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The Saturn 9000-810 system generates digital X-ray images that can be used for general X-ray system not for Mammography. The Saturn 9000-810 system can interface to traditional X-ray generator and get digital X-ray image. The Saturn 9000-810 is intended to be used in same clinical application as traditional film-screen based general radiography system.

The Saturn 9000-810 is equipped with a digital detector. X-ray generator interface, and image acquisition workstation. The digital detector is a-Se deposited plat panel detector. The input X-ray photons are absorbed in a-Se layer that creates an electrical charge which is representation of the X-ray input. The charge is read-out by a matrix scan of the array that converts the charges into a modulated electrical signal. X-ray exposure is controlled by switch box, which also controls the acquisition timing of the detector. Saturn 9000-810 includes acquisition workstation ("AWS") monitor, keyboard and mouse, computer, electronics, and accessory storage. The resultant output signal can be transmitted to remote viewing sites, and/or it can be stored electronically for later viewing. The AWS is used for image acquisition, processing, and display. The AWS can also be used for database management and can send images to archive, review or filming.

This document pertains to the Saturn 9000-810, a digital X-ray system. The information provided is from a 510(k) Premarket Notification.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria in terms of specific performance metrics or thresholds. Instead, it relies on the comparison to a predicate device and conformance to industry standards.

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

The document does not report any clinical test data, including sample size or data provenance for a test set. It explicitly states: "Clinical Tests: Not applicable for special 510(k) procedure." This suggests conformance was primarily based on non-clinical engineering tests and comparison to the predicate device.

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

Given that no clinical tests were reported for this specific 510(k) procedure, there is no information provided regarding experts or ground truth establishment for a clinical test set.

4. Adjudication Method for the Test Set:

No information is provided as no clinical test set was reported.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC comparative effectiveness study was not done or reported in this document. The submission explicitly states "Clinical Tests: Not applicable."

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

This device is an X-ray imaging system, not an AI or algorithm-only device. Therefore, a standalone algorithm performance study as described would not be applicable in this context. The document focuses on the performance of the imaging system itself.

7. The Type of Ground Truth Used:

As no clinical tests were performed or reported, there is no mention of ground truth types (e.g., expert consensus, pathology, outcomes data) for clinical evaluation. The primary "ground truth" for evaluating this device appears to be comparison to the predicate device and conformance to non-clinical engineering standards.

8. The Sample Size for the Training Set:

This document describes a medical imaging device (hardware and software for image acquisition and processing), not a machine learning algorithm that typically requires a training set. Therefore, the concept of a "training set sample size" as it applies to AI/ML is not applicable to this submission.

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

As the device described is not an AI/ML algorithm requiring a training set, this question is not applicable.

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The Saturn 9000-550 system generates digital X-ray images that can be used for general X-ray system not for Mammography. The Saturn 9000-550 system can interface to traditional X-ray generator and get digital X-ray image. The Saturn 9000-550 is intended to be used in same clinical application as traditional film-screen based general radiography system.

The Saturn 9000-550 is equipped with a digital detector, X-ray generator interface, and image acquisition workstation. The digital detector is a-Se deposited plat panel detector. The input X-ray photons are absorbed in a-Se layer that creates an electrical charge which is representation of the Xray input. The charge is read-out by a matrix scan of the array that converts the charges into a modulated electrical signal. X-ray exposure is controlled by switch box, which also controls the acquisition timing of the detector. Saturn 9000-550 includes acquisition workstation ("AWB") monitor, keyboard and mouse, computer, electronics, and accessory storage. resultant output signal can be transmitted to remote viewing sites, and/or it can be stored electronically for later viewing. The AWS is used for image acquisition, processing, and display. The AWS can also be used for database management and can send images to archive, review or filming.

The provided 510(k) summary (K072984) is for a "Special" submission regarding the replacement of a component (the detector) in the Saturn 9000-550 X-ray system. This type of submission, often for modifications to previously cleared devices, typically demonstrates substantial equivalence through technical comparison rather than extensive clinical studies with specific performance acceptance criteria for diagnostic efficacy.

Therefore, the document does not contain the detailed clinical study information and acceptance criteria requested in the prompt. The submission focuses on demonstrating that the modified device (Saturn 9000-550 with a different detector pixel size) maintains the same fundamental technology, indications for use, and safety/effectiveness as its predicate device (Saturn 9000).

