(66 days)
The Revision Knee System Components are indicated for rheumatoid arthritis; post-traumatic arthritis; osteoarthritis; degenerative arthritis; and failed osteotomies, unicompartmental replacement; or total knee arthroplasties. The components are designed for use in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are absent or incompetent. The Revision Knee Components are for single use only and are intended for implantation with bone cement.
These indications are the same as currently used for the Genesis II Constrained Knee System and Revision Knee System cleared via K962137 and K041106.
The Smith & Nephew Revision Knee System contains femoral knee components, tibial components, angled and offset couplers, stem attachments and wedges. The designs of these devices are based upon existing components of the Genesis II Total Knee System and Revision System, previously cleared for market under K951987, K953274, K962137, and K041106.
This is a 510(k) premarket notification for a medical device, specifically the SMITH & NEPHEW REVISION KNEE SYSTEM. These types of submissions typically demonstrate "substantial equivalence" to a predicate device rather than presenting a detailed study proving the device meets specific performance acceptance criteria through clinical trials and statistical analysis.
Therefore, the provided document does not contain the information requested in your prompt regarding acceptance criteria, device performance tables, sample sizes for test sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, type of ground truth, training set sample size, or how ground truth for the training set was established.
Here's why and what information is present:
- Substantial Equivalence: The core of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This means it has the same intended use and the same technological characteristics as the predicate device, or, if it has different technological characteristics, that the differences do not raise different questions of safety and effectiveness.
- Focus of this Document: The document describes the device's intended use, its components, and lists predicate devices to which it claims substantial equivalence. It also lists general safety and effectiveness characteristics.
- No Clinical Study Details: It does not mention any clinical study conducted to establish performance metrics against acceptance criteria. The focus is on comparing the new device to existing, already cleared devices.
Summary of available information related to your prompt, and why other requested information is not present:
- A table of acceptance criteria and the reported device performance: This is not present. The document doesn't define specific numerical acceptance criteria for performance; rather, it asserts similarity to predicate devices.
- Sample size used for the test set and the data provenance: This is not present. There's no mention of a "test set" in the context of clinical or performance data for this submission. The submission relies on the established safety and efficacy of predicate devices.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not present. No such "ground truth" establishment is described for a performance study.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: This is not present. No adjudication method for a test set is mentioned.
- 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 is not present. This device is a knee implant, not an AI-assisted diagnostic tool. MRMC studies are irrelevant to this submission.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is not present. This device is a physical implant, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): This is not present, as no specific performance study with ground truth data is detailed.
- The sample size for the training set: This is not present. This is not an AI/algorithm-based device that would require training data.
- How the ground truth for the training set was established: This is not present.
In conclusion, the provided 510(k) summary is a regulatory document focused on proving "substantial equivalence" of a medical device (a knee implant) to already approved predicate devices, rather than a clinical study report detailing performance against specific acceptance criteria.
§ 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.