Search Results
Found 1 results
510(k) Data Aggregation
(77 days)
KODAK DIGITAL SCIENCE (KDS) MEDICAL IMAGE AND INFORMATION LIBRARY (MIIL)
The KODAK DIGITAL SCIENCE (KDS) Medical Image and Information Library is a DICOM conformant archival product designed for use within a Picture Archiving and Communication System (PACS). The system utilizes a prefetching Archiving and Sommercess to previous imagery.
The system consists of three main components: 1) the host CPU (a Sun SPARCstation 5, SPARCstation 20, or UltraSparc) with pre-installed proprietary software, 2) the magnetic cache, a Sun SPARC storage Redundant Array of Inexpensive Disks (RAID) subsystem, and 3) a KODAK DIGITAL SCIENCE ADL 150 writeable CD jukebox or a Digital Linear Tape (DLT) library. The RAID subsystem, combined with either the CD jukebox or DLT library, are managed by a hierarchical storage library that presents these two subsystems to the system software running on the host CPU as a single, very large filesystem. The power supply provides power to operate the unit from a line voltage for 100, 120, 220, or 240 VAC, 50/60 Hz.
This document is a 510(k) summary for a PACS Storage Device, specifically the KODAK DIGITAL SCIENCE™ (KDS) Medical Image and Information Library (MIL). It primarily focuses on the device's technological specifications and its substantial equivalence to a predicate device, rather than clinical performance or studies involving human expertise. Therefore, many of the requested categories are not applicable or cannot be answered from the provided text.
Here's an breakdown based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the comparison to the predicate device and the FDA's "substantial equivalence" determination. The performance is described in terms of technical specifications.
| Feature / Criteria | Predicate Device (K960981) | This 510(k) Device (K972380) | Acceptance/Performance |
|---|---|---|---|
| Range of Storage | 8 GB to 216 GB | 12 GB - 20 TB | Improved storage capacity (within expected PACS archival capabilities) |
| Type of Interface | SCSI | SCSI | Equivalent |
| Type of Media | 5.25" CD-Recordable | 5.25" CD-Recordable or Digital Linear Tape (DLT) | Expanded media options (DLT added) |
| Jukebox Support | Yes, 150-CD | Yes, 150-CD or 588 DLT Cartridges | Enhanced jukebox capacity for DLT |
| Compression | Yes, lossless 2:1 | Yes, lossless 2:1 or lossy to 50:1 | Equivalent lossless, added lossy compression |
| DICOM Conformant | Yes, Native | Yes, Native | Equivalent, DICOM conformance is a key functional requirement |
| HIS/RIS Interface | Yes | Yes | Equivalent |
| Host Platform | Sun | Sun (SPARCstation 5, 20, or UltraSparc) | Equivalent |
| Database Structure | Distributed | Distributed | Equivalent |
| Indications for Use | Not explicitly stated | DICOM conformant archival product designed for use within a PACS | Functionally equivalent as an archive within a PACS |
| Regulatory Class | Class II | Unclassified (but later determined substantially equivalent for marketing) | Functionally equivalent to Class II predicate |
Study Information:
The provided document describes a 510(k) premarket notification process, which determines "substantial equivalence" to a predicate device rather than conducting a new clinical study to establish performance against acceptance criteria in the same way a device with clinical efficacy claims would. The "study" here is essentially the comparison of features and technical specifications to the predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a technical comparison of device features, not a clinical study involving a test set of data or patient cases.
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)
Not applicable. No ground truth based on expert review or clinical data was established for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring expert adjudication was used.
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
Not applicable. This device is a PACS storage and archival system, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a PACS storage and archival system; it does not contain a standalone algorithm for diagnostic or analytical performance that would be evaluated in this manner.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "truth" in this context is the technical compliance with DICOM standards and the stated technical specifications, and the functional equivalence to the predicate device. This is assessed by comparing technical documentation and features.
8. The sample size for the training set
Not applicable. This device does not use machine learning or AI that would require a training set.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there is no ground truth for it.
Ask a specific question about this device
Page 1 of 1