(164 days)
Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis; failed osteotomies, unicompartmental replacement, or total knee replacement. The Journey II Total Knee system components are indicated for use only with cement and are single use devices.
Subject of this Traditional Premarket Notification are the Journey II XR Knee system. The subject device is a bi-cruciate retaining total knee system which provides the ability for greater flexion to those patients who have the anatomical capability to allow a greater flexion range. Components of this premarket notification include the following components:
- . Medial and lateral cross-linked polyethylene articular inserts which will be available in left and right hand
- o Titanium alloy (Ti-6Al-4V) tibial bases which will be available in left and right hand
The Journey II XR Knee system will use existing Journey II CR femoral components and existing patella components compatible with the Journey II CR femoral as well as device specific instruments.
The provided text describes a 510(k) premarket notification for the Journey II XR Knee System, which is a medical device (a knee prosthesis). This type of document focuses on establishing substantial equivalence to existing legally marketed devices, rather than a robust clinical study proving performance against specific acceptance criteria for a new AI/software device.
A 510(k) summary for a traditional medical device like a knee implant focuses on demonstrating that the new device is as safe and effective as a predicate device, primarily through comparing technological characteristics and mechanical testing. It does not involve the kind of clinical study with human readers, ground truth establishment, or performance metrics (like sensitivity, specificity, AUC) that would be conducted for an AI/software as a medical device (SaMD).
Therefore, based on the provided document, the following points apply:
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A table of acceptance criteria and the reported device performance: Not applicable in the context of this 510(k) submission for a knee implant. The "performance" is demonstrated through mechanical testing and comparison to predicates.
Acceptance Criteria (Implied by 510(k) for mechanical qualities) Reported Device Performance (Mechanical Testing) Withstand expected in vivo loading without failure * Tibiofemoral Contact Area Analysis * Tibiofemoral Constraint Testing * Construct Fatigue Strength Testing * Static testing of the insert locking mechanism * Tibial base plate fatigue performance No new issues related to safety and effectiveness Testing demonstrated no new issues. -
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. "Clinical data was not needed to support the safety and effectiveness of the subject devices" (page 3). The testing was mechanical, not clinical.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI/software in a clinical context (e.g., expert consensus on image interpretation) is not relevant to this mechanical device submission.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is not an AI/software device.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the mechanical testing, the "ground truth" would be the engineering specifications and established test methodologies for evaluating the structural integrity and functional characteristics of knee implants. This is not the same as clinical ground truth.
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The sample size for the training set: Not applicable, as this is not an AI/software device with a training set.
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How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a 510(k) clearance letter for a traditional metallic and polymeric knee prosthesis, not an AI/software device. The demonstration of safety and effectiveness relies on mechanical testing and comparison to predicate devices, not on clinical studies involving human readers or AI algorithm performance metrics.
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.