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The Konica Minolta Xpress Digital Mammography System is a software device that is used in conjunction with a specified Konica computed radiography system, REGIUS Model 190 or REGIUS Model 210 with REGIUS Cassette Plate CP1M200 and the REGIUS Console CS-3000, and a mammography x-ray unit, to produce full field digital mammography images. The Xpress Digital Mammography software with a specified Konica Minolta computed radiography system is designed to replace screen-film based systems for the production of mammographic images. The device is intended to be used for screening and diagnosis of breast cancer. The mammographic images can be interpreted by a qualified physician using either hard copy film or soft copy display at a workstation.

Konica Minolta's Xpress Digital Mammography is a software device that is used in conjunction with currently marketed Konica computed radiography systems to acquire Full Field Digital Mammography Images. Digital mammography can be performed with the specified Konica Minolta computed radiography systems including the activated Xpress Digital Mammography software using any mammography x-ray unit legally marketed in the U.S .. Konica Minolta does not specify a mammography x-ray unit for use with the specified Konica Minolta computed radiography system with the activated Xpress Digital Mammography software.

The components of the specified Konica Minolta computed radiography systems for digital mammography include either REGIUS Models 190 (K052095) or 210 (K092717) Direct Digitizers and the REGIUS Console CS-3000 medical image processing workstation (K051523) with optional bar code reader accessories.

The x-ray images produced by the legally marketed x=ray unit:are captured on a REGIUS image plate and digitized using either REGIUS Model 190 or 210 Direct. Digitized images are imported into the REGIUS Console CS-3000 workstation. The REGIUS Console CS-3000 is identical to the REGIUS Console CS-3000 described in K051523, with the Xpress Digital Manimography software activated. The Xpress Digital Mammography software prov a high resolution reading capability and display options specific to the review of mammographic image.

Soft. copy images can be transferred to any legally marketed diagnostic viewing station that accepts DICOM 3 input. Hard copy images can be generated using any printer legally marketed for use in digital mammography that supports DICOM basic grayscale print management service with a maximum 50 micrometer pixel pitch and film minimum optical density of at least 3.6.

Here's a breakdown of the acceptance criteria and study information for the Konica Minolta Xpress Digital Mammography System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on demonstrating non-inferiority to predicate devices (Fuji Computed Radiography Mammography Suite - FCRMS) and traditional screen-film mammography, rather than specific numerical acceptance thresholds. Therefore, the "acceptance criteria" are implied by the non-inferiority claims, and the "reported device performance" reflects how the device compared to the predicate/screen-film.

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

• Test Set Sample Size (Clinical Study): 210 subjects
  • 60 pathology-proven cancers
  • 130 benign abnormal subjects (benign biopsy findings)
  • 20 negative subjects (confirmed by negative one-year follow-up mammography)
• Data Provenance: Prospective, non-randomized, non-blinded clinical trial conducted at 11 clinical investigational centers. The country of origin is not explicitly stated but implies the US given the FDA submission. Both standard screen-film mammograms and Xpress Digital mammograms were acquired.

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

• Ground Truth for Clinical Study:
  • Pathology: For the 60 cancer cases and 130 benign abnormal cases, ground truth was established by pathology reports.
  • Follow-up Mammography: For the 20 negative cases, ground truth was established by negative one-year follow-up mammography.
• Experts for Phantom Testing: 3 observers participated in rating both the CDMAM and ACR phantoms.
  • Observer A: Seven years' experience of phantom scoring.
  • Observer B: Five years' experience of phantom scoring.
  • Observer C: Five years' experience of phantom scoring.

4. Adjudication Method for the Test Set

• Clinical Study: Not explicitly described as an adjudication method for ground truth. However, 11 radiologists interpreted the 210 cases, scoring each with a BIRADS score and probability of malignancy. The text states, "The final study cohort consisted of 210 subjects: 60 pathology proven cancers, 130 benign abnomal subjects (benign biopsy findings), and 20 negative subjects (confirmed by negative one year follow-up mammography)." This implies that the ground truth for individual cases (cancer/benign/negative) was established independently (pathology/follow-up) rather than through radiologist consensus on the test images themselves. The radiologists' interpretations were then compared against this established ground truth.
• Phantom Testing: The average scores of all three observers were calculated for the CDMAM phantom (contrast-detail diagrams and IQF results) and the ACR phantom (fibers, specks, masses scores). This is a form of consensus/averaging rather than adjudication for differing interpretations.

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

Yes, a multi-reader, multi-case study was performed as part of the clinical trial.

