(24 days)
The Direct Digitizer, REGIUS SIGMA2 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. 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 in mammography.
The Direct Digitizer, REGIUS SIGMA2 is a compact X-ray image reader which uses a stimulable phosphor plate (Plate) as X-ray detector installed in a 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.
The device is comprised of a reading unit with cassette containing Plate.
Plates and cassette remain unchanged from the predicate device, REGIUS SIGMA.
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.
The basic operations of REGIUS SIGMA2 and the predicate device, REGIUS SIGMA, such as a starting, a shut down, a registration-of-patient, a setting of a various condition are operated with the Medical Image Processing Workstation, ImagePilot (operator console) which is cleared 510(k), K071436.
The modification was made from the REGIUS SIGMA to the REGIUS SIGMA2 to increase processing capacity. To increase the processing capacity, the firmware (device mechanical control software) of the reading unit is modified. The outline is as follows.
The processing capacity is increased by controlling the feed sequence.
(1) Increasing the speed of removal of Plate from cassette and the sequence of storage into cassette
(2) Increasing the erasing speed by changing the erasing LED
The feed sequence related to Image Quality (Reading speed, Open/Close timing of sub-scanning nip) is not changed.
Here's a breakdown of the acceptance criteria and study information based on the provided text, using the requested structure:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific numerical acceptance criteria for image quality or processing performance. Instead, it describes a comparative approach where the performance of the new device (REGIUS SIGMA2) is evaluated against a legally marketed predicate device (REGIUS SIGMA).
| Acceptance Criteria Category | Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|---|
| Image Quality | Perform "as well as" the predicate device; no new safety and efficacy issues. | Performance data from non-clinical testing of REGIUS SIGMA2 compared favorably with the predicate device, REGIUS SIGMA, indicating it performed "as well as" the predicate device. |
| Processing Capacity | Increased processing capacity compared to the predicate device. | Processing capacity was increased by modifying firmware to control feed sequence, including faster Plate removal/storage and increased erasing speed. |
| Safety | Meet specified safety standards. | Met IEC60601-1, IEC60601-1-2, 21 CFR 1040.10, IEC60825-1, and ISO14971 standards. Risk analysis reduced identified risks to an acceptable level. |
| Technological Equivalence | Same technological characteristics and principle of operation as the predicate. | Principles of operation and technological characteristics are the same. Plates and cassettes remain unchanged from the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Performance data from non-clinical testing of the REGIUS SIGMA2 is compared with data from the predicate device, REGIUS SIGMA."
- Sample Size (Test Set): Not specified. The phrase "non-clinical testing" suggests laboratory/bench testing rather than human subject data.
- Data Provenance: Not specified, but likely internal Konica Minolta laboratory data, given it's "non-clinical testing." No indication of country of origin or whether it's retrospective or prospective in the traditional sense of human data studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable/not specified. The testing described is "non-clinical" and focuses on device performance metrics rather than image interpretation by experts to establish a "ground truth" for clinical accuracy.
- Qualifications of Experts: N/A.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/none. As the testing is non-clinical, there wouldn't be an adjudication method for human interpretation. The comparison is based on technical performance metrics of the device itself.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The device is an X-ray image reader, not an AI-assisted diagnostic tool for interpretation.
- Effect Size: Not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Yes, in a sense. The described "non-clinical testing" is inherently a standalone evaluation of the device's technical specifications and performance characteristics (e.g., image quality, processing speed) compared to the predicate, independent of human interaction for interpretation. It's evaluating the device's output, not its interpretative assistance to humans.
7. The Type of Ground Truth Used
- Type of Ground Truth: For the "non-clinical testing," the "ground truth" implicitly refers to the established technical performance specifications and acceptable output quality of the predicate device (REGIUS SIGMA), as well as adherence to relevant safety standards. The new device's performance metrics (e.g., image quality, speed) were compared directly against those of the predicate device to ensure equivalence or improvement. There's no mention of pathology, outcomes data, or expert consensus related to diagnostic accuracy from images as the ground truth.
8. The Sample Size for the Training Set
- Sample Size (Training Set): Not applicable/not specified. This device is an X-ray digitizer/reader, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The "firmware (device mechanical control software)" modifications are likely conventional programming changes to optimize mechanical sequences, not an AI model trained on data.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable. As noted above, there's no indication of a "training set" for AI/ML in this context. The "ground truth" for developing the firmware modifications would be engineering specifications and desired operational parameters for mechanical control.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.