Search Results

The Optilume® High Pressure Urological Balloon Dilation Catheter is indicated for dilation of the urinary tract.

The Optilume® High Pressure Urological Balloon Dilation Catheter is an 0.038" (0.97mm) guidewire and flexible cystoscope compatible over-the-wire (OTW) catheter with a dual lumen design with a tapered atraumatic tip. The Optilume® High Pressure Urological Balloon Dilation Catheter is used to exert radial force to dilate narrow urinary tract segments (strictures). The distal end of the catheter is a non-compliant inflatable balloon. The 75 cm long Optilume® High Pressure Urological Balloon Dilation Catheter is supplied in five balloon diameters ranging from 4-10mm and balloon lengths ranging from 20-80mm. The balloon catheter is supplied sterile for single use.

This document is an FDA clearance letter for a medical device called the "Optilume® High Pressure Urological Balloon Dilation Catheter." It details the regulatory review process, including the determination of substantial equivalence to a predicate device.

However, the provided text does not contain information about the acceptance criteria or a study that proves the device meets those acceptance criteria in the context of an AI/ML medical device.

The performance data mentioned in the document are solely related to engineering and material performance tests for a physical medical device (a balloon catheter), not an AI algorithm. These tests include:

• Biocompatibility Testing: Ensuring the materials are safe for use in the body.
• Performance Testing: Evaluating physical attributes like balloon diameter, length, inflation/deflation time, burst strength, and compatibility with other medical equipment.
• Sterilization: Validating the sterilization process.
• Packaging and Distribution: Ensuring the device remains sterile and functional during transport and storage.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving an AI/ML device's performance, as the provided input does not describe such a device or study.

The questions you've asked (about sample sizes for test sets, data provenance, expert ground truth, MRMC studies, standalone performance, training sets, etc.) are highly relevant for AI/ML medical device clearances but are not addressed in this particular FDA letter, as it's for a traditional hardware device.

Ask a specific question about this device

The KARL STORZ Urological Laser Accessories are used with laser fibers during urological endoscopic procedures.

The KARL STORZ Urological Laser Accessories include Sheaths, Obturators, Working Elements, Guiding Probes, Telescope Bridge, Working Insert, and LUER-Lock Tube Connectors and Adaptor.

This FDA 510(k) summary describes Karl Storz Urological Laser Accessories. Based on the provided text, there are no specific AI/ML components mentioned or evaluated through a study. Therefore, the questions related to AI/ML acceptance criteria, performance, and study design are not applicable.

The acceptance criteria and supporting studies focus on traditional medical device performance, biocompatibility, and reprocessing validation.

Here's a breakdown of the given information:

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

• System Interlocking Test
• Flow Test (comparative)
• Bending Force Test | Additional bench testing was performed to ensure the device met its design specifications and is substantially equivalent to its predicate device. Specific quantitative results are not provided in this summary but the conclusion states they were met. |
  | Technological Characteristics | The device's technological characteristics (dimensions, components, irrigation method) are compared to the predicate device to confirm substantial equivalence. | Similar system components, continuous flow irrigation/aspiration.
• Sheath: Diameter: 23.5-27.6Fr., Length: 216.5-239mm (Predicate: 21-24Fr., 235-260.5mm)
• Obturator: Diameter: 19.9-21Fr., Length: 249.5-311.7mm (Predicate: 17.9-21.15Fr., 246.5-377.8mm)
• Laser Guide Probe: Length: 342.7-345.7mm (Predicate: N/A)
• Working Element: Diameter: 1x 4.4mm, 1x 2.5mm; Length: 2x 4.4mm (Predicate: N/A)
• Telescope Bridge: Number of channels: 1 (Predicate: 1-2) |

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 explicitly stated as this is a non-clinical evaluation. The "sample size" would refer to the number of devices or components tested for biocompatibility, reprocessing, and bench performance. The summary only states that tests were performed.
• Data Provenance: Not applicable in the context of clinical data. For non-clinical testing, it's generally conducted by the manufacturer or accredited labs, and the location is not specified in this summary. The studies are prospective in the sense that they are conducted specifically for regulatory submission, but they are not clinical studies on human subjects.

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. This device does not involve expert interpretation for ground truth establishment. Its performance is evaluated through objective, non-clinical tests based on established standards.

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

• Not applicable. This device does not involve human readers or interpretation of diagnostic images requiring adjudication.

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 multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a surgical accessory, not an AI-powered diagnostic tool for human readers.

