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The device is intended for treatment of benign vascular and benign pigmented lesions.

585 is a diode laser device used mainly for dermatology. It includes a main panel with the touch screen display, the optical fiber connector (SMA 905) and the status LEDs. On the rear panel the connectors for footswitch, remote interlock and power supply cable are located. The key switch and the emergency knob are located on the upper part of the device. The laser system is composed of an opto-mechanical block containing the laser source and heat dissipation system, aiming beam, control system and power electronics. The power electrical system is composed of a power supply. The control electronics, based on a microcontroller, manages power electronics, thermalization of the laser source and controls the user interface. Emission is triggered by means of a footswitch.

This FDA 510(k) summary provides information for a laser surgical instrument (585) for dermatological use. However, it does not contain the specific details required to answer your questions about acceptance criteria and a study proving those criteria are met, especially in the context of an AI/algorithm-based device.

The document focuses on demonstrating substantial equivalence to predicate devices for a physical medical device. This means the performance data supplied is primarily related to the physical and electrical safety and characteristics of the laser, not the analytical or clinical performance of an AI model.

Here's a breakdown of why and what information is missing:

• No AI/Algorithm Component: The device described (Quanta System S.p.A. 585) is a physical laser surgical instrument. There is no mention of it containing any AI, algorithm, or software that performs diagnostic, prognostic, or treatment planning functions requiring a "test set," "ground truth," "experts," or "MRMC studies." The "Software Verification and Validation Testing" mentioned refers to the control software for the laser device itself, not an AI component analyzing images or data.
• Performance Data Type: The "Performance data" section refers to:
  • Safety and electromagnetic compatibility (EMC): Compliance with IEC standards (IEC 60601-1, IEC 60601-1-2, IEC 62366, IEC 60601-2-22, and IEC 60825-1). This is about the electrical and physical safety of the laser, not its analytical performance in identifying lesions.
  • Software Verification and Validation Testing: This pertains to the internal control software of the laser device, ensuring it operates correctly, not an AI model.
  • Biocompatibility: Established based on predicate devices, ensuring materials are safe for biological contact. This is also not related to AI performance.
• Substantial Equivalence: The primary argument for approval is "substantial equivalence" to existing laser devices, meaning it has similar intended use, indications for use, and technological characteristics (laser type, wavelength, pulse width, frequency, spot size). This comparison doesn't involve AI performance metrics.

Therefore, I cannot populate the table or answer the specific questions you've asked because the provided document does not describe an AI or algorithm-based device, nor does it contain the type of performance study details requested.

To answer your questions, I would need a 510(k) summary or an FDA approval document for a medical device that incorporates an AI or algorithm component for which clinical performance data, ground truth establishment, and expert review are relevant.

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The CARESTREAM DRYVIEW 5850 Laser Imager is intended to provide highresolution hard copy images from digital imaging source output signals. The device is intended for use with KODAK DRYVIEW media including DVM (DryView mammography) films. The imager with a variety of digital modalities, including, but not limited to, CR (Computed Radiology), DR (Digital Radiology), CT (Computerized Tomography), MRI (Magnetic Resonance Imaging) and FFDM (Full Field Digital mammography). Image resizing is used to preserve true geometric size images. The images are to be used for medical diagnosis and referral to physicians and their patients.

The CARESTREAM DRYVIEW 5850 Laser Imager is intended to provide highresolution hard copy images from digital imaging source output signals. The device is intended for use with KODAK DRYVIEW media including DVM (DryView mammography) films. The imager will interface with a variety of digital modalities, including, but not limited to, CR (Computed Radiology), DR (Digital Radiology), CT (Computerized Tomography), MRI (Magnetic Resonance Imaging) and FFDM (Full Field Digital mammography). Image resizing is used to preserve true geometric size images. The images are to be used for medical diagnosis and referral to physicians and their patients.

The subject device and predicate devices use the same technical design base. The printers receive image data from the modality. User control is performed directly by the modality or through the host control. KODAK DRYVIEW imaging media is removed from a daylight cartridge and transported to the laser imaging station. Image data and media merge at the laser station and the film is scanned. The exposed media is transported through the integrated processor and exits the printer.

Software is used to control the image management and machine functions. AIQC (Automated Image Quality Control) matches printing power with film characteristics to provide consistently high image quality.

The CARESTREAM DRYVIEW 5850 Laser Imager is intended to provide high-resolution hard copy images from digital imaging source output signals for medical diagnosis and referral to physicians and their patients.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not explicitly describe a formal "test set" in the context of clinical or performance data. The evaluation of the device relied on compliance with standards and a comparison to a predicate device. Therefore, no information is available regarding:

• Sample size for a test set.
• Country of origin of data.
• Retrospective or prospective nature of data.

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

This information is not applicable as the document does not describe a study involving a "test set" that required expert establishment of ground truth for a diagnostic outcome. The device is a printer, and its performance evaluation focused on technical specifications and output quality.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3.

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

A MRMC comparative effectiveness study was not performed or reported in the provided document. The focus was on the device's technical performance and equivalence to a predicate, not on how its use might impact human reader performance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is a standalone device in the sense that its primary function is to print images based on digital inputs. However, the document does not describe a "standalone study" in the common understanding of an algorithm's diagnostic performance without human interaction. Instead, it describes technical performance and image quality as objectively measured and compared to standards and a predicate device.

7. Type of Ground Truth Used

The "ground truth" in this context refers to the technical specifications and image quality standards that the device is designed to meet, as well as the performance characteristics of the predicate device. It's about how accurately the printer reproduces digital images, not about diagnostic accuracy of the images themselves. The document states that "Medical personnel review images displayed by the subject device and its predicate. This offers ample opportunity for competent human intervention in case of a malfunction or other failure." This implies the ultimate "ground truth" for diagnostic purposes remains with the human medical expert reviewing the printed image.

8. Sample Size for the Training Set

This information is not applicable. The device is a hardware printer with software control, not an AI/ML algorithm that undergoes "training" with a dataset in the typical sense. Its design and automated functions (like AIQC) are built-in, not learned from a training set of images.

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

This information is not applicable for the same reasons as point 8. The "ground truth" for its internal calibration and quality control (AIQC) would be factory-set parameters and established film characteristics.

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Ask a specific question about this device