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510(k) Data Aggregation
(90 days)
The 360CAS is intended to be used as a planning and intraoperative guidance system to enable open or percutaneous image guided surgical procedures.
The 360CAS is indicated for patients undergoing orthopaedic surgery and where reference to a rigid anatomical structure, such as the pelvis, femur, or tibia, can be identified.
The 360CAS Knee is indicated for the following surgical procedures:
- Total Knee Arthroplasty (TKA)
- For conditions of the knee joint in which the use of computer assisted surgery may be appropriate
The 360CAS Hip is indicated for the following surgical procedures:
- Total Hip Arthroplasty (THA) e.g., open or minimally invasive, where a posterior or anterior approach is used
- For conditions of the hip joint in which the use of computer assisted surgery may be appropriate
The 360 Computer Assisted Surgery (360CAS) is a stereotaxic surgical navigation system for orthopaedic surgical procedures. The 360CAS is intended to be used as a planning and intraoperative quidance system with any manufacturers implant in open or percutaneous orthopaedic surgical procedures. The 360CAS uses optical tracking technology that allows surgeons to map a patient's morphology, navigate surgical instruments and implants and assess the state of the joint throughout the surgery. The system consists of four main components: 360CAS navigation software, which consists of two modules: 360CAS Knee and 360CAS Hip, surgical instruments, spatial tracking components and a navigation cart. 360CAS Knee is a 360CAS navigation software for knee replacement surgery. 360CAS Hip is a 360CAS navigation software for hip replacement surgery. The navigation software interfaces with the optical trackers which are attached to navigation instruments (e.g. pointer, bone fixator(s)).
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| System Accuracy (Knee) | The system enables the determination of the mechanical axes of the lower limb as well as cut and component alignment with a mean translational error of < ±2 mm and a mean rotational error of < ±1°. |
| System Accuracy (Hip) | The system enables the determination of the mechanical axes of the lower limb as well as cut and component alignment with a mean translational error of < ±2 mm and a mean rotational error of < ±1°. (Note: The predicate device for Hip had a rotational error of < ±2°, making the subject device's performance superior or at least equivalent if the "less than" applies to the absolute value.) |
| Electrical Safety | Conducted in accordance with AS/NZS 3551:2012 and IEC 60601-1-2:2014. |
| Electromagnetic Compatibility | Conducted in accordance with IEC 60601-1-2:2014. |
| Software Verification/Validation | Performed according to FDA guidance (Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (2005) and Off-the-Shelf Use in Medical Devices (2019)). Considered a "MAJOR" level of concern. |
| Functional Testing | All functional requirements are fulfilled. |
| Safety Testing | Effectiveness of all risk controls determined in the device risk analysis was verified. |
| Clinical Workflow | Verified that all system components (application, computer platform and accessories) are compatible through complete knee and hip arthroplasty procedures simulated using Sawbones mimicking the patient's anatomy and cadaver laboratories. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily describes bench testing and cadaveric laboratory testing. Specific sample sizes for each test are not explicitly provided, but the types of materials used are:
- ASTM accuracy testing: Not specified, but uses a standardized test procedure according to ASTM F2554-18.
- System accuracy testing: Sawbones mimicking patient's anatomy.
- Clinical accuracy testing: Not specified, but states "in a cadaveric laboratory."
- Clinical workflow testing: Sawbones mimicking the patient's anatomy and cadaver laboratory.
The data provenance is from laboratory and cadaveric studies, not real-world patient data. The country of origin of the data is not explicitly stated, but the applicant company is located in Australia.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The document describes verification and validation activities but does not detail how ground truth was established for these tests or the experts involved.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. The document describes accuracy and workflow testing but does not mention any adjudication method for establishing ground truth or evaluating disagreements.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was done. The device is a surgical navigation system, and the performance testing focuses on its accuracy and functionality, not its impact on human reader performance. No AI-assistance claims are made that would necessitate such a study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, standalone performance testing was done for the device's accuracy. The "System Accuracy" and "Clinical Accuracy" testing (translational and rotational error) are examples of standalone performance evaluations for the navigation system's output. The entire performance data section (bench testing, software V&V) implicitly describes standalone performance, as it assesses the device's inherent characteristics. The design of the device as a "planning and intraoperative guidance system" suggests it assists a human surgeon, but the accuracy metrics are for the system itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the performance testing appears to be based on:
- Standardized test procedures and physical measurements: ASTM F2554-18 for spatial tracking accuracy.
- Engineered or known physical values: Sawbones mimicking patient anatomy and cadaveric laboratories are used to assess the device's ability to measure and guide with specified accuracy (±2mm and ±1°). The "specified accuracy" itself serves as the benchmark for evaluation.
8. The sample size for the training set
This information is not applicable/not provided. The document describes a "stereotaxic surgical navigation system" and "optical tracking technology." While it includes "360CAS navigation software," it does not explicitly mention machine learning or AI models that would require a distinct "training set" in the context of deep learning. The software verification and validation, along with functional testing, imply that the software's performance was evaluated against its design specifications, not through a machine learning training/validation split.
9. How the ground truth for the training set was established
This information is not applicable/not provided as there is no mention of a machine learning training set. The software's "ground truth" would be its design requirements and specifications, validated through standard software V&V processes and functional testing.
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