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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 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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