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510(k) Data Aggregation
(99 days)
NOVA FA DR SYSTEM
Sedecal "NOVA FA DR System" is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
"NOVA FA DR System" refers to a full Digital Radiography system consisting of: NOVA: Automatic Ceiling Suspension NBS: Tilting Vertical Wall Stand system with CXDI Canon Detectors 401C / 401C Compact / 55C / 501C (Option 1) NET: Elevating Table with CXDI Canon Detector (same detectors as Wall Stand) (Option 2) Flexi DT: Mobile Elevating Table SEDECAL SHF Generator Series, output powers: 50 kW / 65 kW / 80 kW Toshiba Tube: maximum heat dissipation: 300 kHU / 400 kHU Ralco Collimator: Manual / Motorized
Here's a breakdown of the acceptance criteria and study information for the Sedecal "NOVA FA DR System" based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes a modification to an existing X-ray system (K090279). The acceptance criterion for this modification is implicitly to demonstrate that the modified device is as safe and effective as the predicate device, with images of at least comparable quality.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| I. Non-Clinical Performance: | |
| - Electrical Safety (IEC 60601-1) | Demonstrated compliance with electrical safety standards. |
| - Electromagnetic Compatibility (IEC 60601-1-2) | Demonstrated compliance with electromagnetic compatibility standards. |
| - Software Integration Functionality | Unmodified software packages integrated and worked properly. |
| - Risk Analysis for Modifications/Integration | Performed for modifications, system integration, elevating table, generators, mobile table, overhead tube stand, and wall stand. |
| II. Clinical Performance (Image Quality): | |
| - Image quality comparable to predicate device | Images found to be of good quality, high resolution, and clinically acceptable. |
| - Image quality for various body structures | Demonstrated good quality for images of chest, skull, abdomen, and extremities. (Implicitly comparable to predicate given "clinically acceptable") |
| - Techniques comparable to predicate device | Techniques employed were comparable to those employed by the predicate panel. |
| III. Substantial Equivalence: | |
| - As safe as predicate | Demonstrated (via non-clinical and clinical tests) as safe as the predicate. |
| - As effective as predicate | Demonstrated (via non-clinical and clinical tests) as effective as the predicate. |
| - Performs as well as or better than predicate | Demonstrated (via non-clinical and clinical tests) performs as well as or better than the predicate. |
| - Materials and construction nearly identical to predicate | Stated that materials and construction methods are nearly identical to the predicate. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not explicitly stated. The document mentions "various human body structures (chest, skull, abdomen, extremities)" were acquired, but no number of cases or patients is provided.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study used "clinical images," implying prospective acquisition for the purpose of the study, but this is not explicitly confirmed. Given Sedecal is based in Spain, it's plausible the images were acquired there, but this is speculation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Number of Experts: One.
- Qualifications of Experts: "Board Certified Radiologist." No specific years of experience are mentioned.
4. Adjudication Method for the Test Set:
- Adjudication Method: None explicitly mentioned. With only one radiologist, there was no need for adjudication for consensus.
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 or AI comparative effectiveness study was performed or mentioned. This submission is for a modification to a digital X-ray system, not an AI-powered diagnostic tool. The focus is on the imaging system itself, not on reader performance improvement with or without AI.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable as the device is a digital X-ray system, not an algorithm, and its performance inherently involves human operation and interpretation.
7. The Type of Ground Truth Used:
- Ground Truth Type: Expert opinion/evaluation by a Board Certified Radiologist. The "good quality, high resolution, and clinically acceptable" assessment served as the ground truth for image quality.
8. The Sample Size for the Training Set:
- Not applicable/Not mentioned. This document describes a 510(k) for a hardware modification and new detectors, not an AI/machine learning algorithm that requires a training set. The "testing" refers to verification and validation of the hardware performance, software integration, and image quality.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable/Not mentioned. As above, there is no training set for an AI algorithm.
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