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Triathlon® Hinge Knee System is intended to be implanted with bone cement for the following condition(s):

• There is destruction of the joint surfaces, with or without significant bone deformity.
• The cruciate and/or collateral ligaments do not stabilize the knee joint.
• The ligaments are inadequate and/or the musculature is weak. And/or
• Revision is required of a failed prosthesis where there has been gross instability, with or without bone loss or inadequate soft tissue.

When used with MRH femur and/or MRH tibial baseplate replacement indicated in revision of an existing prosthesis:

• Revision is required of a failed prosthesis where there has been gross instability, with or without bone loss or inadequate soft tissue.

When used with compatible GMRS components:

• Where segmental resection and/or replacement of femur and/or proximal tibia is required

The subject THK components are a line extension of the previously cleared Triathlon® Hinge Knee System (K223528, K230416). The THK System (K223528, K230416) is a tricompartmental knee system consisting of a stemmed femoral component and a stemmed tibial bearing component connected by a set of previously cleared MRH or THK Bushings and an MRH or THK Axle (K994207, K002552, K223528, K230416). A bumper locks this assembly. This assembly provides motion through the MRH or THK Axle/Bushings combination in the flexion/extension plane. The articulation between the bearing surfaces on the underside of a tibial bearing component and a tibial insert provides motion in the rotating plane. A hinge tibial insert is assembled to a Triathlon® Hinge Revision Tibial Baseplate that incorporates a longitudinal bore to accept a previously cleared MRH Tibial Sleeve (K994207, K002552) or Triathlon Tibial Sleeve (K223528, K230416). Optional distal femoral and tibial augments are available to fill bone defects.

The subject Triathlon® Hinge Small Proximal Tibial Bearing Component and Triathlon® End Cap are sterile, single use devices intended for cemented use only and are being added to the previously cleared THK system (K223528, K230416) as an extension. They can be used with previously cleared MRH Knee components (K994207, K002552), GMRS (K023087, K222056), and Triathlon® Knee System components (K172634, K172326, K190991, K143393, K141056, K132624, K070095, K061521, K053514, K052917, K051948, K051146, K040267).

This FDA 510(k) clearance letter is for a mechanical medical device (a knee implant system), not an AI/software as a medical device. Therefore, the request for "acceptance criteria and the study that proves the device meets the acceptance criteria" using metrics relevant to AI/software (like sensitivity, specificity, MRMC studies, ground truth for training/test sets, etc.) is not applicable here.

The document provided details about the substantial equivalence of the "Triathlon® Hinge Knee System" to previously cleared predicate devices. The "study" proving the device meets acceptance criteria for a mechanical implant typically involves non-clinical (benchtop) testing and engineering analyses to demonstrate performance, material compatibility, and safety, rather than clinical trials or AI performance evaluations with ground truth.

Here's how the provided information relates to the typical evaluation of such a device, addressing the closest analogues to your requested points:

Acceptance Criteria and Device Performance for a Mechanical Implant:

For mechanical implants like the Triathlon® Hinge Knee System, "acceptance criteria" are generally tied to the successful completion of various non-clinical (benchtop) tests and analyses. These tests simulate the physical stresses and conditions the implant will experience in the human body. The "study" proving the device meets these criteria is the execution and successful outcome of these non-clinical tests.

No direct table of "acceptance criteria" vs. "reported device performance" in the AI sense is provided in this 510(k) summary. Instead, the summary lists the types of non-clinical tests performed to demonstrate performance and substantial equivalence to predicate devices. The implied acceptance is that the device passed these tests, meaning its performance in these simulated scenarios was deemed acceptable and comparable to existing, legally marketed devices.

Table of Non-Clinical Tests (Analogous to Performance Metrics):

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The Stryker Global Modular Replacement System, Modular Replacement System and Modular Rotating Hinge Knee Component are sterile, single-use devices intended for use in situations where there is a need for replacement of bone due to radical bone loss. This loss can be related to oncology, trauma or failed previous prosthesis. Specific Indications for Use are listed below.

