Search Results

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.

Ask a specific question about this device

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 in 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 Modular Replacement System Cemented Stems (cleared in K040749):

· Femoral and/or proximal tibial replacement due to:
- Trauma
- Failed previous prosthesis
- Tumor resection

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. The subject Global Modular Replacement System components are unchanged since the last premarket notification for the devices in K222056.

This document is entirely focused on a 510(k) premarket notification for a medical device called the "Global Modular Replacement System." It is a request for approval to market the device, and the content details its intended use, a comparison to legally marketed predicate devices, and a summary of its technological characteristics.

Crucially, this document does not contain any information about acceptance criteria, device performance testing results, ground truth establishment, sample sizes for training or test sets, expert qualifications, or MRMC studies for an AI/software device. The request is specifically for a physical medical device (hip and knee prostheses) and its purpose is to update labeling, including adding a contraindication and updating MRI safety information.

The sections you've requested (acceptance criteria, study details, sample sizes, expert qualifications, ground truth, MRMC studies) are typically relevant for AI/Software as a Medical Device (SaMD) submissions where software algorithms are being evaluated for diagnostic or prognostic purposes.

Therefore, I cannot fulfill your request as the provided text does not contain the information you are asking for. It explicitly states:

"No additional testing was conducted for this submission, as the only changes being made are to modify the labeling to add a contraindication and an update to the MRI safety information to align with an FDA guidance document. Testing performed in the previously cleared premarket notifications is applicable to this submission." (Page 10)

This confirms that no new performance studies, as would be required for an AI/Software component, were performed or are detailed in this 510(k) submission.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

It is the intention of Howmedica Osteonics Corp. to offer GMRS™ Proximal Femoral Components in an anteverted style, so both the standard and trochanteric versions will be available in left and right orientations. These new GMRSTM Proximal Femoral Components offer 15 degrees of anteversion.

The current GMRS™ proximal femoral components have the axis of their femoral neck perpendicular to the center plane of the slot formed by the two anti-rotation tabs when viewed from the distal-to-proximal direction. The subject GMRS™ anteverted proximal femoral components have the axis of their femoral neck at 75 or 105 degrees to the center plane of the slot formed by the two anti-rotation tabs when viewed from the distal-toproximal direction. The difference in the degrees of rotation from the currently available component is 15 degrees, which provides 15 degrees of anteversion (left or right) when implanted with the bowed press-fit stems.

The following design features are common to the new Anteverted Proximal Femoral Components, and the existing GMRS™ Proximal Femoral Components:

• . These components are each available in one size.
• These components are fabricated from cast cobalt-chromium alloy that meets the . requirements of ASTM standard F-75.
• 5 degree 40 minute taper angle to accept Howmedica Osteonics' modular femoral . heads with the same taper
• . 70mm replacement length
• . porous coating and suture holes in the A-P direction for tissue attachment
• . threaded insertion feature on the shoulder to allow for the use of an insertion instrument
• . 26mm distal diameter
• 34mm head-neck offset .

The GMRS™ Trochanteric Proximal Femoral Component has increased material in the region of the greater trochanter for surgeons who prefer an anatomically shaped component.

The Standard and Trochanteric Proximal Femoral Components of the GMRS™ may be used with the GMRS™ Connection Pieces, Extension Pieces and the Press Fit Stems with PureFix™ HA Coating in proximal femoral replacement. These products may also be used with the MRS Body components, and modular stems in proximal femoral replacement.

This document appears to be a 510(k) Premarket Notification summary for a medical device called the "Global Modular Replacement System Anteverted Proximal Femoral Component." It details the device, its intended use, indications, and contraindications. However, it does not include information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as typically required for clinical validation studies of AI/ML-based medical devices.

The information provided is for a traditional medical device (proximal femoral component for hip replacement), not an AI/ML device. Therefore, the questions related to AI/ML device evaluation (like MRMC studies, standalone performance, training sets, etc.) are not applicable to this document.

The 510(k) summary explains that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its clearance, rather than novel clinical performance studies against specific acceptance criteria for a new AI/ML algorithm.

Therefore, I cannot populate the requested table and answer the questions based on the provided text, as this document does not contain the type of information you've requested regarding acceptance criteria and scientific study results for an AI/ML device.

Ask a specific question about this device

The Global Modular Replacement System (GMRS™) Pediatric Tibial Bearing Component is intended to be used to mate the distal femoral components of the Global Modular Replacement (GMRS™) System or the femoral components of the Modular Rotating Hinge (MRH) System to the Pediatric All Polyethylene Tibial Components of the Modular Replacement System The indications for use for the GMRS™ Pediatric Tibial Bearing Component are listed below:

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.

