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Sclerotherapy & Endoscopic Needles are endoscopic accessories intended to introduce a sclerosing agent, vasoconstrictor, or other solutions into selected sites to control actual or potential bleeding lesions in the digestive system or to inject liquid to aid in polypectomy procedures.

Sclerotherapy & Endoscopic Needles are endoscopic accessories intended to introduce a sclerosing agent, vasoconstrictor, or other solutions into selected sites to control actual or potential bleeding lesions in the digestive system or to inject liquid to aid in polypectomy procedures.

Sclerotherapy & Endoscopic Needles (see schematic representation in Figure 1) are made of a flexible catheter with an inner tube connected to the needle at the distal end and a handle with a piston and a luer-lock connection at the proximal end.

All devices of this family group are packed in a medical grade paper pouch and sterilized by ETO. The sterile devices are distributed in carton boxes along with an Instruction for Use.

There are 4 variations of the Sclerotherapy & Endoscopic Needles with different catheter lengths and diameters and different needle lengths and diameters (see Table 1).

The device is used through an endoscope to inject different types of sclerosing agents, vasoconstrictors, or other solutions into selected sites of the digestive system to control actual or potential bleeding. It can be also used to inject liquid into the mucosa to aid in polypectomy procedures.

These procedures can last from 15 minutes. Furthermore, this device comes in contact with the digestive system mucosa.

There are no accessories for this kind of devices.

This document describes the G-Flex Europe SPRL's Sclerotherapy & Endoscopic Needles, which are endoscopic accessories intended to introduce sclerosing agents or other solutions into the digestive system. The 510(k) submission, K222006, establishes substantial equivalence to the Boston Scientific Interject Injection Therapy Needle Catheter (K171454).

Here's an analysis of the acceptance criteria and supporting studies based on the provided document:

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

The document does not explicitly state "acceptance criteria" with numerical targets for clinical performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. The "acceptance criteria" are implied to be that the device performs comparably to the predicate and meets design specifications and relevant standards.

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

The document explicitly states: "No clinical testing was performed to support the medical device as the indications for use are equivalent to the predicate device." Therefore, there is no clinical "test set" in the context of human data. The performance evaluations were based on non-clinical bench testing, biocompatibility testing, sterility validation, and shelf-life studies. The "sample sizes" for these non-clinical tests are not detailed in the summary, nor is the "data provenance" (country of origin), as it pertains to laboratory and manufacturing data rather than patient data.

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

Given that no clinical testing was performed and no "test set" of patient data was used, this information is not applicable.

4. Adjudication method for the test set

Not applicable, as no clinical test set 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. The device is a physical endoscopic accessory, not an AI-assisted diagnostic or treatment system involving human readers.

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

Not applicable. The device is a physical endoscopic accessory, not an algorithm.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" was established by:

• Design Specifications: For bench testing, comparing physical and mechanical characteristics to engineering and design requirements.
• International Standards: For biocompatibility (ISO 10993 series), sterility (ISO 11135-1:2014, ISO 11138-2:2009), packaging (ISO 11607-1:2019), and aging (ASTM F1980-16, ASTM D4169-16). Compliance with these standards serves as the ground truth for safety and performance in their respective domains.
• Predicate Device Characteristics: For the substantial equivalence comparison, the characteristics and established safety/effectiveness of the predicate device (Boston Scientific Interject Injection Therapy Needle Catheter, K171454) served as the "ground truth" baseline.

8. The sample size for the training set

Not applicable, as this device does not involve machine learning or AI models with a training set.

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

Not applicable, as there is no training set for this device.

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Cysto-Gastro Sets are intended to be used to electrosurgically cannulate pancreatic pseudo-cysts endoscopically (via the transgastric or transduodenal wall) as an alternative to surgical or percutaneous treatment.

Each device is made of an outer flexible Teflon tube equipped with a metal tip at the distal end and an HF (high frequency) connector at the proximal end. Some models included an inner Teflon sheet that slides inside the outer sheet and are equipped with an HF needle at the distal tip and an HF connector at the proximal end.

All devices of this family group are packed in a medical grade paper pouch and sterilized by ETO. The sterile devices are distributed in carton boxes along with an Instruction for Use. There are 5 variations of the Cysto-Gastro Sets with different catheter length and diameter, with or without HF needle. However, all variations are delivered sterile and intended for single use.

The provided text details the 510(k) submission for the Cysto-Gastro Sets device. However, it does not describe acceptance criteria or a study that proves the device meets those criteria in the context of an AI/algorithm-driven device for which the prompt's questions (e.g., number of experts, MRMC studies, training set details) are relevant.

The Cysto-Gastro Sets device is an endoscopic electrosurgical accessory, a physical medical device. The studies described are for non-clinical performance data (bench tests, biocompatibility, sterilization, shelf-life) to demonstrate substantial equivalence to a predicate device, not for evaluating the performance of an AI/algorithm.

Therefore, I cannot provide answers to the requested information as the provided document pertains to a physical device and not an AI/algorithm-driven one. There is no mention of acceptance criteria related to AI performance, ground truth, expert adjudication, or MRMC studies.

In summary, the provided document does not contain the type of AI/algorithm performance data requested.

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