Search Results

The XRpad 4336 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 XRpad 4336 MED is a flat panel X-ray detector consisting of an amorphous silicon panel with a directly deposited CsI:Tl scintillator. The XRpad 4336 MED detector has an active area of 43.2cm x 35.5cm at a pixel pitch of 100μm. Data and control communication is accomplished via a Gigabit Ethernet interface or 802.11n WiFi. The detector can be integrated into a fixed room X-ray system to enable digital radiography. The XRpad 4336 MED detector is designed to work with any X-ray system (consisting of an X-ray source, generator, collimator, and positioner) intended for use in generating radiographic images of human anatomy for diagnostic X-ray procedures. Applicable detector parameters, such as dynamic range, exposure time range, energy range, image size, resolution, detective quantum efficiency, etc are designed to support the necessary compatibility.

The provided text does not contain detailed information about the acceptance criteria or a specific study proving the device meets those criteria, as typically found in a clinical performance study. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with performance metrics.

However, based on the available information, here's what can be inferred and what is explicitly stated:

1. A table of acceptance criteria and the reported device performance:

The document states that the device successfully completed "internal nonclinical testing" and "complies with standards and regulations such as UL and IEC." It also mentions that the proposed device and predicate device "have been shown to produce images of equivalent diagnostic quality."

• Acceptance Criteria (Inferred from regulatory compliance and substantial equivalence claim):

  • Compliance with UL and IEC standards (general safety and performance).
  • Produce images of equivalent diagnostic quality to the predicate device.
  • Meet applicable detector parameters such as dynamic range, exposure time range, energy range, image size, resolution, and detective quantum efficiency (implied as supporting compatibility).

• Reported Device Performance:

  • Successfully completed internal nonclinical testing.
  • Complies with UL and IEC standards.
  • Produces images of equivalent diagnostic quality to the predicate device.
  • (Specific numerical performance metrics for acceptance criteria like DQE, resolution, etc., are not provided in this summary.)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document explicitly states: "No clinical studies were conducted in support of the XRpad 4336 MED as agreed upon during Pre-Submission discussions with the Agency for the predicate device (K122495). The conduct of a clinical concurrence study was deemed unnecessary to demonstrate substantial equivalence."

Therefore, there is no test set, sample size, or data provenance from a clinical study to report. The evaluation was based on nonclinical testing and comparison to engineering specifications and performance of the predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Since no clinical studies were conducted and no test set with human-interpreted ground truth was used for a direct performance claim, this information is not applicable and not provided.

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

Not applicable, as no clinical test set was used.

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. The device is a flat panel X-ray detector, not an AI-powered diagnostic tool. No MRMC study was performed, and no AI assistance is mentioned.

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

Not applicable, as the device is hardware (an X-ray detector) and not an algorithm.

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

For the nonclinical testing mentioned, the "ground truth" would be engineering specifications and measurements against established physical standards and benchmarks, rather than clinical ground truth like pathology or expert consensus. The primary "ground truth" for showing equivalence was the performance data and specifications of the predicate device (XRD 1622 AP3 MED X-ray system).

8. The sample size for the training set:

Not applicable, as this is hardware, not an algorithm requiring a training set.

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

Not applicable.

Ask a specific question about this device