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The ACHIEVE PARTIAL KNEE SYSTEM is 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, including prior unicompartmental knee arthroplasty.
• · As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis.

The ACHIEVE™ PARTIAL KNEE SYSTEM is a knee joint femorotibial (unicompartmental) prosthesis that is intended for cementless or cemented fixation.
The implant system consists of individually packaged implants: a metal tibial tray (titanium alloy), a polyethylene tibial insert, and a metal femoral component (titanium alloy or cobalt-chromium). All tibial inserts are composed of a Cross-linked, Vitamin E Ultra High Molecular Weight Polyethylene (Cross-Linked, VE UHMWPE).

This document does not contain information about the acceptance criteria and study detailed in the request. The document is a 510(k) premarket notification for a medical device (ACHIEVE™ Partial Knee System) and focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It explicitly states that clinical testing was not necessary to demonstrate substantial equivalence.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes for test or training sets, data provenance, expert qualifications, ground truth, or MRMC studies, as these aspects are typically associated with clinical trials or performance studies involving AI/software devices.

The document describes engineering tests and analyses performed on the physical components of the knee system. For instance:

• Range of Motion (RoM) Evaluation: Acceptance criteria met per ASTM F2083.
• Femoral Fatigue Testing: Acceptance criteria met per modified ASTM F3210 (10 Mc).
• Tibial Tray Fatigue Testing: Acceptance criteria met per modified ASTM F3140 (10 Mc).
• Component Interlock Strength Testing: Acceptance criteria met for static AP and ML shear testing and static tensile pull-off testing.
• Wear Resistance Evaluation: Wear rate does not represent a new worst-case compared to the predicate device per ISO 14243-3.
• Biocompatibility Assessments: Devices found to be biocompatible per ISO 10993-1 and FDA Guidance.
• Porous Structure Characterization: Meets recommendations of Class II Special Controls Guidance Document per ASTM F1044, ASTM F1147, ASTM F1160, ASTM F1978, and ASTM F1854.
• Shelf-Life Evaluation: Five-year shelf life established per ISO 11607-1 and ISO 11607-2.
• Sterilization Validation: Sterility Assurance Level (SAL) of 10-6 found per ISO 11137-1 and ISO 11137-2.

However, these are all engineering benchmarks for the physical orthopedic implant, not performance metrics for a diagnostic AI/software device.

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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 implants are single-use devices.

The RESTORIS® Porous Partial Knee System is a knee joint femorotibial (unicompartmental) prosthesis. The RESTORIS® Porous Partial Knee System consists of femoral components and tibial baseplate components that are compatible with and intended for use with MAKO's predicate RESTORIS MCK Tibial Onlay Insert Components (K090763 or K133039).

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 implants are single-use devices.

The Porous Femur components: sizes 1 through 8, CoCr with a CoCr porous coating for cementless fixation, asymmetric design (meaning that left medial implants can be used on the right lateral compartment and right medial implants can be used on the left lateral compartment; abbreviated hereafter as LM/RL and RM/LL)

PST® Tibial Baseplate components: sizes 1 through 8. Ti6Al4V allov with MAKO's predicate porous surface (porous structured technology, referred to as "PST®"), asymmetric (LM/RL-RM/LL).

The provided document is a 510(k) premarket notification for a medical device, the RESTORIS® Porous Partial Knee System. It focuses on demonstrating substantial equivalence to a predicate device based on manufacturing materials, design, technological characteristics, and performance data.

However, this document does not contain the information requested regarding acceptance criteria and the study proving a device meets them in the context of AI/ML performance. The device described is a physical knee implant, not an AI-powered diagnostic or therapeutic tool.

Therefore, I cannot extract the following information from this document:

1. A table of acceptance criteria and the reported device performance: This document reports on non-clinical performance testing for a physical implant (e.g., snaplock strength, micromotion, wear), not AI model metrics like sensitivity, specificity, or AUC.
2. Sample size used for the test set and the data provenance: Not applicable to this type of device submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is a physical implant, not an AI-assisted diagnostic.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to physical implant performance testing in this context.
8. The sample size for the training set: Not applicable (no AI model).
9. How the ground truth for the training set was established: Not applicable (no AI model).

The "Performance Data" section lists non-clinical performance testing related to the physical characteristics and function of the knee implant, such as:

• Insert Snaplock Strength
• Tibial Insert / Baseplate Micromotion
• Tibio-Femoral Range of Motion
• Tibio-Femoral Instability
• Tibio-Femoral Contact Area and Stress
• Tibial Insert Fatigue
• Tibial Insert Wear

The conclusion states that "The results of performance testing indicated the device performed within the intended use and did not raise any new safety and efficacy issues. The device was found to be substantially equivalent to the predicate devices." This is the general "acceptance" for a 510(k) submission for this type of device, demonstrating it functions as intended and is as safe and effective as a legally marketed predicate. However, detailed, quantitative acceptance criteria for each test (e.g., "snaplock strength > X N") are not provided in this summary, nor are the specific results for each test.

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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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Indications for use of the proposed devices will not change from the indications for use as described in their respective predicate device 510(k)s; only a change in packaging is being proposed.

All standard UHMWPE components of the following legacy Centerpulse trade names: Apollo® Knee System, APR® Hip System, Bipolar Prosthesis, Epsilon™ Acetabular System, MOST® System, Natural-Knee® System, Natural-Knee® II System. The packaging for the legacy Centerpulse standard UHMWPE devices will be changed from the current packaging to the packaging used for legacy Zimmer, Inc. UHMWPE device in order to standardize packaging within Zimmer, Inc.

