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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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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 intented 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 Engage™ Partial Knee System is a unicompartmental knee system comprised of tibial trays, tibial inserts, tibial anchors, and femoral components. The implant geometry is optimized for the medial compartment. The Engage™ Partial Knee System permits all sizes of femur to be interchangeable with all sizes of tibial trays and associated tibial insert combinations. The tibial anchor are composed of Ti-6AI-4V alloy, the tibial insert is composed of UHMWPE, and the femoral component is composed of CoCrMo alloy. The tibial tray includes pegs and an engineered porous surface, while the femoral component includes pegs and a sintered porous coating; both of which are intended for biological fixation when used without bone cement and to enhance fixation when used with PMMA bone cement. The Engage™ Partial Knee System is intended for cemented or uncemented replacement of the medial compartment of the knee. The tibial anchors provide for supplemental fixation of the tibial tray when implanted without bone cement. The tibial anchor is not used when the tibial tray is implanted with bone cement.

Based on the provided text, the document is a 510(k) Premarket Notification for a medical device called "The Engage™ Partial Knee System." This document primarily focuses on demonstrating the substantial equivalence of this knee implant system to previously cleared predicate devices.

It does NOT describe an AI/ML-driven device or study that proves an AI device meets acceptance criteria.

Therefore, I cannot extract the requested information regarding acceptance criteria for an AI device, sample sizes for a test set, ground truth establishment by experts, MRMC studies, or training sets. The document details performance testing for a physical orthopedic implant device, not an AI algorithm.

The "Performance Data" section (F. PERFORMANCE DATA) lists pre-clinical performance testing conducted for the physical knee system, adhering to FDA guidance and ASTM/ISO standards. These tests are about the mechanical, biological, and material properties of the implant itself, such as:

• Tibial baseplate fatigue strength
• Range of Motion (ROM), contact pressure, and area of tibiofemoral articulation of UHMWPE inserts
• Constraint testing
• Resistance to dislodgement of the tibial insert
• Biomechanical evaluation under cyclic loading
• Evaluation of porous fixation surfaces
• Validation of additive manufacturing process
• Validation of packaging and shelf life
• Bacterial endotoxins test
• Validation of reusable instrument reprocessing parameters

These are tests for a physical medical device, not an AI/ML algorithm.

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The Restoris® Porous Partial Knee System components are intended for 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, either involving, or not involving, previous use of a unicompartmental knee prosthesis.
• . As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis.

The Restoris® Porous Femoral Component and PST Tibial Baseplate are intended for cementless or cemented fixation. The Tibial Baseplate may be used in conjunction with ancillary screw fixation. The porous surfaces of both the femoral and tibial tray components provide biological fixation when used in a cementless application.

The Restoris® Porous Partial Knee System is a unicompartmental knee system that includes porous coated, cast CoCr, asymmetric femoral components in sizes 1 – 8; and Ti6Al4V, asymmetric, porous tibial baseplate components in sizes 1 - 8. The subject femoral and tibial baseplate components are compatible and are intended for use with predicate MAKO Restoris MCK Tibial Onlay Inserts in standard UHMWPE or highly crosslinked vitamin E UHMWPE (K090763, K133039). The sagittal articular surface of the femoral condyle has an extended posterior radius that accommodates flexion up to 155%.

The provided text is a 510(k) summary for the Restoris® Porous Partial Knee System, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting a de novo study to establish new performance criteria. Therefore, the information you're requesting regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI device evaluation metrics (like sensitivity, specificity, etc.) is not present in this document.

This document describes a traditional medical device (a knee implant), not an AI/ML diagnostic or predictive device. The "performance testing" mentioned refers to mechanical and material testing to ensure structural integrity and functional similarity to existing devices.

However, I can extract information related to the device's performance testing and how it relates to demonstrating substantial equivalence, which is the regulatory standard for this type of device.

Here's a breakdown of what is available in the document, framed as closely as possible to your request, but acknowledging the difference in device type:

1. Table of Acceptance Criteria and Reported Device Performance:

For a traditional medical device like a knee implant, "acceptance criteria" are not reported as statistical metrics like sensitivity or specificity. Instead, the "acceptance criteria" are implied by demonstrating that the device performs equivalently or acceptably in terms of mechanical strength, material compatibility, and design features compared to predicate devices. The "reported device performance" refers to the results of these engineering tests.

Explanation of "Acceptance Criteria" for this device: The primary "acceptance criterion" for a 510(k) submission is Substantial Equivalence (SE) to a legally marketed predicate device. This means the new device must have the same intended use and the same technological characteristics as the predicate, or, if it has different technological characteristics, these differences must not raise new questions of safety and effectiveness, and the device must be as safe and effective as the predicate. The performance testing outlined above is designed to demonstrate this substantial equivalence, primarily through mechanical testing and material characterization.

The following points are typically relevant for AI/ML device evaluations and are not applicable to this 510(k) summary for a traditional knee implant. I will explicitly state "Not Applicable" where the information is not provided because it pertains to a different type of device or study.

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

• Not Applicable. This document does not describe a clinical study with a "test set" in the context of AI/ML data. The "testing" refers to benchtop mechanical and material characterization. "Data provenance" such as country of origin or retrospective/prospective is not relevant for this type of engineering performance testing.

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):

• Not Applicable. There is no "ground truth" establishment by medical experts for a "test set" described in this submission. The "truth" for engineering tests is based on established standards, mechanical properties, and comparison to predicate device performance.

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

• Not Applicable. No expert adjudication method is described.

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 is not an AI-assisted device. No MRMC study was conducted.

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

• Not Applicable. This is a physical orthopedic implant, not an algorithm.

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

• Not Applicable. "Ground truth" in the AI/ML sense is not relevant here. The "truth" for the engineering performance tests is adherence to engineering standards and demonstration of comparable mechanical performance to predicate devices.

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML device, so there is no training set.

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

• Not Applicable. No training set is involved.

In summary: The provided document is a regulatory submission (510(k)) for a traditional medical device (a knee implant), focusing on demonstrating substantial equivalence to already marketed devices. It details engineering performance testing (fatigue, material characterization) to ensure the device's physical and mechanical properties are comparable to its predicates, thereby establishing its safety and effectiveness. The questions you've posed are highly specific to the evaluation of AI/ML medical devices, which operate under a different set of performance and validation criteria.

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