(14 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.
LungPoint Procedure Planning, a software only device. As with the predicate, it provides the physician with 3D reconstruction of the patient's lungs, derived from the CT images and thus provides a more realistic view of the lungs. The physician can use the 3D virtual animation and associated images to view and explore pre-selected targets in the lung tissue before conducting a procedure. Like the predicate, the software allows for printing the procedure plan as a map, which consists of a bifurcation-by-bifurcation description of the route to the selected target. The LungPoint Procedure Planning software is installed on an off-the-shelf PC computer, and is intended to be used in conjunction with commercially-available CT scan images that are saved in DICOM format.
The provided text does not contain the detailed performance data, acceptance criteria, or study specifics typically found in a scientific study or detailed regulatory submission for proving a device meets acceptance criteria.
The document is a 510(k) summary for a software-only medical device (LungPoint™ Procedure Planning Software) and primarily focuses on establishing substantial equivalence to a predicate device. It highlights that the modified device has the same intended use, technological characteristics, and hardware as the planning phase of the predicate, using the exact same software and core algorithms.
Here's a breakdown of what can be extracted and what is missing based on your request:
Acceptance Criteria and Device Performance (Not explicit in the document)
The document does not explicitly state specific acceptance criteria in terms of quantitative metrics (e.g., accuracy, precision, sensitivity, specificity) for the LungPoint Procedure Planning Software. Therefore, a table of acceptance criteria and reported device performance cannot be generated from the provided text.
The closest statement regarding "performance" is in Section 8: "The planned modifications were subjected to the Broncus design control process. Appropriate labeling changes, risk analysis, and design verification were performed to assure that the Procedure Planning software continues to meet its intended use." This indicates that verification activities were performed, but the specific metrics used and the results are not detailed.
Study Details (Largely Not Reported)
Since specific performance metrics and a formal study are not detailed, many of your requested items cannot be definitively answered from this 510(k) summary.
1. Sample size used for the test set and the data provenance:
- Not reported. The document states "design verification were performed" but does not specify the size or characteristics of any test set used.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not reported. No information about expert involvement in establishing ground truth for testing is provided.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not reported. Adjudication methods are not mentioned.
4. 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:
- No. A multi-reader multi-case comparative effectiveness study is not mentioned or implied. The device is described as "aiding the physician" but no comparative effectiveness study results are provided.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- It's implied that standalone verification was done ("design verification were performed"), but no specific performance metrics or study details for standalone performance are provided. The device is "software only" and "aids the physician," suggesting its primary function is standalone image processing for planning.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not reported. With no detailed study information, the type of ground truth used for any verification is not specified.
7. The sample size for the training set:
- Not reported. This document pertains to a modification of an already cleared device, and it states the "exact same software (including core algorithms)" are used as the predicate. Information about the training set for the original predicate device or any retraining for this version is not provided.
8. How the ground truth for the training set was established:
- Not reported. As above, no details on the training set or its ground truth establishment are given.
Summary of what the document does indicate regarding "performance" and "studies":
- Reliance on Predicate Device: The core argument for safety and effectiveness is that the LungPoint Procedure Planning Software version 2.0 is substantially equivalent to the planning phase of its predicate device (K091160). It explicitly states: "Both products provide guidance to the physician and use the exact same software (including core algorithms) for planning. The key features: 3D animation and printable plan/map; are identical to those of the planning phase of the predicate device and the same software algorithms are used." This implies that the performance characteristics of the planning component were established with the predicate.
- Design Control Process: "The planned modifications were subjected to the Broncus design control process. Appropriate labeling changes, risk analysis, and design verification were performed to assure that the Procedure Planning software continues to meet its intended use." This is a general statement indicating internal verification processes were followed, but without specific data.
- Risk Management: "Risk management is ensured via a hazard analysis and FMECA, which are used to identify potential hazards. These potential hazards are controlled via software development, verification testing and/or validation testing." This confirms that testing was done to mitigate risks, but again, without specific performance outcomes.
To reiterate, this 510(k) summary provides a high-level overview for regulatory clearance based on substantial equivalence, rather than a detailed scientific publication outlining specific performance studies with quantitative results and acceptance criteria.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).