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HipCheck assists the surgeon to determine quantitative measurements for femoroacetabular impingement (FAI) procedures. HipCheck provides static localization information derived from image processing of intra-operatively acquired static fluoroscopic images, by superposition of virtual measurement tools onto those X-ray images for skeletally mature patients.

HipMap FAI Analysis is a patient-specific report used to support surgeon or radiologist pre-operative clinical decision making. HipMap femoroacetabular impingement (FAI) Analysis provides a morphological analysis of a skeletally mature hip with potential FAI, including measurements and visualizations that describe hip impingement and stability.

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.

Stryker HipMap FAI Analysis is a patient-specific report intended for use by surgeons or radiologists to support pre-operative clinical decision making by providing a morphological analysis of a skeletally mature hip with potential femoroacetabular impingement (FAI), including measurements and visualizations that describe hip impingement and stability. HipMap provides three-dimensional analyses, 3D surface reconstructions, and annotated images to support surgeons with pre-operative clinical decision-making.

Here's a summary of the acceptance criteria and study details for the HipCheck device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: 745 fluoroscopic images.
  • 184 images: Did not contain images of hips, used to test false positive detection.
  • 561 images: From 81 hips.
• Data Provenance: Geographically, images came from 6 clinical sites in the United States, Netherlands, and Germany. The images were collected during product development cadaver labs or from anonymized log files from patients undergoing surgery. This data appears to be a mix of prospective (cadaver labs) and retrospective (anonymized log files) sources.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Number of "Experts" (Taggers): Two people.
• Qualifications of Experts: They were "trained to use the software" for labeling the femur with the precise location of the femoral head and neck. Specific professional qualifications (e.g., radiologist, orthopedist) or years of experience are not specified in the provided text.

4. Adjudication Method for the Test Set

• For the object detection AI/ML model, testing was done against the average value of the two taggers. This implies a form of consensus or averaging for ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study involving human readers with and without AI assistance is explicitly described for the HipCheck Alpha Angle algorithm.
• However, for the HipMap FAI Analysis (a component of the HipCheck device), a segmentation accuracy and reliability study was conducted. This study reviewed:
  • "Performance of Stryker personnel segmenting pelvic CT scans using HipMap workflow software against trained third-party personnel performing image segmentation of the same scans using 510(k) cleared software."
  • "Reliability of segmentation between Stryker personnel (inter-rater reliability)."
  • "Reliability of the HipMap FAI Analysis by comparing clinical measurement outputs generated from the third-party segmentation (external rater vs internal rater), Stryker employee segmentations (inter-rater reliability), and iterations of segmentations performed by the same Stryker employee (intra-rater reliability)."
  • This is a comparative study, but it's focused on segmentation accuracy and reliability between different personnel and software, rather than the "human readers + AI vs. human readers alone" paradigm. Effect sizes are not mentioned in the provided text for this comparison.

6. Standalone Performance (Algorithm Only) Study

• Yes, a standalone performance testing was conducted for the object detection AI/ML model, which is part of the HipCheck device's image processing pipeline. The results are detailed in the table above (90% Lower Bound of -97.5% for detection, and percentage/degree accuracies for coordinate and angle measurements).

7. Type of Ground Truth Used

• For the object detection AI/ML model's standalone performance testing: Expert Consensus/Annotation (labeled by two trained individuals, with the average value used as ground truth).

8. Sample Size for the Training Set

• The sample size for the training set is not explicitly stated in the provided text. It only mentions that the test dataset was "independent of the data used during model training."

9. How the Ground Truth for the Training Set Was Established

• The method for establishing ground truth for the training set is not explicitly stated in the provided text. It can be inferred that it likely followed a similar annotation process to the test set, but specific details are absent.

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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.

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