(27 days)
The two Digital Fluoroscopic Imaging Systems are indicated for use in diagnostic and interventional angiographic procedures of human anatomy. It is intended to replace image intensifier fluoroscopic systems in all diagnostic or interventionnal procedures. These devices are not intended for mammography applications. The Bolus Chasing option submitted here is intended to perform subtracted angiography in real time of the lower limbs for diagnostic purpose.
The provided text contains information about a 510(k) submission for a Digital Fluoroscopic Imaging System with an optional Bolus Chasing feature. However, it does not include specific details about acceptance criteria, a dedicated study proving performance against defined criteria, sample sizes for test or training sets, data provenance, expert qualifications, or adjudication methods for establishing ground truth.
The document focuses on demonstrating substantial equivalence to a predicate device, as opposed to providing a detailed performance study against a set of acceptance criteria.
Therefore, many parts of your request cannot be answered from the provided text.
Here's what can be extracted based on the document:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the provided document. The submission focuses on demonstrating substantial equivalence to a predicate device rather than meeting specific quantifiable performance metrics.
- Reported Device Performance: Not explicitly stated as quantifiable performance metrics. The equivalence is based on the device's design, materials, and intended use being similar to the predicate.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified.
- Data Provenance: Not specified.
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 as no specific test set or ground truth establishment process is described in the context of a performance study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
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
- No MRMC study is mentioned. This device is an imaging system, not an AI-assisted diagnostic tool for interpretation by human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is an imaging system, not an algorithm being evaluated in a standalone capacity. The "Bolus Chasing option" is a feature of the imaging system itself, controlling image acquisition.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable as no specific performance study with ground truth is described. The basis for approval is substantial equivalence to a predicate device for its intended use.
8. The sample size for the training set
- Not applicable. This document describes a medical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable.
Summary of available information regarding the "study" (equivalence demonstration):
The "study" presented here is a Substantial Equivalence (SE) demonstration for the GE Healthcare Innova 4100 and Innova 3100 (with the new Bolus Chasing option).
- Predicate Device: GE Advantx LCV+ Bolus Chasing (K960575)
- Basis of Equivalence: Comparison table and product data sheets (details not provided in the text). The opinion is based on technical and functional similarity to the predicate device.
- Risk Management: The manufacturer states that potential hazards related to the new Bolus Chasing option are controlled by a risk management plan, including:
- Hazard identification
- Risk evaluation
- Software Development and Validation Process
- Testing: Materials are compliant with UL 2601 and IEC 60601-1 standards. Design controls prevent useless X-ray/contrast agent exposure during a Bolus Chasing sequence in case of failure. This implies some form of engineering testing and verification, but not a clinical performance study as typically understood for diagnostic accuracy.
In essence, the document serves as a 510(k) summary demonstrating that the new device is as safe and effective as a previously cleared device, rather than providing a new clinical performance study with defined acceptance criteria.
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.