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BIOTEQ® Pigtail Drainage Catheter Set( One Step Type) is intended to be used for percutaneous drainage of abscesses, cysts, gall bladders and nephrostomies.

The BIOTEQ® Pigtail Drainage Catheter Set ( One Step Type) is used for the drainage pathway of patients' fluids through the catheter out of body . It consist of the following major components: ① F.L.L. Adapter ② Screw Cap ③ Catheter ④ Curve Straightener (Sleeve) ⑤ Wire Cap --- (For With Safety String Lock model only) ⑥ Trocar Stylet ⑦ Trocar Needle ⑧ Sheath ⑨ Suture Wire --- (For With Safety String Lock model only)

Here's a breakdown of the acceptance criteria and the study information for the BIOTEQ® Pigtail Drainage Catheter Set, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document describes performance in general terms rather than specific numerical acceptance criteria.

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

• Sample Size for Test Set: Not explicitly stated. The document indicates "bench testing" was performed, but the number of units tested is not specified.
• Data Provenance: Not explicitly stated, but given the manufacturer (BIOTEQUE CORPORATION) is in Taiwan, it's likely the testing was conducted by or for the manufacturer. The testing is described as "bench testing," which refers to in-vitro laboratory tests, not human data. Therefore, the data would not have a country of origin in the context of patient data, nor is it retrospective or prospective.

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

• Number of Experts: Not applicable. The "ground truth" for this type of device (a medical catheter set) is established through performance against industry standards and specifications during bench testing, not through expert interpretation of a test set.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set:

• Adjudication Method: Not applicable. As the testing involves objective measurement against engineering and biological standards, there is no need for expert adjudication.

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: No. This is a medical device (catheter set), not an AI-powered diagnostic or interpretive tool. Therefore, a multi-reader multi-case comparative effectiveness study or AI assistance is not relevant or applicable.

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

• Standalone Performance Study: Not applicable. This device does not involve an algorithm. The study described is bench testing of the physical, chemical, biological, and sterilization properties of the catheter set.

7. The type of ground truth used:

• Type of Ground Truth: The ground truth for this device's performance is derived from established international and national standards for medical devices, specifically for physical, chemical, biological compatibility, and sterility. Examples include ISO 10993 series, ISO 11607-1, ISO 11135, and USP Pyrogenic standards.

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable. 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:

• Ground Truth for Training Set Establishment: Not applicable.

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