(119 days)
The software's intended use is to assist diagnosis of chest pathology by minimizing anatomical distractions such as the ribs and clavicle in chest x-ray images.
The Bone Suppression Software is a software component for use on diagnostic x-ray systems utilizing digital radiography (DR) or computed radiography (CR) technology. The software option suppresses bone anatomy in order to enhance visualization of chest pathology in a companion image that is delivered in addition to the original diagnostic image.
Here's a breakdown of the acceptance criteria and study information for the Bone Suppression Software, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly list quantitative acceptance criteria for the Bone Suppression Software's performance. It states that "Predefined acceptance criteria were met and demonstrated that the device is as safe, as effective, and performs as well as the predicate device." However, the specific metrics or thresholds for these criteria are not detailed.
Therefore, this section focuses on the qualitative claims made and the reported outcome.
| Acceptance Criteria Category | Reported Device Performance (Qualitative) |
|---|---|
| Safety and Effectiveness | "demonstrated that the device is as safe, as effective, and performs as well as the predicate device." |
| Image Acceptability | "Clinical testing was conducted to evaluate the acceptability of the companion images for assisting diagnosis." (Implied: results were acceptable) |
| Design Output Compliance | "Performance testing was conducted to verify the design output met the design input requirements." (Implied: met requirements) |
| User Needs/Intended Uses | "to validate the device conformed to the defined user needs and intended uses." (Implied: conformed) |
| Substantial Equivalence | "demonstrated that the device is as safe, as effective, and performs as well as the predicate device." (Supports a claim of substantial equivalence to predicates.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided text. The document mentions "Clinical testing was conducted," but does not give a number of cases.
- Data Provenance: Not specified. It's unclear what country the data came from or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The document only mentions "Clinical testing was conducted to evaluate the acceptability of the companion images for assisting diagnosis." It implies that qualified professionals reviewed the images, but their specific roles or experience levels are not detailed.
4. Adjudication Method for the Test Set
- Not specified. The document does not describe any specific adjudication method (e.g., 2+1, 3+1 consensus) for establishing ground truth or evaluating the clinical images.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- MRMC Study: The document does not explicitly state that an MRMC comparative effectiveness study was done comparing human readers with and without AI assistance (bone suppression).
- Effect Size: Not provided. Since an MRMC study is not confirmed, no effect size is discussed. The study's focus was on the "acceptability of the companion images for assisting diagnosis" and demonstrating equivalence to a predicate.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- The document describes the "Bone Suppression Software" as a "software component" that "suppresses bone anatomy in order to enhance visualization of chest pathology in a companion image that is delivered in addition to the original diagnostic image." This heavily implies that the software provides a processed image for human interpretation, rather than a standalone diagnostic output. While the algorithm performs its function independently, the "clinical testing" mentioned focuses on the acceptability of the companion images for assisting diagnosis, indicating an evaluation of the output intended for human review, not a standalone diagnostic performance evaluation against ground truth.
7. The Type of Ground Truth Used
- The document implies that the ground truth for evaluation was based on the "acceptability of the companion images for assisting diagnosis" by clinical review. However, the specific type of ground truth (e.g., pathology, clinical follow-up, expert consensus on disease presence) against which the diagnostic enhancement was measured is not explicitly stated. It appears the ground truth was primarily related to the acceptability and utility of the suppressed images for assisting diagnosis rather than independently verifying the presence or absence of specific pathologies with a definitive gold standard.
8. The Sample Size for the Training Set
- Not specified. The document does not provide any information about the training data or its sample size.
9. How the Ground Truth for the Training Set Was Established
- Not specified. As no information on the training set or its ground truth is provided, the establishment method is unknown.
§ 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.