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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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The Kyocera TRIBRID® Unicompartmental Knee System is indicated for use in patients with the following:

• Painful and disabled knee joint resulting from osteoarthritis, or idiopathic osteonecrosis, of . either the medial or lateral compartments.
• Correction of varus, valgus, or posttraumatic deformity. .
• As an alternative to tibial osteotomy in patients with unicompartmental NIDJD disease. .
• Revision procedures where other treatments or devices have failed. ●
  This device is intended for cemented use only.

KMTI's TRIBRID® Unicompartmental Knee System is a partial knee replacement prostheses intended for application with bone cement. Partial knee replacement components include femoral and tibial components. Femoral baseplates are CoCrMo Alloy while the Tibial implants are Ti6Al4V Alloy. The Tibial bearing inserts are made from Ultra-High Molecular Weight Polyethylene (UHMWPE) variations. Components are available in a variety of designs and size ranges intended for both primary and revision applications.

This document is a 510(k) summary for the Kyocera TRIBRID® Unicompartmental Knee System, a medical device. It focuses on mechanical, non-clinical performance data rather than AI/software performance. Therefore, many of the requested criteria related to AI device performance are not applicable.

Here's an analysis based on the provided document:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on demonstrating that its mechanical performance is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices. The document does not provide specific quantitative pass/fail values as acceptance criteria; rather, it lists the types of tests performed and concludes that the results support substantial equivalence.

Table of Acceptance Criteria and Reported Device Performance:

Study Details (based on the provided document)

Since the document describes a mechanical device and its non-clinical performance testing rather than an AI/software device, many of the typical questions for AI acceptance criteria and studies (e.g., sample size for test set, data provenance, number of experts, MRMC studies, standalone performance) are not applicable.

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated in this summary. Mechanical tests typically use a small number of samples (e.g., 3-6 or more, depending on the standard) to demonstrate compliance with a standard or to compare to predicate devices.
   • Data Provenance: Not applicable. This is in vitro mechanical testing, not human data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. Ground truth for mechanical testing is established by engineering specifications, material properties, and industry standards (e.g., ASTM, ISO), not by expert consensus on clinical data.

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

   • Not applicable. This is for mechanical testing, not interpretation of clinical imagery or data by experts. Test results are typically compared directly to standard requirements or predicate device performance.

4. 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 a knee implant, not an AI-powered diagnostic or assistive tool.

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

   • Not applicable. This is a physical medical device, not an algorithm.

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

   • Mechanical Testing Standards: The "ground truth" for this type of device is compliance with industrial standards (e.g., ASTM, ISO) for mechanical properties, durability, and wear, and demonstrating substantial equivalence to predicate devices that have established safety and effectiveness through their historical use.

7. The sample size for the training set:

   • Not applicable. This is non-clinical mechanical testing, not a machine learning model.

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

   • Not applicable. As above, this is mechanical engineering testing.

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1. Rheumatoid arthritis.
2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
3. Failed osteotomies, unicompartmental replacement, or total knee replacement.
4. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
   The ANTHEM PS Total Knee System is indicated for use only with cement and is a single use device.

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

1. Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;

2. Correction of functional deformity;

3. Revision procedures where other treatments or devices have failed: and

4. 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. HA coated unicompartmental knee implants are available outside the US for use without bone cement.

5. Rheumatoid arthritis.

6. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.

7. Failed osteotomies, unicompartmental replacement, or total knee replacement.

8. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
   Smith & Nephew, Inc. Journey II BCS Knee components are indicated for use only with cement and are single use devices.

9. Rheumatoid arthritis.

10. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.

11. Failed osteotomies, unicompartmental replacement, or total knee replacement.

12. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
    The Journey II Total Knee system components are indicated for use only with cement and are single use devices.

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

1. Noninflammatory degenerative joint disease including osteoarthritis, or avascular necrosis;
2. Correction of functional deformity;
3. Revision procedures where other treatments or devices have failed; and
4. 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. HA coated unicompartmental knee implants are available outside the US for use without bone cement.

