(28 days)
The ExactechGPS is intended for use during preoperative planning and during stereotaxic surgeon in locating anatomical structures and aligning the endoprosthesis with the anatomical structures provided that the required anatomical landmarks can be identified on the patient's preoperative CT scan.
The ExactechGPS Total Shoulder Application is specifically indicated for Total Shoulder Arthroplasty using the Equinoxe system to aid the surgeon in locating anatomical structures and aligning the glenoid component with the anatomical structures.
This submission proposes modifications to the ExactechGPS Total Shoulder Application cleared per #K162567.
The ExactechGPS Total Shoulder Application is an Image Guided Surgery, or Navigation, system designed to guide surgeons during the preparation of the glenoid as part of a total shoulder arthroplasty procedure. The ExactechGPS Total Shoulder Application also offers a preoperative planning feature that enables surgeons to plan a surgical intervention by evaluating implant size, type, and positioning using reconstructed patient bone models in a virtual environment. The ExactechGPS Total Shoulder Application requires patient CT-scan data to undergo segmentation prior to being imported into the software, as part of reconstructing the bone model, for both navigation and planning.
At initial release, the segmentation step was manually conducted by Blue Ortho. This submission proposes the addition of a semi-automatic segmentation option, where surgeons can elect to not send the CT exams to Blue Ortho for segmentation but employ a semiautomatic segmentation process to virtually reconstruct the bony anatomy of the patient in three dimensions. The use of semi-automatic segmentation to virtually recreate patient bone is available for planning only, and not for use during a navigated surgical procedure.
The provided text describes a 510(k) premarket notification for the ExactechGPS Total Shoulder Application. It focuses on a modification to the device, specifically the addition of a semi-automatic segmentation option for preoperative planning.
Here's an analysis of the acceptance criteria and the study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in a table format and corresponding reported device performance values. It discusses the changes in a qualitative manner. The primary acceptance criterion appears to be demonstrating that the modified device, particularly the semi-automatic segmentation, does not negatively impact the overall performance and maintains substantial equivalence to the predicate device.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Software Verification: All design outputs meet specified requirements. | The submission includes software verification testing to ensure all design outputs meet all specified requirements, confirming compliance. |
| System Accuracy Verification: Comparison of system outputs to CT-scan data collected during clinical use. | The submission references system accuracy verification via comparison of system outputs to CT-scan data collected during clinical use, indicating the system's output aligns with real clinical data. |
| Software Validation: Software specifications conform to user needs and intended uses. | The submission includes software validation to ensure software specifications conform to user needs and intended uses, confirming the software meets user and purpose requirements. |
| No Effect on Intended Use: Modifications do not affect device intended use. | The modifications do not affect device intended use. |
| No Effect on General Design Features and Dimensions: Modifications do not affect general device features and dimensions. | The modifications do not affect general device features and dimensions. |
| No Change in Basic Fundamental Scientific Technology: Modifications do not change the device computer language or other basic fundamental technologies. | The modifications do not change the device computer language or other basic fundamental technologies. |
| No Effect on Performance Specifications: Modifications do not affect device accuracy and/or performance. | The modifications do not affect device accuracy and/or performance. |
| No Changes to Hardware Platform: No changes to the hardware platform or system accessories proposed. | No changes to the hardware platform or system accessories are proposed by this submission. |
| Substantial Equivalence to Predicate Device: The modified device is substantially equivalent to the predicate (K162567). | The report concludes that the proposed ExactechGPS Total Shoulder Application is substantially equivalent to the cited predicate, sharing identical indications for use, intended use, stereotaxic surgery technology, and similar/equivalent preoperative planning technology. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "CT-scan data collected during clinical use" for system accuracy verification. However, it does not specify:
- The sample size used for this test set.
- The country of origin of the data.
- Whether the data 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 provide any information regarding the number of experts used, their qualifications, or their role in establishing ground truth for the test set.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method (e.g., 2+1, 3+1, none) 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 comparing human readers with and without AI assistance. The focus is on the device's performance in preoperative planning and stereotaxic surgery, specifically the new semi-automatic segmentation feature.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study
The document refers to "software verification testing" and "software validation," which imply standalone algorithm testing. The semi-automatic segmentation is a feature of the algorithm designed for "planning only, and not for use during a navigated surgical procedure," suggesting its performance as an algorithmic tool is evaluated. However, specific performance metrics for the standalone algorithm are not detailed.
7. Type of Ground Truth Used
The document states "comparison of system outputs to CT-scan data collected during clinical use." This suggests the ground truth for validating system accuracy might be derived from:
- Clinical CT-scan data: Potentially representing actual patient anatomy or expert-verified segmentations based on these scans.
- The initial "manually conducted" segmentations by Blue Ortho could also serve as a ground truth baseline for comparison with the new semi-automatic method.
However, the specific nature of how "ground truth" was established (e.g., expert consensus on CT, pathology, or outcomes) is not explicitly detailed.
8. Sample Size for the Training Set
The document does not specify the sample size used for the training set (if any was used for the semi-automatic segmentation algorithm).
9. How the Ground Truth for the Training Set Was Established
The document does not specify how the ground truth for the training set was established. It only mentions that the "segmentation step was manually conducted by Blue Ortho" at initial release, which implies manual segmentation could have been used for training data, but this is not explicitly stated.
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).