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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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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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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 procedures where other treatments or devices have failed; and
• · 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 Special 510(k) is the Journey II Unicompartmental Knee System (Journey II UK). The subject device is a unicondylar femoral and tibial implant set for treatment of unicompartmental osteoarthritis. The device is intended for appropriate unicondylar, medial or lateral, ACL and PCL preserving joint treatment (partial knee replacement).

Components of this premarket notification consist of a femoral implant, tibia baseplate, modular articular insert, and requisite US Class II surgical instrumentation required will consist of femoral instruments used to make appropriate resections to prepare the femur for said implants and tibial instruments used to make a planar resection and implant preparation of the proximal tibia.

The Journey II UK is a line extension of the Smith & Nephew Unicompartmental Knee line, incorporating previously cleared Smith & Nephew products. It contains design aspects of the existing Journey II Uni Tibial Baseplate and Inserts (S.E. K152315), the Journey Uni (S.E. K102069), and the ZUK (S.E. K160738).

Femoral components are manufactured from Oxinium (Zr-2.5Nb), and feature ten sizes each in left medial/right lateral and right medial/left lateral side (hand) configurations.

Tibial baseplates are manufactured from Titanium alloy (Ti-6Al-4V). They are available in:

• . Ten sizes of implant with a medial primary / lateral secondary use offered in both left and right handedness (listed henceforth as "medial primary"), and
• . Eight sizes of implant with a lateral primary / medial secondary use offered in both left and right handedness (listed henceforth as "lateral primary").

Each are expected to be used in its primarily listed compartment most often, but are designed for use in either medial or lateral compartments.

Modular articular implants are manufactured from cross-linked polyethylene (XLPE) and are available in medial and lateral configurations for use with corresponding baseplate. They are symmetric for use in either right or left hand.

The provided text is a 510(k) summary for the Journey II Unicompartmental Knee System. This document is a premarket notification for a medical device and does not describe acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device. Instead, it details mechanical verification testing for an orthopedic implant.

Therefore, I cannot fulfill the request for information regarding acceptance criteria and a study from this document, as it pertains to a different type of medical device and regulatory submission.

Specifically, the document states: "Clinical data was not needed to support the safety and effectiveness of the subject device." This indicates that no human clinical study, which would typically involve performance metrics and acceptance criteria as outlined in your request, was conducted. The device's safety and effectiveness were established through mechanical testing and comparison to predicate devices, not through a study involving human subjects or AI performance.

To reiterate, the requested information elements (acceptance criteria table, sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set sample size, ground truth for training set) are not applicable to the content of this 510(k) summary for a knee implant.

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