Search Results

1717SCC 127um and 1717SCC 140um are indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. Not to be used for mammography.

While 1717SCC 127um is identical to 1717SCC (K122173), both 1717SCC 127 um and 1717SCC 140um are digital solid state X-ray detectors based on flat-panel technology. These radiographic image detectors and processing unit consist of a scintillator coupled to an a-Si TFT sensor. Both devices are connected to the user PC via wired LAN (ethernet cable) and need to be integrated with a radiographic imaging system. Both devices do not operate as an X-ray generator controller but can be utilized to convert X-ray to light and light to electrical signals for image data digitization.

The RAW files can be further processed as DICOM compatible image files by separate console SW (K160579 / Xmaru View V1 and Xmaru PACS/ Rayence Co.,Ltd.) for a radiographic diagnosis and analysis.

The provided document describes the 510(k) premarket notification for the Rayence Co., Ltd. 1717SCC 127um and 1717SCC 140um digital flat panel X-ray detectors. It claims substantial equivalence to predicate devices (1717SGN / 1717SCN, K150150 and 1717SCC, K122173). The document focuses on demonstrating that the new devices do not raise new concerns for safety and effectiveness compared to the predicates, rather than establishing specific acceptance criteria and providing a detailed study proving the device meets those criteria.

Therefore, the information below is extracted from the document to infer acceptance criteria and describe the studies conducted in the context of demonstrating substantial equivalence, rather than a direct presentation of pre-defined acceptance criteria met by a single study.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set (Clinical Consideration Report for 1717SCC 140um): The document states "sample radiographs of similar age group and anatomical structures." It does not specify an exact number of cases or images.
• Data Provenance: Not explicitly stated, but the submission is from Rayence Co., Ltd. in Korea. The "clinical consideration report" implies human subjects were involved. The exact country of origin for the clinical data is not specified. It is implied to be prospective for the clinical images used for comparison, as they were "taken from both subject devices" for the purpose of the study.

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

• Number of Experts: "a licensed physician" is mentioned. This suggests one expert.
• Qualifications of Experts: Identified as "a licensed physician." Specific specializations (e.g., radiologist) or years of experience are not provided.

4. Adjudication Method for the Test Set

• The document states, "reviewed by a licensed physician to render an expert opinion" and "outcome of a comparative review by an expert for both devices." This suggests a single expert review without formal adjudication by multiple experts.

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, an MRMC comparative effectiveness study was not done. The device itself is an X-ray detector, not an AI-assisted diagnostic tool. The document describes a comparison of the image quality produced by the new detectors versus predicate devices, reviewed by a physician. There is no mention of AI assistance or human reader improvement with/without AI.

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

• Yes, a standalone performance assessment was conducted for the device's technical specifications. The non-clinical test report contains MTF, DQE, and NPS test results of 1717SCC_140µm by using the identical test equipment and same analysis method described by IEC 62220-1. This is a technical performance evaluation of the device itself, independent of a human observer's interpretation of images.

7. The Type of Ground Truth Used

• For standalone performance (MTF, DQE, NPS): These are objective physical measurements against established industry standards (IEC 62220-1). The "ground truth" here is the physical performance of the detector under controlled conditions.
• For clinical consideration (image quality review): The "ground truth" was expert opinion/consensus by a licensed physician on the diagnostic image quality and clarity of anatomical structures.

8. The Sample Size for the Training Set

• Not Applicable. The document describes a medical device (an X-ray detector), not a machine learning or AI algorithm that requires a training set. The device itself is characterized by its physical performance and image output, not by a trained model.

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

• Not Applicable. As per point 8, there is no training set for this type of device.

Ask a specific question about this device

Intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other and pediatric patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. Not intended for mammography.

The Aquarius 8600 1717TC are digital flat panels, specifically termed solid state digital X-Ray detector. This technology couples a scintillator with an a-Si TFT sensor, and through integration with a radiographic imaging system, x-ray images can be captured and digitalized. The resulting RAW files are DICOM 3.0 compatible allowing image files to be processed by IDC Magellan software.

The Aquarius 8600 1717TC and 1417TC represents a modification of our own predicate device cleared under K070079, X3C Digital Radiographic Detector.