Indications for the MRS Stems and Intercalary Stems (presented in K952970):

• This device is intended for use in patients requiring extensive reconstruction of the femur . and/or proximal tibia, including the hip or knee joint, resulting from extensive bone loss. Tumor resection for skeletal lesions (Oncology patients where radical bone resection and replacement may be required), revision surgery for failed arthroplasty, and acute trauma are the primary causes of extensive bone loss. These prostheses are intended for use with bone cement.
• The Intercalary System is intended for use in situations arising from femoral mid-shaft tumor resection, or for prosthetic knee fusion.

Indications for the Global Modular Replacement System (presented in K023087):

• Femoral and/or proximal tibial replacement and total femoral replacement in Oncology cases where radical resection and replacement of bone is required, and in limb salvage procedures where radical resection and replacement of the bone is required. Limb salvage procedures would include surgical intervention for severe trauma, failed previous prosthesis, and/or Oncology indications.

Indications for the GMRS Anteverted Proximal Femoral Component (presented in K032581):

• Femoral replacement in Oncology cases where radical resection and replacement of bone is required, and in limb salvage procedures where radical resection and replacement of bone is required. Limb salvage procedures would include surgical intervention for severe trauma, failed previous prosthesis, and/or Oncology indications. This component may also be used with the Distal Femoral segment components of the GMRS in total femoral replacement.

Indications for the Global Modular Replacement System Press Fit Stems with HA Coating (presented in K022403, and K031217):
Proximal femoral reconstruction secondary to:
o Trauma
o Failed previous prosthesis
o Tumor resection

Indications for the Modular Replacement System Cemented Stems (presented in K040749):
Femoral and/or proximal tibial replacement due to:
o Trauma
o Failed previous prosthesis
o Tumor resection

Indications for the Modular Rotating Hinge Knee System (presented in K002552):

• The Modular Rotating Hinge Knee System is intended for use with bone cement in cases where there is destruction of the joint surfaces, with or without significant bone deformity; the cruciate and/or collateral ligaments do not stabilize the knee joint; the ligaments are inadequate and/or the musculature is weak; and revision of a failed previous prosthesis where there is instability, with or without bone loss or inadequate soft tissue. Expanded indications include for use with bone cement in situations where there is extensive bone loss, including limb salvage procedures for severe trauma, failed previous prosthesis, and/or Oncology indications.

The Global Modular Replacement System (GMRS) is comprised of a number of components that are intended to be used in conjunction with each other, or in conjunction with components of the Modular Replacement System (MRS) or the Modular Rotating Hinge Knee System (MRH). The Modular Rotating Hinge Knee System is a tricompartmental knee system. The system consists of a stemmed femoral component and a stemmed tibial bearing component connected by a set of bushings and an axle. The MRH Tibial Rotating component is a part of the MRH system and mates with the GMRS Standard Proximal Tibia. These devices are intended to be used in clinical situations where there is radical bone loss of the femur and/or proximal tibia. This radical bone loss can be related to oncology (tumor), trauma or failed previous prosthesis.

The provided FDA 510(k) clearance letter and summary for the Stryker Orthopaedics Global Modular Replacement System, Modular Replacement System, and Modular Rotating Hinge Knee Component does not contain information regarding acceptance criteria or a study proving the device meets specific performance criteria.

This document is a clearance letter indicating a determination of "substantial equivalence" to previously marketed predicate devices. It does not present novel performance data or studies against pre-defined acceptance criteria.

The key statements from the document that confirm this are:

• "Non-Clinical Testing: Non-Clinical testing was not required as a basis for substantial equivalence." (Page 8)
• "Clinical Testing: Clinical testing was not required as a basis for substantial equivalence." (Page 8)

The submission focuses on adding a contraindication to the labeling, updating MRI Safety information, and making clerical updates to the Instructions for Use (IFUs). These changes do not necessitate new performance studies for substantial equivalence.

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria and studies because the provided document explicitly states that such testing was not required for this particular 510(k) submission.

