(86 days)
The Digital Imaging Systems (BSR), are intended for use in acquiring diagnosic quality images during cardiac, angiographic, vascular and neurovascular applications.
Digital Imaging System (BSR)
The provided text describes a 510(k) premarket notification for a medical device called the "Digital Imaging System (BSR)". This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than performing a de novo study with acceptance criteria and a detailed study proving performance against those criteria.
Therefore, many of the requested sections regarding acceptance criteria, specific study designs, sample sizes, expert involvement, and ground truth establishment are not applicable or explicitly mentioned in this document. The document focuses on demonstrating that the new device has the same intended use and similar technological characteristics as existing, legally marketed devices.
Here's an attempt to answer the questions based only on the provided text, noting where information is not available:
1. A table of acceptance criteria and the reported device performance
This document does not specify quantitative acceptance criteria or a dedicated performance study with reported metrics against those criteria. The core assertion is substantial equivalence to predicate devices. The "performance" is implicitly deemed acceptable if it matches that of the predicate.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as quantitative metrics. The overarching "acceptance criterion" for a 510(k) is Substantial Equivalence to legally marketed predicate devices. | The device is "intended for use in acquiring diagnostic quality images during cardiac, angiographic, vascular and neurovascular applications." This implicitly assumes its image quality will be comparable to predicate devices. |
2. Sample sized 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 a 510(k) submission for substantial equivalence, not a performance study with a test set of 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)
Not applicable. No explicit ground truth establishment process for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set adjudication is 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
Not applicable. This device is an "Angiographic x-ray system" / "digital imaging system," not an AI-powered diagnostic tool. There is no mention of AI or human reader improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a hardware imaging system, not an algorithm, and the concept of "standalone performance" in this context is not relevant as described in the document.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The document assesses substantial equivalence to predicate devices, not performance against an independent ground truth for diagnostic accuracy.
8. The sample size for the training set
Not applicable. This is a hardware system, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is a hardware system, not a machine learning model.
§ 892.1600 Angiographic x-ray system.
(a)
Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.