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The DirectVision® Catheter, Uncoated is indicated for use in the drainage and/or collection and/or measurement of urine. It is intended to be used as a urological catheter inserted through the urethra for the purpose of draining urine and other fluids from the urinary tract. However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as the nephrostomy tract.

The DirectVision® Catheter,-Uncoated is a flexible tubular device that is inserted through the urethra and used to pass fluids to and from the urinary tract. It is a 100% silicone, latex-free, triple lumen (3-Way) Foley catheter with a straight or angled council tip to facilitate insertion. The DirectVision® Catheter, Uncoated is composed of a silicone tube that trifurcates into three (3) lumens, a silicone balloon, and a two-way valve. Of the three lumens, one lumen is used for urinary drainage and can be connected to a urine collection container (drainage bag or urine meter); one lumen has a two-way valve for inflation/deflation of the Foley balloon; and the third lumen can be used for irrigation of the bladder. The council tip has an opening (eyelet) in the tip that can be used to pass a guidewire or similar device to facilitate catheter insertion. This catheter device will be available with a single or double drainage eyelet, 14 through 24 French shafts, and either a 10 cc or 30 cc balloon. The DirectVision® Catheter, Uncoated is designed to be usable with the PercuVision DirectVision™ Guide System (K091600). In the DirectVision™ Guide System, the DirectVision® Catheter, Uncoated provides a sheath around the microendoscope to facilitate its use. The catheter also incorporates a channel to be used for supplying irrigation to the microendoscope tip for clearing away debris from the field of view during use.

The provided text is a 510(k) premarket notification for the PercuVision DirectVision® Catheter, Uncoated. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive de novo clinical study data with detailed acceptance criteria and performance metrics.

Therefore, the document does not contain the requested information regarding:

• A table of acceptance criteria and reported device performance.
• Sample size and data provenance for a test set.
• Number and qualifications of experts for ground truth establishment.
• Adjudication method for a test set.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study results.
• Standalone algorithm performance data.
• Type of ground truth used (e.g., pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

Instead, the document highlights the device's substantial equivalence to predicate devices, focusing on design, intended use, and materials.

Here's what can be extracted from the document:

1. Acceptance Criteria and Reported Device Performance:

The document doesn't define specific quantitative performance acceptance criteria in the context of a clinical study. Instead, the "acceptance" for this 510(k) relies on demonstrating substantial equivalence to legally marketed predicate devices. The "reported device performance" is implicitly that it functions similarly to the predicate devices and does not raise new questions of safety or effectiveness.

The core of the "study" is a comparison to predicate devices as detailed in the "Comparison to Predicate Device(s)" table and the "Substantial Equivalence Discussion."

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

• Not applicable. This submission does not describe a clinical "test set" in the context of device performance evaluation with a ground truth, as it is a special 510(k) based on substantial equivalence. It likely relies on non-clinical (e.g., bench) testing to demonstrate material properties and functionality are comparable to the uncoated predicate, but this is not detailed here.

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

• Not applicable. No clinical test set with expert-established ground truth is described.

4. Adjudication method for the test set:

• Not applicable. No clinical test set demanding 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 urological catheter, not an AI-driven diagnostic system.

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 consensus, pathology, outcomes data, etc):

• The "ground truth" for this 510(k) is the established safety and effectiveness profile of the predicate devices. The applicant is demonstrating that the new device, despite being uncoated (unlike one predicate), is fundamentally similar enough not to introduce new safety or effectiveness concerns. This is based on the history of the predicate devices and any non-clinical testing performed (which details are not provided in this summary).

8. The sample size for the training set:

• Not applicable. This submission does not involve an algorithm with a training set.

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

• Not applicable. This submission does not involve an algorithm with a training set.

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The DirectVision" Guide System is indicated for use in the visual examination of the urethra and bladder when placing the PercuCath Urologic Catheter.

The DirectVision™ Guide System is comprised of two (2) distinct components: a flexible semirigid microendoscope, and a handheld camera with integral LED illumination and camera control unit (CCU). The microendoscope is designed to work with the Schoelly Imaging Inc. FSC2 light source and CCU (K090601). The DirectVision TM Guide System is indicated for use in the endoscopic examination of the urethra and bladder, when placing the PercuCath™ Urologic Catheter (K090262). The catheter provides a sheath around the microendoscope to facilitate its use. The catheter also incorporates a channel to be used for supplying irrigation to the microendoscope tip for clearing away debris from the field of view during use. The microendoscope coupler is connected to the cleared camera and integral light source such that the light source is collinear with the light fiber optic bundle and the camera is collinear with the image fiber optic bundle. The image transmitted through the image fiber optic bundle to the camera is then displayed on a monitor accessory for the clinician to view.

The provided 510k summary for the DirectVision™ Guide System does not contain information related to specific acceptance criteria or a study demonstrating the device meets such criteria in terms of performance metrics like diagnostic accuracy, sensitivity, or specificity. This document primarily focuses on establishing substantial equivalence to a predicate device based on design, intended use, and general characteristics.

Therefore, many of the requested sections cannot be filled from the provided text.

Here's a breakdown of what can be extracted and what information is missing:

Acceptance Criteria and Device Performance

No specific quantitative or qualitative performance acceptance criteria (e.g., minimum visual acuity, field of view, illumination levels) and no reported device performance against such criteria are detailed in this 510k summary. The summary relies on comparison to a predicate device and adherence to general standards.

Study Information (Missing for Performance)

The document does not describe a performance study in the analytical or clinical sense that would involve a test set, ground truth, or expert review for the DirectVision™ Guide System.

