(90 days)
DIGITIZER DIRECTOR is a DICOM compatible software package which enables any medical facility personal computer (PC) with adequate memory and the appropriate film digitizer to perform secondary image capture of films using the Howtek film digitizer family. DIGITIZER DIRECTOR does not have any image compression capability. DIGITIZER DIRECTOR is an integrated DICOM network product which translates the images from proprietary digitizer format to DICOM format and sends them on to another DICOM application.
DIGITIZER DIRECTOR is a DICOM 3.0 compliant secondary image capture application for the Howtek family of film digitizers, It is a query / retrieve service class provider (QRSCP). DIGITIZER DIRECTOR queries the designated DICOM 3.0 database as each patient record is created. Association is made with the patients already existing in the database. New patient information is required when no association is made. When patient information is complete, the entire patient record is sent to a designated DICOM entity, such as a database or viewing station. DIGITIZER DIRECTOR is a Microsoft Windows NT or Windows 95 based application.
Here's an analysis of the provided text regarding the acceptance criteria and study for the DIGITIZER DIRECTOR device, structured as requested:
Device Name: DIGITIZER DIRECTOR
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific quantitative acceptance criteria or detailed reported device performance metrics. The core of the submission revolves around demonstrating substantial equivalence to a predicate device (Star Technologies FISS) by matching functional characteristics.
| Feature / Criterion | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Input | Digital Image from film digitizer in proprietary format | Digital Image from film digitizer in proprietary format |
| Function Performed | Conversion to DICOM 3.0 Format | Conversion to DICOM 3.0 Format |
| Output | Sent image to specified DICOM application | Sent image to specified DICOM application |
| Store and Forward Option | Yes | Yes |
| Image buffering during Network Downtime | Yes | Yes |
| Compression | No (as per predicate device and intended use limitation) | No |
| DICOM 3.0 Compliance | Compliant with DICOM 3.0 standards (for PACS, QRSCP) | DIGITIZER DIRECTOR is a DICOM 3.0 compliant secondary image capture application. It is a query / retrieve service class provider (QRSCP). DIGITIZER DIRECTOR translates the images from digitizer format to DICOM format and sends them on to another DICOM application. |
| Software Development Quality | Designed, developed, tested, and verified according to ISO 9001 procedures | Howtek certifies that the DIGITIZER DIRECTOR software is designed, developed, tested and verified according to ISO 9001 procedures. These procedures identify individuals within the organization responsible for developing and approving product specifications, coding and testing, validation testing and field maintenance. |
| No Effect on Image Quality | Software does not affect image quality | The software used in this product is used for teleradiology and / or image storage only and does not effect image quality. There is no image processing or compression used with this software. |
| Safety | No failure or latent system design flaw expected to result in death or injury to a patient | "It is our conclusion that there is no software component that we know of in the Howtek DIGITIZER DIRECTOR Application whose failure or latent system design flaw would be expected to result in death or injury to a patient." |
Key Observation: The "acceptance criteria" are primarily based on functional equivalence to the predicate device and adherence to industry standards (DICOM 3.0, ISO 9001) for software development. There are no performance metrics like accuracy, sensitivity, specificity, or processing speed reported as one might find in AI/CAD substantial equivalence. This is characteristic of older 510(k) submissions for devices primarily focused on data conversion and transmission rather than diagnostic interpretation or complex image processing.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a numerical sample size for a "test set" in the context of typical algorithm validation. The validation described is more focused on software functionality and its ability to convert and transmit images, rather than evaluating diagnostic performance on a dataset of patient images.
- Sample Size: Not specified as a discrete number of cases or images.
- Data Provenance: Not specified. The testing described appears to be internal software validation rather than clinical data testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable/not specified.
- Qualifications of Experts: Not applicable/not specified.
This type of "ground truth" and expert review is typically associated with diagnostic algorithms that provide interpretative outputs. Since the DIGITIZER DIRECTOR's function is conversion and transmission, it does not generate diagnostic findings that would require expert-established ground truth.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable.
Similar to point 3, adjudication is not relevant for this type of software.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No.
- Effect Size: Not applicable.
The device is a teleradiology system for image capture, conversion, and transmission. It is not an AI/CAD device intended to assist human readers in making diagnoses. Therefore, an MRMC study comparing human readers with and without AI assistance was not conducted.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
- Standalone Study: Yes, to the extent that it describes "Extensive testing of the software package has been performed by programmers, by nonprogrammers and by potential customers." This testing would have evaluated the software's ability to correctly perform its intended functions (image capture, DICOM conversion, transmission) independently, without a human actively interpreting the output in a diagnostic capacity. However, this is functional testing, not a diagnostic performance study.
7. Type of Ground Truth Used
The concept of "ground truth" in the diagnostic sense (e.g., pathology, longitudinal outcomes) is not applicable to this device. The "truth" for this device's validation is whether it correctly converts proprietary digitizer formats to DICOM 3.0 and transmits them without affecting image quality. This is a functional correctness truth, not a diagnostic truth.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable/not specified.
This device is not an AI/machine learning model that undergoes a training phase with a specific dataset. It is a software application designed for specific functional tasks.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment for Training Set: Not applicable.
As it's not an AI/ML model, there is no "training set" or ground truth established for training. The "truth" for software development would be based on functional specifications and DICOM 3.0 standards.
§ 892.2020 Medical image communications device.
(a)
Identification. A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, and interfaces. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions. This does not include electronic transfer of medical image software functions.(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.