Search Results

The XRpad2 3025 HWC-M, 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 mammonfions .

standard X-ray cassette Bucky

• topad IPU-2 (Interface and Power Un
• KRpad LPT2 Detector Cable
• XRpad Protective Insert 307
• OV Cable IEC 60320 C13
• ........ Cable IEC 60320 CLS
• frigger Cable 5 m/16.5
• ger Cable 20 m/65
• GigE Interface Cable 15.25 m/ Interface Cable 7.6 m/2
• E Interface Cable 30.5 m/100

The provided text is a 510(k) premarket notification for the PerkinElmer XRpad2 3025 HWC-M Flat Panel Detector. It seeks to prove substantial equivalence to a predicate device (PerkinElmer XRpad 4336 MED, K140551) rather than demonstrating that the device meets specific acceptance criteria through a clinical study with a test set of human images.

Therefore, many of the requested elements regarding acceptance criteria, study design, and ground truth establishment for a clinical performance study on human images are not explicitly present or applicable in this document because the submission focuses on non-clinical performance and technical equivalence for an X-ray detector, not an AI/CADe device that interprets images. This document describes the device itself and its technical performance, not its diagnostic accuracy in a clinical setting with human readers.

However, I can extract information related to the technical performance of the device, which serves as the "acceptance criteria" and "proof" in the context of this 510(k) submission.

Summary of Device Acceptance Criteria and Performance (Based on Technical Equivalence):

This submission is a 510(k) for an X-ray flat panel detector, not an AI or CADe device. The "acceptance criteria" here are based on demonstrating that the new device's technical specifications and performance are substantially equivalent to a previously cleared predicate device, ensuring it performs as intended for generating radiographic images.

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document states "The modifications are related to the decrease in dimensions and does not impact image quality." This implies that while the dimensions are different, the critical image quality parameters, which are the 'acceptance criteria' for this type of device, are maintained.

2. Sample size used for the test set and the data provenance:

• This is a non-clinical performance study. The "test set" consists of the device itself undergoing various physical and electrical performance tests.
• The document explicitly states: "PerkinElmer has performed internal non-clinical testing to demonstrate the safety and effectiveness of the XRpad2 3025 HWC-M Flat Panel Detector."
• There is no mention of a sample size of human images or data provenance (country of origin, retrospective/prospective) because this submission is about the technical performance of the X-ray detector hardware, not its diagnostic performance on patient images assessed by humans or AI.

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. This submission relies on engineering and physics measurements to establish the performance of the X-ray detector, not diagnostic interpretations by medical experts. The ground truth for this device's performance would be derived from quantitative measurements like DQE, MTF, resolution, etc., performed in a lab setting.
• The document mentions "BE and MTF are comparable to the predicate device. The non-clinics [sic] findings show that the detector complies with standards and regulations." This refers to objective physical measurements.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. There is no human image interpretation in this submission, so no adjudication of expert opinions is required.

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:

• Not applicable. This is an X-ray detector, not an AI or CADe device. No MRMC study was performed or is relevant for this type of 510(k) submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is an X-ray detector, not an algorithm, so "standalone performance" in the context of AI is not relevant. Its "standalone performance" is its technical image acquisition capabilities.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• The ground truth for this device's "performance" is based on quantitative physical measurements (e.g., Modulation Transfer Function (MTF) to assess spatial resolution, Detective Quantum Efficiency (DQE) to assess dose efficiency, electrical and mechanical tests) according to recognized industry standards (e.g., IEC standards, as implied by "complies with standards and regulations").
• The document specifically mentions "BE and MTF are comparable to the predicate device." BE likely refers to "Beam Energy" or some other physical characteristic.

8. The sample size for the training set:

• Not applicable. This is a hardware device. It does not use a "training set" in the machine learning sense. Its design and validation are based on engineering principles and physical testing.

9. How the ground truth for the training set was established:

• Not applicable. As above, no training set for machine learning is involved.

Ask a specific question about this device