(26 days)
Indicated for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue. It does not make a diagnosis and is not an endoscopic tool. Not for pediatric use.
The inReach System is a device that guides a bronchoscope and bronchial tool to a target in or adjacent to the bronchial tree on a path indicated by CT scan, and visualizes the target and the interior of the tree. The inReach System also enables the placement of radiosurgical and dye markers into soft lung tissue to guide radiosurgery and thoracic surgery.
This 510(k) submission (K081379) is for a Special 510(k) change to an existing device, the superDimension inReach System. This means the submission focuses on demonstrating that modifications made to the device do not alter its fundamental safety or effectiveness. As such, the performance data provided is related to software validation and risk analysis rather than a clinical study evaluating diagnostic performance.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a Special 510(k) for software modifications, the "acceptance criteria" are related to software validation and ensuring the updated system still meets its intended use, rather than a clinical performance metric like sensitivity or specificity.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Software Validation | Performed to assure the inReach System continues to meet its intended use. |
| Risk Analysis | Performed to identify and mitigate potential risks associated with the software changes. |
| Labeling Changes | Appropriate changes made to the Instructions for Use (inReach User Manual) to reflect software modifications. |
| Design Validations | Performed as part of the superDimension design control process. |
| Clinical Performance | Not required to validate the changes for this submission. |
2. Sample Size Used for the Test Set and Data Provenance
The document states, "Clinical tests were not required to validate the changes to the inReach System." Therefore, there is no test set of clinical data (patients/images) used for performance evaluation in this specific 510(k) submission. The testing would have been internal software validation and verification.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
As no clinical test set was used for performance evaluation, no experts were used to establish ground truth for a clinical test set in this submission.
4. Adjudication Method for the Test Set
Since no clinical test set was used, no adjudication method was applied.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No MRMC comparative effectiveness study was done as clinical tests were not required. The submission focuses on software modifications and their impact on functionality, not on human reader performance improvement.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
No standalone clinical performance study was done as clinical tests were not required. The "performance data" refers to software validation and risk analysis.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
For the software validation performed, the "ground truth" would be against defined software requirements and specifications. For instance, a function designed to generate a 3D-Map view would be tested to ensure it accurately generates the map as per its design specifications. This is not clinical ground truth.
8. The Sample Size for the Training Set
The document does not mention any machine learning or AI components that would require a "training set" of data. The software modifications are described as enhancements to GUI, 3D-pathway planning, and navigation capabilities. Thus, no training set of data is applicable or mentioned.
9. How the Ground Truth for the Training Set Was Established
As no training set was used, this point is not applicable.
In summary, this 510(k) submission is for minor software modifications to an already cleared device. The "study" proving the device meets acceptance criteria consists of software validation, risk analysis, and design validations, which are standard procedures for such changes, rather than a clinical efficacy study with patient data.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.