The Aquarius 8600 1717TC and 1417TC integrates the 510(k) cleared flat panel detectors (K122173 and K122919) with IDC Magellan software and workstation. There were no changes made to the cleared panels, workstation or software. All components were integrated and tested to make the Aquarius 8600 1717TC and 1417TC medical devices.

The Aquarius 8600 will be marketed in two possible configurations:
Aquarius 8600 1717TC (tethered, 17 x 17 inch flat panel as a retrofit package with Magellan software) referred to as "1717TC" throughout the rest of this document
Aquarius 8600 1417TC (tethered. 14 x 17 inch flat panel as a retrofit package with Magellan software) referred to as "1417TC" throughout the rest of this document.

The provided text describes a 510(k) submission for the Aquarius 8600, a digital flat panel X-ray detector. However, it does not include information about a study that proves a device meets acceptance criteria related to AI/Machine Learning device performance, as there is no AI component mentioned in this submission. The submission is for a radiographic imaging system and focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data (DQE, MTF, NPS), safety testing, and software lifecycle documentation.

Therefore, many of the requested items (e.g., sample size for test set, data provenance, ground truth establishment, expert adjudication, MRMC study, standalone performance against ground truth, training set details) are not applicable to this specific submission, as they relate to the validation of an AI/ML algorithm rather than a traditional medical imaging hardware component.

I will fill in the relevant information that is present in the document and explicitly state where information is not applicable or not provided.

Acceptance Criteria and Device Performance (Aquarius 8600)

The acceptance criteria here are implicitly defined by demonstrating "substantial equivalence" to a predicate device (IDC X3C Digital Radiographic Detector) through comparable performance metrics and safety standards. The study primarily relies on non-clinical (bench) testing.

1. Table of Acceptance Criteria (based on predicate equivalence) and Reported Device Performance

Note: The increase in NPS values for the Aquarius 8600 at lower spatial frequencies compared to the X3C detector is noted in the table but the document states they have "a similar noise performance profile". This suggests that while raw values may differ, the overall expected noise characteristics for diagnostic purposes were deemed acceptable for substantial equivalence.

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

• Test Set: Non-clinical (phantom) images were used. The document does not specify an exact number of phantom images or specific test scenarios beyond mentioning "Laboratory images using phantoms were acquired."
• Data Provenance: The testing was conducted by Imaging Dynamics Company, Ltd. (IDC) (Canada). The nature of the non-clinical testing (phantoms) means there's no patient data provenance to specify. The study is a pre-market submission for substantial equivalence, relying on bench tests, rather than a clinical trial with retrospective/prospective patient data.

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

• Number of Experts: One expert.
• Qualifications: A "Radiological Technologist certified in the United States of America and Canada." (Note: This is a technologist, not a radiologist, and their role was to review images for diagnostic similarity, not to establish a clinical "ground truth" from patient data.)

4. Adjudication method for the test set:

• Adjudication Method: None explicitly mentioned or applicable beyond the single radiologic technologist's review of phantom images. This was not a multi-reader clinical study requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:

• MRMC Study: No, an MRMC comparative effectiveness study was not conducted. The submission explicitly states: "No clinical testing was performed for this special 510(k) submission." The evaluation was primarily based on non-clinical performance parameters (DQE, MTF, NPS) and a subjective review of phantom images by one technologist.
• Effect Size of Human Readers Improvement: Not applicable, as no MRMC study with human-in-the-loop AI assistance was conducted.

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

• Standalone Performance: Not applicable. This device is a digital X-ray detector, which is hardware, not an AI algorithm. Its "performance" is measured by physics-based parameters (DQE, MTF, NPS) derived from phantom images, not by an algorithm's diagnostic output against a clinical ground truth.

7. The type of ground truth used:

• Type of Ground Truth: For the quantitative performance metrics (DQE, MTF, NPS), the "ground truth" is established by the standardized measurement methodologies described in relevant international standards and best practices for X-ray detector characterization. For the qualitative image review, the "ground truth" was a subjective assessment by a certified technologist comparing images from the new device to the predicate using phantoms. No clinical "ground truth" (e.g., pathology, clinical outcomes) from patient data was used.

8. The sample size for the training set:

• Training Set Sample Size: Not applicable. This is a hardware device; there is no AI/ML algorithm that requires a "training set" in the context of this 510(k) submission.