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.

Total knee components are indicated for rheumatic arthritis, osteoarthritis, osteoarthritis, or degenerative arthritis; failed osteotomies, unicompartmental replacement, or total knee replacement.
The Journey II Total Knee system components are indicated for use only with cement and are single use devices.

1. Degenerative arthritis in the distal femur and patella;
2. A history of patellar dislocation or patellar fracture; and
3. Failed previous surgery (arthroplasty, tibial tubercule elevation, lateral release) where pain, deformity or dysfunction persists.
   The Smith & Nephew Patello-Femoral Implants are intended for implantation with bone cement.

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

1. Noninflammatory degenerative joint disease including osteoarthritis, or avascular necrosis;

2. Correction of functional deformity;

3. Revision procedures where other treatments or devices have failed; and

4. 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. HA coated unicompartmental knee implants are available outside the US for use without bone cement.

5. Rheumatoid arthritis.

6. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.

7. Failed osteotomies, unicompartmental replacement, or total knee replacement.

8. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.

9. Constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral collateral ligament) are incompetent.

10. Hinge knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral ligament) are absent or incompetent.
    The Legion Hinge Knee System is for Cemented Use Only.

11. Rheumatoid arthritis.

12. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.

13. Failed osteotomies, unicompartmental replacement, or total knee replacement.

14. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.

15. Constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral collateral ligament) are incompetent.

16. Hinge knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral ligament) are absent or incompetent.
    The LEGION Knee System - Finned Tibial Wedges are for single use only and are intended for implantation with bone cement.

These devices are indicated for patients with:

1. Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis.
2. Previous tibial condyle or plateu fractures with loss of anatomy or function.
3. Varus or Valgus deformities.
4. Revision of previous arthroplasty procedures.
   The devices are indicated for cemented use only.
   The Zimmer Unicompartmental Knee System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.

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.

Total Knee components are indicated for:

1. Rheumatoid arthritis
2. Post- traumatic arthritis, osteoarthritis, or degenerative arthritis
3. Failed osteotomies, unicompartmental replacement, or total knee replacement
4. The posterior stabilized knee system is designed for use in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
   LEGION Porous CR Narrow Femoral Components are indicated for use without bone cement and are single use devices.
   The Porous Patella and the Porous Tibia Baseplate are indicated for use with or without bone cement, and are single use devices.

The purpose of this Traditional 510(k) is to add MR safety information to the labeling (instructions for use, product labeling and patient implant card) of the subject Smith & Nephew Knee Systems. The technological characteristics, function of the devices, packaging and sterilization remain unchanged. As these products have been in distribution for several years, some parts have undergone changes in the technological characteristics that were assessed in compliance with the FDA's guidanceon "Deciding When to Submit a 510(k) for a Change to an Existing Device" or the FDA predecessor guidance on how to review changes to an existing device. These are not cumulative changes for all Smith & Nephew Knee Systems, but are rather specific changes that only affect certain parts. In the context of this submission, no modifications have been made to the device design, materials, sterilization, or the manufacturing process of the previously cleared devices due to the addition of MR Labeling for this 510(k).

The provided text describes a 510(k) premarket notification for various Smith & Nephew knee systems. The purpose of this submission is not to introduce a new device or significantly change an existing one that would require a new performance study to demonstrate clinical effectiveness or safety based on patient outcomes. Instead, the core of this submission is to add MR safety information to the labeling of existing, already cleared devices.

Therefore, the typical "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of diagnostic or AI-driven devices (which you are asking about) are not applicable to this 510(k) submission.

The "performance data" section in the document, despite its heading, refers specifically to Magnetic Resonance Imaging (MRI) compatibility testing, not clinical performance of the knee implants themselves. This testing aims to demonstrate that the presence of the knee implants does not pose an undue risk or create excessive artifacts during MRI scans.

