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The Clear-Jet Injection Catheter is to be used in conjunction with an endoscopic injections, such as the treatment of esophageal and gastric varies and for submucosal dye marking in the GI tract.

Clear-Jet Injection Catheter consists of a stainless-steel needle attached to inner tube, an Injector Head attached to Catheter tube, and Slider where a standard syringe can be attached for injection of solutions through the lumen of the needle into tissue. It is available in various sizes and working lengths. The needle sizes are 21 gauge (outer diameter 0.8mm) and 23 gauge (outer diameter 0.6mm), and the needle lengths are 4.0mm and 6.0mm. The needle wall thicknesses are 0.1mm, 0.05mm, and the Catheter Tube length (=Working length) includes 1,800mm, 2,300mm.

There are two types of Clear-Jet Injection Catheter such as Head type and Non-head type has the Injector Head made of stainless steel alloys attached to the Catheter Tube, Non -head type does not have the Injector Head made of stainless steel alloys.

This device passes through the working channel of endoscope, and the average contact time with mucosa of the human digestive tract is less than 1 hour. This device is supplied sterile for single-patient use and shall be not reused or re-sterilized.

This is a 510(k) premarket notification for a medical device (Clear-Jet Injection Catheter), which aims to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving a specific device performance against pre-defined acceptance criteria using clinical studies.

Therefore, the requested information regarding "acceptance criteria" and "the study that proves the device meets the acceptance criteria" in the context of a diagnostic AI product is not directly applicable to this document. This document focuses on demonstrating that the new device is as safe and effective as a previously cleared device.

However, I can extract information related to the non-clinical testing that was performed to support the substantial equivalence claim.

Regarding your specific questions:

1. A table of acceptance criteria and the reported device performance:
   This document does not provide a table of acceptance criteria and performance metrics in the way you might see for a diagnostic AI product (e.g., sensitivity, specificity thresholds). Instead, it states that the device was tested to evaluate its substantial equivalence according to various standards for medical devices. The "performance" reported is that the device met these standards and demonstrated substantial equivalence.

   Acceptance Criterion/Standard	Reported Device Performance
   Biocompatibility ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-11:2006	Cytotoxicity, Sensitization, Intracutaneous reactivity and Acute Systemic Toxicity tests were completed and met.
   Performance testing (appearance and dimension)	Performed as per Finemedix's design control system, results met.
   Physical and Chemical Safety Testing (color and transparent, pH, KMnO4 Consumption, Non-Volatile residue, ultraviolet absorption, heavy metal as lead, EO Sterilization residuals test, and sterility test)	Performed as per Finemedix's design control system, results met.
   EO Sterilization Testing ISO 11737-1:2006 and ISO 11737-2:2009	Met the standards.
   Shelf Life Testing ASTM F1980	Met the standard.

2. Sample sized used for the test set and the data provenance:
   The document does not detail specific sample sizes for each non-clinical test. These tests typically involve material samples and/or device units rather than patient data. There is no information on data provenance in terms of country of origin or retrospective/prospective data as this is non-clinical testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   Not applicable, as this is a non-clinical device clearance process, not a diagnostic study requiring expert ground truth for classification.

4. Adjudication method for the test set:
   Not applicable (see #3).

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 is not an AI/diagnostic product that would involve human readers or MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable. The Clear-Jet Injection Catheter is a medical device (catheter), not an algorithm or AI product.

7. The type of ground truth used:
   For the non-clinical tests, the "ground truth" or reference is the established performance specifications and regulatory standards (e.g., ISO standards for biocompatibility, sterility, etc.). Tests are designed to confirm the device meets these pre-defined objectives.

8. The sample size for the training set:
   Not applicable. This is not a machine learning model; therefore, there is no "training set."

9. How the ground truth for the training set was established:
   Not applicable (see #8).

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