(123 days)
OTS Hip is indicated to enable planning of orthopedic surgical procedures based on CT and X-Ray medical imaging data of the patient anatomy. It is an intraoperative image-guided localization system that enables navigated surgery. It links a freehand probe, tracked by a passive marker sensor system, to virtual computer image space on a patient's preoperative image data being processed by the OTS platform.
The system is indicated for orthopedic hip surgical procedures where a reference to a rigid anatomical structure, such as the pelvis, can be identified relative to a system generated model of the anatomy. The system aids the surgeon to accurately navigate a compatible prosthesis to the preoperatively planned position.
The system is designed for orthopedic surgical procedures including:
- Pre-operative planning of total hip arthroplasty (THA)
- Intraoperative navigated surgery for THA using a posterior approach
OTS Hip is a system to support a surgeon with preoperative planning and intraoperative guidance during orthopedic hip joint replacement surgery.
The OTS Hip device is a modified device from the company's previously cleared OTS Hip (K232140).
OTS Hip is comprised of software systems and hardware components that work together to form a stereotaxic system. The system uses medical imaging data in DICOM format that is loaded into the system for access in the software that are part of the system.
OTS Hip software consists of OTS Hip Plan (OHP), which is a 3D preoperative planning software, and OTS Hip Guide (OHG) that provides intraoperative real-time navigation for the guidance of surgical tools and prosthetic components in relation to the preoperatively determined goal positions.
OHP is a software for preoperative planning prior to a THA (Total Hip Arthroplasty) surgery. OHP enables the orthopedic surgeon to prepare surgery by analyzing the patient anatomy in a 3D environment based on medical imaging data.
OHG imports the result from the preceding planning stage, a released plan, with the 3D model and planned data, from the database of the OTS system. In addition, OHG monitors the real-time information of the position of instruments and prosthetic components in a 3D environment by means of medical imaging data.
The components of the OHG device include a camera and computer stand with an electrical system to which a camera and a medical panel PC are attached, a footswitch, a keyboard, Tracers (passive markers), adapters that hold the Tracers and can be mounted to compatible surgical instruments and that are used for calibration, and tools and instruments that are used during surgery.
The OTS Hip is compatible with the following components:
- PINN GB OFFSET GRATER HANDLE, DePuy Synthes 2550-00-100
- Emphasys offset reamer, DePuy Synthes 4811-00-510
- Greatbatch Offset Cup Impactor, DePuy Synthes 2550-00-115
- Pinnacle straight impactor, DePuy Synthes 2217-50-041
- Emphasys straight impactor, DePuy Synthes 4812-00-150
- Kincise Pinnacle Straight Shell Impactor, DePuy Synthes 2000-02-002 (long)
- Kincise Pinnacle Straight Shell Impactor, DePuy Synthes 2000-02-012 (short)
- Kincise Emphasys Straight Shell Impactor, DePuy Synthes 2000-03-001 (long)
- Kincise Emphasys Straight Shell Impactor, DePuy Synthes 2000-03-012 (short)
The provided text describes two validation studies for the OTS Hip's machine learning algorithms: "CT Algorithm Segmentation and Landmark Validation" and "Sacral Slope Landmark Identification Algorithm Validation." The acceptance criteria and the studies proving the device meets these criteria are detailed below for each.
1. CT Algorithm Segmentation and Landmark Validation
Acceptance Criteria:
- The ML-models overall met the acceptance criteria (specific numerical criteria are not detailed in the provided text).
- Accuracy of Machine Learning (ML) algorithms for segmentation and landmark identification.
Study Proving Acceptance:
| Sub-category | Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|---|
| Overall Model Performance | The ML-models overall met the acceptance criteria. | The ML-models overall met the acceptance criteria. |
| Accuracy of Algorithms | Validation testing demonstrated the accuracy of Machine Learning (ML) algorithms for segmentation and landmark identification. | The results of segmentation and landmark ML algorithms were compared with the manually annotated "ground truth" segmentations and landmarks of the test dataset, demonstrating accuracy. |
Additional Information on the Study:
- Sample size for the test set and data provenance:
- Sample Size: 90 datasets.