Here's why the questions you asked cannot be fully answered or are not relevant to this specific regulatory submission:

• No new device performance for clinical outcomes: This submission isn't about proving a device (like an AI algorithm) is effective at diagnosing or treating a condition. It's about ensuring an existing physical implant is safe in an MRI environment.
• No diagnostic or AI algorithm: The "device" in question here is a knee implant, not a software algorithm that generates clinical insights or diagnoses. Therefore, terms like "multi reader multi case (MRMC) comparative effectiveness study," "standalone (algorithm only) performance," "ground truth," or "training set" are not applicable.

However, I can extract the relevant information regarding the MR safety testing which serves as the "study" for this particular 510(k) submission:

Acceptance Criteria and Study for MR Safety Labeling (as described in the document):

Since this 510(k) is specifically for adding MR safety information to the labeling of already cleared devices, the "acceptance criteria" and "study" revolve around demonstrating the device's compatibility with MRI environments, not its clinical performance as a knee implant.

1. Table of Acceptance Criteria and Reported Device Performance (for MR Safety)

Summary of Device Performance: The document states that "MR Safety testing/assessments support the appropriate MR parameters and symbols found in the subject device labeling." This implies that the devices met the requirements of the referenced ASTM and IEC standards for MR compatibility, allowing defined MR conditions (e.g., specific field strengths, gradients, RF levels) for imaging patients with these implants.

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

• Sample Size: The document does not specify the sample size for the MR safety testing. These tests are typically conducted on representative samples of the implant devices themselves, not on human patients.
• Data Provenance: The testing references industry standards (ASTM, IEC, ISO/TS), indicating that the tests were performed in a controlled laboratory environment in accordance with these established protocols. The country of origin of the data is not specified but is presumed to be where Smith & Nephew conducted their R&D and testing. Since it's device testing, not patient data, the retrospective/prospective distinction is not applicable.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not Applicable: For MR safety testing of physical implants, "ground truth" as established by human experts (like radiologists interpreting images) is not the primary method. The "ground truth" for MR safety is determined by the physical properties of the materials and the design of the device, measured against established engineering and safety standards. The experts involved would be engineers and physicists specializing in MRI safety and material science.

4. Adjudication Method for the Test Set:

• Not Applicable: Adjudication methods (like 2+1 or 3+1 for clinical interpretations) are not relevant here. The results of MR safety testing are quantitative measurements (e.g., temperature rise, displacement force, torque, artifact size) subject to direct measurement and comparison against defined thresholds in the standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No: This is not applicable. MRMC studies are used to assess the impact of a diagnostic tool (like an AI algorithm) on human reader performance. This submission is about the physical safety of an implant in an MRI scanner.

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

• No: This is not applicable as there is no algorithm being tested in this submission.

7. The Type of Ground Truth Used:

• Technical Standards and Physical Measurements: The "ground truth" for MR safety is established by international and national technical standards (ASTM, IEC, ISO/TS) that define acceptable limits for magnetic force, torque, heating, and image artifact. The studies involve physical measurements of these parameters using specialized testing equipment.

8. The Sample Size for the Training Set:

• Not Applicable: There is no "training set" in the context of MR safety testing of physical implants, as this is not an AI/machine learning submission.

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

• Not Applicable: As there is no training set, this question is not relevant.

In summary, this 510(k) submission is a prime example of a regulatory clearance based on engineering and performance testing against recognized standards for physical device properties (MR compatibility), rather than clinical efficacy studies or AI performance metrics.

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The Signature Orthopaedics' TLC Unicompartmental Knee comprising the femur component, tibial component and meniscal inserts is designed for a single compartment of the natural knee joint. The TLC Unicompartmental Knee is indicated for cemented use in partial knee arthroplasty procedures. Partial replacement of the articulating surfaces of the knee is indicated only when only one compartment of the joint is affected due to the compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty.

