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The CO pilot is intended for installation on an off-the-shelf PC (REGIUS Unitea / 510(K) number: K071436) meeting or exceeding minimum specifications. The CO pilot software primarily facilitates processing and presentation of medical images on display monitors suitable for the medical task being performed. The CO pilot software can process and display images from the following modality types: Plain X-ray Radiography, X-ray Computed Tomography, Magnetic Resonance imaging, Ultrasound, Nuclear Medicine and other DICOM compliant modalities. The CO pilot must not be used for primary image diagnosis in mammography.

The "CO Pilot Software" is intended for installation on REGIUS Unitea (510(K) number: K071436), and provides unit for creating display-use annotation such as line, curve, and character information, unit for measuring the distance between 2 points and angle formed between 3 points and Transfer GUI data to the GUI control module to REGIUS Unitea System Control Program

The provided text is a 510(k) summary for a medical device called "CO Pilot" and the associated FDA clearance letter. It states that the CO Pilot is a software intended for installation on REGIUS Unitea (a Picture Archiving Communications System) and provides functions for creating annotations (line, curve, character information), measuring distances and angles, and transferring GUI data. It can process and display images from various modalities but "must not be used for primary image diagnosis in mammography."

The summary explicitly states: "Verification and Validation showed equivalent evaluation outcome with the predicate devices, which has supported a fact that no impacts in technological characteristics such as design, material chemical composition energy sauce and other factors of the proposed device were recognized. The all evaluation results can assure that there is no safety, effectiveness and performance issue or no differences were found in further than the predicate devices have which has been regally marketed the United States. Therefore, we confirmed that the function quality of proposed device has the substantial equivalency with orthopedic or chiropractic supporting functions quality that predicate devices have."

This indicates that Konica Minolta relied on demonstrating substantial equivalence to predicate devices rather than conducting a separate study with specific acceptance criteria and performance metrics for the CO Pilot itself. The summary does not include a detailed study that defines specific acceptance criteria, test sets, ground truth establishment, or multi-reader studies for the CO Pilot's performance. Instead, it argues that its performance is equivalent to already cleared devices through verification and validation activities.

Therefore, many of the requested details cannot be extracted directly from the provided text because these types of studies were not presented in this 510(k) summary as a means to prove the device meets acceptance criteria.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

The document does not provide a table of acceptance criteria for the CO Pilot's performance beyond stating that its "function quality" is substantially equivalent to predicate devices. It doesn't report specific performance metrics like sensitivity, specificity, accuracy, or measurement precision for the CO Pilot itself.

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

This information is not provided in the 510(k) summary. The summary refers to "Verification and Validation" but does not detail the datasets or studies used for these activities.

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)

This information is not provided.

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

This information is not provided.

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

A MRMC comparative effectiveness study is not mentioned. The device's primary function is annotation and measurement, not necessarily to assist human readers in diagnosis in a way that would typically be evaluated by an MRMC study demonstrating improved diagnostic accuracy.

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

The document does not describe a standalone performance study in the traditional sense for diagnostic accuracy. The device "primarily facilitates processing and presentation of medical images on display monitors" and provides "display-use annotation" and "measuring" functions. Its performance would likely be assessed on the accuracy of these functions rather than diagnostic output.

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

This information is not provided. Given the device's functions (annotation, measurement), ground truth would likely refer to the accuracy of these measurements relative to a known standard or expert measurement, but the details are not here.

8. The sample size for the training set

This information is not provided. Given the device's functions as annotation and measurement tools, it's less likely to involve a "training set" in the context of machine learning, unless specific automation features exist that weren't elaborated.

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

This information is not provided.

Summary of available information regarding acceptance criteria and study:

The 510(k) summary for CO Pilot (K133730) does not present specific acceptance criteria in a quantitative manner or a detailed study with performance metrics for the device itself. Instead, it relies on demonstrating substantial equivalence to its predicate devices (REGIUS Unitea K071436, Acies K101842, Opal-RAD TM K063337) through "Verification and Validation."

The core argument is:

• Acceptance Criteria (Implicit): The CO Pilot's "function quality," safety, effectiveness, and performance should be equivalent to or not inferior to the legally marketed predicate devices.
• Study Proving Acceptance (Method): "Verification and Validation" activities were conducted. These activities "showed equivalent evaluation outcome with the predicate devices" and confirmed "no impacts in technological characteristics" and "no differences were found" in comparison to the predicates.

No specific data related to test sets, ground truth, expert involvement, or quantitative performance metrics for the CO Pilot itself are provided in this summary.

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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).

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.

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The Direct Digitizer, REGIUS SIGMA 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 SIGMA 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.

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 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.

This 510(k) summary for the Direct Digitizer, REGIUS SIGMA, primarily focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and adherence to safety standards. It does not contain detailed information about acceptance criteria or a specific study proving device performance against such criteria in terms of diagnostic accuracy or clinical effectiveness.

The document states: "The performance test results show that there is no new safety and efficacy issue of the REGIUS SIGMA." However, it does not elaborate on what these performance tests entailed, what specific metrics were measured, nor what were the acceptance criteria for those metrics.

Therefore, many of your requested points cannot be answered from the provided text.

Here's an analysis of what can and cannot be answered:

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

• Cannot be provided. The document does not specify performance acceptance criteria related to diagnostic accuracy or clinical effectiveness, nor does it report specific device performance metrics against such criteria. It mentions meeting safety standards (IEC60601-1 Ed.2, IEC60601-1-2 Ed.3, 21 CFR 1040.10, IEC60825-1) and ISO14971 for risk management, which are general safety and quality standards, not specific performance metrics.

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

• Cannot be provided. The document does not describe any specific clinical or performance test set, its size, or its provenance.

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)

• Cannot be provided. Since no test set is described for diagnostic performance, ground truth establishment methods or expert qualifications are not mentioned.

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

• Cannot be provided. No test set or adjudication method is described.

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 study described. This device is an X-ray image reader (hardware) and does not appear to incorporate AI for diagnostic assistance based on the description. Therefore, an MRMC study comparing human readers with/without AI assistance would not be relevant to this specific device submission as described.

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

• Not applicable/Cannot be determined from the text. This device is hardware for digitizing X-ray images. It's not an AI algorithm.

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

• Cannot be provided. No ground truth for diagnostic performance is mentioned.

8. The sample size for the training set

• Not applicable/Cannot be provided. This is hardware, not a machine learning model, so there is no "training set" in the sense of data used to train an algorithm.

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

• Not applicable/Cannot be provided. As above, no training set for an algorithm is mentioned.

Summary from the document:

The 510(k) submission for the Direct Digitizer, REGIUS SIGMA, focuses on demonstrating substantial equivalence to predicate devices (Direct Digitizer, REGIUS Model 110, and Point-of-Care CR360) based on:

• Similar principles of operation and technological characteristics.
• Performance test results showing no new safety and efficacy issues. (Specific criteria or results are not detailed in this summary).
• Adherence to recognized safety and EMC standards:
  • IEC60601-1 Ed.2 (electrical safety)
  • IEC60601-1-2 Ed.3 (electromagnetic compatibility)
  • 21 CFR 1040.10, IEC60825-1 (radiation safety, specifically laser safety for the reading mechanism)
  • ISO14971 (risk management)

The key takeaway is that this approval is based on demonstrating the new device performs "similarly" to previously cleared devices and meets applicable safety standards, rather than providing a detailed clinical study with specific acceptance criteria for diagnostic performance.

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