(228 days)
The TC-PLUS™ Solution Knee is intended as a cemented surface replacement in treating patients who are candidates for primary total knee arthroplasty or revision knee arthroplasty. It is indicated for degenerative, post-traumatic or rheumatoid arthritis, avascular necrosis of the femoral condyle, post-traumatic loss of joint configuration, in particular in the event of patello-femoral erosion, functional disability or an earlier patellectomy; moderate varus, valgus or flexure deformity and to correct earlier unsuccessful attempts at surgery.
The TC-PLUS™ Solution is a tri-compartmental total knee prosthesis comprised of femoral, patellar and tibial components with an intrinsic Standard, Posterior Stabilized (PS) and Ultratibial PE-insert. Congruent components are available. The PS is available for indications requiring greater stability and the Ultracongruent option may be used as an alternative for increasing A/P stability.
This document is a 510(k) summary for a knee joint prosthesis, the TC-PLUS™ Solution Knee. It does not describe or include a study that proves the device meets specific acceptance criteria based on performance metrics like accuracy, sensitivity, or specificity, which would be typical for AI/ML-driven devices.
Instead, this submission focuses on demonstrating substantial equivalence to a previously legally marketed device (the Encore Foundation Knee System, K923277) through in vitro biomechanical testing. The acceptance criteria here are implicitly related to industry standards for mechanical strength, wear, and fatigue for knee prostheses, rather than diagnostic or analytical performance.
Therefore, many of the requested categories for AI/ML device studies are not applicable to this document. I will fill in the applicable information and explicitly state when a category is not relevant to this type of device submission.
Acceptance Criteria and Device Performance (for a Knee Prosthesis)
| Acceptance Criteria Category | Reported Device Performance | Comments |
|---|---|---|
| Biomechanical Testing | "All test results are sufficient for in vivo loading." | This is a general statement indicating the device passed relevant biomechanical tests for knee prostheses. Specific numerical thresholds or performance values (e.g., fatigue life, wear rates, load-bearing capacity) are not detailed in this summary document but would have been part of the full submission. |
| Material Compatibility | Implicitly compatible with human tissue (Polymer/Metal/Polymer components) | The device is made of standard materials used in knee prostheses (polymer, metal) which have established biocompatibility. No specific tests or criteria are mentioned in this summary. |
| Sterilization Efficacy | Not explicitly stated in this summary. | Sterilization validation would be a standard requirement for such a device, but no performance data is reported here. |
| Manufacturing Quality | Not explicitly stated in this summary. | Compliance with Quality System Regulation (21 CFR Part 820) is mentioned in the FDA letter, but no specific performance data from quality checks are included in this summary. |
| Equivalence to Predicate Device | Substantially equivalent to the Encore Foundation Knee System (K923277, SE date 02/09/93). | This is the primary "acceptance criterion" for a 510(k) pathway – demonstrating the new device is as safe and effective as a legally marketed predicate device. This is achieved through comparison of indications, technological characteristics, and performance data (like biomechanical testing). |
Study Details (as inferrable for a traditional medical device like a knee prosthesis)
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of device performance in a diagnostic or analytical sense. For biomechanical testing, the "sample size" would refer to the number of prosthetic components tested for each specific mechanical property (e.g., fatigue, wear). This information is not provided in the 510(k) summary but would be detailed in the full biomechanical test reports submitted to the FDA. Data provenance would be from laboratory testing.
- Data Provenance: Laboratory testing of manufactured components.
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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" in this context typically refers to objective measurements or engineering standards established by qualified engineers and scientists in biomechanics, materials science, etc., rather than expert clinical consensus as defined for AI/ML models.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is a concept used in expert consensus for diagnostic interpretation. Biomechanical testing relies on objective measurements against engineering specifications.
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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. This is a physical prosthetic device, not a diagnostic imaging AI algorithm.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical prosthetic device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For biomechanical testing, the "ground truth" is defined by established engineering principles, material science properties, regulatory standards (e.g., ISO, ASTM for orthopedics), and comparative performance against the predicate device. It's objective, quantitative data from physical tests.
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The sample size for the training set:
- Not applicable. This is not an AI/ML device that uses a "training set." Device design and materials development are based on extensive prior knowledge and engineering principles, not machine learning model training.
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How the ground truth for the training set was established:
- Not applicable. As above, this is not an AI/ML device.
§ 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.