The TLC Unicompartmental Knee system is a modular knee system consisting of a femoral component, meniscal insert and a tibial baseplate. The femoral component is manufactured from cast cobalt chromium alloy and are intended for use with bone cement. The tibial baseplate component is manufactured from titanium alloy and intended for use with bone cement. The meniscal insert is manufactured from UHMWPE.

This document is an FDA 510(k) clearance letter for a medical device (TLC Unicompartmental Knee System). It grants the manufacturer permission to market the device based on its substantial equivalence to previously cleared predicate devices.

Crucially, this document does not contain information about acceptance criteria or a study proving the device meets those criteria (e.g., performance metrics, sample sizes, ground truth establishment, or multi-reader studies).

The "Performance Testing" section lists the types of non-clinical tests performed (e.g., Range of motion analysis, Tibial plate fatigue testing), but it does not provide any specific acceptance criteria or the results of these tests. It merely states that "Non-clinical testing and engineering evaluations were conducted to verify that the performance of the TLC UniKnee system is adequate for anticipated in-vivo use."

Therefore, I cannot extract the information required to populate the requested table and answer the questions directly from the provided text. The document focuses on regulatory clearance based on substantial equivalence, not on a detailed clinical or performance study demonstrating specific achievement of acceptance criteria.

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The patient-specific Bodycad Unicompartmental Knee System (Bodycad UKS) is indicated for unicompartmental knee arthroplasty (UKA) in patients with advanced knee osteoarthritis (OA) of the medial compartment with evidence of adequate healthy bone to support the implanted components. Candidates for unicompartmental knee replacement include those with:
· joint impairment due to osteoarthritis or traumatic arthritis of the knee.
· varus deformity of the knee, and
· as an alternative to tibial osteotomy in patients with unicompartmental OA.
The patient-specific Bodycad UKS components fit within an envelope of dimensions that are specific to each patient. The Bodycad UKS femoral component and tibial baseplate are intended fixation. A Bodycad screw must be used for fixation of the femoral component.

The Bodycad Unicompartmental Knee System (BUKS) is a patient-specific prosthesis that consists of femoral and tibial implants for replacement of the medial tibiofemoral compartment of the knee. The patient-specific femoral and tibial components and single-use cutting quides are manufactured from CAD and CAM files generated from Bodycad software, which are based on MRI or CT images of the patient's knee and input from the surgeon. The BUKS is for cemented use only and is sterilized by gamma radiation.
The subject of this 510(k) notification is a line extension and design update that includes a new tibial baseplate that is compatible with the BUKS system (K163700, K181302) and instruments that are compatible with the new tibial baseplate.
Materials: Wrought Cobalt-28Chromium-6Molybdenum Alloy (CoCrMo; ASTM F1537-11) for the femoral component and screw, wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (Ti6Al4V ELI; ASTM F136-13) for the tibial baseplate, locking pin, and screw, Ultra-High-Molecular-Weight Polyethylene (UHMWPE; F648-14) for the tibial insert.

The provided text is a 510(k) summary for the Bodycad Unicompartmental Knee System. This document is a regulatory submission for a medical device and describes its intended use, technological characteristics, and a comparison to predicate devices to demonstrate substantial equivalence.

Based on the content, the document does NOT describe the acceptance criteria or a study proving the device meets those criteria in the context of an AI/algorithm-based medical device. This document is for a physical medical implant (a knee system) and the performance data presented relates to mechanical testing and surgeon-user validation for the physical device, not an AI or software algorithm.

Therefore, I cannot extract the requested information regarding AI/algorithm performance, acceptance criteria, sample sizes for test/training sets, expert ground truth establishment, or MRMC studies.

The document primarily focuses on demonstrating the substantial equivalence of a physical knee implant (Bodycad Unicompartmental Knee System) to previously cleared predicate devices through design comparison and mechanical performance testing, not on the performance of a software algorithm or AI.

