(293 days)
The TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH IBLOCK is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures. It is specifically indicated for: Total Knee Arthroplasty
As the equivalent TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH PRAXITELES, the TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH IBLOCK consists of the following major components and subsystems: - The Station (Surgetics or NanoStation), consisting of a mobile computer system and an optical localizer - . Ancillary instruments, a specific motorized cutting block and reflective markers used for reference and registration - TOTAL KNEE SURGETICS software application with iBlock option . The main modification to the predicate device K081232 concerns the modification of the motorized cutting block PRAXITELES®.
The provided text describes a 510(k) summary for the TOTAL KNEE SURGETICS Navigation System with iBlock. Based on the available information, here is an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance | Study Type |
|---|---|---|
| Accuracy of the system for intended use | "Analyses show that the accuracy and performance of the system are adequate for its intended use" | Non-clinical setting (bench testing, specimen) |
| Performance of the system for intended use | "Analyses show that the accuracy and performance of the system are adequate for its intended use" | Non-clinical setting (bench testing, specimen) |
| Device does not raise new safety issues | "tested in a non clinical setting (bench testing, specimen) to assess that no new safety and efficiency issues were raised with this device." | Non-clinical setting (bench testing, specimen) |
| Device does not raise new efficiency issues | "tested in a non clinical setting (bench testing, specimen) to assess that no new safety and efficiency issues were raised with this device." | Non-clinical setting (bench testing, specimen) |
| Performance not reduced compared to predicate device | "and not reduced in comparison to the predicate device." | Comparison to predicate device (K081232) performance via non-clinical testing |
2. Sample Size Used for the Test Set and Data Provenance
The document states, "The TOTAL KNEE SURGETICS Navigation System with iBlock was tested in a non clinical setting (bench testing, specimen)". While it specifies "specimen," it does not provide a specific sample size for the test set or specify the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not specify the number of experts used to establish the ground truth for the test set or their qualifications. The testing appears to be non-clinical (bench testing, specimen), which typically relies on established physical standards or measurements rather than expert consensus on images.
4. Adjudication Method for the Test Set
The document does not mention an adjudication method (such as 2+1 or 3+1). Given it's non-clinical testing on specimens, human adjudication in the typical sense for image interpretation would not be applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted for this device. The study described is a non-clinical performance evaluation, not a study involving human readers or AI assistance. The device is a surgical navigation system, not an AI-based diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
The performance testing was a standalone evaluation of the device in a non-clinical setting. The statement "tested in a non clinical setting (bench testing, specimen)" implies testing the system's inherent performance characteristics (accuracy, efficiency) without direct human-in-the-loop clinical scenarios.
7. The Type of Ground Truth Used
The ground truth for the non-clinical testing (bench testing, specimen) would likely be established through physical measurements and engineering specifications to determine the accuracy of the system's guidance and its motorized cutting block. This is not explicitly stated as "expert consensus, pathology, or outcomes data," but rather implied by the nature of non-clinical, benchtop testing for a navigation system.
8. The Sample Size for the Training Set
The document does not provide information about a training set size. This device is a navigation system, and the testing described is for its performance, not for an AI model that requires a training set in the conventional sense. The "TOTAL KNEE SURGETICS software application with iBlock option" likely refers to the operational software, not a machine learning algorithm that needs a training set.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a training set in the context of an AI/machine learning model, there is no information about how its ground truth would have been established.
§ 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).