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OrthoPACS is intended for the manipulation and displaying of medical images by a suitable licensed and qualified healthcare professional. It can show images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards. OrthoPACS also uses such images, in conjunction with templates for prosthetic devices, for the purposes of choosing the nature and characteristics of the prosthetic device to be used when planning a potential surgical procedure.

eTrauma's OrthoPACS is a Digital Info-Imaging System for orthopaedic specific applications in office, private practice, surgery and clinics. The system allows orthopaedic surgcons to navigate quickly through a typical office day by using an efficient and fast system for viewing clinical images and retrieval of information regarding patient historicals whether tocal or residing on other digital information systems such as electronic medical record and/or practice management software. The four general classes of users for OrthoPACS include x-ray technicians, office managers, physicians and nurses. OrthoPACS consists of the following components: Acquisition and Transmission Modules, Viewing Station Module, Storage Module, RemoteImage Accessibility.

The provided 510(k) summary for the OrthoPACS device (K033825) does not contain performance data or a study that establishes acceptance criteria for the device's specific functions as a medical image management system or for its use with prosthetic templates.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Not available. The document states:
"#### 7. PERFORMANCE DATA: The subject device is developed according to ISO 9001:1994 and complies with ISO 13485:1996."

This statement indicates compliance with general quality management system standards (ISO 9001 and ISO 13485). It does not provide specific quantitative performance metrics, acceptance criteria, or a study demonstrating clinical or technical performance of the device's image manipulation, display, or prosthetic templating functions.

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

Not applicable/Not mentioned. Since no specific performance study is detailed, there is no mention of a test set, its sample size, or data provenance.

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

Not applicable/Not mentioned. No performance study is detailed, therefore no ground truth establishment is described.

4. Adjudication Method for the Test Set

Not applicable/Not mentioned. No performance study is detailed.

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

No. The document does not mention an MRMC study or any comparative effectiveness study with human readers, either with or without AI assistance. The device's description is that of an image management system, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

No. The document does not describe any standalone performance study of an algorithm.

7. Type of Ground Truth Used

Not applicable/Not mentioned. No performance study is detailed.

8. Sample Size for the Training Set

Not applicable/Not mentioned. As this is an image management system and not an AI/ML device relying on a training set, this information is not relevant or provided.

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

Not applicable/Not mentioned. (See point 8)

Summary of Device and Regulatory Context for K033825:

The K033825 submission for OrthoPACS is for an image archiving and communication system (PACS) with specific orthopaedic applications, including the use of templates for prosthetic devices. The key aspects of the submission are:

• Intended Use: Manipulation and display of medical images by a qualified healthcare professional, showing images from different modalities, interfacing with storage/printing devices, and using templates for prosthetic device planning.
• Predicate Devices: Sectra Orthopedic Package (K031590) and Cedara I-SoftView (K022881).
• Regulatory Determination: The FDA determined that OrthoPACS was substantially equivalent to its predicate devices based on the information provided, which likely focused on the functional equivalence of its image display, manipulation, and storage features, as well as its existing quality certifications (ISO 9001, ISO 13485). For this type of device (a PACS system), specific clinical performance studies demonstrating diagnostic accuracy are typically not required unless new functionalities or AI algorithms are introduced that make diagnostic claims. The "performance data" referred to in section 7 is limited to compliance with quality management systems, which is common for PACS predicate device submissions.

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The Remotelmage™ System is indicated to be used for remote viewing of medical image data.

Remotelmage is a client-server software system designed to allow access to medical images by licensed medical professionals. This product is intended to allow the review of images from a modality of digital imaging systems (including the Vidar (K933632) film digitizer, a digital camera, a radiography system (PACS) or other modality) using a personal computer for standard Internet access. Remotelmage software is installed on a computer configured with connections to a mode of digital imaging and the internet. Once images are obtained, the Remotelmage™ software converts the images from their original format to JPEG format and transmits them over 128 bit SSL encryption to an Internet server where they are stored for a specified period of time. Authorized medical personnel, upon password authentication, may download the images over 128 bit SSL encryption for viewing. The software program is written in C and is approximately 1 megabyte in size.

Here's a breakdown of the acceptance criteria and study information for the Remotelmage™ System, based on the provided 510(k) Premarket Notification:

Acceptance Criteria and Device Performance Study for Remotelmage™ System

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The provided document is a 510(k) summary, which often focuses on establishing substantial equivalence to a predicate device rather than detailed clinical trial results for efficacy or accuracy. The "acceptance criteria" here are derived from the performance testing described.

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

• Sample Size: 2,016 images.
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It describes "transmitting 2,016 images in an aggregate for a seven day period." This implies the images were test data generated or selected for testing the system's transmission capabilities rather than a dataset of clinical cases with established diagnoses.

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

• Number of Experts: Not applicable. The "ground truth" in this context is simply the successful delivery and usability of the images, not a medical diagnosis or interpretation. The testing focused on technical performance of image transmission.
• Qualifications of Experts: Not applicable, as no experts were mentioned for establishing ground truth related to medical interpretation.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. The testing described is a technical performance test of image transmission and delivery, not a diagnostic study requiring adjudication of expert interpretations. The device's "acceptance" was based on whether the images were successfully sent and received in a usable format.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The device is an image communication system, not a diagnostic aid that would typically undergo an MRMC study to compare human readers' performance with and without AI assistance. The study focused on the technical delivery of images.
• Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: Not applicable, as no MRMC study or AI assistance comparison was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• Standalone Performance: The testing described is essentially a standalone technical performance test of the system's ability to transmit images. The "algorithm" here is the software system for image conversion, encryption, transmission, and retrieval. The testing verifies its functionality without direct human intervention in the transmission process itself (though a human initiated the transmission and verified receipt).

7. The Type of Ground Truth Used:

• Type of Ground Truth: The ground truth used was successful image delivery and usability. This means confirming that the transmitted images arrived at the destination in their complete, original (or correctly converted JPEG), and viewable format, without loss or corruption. It essentially validates the technical function of the transfer process.

8. The Sample Size for the Training Set:

• Sample Size for Training Set: The document does not describe a "training set" in the context of machine learning. The Remotelmage™ System is a software for image communication, not an AI or machine learning algorithm that requires training data for its core function. "Testing procedures adhered to during development and testing stages of the device software prior to release" are mentioned, but these refer to general software development quality assurance, not AI model training.

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

• Ground Truth for Training Set Establishment: Not applicable, as there is no mention of a training set for an AI/ML model for this device.

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