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Lakeshore Technologies Inc., formally Syracuse Scientific Inc., intends to use its SS960 CCD TV camera in combination with its Image Star II digital image processor for the presentation of Fluoroscopic or Radiographic TV images as presented by the image intensifier of the X-ray system.
A) The images may also be used to assist in operative procedures.
B) This device is to be used in diagnostic radiology or cardiology.
C) The clinical settings for this device are hospitals and for medical centers.
D) This device is to be used by a qualified radiologist or cardiologist.
E) This device is substantial equivalent to our Fluorecord Imaging System (510k K952493) in terms of the operation, design and intended use.

The Image Star II digital image processor in combination with the SS960 CCD TV camera makes up a simple, low cost, high performance imaging system. This system is designed to be used in place of the conventional 100mm or 105mm spot film cameras for any standard RF procedure. This digital imaging system will be used instead of, or in addition the standard spot film device. This system is designed to interface easily, in a generion no, ner, to any x-ray system that is designed to accommodate a spot rapid and /or cinc camers. The SS960 CCD TV camera will present a flickerless image when interfaced to anex. Flux generator performing pulsed fluoroscopy and/or cine radiography.

Image Star II is a complete digital imaging system and is comprised of two main components; a main acquisition control unit or Work Station and a Review Station. Images are acquired, processed, displayed and reviewed to allow high quality image analysis and diagnosis with the following special features: Image Analysis, Image Processing, Exams storage, CD Recording, Intranet Server and Medical Report Editing. This system performs functions such as edge enhancement, noise reduction, multi frame loop, and digital subtraction. This makes it useful for diagnostic radiology. cardiology. or mobile C-arm use.

The Work Station is interfaced to the x-ray generator and TV camera and is primarily used for acquisition. The Review Station is an optional independent Station connected yo the Work Station through a high speed network and is primarily used for storage and review. Recorded images can be reviewed on both the Work Station and the Review Slation. Studies can be opened, edited, analyzed. saved to a medical report and printed. Current or past patient studies can be viewed. Recorded images or image sequences can be zoomed, the window and level adjusted, annotation added and many other features. Patient data can be added, edited or deleted prior to the actual date and time of the exam. Patient data and information from a recorded study can be easily viewed. A full data redundancy system is used to store and maintain study data to eliminate loss or damage. Interfacing to the Work Station and Review Station is accomplished with the use of a standard text keyboard and mouse. An optional Touch Screen can also be used to interface with the Graphies User Interface.

The camera is a two piece configuration including a camera head and a camera control unit (CCU). The camera head is a single board design utilizing a single flexible intercombetting cable for power and low voltage digital signal (I.VDS) output to the CCU. The CCU has both standard video outputs such as 1049/60 Hz interlaced or XVGA and also an LVDS digital output to the Image Star image processor.

This system is DICOM 3.0 compliant for interfacing to a DICOM network and can be connected to paper printers for generating medical report documents.

Here's an analysis of the provided 510(k) summary for the Lakeshore Technologies Inc. "Image Star II" device, focusing on acceptance criteria and study information.

Missing Information: It's important to note that the provided 510(k) summary does not contain information about specific acceptance criteria or a study designed to prove the device meets those criteria. 510(k) submissions for devices like the Image Star II often rely on demonstrating substantial equivalence to a predicate device rather than presenting formal performance studies with defined acceptance criteria in the manner one might see for novel diagnostic AI.

The document primarily focuses on describing the device, its intended use, and comparing its specifications to a predicate device to claim substantial equivalence.

Based on the provided text, here's what can be extracted and what remains unknown regarding acceptance criteria and performance studies:

Acceptance Criteria and Device Performance Study Analysis: Lakeshore Technologies Inc. "Image Star II" (K052610)

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified. No formal "test set" in the context of a performance study with quantitative metrics is mentioned. The equivalence claim appears to be based on design, functionality, and specification comparison.
• Data Provenance: Not specified. Given the nature of a 510(k) for an image processor, the "data" would typically be the images it processes. There's no information on a specific dataset or its origin used for evaluation.

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

• Number of Experts: Not applicable. The document does not describe a study involving expert-established ground truth for a test set.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No formal test set or ground truth establishment described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study Done: No. The provided information does not describe any MRMC study. The submission focuses on the device itself as an image processor, not on its impact on human reader performance in a controlled study scenario.
• Effect Size of Human Reader Improvement with AI vs. without AI: Not applicable, as no MRMC study was conducted or reported.

6. Standalone (Algorithm Only) Performance Study

• Standalone Study Done: No. While the device is an "Image Star II digital image processor," the 510(k) does not present a standalone, quantitative performance study of its processing capabilities against defined metrics. Its performance is implied to be equivalent to or improved over the predicate based on its features and technical specifications (e.g., CCD camera, digital processing capabilities).

7. Type of Ground Truth Used

• Type of Ground Truth: Not applicable. No ground truth is described as having been established for evaluating the device's performance in a study. The "ground truth" for a device like this is inherently linked to its ability to present diagnostic images clearly, which is assessed through equivalence to existing, accepted systems in diagnostic radiology/cardiology.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is an image processor, not an AI/ML algorithm that typically requires a distinct training set in the modern sense. Its functionality is based on established digital image processing techniques (edge enhancement, noise reduction, etc.) rather than learning from a large dataset.

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

• Ground Truth Establishment for Training Set: Not applicable.

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