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

• No, a standalone (algorithm only) performance evaluation was not done. This device is not an algorithm or AI system.

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

• The "ground truth" for this device's evaluation is defined by adherence to recognized international and industry standards for biocompatibility, reprocessing, and engineering design specifications. For example:
  • Biocompatibility: ISO 10993 series.
  • Reprocessing: ISO 14937, ISO 17665-1, AAMI TIR 30:2011, ASTM F3208-17, ISO 15883-5.
  • Bench Performance: Internal design specifications and comparative testing against the predicate.

8. The sample size for the training set

• Not applicable. This device does not involve machine learning and therefore has no "training set."

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

• Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

Ask a specific question about this device

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.

Ask a specific question about this device

United Urologics Intermittent Catheter is intended to be used as a urinary incontinence device designed to drain urine from the bladder.

The United Urologics Intermittent Catheter is a sterile, single use, disposable, urinary incontinence device designed to drain urine from the bladder. The device is manufactured of a flexible tube with a smooth radius, atraumatic tip to facilitate introduction into the urethra. The catheter is manufactured with drainage holes in the side of the tubing closest to the tipped end of the catheter in order to allow drainage of urine from the bladder through the central lumen of the catheter tube. The catheter may be provided with a funnel bonded to the end of the catheter tube opposite the tipped end. During use, the funnel or flared end of the catheter may be attached to a universal adapter to facilitate drainage of the urine into a standard urinary collection bag (the collection bag and universal adapter are not part of this device).

The device may be used by the patient or caregiver in a healthcare facility, hospital, and home or public restroom facilitate drainage of urine from the bladder.

This document is a 510(k) summary for the United Urologics Intermittent Catheter, establishing its substantial equivalence to a predicate device. It does not contain information about a specific study testing the device against acceptance criteria in the context of AI/machine learning performance. The information provided relates to the regulatory submission for a medical device.

Therefore, many of the requested categories are not applicable to the content provided.

However, I can extract information related to the device's performance characteristics and testing as described for its regulatory approval.

Here's the breakdown based on the provided text, indicating where information is not applicable (N/A) for an AI/ML context:

1. Table of acceptance criteria and reported device performance:

The document describes the device's technical characteristics and how it was tested according to relevant international standards. It doesn't present a table of specific acceptance criteria in the format of "metric X value must be > Y" with a corresponding "device achieved Z." Instead, it states that the device was designed and tested in accordance with specified standards.

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 specified in the document. The text refers to "testing" that was "completed" but does not provide details on sample sizes for biocompatibility, sterilization, or functional tests.
• Data Provenance: Not specified. This document is a regulatory submission, not a research paper detailing study methodology origins.

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

• N/A. This is a medical device approval document, not an AI/ML study involving expert ground truth establishment for a test set. The "ground truth" for this device's performance relies on its physical and functional characteristics meeting engineering and safety standards.

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

• N/A. Not relevant for this type of device and regulatory submission.

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:

• N/A. This document pertains to a physical medical device (intermittent catheter) and does not involve AI or human readers.

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

• N/A. This document pertains to a physical medical device and does not involve an algorithm.

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

• The "ground truth" for this device is based on compliance with established international engineering and safety standards for medical devices (e.g., BS EN 1616, BS EN 1618, ISO 10993, ANSI/AAMI/ISO 11135). For biocompatibility, this would involve laboratory test results (e.g., cytotoxicity assays, irritation tests). For sterilization, it would involve sterility assurance level (SAL) validation.

8. The sample size for the training set:

• N/A. This document does not concern an AI/ML device that requires a training set.

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

• N/A. This document does not concern an AI/ML device.

Ask a specific question about this device

United Urologics Closed System Intermittent Catheterization kit is intended to be used to drain urine from the patient's bladder into a collection bag.

The United Urologics Closed System Catheter is a pre-lubricated sterile, single use, disposable, urinary incontinence device designed to drain urine from the patient's bladder into a urine collection bag. The device is manufactured of a flexible tube with a smooth radius, atraumatic tip to facilitate introduction into the urethra. The catheter is manufactured with drainage holes in the side of the tubing closest to the tipped end of the catheter in order to allow drainage of urine from the bladder through the central lumen of the catheter tube. The catheter is provided with a funnel bonded to the end of the catheter tube opposite the tipped end. The catheter is prelubricated with a water soluble lubricant and sealed in a urine collection bag. It is designed with a molded silicone tip at the top of the bag which acts as an introducer sheath for the tip of the catheter. This introducer and holding mechanism on the inside of the bag, provide a mechanism for inserting and advancing the catheter to the bladder without direct hand contact to the catheter.

