(219 days)
The BLUE NAVIGATION SYSTEM is intended for use during stereotaxic surgery to help surgeons locate anatomical structures and align endoprostheses. It is specifically indicated for Total Knee Arthroplasty.
The BLUE NAVIGATION SYSTEM is an image guided, or navigation, system for orthopedic surgical procedures. It is intended to intraoperatively compute and display information such as distances and angles related to surgical instrument position. It provides this data to help surgeons make decisions, and is not intended to make surgical decisions or replace surgical actions. The station is composed of an optical localizer system, a computer, and a screen. The localizer tracks in real time the positions of trackers rigidly attached to patient bone or surgical instruments. The BLUE NAVIGATION SYSTEM is imageless, meaning there is no need for preoperative images (CR or MRI), but is based on intraoperative patient anatomical landmarks that are digitized at the beginning of the procedure by the surgeon. The station uses these landmarks to compute useful information that is displayed on a screen to help surgeons position prosthetic components.
The provided document focuses on the 510(k) summary for the BLUE NAVIGATION SYSTEM, detailing its intended use, comparison to predicate devices, and a general statement about performance testing. However, it does not provide specific quantitative acceptance criteria or detailed results of a study demonstrating the device meets such criteria.
The document states:
"Analyses show that the accuracy and performance of the system was adequate for its intended use and not reduced in comparison the predicate devices."
"BLUE NAVIGATION SYSTEM was tested in a non-clinical setting and anatomical testing) to assess that no new safety and effectiveness issues were raised in the device."
This is a general statement of compliance, not a presentation of specific acceptance criteria and the data to show they were met.
Therefore, for most of your questions, the information is not available in the provided text.
Here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Specific quantitative criteria are not provided in the document. | "the accuracy and performance of the system was adequate for its intended use and not reduced in comparison the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified. The document only mentions "non-clinical setting and anatomical testing."
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set:
- Not specified.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Was it done? Not mentioned. The focus is on the device's standalone performance relative to predicate devices.
- Effect size: Not applicable, as an MRMC study is not mentioned.
6. Standalone (Algorithm Only) Performance Study:
- Was it done? Yes, implicitly. The "Performance Testing" section describes testing of the "BLUE NAVIGATION SYSTEM" itself to assess its accuracy and performance. This implies a standalone evaluation of the device's capabilities without human-in-the-loop performance measurement.
7. Type of Ground Truth Used:
- Not explicitly stated. Given the context of an imageless navigation system relying on "intraoperative patient anatomical landmarks that are digitized," the ground truth for accuracy measurements would likely involve physical measurements or highly accurate reference systems in the non-clinical and anatomical testing settings, rather than expert consensus on images or pathology.
8. Sample Size for the Training Set:
- Not specified.
- The device is "imageless," meaning there's "no need for preoperative images (CR or MRI)," which typically form the basis of training sets for image-based AI. This suggests that if machine learning is involved, the 'training' might be related to internal calibration or statistical models derived from engineering data, rather than a traditional medical image training set. However, the document does not elaborate on any machine learning or AI components specifically, beyond its function as a navigation system.
9. How Ground Truth for the Training Set was Established:
- Not applicable as a traditional training set with established ground truth, as understood in machine learning contexts, is not described or implied. If there are internal models, their 'ground truth' would be derived from precisely engineered physical measurements during development and calibration, rather than clinical consensus.
§ 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).