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

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

The UNIKO PointCloud™ Knee Instruments use the TKA surqical plan that is output from the Vault® System Surgical Planning Software which was previously cleared by FDA through K124051. The surgeon plans a primary total knee replacement surgery using the Vault System and the output data file from the individualized surgical plan is utilized by the UNIKO PointCloud™ Knee Instruments (the subject of this submission) to create the necessary files for the production of patient specific cutting guides for the initial cuts to the distal femur and proximal tibia.

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 quides (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 example AP, posterior condylar or transepicondylar (TEA) axis) 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 Knee Cutting Guides are patient specific and are intended as single use instruments compatible with TKA femoral and tibial components of the DJO Surgical EMPWR 3D Knee System.

The provided text describes a 510(k) premarket notification for the UNIKO PointCloud™ Knee Instruments, a surgical instrument system for Total Knee Replacement. It details the device's intended use, technological characteristics, and performance data to demonstrate substantial equivalence to predicate devices.

However, the document does not contain the specific information required to answer all parts of your request, especially regarding "acceptance criteria" and the type of study typically associated with AI/ML-based medical devices (like MRMC studies, ground truth establishment for large datasets, and detailed performance metrics beyond general accuracy statements). The device described is a set of physical surgical instruments (cutting guides) derived from pre-operative planning software, not an AI/ML algorithm that interprets imaging or diagnoses conditions directly.

Therefore, many of your requested points related to AI/ML evaluation (like expert consensus for ground truth, adjudication methods, MRMC studies, training set details) are not applicable or not provided in this document.

I will fill in the information that is available in the document and explicitly state when information is not present or not applicable to this type of device.

Device Description: UNIKO PointCloud™ Knee Instruments

The UNIKO PointCloud™ Knee Instruments are patient-specific cutting guides (jigs) made from polyoxymethylene. These guides assist surgeons in performing initial distal femoral and proximal tibial bone cuts and establishing references for femoral orientations during Total Knee Arthroplasty (TKA) surgery. They are based on a pre-operative surgical plan generated by the Vault® System Surgical Planning Software (previously FDA cleared) using patient imaging data. After these initial cuts, conventional knee instrumentation is used for subsequent steps.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes several "acceptance criteria" generally, but does not provide a specific table with quantitative thresholds. It states that the device "met the biocompatibility requirements," "met the user needs," and "within the acceptance criteria of the study" for various tests.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: The document does not specify a numerical sample size for the "test set" in terms of number of patients/cases for the cadaver study or the human factors/usability study. It mentions a "cadaveric model" for accuracy testing and "all surgical teams" for usability.
• Data Provenance:
  • Country of Origin: Not specified.
  • Retrospective or Prospective: Not specified. The descriptions suggest prospective testing within a cadaveric laboratory setting and a simulated clinical environment for usability. The pre-operative surgical plan is based on patient imaging scans (presumably from real patients, though no details are given on how these scans were acquired or sampled for the design/testing process).

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided as the device is a physical instrument derived from a surgical plan. The "ground truth" for its performance is assessed by its physical accuracy, alignment, and usability in practical settings, compared to the pre-operative plan (which a surgeon approves). The document does not describe a clinical study where human experts (e.g., radiologists) are assessing images based on AI output.

4. Adjudication Method for the Test Set

Not applicable/Not provided. This type of adjudication is typically relevant for studies involving human interpretation of medical images or data, especially when establishing ground truth for AI algorithms. For a surgical instrument, performance is assessed through engineering tests, dimensional accuracy, and functional usability within a simulated or cadaveric environment.

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

No, an MRMC study was not done.
This type of study is specifically designed to evaluate the impact of AI assistance on the diagnostic performance of human readers (e.g., radiologists interpreting images). The UNIKO PointCloud™ Knee Instruments are physical surgical guides, not an AI diagnostic tool. Therefore, a MRMC study is not relevant to their evaluation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not directly applicable in the sense of an AI diagnostic algorithm.
The device itself is a physical instrument. Its "performance" in a "standalone" sense would relate to its manufacturing accuracy and ability to fit the anatomy as planned.
The document mentions that the pre-op surgical plan is an "output from the Vault® System Surgical Planning Software" (previously cleared by FDA through K124051). The UNIKO instruments utilize this output. The "Accuracy in Cadaver Testing Study" assesses how accurately the instruments (the physical cutting guides) align with the pre-operative plan.
The process involves human approval ("Surgeon approves plan"), meaning it's a human-in-the-loop system in the overall surgical workflow, but the "device" itself is the physical guide, not the software.

7. The Type of Ground Truth Used

For the performance testing of the physical instruments:

• Cutting Guide Leg Alignment Validation & Jig Design Accuracy Validation: The ground truth appears to be the pre-operative surgical plan output by the Vault System Surgical Planning Software, against which the manufactured jigs and their ability to guide cuts are compared. This pre-operative plan is surgeon-approved.
• Accuracy in Cadaver Testing Study: The "ground truth" for this study is also the pre-operative surgical plan (i.e., the intended resection thickness and angles) compared to the actual resections performed using the UNIKO guides on cadavers. Comparison is also made against "literature values for conventional knee surgical instruments."
• Usability Validation: The "ground truth" for usability is successful completion of surgical steps and surgeon satisfaction, likely assessed against predefined qualitative and quantitative metrics for task completion, errors, and user feedback.

8. The Sample Size for the Training Set

Not applicable/Not provided. The UNIKO PointCloud™ Knee Instruments are physical cutting guides. They are "manufactured based on surgical plan," not "trained" in the way an AI/ML algorithm is trained on a dataset. The software (Vault System Surgical Planning Software) that generates the surgical plan would have undergone its own development and validation, which might involve training data if it includes machine learning components, but those details are not provided in this 510(k) summary for the instruments.

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

Not applicable/Not provided. As explained in point 8, the product being cleared is a physical instrument, not an AI algorithm requiring a training set with established ground truth. The "training" of the plan-generating software (Vault System Surgical Planning Software) is outside the scope of this document.

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