The device may be used by the patient or caregiver in a healthcare facility, hospital, and home or public restroom facility to facilitate drainage of urine from the bladder.

The provided text is a 510(k) summary for a medical device (United Urologics Closed System Catheter). It describes the device, its intended use, and comparative information with a predicate device to establish substantial equivalence. However, this document does not contain information about acceptance criteria and a study that proves the device meets those criteria in the context of an AI/ML medical device.

The document primarily focuses on:

• Regulatory information: Device classification, product code, regulations.
• Predicate device comparison: Highlighting similar technological characteristics and materials.
• Performance characteristics (non-AI/ML): Functionality, biocompatibility, and sterilization, all conforming to established international standards for physical medical devices, not AI/ML performance.

Therefore, I cannot fulfill your request for the specific points related to acceptance criteria and study details for an AI/ML device.

The questions you asked (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set sample size) are highly relevant for the evaluation of AI/ML-driven medical devices. However, this document is about a traditional physical medical device (a catheter) and does not involve AI/ML.

Ask a specific question about this device

The COOK® Urological Graft is for implantation to reinforce soft tissues where weakness exists in the urological anatomy, including temporary wound or solid organ support in the kidney. The Urological Graft is supplied sterile and intended for one-time use.

The COOK® Urological Graft is a bioabsorbable, extracellular collagen matrix that is identical to the predicates SURGIS Mesh (K980431) and SURGISIS® Sling (K992159), also manufactured by COOK Biotech Incorporated, and to Vicryl Mesh bag (K051701), manufactured by Ethicon. The device is manufactured from porcine small intestinal submucosa (SIS), packaged in a lyophilized (dried) state and supplied sterile in a sealed double pouch system.

The provided text describes a 510(k) submission for the COOK® Urological Graft and does not contain information about acceptance criteria or a study proving the device meets said criteria in the way typically found for AI/ML medical devices (e.g., performance metrics like sensitivity, specificity, AUC).

Instead, this document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, which is the cornerstone of the 510(k) pathway. The study mentioned refers to the type of testing performed to prove this equivalence, rather than a performance study against specific acceptance criteria for a novel AI/ML algorithm.

Therefore, the requested information cannot be fully provided as the context is different from what the prompt anticipates for AI/ML device studies.

However, I can extract what is relevant to the prompt, even if it's not a direct match to the AI/ML framework:

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

This document does not define specific "acceptance criteria" in terms of quantitative performance metrics (like sensitivity, specificity, or AUC) that an AI/ML model would need to meet. For a 510(k) submission of a traditional medical device like the COOK® Urological Graft, the primary "acceptance criterion" is substantial equivalence to predicate devices.

Reported Device Performance (as it relates to substantial equivalence):

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 mentions "bench, animal, biocompatibility and clinical testing" to establish equivalence. However, it does not provide details on:

• The specific sample sizes used for these tests.
• The data provenance (e.g., country of origin, retrospective/prospective nature) for any clinical data.

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 is not applicable as the device is a physical surgical graft, not an AI/ML diagnostic or prognostic tool that requires expert-established ground truth on a test set. The "ground truth" for demonstrating equivalence would be derived from the performance and characteristics of the predicate devices and the results of the specific engineering, animal, and clinical tests performed on the COOK® Urological Graft itself.

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

Not applicable for a physical medical device submission demonstrating substantial equivalence. Adjudication methods are typically relevant for human interpretation or AI/ML output assessment where discrepancies might arise.

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 surgical graft, not an AI-assisted diagnostic tool, so MRMC studies or human reader improvement with AI are not relevant.

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

Not applicable. The device is a physical surgical graft, not an algorithm.

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

For this type of device, the "ground truth" for demonstrating substantial equivalence would be based on:

• Material properties data: Bench testing results on tensile strength, bioabsorption rates, pore size, etc.
• Biocompatibility data: Standardized tests for cytotoxicity, sensitization, irritation, etc., according to ISO standards.
• Animal study data: In vivo performance in terms of tissue integration, host response, strength, and degradation over time.
• Clinical safety and performance data (if collected): Surgical outcomes, adverse event rates, and efficacy in repairing or reinforcing tissues, compared to predicates. This data would be against established clinical endpoints and observations from healthcare professionals and patient outcomes.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that uses a "training set."

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

Not applicable. This is not an AI/ML device, so there is no training set or ground truth in that context.

