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The patient-specific Bodycad Unicompartmental Knee System (Bodycad UKS) is indicated for unicompartmental knee arthroplasty (UKA) in patients with advanced knee osteoarthritis (OA) of the medial compartment with evidence of adequate healthy bone to support the implanted components. Candidates for unicompartmental knee replacement include those with:
· joint impairment due to osteoarthritis or traumatic arthritis of the knee.
· varus deformity of the knee, and
· as an alternative to tibial osteotomy in patients with unicompartmental OA.
The patient-specific Bodycad UKS components fit within an envelope of dimensions that are specific to each patient. The Bodycad UKS femoral component and tibial baseplate are intended fixation. A Bodycad screw must be used for fixation of the femoral component.

The Bodycad Unicompartmental Knee System (BUKS) is a patient-specific prosthesis that consists of femoral and tibial implants for replacement of the medial tibiofemoral compartment of the knee. The patient-specific femoral and tibial components and single-use cutting quides are manufactured from CAD and CAM files generated from Bodycad software, which are based on MRI or CT images of the patient's knee and input from the surgeon. The BUKS is for cemented use only and is sterilized by gamma radiation.
The subject of this 510(k) notification is a line extension and design update that includes a new tibial baseplate that is compatible with the BUKS system (K163700, K181302) and instruments that are compatible with the new tibial baseplate.
Materials: Wrought Cobalt-28Chromium-6Molybdenum Alloy (CoCrMo; ASTM F1537-11) for the femoral component and screw, wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (Ti6Al4V ELI; ASTM F136-13) for the tibial baseplate, locking pin, and screw, Ultra-High-Molecular-Weight Polyethylene (UHMWPE; F648-14) for the tibial insert.

The provided text is a 510(k) summary for the Bodycad Unicompartmental Knee System. This document is a regulatory submission for a medical device and describes its intended use, technological characteristics, and a comparison to predicate devices to demonstrate substantial equivalence.

Based on the content, the document does NOT describe the acceptance criteria or a study proving the device meets those criteria in the context of an AI/algorithm-based medical device. This document is for a physical medical implant (a knee system) and the performance data presented relates to mechanical testing and surgeon-user validation for the physical device, not an AI or software algorithm.

Therefore, I cannot extract the requested information regarding AI/algorithm performance, acceptance criteria, sample sizes for test/training sets, expert ground truth establishment, or MRMC studies.

The document primarily focuses on demonstrating the substantial equivalence of a physical knee implant (Bodycad Unicompartmental Knee System) to previously cleared predicate devices through design comparison and mechanical performance testing, not on the performance of a software algorithm or AI.

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The patient-specific Bodycad Unicompartmental Knee System (Bodycad UKS) is indicated for unicompartmental knee arthroplasty (UKA) in patients with advanced knee osteoarthritis (OA) of the medial compartment with evidence of adequate healthy bone to support the implanted components. Candidates for unicompartmental knee replacement include those with:

· joint impairment due to osteoarthritis or traumatic arthritis of the knee,

• · varus deformity of the knee, and
• · as an alternative to tibial osteotomy in patients with unicompartmental OA.

The patient-specific Bodycad UKS components fit within an envelope of dimensions that are specific to each patient. The Bodycad UKS femoral component and tibial baseplate are intended for cemented fixation. The Bodycad screws must be used for fixation of the femoral and tibial components.

The Bodycad Unicompartmental Knee System (Bodycad UKS) is a patient-specific prosthesis that consists of femoral and tibial implants for replacement of the medial tibiofemoral compartment of the knee. The patient-specific femoral and tibial components and single-use cutting guides are manufactured from CAD and CAM files generated from validated Bodycad software, which are based on MRI or CT images of the patient's knee and input from the surgeon. The Bodycad UKS is for cemented use only. The Bodycad UKS is sterilized by gamma radiation.

