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The Single-use 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 Single-use 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 device models are Y-09-40, Y-09-50, Y-10-40, Y-10-50, Y-11-40, Y-11-50, Y-12-40, and Y-12-50.

The device is composed of access sheath and dilator. The access sheath consists of sheath tube and connector. The dilator consists of dilator tube and dilator base. Single-use Ureteral Access Sheath is sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of 3 years.

The provided FDA 510(k) clearance letter details the substantial equivalence for a "Single-use Ureteral Access Sheath." This document does not contain information about an AI/ML-driven device or study results proving a device meets acceptance criteria related to AI/ML performance.

The information provided describes a medical device, its intended use, and various performance tests to ensure its safety and effectiveness compared to a predicate device. These tests are standard for a physical medical device (like biocompatibility, sterility, shelf-life, and mechanical bench tests) and are not related to artificial intelligence or machine learning performance metrics found in an AI/ML-driven medical device study.

Therefore, I cannot fulfill your request to describe acceptance criteria and study proving an AI/ML device meets them based on the provided text. The document clearly states "VIII. Clinical study: Not applicable" for this device, which further confirms the absence of data related to human reader performance with or without AI assistance, or algorithm-only performance.

If you have a document describing an AI/ML device, I would be happy to analyze it according to your requested criteria.

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The Single-use 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 Single-use Ureteral Access Sheath is a prescription device intended to provide physicians with access to the urinary tract and the capability to serve as a pathway for device exchanges. Similar to all ureteral access sheath sets, this device also safeguards the ureter during device exchanges, thus helping to minimize tissue trauma. The Single-use Ureteral Access Sheath consists of two components: the inner semi-rigid dilator assembly and the outer semi-rigid sheath assembly, both of which have a hydrophilic coating to allow for smooth and easy deployment into the upper tracts over a preplaced ureteral guidewire. The sheath has a locking mechanism that attaches to the luer lock hub of the inner dilator, allowing the sheath and dilator to move as a single unit. To ease the insertion of the Single-use Ureteral Access Sheath into the body orifice, the dilator is advanced over a 0.038 inch guidewire. Since both the sheath and dilator are radiopaque, they can be monitored using X-ray (fluoroscopy) to ensure their accurate positioning during the placement process. The Single-use Ureteral Access Sheath is designed to accommodate endoscopes and other urological instruments with an outer diameter (OD) that is compatible with the sheath's inner diameter (ID) of 10Fr, 11Fr, 12Fr, 13Fr, and 14Fr. The inner layer of the sheath is made of stainless steel to provide radial rigidity that remains patent and intact after the dilator is removed, allowing endoscopes and other urological instruments to pass easily along the lumen of the Access Sheath. The Single-use Ureteral Access Sheath is offered in five French size combinations: 10Fr/12Fr, 11Fr/13Fr, 12Fr/14Fr, 13Fr/15Fr, and 14Fr/16Fr, and four lengths: 35cm, 45cm, 50cm, 55cm. The device is constructed using biologically safe materials and is provided in a sterile condition, intended for single use only.

The provided 510(k) clearance letter is for a "Single-Use Ureteral Access Sheath" (K251599), which is a physical medical device and not an AI or software-based device.

Therefore, many of the requested points related to AI/software performance, such as:

• MRMC comparative effectiveness study
• Standalone (algorithm only) performance
• Sample size and ground truth for training set
• Number of experts and their qualifications for ground truth establishment
• Adjudication method for test set

do not apply to this device and its associated performance data.

The performance data provided in the 510(k) summary focuses entirely on non-clinical performance data for a physical device, including:

• Biocompatibility Testing
• Sterility Testing
• Functional and Mechanical Performance Testing (e.g., appearance, size, patency, breaking force, friction, etc.)

Based on the information provided in the 510(k) clearance letter for the Single-Use Ureteral Access Sheath (K251599), here's a breakdown of the requested information:

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

The document lists various performance tests conducted but does not explicitly state the quantitative acceptance criteria for each test or the specific numerical results obtained. It generally states that "All evaluation acceptance criteria were met" for biocompatibility and implies successful results for performance testing by concluding substantial equivalence.

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The CoralWell™ Single-use 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. It is designed to establish a conduit for the treatment of urinary stones or other urinary diseases during the endoscopic procedures.

Not Found

This FDA 510(k) clearance letter for the CoralWell™ Single-use Ureteral Access Sheath does not contain any information about acceptance criteria or a study that proves the device meets acceptance criteria.

The letter is a regulatory document confirming that the FDA has reviewed MacroLux Medical Technology Co., Ltd.'s premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. It outlines various regulatory requirements the manufacturer must adhere to (e.g., Quality System regulation, UDI Rule, adverse event reporting), but it does not detail performance testing or clinical studies.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and the reported device performance: This information is not present in the provided document.
2. Sample sized used for the test set and the data provenance: Not available. The document is about regulatory clearance, not performance testing details.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available, as no performance study is described.
4. Adjudication method: Not available.
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 device is a physical medical instrument (ureteral access sheath), not an AI/software device. Therefore, an MRMC study with AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as it's not an algorithm.
7. The type of ground truth used: Not available.
8. The sample size for the training set: Not applicable, as this is a physical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

To obtain information about performance criteria and testing for such a device, one would typically need to review the actual 510(k) submission summary or a separate technical document from the manufacturer, which would contain details of bench testing, biocompatibility studies, and potentially animal or clinical performance data if submitted. The clearance letter itself is a summary of the FDA's regulatory decision, not a detailed technical report.