Here's why the requested information is absent and what is provided:

1. A table of acceptance criteria and the reported device performance: This is not present. The document provides a technical comparison table between the predicate and proposed device, highlighting key specifications like detector technology, selenium layer thickness, imaging area, detector pixel size, image bit depth, and data interface. There are no performance metrics (e.g., sensitivity, specificity, accuracy) provided against specific acceptance criteria.

2. Sample size used for the test set and the data provenance: This information is not provided because a clinical test set demonstrating diagnostic performance against a ground truth is not typically required or presented for a "Special" 510(k) focusing on component replacement that doesn't alter the fundamental scientific technology or indications for use.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no diagnostic performance study described.

4. Adjudication method for the test set: Not applicable.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study is not mentioned. The submission is not focused on comparing improvements with AI assistance, as it's an X-ray detector.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is for an X-ray imaging system, not an AI algorithm.

7. The type of ground truth used: Not applicable, as no diagnostic performance study is described.

8. The sample size for the training set: Not applicable, as this is not an AI/algorithm submission requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

What the document does provide to demonstrate substantial equivalence:

• Device Description: The Saturn 9000-550 is described as using an a-Se deposited flat panel detector, similar to the predicate. The operational principle (X-ray absorption, charge creation, readout) is consistent.
• Indications for Use: Explicitly states that the Saturn 9000-550 maintains the same indications for use as the predicate device: "generates digital X-ray images that can be used for general X-ray system not for Mammography" and "is intended to be used in same clinical application as traditional film-screen based general radiography system."
• Comparison Table (Predicate vs. Proposed Device):
  • Detector Technology: Both use "a-Se, Direct."
  • Thickness of Se layer: Both "450μm."
  • Imaging Area: Both "14" X 17"."
  • Image Bit Depth: Both "14bits."
  • Image Data Interface: Both "Camera Link."
  • Control Box, Switch Box, Image Acquisition Software, Accessories: All are "Same as Saturn 9000."
  • Key Difference: The only highlighted difference in the comparison table is the Detector Pixel size, which changed from "139μm" in the predicate (Saturn 9000) to "168μm" in the proposed device (Saturn 9000-550). For this type of submission, the manufacturer would have demonstrated that this change in pixel size does not adversely affect image quality or diagnostic performance to a degree that would raise new questions of safety or effectiveness, often through non-clinical bench testing or technical rationale, but not typically through a full-scale clinical trial with acceptance criteria for diagnostic accuracy.

In summary, for K072984, the acceptance criteria are implicitly that the new device component (the detector) renders images that are safe and effective for the stated indications, and that its performance is substantially equivalent to the predicate device, despite the change in pixel size. This is established through a technical comparison and the absence of any new or different indications for use or questions of safety/effectiveness arising from the modification. The study mentioned is the comparison itself, showing technical equivalence and that the change in pixel size is not deemed significant enough to require a full clinical performance study with specific diagnostic outcome-based acceptance criteria often reserved for novel devices or major changes in intended use.

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The Saturn 9000-750 system generates digital X-ray images that can be used for general X-ray system not for Mammography. The Saturn 9000-750 system can interface to traditional X-ray generator and get digital X-ray image. The Saturn 9000-750 is intended to be used in same clinical application as traditional film-screen based general radiography system.

The Saturn 9000-750 is equipped with a digital detector, X-ray generator interface, and image acquisition workstation. The digital detector is a-Se deposited plat panel detector. The input X-ray photons are absorbed in a-Se layer that creates an electrical charge which is representation of the Xray input. The charge is read-out by a matrix scan of the array that converts the charges into a modulated electrical signal. X-ray exposure is controlled by switch box, which also controls the acquisition timing of the detector. Saturn 9000-750 includes acquisition workstation ("AWB") monitor, keyboard and mouse, computer, electronics, and accessory storage resultant output signal can be transmitted to remote viewing sites, and/or it can be stored electronically for later viewing. The AWS is used for image acquisition, processing, and display. The AWS can also be used for database management and can send images to archive, review or filming.

This 510(k) summary describes a digital X-ray system, the Saturn 9000-750, which is intended for general X-ray imaging (not mammography). However, the provided document does not contain acceptance criteria or study data demonstrating that the device meets such criteria.