• Human Readers: 11 radiologists interpreted the 210 screen-film and Xpress Digital images. They were blinded to patient histories, mammography films, and results.
• AI (Device) vs. Human Readers: This study compared the device (Xpress Digital) to traditional screen-film mammography, both interpreted by human readers. It did not directly measure the effect size of how much human readers improve with AI vs. without AI assistance (i.e., AI-assisted reading vs. unassisted reading). Instead, it compared two different imaging modalities (digital vs. film), both interpreted by humans. The device itself is the imaging system, not an AI interpretation aid.

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

No. The clinical study involved human radiologists interpreting both the Xpress Digital mammograms and the screen-film mammograms. The device itself is an imaging system, not an AI algorithm for automated interpretation.

7. Type of Ground Truth Used

• Clinical Study:
  • Pathology: For cancer cases and benign abnormal subjects (biopsy findings).
  • Outcomes Data (Follow-up Mammography): For negative subjects (negative one-year follow-up mammography).

8. Sample Size for the Training Set

The document does not mention a training set or any machine learning components that would require one. The Xpress Digital Mammography System is described as a "software device" for image acquisition and display, and the studies performed relate to its physical and clinical performance as an imaging system, not an AI diagnostic algorithm.

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

Not applicable, as no training set or machine learning components are described or implied.

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The Direct Digitizer, REGIUS Model 210 is an X-ray image reader which uses a stimulable phosphor plate (Plate) as X-ray detector installed in a separate cassette. It reads the image recorded on the Plate and transfers the image data to an externally connected device such as a host computer, an order input device, an image display device, a printer, an image data filing device, and other image reproduction devices. REGIUS Model 210 also reads the image data of long areas of anatomy and to verify the position for a radiotherapy location. It is designed and intended to be used by trained medical personnel in a clinic, a radiology department in a hospital and in other medical facilities.

This device is not intended for use with FFDM systems

The Direct Digitizer, REGIUS Model 210 is an X-ray image reader which uses a stimulable phosphor plate (Plate) as X-ray detector installed in a separate cassette, and reads the Image recorded on the Plate by inserting a cassette in the entrance slot of this device. By means of laser scan and photoelectric method, this device reads the X-ray image data created in form of a latent image on the Plate exposed by an external X-ray generating device, and converts the read data into digital. REGIUS Model 210 also enables to use of multiple cassette to obtain images of long areas of anatomy and then to present the images as a single composite image (Long Length Imaging feature), and to use Read-Only Cassettes and Exposure-Only Cassettes used for Radiotherapy localization.

Different points between REGIUS Model 210 and REGIUS Model 190, which is approved 510(k) number: K052095 is that REGIUS Model 210 has higher processing capacity than REGIUS Model 190. To increase the processing capacity, the software algorithm is modified. However, the hardware remains unchanged. The exterior appearance is slightly modified.

The basic operations of REGIUS Model 210 such as a starting, a shut down, a registration-of-patient, a setting of a various condition are operated with the optional Image Processing Work Station, REGIUS CONSOLE CS-2000/3000 (510(k) cleared, K051523, July 20, 2005). Then the image data transfer to an externally connected device such as a host computer, an order input device, an image display device, a printer, an image data filing device, and other image reproduction devices.

This document is for a 510(k) premarket notification for a medical device called the "Direct Digitizer, REGIUS Model 210". The document establishes substantial equivalence to a predicate device and includes information about the device's intended use and classification. However, it does not contain the specific details about acceptance criteria, study design, or performance metrics that are requested in your prompt. This is typical for a 510(k) summary, which focuses on regulatory compliance and equivalence rather than detailed clinical trial results.

Therefore, I cannot provide the requested information from the provided text. The document does not describe:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study or effect size.
6. Standalone performance of the algorithm.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document primarily focuses on:

• Device Identification: Company, correspondent, submission date, registration number, trade name, classification name, and classification.
• Predicate Device: Direct Digitizer, REGIUS Model 190 (K052095).
• Device Description: An X-ray image reader using a stimulable phosphor plate (Plate) to convert X-ray images into digital data. It also supports Long Length Imaging and Read-Only/Exposure-Only Cassettes for Radiotherapy localization. The key difference from the predicate is a modified software algorithm for higher processing capacity, while hardware remains unchanged.
• Intended Use: For trained medical personnel in clinics, radiology departments, and other medical facilities to read X-ray images from phosphor plates and transfer data to external devices. Not intended for use with FFDM systems.
• Substantial Equivalence: Claimed to be substantially equivalent to the REGIUS Model 190.
• Compliance Standards: IEC 60601-1 (Safety), IEC 60601-1-2 (EMC), 21 CFR 1040.10, IEC 60825-1 (Radiation safety).

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