(124 days)
The EVOLUTION™ Unicondylar Knee System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:
- non-inflammatory degenerative joint disease: including osteoarthritis, traumatic arthritis, or avascular necrosis
- correction of functional deformity;
- revision procedures where other treatments or devices have failed: and treatment of fractures that are unmanageable using other techniques.
The EVOLUTION™ Unicondylar Knee System is indicated for patients with unicompartmental joint disease secondary to the above indications with or without valgus, varus, or flexion deformities where all ligaments are intact.
The EVOLUTION™ Unicondylar Knee System is for cemented use only.
The design features of the EVOLUTION™ Unicondylar Knee System are summarized below:
- Femoral components manufactured from Cobalt Chrome Alloy
- Femoral component sizes 1 5, Resurfacing- or Resection-based .
- Tibial inserts manufactured from UHMWPE
- Tibial insert: Universal, sizes 1 - 5
- Tibial insert: Conforming, sizes 1 5, left and right .
- Tibial component thickness: 8, 9, 10, 11, 12mm
- Tibial bases manufactured from Titanium Alloy
- Tibial base sizes 1 – 5, left and right
- All-poly tibial components manufactured from UHMWPE
- All-poly Universal: sizes 1 - 5, left and right
- All-poly Conforming: sizes 1 - 5, left and right
- All-poly tibial component thickness: 7, 8, 9, 10, 11, 12mm
The EVOLUTION™ Unicondylar Knee System was evaluated via mechanical testing and engineering analyses; including static stability, contact area, lock detail, femoral component strength, range of motion, and wear testing. A review of these results indicates that the EVOLUTION™ Unicondylar Knee System components are equivalent to predicate devices and are capable of withstanding expected in vivo loading without failure.
The provided text describes a 510(k) premarket notification for the "EVOLUTION™ Unicondylar Knee System." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through a new clinical effectiveness study.
Therefore, the document does not contain information about explicit acceptance criteria and a study designed to prove the device meets those criteria in the way envisioned by the posed questions (e.g., performance metrics, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance).
Instead, the "study" demonstrating the device's acceptability is based on showing equivalence to existing devices through mechanical testing and engineering analyses, along with a comparison of design features and materials.
Here's a breakdown based on the provided text, addressing the questions where applicable and explaining why certain information is not present:
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Table of acceptance criteria and the reported device performance:
Acceptance Criteria (Implied) Reported Device Performance Functional equivalence to predicate devices. "The EVOLUTION™ Unicondylar Knee System components are equivalent to predicate devices" Capability of withstanding expected in vivo loading without failure. "capable of withstanding expected in vivo loading without failure" Safety and effectiveness supported by substantial equivalence. "The safety and effectiveness of the EVOLUTION™ Unicondylar Knee System are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification." Indications for use identical to previously cleared predicate devices. "The indications for use of the EVOLUTION™ Unicondylar Knee System are identical to the previously cleared predicate devices." Design features and materials substantially equivalent to predicate devices. "The design features and materials of the subject devices are substantially equivalent to those of the predicate devices." Fundamental scientific technology unchanged relative to predicate devices. "The fundamental scientific technology of the modified devices has not changed relative to the predicate devices." Note: The "acceptance criteria" here are implied by the 510(k) process, which is about demonstrating substantial equivalence, not setting and meeting novel performance thresholds. The "reported device performance" directly addresses these equivalence claims.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This information is not applicable/not provided because the submission relies on mechanical testing, engineering analyses, and comparison to predicate devices, not a clinical "test set" of patients with discrete performance metrics.
- The "study" here is primarily a comparison document and technical report, not a clinical trial.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This information is not applicable/not provided. Ground truth in the context of a clinical test set is not relevant for this type of submission. The "ground truth" for demonstrating equivalence largely lies in technical specifications, material properties, and mechanical test results, assessed by engineers and regulatory bodies.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not applicable/not provided. There was no clinical "test set" requiring adjudication.
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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:
- This information is not applicable/not provided. This is a medical device (knee implant) submission, not an AI or imaging diagnostic device.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This information is not applicable/not provided. Not an AI or software device. Performance is assessed through mechanical testing and equivalence, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" in this context is the established safety and effectiveness of the predicate devices, as well as accepted engineering principles, material science standards, and mechanical testing results. The submission argues that because the new device's design, materials, and mechanical performance are equivalent to these established devices, it also shares their safety and effectiveness profile.
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The sample size for the training set:
- This information is not applicable/not provided. There is no "training set" in the context of an implantable medical device submission based on substantial equivalence.
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How the ground truth for the training set was established:
- This information is not applicable/not provided. See point 8.
§ 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace part of 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 consist of a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.