(179 days)
The ACCIN Total Knee System components are for use in total knee arthroplasty as a result of:
• Painful, disabling joint disease of the knee resulting from degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis;
• Post-traumatic loss of knee joint configuration and function
• Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability;
• Revisions of previous unsuccessful knee replacement or other procedure.
Additional indications for posteriorly stabilized components:
• Ligamentous instability requiring implant bearing surfaces with increased constraint;
• Absent or non-functioning posterior cruciate ligament.
These devices are single use only and are intended for implantation with bone cement.
The Accin™ total knee system consists of a series of cobalt chrome femoral components, a series of cobalt chrome tibial tray components and a series of UHMWPE modular tibial bearing components.
The provided text describes a 510(k) premarket notification for the "Accin™ total knee system," a medical device, and its comparison to predicate devices, rather than an AI/ML powered device. Therefore, the questions related to AI/ML specific criteria (such as AI improvement effect size, standalone algorithm performance, training set details, ground truth establishment for training set, and AI/ML acceptance criteria) are not applicable.
However, I can provide information based on the available text regarding the testing and comparison of the Accin™ total knee system to its predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with specific quantitative targets and the device's reported performance against those targets. Instead, it states that the device "meets the requirements of the current FDA Guidance documents on total knee arthroplasty product" and passed a series of tests. The "acceptance criteria" here implicitly refer to the requirements outlined in the FDA guidance documents and ASTM standards.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Requirements of FDA Guidance documents on total knee arthroplasty devices | "Testing has shown that the Accin™ total knee system meets the requirements of the current FDA Guidance documents on total knee arthroplasty product." |
| ASTM Standard F1800 | Tests were performed according to this standard. |
| ASTM Standard F2083 | Tests were performed according to this standard. |
| ASTM Standard F1223 | Tests were performed according to this standard. |
| Safety and Effectiveness | "Analysis has shown that the proposed device is equivalent to the predicate devices" in terms of safety and effectiveness, and "the minor differences in the proposed device will not impact the safety or effectiveness of the total knee system for its intended use." |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "numerous tests were performed on the Accin™ total knee system" but does not specify the sample size (number of devices or components tested) for these tests.
The data provenance is not explicitly stated in terms of country of origin or whether the study was retrospective or prospective. Given the nature of a 510(k) submission for a physical medical device, the "tests" likely refer to mechanical and material property testing in a laboratory setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable as the submission pertains to a physical medical device (a knee implant) and its mechanical/material performance, not an AI/ML algorithm that requires expert-established ground truth from data for diagnostic or prognostic purposes.
4. Adjudication Method for the Test Set
This question is not applicable for the same reasons as point 3. Testing for medical device equivalence typically involves engineering and materials science analyses, not expert adjudication of clinical cases.
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 as the submission is for a physical medical device, not an AI/ML powered device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the submission is for a physical medical device, not an AI/ML powered device.
7. The Type of Ground Truth Used
The "ground truth" for this medical device comes from established engineering and material science principles, FDA guidance documents, and ASTM standards for testing the mechanical properties, wear resistance, and biocompatibility of total knee arthroplasty devices. The equivalence is established by demonstrating that the new device meets these recognized standards and performs comparably to the predicate devices.
8. The Sample Size for the Training Set
This question is not applicable as the submission is for a physical medical device, not an AI/ML powered device. There is no "training set" in the context of an AI/ML algorithm.
9. How the Ground Truth for the Training Set was Established
This question is not applicable for the same reasons as point 8.
§ 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.