(110 days)
The Ortoma Treatment Solution system is intended to be an intraoperative image-guided localization system to enable navigated surgery. It links a freehand probe, tracked by a passive marker sensor system, to virtual computer image space either on a patient's preoperative image data being processed by OTS platform, or on an individual 3D-model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface.
The system is indicated for hip surgical procedures, in which the use of navigated surgery is considered to be safe and effective, and where a reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT-based model of the anatomy. The system aids the surgeon to accurately navigate a hip prosthesis to the preoperatively planned position.
Example orthopedic surgical procedures include but are not limited to:
Total Hip Arthroplasty (THA) using posterior approach.
Preoperative planning and intraoperative navigated surgery for joint replacement with Stryker Exeter X3 Rimfit cups.
The Ortoma Treatment Solution – OTS is a stereotactic navigation system, supporting the surgeon with positioning information in relation to the individual patient anatomy before and during orthopedic hip joint replacement surgery.
OTS consists of two software parts:
- Ortoma Hip Plan OHP, a 3D preoperative planning application .
- . Ortoma Hip Guide - OHG, provides real-time navigation for guidance of surgical tools and prosthetic components in relation to the preoperatively determined goal position
OHP has support for PACS (Picture Archiving Communication System) solutions already available at Hospitals. The PACS system handles the DICOM (Digital Imaging and Communications in Medicine) data obtained from Computed Tomography (CT) scans of patients. DICOM data from the PACS system is uploaded into the OHP and an illustrative 3D image of the unique patient´s anatomy is created.
The OHP application includes functions to define the measurements of the individual patient anatomy, such as the offset, anteversion and leg length. The surgeon selects prosthetic components in relation to the anatomy data and measurements obtained in the application, to virtually decide the position of the prosthetic components.
The OHG application functions as a positioning system in relation to the preoperatively planned goal position. The system includes passive retro-reflective markers with camera, monitor and adapters to attach the passive retro-reflective markers to surgical instruments. The OHG gives the surgeon real-time positioning information, while the orthopedic surgeon positions the surgical instruments and prosthetic components during the implant surgery, in relation to the patient anatomy as previously planned. The surgeons decide based on their clinical knowledge and experience how the surgery should be performed.
The OTS is compatible with the following Stryker components: Stryker Asnis III 4.0x20 mm full thread stainless steel, Stryker Holding Sleeve for Screwdrivers, Stryker Cannulated Screwdriver with AO Coupling - Hex 2.5mm, Stryker Ortholock Ex-Pin 150x4 mm screw, Stryker quick release apex, Stryker Reamer, and Stryker Cup Inserter.
Here's a breakdown of the acceptance criteria and the study used to demonstrate the device meets those criteria, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria | Reported Device Performance (Mean ± SD) |
|---|---|---|
| Inclination | Within the safe zone of ± 10° as defined by Lewinnek et al. | -0.30° ± 1.95° |
| Anteversion | Within the safe zone of ± 10° as defined by Lewinnek et al. | -0.26° ± 1.90° |
| Distance | Below acceptable accuracy level of ±3mm for stereotactic systems. (Maximum deviation also mentioned as a criterion for acceptable performance implicitly) | 1.45 mm ± 0.59 mm (Max: 2.64 mm) |
| Pin Attachment | An upper limit of potential motion during surgery. (Implicitly, the observed motion should be within an acceptable range, which was effectively demonstrated by the results). | Bias about 0.5 mm or lower (7/8 surgeries); about 0.9 mm (1 surgery) |
Note: The document explicitly states that the results for Inclination and Anteversion were "not outside the safe zone of ± 10°" and the mean deviation for Distance was "below the acceptable accuracy level of ±3mm."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 7 hips (from 4 human cadavers). One hip was excluded due to "unacceptable bone in the acetabulum and surrounding bone for reliable navigation."
- Data Provenance: The data was generated from a "simulated clinical conditions" study using human cadavers. Thus, it's a prospective study conducted in a controlled lab environment. The country of origin is not explicitly stated, but the sponsor "Ortoma AB" is located in Sweden, suggesting the study likely took place in Sweden or a neighboring country.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- The document does not explicitly state the number of experts used or their qualifications for establishing the ground truth for the cadaver study.
- However, the ground truth was established by postoperative CT-scan reference data. This implies that the 'ground truth' itself was derived instrumentally rather than through expert consensus on images. Surgical procedure (THA) and interpretation of CT scans would have been performed by qualified personnel, but they are not detailed as "experts establishing ground truth."
4. Adjudication Method for the Test Set
- The document does not describe an adjudication method involving multiple human readers for interpreting the results of the cadaver study. The "ground truth" was derived from postoperative CT scans, which are objective measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described. The study focused on the device's standalone accuracy in a cadaver model guided by predefined surgical techniques (Stryker Exeter X3 Rimfit Acetabular Cup THA using a posterior approach). The effect size of human readers improving with or without AI assistance is not reported.
6. Standalone (Algorithm Only) Performance Study
- Yes, the described study is essentially a standalone performance study. The "Ortoma Treatment Solution - OTS" device's accuracy was assessed by comparing its intraoperative guidance results (inclination, anteversion, distance) against a post-operative CT-scan derived ground truth. This evaluates the algorithm's guidance performance without explicitly measuring its impact on human surgical performance.
7. Type of Ground Truth Used
- The primary ground truth used was postoperative CT-scan reference data. This is an instrumental, objective measure of the final implanted prosthesis position.
8. Sample Size for the Training Set
- The document does not provide information regarding the sample size used for the training set. The study described is a validation study, not a description of the model development or training.
9. How Ground Truth for the Training Set Was Established
- The document does not provide information on how the ground truth for the training set was established, as details about the training process are not included in this summary.
§ 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).