(81 days)
The Olicon Imaging Systems, NT Archive Systems stores and retrieves digital images together with information about the DICOM standard network protocol. communicates with other devices via the DICOM standard network protocol.
The NT ARCHIVE SYSTEM is a device for filing digital radiological images for storage and retrieval. The system design is layered with three storage technologies; magnetic, magneto-optical and DLT tape.
This document is a 510(k) summary for the Olicon Imaging Systems, Inc. NT Archive Systems. It describes a digital archive system for medical images.
Based on the provided text, the device described is a digital archive system for medical images, not a medical device that diagnoses or treats conditions. Therefore, concepts like "acceptance criteria" related to diagnostic accuracy, "device performance" in terms of clinical outcomes, "sample sizes" for test sets of patients, "ground truth" derived from expert consensus or pathology, or "multi-reader multi-case (MRMC) comparative effectiveness studies" are not applicable to this submission.
The document focuses on demonstrating substantial equivalence to a predicate device (Olicon Archive K922164) based on its technological characteristics, indications for use, and compliance with general regulatory standards.
Here's a breakdown of the requested information based on the provided text, indicating where the information is not applicable (N/A) for this type of device:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (as implied by the 510(k)) | Reported Device Performance (as stated in the 510(k)) |
|---|---|
| Storage and retrieval of digital radiological images | The NT Archive System is a device for filing digital radiological images for storage and retrieval. The system design is layered with three storage technologies; magnetic, magneto-optical and DLT tape. |
| Archival of medical images with associated information | The NT Archive Systems will be used to digitally store medical images for archival together with information about the images. |
| Communication via DICOM standard network protocol | Communicates with other devices via the DICOM standard network protocol. |
| Compliance with Federal Performance Standards (21 CFR, part 1000) | The NT Archive is subject to and in compliance with the Federal Performance Standards, defined in 21 CFR, part 1000. |
| Manufactured in accordance with voluntary standards | The NT Archive has been and will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey. |
| Hazard analysis conducted | The submission contains the results of an hazard analysis. All potential hazards have been classified as MINOR. |
| Substantially equivalent to predicate device (K922164) | The NT Archive is basically an update of the current Olicon Archive (K922164). The submitter certifies the device contains adequate information and data to enable FDA - CDRH to determine substantial equivalence. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- N/A. This device does not involve a "test set" in the sense of clinical data or patient images for performance evaluation of a diagnostic algorithm. It's an archiving system. The "test" would be functional testing of the software and hardware for storage and retrieval, which is not detailed in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- N/A. Ground truth for clinical interpretation is not applicable as this is an archiving system, not an interpretive device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Adjudication methods are not applicable as there is no "test set" for clinical evaluation.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- N/A. MRMC studies are not applicable as this is an archiving system, not a diagnostic AI system intended to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. The concept of "standalone performance" for an algorithm for clinical interpretation is not applicable here. The device itself is "standalone" in its primary function of archiving, but its performance is measured by its functional capabilities (storage, retrieval, DICOM compatibility) rather than diagnostic accuracy. The document states: "Images and information being stored and retrieved are interpreted by a physician, providing ample opportunity for competent human intervention," indicating the device's role is to support, not replace, human interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- N/A. No clinical ground truth is applicable. The "ground truth" for this device would be whether it accurately stores and retrieves the digital images as intended.
8. The sample size for the training set
- N/A. There is no "training set" in the context of machine learning or AI as this device is an archive system.
9. How the ground truth for the training set was established
- N/A. Not applicable, as there is no training set mentioned or implied for this type of device.
§ 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.