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The Modular Rotating Hinge Knee System is intended to be implanted with bone cement for the following conditions:

• · There is destruction of the joint surfaces, with or without significant bone deformity
• · The cruciate and/or collateral ligaments do not stabilize the knee joint
• · The ligaments are inadequate and/or the musculature is weak and/or
  · Revision is required of a failed prostheses where there has been gross instability, with or without bone loss or inadequate soft tissue

Indication for Use for Duracon Components (Cobalt Chrome & Titanium Stems, and Tibial Wedges) and Stryker Stem Components:
Indications for use of total knee replacement prostheses include:

• · noninflammatory degenerative joint disease including osteoarthritis or avascular necrosis;
• rheumatoid arthritis;
• · correction of functional deformity;
• · revision procedures where other treatments or devices have failed;
• · post-traumatic loss of joint anatomy, particularly when there is patello-femoral erosion, dysfunction or prior patellectomy: and
• · irreparable fracture of the knee.

Indications for US and Rest of World for Total Stabilizer Offset Adapter:
Indications for use of total knee replacement prostheses include:

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

• 2. Rheumatoid arthritis;

3. Correction of functional deformity:
4. Revision procedures where other treatments or devices have failed;
5. Post-traumatic loss of joint anatomy, particularly when there is patello-femoral erosion, dysfunction or prior patellectomy: and.
6. Irreparable fracture of the knee
   When the Total Knee Replacement Prosthesis is used with the components of the Modular Rotating Hinge Knee System, the indication for the Modular Rotating Hinge Knee with Offset Adapters is as follows:
   The Rotating Hinge Knee Systems are intended to be implanted with bone cement for the following condition(s):
7. There is destruction of the joint surfaces, with or without significant bone deformity.
8. The cruciate and/or collateral ligaments do not stabilize the knee joint.
9. The ligaments are inadequate and/or the musculature is weak and/or,
10. Revision is required of a failed prosthesis where there has been gross instability, with or without bone loss or inadequate soft tissue.

GMRS Pediatric Tibial Bearing Component:
Replacement of the distal femur and/or proximal tibia in Oncology cases where radical resection and replacement of bone is required, and in limb salvage procedures where radical resection and replacement of the bone is required. Limb salvage procedures would include surgical intervention for severe trauma, failed previous prosthesis, and/or Oncology indications. This smaller size component is intended to be used in patients with a smaller bone structure, or in skeletally immature patients. This component is intended for use with bone cement.

MRS Pediatric All Poly Tibial Component:
MRS Pediatric All Polyethylene Tibial Component is intended to be used in oncology patients where radical resection of the distal femur/proximal tibia is required. Additional indications include limb salvage procedures where radical resection and replacement of the distal femur/proximal tibia is required. Limb salvage includes surgical intervention for severe trauma, failed previous knee arthroplasties, and/or oncology indications.

The Modular Rotating Hinge (MRH) Knee System is a tri-compartmental knee system that consists of a stemmed femoral component and a stemmed tibial rotation component, connected by a set of bushings and an axle. A bumper locks this assembly. This assembly provides motion through the axle/bushing combinations in the flexion/extension plane. The articulation between the cylindrical bearing surfaces on the underside of the tibial rotating component and a tibial insert provide motion in the rotation plane. The tibial insert is assembled to a tibial stemmed tray which incorporates a longitudinal bore to accept a tibial sleeve.
The Modular Rotating Hinge Knee System is designed to provide varus/valgus stability throughout the range of motion, internal/external rotation about the tibial axis, constrained by the bearing surface radius on the tibial rotating component, and an extensive range of size, modularity and resection options. The implant system consists of a femoral component in five sizes, a tibial rotating component in five sizes, tibial crossover bearing components in various sizes, bumper inserts, tibial and femoral augmentation components and a tibial sleeve. The MRH Knee System is compatible with components of the Kinemax/Kinematic Knee System, Duracon Knee System, Howmedica Total Stabilizer Knee System, and the GMRS/MRS System.

