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The OPTION-vf is intended to provide drainage of the urinary bladder.

The OPTION-yf is indicated for use only for urinary bladder drainage in female patients: 1) who have acute conditions that require short-term (14 days or less) urinary management; 2) who are capable of operating the device in accordance with its instructions for use; and 3) for whom normal bladder cycling is not contraindicated.

The OPTION-yf is an indwelling catheter that provides drainage of the urinary bladder. It is a sterile, single-use, disposable device that is to be prescribed by a physician and inserted and removed by an appropriate health care professional. The device is composed of biocompatible silicone elastomers, and consists of: a flexible shaft with two opposing eyelets in the proximal tip for urine entry, one internal lumen for urine drainage and a second lumen for balloon inflation; a retention balloon; an adjustable retainer ring; a self-sealing balloon inflation microvalve port; and a urine discharge bulb with integral valve. The catheter may be used with the Continuous Drainage Adaptor accessory to provide continuous urinary drainage.

The provided text describes the OPTION-vf™ Urinary Catheter with Adaptor and its 510(k) summary for clearance. However, it does not contain the detailed acceptance criteria, the study design, or the specific performance metrics typically associated with proving a device meets acceptance criteria in the way a diagnostic AI/ML device would.

The document primarily focuses on establishing substantial equivalence to predicate devices based on device description, intended use, and materials. The "Supporting Information" section briefly mentions "verification test results" but does not elaborate on what these tests were, their acceptance criteria, or the results.

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

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

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

• Cannot be generated. The document does not specify quantitative acceptance criteria or reported performance metrics for the device. It states, "A risk analysis for the OPTION-yf with adaptor and the verification test results reported in this 510(k) application substantiate equivalence to the predicate devices." This is a general statement, not a detailed report of criteria and results.

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

• Not applicable / Not provided. The text does not describe a clinical study in the typical sense with a "test set" of patients or data for performance evaluation. The "verification test results" mentioned are likely engineering or bench tests, not clinical performance studies with patient 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)

• Not applicable / Not provided. No "test set" and thus no ground truth established by experts is mentioned.

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

• Not applicable / Not provided. No "test set" 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 / Not provided. This device is a urinary catheter, not an AI-assisted diagnostic tool for human readers.

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

• Not applicable / Not provided. This is a physical medical device, not an algorithm.

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

• Not applicable / Not provided. No ground truth for clinical performance is mentioned. The "equivalence" is based on device design, materials, and intended use compared to predicates.

8. The sample size for the training set

• Not applicable / Not provided. This is not an AI/ML device, so there is no training set.

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

• Not applicable / Not provided. As there is no training set, there is no ground truth for it.

Summary based on the provided text:

The document describes the OPTION-vf™ Urinary Catheter with Adaptor and its submission for 510(k) clearance by Opticon Medical. The primary method for proving the device meets regulatory requirements is through substantial equivalence to existing predicate devices (K023090 OPTION-vf™ Urinary Catheter, K760093 Bardex® Silicone Foley Catheter, and BARD® Adaptor and Tubing).

The claim of substantial equivalence is supported by:

• Device Description: The OPTION-vf™ is an indwelling, sterile, single-use, disposable silicone catheter with a flexible shaft, eyelets, lumens, a retention balloon, an adjustable retainer ring, a self-sealing balloon inflation microvalve port, and a urine discharge bulb with an integral valve. The adaptor allows for continuous drainage by holding the valve open.
• Intended Use: Drainage of the urinary bladder in female patients for acute, short-term (≤14 days) conditions, who can operate the device, and for whom normal bladder cycling is not contraindicated.
• Comparison to Predicate Device: The OPTION-vf™ with the adaptor functions similarly to typical continuous drainage Foley catheters (like the Bardex® Silicone Foley Catheter) by providing continuous drainage when the adaptor holds the discharge valve open.
• Supporting Information: A risk analysis and "verification test results" are stated to "substantiate equivalence." However, the details of these tests, their specific acceptance criteria, and the reported results are not provided in this summary.

Conclusion stated: The OPTION-vf™ urinary catheter with adaptor is substantially equivalent to the predicate devices and does not raise any new questions of safety or efficacy.

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The OPTION-vf is intended to provide drainage of the urinary bladder.

The OPTION-yf is indicated for use only for urinary bladder drainage in female patients: 1) who have acute conditions that require short-term (14 days or less) urinary management; 2) who are capable of operating the device in accordance with its instructions for use; and 3) for whom normal bladder cycling is not contraindicated.

The OPTION-vf is an indwelling catheter that provides controlled drainage of the urinary bladder. It is a sterile, single-use, disposable device that is to be prescribed by a physician and inserted and removed by an appropriate health care professional. The device is composed of biocompatible silicone elastomers, and consists of a flexible shaft with two opposing eyelets in the proximal tip for urine entry, one internal lumen for urine drainage and a second lumen for balloon inflation; a retention balloon; an adjustable retainer ring; a self-sealing balloon inflation microvalve port; and a urine discharge bulb with integral valve.

The device is inserted through the urethra to position the proximal tip and balloon into the urinary bladder. Once the catheter is properly inserted, the teardrop-shaped balloon is inflated with 5 to 10 cc of sterile water through the microvalve port via a standard syringe and a blunt cannula. The retainer ring is then adjusted to the urinary meatus, thus gently anchoring the device in place. Removal of the OPTION-vf follows aspiration of the fluid from the balloon.

The patient-operated discharge valve within the OPTION-vf is housed within the discharge bulb. When the bulb is squeezed, the valve opens allowing urine to pass. When the bulb is released, the valve closes, providing the patient with direct control over urinary drainage. The OPTION-vf thus allows the patient to mimic normal voiding and permits patient mobility and comfort by eliminating the need for urine collection bags and tubing.