Ask a specific question about this device

The Stonebuster Endoscopic System for Stone Removal (SESSR) Catheter for Endoscopy is intended to provide access to the ureteral canal and to be used to guide the currently available visualization devices and accessory devices such as bionsy forceps, cytology brushes, stone retrieval baskets, etc. during endoscopic procedures.

The indications for use of the catheter are in urological applications.

The Stonebuster Endoscopic System for Stone Removal (SESSR) Delivery Catheter is a sterile, single-use device comprised of one main component: a flexible triple lumen delivery catheter with three Luer-Lock delivery ports. This device is intended to provide access to the ureteral canal and to be used to guide the currently available visualization devices and accessory devices such as biopsy forceps, cytology brushes, stone retrieval baskets, etc. during endossopic procedures.

The SESSR Delivery Catheter is introduced into the desired anatomical location through the SESS sheath with a minimum working channel diameter of 4.3mm. The distal tip of the SESSR is straight or benefit at minimum of 6.5 mm from the distal tip of 10 degrees providing the physician with (when using visualization devices) a wider field of view.

The provided document (K083788) describes the Stonebuster Endoscopic System for Stone Removal (SESSR) and its substantial equivalence to predicate devices, but it does not contain details about acceptance criteria, a specific study proving device performance against those criteria, or clinical trial data as requested.

The basis for clearance is demonstrating substantial equivalence to legally marketed predicate devices, not through a study proving predefined acceptance criteria. Therefore, most of the requested fields cannot be directly answered from the provided text.

Here's a breakdown of what can be extracted and explanations for what cannot:

1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify quantitative acceptance criteria or report device performance against such criteria. The "performance" assessment is based on a comparison to predicate devices, focusing on design, materials, and intended use.

2. Sample size used for the test set and the data provenance
Not applicable. This was a 510(k) submission based on substantial equivalence, not a clinical study with a "test set" in the context of AI/algorithm performance. The data provenance includes material specifications and sterilization validation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No "ground truth" was established by experts for a test set in this 510(k) submission.

4. Adjudication method for the test set
Not applicable. No test set requiring adjudication was used.

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 medical instrument (catheter), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study or AI-related performance metrics are irrelevant.

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the context of an algorithm's ground truth. The "truth" for this submission was demonstrating that the device's design, materials, and intended use were comparable to existing, legally marketed predicate devices, and that it met relevant standards for sterility.

8. The sample size for the training set
Not applicable. No training set was used, as this is not an AI/algorithm-based device.

9. How the ground truth for the training set was established
Not applicable. No training set was used.

Summary of what the document does provide regarding device evaluation:

• Sterility Testing: A full cycle, single lot batch validation was completed to ensure sterility using ethylene oxide (EtO) gas, contracted with STS Life Sciences Division of Ethox. The reports of these results were included in Section 14.1 of the submission.
• Shelf Life: Currently set at six months, with ongoing monitoring of samples to ensure sterility and functionality, with plans to adjust the shelf life based on these observations.
• Bench Testing: The conclusion mentions "bench test results conducted with the Stonebuster Endoscopic System for Stone Removal (SESSR)." However, the document does not detail these bench tests, their methodologies, or specific quantitative results beyond stating they support substantial equivalence.
• Comparison to Predicate Devices: The primary "proof" of meeting safety and effectiveness is through a detailed comparison (Table 1) to two predicate devices:
  • Boston Scientific Corporation UASS Ureteral Access Sheath (K022135)
  • Bard Dual Lumen Ureteral Catheter (K032521)
    This comparison covers indications for use, shaft material, hub material, sterility, single-use nature, and number of lumens. The sponsor argues that any differences are "insignificant with respect to safety and effectiveness."

In essence, for a traditional 510(k) such as this, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to predicate devices, supported by foundational tests like sterility validation and general engineering/material specifications, rather than a clinical trial or algorithm performance study.

Ask a specific question about this device

The Nipro Hydrophilic Guidewires are designed for use in urological, laparoscopic, and radiological procedures where a smooth guidewire is desired to introduce/position catheters, direct and maintain access, and be used to guide and exchange endoscopic accessories.

The subject devices is contructed from a superelastic Nitinal core wire. A plastic cladding is applied over the core with a hydrophilic coating applied over that to provide a virtually frictionless surface when wet. The polymer cladding is impregnated with a radiopacive agent for enhanced contrast under fluoroscopy.

The provided text describes a 510(k) premarket notification for a medical device, the Nipro Hydrophilic Guidewire. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a new standalone clinical study to prove effectiveness. Therefore, many of the requested elements for a study proving device acceptance criteria are not directly applicable or explicitly stated in this document.

