Search Results

High Pressure Tubing is indicated for use in PTCA surgery to connect the angiographic catheter and the angiographic syringe to deliver contrast media.

High Pressure Tubing is designed as a connecting line for injection of contrast media during coronary angiographic procedures. The device has a pressure resistance of 1200psi (8.3MPa); It is divided into two series according to the luer connector combination. ETM series consists of tubing and rotating male luer connecters, and the ETF series consists of tubing and rotating male luer connecter; The rotating male luer connector and female luer connector are made of polycarbonate and silica gel; The tubing is made of polyurethane, and the middle of the tube wall also contains nylon braided wire, which does not contact with outside. The High is for single use only, non-pyrogenic, sterilized by EO gas and the sterilization process is validated.

The question asks to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text. However, the provided text is a 510(k) Pre-market Notification for a "High Pressure Tubing" device, which describes its comparison to a predicate device and includes information about performance testing, but it does not contain information typically found in a study proving an AI/ML device meets acceptance criteria.

Specifically, the document discusses a medical device that is a physical product (High Pressure Tubing) used in PTCA surgery. It does not mention any AI or machine learning components. Therefore, information regarding "sample sizes used for the test set," "data provenance," "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," "sample size for training set," or "how ground truth for training set was established" is completely absent and not applicable to this document.

The document primarily focuses on establishing substantial equivalence to a predicate device by comparing technological characteristics and presenting results of biocompatibility and bench testing.

Based on the provided text, the following information can be extracted regarding the physical device's performance testing, which is analogous to "acceptance criteria" and "device performance" for a non-AI medical device:

1. Table of Acceptance Criteria and Reported Device Performance (as inferred from the bench testing section):

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not Applicable. The document describes performance and bench testing of a physical medical device, not a software or AI/ML device. Specific sample sizes for each test are not provided, nor is data provenance in the context of clinical studies (e.g., country of origin, retrospective/prospective). The tests were conducted to assure reliable design and performance.

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):

• Not Applicable. This information is relevant for AI/ML device validation where human experts establish ground truth. For this physical device, the "ground truth" is established by adherence to recognized international standards (e.g., ISO 10993, ISO 8536-4, ISO 80369-7, ISO 80369-20).

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

• Not Applicable. Adjudication methods are used in clinical studies or expert reviews for AI/ML devices to resolve discrepancies in ground truth establishment. This document pertains to physical device testing.

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. MRMC studies are specific to AI/ML devices involving human readers. This document is about a physical high-pressure tubing.

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

• Not Applicable. This concept is only relevant for AI/ML algorithms.

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

• Not Applicable. For this physical device, "ground truth" is adherence to established engineering specifications and international standards for medical device safety and performance.

8. The sample size for the training set:

• Not Applicable. This device is a physical product and does not involve AI/ML models that require training data.

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

• Not Applicable. This device is a physical product and does not involve AI/ML models that require training data.

In summary, the provided document is a 510(k) Pre-market Notification for a conventional (non-AI/ML) medical device. Therefore, most of the questions related to AI/ML device validation are not applicable. The "acceptance criteria" and "device performance" for this specific device are demonstrated through adherence to relevant international standards and successful completion of biocompatibility and bench testing as listed above.

Ask a specific question about this device