(375 days)
The Acculoc Total Knee System is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, primary and secondary traumatic arthritis, avascular necrosis of the femoral condyle, posttraumatic loss of joint configuration. Moderate valgus, varus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. This device may also be indicated in correction of unsuccessful osteotomy, arthrodesis, or failure of previous arthroplasty procedure. The Acculoc Total Knee System is designed for cemented use only.
The Acculoc Total Knee System is of the fixed bearing type with a posterior stabilized design and cruciate retained design. It is a Patellofemorotibia, polymer.metal/polymer, semi-constrained, cemented knee prosthesis that consists of a femoral component, tibial insert, tibial tray and patellar component. The femoral component articulates with the tibial insert component. The underside of the tibial insert component is flat and "snaps" into the tibial baseplate component. The design and sizing of the femoral components correspond to the natural femoral anatomy, enhancing stress distribution and restoring original femoral dimensions and normal rotation, extension and flexion. Each femoral component has the same intercondylar distance and radius of curvature. Each tibial insert component is complimentarily shaped to conform to the femoral component. The dome shape of each UHMWPE patellar component provides excellent contact with the femoral component and evenly distributes stresses. The dome shape of each patellar component also simplifies implantation by eliminating the need for rotational orientation.
This document describes the Acculoc Total Knee System, a medical device for knee arthroplasty. The information provided is primarily focused on its 510(k) submission for substantial equivalence to other legally marketed devices. Therefore, the details regarding specific acceptance criteria, performance studies with reported metrics, and related methodology are presented in a manner typical for such submissions, which may not align directly with the detailed breakdown requested for AI/algorithm-based devices.
Here's an analysis based on the provided text, addressing your questions to the extent possible:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with specific numerical targets and corresponding device performance values like a typical AI/algorithm efficacy study would. Instead, it states that the device was tested for various performance aspects and performs as well, or better than, predicate devices. The acceptance is based on demonstrating substantial equivalence to these predicates.
| Acceptance Criteria Category (Implied) | Reported Device Performance (Summary) |
|---|---|
| Fatigue performance of tibial tray | "performs as well, or better than, the U2 Total Knee system, Progressive Orthopaedic Total Knee System, LOSPA TKR System and NovoKnee Total Knee System" |
| Interlock mechanism strength (tibial tray and tibial insert) | "performs as well, or better than, the U2 Total Knee system, Progressive Orthopaedic Total Knee System, LOSPA TKR System and NovoKnee Total Knee System" |
| Shear fatigue strength of tibial insert post | "performs as well, or better than, the U2 Total Knee system, Progressive Orthopaedic Total Knee System, LOSPA TKR System and NovoKnee Total Knee System" |
| Contact pressures and areas | "performs as well, or better than, the U2 Total Knee system, Progressive Orthopaedic Total Knee System, LOSPA TKR System and NovoKnee Total Knee System" |
| Lateral subluxation of patellar component | "performs as well, or better than, the U2 Total Knee system, Progressive Orthopaedic Total Knee System, LOSPA TKR System and NovoKnee Total Knee System" |
| Knee constraint tests | "performs as well, or better than, the U2 Total Knee system, Progressive Orthopaedic Total Knee System, LOSPA TKR System and NovoKnee Total Knee System" |
| Jump distance test | "performs as well, or better than, the U2 Total Knee system, Progressive Orthopaedic Total Knee System, LOSPA TKR System and NovoKnee Total Knee System" |
| Range of motion performance | "performs as well, or better than, the U2 Total Knee system, Progressive Orthopaedic Total Knee System, LOSPA TKR System and NovoKnee Total Knee System" |
| Biocompatibility | "Biocompatibility risk assessment and pyrogenicity testing has been conducted." (Implies compliance with standards) |
| Pyrogenicity | "Biocompatibility risk assessment and pyrogenicity testing has been conducted." (Implies compliance with standards) |
| Withstanding expected in vivo loading | "capable of withstanding expected in vivo loading without failure." |
2. Sample size used for the test set and the data provenance
The document describes performance testing of mechanical properties of the device components (fatigue, strength, etc.) rather than clinical data or a "test set" in the context of an AI/algorithm. Therefore, concepts like patient sample size or data provenance (country, retrospective/prospective) are not applicable to the reported testing. These tests typically involve a defined number of physical samples of the device components undergoing simulated wear and stress conditions in a lab. The specific number of samples for each test is not provided in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable. The "ground truth" for mechanical performance tests of a knee implant is established by engineering specifications, material science standards (e.g., ASTM F75, F136, F648), and comparison to predicate devices, not by expert human interpretation of data like in image analysis.
4. Adjudication method for the test set
This question is not applicable, as there is no "test set" in the sense of clinical data requiring expert adjudication. The assessment is based on physical testing against engineering standards and comparison with predicate devices.
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 question is not applicable. The Acculoc Total Knee System is a physical medical implant (prosthesis), not an AI algorithm or a diagnostic tool that involves "human readers" or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a physical medical implant.
7. The type of ground truth used
The "ground truth" for this device's performance is based on engineering standards and material specifications (e.g., ASTM F75 for CoCrMo Alloy, ASTM F136 for Ti-6Al-4V ELI, ASTM F648 for UHMWPE), and comparative performance metrics against legally marketed predicate devices under simulated physiological conditions.
8. The sample size for the training set
This question is not applicable. This device is not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established
This question is not applicable for the same reason as above.
§ 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.