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The CS 7600 is a digital intraoral dental radiographic imaging system intended for use by dentists and dental sub-specialists. The system captures, displays and stores diagnostic intraoral radiographic images. It consists of a scanner, re-usable imaging plates, acquisition software, disposable hygienic barrier envelopes, and optional Scan & Go device.

The CS 7600 is indicated for use in dental digital radiography using imaging plates (phosphor storage screens) for dental intra-oral x-ray imaging.

The CS 7600 is a computed radiography system for dental intraoral applications. Imaging plates (i.e., storage phosphor plates) are exposed in the same way as traditional x-ray film. The x-ray images on these plates are then fed into a small computed radiography system and scanned using a laser. The scanned image data from the plates is digitized, and the images are displayed on a monitor and saved to computer.

The CS 7600 system is capable of scanning the X-ray exposed imaging plates at various speeds, sizes and resolutions. Once an imaging plate is scanned, the image data is automatically erased from the plate and the plate ejected for reuse.

Re-usable intraoral imaging plates of sizes 0, 1, 2, 3 and 4 are included with the device, as are disposable hygienic barrier sheaths. The system includes an optional Scan and Go system, which uses RFID technology to automatically recognize imaging plates as they are scanned.

Here's an analysis of the provided text regarding the acceptance criteria and study for the CS 7600 Dental Computed Radiography System:

Summary of Device Acceptance and Study Information for the CS 7600 Dental Computed Radiography System

Based on the provided 510(k) summary (K111649), the CS 7600 system's acceptance was predicated on its substantial equivalence to predicate devices, rather than meeting specific, numerical performance acceptance criteria and a detailed study demonstrating those metrics.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

• Indications for use
• Operating principle and technology
• Energy used
• Materials | Demonstrated substantial equivalence to Kodak CR 7400 (K060079) and Soredex Digora Optime (K041050) in terms of:
• Indications for use: Dental intraoral radiographic imaging
• Operating principle and technology: Computed radiography using phosphor plates for dental diagnostic imaging
• Energy used: X-ray
• Materials: Re-usable imaging plates (sizes 0, 1, 2, 3, 4), disposable hygienic barrier envelopes, scanner. |
  | Safety and Effectiveness:
• Meeting user requirements
• Compliance with regulations (e.g., FCC for RFID) | "Results of testing demonstrate that the device is safe and effective in meeting user requirements in accordance with its intended use."
  RFID technology tested for FCC and international low power transmitter compliance. |

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

The 510(k) summary does not provide details on a specific "test set" in the context of clinical image evaluation or performance metrics. The testing mentioned is primarily non-clinical, verification and validation testing of software, hardware, and media. Therefore, information on sample size for a test set and data provenance (country of origin, retrospective/prospective) is not specified.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the 510(k) summary. The submission heavily relies on non-clinical testing and substantial equivalence, not a clinical study involving expert interpretation of images relative to a ground truth.

4. Adjudication Method for the Test Set

This information is not provided as there is no described clinical test set requiring adjudication in this 510(k) summary.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not described or presented in this 510(k) summary. The submission focuses on the device itself (the CR system) and its equivalence to other CR systems, not on a human reader's performance with or without AI assistance generated by the device.

6. Standalone (Algorithm Only) Performance Study

As the CS 7600 is a computed radiography system (a hardware and software system for acquiring, processing, and displaying images), it does not feature an "algorithm only" component in the sense of an AI diagnostic algorithm. Its performance is inherent to its image acquisition and processing capabilities. Thus, a standalone algorithm-only performance study as typically understood for AI/CAD devices was not performed or described. The performance is tied to the system as a whole.

7. Type of Ground Truth Used

The 510(k) summary focuses on the technical performance and substantial equivalence of the imaging system. Therefore, the concept of "ground truth" as it applies to clinical diagnoses (e.g., pathology, expert consensus, outcomes data) is not relevant or mentioned for this submission. The "ground truth" for non-clinical testing would relate to engineering specifications and regulatory compliance.

8. Sample Size for the Training Set

The 510(k) summary does not mention a "training set" in the context of machine learning or AI. The device is a traditional computed radiography system, not a device with a machine learning component requiring a training set for model development.

9. How Ground Truth for the Training Set Was Established

Since there is no mention of a training set, the method for establishing its ground truth is not applicable/not provided.

In conclusion, this 510(k) summary for the CS 7600 Dental Computed Radiography System focuses on demonstrating substantial equivalence to predicate devices and verifying general safety and effectiveness through non-clinical testing. It does not present detailed performance metrics, clinical study results, or information typically associated with AI/CADe submissions regarding reader performance, ground truth establishment, or training/test set specifics.

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