(99 days)
The software's intended use is to allow post-capture positioning and joining of individual images to produce an additional composite image. The software is sold only for use on Carestream Health system solutions and is available as an integrated feature within the DirectView software.
The DR Long Length Imaging Software is a software component for use on a diagnostic x-ray system utilizing digital radiography (DR) technology. The software option is comprised of image stitching software and a manual stitch editor that allows user adjustment to automatic stitching results. The software allows up to 5 separately acquired DR images to be stitched together to create a "composite" long length image.
The acceptance criteria and study details for the DR Long Length Imaging Software (K130567) are as follows:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Diagnostic Acceptability | Composite images must be clinically acceptable for diagnostic use. | "Predefined acceptance criteria were met and demonstrated that the device is as safe, as effective, and performs as well as the predicate device." (Implies diagnostic acceptability was achieved). |
| Design Input/Output Verification | Design output must meet design input requirements. | "Performance testing was conducted to verify the design output met the design input requirements..." |
| User Needs/Intended Use Validation | Device must conform to defined user needs and intended uses. | "...and to validate the device conformed to the defined user needs and intended uses." |
| Safety and Effectiveness Equivalence | Device must be as safe, as effective, and perform as well as the predicate device. | "Predefined acceptance criteria were met and demonstrated that the device is as safe, as effective, and performs as well as the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample size used for the clinical testing (test set). It only mentions that "Clinical testing was conducted to evaluate the acceptability of the composite images for diagnostic use."
The data provenance (country of origin, retrospective/prospective) is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide information on the number of experts used or their qualifications for establishing ground truth in the clinical testing.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it provide any effect size for human readers improving with or without AI assistance. The study described focuses on the device's performance in creating diagnostically acceptable images.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
The testing description includes "Nonclinical testing was conducted under simulated use conditions," which could imply standalone algorithm performance was assessed for technical aspects, but the primary clinical evaluation was described as "acceptability of the composite images for diagnostic use," suggesting human review. The software includes a "manual stitch editor that allows user adjustment to automatic stitching results," indicating a human-in-the-loop component is integral to its intended use. Therefore, a purely standalone clinical performance study for diagnostic interpretation does not appear to be the focus.
7. The Type of Ground Truth Used
The ground truth for the clinical testing was based on the "acceptability of the composite images for diagnostic use." This implies a qualitative assessment by medical professionals, likely radiologists, but the specific method (e.g., expert consensus) is not detailed.
8. The Sample Size for the Training Set
The document does not provide information about a training set or its sample size. The focus is on validation testing of the software.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned, there is no information on how its ground truth was established.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.