(257 days)
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.
| Test/Validation Area | Acceptance Criteria (as described) | Reported Device Performance |
|---|---|---|
| Biocompatibility Testing | Met Biocompatibility requirements per ISO 10993-1:2009 for limited exposure (up to 24 hours) of an external communicating device in direct contact to patient tissue. | Met: Biocompatibility testing demonstrated that the device met the requirements per ISO 10993-1:2009. |
| Cutting Guide Leg Alignment Validation | Capable of accurately producing the planned limb alignment from the Vault Software within the acceptance criteria of the study. | Met: The UNIKO PointCloud™ Knee Instruments are capable of accurately producing the planned limb alignment from the Vault Software within the acceptance criteria of the study. Could accommodate varus/valgus cut angles of up to +/- 10 Degrees for the femur and tibia for severe deformities. |
| Jig Design Accuracy Validation | Standard deviation of errors for varus/valgus angles, internal/external rotation, flexion/extension angles, and anterior/posterior slope angles were within the acceptance criteria of the protocol, given various levels of user training. | Met: Testing showed that the standard deviation of errors for the varus/valgus angles, internal/external rotation, flexion/extension angles and anterior/posterior slope angles were within the acceptance criteria of the protocol, even with varying user training levels. |
| Accuracy in Cadaver Testing Study | Comparable accuracy relative to planned values for resection thickness. At least comparable to accuracy achieved using conventional jig-based instrumentation reported in literature. | Met: The difference between the measured resection thickness versus that specified in the pre-operative plan demonstrated a comparable accuracy relative to the planned values. Accuracy was at least comparable to the accuracy achieved using conventional jig-based instrumentation reported in the literature. |
| Usability Validation | All surgical teams able to perform all steps outlined in the validation plan. Surgeon satisfaction with the system exceeded the acceptance criteria. | Met: All surgical teams were able to perform all steps outlined in the validation plan. The overall acceptance criteria of this usability study were met, and surgeon satisfaction with the system exceeded the acceptance criteria of the study. The studies validated that the instruments are a safe and effective means of performing TKA. |
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.
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.