(210 days)
The Sculptor Robotic Guidance Arm (RGA) is intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.
The Sculptor RGA is indicated for use in unicompartmental knee replacement, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT-based model of the anatomy.
Stanmore Implants Sculptor RGA utilizes a robotic arm to limit the surgeon's operation of a milling (cutting) tool to a safe area and a tracking arm to determine and monitor the location of the patient, providing dynamic referencing relative to the position of the robotic arm and the surgical plan; the device allows the surgeon to remove bone corresponding to the implant's shape as determined pre/intra operatively.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Sculptor Robotic Guidance Arm (RGA):
1. Table of Acceptance Criteria and Reported Device Performance:
The provided 510(k) summary does not explicitly state quantitative acceptance criteria in a table format. Instead, it describes various verification and validation activities conducted to ensure the device's functionality, accuracy, and safety. The performance is reported in terms of successful verification and clinical radiographic outcomes.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Non-Clinical Testing: | |
| Electromagnetic Compatibility (EMC) and Electrical Safety | Testing performed and included in verification activities. |
| Software Control Verification and Validation | Verification of software flow, device safety, touch screen calibration, setup/shutdown procedures, individual hardware component function, correct interoperation of components, registration procedures, bone sculpting function, boundary data integrity, software thresholding, segmentation, data import, 3D model creation, joint/implant selection, landmarking, planning, workflow, patient file management, data integrity, backup, CD burning. |
| System Level Accuracy and Functionality (Sawbone models) | Evaluated setup, registration, and overall accuracy and functionality of the system in supporting unicondylar knee replacement. |
| Clinical Performance: | |
| Accurate Bone Preparation for Unicompartmental Knee Replacement | Radiographic assessment confirmed the Sculptor accurately prepares the bone for unicompartmental knee replacement and validates the system's intended use. |
| Good Radiographic Outcomes with Implant Placement | Demonstrated good radiographic outcomes with respect to implant placement in a clinical study. |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Description: The "clinical case series" serves as the primary test set for demonstrating clinical performance.
- Sample Size: 35 patients (36 knees).
- Data Provenance: Prospective, single-site, conducted in the United Kingdom.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Number of Experts: Two orthopedic surgeons.
- Qualifications: "Orthopedic surgeons." No further details on years of experience or sub-specialty are provided in this document.
4. Adjudication Method for the Test Set:
- Adjudication Method: Implicitly, a consensus or independent review model. "Assessments of lateral and A/P radiographs were performed by two orthopedic surgeons. Their analyses confirmed..." This suggests they both reviewed the radiographs and their analyses "confirmed" the findings, implying agreement or a common conclusion without explicitly stating a formal adjudication process like 2+1 or 3+1 voting. It doesn't indicate a disagreement resolution method if there was one.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- MRMC Study: No, an MRMC comparative effectiveness study was not explicitly described.
- Effect Size of Human Readers with/without AI: Not applicable, as no MRMC study comparing human readers with and without AI assistance was reported. The clinical study described is a single-arm series, focusing solely on the device's performance in preparing bone for implantation, without direct comparison to human readers or unassisted procedures.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done:
- Standalone Performance: The Sculptor RGA is described as a "Robotic Guidance Arm" intended to "assist the surgeon." The entire description emphasizes its role as a tool for the surgeon, limiting the surgeon's operation and providing dynamic referencing. Therefore, the presented performance data, especially the clinical case series, inherently involves human-in-the-loop performance, as the surgeon is operating the milling tool guided by the robot. The non-clinical testing of software and hardware functions could be considered "standalone" in terms of verifying the system's internal accuracy, but not its clinical utility in isolation.
7. The Type of Ground Truth Used:
- Clinical Ground Truth: Radiographic assessment of implant placement. For the clinical case series, "Assessments of lateral and A/P radiographs were performed by two orthopedic surgeons" to confirm accurate bone preparation and implant positioning.
- Non-Clinical Ground Truth: For the non-clinical lab testing, Sawbone models were used, with the "true" or ideal preparation likely defined by the pre-operative planning and intended implant fit.
8. The Sample Size for the Training Set:
- Training Set Sample Size: The document does not provide any explicit information about a training set or its sample size. This type of submission (510(k) for a robotic guidance system) often focuses more on functional verification and clinical validation rather than machine learning model training sets in the modern sense.
9. How the Ground Truth for the Training Set was Established:
- Training Set Ground Truth Establishment: As no training set information is provided, how its ground truth was established is not discussed in the document.
§ 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).