Materials: CoCrMo (ASTM F1537-11) for the femoral component, Ti6Al4V ELI (ASTM F136-13) for the tibial component, UHMWPE (F648-14) for the tibial insert

The provided text describes a medical device, the Bodycad Unicompartmental Knee System, and its regulatory clearance. However, it does not contain information related to specific acceptance criteria, a study proving the device meets those criteria, or performance data in terms of metrics like sensitivity, specificity, or accuracy.

The "performance data" section states: "Validation testing was performed for CT and MRI imaging modalities and demonstrated substantial equivalence of the 3D digital bone models being equivalent for data extracted from CT and MR images." This indicates a technical validation of the 3D model generation process from imaging, not a clinical performance study with defined acceptance criteria for device efficacy or outcomes.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text, as this information is absent.

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The patient-specific Bodycad Unicompartmental Knee System (Bodycad UKS) is indicated for unicompartmental knee arthroplasty (UKA) in patients with advanced knee osteoarthritis (OA) of the medial compartment with evidence of adequate healthy bone to support the implanted components. Candidates for unicompartmental knee replacement include those with:

· joint impairment due to osteoarthritis or traumatic arthritis of the knee,

· varus deformity of the knee, and

· as an alternative to tibial osteotomy in patients with unicompartmental OA.

The patient-specific Bodycad UKS components fit within an envelope of dimensions that are specific to each patient. The Bodycad UKS femoral component and tibial baseplate are intended for cemented fixation. The Bodycad screws must be used for fixation of the femoral and tibial components.

The Bodycad Unicompartmental Knee System (Bodycad UKS) is a patient-specific prosthesis that consists of femoral and tibial implants for replacement of the medial tibiofemoral compartment of the knee. The patient-specific femoral and tibial components and single-use cutting guides are manufactured from CAD and CAM files generated from validated Bodycad software, which are based on MRI images of the patient's knee and input from the surgeon. The femoral component is fabricated from wrought Cobalt-Chrome alloy (CoCr) with a centrally located peg and provision for ancillary fixation with a CoCr bone screw. The tibial implant consists of a Titanium (Ti) alloy baseplate with one to three posterior spikes and provision for ancillary fixation with a Tit alloy bone screw. The polyethylene insert is fabricated from Ultra-High-Molecular-Weight- Polyethylene (UHMWPE), compression molded and machined GUR 1020. The tibial-femoral articulation is an unconstrained design. This device is for cemented use.

Materials: CoCrMo (ASTM F1537-11) for the femoral component. Ti6Al4V ELI (ASTM F136-13) for the tibial component, UHMWPE (F648-14) for the tibial insert

The provided text is a 510(k) Summary for the Bodycad Unicompartmental Knee System. It describes the device, its indications for use, and a comparison to predicate devices, as well as a list of performance tests conducted.

However, the document does not contain the information requested in the prompt regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning data provenance, expert adjudication, MRMC studies, or training/test set details for an AI/algorithm-driven device performance study.

The "Performance Data" section lists various mechanical and material tests performed on the knee system components (fatigue strength, range of motion, constraint testing, screw strength, contact pressure, etc.), as well as cadaver laboratory testing for surgical technique and implant fit, and evaluation of single-use cutting guides. This section focuses on the physical and functional characteristics of the medical device itself, not on the performance of a diagnostic algorithm or AI system for which the requested details about ground truth, expert readers, and sample sizes would be relevant.

The closest mention of software is that the patient-specific implant components and cutting guides are manufactured from CAD-CAM models created from the patient's MRIs and input from the surgeon, using proprietary software. It states: "This software, and off-the-shelf software, were validated per the FDA guidance document 'Guidance for the content of premarket submissions for software contained in medical devices'." However, this refers to validation of the manufacturing software workflow, not a diagnostic AI system predicting disease state or lesion characteristics.

Therefore, based on the provided text, I cannot answer the specific questions about acceptance criteria and a study proving the device meets them in the context of an AI/algorithm-driven diagnostic performance study.

The document details the regulatory clearance of a medical device (a knee implant system), not an AI software as a medical device (SaMD). The acceptance criteria mentioned are related to the physical performance, material integrity, and surgical fit of the implant, not the diagnostic performance of an AI.

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