(206 days)
Smith & Nephew Disposable Knee Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew, Inc. Genesis II and Legions total knee systems and their cleared indications for use for Total Knee Replacement.
Subject of this Traditional 510(k) Premarket Notification are the Smith & Nephew, Inc. Disposable Knee Instruments. The subject devices are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew, Inc. Genesis II and Legions total knee systems and their cleared indications for use for Total Knee Replacement.
This document is a 510(k) premarket notification for "Disposable Knee Instruments" by Smith & Nephew, Inc. It seeks to demonstrate substantial equivalence to previously cleared predicate devices.
This submission does not contain information about acceptance criteria or a study proving that the device meets such criteria in terms of performance metrics like sensitivity, specificity, accuracy, or other quantitative measures. This is typical for submissions of this nature, especially for surgical instruments, where equivalence is primarily established through design, material, and intended use comparison rather than a clinical performance study with statistical endpoints.
Here's a breakdown of the requested information based on the provided document, with notes where information is not applicable or present:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | Demonstrated through ISO 10993 testing or use of previously cleared predicate raw materials. |
| Dimensions | Similar or equivalent to predicate devices. |
| Surgical Procedures | Share identical surgical procedures with predicate devices. |
| Sterilization Procedures | Utilize the same sterilization procedures as predicate devices. |
| Nature of Body Contact | Similar to predicate devices. |
| Intended Use | To assist in the implantation of Smith & Nephew, Inc. Genesis II and Legions total knee systems, as per their cleared indications for use for Total Knee Replacement. This matches the predicate devices' intended use. |
Explanation: The acceptance criteria for this device are established by demonstrating substantial equivalence to predicate devices across several key attributes. The "reported device performance" refers to the claim of similarity or identity to the predicate devices for these attributes. There are no quantitative performance metrics (e.g., accuracy, precision) stated that typically define acceptance criteria for diagnostic devices or more active therapeutic devices.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. This submission is for surgical instruments, and substantial equivalence is demonstrated through design and functional comparison, not through a "test set" of patient data or clinical outcomes.
- Data Provenance: Not applicable. No clinical data or patient data is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There is no "test set" of medical cases requiring expert ground truth establishment.
4. Adjudication method for the test set
- Not applicable. There is no "test set" requiring adjudication.
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
- Not applicable. This device is a set of disposable surgical instruments, not an AI or imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a set of disposable surgical instruments, not an algorithm.
7. The type of ground truth used
- Not applicable. No ground truth in the context of clinical outcomes or diagnostic accuracy is used. The "ground truth" for this submission is established through engineering and material standards (e.g., ISO 10993 for biocompatibility) and comparison to existing, cleared devices.
8. The sample size for the training set
- Not applicable. This device is a set of disposable surgical instruments, not a machine learning model.
9. How the ground truth for the training set was established
- Not applicable. This device is a set of disposable surgical instruments, not a machine learning model.
§ 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.