(85 days)
Smith and Nephew Unicondylar Knee Systems are indicated for restoring either compartment of a knee that has been affected by the following:
- Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
- Correction of functional deformity;
- Revision procedures where other treatments or devices have failed; and
- Treatment of fractures that are unmanageable using other techniques
Smith and Nephew Bicompartmental Knee Systems are intended to be used for those patients whereby conditions exist that cannot be solely addressed by a device that treats a single compartment (i.e. unicondylar or patellofemoral prosthesis) of the knee.
Indications include:
- Post-traumatic arthritis;
- Degenerative arthiritis; and
- Failed osteotomies, hemi-arthroplasties; and unicompartmental replacement
These indications will be used for Smith and Nephew Bicompartmental Knee Systems, whereby the medial condyle and patellofemoral regions have been affected by one or more of these conditions.
The Smith and Nephew Patello-Femoral Joint Knee Systems are indicated for replacement of the femoral side of the patello-femoral joint. They are intended to be used in patellofemoral arthoplasty in patients with:
- Degenerative arthritis in the distal femur and patella.
- A history of patellar dislocation or patellar fracture.
- Failed previous surgery (arthroplasty, tibial tubercle elevation, lateral release) where pain, deformity or dysfunction persists.
Subject of this Traditional 510(k) Premarket Notification are manual instruments associated with the Smith & Nephew Unicompartmental and Bicompartmental Knee Systems. The subject devices are accessory devices and are intended to be used to assist in the implantation of the Unicompartmental and Bicompartmental Knee Systems designed and manufactured by Smith & Nephew. The Smith & Nephew Unicompartmental and Bicompartmental Knee System Instruments can be separated into instrument families which are categorized as follows: Trials, Cutting Instruments and Cutting Guides; Cutting Blocks, Alignment Instruments, Impactors and Handles; and Speed Pins and Adaptors.
This document is a 510(k) Premarket Notification for manual instruments associated with Smith & Nephew Unicompartmental and Bicompartmental Knee Systems. It does not contain information about acceptance criteria or a study proving device performance in the way a clinical study would for efficacy.
Instead, this submission focuses on demonstrating "substantial equivalence" of the instruments to predicate devices. Substantial equivalence means the new device is as safe and effective as a legally marketed device (the predicate device) that is not subject to premarket approval (PMA).
Here's why the requested information cannot be fully provided based on the given document:
- Type of Device: These are "accessory devices" - surgical instruments used during a knee replacement surgery. They are not the implants themselves nor are they a diagnostic AI device. Their "performance" is about their ability to facilitate proper implantation, not about diagnostic accuracy or clinical outcomes that would be measured in a traditional study.
- Nature of 510(k) Submission for Instruments: For instruments, the focus is typically on material compatibility, sterility, manufacturing processes, and functional similarity to existing instruments, rather than a clinical effectiveness study with human subjects.
However, I can extract information related to the substantial equivalence argument, which serves as the "study" in this context for demonstrating that the instruments meet their intended purpose.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Note: For surgical instruments, "acceptance criteria" and "device performance" are typically related to their physical properties, functionality, and manufacturing robustness, rather than clinical metrics like sensitivity or specificity. The "performance" here is their ability to be "substantially equivalent" to existing, cleared instruments.
| Acceptance Criteria (Implied) | Reported Device Performance (Summary of Substantial Equivalence Argument) |
|---|---|
| Material Compatibility: Share same raw materials with predicates. | The subject instruments share the same raw materials as predicate instruments. |
| Manufacturing Process: Manufactured through same processes as predicates. | The subject instruments are manufactured through the same processes as predicate instruments. |
| Sterilization Procedures: Utilize same sterilization procedures as predicates. | The subject instruments utilize the same sterilization procedures as predicate instruments. |
| Nature of Body Contact: Have similar nature of body contact as predicates. | The subject instruments have a similar nature of body contact as predicate instruments. |
| Design and Function: Similar in design and function to competing instrumentation. | The subject instruments are similar in design and function to competing unicompartmental and bicompartmental surgical instrumentation currently on the market. |
| Intended Use: Assist in implantation of Unicompartmental and Bicompartmental Knee Systems, aligning with indications of predicate implants. | The subject instruments are intended to be used to assist in the implantation of Smith & Nephew Unicompartmental and Bicompartmental Knee Systems, with established Indications for Use for the knee systems themselves. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of this device and submission type. This is a comparison of instrument features and manufacturing, not a clinical trial on a patient cohort.
- Data Provenance: Not applicable. The "data" consists of design specifications, material compositions, manufacturing processes, and functional descriptions of the subject and predicate instruments. It's a technical comparison, not based on patient data from a specific country or retrospective/prospective collection.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. "Ground truth" in the sense of clinical diagnosis or outcome is not established for surgical instruments in this type of submission. The "truth" is established by engineering and manufacturing standards and comparison to existing, cleared devices.
- Qualifications of Experts: The review is conducted by the FDA, specifically the Division of Surgical, Orthopedic and Restorative Devices, Office of Device Evaluation. Their experts (e.g., engineers, scientists, medical officers) assess the technical and regulatory aspects of the submission. The submission itself is prepared by regulatory affairs and engineering teams at Smith & Nephew, Inc.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no "test set" requiring adjudication in a clinical or diagnostic sense. The FDA's review process itself involves a regulatory assessment against the predicate devices and applicable regulations.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is for evaluating diagnostic performance or the impact of a device on human interpretation (e.g., radiologists reading images). The devices in question are surgical instruments.
- Effect Size of AI Improvement: Not applicable, as there is no AI component mentioned in the context of these surgical instruments.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. These are physical surgical instruments; they do not have an "algorithm-only" or "human-in-the-loop" performance in the way a software algorithm would.
7. The Type of Ground Truth Used
- Type of Ground Truth: For the "study" (i.e., the substantial equivalence argument), the "ground truth" is the established safety and effectiveness of the legally marketed predicate devices, as determined by FDA clearance. The submission aims to demonstrate that the new instruments are functionally identical or very similar to these cleared predicates in terms of their physical and functional attributes.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. There is no "training set" in the context of mechanical surgical instruments and a 510(k) substantial equivalence submission. This concept applies to machine learning algorithms.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set Establishment: Not applicable, for the same reason as point 8.
§ 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.