(107 days)
PhantomMSK Trauma is an image-processing software indicated to assist in the positioning of Orthopedic Trauma components. It is intended to assist in precisely positioning Orthopedic Trauma components intraoperatively by measuring their positions relative to the bone structures of interest, provided that the points of interest can be identified from radiology images. Clinical judgement and experience are required to properly use the device is not for primary image interpretation. The software is not for use on mobile phones.
The PhantomMSK Trauma is a non-invasive software system that provides image analysis tools for Orthopedic Trauma procedures that use fluoroscopic imaging to assist with implant, instrument and anatomic alignment. PhantomMSK Trauma provides templating, measurement, and distortion correction tools for intraoperative fluoroscopic image assessment. PhantomMSK Trauma does not include any custom computer hardware and is a software-based device that can be run on a "commercial off-the-shelf" system (i.e. PC, keyboard, mouse, touchscreen monitor etc.) that meet minimum performance requirements. Furthermore, PhantomMSK Trauma operates on image principles that are not vendor specific. To operate PhantomMSK Trauma, a fluoroscopic image is acquired from a C-arm and displayed outside the sterile field, where the image analysis tools can be used at the surgeon's discretion.
Fluoroscopic distortion is attributed to external electromagnetic interference and the mapping of the planar image on a curved input phosphor. The PhantomMSK Trauma uses software features in conjunction with its radiopaque calibration array, which attaches to the C-arm image intensifier, to calculate and correct for fluoroscopic distortion.
This document, K192279, is an FDA 510(k) Premarket Notification for the device "PhantomMSK Trauma." Based on the provided text, the device itself is an image-processing software intended to assist in the positioning of Orthopedic Trauma components. It offers templating, measurement, and distortion correction tools for intraoperative fluoroscopic image assessment.
However, the provided text does not contain specific acceptance criteria, reported device performance metrics (e.g., accuracy, sensitivity, specificity), details about test set sample sizes and provenance, the number and qualifications of experts for ground truth establishment, adjudication methods, details of any multi-reader multi-case (MRMC) studies, or information about the training set (size, ground truth establishment).
The document states that "Verification and validation testing were done at the code and system level according to written test protocols established before testing was conducted to ensure that all templating overlay, measurement, and distortion correction tools performed as expected." It also mentions that "The test results were reviewed by designated technical professionals to ensure acceptability criteria were satisfied prior to the release of the software," and that "Test results meet the required pass/fail criteria."
While these statements confirm that testing was performed against pre-defined criteria, the specific details of those criteria and the quantitative results are not included in this FDA 510(k) summary. The summary focuses on demonstrating substantial equivalence to a predicate device, PhantomMSK (K182332), rather than providing a detailed performance study report.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported performance metrics, or specific details about sample sizes, expert qualifications, adjudication methods, or MRMC studies for a performance study based solely on the provided text. The document indicates that such testing was performed internally by the manufacturer, but the results and methodologies are not publicly detailed here beyond general statements.
In summary, based on the provided document, I can report the following:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in quantitative terms. The document vaguely refers to "written test protocols established before testing was conducted to ensure that all templating overlay, measurement, and distortion correction tools performed as expected" and "acceptable criteria were satisfied."
- Reported Device Performance: Not explicitly stated in quantitative metrics (e.g., accuracy, precision). The conclusion broadly states, "performance data demonstrate that the PhantomMSK Trauma does not raise different questions of safety or effectiveness."
2. Sample sizes used for the test set and the data provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The document only mentions that "The test results were reviewed by designated technical professionals."
4. Adjudication method for the test set:
- Not specified.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done:
- Not indicated or described in the provided text. The document focuses on demonstrating substantial equivalence based on technical characteristics and intended use.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- The document implies that testing was done on the software's functionality, but does not provide details on whether this was a standalone algorithmic performance study or part of a human-in-the-loop workflow. The device itself is described as "image-processing software indicated to assist in the positioning...Clinical judgement and experience are required to properly use the device."
7. The type of ground truth used:
- Not explicitly defined. The testing mentioned refers to ensuring "templating overlay, measurement, and distortion correction tools performed as expected," implying comparisons against expected or reference values for these functions.
8. The sample size for the training set:
- No information about a training set is provided in this 510(k) summary, as it is primarily focused on post-development verification and validation.
9. How the ground truth for the training set was established:
- No information about a training set is provided.
§ 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).