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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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The patient-specific Bodycad Unicompartmental Knee System (Bodycad UKS) is indicated for unicompartmental knee arthroplasty (UKA) in patients with advanced knee osteoarthritis (OA) of the medial compartment with evidence of adequate healthy bone to support the implanted components. Candidates for unicompartmental knee replacement include those with:

· joint impairment due to osteoarthritis or traumatic arthritis of the knee,

• · varus deformity of the knee, and
• · as an alternative to tibial osteotomy in patients with unicompartmental OA.

The patient-specific Bodycad UKS components fit within an envelope of dimensions that are specific to each patient. The Bodycad UKS femoral component and tibial baseplate are intended for cemented fixation. The Bodycad screws must be used for fixation of the femoral and tibial components.

The Bodycad Unicompartmental Knee System (Bodycad UKS) is a patient-specific prosthesis that consists of femoral and tibial implants for replacement of the medial tibiofemoral compartment of the knee. The patient-specific femoral and tibial components and single-use cutting guides are manufactured from CAD and CAM files generated from validated Bodycad software, which are based on MRI or CT images of the patient's knee and input from the surgeon. The Bodycad UKS is for cemented use only. The Bodycad UKS is sterilized by gamma radiation.

Materials: CoCrMo (ASTM F1537-11) for the femoral component, Ti6Al4V ELI (ASTM F136-13) for the tibial component, UHMWPE (F648-14) for the tibial insert

The provided text describes a medical device, the Bodycad Unicompartmental Knee System, and its regulatory clearance. However, it does not contain information related to specific acceptance criteria, a study proving the device meets those criteria, or performance data in terms of metrics like sensitivity, specificity, or accuracy.

The "performance data" section states: "Validation testing was performed for CT and MRI imaging modalities and demonstrated substantial equivalence of the 3D digital bone models being equivalent for data extracted from CT and MR images." This indicates a technical validation of the 3D model generation process from imaging, not a clinical performance study with defined acceptance criteria for device efficacy or outcomes.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text, as this information is absent.

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The patient-specific Bodycad Unicompartmental Knee System (Bodycad UKS) is indicated for unicompartmental knee arthroplasty (UKA) in patients with advanced knee osteoarthritis (OA) of the medial compartment with evidence of adequate healthy bone to support the implanted components. Candidates for unicompartmental knee replacement include those with:

· joint impairment due to osteoarthritis or traumatic arthritis of the knee,

· varus deformity of the knee, and

· as an alternative to tibial osteotomy in patients with unicompartmental OA.

The patient-specific Bodycad UKS components fit within an envelope of dimensions that are specific to each patient. The Bodycad UKS femoral component and tibial baseplate are intended for cemented fixation. The Bodycad screws must be used for fixation of the femoral and tibial components.

The Bodycad Unicompartmental Knee System (Bodycad UKS) is a patient-specific prosthesis that consists of femoral and tibial implants for replacement of the medial tibiofemoral compartment of the knee. The patient-specific femoral and tibial components and single-use cutting guides are manufactured from CAD and CAM files generated from validated Bodycad software, which are based on MRI images of the patient's knee and input from the surgeon. The femoral component is fabricated from wrought Cobalt-Chrome alloy (CoCr) with a centrally located peg and provision for ancillary fixation with a CoCr bone screw. The tibial implant consists of a Titanium (Ti) alloy baseplate with one to three posterior spikes and provision for ancillary fixation with a Tit alloy bone screw. The polyethylene insert is fabricated from Ultra-High-Molecular-Weight- Polyethylene (UHMWPE), compression molded and machined GUR 1020. The tibial-femoral articulation is an unconstrained design. This device is for cemented use.

Materials: CoCrMo (ASTM F1537-11) for the femoral component. Ti6Al4V ELI (ASTM F136-13) for the tibial component, UHMWPE (F648-14) for the tibial insert

The provided text is a 510(k) Summary for the Bodycad Unicompartmental Knee System. It describes the device, its indications for use, and a comparison to predicate devices, as well as a list of performance tests conducted.

However, the document does not contain the information requested in the prompt regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning data provenance, expert adjudication, MRMC studies, or training/test set details for an AI/algorithm-driven device performance study.

