(92 days)
- Moderately disabling joint disease of the knee resulting from painful osteo- or post . traumatic arthritis
- Revision of previous unsuccessful surgical procedures, either involving, or not . involving, previous use of a unicompartmental knee prosthesis
- As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis .
- Where bone stock is of poor quality or inadequate for other reconstructive techniques as . indicated by deficiencies of the femoral condyle/tibial plateau.
These components are intended for implantation with bone cement.
The Triathlon® PKR System is a modular unicondylar knee prostheses consisting of sterile, single-use components intended for replacement of the medial or lateral femoral condyle regions for either the right or left knee.
This document, K071881, pertains to the 510(k) summary for the Triathlon® PKR System, a knee prosthesis. It focuses on demonstrating substantial equivalence to predicate devices rather than providing performance data against specific acceptance criteria for a novel device. Therefore, much of the requested information regarding acceptance criteria, study details, and ground truth establishment is not present in this type of submission.
Here's a breakdown of the available information based on your request:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as quantifiable metrics. The submission's primary "acceptance criteria" for the 510(k) clearance process is demonstrating substantial equivalence to legally marketed predicate devices in terms of intended use, design, materials, and operational principles.
- Reported Device Performance: The document states that "Based upon the mechanical testing, the Triathlon® PKR System is substantially equivalent for its intended use to other femorotibial replacement knees currently on the market." However, no specific performance metrics (e.g., wear rate, fatigue strength values, range of motion, clinical outcomes) or a comparison table against acceptance criteria are provided in this summary. Instead, it refers to "mechanical testing" generally.
2. 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 provided in the 510(k) summary. The submission focuses on demonstrating substantial equivalence through design and material comparisons and the mention of general mechanical testing, not a clinical study with a test set of patients.
3. 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 establishment by experts for a test set is typically relevant for studies evaluating diagnostic or AI-driven devices. This submission concerns a physical implant (knee prosthesis).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not applicable/not provided for the same reasons as point 3.
5. 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. MRMC studies are relevant for diagnostic devices, particularly those involving human interpretation of images with or without AI assistance. This submission does not describe such a study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This information is not applicable/not provided. This device is a physical knee implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the purpose of substantial equivalence for a physical implant, the "ground truth" is typically established through:
- Material properties and design specifications: Demonstrating that the materials and design conform to established standards and are equivalent to predicate devices.
- Mechanical testing: In vitro laboratory tests (e.g., fatigue, wear, strength) serve as the "ground truth" for demonstrating the physical robustness and performance characteristics under simulated conditions. The summary mentions "mechanical testing" but does not detail the specific tests or their results.
- Clinical history of predicate devices: The long-standing safe and effective use of the predicate devices implicitly forms a "ground truth" for the intended use and performance expectations.
8. The sample size for the training set
- This information is not applicable/not provided. A "training set" is relevant for machine learning algorithms, not for the regulatory submission of a physical medical device like a knee prosthesis.
9. How the ground truth for the training set was established
- This information is not applicable/not provided for the same reason as 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.