(171 days)
PhantomMSK is an image-processing software indicated to assist in the positioning of Total Hip Replacement components. It is intended to assist in precisely positioning Total Hip Replacements 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. The device is not for primary image interpretation. The software is not for use on mobile phones.
The PhantomMSK is a non-invasive software system that provides image analysis tools for Total Hip Replacement procedures that use fluoroscopic imaging to assist with implant and anatomic alignment. Total Hip Replacement aims to restore native hip biomechanics, since an unstable or asymmetrical pelvic anatomy may increase the risk of postoperative complications. Several alignment considerations during Total Hip Replacement include leg length, femoral offset, cup inclination, femoral abduction, pelvic tilt and pelvic obliquity. To assist surgeons with these alignments, PhantomMSK provides templating, measurement, and distortion adaptation tools for intraoperative fluoroscopic image assessment. PhantomMSK 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 operates on image principles that are not vendor specific. To operate PhantomMSK, 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 uses software features in conjunction with its radiopaque calibration array, which attaches to the C-arm image intensifier, to calculate and adapt for fluoroscopic distortion.
The provided text describes the 510(k) premarket notification for OrthoGrid Systems, Inc.'s PhantomMSK device. While it mentions that "acceptance criteria were satisfied" and "test results meet the required pass/fail criteria," it does not provide the specific acceptance criteria or the reported device performance in a quantitative manner.
However, based on the general description of verification and validation testing, we can infer some aspects and highlight what information is missing according to your request.
Here's an attempt to answer your questions based on the provided text, and specifying where information is missing:
Device: PhantomMSK
Description: Image-processing software to assist in the positioning of Total Hip Replacement components intraoperatively by measuring their positions relative to bone structures using fluoroscopic images.
1. Acceptance Criteria and Reported Device Performance
The document states: "acceptance criteria were satisfied prior to the release of the software" and "Test results meet the required pass/fail criteria." However, the document does not explicitly list the specific acceptance criteria or quantitative performance results in a table format.
Missing Information: Specific numerical thresholds for accuracy, precision, or other performance metrics.
| Criteria Category | Acceptance Criteria (Not provided in text) | Reported Device Performance (Not provided in text) |
|---|---|---|
| Functional Performance | ||
| Templating Accuracy | e.g., within X mm or degrees | Specific measurement accuracy data |
| Measurement Accuracy | e.g., within Y mm or degrees | Specific measurement accuracy data |
| Distortion Adaptation | e.g., reduce distortion by Z% | Specific distortion correction performance |
| Compatibility | ||
| C-arm Compatibility | Operates with GE OEC 9900/9800 Elite | All specified C-arms supported |
| Image Intensifier Size | 34.5 to 38.5 cm outer diameter | All specified sizes supported |
| Software Performance | ||
| Stability/Reliability | e.g., no crashes, consistent output | Implied "performed as expected" |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Testing verification and validation were done at the code and system level according to written test protocols... Specifically, testing was performed with the GE OEC 9900 and 9800 Elite Composite Video Signal and for Carms having an outer diameter of the image intensifier ranging between 34.5 to 38.5 cm."
- Sample Size for Test Set: Not explicitly stated. The text mentions "testing was performed with the GE OEC 9900 and 9800 Elite Composite Video Signal and for Carms having an outer diameter of the image intensifier ranging between 34.5 to 38.5 cm," implying a range of compatibility tests, but not the number of cases or images used.
- Data Provenance: Not explicitly stated. The location or whether the data was retrospective or prospective is not mentioned. It seems to be related to internal testing data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not explicitly stated. The document mentions: "The test results were reviewed by designated technical professionals to ensure acceptability criteria were satisfied." It does not specify how many, or their role in establishing ground truth (vs. just reviewing test results).
- Qualifications of Experts: "designated technical professionals." No further specific qualifications (e.g., radiologists, years of experience) are provided.
4. Adjudication Method for the Test Set
- Adjudication Method: Not provided. The document only states that "test results were reviewed by designated technical professionals." It does not describe a method like 2+1, 3+1, or any multi-reader adjudication process for ground truth establishment.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done: No indications of an MRMC comparative effectiveness study. The focus seems to be on the device's functional performance and compatibility rather than human reader improvement with AI assistance.
- Effect Size of Human Reader Improvement: Not applicable as no MRMC study was described.
6. Standalone (Algorithm Only) Performance Study
- Standalone Study Done: Yes, implicitly. The "Test results were reviewed by designated technical professionals to ensure acceptability criteria were satisfied." and verifying "all templating, measurement, and distortion adaptation tools performed as expected," refers to the algorithm's performance without a human in the loop, beyond using it as a tool. The device is a "software system that provides image analysis tools," suggesting its primary function is algorithmic processing and measurement.
- However, specific quantitative results of this standalone performance are not provided.
7. Type of Ground Truth Used
- Type of Ground Truth: The document does not explicitly state how ground truth was established for the performance evaluation. It implies that the "expected" performance of templating, measurement, and distortion adaptation tools against known inputs or standards was confirmed.
- It is likely based on simulated or phantom data with known measurements/distortions for validation, rather than expert consensus on clinical cases or pathological findings, given the nature of image processing and measurement tools. However, this is an inference; it's not explicitly stated.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not provided. The document focuses on verification and validation testing, which pertains to the performance of the final device, not the training of any underlying models. The description of PhantomMSK doesn't explicitly state it uses machine learning models requiring a "training set" in the modern AI sense, though it's "image-processing software."
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Established: Not applicable/Not provided. As the document does not mention a training set, the method for establishing its ground truth is also not mentioned.
§ 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).