The OPTION-vf™ Urinary Catheter is a medical device, and the provided documentation describes its performance based on engineering and clinical testing. This is not a study of a device using AI, but rather a traditional medical device submission. Therefore, some of the requested information regarding AI-specific criteria (like sample sizes for test/training sets for AI, number of experts for ground truth, adjudication methods, MRMC studies, standalone AI performance) is not applicable.

Here's an analysis of the provided text based on your request, focusing on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantified, measurable table format typical for a vision-based AI device. Instead, it discusses the device's conformance to a standard and clinical trial outcomes that demonstrate safety and effectiveness.

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

• Sample Size for Test Set: The document states "In a multi-center randomized clinical trial, female patients requiring short-term urinary catheterization were treated with either a standard Foley indwelling catheter or the experimental Opticon-vf™ catheter." It does not specify the exact number of female patients included in this clinical trial.
• Data Provenance: The study was a "multi-center randomized clinical trial." The country of origin is not explicitly stated, but the submission is to the FDA (USA), implying that at least one of the centers could be in the USA. The data is prospective, gathered during a clinical trial.

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

This information is not applicable for this device. For a traditional medical device like a catheter, "ground truth" is typically established through physiological measurements (e.g., bacteriuria culture results, residual bladder volume measurements) and reported clinical observations by healthcare professionals during the trial, rather than expert consensus on image interpretation or diagnostic judgments.

4. Adjudication Method for the Test Set

This is not applicable as there's no mention of an adjudication process for diagnostic or interpretative outcomes. Clinical trial outcomes are typically assessed based on pre-defined endpoints.

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

No, an MRMC study was not done. MRMC studies are typically for diagnostic imaging devices where multiple readers evaluate the same cases. This is a functional medical device (urinary catheter). The clinical trial compared the OPTION-vf to a standard Foley catheter in a patient population, not comparing human readers' performance with and without AI.

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

This is not applicable as the OPTION-vf is a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for the clinical trial was based on:

• Clinical Measurements: Incidence of significant bacteriuria (likely via urine culture), mean residual bladder volume (likely via ultrasound or post-void catheterization).
• Adverse Event Reporting: Documented by healthcare professionals.
• Patient Reported Outcomes: Data from patient questionnaires regarding aspects like mobility, pain/discomfort, self-consciousness, sleep disruption, and ability to shower/dress.

8. The Sample Size for the Training Set

This is not applicable as this is not an AI device requiring a training set. Engineering tests and clinical trials were performed.

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

This is not applicable as there is no training set for an AI algorithm.

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The OPTICON™ Direct Male Urinary Catheter for Continuous Drainage is used to pass fluids from the urinary bladder. It must be connected to standard drainage tubes, drainage tube adaptors, tubes and bags.

The OPTICON™ Direct Male Urinary Catheter for Continuous Drainage is a sterile, single use/disposable, flexible, tubular catheter that is inserted through the urethra to pass urine from the urinary bladder, when connected to standard drainage tube adaptors, tubes and bags. The catheter is manufactured from soft biocompatible silicone. The male catheter requires an introducer for insertion. OPTICON™ Medical currently recommends the use of a commonly available introducer, (such as the Bard 0420 Wire Stylet) to aid in insertion. This introducer is not sold by OPTICON™ Medical, nor is the introducer included in the packaging for the OPTICON™ Direct Male Urinary Catheter for Continuous Drainage Catheter. The catheter is to be used only with standard urinary drainage tubes, drainage tube adaptors, tubes and bags.

Here's an analysis of the provided text regarding the acceptance criteria and study for the OPTICON™ Direct Male Urinary Catheter for Continuous Drainage:

This document is a 510(k) Summary from 1997, which means it describes a medical device seeking market clearance in the US, generally based on substantial equivalence to a predicate device. For devices seeking clearance in this manner, the level of clinical study and detailed performance reporting is typically less extensive than for novel devices requiring PMA approval.

Based on the provided text, here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document explicitly states that the device was tested against and met "all performance requirements" of ASTM Standard F623-89. However, the specific criteria within that standard (e.g., balloon inflation, flow rate, biocompatibility, tip strength) and the quantifiable results for each are not provided in this summary. To get those details, one would need to consult ASTM Standard F623-89 itself.

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

• Sample Size: Not specified in the provided text. The document states "The OPTICON™ Direct Male Urinary Catheter for Continuous Drainage has been tested," implying a physical test rather than a clinical study with human subjects for performance evaluation in this context.
• Data Provenance: Not applicable in the context of human data. The testing refers to laboratory or bench testing against an engineering standard.

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

• This question is not applicable to the type of testing described in the document. ASTM F623-89 is an engineering standard for device performance, not a standard requiring expert clinical judgment for "ground truth" establishment in a diagnostic or clinical outcome sense. The 'ground truth' is the standard's defined pass/fail criteria for physical properties.

4. Adjudication Method for the Test Set

• Not applicable. This was a bench test against a standard, not a clinical study involving multiple reviewers or subjective assessments.

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

• No, an MRMC study was not done. The document describes bench testing against an ASTM standard, not a clinical study involving human readers or comparative effectiveness with or without AI. AI assistance is not mentioned as part of this device or its testing.

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

• Not applicable. This device is a urinary catheter, not an algorithm or AI-driven system.

7. The Type of Ground Truth Used

• Bench Test Standard (ASTM F623-89): The "ground truth" or reference for evaluating performance was the set of predefined performance specifications and test methods outlined in ASTM Standard F623-89 for Foley Catheters. The device either met these objective physical/mechanical criteria or it did not.

8. The Sample Size for the Training Set

• Not applicable. This device is a physical medical device, not an AI or machine learning model that requires a "training set."

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

• Not applicable. As above, no training set was used for this device.

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