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The Optimos™ Cystotome is intended for use as an electrosurgical accessory to cannulate the transgastric or transduodenal wall and into a pancreatic pseudocyst that is visibly bulging into the gastrointestinal tract. This device is supplied sterile and is intended for single use only.

Device Description

Optimos™ Cystotome is an electrode which uses heat generated from the application of high frequency (HF) energy through the monopolar electrode to puncture a hole in tissue. Following a fine-needle aspiration (FNA) procedure, it is positioned over a guidewire, so the applied part is located at the area of interest. The Optimos™ Cystotome is for use to drain pancreatic pseudocysts. The Optimos™ Cystotome is a single use device provided sterile to the user. No reprocessing is performed by the user. The device is provided in three sizes, which have different diameters and tip lengths. The device itself consists of 3 parts: handle, sheath, and tip.

AI/ML Overview

The device is the Optimos™ Cystotome. The study described focuses on bench testing to demonstrate substantial equivalence to a predicate device, the Wilson-Cook Cystotome.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
1. The ability to puncture 2 type tissues (Porcine stomach and Duodenum).	The test results showed that all test samples meet the required performance, puncture tissues. The Optimos™ Cystotome successfully punctured both porcine stomach and duodenum tissues.
2. Substantial equivalence of thermal damage: There should be no significant difference in measurement of size (length, width, and depth) of the thermal damage zone between subject device and predicate device.	The thermal effects were evaluated on both the subject device and the equivalent device (Wilson-Cook CST-10 Cystotome Cystoenterostomy Needle Knife). The performance of the Optimos™ Cystotome was comparable to the predicate device at 18, 100, and 120W on porcine stomach tissue and duodenum in the mucosa, submucosa, and muscularis propria. The damage zone was measured under a microscope and analyzed using histological strain and NADH. The test results met the acceptance criteria, indicating comparable thermal damage.
Additional Bench Testing:
Visual test, dimensional test, continuity test, endoscopic compatibility test, device operability test, high frequency dielectric strength test, detachable connector retention test, injection & leakage test, and tensile strength test (with corresponding acceptance criteria for each)	All tests passed the set acceptance criteria. System tests confirmed compatibility with fine needle aspiration, guidewire, endoscope, and ESU.
Biocompatibility Testing (for various test items)	All biocompatibility tests (Cytotoxicity, Intracutaneous reactivity, Sensitization (GPMT), Acute systemic toxicity, Material mediated pyrogenicity test) passed. For example, Cytotoxicity showed a reactivity grade of 0, Intracutaneous reactivity showed no abnormal signs and a mean score of 0.00, and Sensitization showed a score of 0.0.
Electrical Safety and Electromagnetic Compatibility (EMC) against standards:
EN 60601-1 (2006) + A1:2013, IEC 60601-1:2005/AMD1:2012, IEC 60601-1-2, IEC 60601-2-2:2017, IEC 60601-2-18	All listed electrical safety and EMC standards were passed (P).

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

Sample Size for Thermal Effects Comparison:
- Optimos™ Cystotome (Subject Device): 18 samples (Model number OCT1906)
- Cystotome™ Cystoenterostomy Needle Knife (Predicate Device): 18 samples (Model number CST-10)
Data Provenance: This was a bench test conducted in a laboratory setting using porcine stomach and duodenum tissue. The document does not specify the country of origin of the data beyond the manufacturer (Taewoong Medical Co., Ltd. from Korea) performing the tests. It is retrospective in the sense that the data has already been collected and analyzed.

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

The document does not specify the use of experts to establish ground truth for the bench testing. The ground truth for thermal damage was established by quantitative measurements of thermal damage zones under a microscope, analyzed using histological strain and NADH.

4. Adjudication method for the test set

An explicit adjudication method (e.g., 2+1, 3+1) is not mentioned or implied. The measurements and evaluations appear to be made against objective criteria.

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 comparative effectiveness study was done. This device is an electrosurgical accessory, not an AI-assisted diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not applicable.

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

N/A. This is a medical device (Cystotome), not an algorithm. The performance described is for the device itself (its ability to puncture tissue and the thermal effects it produces) in controlled bench testing.

7. The type of ground truth used

For the thermal effects comparison, the ground truth was objective physical measurements derived from histological analysis of tissue samples (porcine stomach and duodenum). This involved measuring the length, width, and depth of the thermal damage zone under a microscope and analyzing it using histological strain and NADH.

8. The sample size for the training set

N/A. This device does not involve machine learning or AI, so there is no concept of a training set.

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

N/A. As there is no training set, this question is not applicable.

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