(164 days)
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.
§ 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.