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510(k) Data Aggregation
(104 days)
PERKINELMER XRD 1622 AP3 MED FLAT PANEL DETECTOR
The XRD 1622 AP3 MED, when used with a radiographic imaging system, is indicated for use in generating radiographic images of human anatomy for diagnostic X-ray procedures, wherever conventional screen-film (SF), digital radiography (DR), or computed radiography (CR) systems may be used. It is not intended for mammographic use.
The XRD 1622 AP3 MED is a flat panel x-ray detector consisting of an amorphous silicon panel with a directly deposited CsI:Tl scintillator. The XRD 1622 AP3 MED detector has an active area of 41cm x 41cm at a pixel pitch of 200μm. Data and control communication is accomplished via a Gigabit Ethernet interface. The detector can be integrated into a fixed room x-ray system to enable digital radiography.
Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the PerkinElmer XRD 1622 AP3 MED Flat Panel Detector:
Acceptance Criteria and Device Performance Study
The primary study presented aims to demonstrate substantial equivalence to a predicate device, focusing on "equivalent diagnostic quality" of the generated images.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Image Quality / Diagnostic Equivalence | Produce images of equivalent diagnostic quality compared to the predicate device. | "The PerkinElmer XRD 1622 AP3 MED flat panel detector has successfully completed external testing in actual user testing facility and was found to produce images of equivalent diagnostic quality in a study of 30 image pairs of different anatomical regions reviewed by three board certified radiologists." |
| "The proposed device and predicate device (flat panel detector of the predicate) both utilize similar technology and materials, are similar in design and construction, and have been shown to produce images of equivalent diagnostic quality in a clinical setting." | ||
| Non-Clinical Testing / Specifications | Meet internal specifications, standards, and regulations (UL, IEC). Conform to product safety, radiology, and imaging standards. | "The PerkinElmer XRD 1622 AP3 MED flat panel detector has successfully completed internal nonclinical testing, complies with standards and regulations such as UL and IEC. The device has completed verification and validation testing to confirm it meets the specifications and operates as planned. Tests included image quality test with internal experts. The product, manufacturing and development processes have been showen to conform to product safety, radiology and imaging standards." |
Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than setting explicit quantifiable performance metrics as "acceptance criteria" in the same way a de novo submission might. The key acceptance criterion here is the subjective assessment of "equivalent diagnostic quality."
2. Sample Size and Data Provenance for the Test Set
- Sample Size for Test Set: 30 image pairs.
- Data Provenance: "external testing in actual user testing facility." This implies prospective data collection, possibly within a clinical environment, specifically for the purpose of this evaluation. The country of origin is not explicitly stated.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Three.
- Qualifications of Experts: "board certified radiologists." The number of years of experience is not specified.
4. Adjudication Method for the Test Set
The adjudication method is not explicitly stated. It mentions the images were "reviewed by three board certified radiologists," but it doesn't detail how their opinions were combined or resolved if there were disagreements (e.g., 2+1, 3+1, majority vote, etc.). It simply concludes they "found to produce images of equivalent diagnostic quality."
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? Not explicitly in the sense of comparing human readers with vs. without AI assistance. The study described is a comparison of two different imaging devices (the new device vs. the predicate device), with human readers assessing the image quality from both. It evaluates the diagnostic equivalence of the devices, not the improvement of human readers with AI assistance.
- Effect Size of Human Readers' Improvement with AI vs. without AI assistance: Not applicable, as this type of study was not conducted or reported.
6. Standalone (Algorithm Only) Performance Study
This device is a hardware component (Flat Panel Detector), not an AI algorithm. Therefore, a "standalone algorithm only" performance study is not applicable. The device's performance is intrinsically linked to its ability to capture images that can be interpreted by humans.
7. Type of Ground Truth Used
The ground truth for the comparison was expert consensus / subjective evaluation of diagnostic quality by three board-certified radiologists. They assessed the "equivalent diagnostic quality" of images produced by the new device compared to the predicate device.
8. Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device is a hardware component (a flat panel detector), not an AI-driven software or algorithm that requires a "training set" in the conventional machine learning sense. The device's design and engineering are based on established physics and imaging principles, not trained on a dataset.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set Establishment: Not applicable for the same reasons as #8. The "training" for such a device is its engineering, calibration, and adherence to physical principles and manufacturing specifications.
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