(21 days)
I DECLEAR THAT THE PIVOTING COMPENSATION FILTER FOR THE HEAD IS FOR ROTATIONAL examinations of digital and dsa cerebral arteriograms and is substantially equivlent to previously accepted device Little Prism K913659C.
PIVOTING COMPENSATION FILTERS FOR THE HEAD, PCF Head
This document is a 510(k) clearance letter from the FDA for a device called "Pivoting Compensating Filters for the Head (Cerebral Arteriograms)". It states that the device is substantially equivalent to a previously accepted device.
Unfortunately, this letter and the associated "Indications For Use" form do not contain any information about acceptance criteria or a study proving the device meets them. The document is a regulatory approval, not a technical performance report.
Therefore, I cannot provide the requested information from the given text.
To address your request, if this were a document that contained the relevant information, here's how I would structure the answer for a hypothetical study:
Hypothetical Study Information (Information not available in the provided text)
Since the provided documents are a 510(k) clearance letter and an Indications For Use form, they do not contain the detailed technical study information requested. The following sections are presented as a template for what would be provided if such information were available.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| [e.g., Sensitivity ≥ 90%] | [e.g., Sensitivity: 92.5% (95% CI: 90.1-94.8%)] |
| [e.g., Specificity ≥ 85%] | [e.g., Specificity: 88.0% (95% CI: 85.5-90.2%)] |
| [e.g., Image Quality Score (e.g., 4.0 out of 5)] | [e.g., Mean Image Quality Score: 4.2] |
| [e.g., Reduction in dose by X%] | [e.g., Average dose reduction: 25%] |
2. Sample Size and Data Provenance for Test Set
- Sample Size: [e.g., 500 cerebral arteriogram cases]
- Data Provenance: [e.g., Retrospective data collected from multiple hospitals in the United States and Canada]
3. Number and Qualifications of Experts for Ground Truth (Test Set)
- Number of Experts: [e.g., 3]
- Qualifications: [e.g., Board-certified neuroradiologists with an average of 15 years of experience in interpreting cerebral angiograms.]
4. Adjudication Method for Test Set
- Adjudication Method: [e.g., 2+1 (Primary reads by two experts, with a third expert adjudicating any discrepancies).]
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Conducted: [e.g., (Yes/No)]
- Effect Size (If Yes): [e.g., Human readers using AI assistance demonstrated a statistically significant improvement in lesion detection accuracy by an average of 10% (from 80% to 90%) compared to reading without AI assistance. Reader confidence scores also increased by an average of 0.5 points on a 5-point scale.]
6. Standalone (Algorithm Only) Performance Study
- Standalone Study Conducted: [e.g., (Yes/No)]
- Performance (If Yes): [e.g., The algorithm achieved an AUC of 0.95 for detecting cerebral vascular anomalies, with a sensitivity of 93% and specificity of 89% at a predefined operating point.]
7. Type of Ground Truth Used (Test Set)
- Ground Truth Type: [e.g., Expert consensus based on clinical follow-up, surgical findings, or cross-modality imaging (e.g., MRA, CTA) where available.]
8. Sample Size for Training Set
- Sample Size: [e.g., 5,000 cerebral arteriogram cases]
9. How Ground Truth for Training Set Was Established
- Ground Truth Method: [e.g., Ground truth for the training set was established through a combination of expert radiologist annotations (single reader annotation for efficiency, followed by an automated quality check for consistency) and correlating with existing radiological reports and structured clinical data.]
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. 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). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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.