(289 days)
The Volume Control Delivery Syringe is used for the controlled inflation of balloon catheters during angioplasty procedures.
In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, B. Braun Medical, Inc. intends to introduce into interstate commerce a Volume Control Delivery Syringe. The Volume Control Delivery Syringe is used for the controlled inflation of balloon catheters during angioplasty procedures.
This looks like a 510(k) summary for a medical device submitted in 1997. The level of detail you're requesting regarding acceptance criteria, study design, and ground truth is typical for more recent AI/ML device submissions. Based on the provided text, the device is a "Volume Control Delivery Syringe," which is a relatively simple, non-AI medical device used for inflation during angioplasty.
Therefore, many of the questions you've asked are not applicable to this type of device and the information provided. I will answer what I can based on the text.
1. A table of acceptance criteria and the reported device performance
The document mentions "required release specifications" and "product design specifications" but does not provide a table or specific quantitative acceptance criteria or reported performance for the device (e.g., flow rate, pressure accuracy, volume accuracy). It states:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| General: | "All finished products are tested and must meet all required release specifications before distribution." |
| Physical Testing | "The physical testing is defined by Quality Control Test Procedure documents. These tests are established testing procedures and parameters which conform to the product design specifications." |
| Visual Examination | (In process and finished product) - No specific criteria or performance reported. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. For a non-AI device like this syringe, testing would typically involve manufacturing quality control and lab-based performance testing rather than a clinical "test set" in the context of clinical data.
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)
This is not applicable as there is no "ground truth" establishment in the context of clinical data or expert evaluation for this type of device. The quality control process involves meeting defined product specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. There is no "test set" and no adjudication method described.
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
This is not applicable. This is not an AI device, and therefore, no MRMC study or AI assistance comparison was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This is not applicable. The "ground truth" for this device's performance would be its adherence to its engineering and design specifications as verified through physical and visual testing during manufacturing and quality control.
8. The sample size for the training set
This is not applicable. This is not an AI device; therefore, there is no "training set."
9. How the ground truth for the training set was established
This is not applicable. This is not an AI device.
§ 870.1650 Angiographic injector and syringe.
(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.