(22 days)
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:
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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.
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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.
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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.
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Adjudication method for the test set: Not applicable.
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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.
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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.
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The type of ground truth used: Not applicable, as no diagnostic performance study is described.
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The sample size for the training set: Not applicable, as this is not an AI/algorithm submission requiring a training set.
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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.
§ 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.