Search Results

The Micromedical Printer Interface is used to download ECG data from a Micromedical ECG monitor and print ECG recordings on standard letter-sized paper by using one of a number of standard commercially available Canon or Hewlett Packard ink jet printers.

The Micromedical Printer Interface receives data from a Micromedical ECG monitor and transmits it through a parallel cable to one of a number of commonly available Canon or H-P bubble jet printers to print the ECG tracing on standard-sized paper.

This 510(k) pertains to a hardware device (Printer Interface) rather than an AI/ML powered software device. Therefore, the requested information regarding acceptance criteria, study details, and ground truth establishment, which are typical for AI/ML device evaluations, are not applicable here.

The provided document describes the Micromedical Printer Interface as a device that receives data from a Micromedical ECG monitor and transmits it to a standard ink jet printer to print ECG tracings. The basis for clearance is substantial equivalence to an existing predicate device, the Ralin CorFax.

Here's why the AI/ML-specific questions are not applicable:

• Device Type: This is a hardware interface for printing, not an algorithm or software that processes or interprets medical data.
• Substantial Equivalence: The clearance is based on comparing the new device to a legally marketed predicate device, demonstrating that it's as safe and effective. This typically involves performance bench testing, electrical safety, EMC testing, and ensuring the output is clinically equivalent to the predicate, rather than clinical studies with human readers or specific statistical performance metrics against a ground truth as would be done for an AI/ML algorithm.
• Lack of AI/ML Component: The submission explicitly mentions "proprietary algorithms to receive the data from ECG monitors and transmit it to a printing device," but this refers to the internal software/firmware necessary for device function (e.g., data formatting, communication protocols), not AI/ML algorithms for medical diagnosis or interpretation.

Therefore, the requested table and detailed study information for AI/ML devices cannot be extracted from this 510(k) submission.

Ask a specific question about this device

The KODAK Ektascan Imagelink System (KEIS) is a DICOM conferment product designed for use within a Picture Archiving and Communication System (PACS).

The KODAK Ektascan Imagelink System is composed of two major components, the KODAK Digital Science Medical Modality Acquisition Unit and the KODAK Digital Science Medical Printer Interface Unit. These systems can exit together or independently on a network.

The KODAK Ektascan Imagelink System [KEIS] is composed of components common to all image management systems for image acquisition, printing, review, archive/retrieval, and communications. These components can be combined into customized solutions for the management of diagnostic image information.. Evaluation of soft and or hard copy output provides adequate opportunity for competent human intervention.

This 510(k) summary describes a Picture Archiving and Communications Systems (PACS) Component, specifically the KODAK Digital Science Medical Printer Interface Unit (K961740) and its associated Medical Modality Acquisition Unit. The document explicitly states it is a comparison to a predicate device and does not contain information about acceptance criteria or a study proving the device meets said criteria.

The document is a "510(k) SUMMARY OF SAFETY AND EFFECTIVENESS" for a medical device that has been classified as Class II, a classification for devices that are considered to pose a moderate risk to patients and thus require general and special controls to assure their safety and effectiveness.

The purpose of a 510(k) submission is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. This is primarily achieved through a "comparison of features" table, as provided in the document.

Therefore, I cannot provide the requested information because it is not present in the provided text. The document focuses on establishing substantial equivalence to a predicate device based on features and intended use, rather than presenting acceptance criteria and performance study results.

Ask a specific question about this device