(29 days)
The 360CAS Knee is intended to be used as a planning and intraoperative guidance system in open or percutaneous image guided surgical procedures. The 360CAS Knee 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 360 Computer Assisted Surgery (360CAS) is a stereotaxic surgical navigation system designed for orthopedic surgical procedures. The 360CAS device consists of four main components: 360CAS Navigation Software, Surgical Instruments, Spatial Tracking Components, and the Navigation Cart. It is intended to be used as a planning and intraoperative guidance system in open or percutaneous orthopedic surgical procedures. This device utilizes optical tracking technology, enabling surgeons to map patient morphology, navigate surgical instruments, and assess joint conditions throughout the surgery. Optical trackers are attached to navigation instruments, and the Spatial Tracking Components locate the 3D position of these instruments in space. The coordinates are relayed to the 360CAS Navigation Software, which provides the user with relevant orientation and position information. The 360CAS Knee is a specific application of the 360CAS Navigation Software tailored for knee replacement surgery.
The provided text describes a 510(k) premarket notification for the "360CAS Knee" device. However, it does not include detailed acceptance criteria or a comprehensive study report proving the device meets these criteria. The document states that "Design verification and validation testing demonstrated that the 360CAS System meets all design requirements and is as safe and effective as its predicate device (K223927)." It lists the types of performance tests performed but does not provide the specific acceptance criteria or the reported device performance values for these tests.
Based on the provided text, I can infer some general information about the performance tests, but I cannot fill in the table with specific quantitative acceptance criteria or reported performance values as that information is not present.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Required Value) | Reported Device Performance (Achieved Value) |
|---|---|
| Software Verification and Validation Testing (IEC 62304) | "Meets all design requirements" (Specifics not provided) |
| Positional Accuracy Testing (ASTM F2554) | "Achieve the same system accuracy" as predicate (Specific values not provided) |
| Systems accuracy testing | "Achieve the same system accuracy" as predicate (Specific values not provided) |
| Non-clinical surgical simulations on bone models | "Meets all design requirements" (Specifics not provided) |
Explanation: The document states that these tests were performed and that the system "meets all design requirements" and "achieve the same system accuracy" as the predicate device (K223927). However, the specific numerical acceptance criteria (e.g., accuracy within X mm, recall > Y%) and the actual measured performance values are not disclosed in this summary.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the provided text. The tests mentioned are "Software Verification and Validation Testing," "Positional Accuracy Testing (ASTM F2554)," "Systems accuracy testing," and "Non-clinical surgical simulations conducted on bone models." These typically involve controlled test environments and/or cadaveric/bone models rather than patient data.
- Data Provenance: Not specified. Given the nature of the tests (software V&V, positional accuracy, non-clinical simulations), it primarily involves engineering and lab data, not patient data in the typical sense of retrospective/prospective clinical studies.
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)
Not applicable. The tests performed are engineering and lab-based (software, positional accuracy, simulations on bone models), not clinical studies involving expert interpretation of patient data to establish ground truth for diagnostics or treatment efficacy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is typically relevant for studies involving human interpretation (e.g., image reading) where consensus is needed. The described tests are objective engineering measurements and simulations.
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. The document describes a computer-assisted surgery system, not an AI-assisted diagnostic imaging system that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in the sense that the "Performance Data" section discusses "Positional Accuracy Testing," "Systems accuracy testing," and "Software Verification and Validation Testing." These would primarily evaluate the algorithm/system's performance independently of a specific human operator for its core functions (tracking, calculations, etc.). While it's a surgical navigation system and human surgeons are the ultimate users, these tests assess the technical accuracy and functionality of the device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth would be based on:
- For Software V&V: Defined software requirements and specifications.
- For Positional Accuracy/Systems Accuracy: Precisely measured physical references and known values.
- For Non-clinical surgical simulations: Predefined surgical plans, anatomical landmarks on the bone models, and accurate measurement tools (e.g., CMMs, highly accurate optical trackers).
8. The sample size for the training set
Not applicable. This device is described as a "stereotaxic surgical navigation system" that uses "optical tracking technology." The description does not indicate that it is an AI/machine learning model that requires a "training set" in the conventional sense of supervised learning on a large dataset of patient images or outcomes. It appears to be a rule-based or model-based system, for which the term "training set" is not relevant.
9. How the ground truth for the training set was established
Not applicable, as there's no indication of a training set as would be found with an AI/ML model.
§ 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).