Search Results

The XRpad2 4336 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 mammographic use.

The XRpad2 4336 HWC-M is a lightweight, cassette-sized, flat panel X-ray detector for digital radiography. The X-ray detector consists of an amorphous silicon flat panel with a directly deposited CsI:T1 scintillator and dedicated read-out, scan, and control electronics, all packaged in a carbon-fiber and aluminum enclosure. The outside dimensions of the detector are 460.0 mm × 383.6 mm × 15.5 mm, which fits into a standard X-ray cassette Bucky.

The detector can be integrated into a fixed room X-ray system to enable digital radiography.

This document describes the 510(k) summary for the PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector, which seeks to establish substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative table format with corresponding "reported device performance" values for the XRpad2 4336 HWC-M. Instead, it relies on demonstrating equivalence to a predicate device (PerkinElmer XRpad 4336 MED, K140551) through non-clinical testing and stating that the physical values are "comparable."

However, a comparison chart for device characteristics is provided (Page 5), which implicitly indicates the performance metrics considered for demonstrating equivalence. The "acceptance criteria" for the new device are essentially that its performance is equivalent to the predicate.

2. Sample Size Used for the Test Set and Data Provenance

A new clinical study was not conducted for the XRpad2 4336 HWC-M device. The clinical data supporting the predicate device, XRpad 4336 MED, was derived from testing for K122495 (XRD 1622 AP3 MED). Therefore, no specific "test set" sample size or data provenance is provided for the current device's clinical performance. The current device relies on demonstrating that its differences "do not invalidate the applicability of the clinical study data submitted in K122495."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Since a new clinical study was not conducted for this device, and it relies on previous clinical data, this information is not provided in the document. The document refers to the predicate clearance (K140551) which itself references K122495 for clinical data. Details on experts and ground truth for K122495 are not in this document.

4. Adjudication Method for the Test Set

As no new clinical study test set was used for this device, a specific adjudication method is not described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done for the XRpad2 4336 HWC-M. The submission focuses on non-clinical equivalence to a predicate device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This device is a flat panel X-ray detector, not an AI algorithm. Therefore, a standalone (algorithm only) performance study as typically understood for AI/CAD systems is not applicable or performed. Its performance is measured by image quality metrics (like DQE, MTF) and compared to a predicate device.

7. Type of Ground Truth Used

For the current device, direct clinical ground truth (e.g., pathology, outcomes data) was not established in a new study. The device's "ground truth" for clinical performance is indirectly established by demonstrating its equivalence to a predicate device whose clinical effectiveness was previously established, likely through methods typical for X-ray detectors (e.g., image quality assessment, possibly expert consensus on diagnostic images from K122495).

8. Sample Size for the Training Set

This device is an X-ray detector, not a machine learning algorithm that requires a "training set" in the conventional sense. The document describes engineering, design, and performance validation, not algorithmic training.

9. How the Ground Truth for the Training Set Was Established

As this is not an AI/ML device requiring a training set, this question is not applicable.

Ask a specific question about this device

The XRoad 4343 F 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 4343 F MED is a lightweight, cassette-sized, flat panel X-ray detector for digital radiography. The X-ray detector consists of an amorphous silicon flat panel with a directly deposited CsI:T1 scintillator and dedicated read-out, scan, and control electronics, all packaged in a carbon-fiber and aluminum enclosure. The outside dimensions of the detector are 460 mm × 15 mm, which fits into a standard X-ray cassette Bucky. The active area is 430 mm × 430mm at a pixel pitch of 100um. The detector can be integrated into a fixed room X-ray system to enable digital radiography.

The PerkinElmer XRpad 4343 F MED Flat Panel Detector is a digital radiography device. The acceptance criteria and supporting study details are as follows:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list quantitative acceptance criteria in a dedicated table format with corresponding reported performance for the XRpad 4343 F MED. Instead, it relies on demonstrating equivalence to a predicate device (XRpad 4336 MED, K140551) through comparable non-clinical performance values and the applicability of the predicate's clinical data.

However, key comparative performance characteristics are presented:

Differences noted for the proposed device (not framed as acceptance criteria but as distinguishing features from the predicate):

• Pixel matrix: 3556 × 4320 pixels (Predicate) vs. 4318 × 4320 pixels (Proposed)
• Active area: 355 mm × 430 mm (Predicate) vs. 430 mm × 430 mm (Proposed)
• External dimensions: 384 mm × 460 mm × 15 mm (Predicate) vs. 460 mm × 460 mm × 15 mm (Proposed)
• Weight: Approximately 4 kg (Predicate) vs. Approximately 5 kg (Proposed)
• Communication interface: Gb Ethernet or 802.11n WiFi (Predicate) vs. Gb Ethernet, No wireless capability (Proposed)
• Power: External power supply or battery (Predicate) vs. External power supply (Proposed)
• Battery capacity: 53Wh (Predicate) vs. No battery option (Proposed)

The foundational acceptance criterion is "Substantial Equivalence" to the predicate device, demonstrated by showing that the proposed device has comparable performance and operational standards, produces images of equivalent diagnostic quality, and that potential hazards have been studied and controlled.

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

• The document states that a new clinical study was not required for the XRpad 4343 F MED device.
• Instead, the predicate device, XRpad 4336 MED, was cleared using clinical data derived from testing to support K122495 (XRD 1622 AP3 MED).
• The document implies that the "clinical study data submitted in K122495" served as the basis for the clinical evaluation, but it does not provide details on the sample size or data provenance (e.g., country of origin, retrospective/prospective nature) for K122495. It only states that this data was deemed "applicable" to the XRpad 4336 MED and, through non-clinical testing, also applicable to the XRpad 4343 F MED.

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

• The document does not provide information on the number of experts or their qualifications, as it refers to a prior 510(k) submission (K122495) for clinical data.

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

• The document does not provide information on the adjudication method, as it refers to a prior 510(k) submission (K122495) for clinical data.

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 comparative effectiveness study was done or reported in this 510(k) summary for the XRpad 4343 F MED, nor does it involve AI assistance. This device is a flat panel x-ray detector, not an AI-powered diagnostic tool. The document relies on demonstrating non-inferiority/equivalence to a predicate physical device.

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

• This question is not applicable as the XRpad 4343 F MED is a hardware device (flat panel detector) for capturing radiographic images, not a standalone algorithm.

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

• The document does not explicitly state the type of ground truth used for the clinical data referenced from K122495.
• However, given the nature of radiographic imaging devices, it is highly probable that the ground truth for the clinical data in K122495 would have been established through expert radiological interpretation and potentially confirmed by pathology or clinical outcomes, but this is not confirmed in the provided text.

8. The sample size for the training set:

• The document does not mention any training set for the XRpad 4343 F MED, as it is a hardware device and not an algorithm requiring a training set in the AI/machine learning sense.

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

• This question is not applicable as no training set (in the context of algorithms) is mentioned or used for this device.

Ask a specific question about this device

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