IMAGESERVER 2000 PICTURE ARCHIVING SYSTEM by SECTRA-IMTEC AB

This document is a 510(k) summary for the SECTRA ImageServer 2000 Picture Archiving System, dated August 16, 1996. It outlines the safety and effectiveness information for regulatory submission.

Based on the provided text, the document does not contain the detailed information required to answer the request about acceptance criteria and a study proving device performance. The summary focuses on regulatory compliance and general safety statements rather than specific performance metrics or clinical study results.

Here's why and what information is missing:

Acceptance Criteria and Reported Device Performance: The document states that the system will "digitally store images for archival together with information about the images." It doesn't provide any quantitative performance metrics (e.g., accuracy, speed, image quality retention, error rates, clinical outcomes) that would serve as acceptance criteria or reported performance data. Therefore, a table of acceptance criteria and reported device performance cannot be generated.
Study Details: There is no mention of a specific study, clinical trial, or performance evaluation that was conducted to demonstrate the device's efficacy or safety in terms of clinical outcomes or diagnostic accuracy.
- Sample size and data provenance: Not mentioned.
- Number of experts and qualifications: Not mentioned.
- Adjudication method: Not mentioned.
- MRMC comparative effectiveness study: Not mentioned.
- Standalone (algorithm only) performance: Not applicable as this is an archiving system, not an AI diagnostic algorithm.
- Type of ground truth: Not mentioned.
- Sample size for training set: Not applicable as this is an archiving system, not an AI diagnostic algorithm.
- How ground truth for training set was established: Not applicable.

The document primarily states:

The ImageServer System will be used for digitally storing images and associated information.
Typical users are trained medical professionals.
It complies with Federal Performance Standards (21 CFR, part 1000).
It was manufactured in accordance with voluntary standards.
The User's Guide contains information for safe and effective use.
A hazard analysis was performed.

This information is insufficient to address the questions posed, which are typically relevant to diagnostic or therapeutic devices undergoing performance validation. The SECTRA ImageServer 2000, as described, is a Picture Archiving System (PACS), and its "performance" is more related to its functionality in storing, retrieving, and displaying images, rather than diagnostic accuracy.

Summary

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Department of Health and Human Services Center for Devices and Radiological Health Office of Device Evaluation Pre-Market Notification Section

16 August 1996

K9633395

SECTRA Doc. no: 3-96.842-2.0/da-fri A

510(k) summary of safety and effectiveness information for the SECTRA ImageServer 2000 Picture Archiving System

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

The ImageServer 2000 System will be used for digitally store images for archival together with informaton about the images. The typical users are trained medical professionals at a radiology deparment.

The undersigned certifies that the 510(k) Pre-Market Notification for the above referenced product contains adequate information and data to enable CDRH to determine substantial equivalence to Olicon Imaging Systms, Inc. (K922164). This information and data is summarized as follows:

1. The ImageServer system is subject to and in compliance with the Federal Performance Standards, defined in 21 CFR, part 1000.
1. The ImageServer system has been and will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey.
1. The ImageServer User's Guide contains comprehensive information on how to operate the system to ensure a safe and effective use.
1. The submission contains the results of an hazard analysis.

signature

Dan Fristedt Quality Assurance Manager SECTRA AB Linköping, Sweden Telephone: +46 13 23 52 00

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Regulation Number and Section

§ 892.2010 Medical image storage device.

(a)
Identification: A medical image storage device is a hardware device that provides electronic storage and retrieval functions for medical images. Examples include electronic hardware devices employing magnetic and optical discs, magnetic tapes, and digital memory.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.