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Unicompartmental knee implants 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; and · Partial revisions to replace the tibial insert of the previously implanted JOURNEY II UK knee in the femoral and tibial components are well-fixed.

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

The JOURNEY II Unicompartmental Knee System includes femoral components, tibial inserts that restore either compartment of the knee (K190085, K230653). JOURNEY II UK provides joint replacement on a single condylar compartment, meaning that only one condyle will be replaced instead of the entire femoral component replaces the damaged condylar component of the femur. The tibial baseplate replaced the damaged part of the tibial insert is the articulating surface which allows the knee to bend and flex smoothly and is placed above the tibial baseplate.

The Smith & Nephew JOURNEY II Unicompartmental Knee System consists of OXINUM femoral components, titanium tibial baseplates, and cross-linked polyethylene (XLPE) tibial inserts.

The provided text is a 510(k) summary for the JOURNEY II Unicompartmental Knee System. It focuses on labeling updates and explicitly states that there are no changes to the design features, materials, or manufacturing methods of the device.

Therefore, the document does not contain any information regarding acceptance criteria or a study that proves the device meets acceptance criteria for performance in the typical sense of a new or significantly modified medical device that would require such studies. It explicitly states:

"Therefore, since there are no changes to the design features, materials, or manufacturing methods of the subject I I Unicompartmental Knee System devices, no performance testing (bench, animal, clinical) was required." and "Not Applicable." and "No modifications are being introduced to the subject devices as a result of this filing."

Hence, I cannot provide the requested information from this document. The submission is a request for clearance for labeling updates only, not for a new or modified device requiring new performance studies.

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

• · Non-inflammatory degenerative joint 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 are intended for implantation only with bone cement

The subject of this traditional 510(k) is to add the MR safety information to the Journey II Unicompartmental Knee System (Journey II UK) labeling. The Journey II UK was cleared under K190085.

Journey II UK system consist of a femoral implant, tibia baseplate, modular articular insert, and requisite US Class II surgical instruments.

The package insert and label of Journey II UK is being updated to add MR conditional information.

The indication for use of Journey II UK system was updated to clarify the definition of the revision cases. This change does not change the indication for use.

The provided text describes a 510(k) premarket notification for the Smith & Nephew JOURNEY II Unicompartmental Knee System. This submission is primarily to add MR safety information to the labeling and clarify the definition of revision cases for an already cleared device (K190085).

Therefore, the "device" in question for this specific submission is essentially the MR safety information for the JOURNEY II Unicompartmental Knee System, not a new or modified implant design. The performance data presented pertains to the MR compatibility of the existing implant.

Here's the breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in a quantitative format for the MR safety tests. Instead, it states that testing was conducted "as per the FDA's guidance 'Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment', December 11, 2014 and the standards listed below." The implicit acceptance criterion is that the device demonstrates MR compatibility according to these standards, allowing it to be labeled as MR Conditional.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document relates to testing of the implant's physical properties for MR compatibility, not a clinical study on patients. Therefore, the "sample size for the test set" would refer to the number of implant components tested. This information is not provided in the document. The data provenance would be laboratory testing, not patient data, and thus country of origin or retrospective/prospective does not apply in this context.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable. The "ground truth" for MR compatibility testing is established by adherence to recognized ASTM standards and FDA guidance, performed by engineers or technicians experienced in medical device testing. It does not involve expert clinical assessment or interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as this is laboratory testing against standards, not a clinical assessment requiring adjudication of diagnostic findings.

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 document does not describe a comparative effectiveness study, MRMC study, or AI-assisted diagnostic device. It pertains to the MR compatibility of a knee implant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithmic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the performance data (MR compatibility) is defined by the ASTM test standards (ASTM F2052, ASTM F2213, ASTM F2182, ASTM F2119) and FDA guidance ("Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment"). These standards provide the methodology and criteria for evaluating the physical interactions of an implant with an MR environment.

8. The sample size for the training set

Not applicable. This is not a study involving a training set for an AI/machine learning model.

9. How the ground truth for the training set was established

Not applicable.

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