(105 days)
HipCheck provides static localization information derived from image processing of intra-operatively acquired X-ray images, by superposition of virtual measurement tools onto those X-ray images.
HipCheck assists the surgeon to determine quantitative measurements during femoroacetabular impingement procedures.
HipCheck enables the surgeon to intraoperatively measure alpha angle during hip arthroscopy procedures for femoroacetabular impingement. The software is provided to the user pre-installed on a mobile touchscreen tablet for which it has been tested for compatibility.
Alpha angle is a value used to indicate cam deformity of the femoral head, seen in patients presenting with femoroacetabular impingement. HipCheck provides a visualization tool for surgeons to determine the alpha angle intraoperatively, using virtual measurement tools superimposed on X-ray images collected during the procedure, which informs clinical decision making.
HipCheck is not patient contacting. The user is instructed to appropriately drape the tablet when used in the sterile field.
The femoral head detection algorithm on which the alpha angle algorithm is built, is based on the Femoral Head Detector algorithm used in the FluoroMap 1.0 software, which belongs to the secondary predicate device, the FluoroMap Computer Assisted Surgery System (K103400).
The provided text does not contain specific acceptance criteria, reported device performance metrics, or detailed study results for HipCheck. While it mentions various types of testing conducted (software, alpha angle performance, mechanical, electrical safety, EMC, simulated-use), it only states that all testing had "overall passing results" and "demonstrates that HipCheck performs as intended."
Therefore, I cannot fulfill all parts of your request with the given information. Below is a summary of what can be extracted and indications of what is missing.
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly detailed in the provided document. The document states that testing was conducted for "overall passing results" but does not specify the numerical acceptance criteria or the measured performance values for HipCheck.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size for any test sets used. It only mentions "simulated-use environment by surgeon and nurse users" for design validation. There is no information about the country of origin of the data 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
The document does not specify the number of experts used or their qualifications for establishing ground truth for any test sets. It mentions "surgeon and nurse users" for simulated-use testing but not in the context of ground truth establishment.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it provide an effect size for human readers with and without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study
The document describes "Alpha Angle Performance Testing" including "verification testing based on the identified design requirements and software requirement specifications of the Alpha Angle Core Algorithm," which suggests standalone algorithm testing. However, no specific performance metrics (e.g., accuracy, precision, recall) are reported for this standalone performance.
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for any of the testing. For example, it doesn't mention whether pathology, expert consensus, or outcomes data were used.
8. Sample Size for the Training Set
The document does not mention any training set or its sample size.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned, there is no information on how its ground truth was established.
Summary of Device Features and Testing Mentioned:
- Device Name: HipCheck
- Purpose: Provides static localization information derived from image processing of intra-operatively acquired X-ray images, by superposition of virtual measurement tools onto those X-ray images. Assists the surgeon to determine quantitative measurements (specifically alpha angle) during femoroacetabular impingement procedures.
- Core Technology: Alpha angle algorithm built on the Femoral Head Detector algorithm from the FluoroMap 1.0 software (secondary predicate K103400).
- Testing Conducted:
- Software testing (considered "moderate" level of concern).
- Alpha Angle Performance Testing (verification and validation to meet design requirements and user needs).
- Mechanical testing (battery life, tablet weight, securement, UI temperature/functionality, RF ablation interference, mounting arm staying force, simulated-use testing).
- Electrical safety and Electromagnetic Compatibility (EMC) testing (compliant with IEC 60601-1 and IEC 60601-1-2 standards).
- Results: All testing had "overall passing results" and "demonstrates that HipCheck performs as intended."
- No Clinical Studies or Animal Studies: The device was supported by non-clinical testing only.
§ 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).