This document is a 510(k) premarket notification for several knee joint prostheses and related components. The submission's purpose is to modify the labeling of these devices to include "MR Conditional" information. Therefore, the "device" in question for this prompt is the MR Conditional labeling for the existing knee implant systems, not a new or modified implant design itself. The study discussed relates to the safety of these existing implants in an MRI environment.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a "sample size" in terms of number of physical devices tested or a number of patients or images. The testing described is non-clinical testing (phantom/bench testing) performed on the device components themselves to evaluate their interaction with MRI fields.

• Sample Size: Not specified as typically understood for clinical studies (e.g., number of patients/images). This refers to physical samples of the device components or simulated constructs used in bench testing.
• Data Provenance: This is non-clinical/bench testing data, likely generated in a laboratory setting by the manufacturer or a contract testing facility. "Country of origin" for non-clinical testing is not specified, but the applicant is based in Mahwah, New Jersey, USA. The testing is retrospective in the sense that it's performed on manufactured devices, but it's a prospective evaluation of their MRI safety characteristics.

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

For this type of non-clinical, MRI safety testing, "ground truth" is not established by human experts in the same way it would be for diagnostic image interpretation. The "ground truth" is determined by the physical measurements against established safety standards (e.g., ASTM standards for magnetic force, torque, heating, and artifact). The "experts" involved would be technicians and engineers skilled in conducting these specific non-clinical tests and interpreting their results against the predefined standard limits. Their qualifications would involve expertise in materials science, biomechanics, and MRI physics, along with knowledge of the relevant ASTM standards and FDA guidance documents. The document does not specify the number or specific qualifications of these individuals.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are typically for clinical studies where human reviewers assess data. For non-clinical, objective measurements against established standards, the test results themselves, when within the specified limits of the standards, serve as the "adjudication."

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

No. The document explicitly states: "Clinical testing was not required as a basis for substantial equivalence." This is a non-clinical evaluation of device safety with MRI, not a comparative study of diagnostic performance or human reader improvement.

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

Not applicable. This device is a physical knee implant component, not an algorithm or AI software. The testing evaluated the physical device's interaction with MRI machines.

7. Type of Ground Truth Used

The ground truth used in this submission is based on established engineering and medical device safety standards (specifically ASTM standards F2052-15, F2213-17, F2119-07, F2182-19e1) and FDA guidance documents (e.g., "Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment..." and the May 2021 guidance document for heating in tissue). The "truth" is whether the measured physical properties (displacement, torque, artifact, heating) fall within the acceptable limits defined by these recognized standards and guidance.

8. Sample Size for the Training Set

Not applicable. This is not a machine learning or AI-based device, so there is no "training set." The testing performed is non-clinical for MRI safety.

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

Not applicable, as there is no training set for this type of device.

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The Stryker Global Modular Replacement System components are sterile, single-use devices intended for use in situations where there is a need for replacement of bone due to radical bone loss. This loss can be related to oncology, trauma or failed previous prosthesis.

Specific Indications for Use are listed below.

Indications for the MRS Stems and Intercalary Stems presented in K952970:

• This device is intended for use in patients requiring extensive reconstruction of the femur and/or proximal tibia, including the hip or knee joint, resulting from extensive bone loss. Tumor resection for skeletal lesions (Oncology patients where radical bone resection and replacement may be required), revision surgery for failed arthroplasty, and acute trauma are the primary causes of extensive bone loss. These prostheses are intended for use with bone cement.
• . The Intercalary System is intended for use in situations arising from femoral mid-shaft turnor resection, or for prosthetic knee fusion.

Indications for the Global Modular Replacement System presented in K023087:

• . Femoral and/or proximal tibial replacement and total femoral replacement in Oncology cases where radical resection and replacement of bone is required, and in limb salvage procedures where radical resection and replacement of the bone is required. Limb salvage procedures would include surgical intervention for severe trauma, failed previous prosthesis, and/or Oncology indications.