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

• Ground Truth Establishment for Training Set: Not applicable, as there is no training set for an AI/ML algorithm.

Ask a specific question about this device

The XR5 diagnostic X-ray system is intended for use on adult and pediatric patients for taking diagnostics radiographic exposure of all body parts and operated by a qualified/trained doctor or technician. The XR5 diagnostic X-ray system is designed to be used with conventional film/screen, CR cassettes or digital detectors. NOT intended for Mammography use.

The XR5 diagnostic X-ray system is used for image capture by using X-rays on a patient's body. The XR5 is a conventional X-ray machine, with an intuitive operation console to provide the user an easy way to manage optimal conditions for quality images. The high frequency generator is capable of delivering the exposition dose appropriate for general X-ray and diagnostic images of a patient. This system is made to use other detector options including: conventional films, CR, or Digital Flat Panel Detectors. Please note that the quality of the image in any detector depends on the manufacture of the receptor device. The XR5 diagnostic X-ray system doesn't provide an AEC feature.

The provided text describes the OSKO, INC. XR5 Diagnostic X-ray System, which is a conventional X-ray machine. However, the document (a 510(k) summary) focuses on demonstrating substantial equivalence to a predicate device (Multix Fusion by Siemens Medical Solutions USA, Inc.) rather than outlining specific acceptance criteria or a dedicated study proving the device meets those specific acceptance criteria in terms of clinical performance metrics.

Instead, the document emphasizes:

• Technical equivalence: Comparing specifications like generator type, image acquisition methods, and the use of FDA-cleared digital detectors.
• Compliance with safety and electrical standards: Referencing IEC 60601-1, IEC 60601-2-54, and EN60601-1-2.
• Performance of individual components: The digital detectors are evaluated based on DQE, MTF, and line resolution, with these parameters serving as indicators of their performance.

Therefore, many of the requested items (e.g., specific acceptance criteria for diagnostic accuracy, sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance) are not detailed in this type of regulatory submission, as it's not a clinical performance study report for diagnostic accuracy of the overall system.

Here's an attempt to answer the questions based only on the provided text, with many fields explicitly stated as "Not Applicable" or "Not Provided" due to the nature of the document:

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

The document does not explicitly define specific "acceptance criteria" for diagnostic performance of the overall XR5 system as a diagnostic device (e.g., sensitivity, specificity, accuracy for a particular condition). Instead, it relies on demonstrating substantial equivalence to a predicate device by comparing technical specifications and performance of key components (digital detectors). The "reported device performance" primarily refers to the technical specifications and the performance metrics of the digital detectors used with the system.

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

• Sample Size for Test Set: Not provided. The document states that "Bench performance parameters for the digital detectors are sufficient to demonstrate substantial equivalence to a predicate device" and that "Clinical images are not necessary to establish substantial equivalence based on the previously FDA cleared detectors." This implies that a formal clinical test set with a specific sample size for diagnostic performance was either not conducted or not deemed necessary for this 510(k) submission.
• Data Provenance: Not provided for any clinical data. Non-clinical performance data for the detectors references the IEC 62220-1:2003 Standard.

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)

Not applicable/Not provided. No clinical test set to establish ground truth for diagnostic accuracy is described.

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

Not applicable/Not provided. No clinical test set for diagnostic accuracy 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

Not applicable/Not provided. This device is a conventional X-ray system, not an AI-powered diagnostic tool, and no MRMC study is mentioned.

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

Not applicable/Not provided. This device is a conventional X-ray system, not an algorithm, and no standalone performance study in this context is mentioned.

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

Not applicable/Not provided for diagnostic accuracy of the overall system. The document does not describe the establishment of clinical ground truth for diagnostic accuracy for the XR5 system itself. For the digital detectors, their performance metrics (DQE, MTF, line resolution) are physics-based measurements rather than clinical ground truth on patient outcomes.

8. The sample size for the training set

Not applicable/Not provided. This device is a hardware X-ray system, not an AI algorithm requiring a training set. The firmware is "programmed with ANSI C language," suggesting traditional software development and testing rather than machine learning training.

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

Not applicable/Not provided. As above, this device is a hardware X-ray system; no training set for an AI algorithm is mentioned.

Ask a specific question about this device