The "Performance Data" section lists various mechanical and material tests performed on the knee system components (fatigue strength, range of motion, constraint testing, screw strength, contact pressure, etc.), as well as cadaver laboratory testing for surgical technique and implant fit, and evaluation of single-use cutting guides. This section focuses on the physical and functional characteristics of the medical device itself, not on the performance of a diagnostic algorithm or AI system for which the requested details about ground truth, expert readers, and sample sizes would be relevant.

The closest mention of software is that the patient-specific implant components and cutting guides are manufactured from CAD-CAM models created from the patient's MRIs and input from the surgeon, using proprietary software. It states: "This software, and off-the-shelf software, were validated per the FDA guidance document 'Guidance for the content of premarket submissions for software contained in medical devices'." However, this refers to validation of the manufacturing software workflow, not a diagnostic AI system predicting disease state or lesion characteristics.

Therefore, based on the provided text, I cannot answer the specific questions about acceptance criteria and a study proving the device meets them in the context of an AI/algorithm-driven diagnostic performance study.

The document details the regulatory clearance of a medical device (a knee implant system), not an AI software as a medical device (SaMD). The acceptance criteria mentioned are related to the physical performance, material integrity, and surgical fit of the implant, not the diagnostic performance of an AI.

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These devices are indicated for patients with:

• Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis.
• Previous tibial condyle or plateau fractures with loss of anatomy or function.
• Varus or valgus deformities.
• Revision of previous arthroplasty procedures.
  These devices are indicated for cemented use only.
  The Zimmer Unicompartmental Knee System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.

The Zimmer Unicompartmental Knee System (ZUK) is a prosthesis that replaces only one compartment of the knee condyles. It is unconstrained in the anteroposterior and mediolateral directions and also allows unconstrained internal/external rotation between the femoral and tibial components. This movement is limited only by the ligaments and other soft tissues surrounding the device.

The Zimmer Unicompartmental Knee System Vivacit-E Articular Surface is a medical device. The provided text describes the non-clinical performance and conclusions for this device, focusing on material characteristics and mechanical properties. There are no clinical performance studies described.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text details non-clinical performance and conclusions based on bench testing. Therefore, there is no human "test set" or associated patient data from which to derive sample size or data provenance (country of origin, retrospective/prospective). The "test set" in this context refers to the physical samples of the device components and materials subjected to laboratory testing. The document does not specify the number of samples used for each bench test.

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

As this is a non-clinical, bench-testing study, the concept of "experts" establishing ground truth in the context of clinical interpretation or diagnosis does not apply. The ground truth for these tests is based on the physical and mechanical properties of the device components as measured by standardized testing methods and engineering principles. The experts involved would be engineers, material scientists, and quality assurance personnel who design, conduct, and interpret these tests, but their number and specific qualifications are not detailed in this summary.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involving interpretation of medical images or patient outcomes. Since this report describes non-clinical bench testing, no such adjudication method was used. The "results" are objective measurements against predefined engineering specifications and standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No MRMC comparative effectiveness study was done. The description explicitly states: "Clinical data and conclusions were not needed for this device." The study focuses on the physical properties and performance of the device's material and components through bench testing, not on human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

This question relates to AI/algorithm performance. No AI/algorithm standalone performance study was done. The device is a physical knee prosthesis component, not an AI software or system.

7. Type of Ground Truth Used

The ground truth used for these non-clinical performance studies is derived from established engineering standards, material science principles, and functional requirements for knee prostheses. Results from bench tests (e.g., wear rate measurements, fatigue strength, delamination resistance, assembly force) are compared against these predetermined specifications and accepted industry benchmarks to determine if the device meets its performance objectives.

8. Sample Size for the Training Set

Similar to the "test set," the concept of a "training set" is not applicable here as this is a non-clinical, bench-testing study of a physical medical device. There is no machine learning model being trained.

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

As there is no training set mentioned in the context of this non-clinical bench study, this question is not applicable.

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