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

The OPTION-vm is indicated for use only for urinary bladder drainage in male 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-vm 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; 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 is a 510(k) summary for the OPTION-vm™ Urinary Catheter. It outlines the device's description, intended use, comparison to predicate devices, and concludes with a statement of substantial equivalence. However, it does not contain information about specific acceptance criteria or a study proving the device meets acceptance criteria in the format requested.

The document states, "Verification test results reported in this 510(k) application substantiate equivalence to the predicate devices." This implies that some testing was performed, but the details of these tests, including specific acceptance criteria, sample sizes, ground truth establishment, or expert involvement, are not provided in this summary.

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

Here's an attempt to answer the questions based only on the available information, noting where information is missing:

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

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 for Test Set: Not specified.
• Data Provenance: Not specified. It can be inferred that any testing would have been conducted by the manufacturer, Opticon Medical, based in Dublin, OH, USA. Whether the data was retrospective or prospective is not mentioned.

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)

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

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

• Adjudication Method: Not specified.

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

• MRMC Study Done: No. This device is a urinary catheter, not an AI-assisted diagnostic tool for human readers.
• Effect Size: Not applicable.

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

• Standalone Performance: Not applicable. This is a physical medical device (urinary catheter), not an algorithm.

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

• Type of Ground Truth: Not specified. For a physical device, ground truth would typically refer to established performance standards or functional requirements validated through engineering tests, biocompatibility tests, etc., rather than expert consensus on diagnostic images or pathology.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is a physical device, not a machine learning algorithm that requires a training set.

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

• Ground Truth Establishment for Training Set: Not applicable. This is a physical device.

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