(245 days)
The OrthoPilot® Next Generation Platform is a system for computer-aided navigation of surgical instruments. Its purpose is to position endoprosthesis in arthroplasty in the patient. It aids the surgeon in accurately positioning the cutting guides, drills and reamers for endacement surgery (such as total knee, revision knee, unicondylar knee, and total hip systems) and provides intraoperative measurement. It indicates angles and positions for implant placement.
Aesculap's OrthoPilot® Next Generation is a computer assisted surgical navigation system that uses proprietary software to provide anatomical information to a surgeon. The hardware in the system consists of the following primary components: stereotaxic camera, computer (w/ monitors), rigid bodies (transmitters), passive markers, power supply, various tagged instruments, an ultrasound module, transport cart and stand. The computer accepts input from the transmitters on the rigid bodies either mounted to the patients bones or mobile to palpate anatomical landmarks in conjunction with a camera to monitor the spatial location of the transmitters in relation to each other and/or instruments. The computer can also accept spatial input for anatomical landmarks from an ultrasound unit. The software modules for the OrthoPilot Next Generation consist of modules for both a knee suite and a hip suite.
The provided text is a 510(k) summary for the "Aesculap OrthoPilot Next Generation" surgical navigation system. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria in the context of diagnostic or interpretive performance.
Therefore, much of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of diagnostic performance (e.g., sensitivity, specificity, accuracy, human reader improvement with AI) cannot be extracted from this document, as it describes a computer-assisted surgical navigation system and not an AI-driven diagnostic device.
However, I can extract information related to the device's performance data based on the context of a surgical navigation system, which focuses on verification and validation of changes to the device.
Here's what can be gathered:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a table of specific quantitative acceptance criteria (e.g., error margins in millimeters or degrees for navigation) and corresponding reported device performance. Instead, it mentions that the device was verified and validated for certain aspects.
| Acceptance Criterion (Abstracted from 'Performance Data' section) | Reported Device Performance |
|---|---|
| Sterilization | Verified and validated (details not provided) |
| Shelf Life | Verified and validated (details not provided) |
| Navigation Performance | Verified and validated (details not provided) |
| Software Acceptance Tests | Verified and validated (details not provided) |
| Software Life Cycle Testing | Verified and validated (details not provided) |
| Compliance with International Standards | Complies with IEC 60601-1, IEC 62304, ISO 14971 (stated) |
2. Sample size used for the test set and the data provenance
The document does not detail specific "test sets" in the diagnostic sense, nor does it provide sample sizes (e.g., number of procedures, patients, or data points) for the verification and validation activities mentioned. Data provenance (country of origin, retrospective/prospective) is also not discussed. The performance data refers to testing conducted on the device components and software.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided. The device is a surgical navigation system, and "ground truth" for its performance would likely be related to precision and accuracy measurements in a lab or cadaveric setting, not expert consensus on diagnostic images.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable and not provided.
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
Not applicable and not provided. This device is not an AI-driven diagnostic tool to assist human readers. It is a computer-assisted surgical navigation system.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This concept doesn't directly apply here in the context of a diagnostic algorithm. The device, being a surgical navigation system, works with human surgeons in the loop. Its "standalone performance" would be its inherent accuracy and precision in guiding instruments, which is what "navigation performance" verification and validation would cover. However, specific details of this testing are not given.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not specify the type of "ground truth" for the verification and validation of the navigation system's performance. For a surgical navigation system, "ground truth" would typically involve highly precise measurements of physical placement, angles, or trajectories compared to ideal or calibrated values. This might be established through metrology equipment or other highly accurate measurement systems in a controlled environment.
8. The sample size for the training set
Not applicable and not provided. This document does not describe an AI/machine learning model that requires a training set. The software is proprietary and provides anatomical information to the surgeon.
9. How the ground truth for the training set was established
Not applicable and not provided, as there is no mention of a training set for 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).