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The UNIKO PointCloud™ Knee Instruments are intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient MRI scans.

The UNIKO PointCloud™ Knee Instruments are compatible with the femoral and tibial components of the DJO Surgical EMPWR 3D Knee System and the Maxx Orthopedics Freedom Total Knee System. The Indications for Use of the DJO Surgical EMPWR 3D Knee System and the Maxx Orthopedics Freedom Total Knee System remain the same as those cleared in the manufacturer's clearances for the implant system.

The UNIKO PointCloud™ Knee Instruments are patient specific cutting guides which are machined from polyoxymethylene material by the by means of customized off-the-shelf software. These guides (also called jigs) aid the surgeon in making the initial distal femoral and the initial proximal tibial bone cuts along with establishing the references for femoral orientations used during total knee arthroplasty surgery. The surgeon then continues the surgical procedure with the conventional knee instrumentation provided by the implant manufacturer for the implant and size specific cuts required for implantation of the femoral and tibial total knee implants.

The UNIKO PointCloud™ Knee Instruments are patient specific and are intended as single use instruments compatible with the TKA femoral and tibial components of the DJO Surgical EMPWR 3D Knee System and the Maxx Orthopedics Freedom Total Knee System.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list "acceptance criteria" with numerical targets in a formal table separate from the performance data. However, the study aims to demonstrate that the device's accuracy is "at least comparable to those of the UNIKO PointCloud™ Knee Instruments (K193312)" (the secondary predicate device) and "substantially better than the literature reported results from convention total knee surgery."

Therefore, the implicit acceptance criteria are defined by the performance of the predicate device (K193312) and improvements over conventional surgery.

2. Sample Size and Data Provenance

• Sample Size for Test Set: 3 experienced orthopedic surgeons each performed 3 TKAs on 3 different cadaveric knees. This implies a total of 9 cadaveric knees in the test set.
• Data Provenance: The study was a cadaver study, which is a prospective study using human cadaveric specimens. The country of origin is not specified but is likely the US given the FDA submission.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: 3 experienced orthopedic surgeons.
• Qualifications of Experts: All 3 surgeons had prior experience using patient-specific instruments from different manufacturers. More specific qualifications (e.g., years of experience, fellowship training) are not provided.

4. Adjudication Method

The document does not explicitly describe an adjudication method for establishing ground truth or evaluating disagreements among the three surgeons. The text states: "All 3 surgeons had prior experience using patient-specific instruments from different manufacturers. Each surgeon performed 3 TKAs on 3 different knees." It then describes how measurements were taken and compared. There's no mention of a consensus process, independent review, or tie-breaking mechanism.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly done to evaluate human readers with AI vs. without AI assistance.

The study involved surgeons using the UNIKO PointCloud™ Knee Instruments (which are derived from AI/software planning). Their performance was compared to:

1. The UNIKO PointCloud™ Knee Instruments (K193312) – the secondary predicate device.
2. Published literature on conventional Total Knee Arthroplasty (TKA), which would represent the "without AI assistance" or conventional approach.

While it makes a comparison, it's not structured as a typical MRMC study evaluating reader performance with and without an AI tool in a diagnostic or image interpretation context. Instead, it assesses the surgical accuracy achieved by surgeons using the AI-derived guides against historical data/predicate.

6. Standalone Performance Study

Yes, a standalone performance study was done. The "cadaver study" directly evaluated the accuracy of the UNIKO PointCloud™ Knee Instruments (the algorithm-generated cutting guides) in terms of angular measurements and resection thickness when used by surgeons. This study assesses the performance of the device itself (the guides produced by the algorithm) after the pre-operative planning.

7. Type of Ground Truth Used

The ground truth used for performance evaluation appears to be:

• Pre-operative plan: The "accuracy of the resection thickness versus that specified in the pre-operative plan" was examined. This implies the pre-operative plan generated by the Vault® System Surgical Planning Software serves as a reference.
• Direct measurements: The study involved "measuring of the following angular measurements: varus/valgus, flexion/extension and internal/external rotation of the femur and varus/valgus and flexion/extension of the tibia." The comparison of these direct measurements to planned values or predicate performance forms the basis of the ground truth for accuracy.

8. Sample Size for the Training Set

The document does not specify the sample size for the training set used for the "Vault® System Surgical Planning Software" or for the UNIKO PointCloud™ Knee Instruments. It mentions that the Vault System was "previously cleared by FDA through K124051," and that the UNIKO PointCloud™ Knee Instruments use the output from this software.

9. How the Ground Truth for the Training Set Was Established

The document does not provide information on how the ground truth for the training set of the underlying Vault® System Surgical Planning Software or the UNIKO PointCloud™ Knee Instruments was established. It only states that the planning software "creates pre-op surgical plan based on MRI data" and that "Surgeon approves plan" before guides are manufactured.

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