However, I can extract the information relevant to the substantial equivalence comparison and performance testing that demonstrates the device meets certain criteria.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states that the Nipro Hydrophilic Guidewire is either identical or very similar to predicate devices in materials, design, technological characteristics, and indications for use. It claims that "Performance, voluntary standards, and biocompatibility tests demonstrate that the devices are substantially equivalent." While specific quantitative acceptance criteria are not detailed in this summary, the general criterion is "Substantial Equivalence" to the predicate device.

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

This document does not describe a "test set" in the context of a prospective clinical study with human patients for this 510(k) submission. The evaluation is based on comparisons to predicate devices and likely bench testing and biocompatibility assessments. Therefore, "sample size" and "data provenance" in the clinical study sense are not applicable here.

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

Not applicable. The ground truth for a 510(k) relies on regulatory standards, established predicate device performance, and laboratory/biocompatibility testing, not expert consensus on a clinical test set.

4. Adjudication Method for the Test Set

Not applicable for a 510(k) submission based on substantial equivalence and non-clinical testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study is not mentioned as part of this 510(k) submission. This type of study is typically used for diagnostic devices to compare human reader performance with and without AI assistance, which is outside the scope of demonstrating substantial equivalence for a guidewire.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, this refers to a medical device (guidewire) and not an algorithm. Therefore, "standalone" algorithm performance is not applicable.

7. The Type of Ground Truth Used

The "ground truth" for this 510(k) submission is established by:

• Predicate Device Characteristics: The established safety and effectiveness profile of the legally marketed predicate devices (Nipro Hydrophilic Guidewire (K001251) and Terumo Medical Corporation RadiFocus Guidewire (K926214, K923607)).
• Voluntary Standards: Adherence to recognized industry standards for guidewires.
• Biocompatibility Testing: Results of laboratory tests confirming material safety.
• Performance Testing: Bench-top testing to verify physical and functional properties deemed equivalent to the predicate.

8. The Sample Size for the Training Set

Not applicable. This device is a physical guidewire and would not have a "training set" in the context of machine learning or AI models.

9. How the Ground Truth for the Training Set Was Established

Not applicable. See point 8.

Ask a specific question about this device

The Advanced Urological Catheter is used to pass fluids to or from the urinary tract.

Not Found

This document is a 510(k) clearance letter for the "Advanced Urological Catheter" by EntraCare LLC. It details the regulatory approval process but does not contain information regarding
acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or any of the other specific study-related details requested.

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

The document primarily focuses on:

• The product name and applicant.
• The regulatory classification and product codes.
• Confirmation of substantial equivalence to a legally marketed predicate device.
• General regulatory requirements the manufacturer must adhere to.
• The intended use of the device: "The Advanced Urological Catheter is used to pass fluids to or from the urinary tract."

Ask a specific question about this device

VOMED insufflation needles are reusable devices for temporary use in conjunction with FDA-cleared insufflators to blow gas or powder into a tube, cavity, or organ. They are generally used as accessories to devices that provide access, illumination and visualization of internal structures and for manipulating soft tissuc. The devices are indicated for therapeutic and diagnostic laparoscopic and urological procedures.

VOMED suction and irrigation tubes and handles are reusable accessories designed for the suction of fluids from wounds and body cavities and/or the irrigation of surgical sites. They are general accessories of devices that provide access, illumination and visualization of internal structures and for manipulating soft tissue. The suction and irrigation devices are indicated for therapeutic laparoscopic and urologic procedures.

VOMED insufflation needles are reusable devices for temporary use in conjunction with FDA-cleared insufflators. VOMED suction and irrigation tubes and handles are reusable accessories.

The provided document is a 510(k) premarket notification letter from the FDA to VOMED Volzer Medizintechnik GmbH & Co. concerning their Endoscopic and Urologic Accessories, specifically VOMED Insufflation Needles and VOMED Suction & Irrigation Devices. This type of document declares substantial equivalence to a predicate device, allowing the device to be marketed.

Crucially, this document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

The letter focuses on regulatory approval based on substantial equivalence, meaning the device is considered as safe and effective as a legally marketed predicate device. This typically involves demonstrating that the new device has the same intended use, technological characteristics, and performance characteristics (if applicable) as the predicate.

Therefore, I cannot provide the requested information from this document. The document primarily serves as an FDA clearance letter and does not detail the technical studies that would typically lead to acceptance criteria and performance data.

Ask a specific question about this device