(192 days)
The Tactile Guidance System - Hip is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. The Tactile Guidance System - Hip is indicated for use in surgical hip procedures, 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. These procedures include: Acetabular reaming during total hip arthoplasty (THA)
The TGS - Hip is a stereotaxic instrument that includes an optical detector, computer, dedicated instrumentation, operating software, tools and accessories, and a robotic arm. The TGS – Hip is enabled for use in conjunction with a 30 party drill system (e.g., Stryker drill system) in order to support the surgeon's preparation of the acetabulum during total hip arthroplasty. The TGS – Hip uses patient CT data to assist the physician with presurgical planning and interpretive navigation. The TGS - Hip robotic arm serves as an "intelligent" tool holder or tool guide used by a surgeon for stereotactic guidance during minimally invasive orthopedic surgical procedures. The TGS - Hip robotic arm, an electromechanical arm, is passively constrained by software-defined spatial boundaries implemented through the use of the robotic arm and is designed to support a surgeon's preparation of an anatomical site for an orthopedic implant with standard surgical tools such as burrs and reamers.
The provided text describes the acceptance criteria and the study for the MAKO Surgical Corp.'s Tactile Guidance System - Hip (TGS - Hip).
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that the performance data for the TGS-Hip satisfied all required acceptance criteria. However, the specific quantitative acceptance criteria (e.g., specific accuracy thresholds for reaming, registration accuracy) are not detailed within the provided text. The description of the reported device performance is qualitative.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| (Specific quantitative criteria not provided in the document, but implicitly met for): | Setup, registration, and overall accuracy and functionality of the system in supporting acetabular reaming during THA were evaluated and found satisfactory. |
| Validation of system's intended use | Postoperative x-rays/CT scans of cadaveric material were obtained and evaluated, and the results supported the system's intended use. |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: The document mentions "sawbone models" and "cadaveric material." It does not specify the exact number of either for the testing.
- Data Provenance: The testing was conducted in a "laboratory." The provenance of the sawbone models is not specified. The cadaveric material is a prospective acquisition for the lab testing. No country of origin for the cadaveric data is given, but it can be inferred as originating from a laboratory setting. No retrospective human patient data was used.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- Number of Experts: The document does not specify the number of experts.
- Qualifications of Experts: The document does not specify the qualifications of the experts who evaluated the results from the cadaveric testing (e.g., who evaluated the postoperative x-rays/CT scans). It only implies that an evaluation was performed.
4. Adjudication Method for the Test Set:
- The document does not specify an adjudication method. It notes that postoperative x-rays/CT scans were "obtained and evaluated," but the process for consensus or resolution of discrepancies, if any, is not described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done. The study described focuses on the device's performance in a laboratory setting on sawbones and cadavers, not on comparing human reader performance with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in spirit, a standalone performance was essentially done for certain aspects. The described testing focused on the system's ability to support the surgeon and operate accurately. While a surgeon uses the robotic arm, the "accuracy and functionality of the system" and the validation of its "intended use" through post-operative imaging evaluate the device's technical performance. The robotic arm is passively constrained by software-defined spatial boundaries, indicating the algorithm's direct role in guiding the tool.
7. The Type of Ground Truth Used:
- For the sawbone models, the ground truth would likely be design specifications or engineering measurements for the desired reaming and registration.
- For the cadaveric material, the ground truth was established by postoperative x-rays/CT scans, which provide anatomical verification of the reaming and implant placement (though implant placement is not explicitly mentioned for validation, only "acetabular reaming"). This is a form of imaging-based anatomical truth.
8. The Sample Size for the Training Set:
- The document does not provide information on the sample size for a training set. The described studies are verification and validation tests, not machine learning model training. The system uses "patient CT data to assist the physician with presurgical planning," but this is patient-specific input for operation, not a training dataset for an AI model in the modern sense.
9. How the Ground Truth for the Training Set was Established:
- As no training set is described for a machine learning model, this information is not applicable based on the provided text. The device uses patient CT data for "presurgical planning and interpretive navigation," which means the CT itself serves as the anatomical ground truth for planning each individual surgery.
§ 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).