Indications for the Global Modular Replacement System Press Fit Stems with HA Coating (presented in K022403, and K031217):

• Proximal femoral reconstruction secondary to: 0
  • Trauma o
  • Failed previous prosthesis о
  • Tumor resection O

Indications for the GMRS Anteverted Proximal Femoral Component (presented in K032581)

• Femoral replacement in Oncology cases where radical resection and replacement of bone is . required, and in limb salvage procedures where radical resection and replacement of bone is required. Limb salvage procedures would include surgical intervention for severe trauma, failed previous prosthesis, and/or Oncology indications. This component may also be used with the Distal Femoral segment components of the GMRS in total femoral replacement.
  Indications for the Modular Replacement System Cemented Stems (cleared in K040749):

• Femoral and/or proximal tibial replacement due to: ●

  • Trauma O
  • Failed previous prosthesis O
  • Tumor resection o

Indications for the Modular Rotating Hinge Knee System (cleared in K002552)

The Modular Rotating Hinge Knee System is intended for use with bone cement in cases where there is destruction of the joint surfaces, with or without significant bone deformity; the cruciate and/or collateral ligaments do not stabilize the knee joint; the ligaments are inadequate and/or the musculature is weak; and revision of a failed previous prosthesis where there is instability, with or without bone loss or inadequate soft tissue.

Expanded indications include for use with bone cement in situations where there is extensive bone loss, including limb salvage procedures for severe trauma, failed previous prosthesis, and/or Oncology indications.

The Global Modular Replacement System is comprised of a number of components that are intended to be used in conjunction with each other, or in conjunction with components of the Modular Replacement System or the Modular Rotating Hinge Knee System. These devices are intended to be used in clinical situations where there is radical bone loss of the femur and/or proximal tibia. This radical bone loss can be related to oncology (tumor), trauma or failed previous prosthesis.

This document is a 510(k) premarket notification from Howmedica Osteonics Corp., dba Stryker Orthopaedics, for their Global Modular Replacement System, Modular Replacement System, and Modular Rotating Hinge Knee. The submission, K222056, aims to modify the labeling of these devices to include MR Conditional language and to add an additional contraindication to the GMRS Press Fit Stems with Hydroxyapatite.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

   The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics for clinical outcomes. Instead, it focuses on non-clinical testing for MR compatibility and states that these tests were performed according to recognized ASTM standards. The "acceptance criteria" can be inferred as meeting the requirements of these standards.

   Acceptance Criteria (Inferred)	Reported Device Performance
   Compliance with ASTM F2052-15 for Magnetically Induced Displacement Force	Testing performed as outlined in FDA guidance.
   Compliance with ASTM F2213-17 for Magnetically Induced Torque	Testing performed as outlined in FDA guidance.
   Compliance with ASTM F2119-07 (2013) for Image Artifacts	Testing performed as outlined in FDA guidance.
   Compliance with ASTM F2182-19e1 for Heating by RF Fields (including additional analyses for tissue heating)	Testing performed as outlined in FDA guidance.

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 describes non-clinical testing performed on the devices themselves, not on human subjects. Therefore, the concept of a "test set" in the context of clinical data (e.g., patient cases) does not apply here. The "samples" would be the physical devices or components tested. The document does not specify the number of devices tested for each non-clinical evaluation (e.g., how many different GMRS components were subjected to MR compatibility testing). The data provenance is non-clinical laboratory testing, not human-derived data, and thus country of origin or retrospective/prospective status is not applicable 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 information is not applicable. Ground truth, in the sense of clinical diagnoses or outcomes, is not established for this type of non-clinical device testing. The "ground truth" for MR compatibility is determined by the physical properties of the materials and design, evaluated against established engineering standards like ASTM.

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

   This information is not applicable. Adjudication methods are used in clinical studies or expert reviews to resolve discrepancies in diagnoses or assessments from multiple reviewers. For non-clinical engineering tests, the outcome is determined by measurements against predefined tolerances within the ASTM standards.

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:

   No MRMC comparative effectiveness study was done. The submission is for a medical device (orthopedic implants), not an AI-powered diagnostic or assistive tool.

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

   Not applicable. The device is a physical orthopedic implant, not an algorithm.

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

   The "ground truth" for the non-clinical testing is based on established engineering principles and the requirements defined in the ASTM standards (e.g., limits for magnetically induced displacement, torque, image artifact levels, and localized heating).

8. The sample size for the training set:

   Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."

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

   Not applicable. There is no training set for this type of device.

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