(212 days)
Knee is a stereotaxic system including a dedicated intraoperative standalone software and surgical instruments. Knee " is intended for primary Total Knee Replacement, to assist the surgeon in determining reference alignment axes in relation to anatomical landmarks, in order to position the cutting guide regarding computed mechanical axis. The Knee includes smart glasses as a Head Mounted Device (HMD) for displaying information to the user intraoperatively. The smart glasses should not be relied upon solely and should always be used in conjunction with traditional methods.
The main purpose of Knee* is to assist the surgeon during the primary Total Knee Replacement (TKR) intervention. Knee* includes KneePlus software and reusable KneeTools instruments.
Knee* provides information to help locate and orientate the main femoral and tibial cutting planes as required in knee replacement surgery. Knee* allows the surgeon to adjust the cutting plane orientation and the resection level. This includes means for the surgeon to collect anatomical references during the TKR intervention using the KneeTools instruments. KneePlus software locates in a 3D reference frame the KneeTools instruments which include markers. All collected coordinates are treated by KneePlus algorithms to provide to the surgeon relevant orientation of the tracked cutting guide.
The KneePlus software is installed on a monocular near-eye HMD and provides the field of vision of the embedded HMD camera with additional information on an opaque 2D OLED screen. The surgeon uses this near-eye display in a very similar way he uses a traditional monitor such as the primary predicate device (Navitrack® System - OS Knee Universal, K110054): the surgeon can choose to look at the screen only when needed. The near-eye display is similar to what would be displayed on the screen of a tablet, smart phone or laptop positioned on a table next to the user.
The provided text is a 510(k) summary for the "Knee+" device. While it describes non-clinical performance data and mentions performance comparison studies, it does not contain a detailed study proving the device meets specific numerical acceptance criteria with a breakdown of sample sizes, ground truth establishment methods, or expert qualifications as requested.
Therefore, I cannot fully complete the requested table and answer all questions directly from the provided text. The document focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive, detailed clinical study report against pre-defined acceptance criteria.
However, I can extract the information that is present and highlight what is missing.
Missing Information
The provided document does NOT explicitly state:
- A table of specific numerical acceptance criteria.
- The reported device performance against numerical acceptance criteria.
- Details of the test set sample size, country of origin, or whether it was retrospective/prospective for the accuracy comparison.
- The number of experts or their qualifications used to establish ground truth.
- Adjudication methods for the test set.
- Whether an MRMC comparative effectiveness study was done, or the effect size of human readers improving with AI assistance.
- Whether a standalone (algorithm only) performance study was done.
- The actual "type of ground truth" used (beyond "simulated use (cadaveric specimens with orthopedic surgeon)", which implies surgical assessment rather than pathology or long-term outcomes).
- The sample size for the training set.
- How the ground truth for the training set was established.
Information Extracted from the Document
Here's a summary of the relevant information provided:
1. Acceptance Criteria and Reported Device Performance
The document states:
- "Bench testing was conducted in order to demonstrate that KneePlus software performs according to its requirements and specifications. In particular, overall system repeatability and accuracy were tested."
- "Performance comparison studies have been performed between Pixee Medical's device and the primary predicate device (Navitrack® System - OS Knee Universal) on test bench (sawbones) and simulated use (cadaveric specimens with orthopedic surgeon). The aim was to compare the accuracy of both systems and therefore assess the performance of Knee+."
- "Even though differences in technology can be noticed between the predicate device and Knee+, a comparison study between Knee+ and Navitrack® - OS Knee Universal (bench testing and cadaveric testing) confirmed that the subject device and its primary predicate have the same accuracy."
Crucially, numerical acceptance criteria for accuracy and repeatability are not provided, nor are the specific numerical results for Knee+ or the predicate device. The document only states that their accuracy was confirmed to be "the same."
| Criterion Type | Acceptance Criteria (Not Explicitly Stated Numerically) | Reported Device Performance (Not Explicitly Stated Numerically) |
|---|---|---|
| System Accuracy | Performs according to requirements/specifications; comparable to predicate. | Confirmed to have the "same accuracy" as the predicate device (Navitrack® System - OS Knee Universal) in bench and cadaveric testing. |
| System Repeatability | Performs according to requirements/specifications. | Tested, but no specific numerical result or comparative statement provided. |
2. Sample Sizes and Data Provenance
- Test Set Sample Size: Not explicitly stated. The studies involved "test bench (sawbones)" and "cadaveric specimens."
- Data Provenance: Implied to be lab-based (bench and cadaveric studies), likely in France (where Pixee Medical is located and indicated as "Besançon FRANCE"). Not specified as retrospective or prospective clinical data.
3. Number of Experts and Qualifications
- Experts: Not explicitly stated how many, but involved "orthopedic surgeon" for cadaveric studies. No specific number or years of experience mentioned.
4. Adjudication Method
- Adjudication Method: Not specified.
5. MRMC Comparative Effectiveness Study
- MRMC Study: Not mentioned or implied. The focus was on device accuracy comparison to a predicate, not human reader improvement with AI assistance.
6. Standalone Performance Study
- Standalone Performance: The non-clinical testing includes "Bench testing was conducted in order to demonstrate that KneePlus software performs according to its requirements and specifications. In particular, overall system repeatability and accuracy were tested." This implies a standalone technical performance assessment of the device/software itself, separate from human interaction, although the specific metrics and results are not provided. The cadaveric studies involved a surgeon, so that portion wasn't purely standalone.
7. Type of Ground Truth Used
- Ground Truth:
- For bench testing: Implied to be based on precise physical measurements of known targets on sawbones.
- For cadaveric testing: Based on the assessment made during "simulated use (cadaveric specimens with orthopedic surgeon)," which would rely on the surgeon's anatomical knowledge and surgical expertise/measurements. This isn't pathology or long-term clinical outcomes data.
8. Sample Size for the Training Set
- Training Set Sample Size: Not mentioned.
9. How Ground Truth for Training Set Was Established
- Training Set Ground Truth: Not mentioned. The document focuses on verification and validation of the device's performance, not the details of its developmental training data.
§ 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).