This document describes an "Oxygenless Packaging Conversion of Legacy Centerpulse Standard Polyethylene Devices" for various joint replacement systems. The study focuses on comparing a new packaging configuration to existing ones rather than the performance of the medical device itself. As such, many of the typical acceptance criteria and study data points for a traditional medical device (e.g., accuracy, sensitivity, specificity, clinical outcomes, multi-reader studies) are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not explicitly state the numerical sample size. It refers to "samples" being tested.
• Data Provenance: The study was non-clinical performance testing. The origin of the data (country) is not specified, but the submitter is Zimmer, Inc., P.O. Box 708, Warsaw, IN 46581-0708, USA, implying the testing likely occurred within the USA or was overseen by a US-based entity. The study is retrospective in the sense that it compares existing packaging configurations (legacy Zimmer and legacy Centerpulse) and their performance after "long-term shelf-life aging."

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

This information is not applicable. The study is a non-clinical performance test of packaging, not a clinical study requiring expert interpretation of medical data or ground truth establishment in a clinical context. The "ground truth" here is the objective measurement of residual oxygen and surface oxidation.

4. Adjudication Method for the Test Set

This information is not applicable. There was no need for adjudication as the study involved objective measurements of chemical properties (residual oxygen, surface oxidation) rather than subjective interpretations.

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

This information is not applicable. An MRMC study is relevant for evaluating the impact of AI on human reader performance in interpreting medical images or data. This submission focuses on the performance of device packaging, not AI.

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

This information is not applicable. This is not an AI or algorithm-based device. The study evaluates the performance of physical packaging.

7. Type of Ground Truth Used

The "ground truth" for this non-clinical study was based on objective measurements of:

• Residual oxygen levels within the package.
• Surface oxidation index on the Ultra High Molecular Weight Polyethylene (UHMWPE) components after long-term shelf-life aging.

8. Sample Size for the Training Set

This information is not applicable. This is a non-clinical performance study of packaging, not a machine learning or AI-based device that would require training data.

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

This information is not applicable as there is no training set for this type of non-clinical packaging study.

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The Natural-Knee II Unicompartmental Knee is intended for use in:

• Unicompartmental noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis and arthritis secondary to a variety of diseases and anomalies;
• Passively correctable valgus-varus deformity and moderate flexion contracture;
• Those patients with failed previous surgery where pain, deformity or dysfunction persists.

The N-K II Unicompartmental All-Poly Tibia is intended to be used only with bone cement. The modular metal/polymer N-K II Unicompartmental Tibia and Femur are intended for use with or without bone cement.

The Natural-Knee II Unicompartmental Knee System is a conservative, cost-effective alternative to total knee replacement for patients with osteoarthritis primarily confined to one compartment. The N-K II Unicompartmental Knee System is intended for resurfacing of one side of the knee joint.

The N-K II Unicompartmental Modular Metal-backed Tibia is similar to the previously cleared N-K II Unicompartmental Tibia (K955778). The wrought titanium alloy tibial baseplate is a symmetrically designed component, eliminating the need for left/right orientations. The baseplate features three smooth pegs on the underside which aid in positioning and rotational stability. A smooth surface finish is provided on the inner surface of the tibial tray to minimize the potential for polyethylene wear. A screw hole is placed in the center of the baseplate for optional screw fixation. The baseplate is available in either a porous or non-porous version.

The all-poly tibia is designed with a single keel to position the component on the tibia and increase stability. Cement grooves on both the medial and lateral side of the keel increase the anchoring effect of the keel, while a dovetail cement channel around the perimeter of the distal surface, along with a T-pattern dovetail cement channel, act to resist movement in all directions. It is to be used only with bone cement for application directly onto the patient's resected proximal tibia.

The metal-backed and the all-poly tibias are both available in 6 sizes (1-6). The modular metal-backed tibia will be offered in 3 thicknesses (9, 11, and 13 mm). The insert thickness reflects the total amount of bone to be resected. The all-poly insert will be available in 4 thicknesses (7, 9, 11, and 13mm), in which the thickness is measured at the thinnest point from the distal to the proximal surface of the component.

The design of the femoral component of the proposed N-K II Unicompartmental Knee System will not change. This premarket notification only seeks to obtain clearance for the addition of cementless use of the previously cleared porous-coated femur (K955778).

The provided text is a 510(k) summary for a medical device (Natural-Knee® II Unicompartmental Knee System). It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria or a study proving that the device meets such criteria.

The 510(k) summary focuses on demonstrating "substantial equivalence" to already cleared predicate devices based on design features, indications for use, materials, and labeling. It does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes for a test set or data provenance for performance evaluation.
• Information about experts for ground truth establishment.
• Adjudication methods.
• A multi-reader multi-case (MRMC) comparative effectiveness study.
• A standalone algorithm performance study.
• Details about the type of ground truth used for performance evaluation.
• Sample size for a training set or how ground truth was established for training.

Therefore, I cannot fulfill your request for this specific information based on the provided text. The document's purpose is to establish substantial equivalence for regulatory clearance, not to report on specific performance criteria derived from clinical or technical studies that would typically be associated with AI/software-as-a-medical-device performance claims.

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