesn't elaborate on the number of catheters tested for each criterion.

The data provenance is from Well Lead Medical Co. LTD (the manufacturer) and is part of their 510(k) submission to the FDA. It is prospective testing conducted by the manufacturer specifically to demonstrate compliance for their device.

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

This information is not applicable to this type of device and testing. The acceptance criteria are based on objective physical and material properties, defined by industry standards (ASTM F623-99, ISO 10993-1) and the manufacturer's internal criteria, not on expert interpretations of medical images or conditions.

4. Adjudication method for the test set

This information is not applicable. The tests performed are objective, measurable physical properties, not subjective assessments requiring adjudication by multiple experts.

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

This information is not applicable. This device is a urological catheter, not an AI-powered diagnostic tool requiring human interpretation. Therefore, an MRMC study is not relevant.

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, so "standalone performance" in the context of AI is not relevant. The performance refers to the physical and material properties of the catheter itself.

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

The "ground truth" for this device's performance is established by objective physical measurements and adherence to recognized industry standards.

• For performance criteria like "Flow Rate Through Drainage Lumen" or "Balloon Volume Maintenance," the ground truth is defined by the numerical specifications and limits set by ASTM F623-99 and/or Well Lead's internal acceptance criteria.
• For biocompatibility, the ground truth is determined by the results of specific assays as mandated by ISO 10993-1 (e.g., cell viability for cytotoxicity, inflammatory response for implantation, etc.).

8. The sample size for the training set

This information is not applicable. This is a physical medical device, not a machine learning model, so there is no concept of a "training set."

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

This information is not applicable as there is no training set for this device.

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The Well Lead PVC Hydrophilic Urethral Catheter is launched for clean intermittent catheterization-CIC treatment and indicated for use by patients with chronic urine retention. The catheter is inserted into the bladder through the urethra for emptying the bladder.

The Well Lead PVC Hydrophilic Urethral Catheter is a flexible tubular single use urinary catheter that is inserted through the urethra to allow drainage of the bladder. The device consists of disposable polyvinyl chloride catheter (medical grade PVC) coated with hydrophilic polymer. When the catheter is immersed in water for 30 seconds it becomes slippery and ready to use.
The catheters come in sizes from 12Fr-24Fr for Male, 12Fr-24Fr for Female and 6Fr-10Fr for Pediatric.

The provided text describes the regulatory submission for the Well Lead PVC Hydrophilic Urethral Catheter. However, it does not contain information about a study comparing the device's performance against specific acceptance criteria in the context of an AI/human-in-the-loop system. The document is primarily a 510(k) summary demonstrating substantial equivalence to a predicate device for a medical catheter, focusing on non-clinical performance and biocompatibility.

Therefore, many of the requested categories related to AI models, clinical studies, ground truth establishment, and expert involvement are not applicable to the provided information.

Here's an analysis based on the information available:

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

The document lists performance tests with the standard they were tested to and the result ("Complies"). These can be considered the acceptance criteria for those specific physical and material properties.

*Note: For sterility, ETO residual, and biocompatibility, the document states the validation method or that the tests were performed, which implies the results met the criteria for approval, even if the exact "Complies" is not explicitly stated in the table for every test as it is for others.

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

For the non-clinical performance testing (Flow Rate, Strength, Connector Security, Coefficients of Friction), testing was completed on 3 different size catheters: 8Fr (pediatric size), 14Fr, and 24Fr. The document doesn't specify the number of units per size.
For other tests like packaging and biocompatibility, the sample size is not explicitly stated.
The data provenance (country of origin, retrospective/prospective) is not mentioned for these tests. This is a medical device submission, not a clinical trial or AI study, so standard data provenance details for patient data are not relevant here.

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

Not applicable. This document is about the physical and chemical properties of a medical device, not an AI model requiring expert-established ground truth from images or patient data.

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

Not applicable. This is not an AI model evaluation study involving human adjudication of results.

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 document does not describe an AI device or an MRMC study.

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

Not applicable. This document does not describe an AI algorithm.

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

For the non-clinical tests, the "ground truth" is defined by the standards (e.g., ISO 11607, EN1616) they were tested against. The physical and chemical properties of the catheter (e.g., flow rate, strength, seal integrity, biocompatibility) are measured against these established engineering and biological safety standards.

8. The sample size for the training set

Not applicable. This document does not describe an AI model with a training set.

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

Not applicable. This document does not describe an AI model.

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The device is intended for Oral intubation and drainage of the subglottic space for airway management.

Well Lead Endotracheal Tube with Evacuation Lumen-Oral (6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0mm) The Well Lead Endotracheal Tube with Evacuation Lumen is sterile; single-use devices supplied with a standard 15mm connector. It is made of Polyvinylchloride. In addition to the main lumen, the tube has a separate lumen which has a dorsal opening above the cuff. Access to the lumen is accomplished via a clear connecting tube with a capped Luer connector. The tube incorporates a Magill curve, a tip with Murphy Eye and a radiopaque line to assist in radiographic visualization.

