(85 days)
The Advantx LCN+ angiographic imaging system is intended for general purpose diagnostic angiographic fluoroscopy and radiography study.
The Advantx LCLP+ angiographic imaging system is intended for general purpose diagnostic angiographic fluoroscopy and cardiography study.
The Advantx LCN+ is a biplane x-ray system consisting of a floor mounted three-axis C-arm and a ceiling suspended C-arm that addresses all angiographic procedures that require a 32 cm Image Intensifier.
The Advantx LCLP+ is a biplane x-ray system consisting of a floor mounted three-axis C-arm and a ceiling suspended C-arm that addresses all angiographic procedures that require a 22 cm Image Intensifier.
The Advantx LCN+ angiographic imaging system is an angiographic and radiographic biplane positioner for use with the x-ray system Advantx. It consists of an angiographic biplane positioner, a vascular table and an x-ray system.
The Advantx LCLP+ angiographic imaging system is an angiographic and cardiographic biplane positioner for use with the x-ray system Advantx. It consists of an angiographic biplane positioner, a vascular table and an x-ray system.
The provided text describes two angiographic imaging systems, the Advantx LCN+ and Advantx LCLP+, and their substantial equivalence to existing devices. However, it does not include detailed acceptance criteria or a study proving the device meets specific performance metrics in the way typically expected for a medical device performance study (e.g., diagnostic accuracy, sensitivity, specificity, or image quality assessments with quantitative metrics and statistical analysis).
Instead, the documentation focuses on:
- Safety and regulatory compliance: Demonstrating that the devices comply with 21CFR and UL 187 standards, have risk management in place (FMEA), and do not pose added safety risks.
- Substantial Equivalence: Asserting that the devices are substantially equivalent to currently marketed angiographic imaging systems for their stated intended uses. This is a regulatory pathway, not a performance study in the clinical sense.
Therefore, many of the requested sections (Table of acceptance criteria and reported performance, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, training set details) cannot be extracted from the provided text because such a detailed performance study with quantitative acceptance criteria and results is not present. The document focuses on regulatory clearance through substantial equivalence based on safety and existing device types.
Here's a breakdown of what can be inferred or explicitly stated based on the given information:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, specific, quantifiable performance acceptance criteria (e.g., minimum sensitivity, detection rate, image resolution targets) and their corresponding reported device performance metrics are not explicitly stated. The "performance" described is primarily related to safety, design, and regulatory compliance.
| Acceptance Criteria Category | Specific Criteria (as inferred) | Reported Device Performance (as stated) |
|---|---|---|
| Safety | Compliance with regulatory standards (21 CFR, UL 187) | "The Advantx LCN+/LCLP+ angiographic imaging system complies with 21CFR and UL 187." "This system poses no added safety risk." |
| Risk Management | Identification and control of potential hazards (unintended x-ray emission, excessive radiation, mechanical/electrical hazards) | Hazards identified in Risk Management Summary; controlled by FMEA, system evaluation, adherence to Industrial Standards (UL). |
| Design Integrity | Prevention of single-point failures causing unintended motion | "There are hardware and software redundancies to prevent single point failures that could cause unintended motion." |
| Substantial Equivalence | Equivalence to currently marketed devices regarding standards and intended uses | "The Advantx LCN+/LCLP+ x-ray angiographic system is substantially equivalent to currently marketed angiographic imaging systems that comply with the same or equivalent standards and have the same intended uses." |
| Manufacturing/Materials | Compliance with UL 187 for construction and materials | "All construction and materials are compliant with UL 187." |
2. Sample size used for the test set and the data provenance
Not specified. The document does not describe a performance "test set" in the context of clinical or image quality evaluation. The evaluation appears to be a review of design, construction, and safety documentation for regulatory clearance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not specified. Ground truth establishment by experts for a test set is not mentioned, as no such test set or study is described in detail.
4. Adjudication method for the test set
Not applicable/Not specified. No adjudication method is mentioned.
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. The document does not describe an MRMC study, nor does it refer to AI or human-in-the-loop performance. This is an X-ray angiographic system, not an AI-powered diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No. This is an imaging acquisition system, not an algorithm, so standalone performance in the context of AI or image analysis is not relevant.
7. The type of ground truth used
Not applicable/Not specified. The concept of "ground truth" as used in performance studies (e.g., pathology for a lesion, outcomes data for a diagnosis) is not relevant or addressed in the provided documentation, which focuses on device safety and regulatory compliance.
8. The sample size for the training set
Not applicable/Not specified. No training set is mentioned as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable/Not specified. No training set ground truth is relevant or mentioned.
§ 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.