Ask a specific question about this device

The Single-use 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 Single-use Ureteral Access Sheath is a prescription device intended to provide physicians with access to the urinary tract and the capability to serve as a pathway for device exchanges. Similar to all ureteral access sheath sets, this device also safeguards the ureter during device exchanges, thus helping to minimize tissue trauma. The Single-use Ureteral Access Sheath consists of two components: the inner semi-rigid dilator assembly and the outer semi-rigid sheath assembly, both of which have a hydrophilic coating to allow for smooth and easy deployment into the upper tracts over a preplaced ureteral guidewire. The sheath has a locking mechanism that attaches to the luer lock hub of the inner dilator, allowing the sheath and dilator to move as a single unit. To ease the insertion of the Single-use Ureteral Access Sheath into the body orifice, the dilator is advanced over a 0.038 inch guidewire. Since both the sheath and dilator are radiopaque, they can be monitored using X-ray (fluoroscopy) to ensure their accurate positioning during the placement process. The Single-use Ureteral Access Sheath is designed to accommodate endoscopes and other urological instruments with an outer diameter (OD) that is compatible with the sheath's inner diameter (ID) of 10Fr, 11Fr, 13Fr, and 14Fr. The inner layer of the sheath is made of stainless steel to provide radial rigidity that remains patent and intact after the dilator is removed, allowing endoscopes and other urological instruments to pass easily along the lumen of the Access Sheath. The Single-use Ureteral Access Sheath is offered in five French size combinations: 10Fr/12Fr, 11Fr/13Fr, 12Fr/14Fr, 13Fr/15Fr, and 14Fr/16Fr, and two lengths: 35cm and 45cm. The device is constructed using biologically safe materials and is provided in a sterile condition, intended for single use only.

The device in question is the Single-use Ureteral Access Sheath (K240167). The provided document is a 510(k) summary, which outlines the device's characteristics and the studies performed to demonstrate its substantial equivalence to a legally marketed predicate device.

Here's a breakdown of the requested information based on the provided text:

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

The document details performance testing for various attributes. While it states "All evaluation acceptance criteria were met" for specific categories (e.g., Biocompatibility), it does not explicitly list numerical or qualitative acceptance criteria for each functional/mechanical test in a table form, nor does it provide the exact reported performance values. It only lists the tests conducted.

2. Sample size 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 non-clinical performance tests (biocompatibility, sterility, functional/mechanical testing).
The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin of the data mentioned for the performance testing. However, the applicant is Hunan Vathin Medical Instrument Co., Ltd., located in China, suggesting the testing was likely conducted by or for the manufacturer.

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 device is a physical medical instrument (Ureteral Access Sheath), not an AI/Software as a Medical Device (SaMD) that requires expert consensus for ground truth establishment. Therefore, this information is not applicable. The "ground truth" for this device is based on objective measurements and compliance with recognized standards.

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

As this is not a clinical study involving human interpretation or subjective assessment necessitating adjudication, this information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical imaging or diagnostic studies.

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 MRMC study was conducted. This device is a physical medical instrument and does not involve AI assistance or human reader interpretation in its intended use.

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

This refers to AI/software performance. This device is a physical medical instrument, so this concept is not applicable.

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

The "ground truth" used for this device's performance evaluation is based on objective measurements and tests against established engineering, material, and biocompatibility standards. For example:

• Biocompatibility: In vitro and in vivo tests according to ISO 10993-1, measured against scientific criteria (e.g., cell viability for cytotoxicity, skin reaction for irritation).
• Sterility: Measured by sterility assurance level (SAL) achieved through validated sterilization processes per ISO 11135.
• Functional/Mechanical: Measured by physical properties (e.g., dimensions, force resistance, patency, leakage) against pre-defined specifications derived from engineering principles and comparison to the predicate device.

8. The sample size for the training set

This device does not involve a "training set" in the context of machine learning or AI. It is a physical medical device.

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

As there is no training set for this physical device, this question is not applicable.

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The device is intended to use in urologic endoscopic procedures to facilitate the passage of endoscopes.

The Single Use 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 five components: outer sheath base, outer sheath, dilator tube, locking clip and joint. 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 effective length of sheath from 10.0cm (shortest) to 55cm (longest). The device is packaged in a peel-open pouch with a two-year shelf life.

The request is to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided FDA 510(k) summary.

However, the provided document does not contain information related to an AI/ML device or its performance criteria, expert review, MRMC studies, or training/test set details. The product described is a "Single Use Ureteral Access Sheath," which is a physical medical device. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device through bench testing, material biocompatibility, and sterilization validation, not AI/ML model performance.

Therefore, I cannot fulfill the request as it pertains to AI/ML device performance and related study details, as these are not present in the provided text.

Based on the document, here's what can be inferred about the criteria for this specific device:

Device: Single Use Ureteral Access Sheath (A physical medical device, not an AI/ML diagnostic tool)

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

The document describes the performance data through bench testing and compliance with various standards. It does not present specific quantitative acceptance criteria in a table format with corresponding performance results for each criterion, but rather states that tests were "passing" and standards were "met."

Sections that cannot be addressed due to the nature of the device and information in the document:

• 2. Sample sizes used for the test set and the data provenance: Not applicable to a physical device evaluated by bench testing; no "test set" of patient data is mentioned.
• 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/ML diagnostics is not relevant for this physical device.
• 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, as this is not an AI/ML device.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/ML device.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable; the "truth" is based on material properties, mechanical performance, and compliance with recognized standards.
• 8. The sample size for the training set: Not applicable; no AI/ML model training is described.
• 9. How the ground truth for the training set was established: Not applicable.

In conclusion, the provided document describes a 510(k) submission for a physical medical device. The "acceptance criteria" discussed relate to engineering, material, and sterilization standards for medical devices, rather than the performance of an AI/ML algorithm.

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