The provided text describes a 510(k) submission for a medical device, the "Well Lead Endotracheal Tube with Evacuation Lumen," and its substantial equivalence to predicate devices. However, this submission does not contain the kind of detailed study information (like a comparative effectiveness study with human readers, specific performance metrics, ground truth establishment, or sample sizes for training/test sets) that would be relevant for an AI/ML powered device.

The study described is a non-clinical performance evaluation against established standards for endotracheal tubes. Therefore, I cannot fully complete the requested table and information, as much of it pertains to AI/ML device evaluations which are not present in this document.

Here's what can be extracted and inferred from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not applicable. This was a non-clinical performance test against engineering standards, not a study involving patient data or a "test set" in the AI/ML context. The submission doesn't specify the number of devices tested for each parameter.
• Data Provenance: Not applicable in the context of patient data. The non-clinical tests were conducted on the device itself.

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 expert consensus, is not relevant for this type of non-clinical device testing, which focuses on adherence to engineering standards.

4. Adjudication method for the test set

• Not applicable. There was no need for adjudication as the testing involved objective measurements against established standard limits.

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

• No, a MRMC comparative effectiveness study was not done. This device is an endotracheal tube, not an AI-powered diagnostic or assistive tool for human readers.

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

• Not applicable. This is not an algorithm-based device.

7. The type of ground truth used

• The "ground truth" for this submission was the established engineering and performance specifications defined by the EN1782:1998 and ISO 5361-1:1999 standards for endotracheal tubes. The device's physical and functional characteristics were measured and compared against these predefined limits.

8. The sample size for the training set

• Not applicable. There is no AI/ML component, so no training set was used.

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

• Not applicable. There is no AI/ML component, so no training set or its ground truth establishment is relevant.

Summary of the study that proves the device meets the acceptance criteria:

The study was a series of non-clinical performance tests conducted on the Well Lead Endotracheal Tube with Evacuation Lumen. These tests evaluated various physical and functional attributes of the device, such as surface finish, dimensions, connector integrity, cuff characteristics (herniation, resting diameter, inflation), tube curvature, bevel angle, and the security of the evacuation lumen construction.

The device was tested according to EN1782:1998 and ISO 5361-1:1999 standards. The results of all these tests reportedly fell within the required limits of the respective standards, thereby demonstrating the device's compliance and substantial equivalence to legally marketed predicate devices. This type of testing is standard for demonstrating the safety and performance of medical devices like endotracheal tubes, which are subject to specific material and functional requirements.

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The Well Lead All Silicone Foley Catheters With Temperature Sensor are intended for use in the drainage/collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgical or post-surgical intervals.

The Well Lead all Silicone Foley Catheters with Temperature are two-way Foley Catheters which are used in the drainage/collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgical or post-surgical intervals.

This submission is for a medical device (Well Lead All Silicone Foley Catheter with Temperature Sensor), not an AI/ML device, so the requested information regarding AI-specific criteria (like MRMC studies, ground truth establishment for training sets, etc.) is not applicable. The provided document is a 510(k) summary for a medical device and describes its intended use and general performance testing for substantial equivalence to predicate devices, but does not detail AI/ML acceptance criteria or studies.

However, I can extract the relevant information about the non-AI device's performance testing and acceptance criteria as described in the summary:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a distinct "test set" sample size or data provenance in the context of device performance studies. It refers to testing previously conducted for predicate devices and testing for the current device's components.

• For Foley Catheter components: "All of the appropriate testing for the Foley Catheters was completed and submitted in the previously cleared submission K082815 all the materials are the same as the Foley Catheters in this submission." This implies reliance on prior testing, the details of which are not within this summary.
• For Temperature Sensor: "The testing for the Temperature Sensor can be found in Section 11 the Performance Testing section and in Section 14 Biocompatibility Testing." Specific details about sample size or provenance for this testing are not provided in this summary.

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

This section is not applicable as the device is a physical medical device, not an AI/ML diagnostic tool requiring expert ground truth for image interpretation or similar tasks.

4. Adjudication method for the test set

This section is not applicable for the same reasons as above. Device performance is typically assessed through engineering tests, material compatibility tests, and functional evaluations against specifications, not through expert adjudication in the traditional sense.

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

This section is not applicable as the device is a physical medical device, not an AI/ML system.

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

This section is not applicable as the device is a physical medical device, not an AI/ML algorithm.

7. The type of ground truth used

For physical medical devices like this, "ground truth" typically refers to established engineering standards, material specifications, physiological measurement accuracy (for the temperature sensor), and successful performance in functional tests. The summary implies that the ground truth for performance is established by demonstrating compliance with these standards and equivalence to legally marketed predicate devices.

8. The sample size for the training set

This section is not applicable as the device is a physical medical device and does not involve AI/ML training sets.

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

This section is not applicable as the device is a physical medical device and does not involve AI/ML training sets.

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