Information Not Applicable / Not Provided in the Document:

1. A table of acceptance criteria and the reported device performance: Not provided. The summary focuses on design and safety compliance rather than performance metrics.
2. Sample size used for the test set and the data provenance: Not applicable as no performance study is described.
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.
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 an endoscope, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device does not use an algorithm for standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Information Available & Relevant to the Submission:

While not a "performance study" in the requested sense, the submission details compliance with general performance standards relative to endoscopes.

Predicate Device Comparison (Indirect 'Performance' Justification):

The submission establishes substantial equivalence to the Davlite Microendoscope (K020310) based on:

• Intended Use: Both are for visual examination within the body. The DirectVision™ Guide System specifies use in the urethra and bladder when placing the PercuCath™ Urologic Catheter, while the Davlite Microendoscope has a broader indication for viewing "an interior cavity of the human body."
• Design: Both are flexible microendoscopes with glass fiber optic bundles for light and image, an objective lens at the tip, and a camera adapter.
• Body Contact Material: Both use biocompatible materials (Polyimide and glass for DirectVision™, Polymer and glass for Davlite).
• Performance Standard: Both adhere to ISO 8600.
• Biocompatibility: Both are declared biocompatible.
• Sterility: Both are supplied non-sterile.
• Re-Use: Both are multi-use devices.

Recognized Consensus Standards Met (Acceptance Criteria for Safety & Design):

The DirectVision™ Guide System meets requirements of the following recognized consensus standards, which can be seen as "acceptance criteria" for the safety, design, and processing of the device:

• ISO 8600-1:2005 (Optics and Photonics -- Medical Endoscopes Information to be Provided by the Manufacturer for the Processing of Resterilizable Medical Devices)
• AAMI TIR12: 2004 (Designing, Testing, and Labeling Reusable Medical Devices for Preprocessing in Health Care Facilities)
• AAMI / ANSI ST81:2004 (Sterilization Of Medical Devices - Information To Be Provided By The Manufacturer For The Processing Of Resterilizable Devices)
• AAMI / ANSI ST35:2003 (Safe Handling and Biological Decontamination of Reusable Medical Devices in Health Care Facilities and in Nonclinical Settings)
• IEC 60601-2-18 (Particular Requirements for the Safety of Endoscopic Equipment)
• ISO10993-1:2003 (Biological Evaluation of Medical Devices)

The submission implies that by meeting these standards and demonstrating substantial equivalence to a legally marketed predicate, the device is considered safe and effective for its intended use, without requiring a specific performance study in the document provided.

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The PercuCath™ Catheter is indicated for use in the drainage and/or collection and/or measurement of urine. It is intended to be used as a urological catheter inserted through the urethra for the purpose of draining urine and other fluids from the urinary tract. However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as the nephrostomy tract.

The PercuCath™ Urinary Catheter is a flexible tubular device that is inserted through the urethra and used to pass fluids to and from the urinary tract. The PercuCath™ Urinary Catheter is a 100% silicone, latex-free, triple lumen (3-Way) Foley catheter with a lubricious hydrophilic coating and a straight or angled council tip to facilitate insertion. It is composed of a silicone tube that trifurcates into three lumens, a silicone balloon, and a two-way valve. When activated, the valve permits flow in either of two directions, i.e., for inflation or deflation of the balloon. Of the three lumens, one lumen is used for urinary drainage and can be connected to a urine collection container (drainage bag or urine meter); one lumen has a two-way valve for inflation/deflation of the Foley balloon; and, the third lumen can be used for irrigation of the bladder. The council tip has an opening (eyelet) in the tip that can be used to pass a guidewire or similar device to facilitate catheter insertion. The PercuCath™ Urinary Catheter will be available with a single eyelet or double eyelet, 14 through 24 Fr. Shafts (i.e.,14, 16, 18, 20, 22, and 24), and either a 10 cc or 30 cc balloon.

The PercuCath™ Urinary Catheter is a urological Foley catheter. The provided text indicates the device underwent mechanical testing to demonstrate its performance and substantial equivalence to predicate devices. However, the document does not provide explicit acceptance criteria in a quantitative or qualitative manner other than "met the design specifications" and "substantially equivalent to the predicate devices."

Here's an attempt to structure the information based on your request, highlighting what is available and what is not:

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

Note: The document does not define specific numerical or descriptive design specifications or performance metrics for the acceptance criteria.

The study conducted was mechanical testing. The purpose was to show that the PercuCath™ Urinary Catheter met its design specifications and was substantially equivalent to its predicate devices.

Here's the breakdown of the other requested information based on the provided text. Much of this information is not detailed or available in the provided 510(k) summary.

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. The document only mentions "Mechanical testing was performed."
• Data provenance: Not specified. It's unclear if this refers to physical device testing in a lab or data collected from a particular region. Given it's mechanical testing, it's likely lab-based and not geographically specific in the sense of patient data.
• Retrospective or Prospective: Not applicable for mechanical testing of a device's physical properties.

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 as this was mechanical testing, not a study requiring expert clinical assessment or ground truth establishment in a medical context. The "ground truth" would be the engineering specifications the device was tested against.

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

• Not applicable. Adjudication methods are typically used for clinical studies involving human interpretation or subjective data, not for mechanical testing of device performance against specifications.

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. The device is a physical medical device (urinary catheter), not an AI-powered 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 consensus, pathology, outcomes data, etc.)

• For mechanical testing, the "ground truth" would be the predetermined design specifications and performance standards for urological catheters, and potentially the performance characteristics of the predicate devices. These standards are typically based on engineering principles and regulatory requirements, rather than clinical "ground truth" from patients or expert consensus in an imaging context.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable. This is not an AI/ML device that requires a training set.

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