The document primarily focuses on:

• Identification of the device and submitter information.
• Comparison to a predicate device (Saturn 9000). This comparison highlights technical specifications, noting that the proposed device (Saturn 9000-750) has a larger imaging area (17" x 17" vs. 14" x 17") and a different detector pixel size (168µm vs. 139µm) but maintains the same a-Se direct technology, Se layer thickness, image bit depth, and software as the predicate.
• Indications for use, stating it generates digital X-ray images for general X-ray systems and is intended for the same clinical applications as traditional film-screen based general radiography systems.
• An FDA letter confirming substantial equivalence to legally marketed predicate devices, implying that the safety and effectiveness are established by its similarity to an already approved device, rather than through new performance studies detailed in this summary.

Therefore, I cannot provide the requested information in the table or answer questions 2-9 because the provided text does not contain any details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert adjudication for this specific submission.

The FDA's substantial equivalence determination for this device (K072983) is based on its comparison to the predicate device (K063710). This means that the regulatory pathway relied on demonstrating that the new device is as safe and effective as the predicate, rather than requiring extensive new clinical performance studies with defined acceptance criteria to be submitted within this specific 510(k) summary. The performance of the predicate device would have been previously evaluated.

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The Saturn 9000 system generates digital X-ray images that can be used for general X-ray system not for Mammography. The Saturn 9000 system can interface to traditional X-ray generator and get digital X-ray image. The Saturn 9000 is intended to be used in same clinical application as traditional film-screen based general radiography system.

The Saturn 9000 Is equipped with a digital detector, X-ray generator interface, and image acquisition workstation. The digital detector is a-Se deposited plat panel detector. The input X-ray photons are absorbed in a-Se layer that creates an electrical charge which is representation of the X-ray input. The charge is read-out by a matrix scan of the array that converts the charges into a modulated electrical signal. X-ray exposure is controlled by switch box, which also controls the acquisition timing of the detector. Saturn 9000 includes acquisition workstation ("AWS") monitor, keyboard and mouse, computer, electronics, and accessory storage. The resultant output signal can be transmitted to remote viewing sites. and/or it can be stored electronically for later viewing. The AWS is used for image acquisition, processing, and display. The AWS can also be used for database management and can send images to archive, review or filming,

The provided 510(k) summary for the New Medical Co., LTD. Saturn 9000 focuses on demonstrating substantial equivalence to a predicate device for general X-ray imaging, excluding mammography. It relies heavily on non-clinical testing and a "concurrence study" but provides very limited detail about the clinical study design or its results in terms of specific performance metrics or acceptance criteria related to a specific product.

Therefore, many of the requested details about acceptance criteria, specific device performance, sample sizes, ground truth establishment, expert qualifications, and MRMC studies are not available in the provided text.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Limitations: The document does not provide specific numerical acceptance criteria (e.g., minimum AUC, sensitivity, specificity) or specific numerical performance results for the Saturn 9000. It relies on a general statement of "compatibility" and "concurrence."

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

• Sample Size for Test Set: Not explicitly stated. The document mentions a "concurrence study" and an "independent clinical trial" but does not specify how many patients or images were included.
• Data Provenance: Not explicitly stated. The context implies the study was conducted to support a submission in the US (FDA), but the country of origin of the actual patient data is not mentioned. It is also not specified whether the data was retrospective or prospective.

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

• This information is not provided in the document. The abstract nature of the clinical study description means there is no detail on who established ground truth or their qualifications.

4. Adjudication Method for the Test Set

• This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• No, an MRMC comparative effectiveness study involving AI assistance was not done. The device being described is a digital X-ray image capture device (hardware), not an AI algorithm. The study described is a "concurrence study" aimed at showing the device produces images comparable to a predicate device, which is a film-screen system.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• This question is not applicable as the Saturn 9000 is a hardware device (digital X-ray system), not an AI algorithm. Its performance is inherent in its ability to capture images.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• This information is not explicitly stated. Given it's a "concurrence study" comparing a new digital system to a traditional film-screen system, the "ground truth" likely revolved around comparing image quality and diagnostic utility as interpreted by human readers, possibly against the findings on the predicate device's images (e.g., if a lesion was visible on film, was it also visible on the digital image?). However, the specific methodology for establishing this "ground truth" (e.g., expert consensus on specific clinical findings) is not detailed.

8. The Sample Size for the Training Set

• This information is not applicable/not provided. The Saturn 9000 is a hardware device, not an AI model that requires a training set of images in the typical sense. Any "training" would be related to calibrating the hardware itself, not an algorithm's learning.

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

• This information is not applicable/not provided for the same reasons as point 8.

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