The GMRS™ Pediatric Tibial Bearing Component is a single use device that is available in one size. The GMRS™ Pediatric Tibial Bearing Component is designed to mate with the all sizes of the femoral components of the GMRS™ or the MRH systems, and the MRS pediatric all poly tibial components. The design of this GMRS™ Pediatric Tibial Component is similar to the design of the existing MRH XS/XL Tibial Bearing Component - this component is stemmed, and connects to the femoral component by a set of bushings and an axle. A bumper locks this assembly. In terms of dimensions, the subject The GMRS™ Pediatric Bearing has a smaller distal stem diameter, and reduced anterior-posterior and medio-lateral dimensions when compared to the MRH XS/XL Tibial Bearing Component. These reduced dimensions are identical to those seen in the MRS Pediatric Tibial Bearing Component.

This document describes a 510(k) premarket notification for a medical device, the Global Modular Replacement System (GMRS™) Pediatric Tibial Bearing Component. It focuses on demonstrating substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria in the way a diagnostic AI product might.

Therefore, many of the requested categories (like sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable to this type of submission.

However, I can extract information related to the device description and the method used to demonstrate equivalence.

Here's a breakdown of the requested information based on the provided document:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in the traditional sense of a diagnostic performance study (e.g., sensitivity, specificity thresholds). Instead, the pivotal point for device acceptance in a 510(k) is demonstrating substantial equivalence to a legally marketed predicate device.

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

• Sample Size for Test Set: Not applicable. This was not a clinical trial with a "test set" in the context of diagnostic performance. The evaluation was based on a comparison to predicate devices and engineering analysis.
• Data Provenance: Not applicable in the context of clinical data. The "data" provided was primarily design specifications and an engineering analysis (FEA) comparing the new device to existing designs.

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 was no "test set" requiring ground truth established by experts.

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

• Not applicable. There was no "test set" requiring adjudication.

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 a mechanical orthopedic implant, not an AI-assisted diagnostic tool.

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

• Not applicable. This is a mechanical orthopedic implant, not an algorithm.

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

• Not applicable in the conventional sense. The "ground truth" for this submission revolves around the design, materials, and functional equivalence to already approved predicate devices. The primary evidence presented was Finite Element Analysis (FEA), which is a computational method to predict how a product reacts to forces, heat, fluid flow, and other physical effects. Its "truth" is based on established engineering principles and validation against physical testing methods, though no specific validation data is in this summary.

8. The sample size for the training set

• Not applicable. There was no "training set."

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

• Not applicable. There was no "training set."

Ask a specific question about this device

The GMRS Adapter is intended to mate the Proximal Femoral Components and Femoral Bodies of the MRS or Proximal Femoral Body or Extension Pieces of the GMRS to the distal femoral stems of the Restoration™M Modular Hip System. The GMRS adapter is intended for use with the above-noted components in proximal femoral replacement indicated 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. Adequate bone stock must be present to allow the use of the Restoration™ Modular Distal Femoral Stems. Indications and contraindications of the GMRS Adapter when used with the Proximal Femoral Bodies of the MRS and GMRS, and the distal femoral stems of the Restoration™ Modular Hip System follow:

Indications

Proximal 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.

The GMRS Adapter is a single use, two piece design consisting of the Adapter and the Adapter Locking Screw The GMRS Adapter is fabricated from titanium alloy (titanium -6 Aluminum-4 Vanadium) and is available in four sizes: standard, +10mm, +20mm, and +30mm. The proximal portion of the GMRS Adapter serves as the male portion of a taper lock that is assembled to the female taper in the distal end of the MRS or GMRS Proximal Femoral Component or Extension Pieces. The distal portion of the GMRS Adapter contains a female taper that accepts the male taper of the Restoration™ Modular Distal Femoral Stems. There are scribe marks on the GMRS Adapter to allow the surgeon to orient the amount of anteversion of the MRS or GMRS Proximal Femoral Component. The proximal portion of the male taper of the GMRS Adapter contains a female thread that serves two purposes: 1) to accept the GMRS Adapter Locking Screw after the taper lock has been engaged; and 2) for mating with a separation instrument should the surgeon need to reposition the adapter after it has been assembled to the Distal Stems of the Restoration™ Modular Total Hip System.

