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Indications for JOURNEY II Unicompartmental Knee System:

Unicompartmental knee implants are indicated for restoring either compartment of a knee that has been affected by the following:

• Non-inflammatory degenerative ioint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;

• Correction of functional deformity:

• Revision of previous arthroplasty procedures:

• Treatment of fractures that are unmanageable using other techniques.

Unicompartmental knee implants are single-use only and intended for implantation only with bone cement.

Indications for ENGAGE™ Partial Knee System:

The ENGAGE™ Partial Knee System is intended for medial unicompartmental knee arthroplasty to treat one or more of the following conditions:

• Moderately disabling joint disease of the knee resulting from painful osteo- or post-traumatic arthritis.

• Revision of previous unsuccessful surgical procedures including prior unicompartmental knee arthroplasty

• As an alternative to tibial osteotomy in patients with Unicompartmental osteoarthritis.

The femoral component and tibial tray are intended for cemented fixation. The porous surfaces of both the femoral and tibial tray components provide biological fixation when used in a cementless application. When the tibial tray is implanted without the use of bone cement, the tibial anchor should be used. When the tibial tray is implanted with bone cement, the tibial anchor should not be used.

The purpose of this Traditional 510(k) submission is to seek FDA clearance of the existing devices ENGAGE™ Partial Knee System and JOURNEY II Unicompartmental Knee System components to be used in various combinations to create a hybrid unicompartmental knee system.

No new or modified knee implant components or new device-specific instruments are being introduced as a result of this filing where, ENGAGE™ Partial Knee System used with JOURNEY II Unicompartmental Knee System, are both FDA 510(k) cleared as follows: K190439 (S.E. 11/21/2019) - ENGAGE™ Partial Knee System; K191211 (S.E. 07/25/2019) and K190085 (S.E. 02/11/2019) - JOURNEY II Unicompartmental Knee System.

Together with the existing Smith+Nephew knee implants, these devices will be marketed under the trade name JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee System. Only the use of the respective unicompartmental knee femoral/tibial devices in a hybrid device combination is changing. As a result of the acquisition of ENGAGE Surgical, ENGAGE product line in the US. Smith+Nephew now has responsibility for the ENGAGE™ Partial Knee System and has been listed as the specification developer and the complaint file establishment. The JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee System is an implant system intended for unicompartmental knee arthroplasty. The subject device is a unicondylar femoral and tibial implant set in a hybrid system that incorporates JOURNEY II Unicompartmental Knee System with ENGAGE components, where the JOURNEY II Unicompartmental Knee System components are cemented and the ENGAGE components are cementless. To better fit the patient, the system consists of various sizes for the femoral and tibial components.

The provided text describes the submission of a medical device (JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee System) for FDA clearance. It states that "Clinical data was not needed to support the safety and effectiveness of the subject device" and "No new or modified unicompartmental knee implant components or device specific instruments are being introduced as a result of this filling." Instead, the submission relies on the substantial equivalence to previously cleared predicate devices.

Therefore, the document does not present a study with acceptance criteria and device performance results as typically seen with new device submissions. The "study" here is essentially a demonstration of substantial equivalence to existing devices.

However, I can extract the information based on the statement provided in the text that "Additional mechanical testing (Contact Area Analysis) was conducted on the subject device to support the use of the components in combination." This indicates that some non-clinical testing was performed.

Here's the breakdown of the information based on the provided text, acknowledging the limitations due to the nature of the submission (substantial equivalence rather than a de novo clinical study):

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria or reported device performance from a new clinical study. The assessment is based on the components being identical to previously cleared devices.

However, it mentions "Additional mechanical testing (Contact Area Analysis) was conducted on the subject device to support the use of the components in combination." While specific numerical criteria and results for this "Contact Area Analysis" are not provided, the conclusion is that "Based on the testing, there are no new issues related to the safety and effectiveness of the subject device." This implicitly means the results met the required performance for safety and effectiveness when used in combination, consistent with the predicates.

2. Sample Size Used for the Test Set and Data Provenance

Since no clinical study was conducted, there are no human test subjects or data provenance in the traditional sense. The "test set" for the "Contact Area Analysis" would refer to mechanical samples of the device components. The sample size for this mechanical testing is not specified in the document. The data provenance would be from laboratory testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable. This was mechanical testing, not a clinical study requiring expert ground truth for interpretation of patient data.

4. Adjudication Method for the Test Set

Not applicable, as this was mechanical testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC or comparative effectiveness study was conducted, as no clinical data was required or submitted.

6. Standalone (Algorithm Only Without Human-in-the Loop Performance) Study

Not applicable, as this is a physical medical implant device, not an algorithm or AI system.

7. Type of Ground Truth Used

For the "Contact Area Analysis," the "ground truth" would be the engineering specifications and performance benchmarks derived from regulatory standards and the performance of the predicate devices.

8. Sample Size for the Training Set

Not applicable, as this is a physical device and not an AI/ML model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as this is a physical device and not an AI/ML model.

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