- Data Provenance:
- Country of Origin: US (45.6%), Japan (33.3%), and the European Union (21.1%).
- Retrospective/Prospective: Not explicitly stated, though "data collected from human cadaver studies" for "system level validation" might hint at existing data. For the ML validation, it mentions "cases were then separated into training and testing datasets," suggesting a retrospective approach from a collected dataset.
- The OUS dataset was unblinded.
- The data from Japan included a high percentage of dysplastic hips with accompanying marked degenerative change, representing a worst-case scenario.
- Images from multiple CT equipment manufacturers were included.
- Independent datasets were used between training and testing for OUS datasets, though collected from the same site.
- Number of experts used to establish the ground truth for the test set and qualifications of those experts:
- Number of Experts: Not explicitly stated, but "Appropriately qualified clinical experts" established the ground truth. "A third reviewer" was used for validation.
- Qualifications: "Appropriately qualified clinical experts."
- Adjudication method for the test set:
- Method: "Using objective criteria, cases were evaluated by blinded annotators." "Cases assigned to the test dataset were then validated by a third reviewer who was not included in the annotation process of the training data." This indicates a form of multi-reviewer consensus/adjudication.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not explicitly mentioned or implied.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Yes, the validation focused on the accuracy of the ML algorithms compared to ground truth, implying standalone performance.
- The type of ground truth used: Manually annotated "ground truth" segmentations and landmarks established by "appropriately qualified clinical experts" through a consensus-like process (blinded annotators + third reviewer validation).
- The sample size for the training set: Not explicitly stated, but distinct from the 90 test datasets.
- How the ground truth for the training set was established: Established by "Appropriately qualified clinical experts" through a process of "blinded annotators” and validation by a third reviewer. "None of the datasets used for training was used for testing."
2. Sacral Slope Landmark Identification Algorithm Validation
Acceptance Criteria:
- The ML-model met the acceptance criteria (specific numerical criteria are not detailed in the provided text).
- Accuracy of Machine Learning (ML) algorithms for Sacral Slope landmark added for x-ray images.
Study Proving Acceptance:
| Sub-category | Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|---|
| Overall Model Performance | The ML-model met the acceptance criteria. | The ML-model met the acceptance criteria. |
| Accuracy of Algorithms | Validation testing demonstrated the accuracy of Machine Learning (ML) algorithms for Sacral Slope landmark added for x-ray images. | The results of the Sacral Slope landmark ML algorithm were compared with the manually annotated "ground truth" landmarks of the test dataset, demonstrating accuracy. |
Additional Information on the Study:
- Sample size for the test set and data provenance:
- Sample Size: 503 x-ray images from 276 US patients.
- Data Provenance:
- Country of Origin: US patients.
- Retrospective/Prospective: Not explicitly stated, but "cases were then separated into training and testing datasets," suggesting a retrospective approach from a collected dataset.
- Representative of the US population in terms of gender, age, and ethnicity.
- Included images from multiple x-ray equipment manufacturers.
- Number of experts used to establish the ground truth for the test set and qualifications of those experts:
- Number of Experts: Not explicitly stated, but "Appropriately qualified clinical experts" established the ground truth. "A third reviewer" was used for validation.
- Qualifications: "Appropriately qualified clinical experts."
- Adjudication method for the test set:
- Method: "Using objective criteria, cases were evaluated by blinded annotators." "Cases assigned to the test dataset were then validated by a third reviewer who was not included in the annotation process of the training data." This indicates a form of multi-reviewer consensus/adjudication.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not explicitly mentioned or implied.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Yes, the validation focused on the accuracy of the ML algorithms compared to ground truth, implying standalone performance.
- The type of ground truth used: Manually annotated "ground truth" landmarks established by "appropriately qualified clinical experts" through a consensus-like process (blinded annotators + third reviewer validation).
- The sample size for the training set: Not explicitly stated, but distinct from the 503 x-ray images/276 patients in the test set.
- How the ground truth for the training set was established: Established by "Appropriately qualified clinical experts" through a process of "blinded annotators” and validation by a third reviewer. "None of the x-ray images or patients included in the training dataset were re-used in the test dataset."
§ 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).