The GMRS Adapter Locking Screw is fabricated from titanium alloy (titanium- 6 Aluminum -4 Vanadium) and is available in four sizes that correspond to the sizes of the Adapter: standard; +10mm, +20mm, and +30mm. The GMRS Adapter Locking Screw is used to augment the taper lock of the GMRS Adapter into the Restoration™ Modular Distal Femoral Stems. The GMRS Adapter Locking Screw is packaged with the corresponding size GMRS Adapter.

This document is a 510(k) summary for the Global Modular Replacement System (GMRS) Adapter, a medical device for hip replacement. The information provided heavily focuses on the device's intended use, description, indications, and contraindications. It does not contain any information regarding acceptance criteria, performance studies, sample sizes, expert ground truth establishment, or any of the other specific details requested in the prompt.

Therefore, I cannot fulfill the request as the necessary information is not present in the provided text.

Here's why, based on the requested points:

1. A table of acceptance criteria and the reported device performance: Not found. The document describes the device and its intended use, but no performance metrics are mentioned.
2. Sample size used for the test set and the data provenance: Not found. No studies involving test sets are described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not found. No information about expert review or ground truth is provided.
4. Adjudication method: Not found. No adjudication process is mentioned.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not found. The document is not a study report; it's a regulatory submission summary.
6. Standalone (algorithm only) performance: Not applicable. This is a physical medical device, not an algorithm.
7. Type of ground truth used: Not found. No ground truth is established as no performance study is described.
8. Sample size for the training set: Not applicable/Not found. This is a physical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established: Not applicable/Not found.

The document essentially states what the device is, what it's used for, and who it's for, in the context of a regulatory submission seeking substantial equivalence. It does not provide the kind of study data typically associated with performance evaluation and acceptance criteria.

Ask a specific question about this device

The Global Modular Replacement System (herein referred to as the GMRS) is intended to be used with the components of the Howmedica Osteonics Modular Replacement System (MRS), the Howmedica Osteonics Modular Rotating Hinge Knee System (MRH), and/or the Howmedica Osteonics Kinematic Rotating Hinge Knee System (KRH) in situations where replacement of extensive bone loss in the femur and/or proximal tibia is required. The Proximal Femoral Module and Distal Femoral Module of the GMRS may be used together, or with the components of the MRS, in replacement of the total femur. Indications and contraindications for this type of replacement are listed below:

Indications

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 bone is required. Limb salvage procedures would include surgical intervention for severe trauma, failed previous prosthesis, and/or Oncology indications.

The 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 Howmedica Osteonics' Modular Rotating Hinge Knee, Kinematic Rotating Hinge Knee, and/or the Modular Replacement System. There are three modules of the GMRS:

• Proximal Femoral Module
• Distal Femoral/Proximal Tibial Module
• Total Femur

Each of these modules is comprised of different components. The modules, and their individual components, are described below:

Proximal Femoral Module

The Proximal Femoral Module of the GMRS contains the following components:

• Proximal Femoral Components
• Extension Pieces
• GMRS Press Fit Stems with PureFix™ HA

Distal Femoral/Proximal Tibial Module

The Distal Femoral/Proximal Tibial Module of the GMRS contains the following new components:

• Distal Femoral Components
• Extension Pieces (as described in the section above)
• Small bushings
• Small Axle
• Proximal Tibial Component
• Proximal Tibial Inserts
• Proximal Tibia Rotating Components

Total Femur

Replacement of the total femur is accomplished by combining the following components of the GMRS:

• Proximal Femoral Component
• Extension Pieces
• Connection Pieces
• Distal Femoral Component (with appropriate bushings, axle, etc.)
• Proximal Tibial Component (with appropriate tibial rotating component, tibial insert component)

The provided document is a 510(k) Summary for the Global Modular Replacement System (GMRS). It discusses the device's intended use, indications, contraindications, and describes its components, as well as listing equivalent predicate devices.

However, it does not contain any information about acceptance criteria or specific studies that quantify the device meets acceptance criteria. The document states that "Testing was presented to support a claim of substantial equivalence to the predicate devices," but it does not detail what tests were performed, what the acceptance criteria for those tests were, or what the reported device performance was.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: This information is not present in the document.
2. Sample size used for the test set and the data provenance: This information is not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present.
4. Adjudication method for the test set: This information is not present.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: This information is not present.
6. If a standalone study was done: This information is not present.
7. The type of ground truth used: This information is not present.
8. The sample size for the training set: This information is not present.
9. How the ground truth for the training set was established: This information is not present.

The document focuses on regulatory classification, intended use, and equivalence to existing devices, common for a 510(k) submission, rather than detailed performance study results.

Ask a specific question about this device