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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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UHR Bipolar:
· Femoral head/neck fractures or non-unions.
· Aseptic necrosis of the femoral head.
· Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion.
Other Considerations:
· Pathological conditions or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
• Salvage of failed total hip arthroplasty.

Restoration GAP II Acetabular Shell:
· Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatic arthritis or late stage avascular necrosis.
· Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
· Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.
· Where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
· Segmental and/or cavitary acetabular defects which make it difficult to restore normal hip biomechanics or to reconstitute the normal structural continuity and integrity of the acetabulum, using standard total hip replacement acetabular components and procedures.

The devices covered by this submission are Stryker Hip System components:

• UHR Bipolar femoral head
• Restoration GAP II Acetabular Shell
  These devices have been previously determined substantially equivalent in prior 510(k) submissions and are commercially available.
  The purpose of this submission is to modify the labeling of these Stryker Hip System components to add MR Conditional labeling.

This document is a 510(k) summary for medical devices (UHR Bipolar Implants and Restoration GAP II Implants) and focuses on the modification of labeling to include MR Conditional information. It does not describe an AI medical device or a study involving human readers or ground truth determination in the context one would typically find for AI/diagnostic devices.

Therefore, many of the requested details about acceptance criteria, device performance, sample sizes, expert qualifications, and study designs are not applicable to the content of this document.

Here's an attempt to answer the questions based only on the provided text, highlighting what is not applicable:

1. Table of acceptance criteria and the reported device performance

   This document is a 510(k) submission for an existing medical device, primarily focused on updating labeling to include MR Conditional information. It does not describe performance metrics in the way an AI diagnostic device would (e.g., sensitivity, specificity). The "acceptance criteria" here are related to proving safety in an MR environment.

   Acceptance Criteria (for MR Safety)	Reported Device Performance (Compliance)
   Magnetically Induced Displacement Force (per ASTM F2052-15)	Tests performed, results indicate MR Conditional status is appropriate
   Magnetically Induced Torque (per ASTM F2213-17)	Tests performed, results indicate MR Conditional status is appropriate
   Image Artifact (per ASTM F2119-07)	Tests performed, results indicate MR Conditional status is appropriate
   Heating by RF Fields (per ASTM F2182-19)	Tests performed, results indicate MR Conditional status is appropriate

   Note: The document states "The labeling has been modified to include the MR conditional symbol, and to provide the parameters under which a patient who has the device can be safely scanned," implying that the devices met the acceptance criteria for the MR safety tests performed.

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

   This document describes non-clinical laboratory testing on the device itself for MR compatibility. It does not involve a "test set" of patient data or clinical images. Therefore, questions of sample size for a test set, country of origin, or retrospective/prospective nature are not applicable. The tests were performed on the device components.

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. No "ground truth" establishment by experts is described as this is non-clinical device testing, not a diagnostic or AI performance study.

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

   Not applicable. No "test set" of cases or adjudication of expert opinions is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

   Not applicable. This is not a study involving human readers or AI assistance.

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

   Not applicable. This document does not describe an algorithm or AI device.

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

   Not applicable. The "ground truth" in this context is the physical properties and behavior of the device components under MR conditions, as measured by standardized tests (e.g., compliance with ASTM standards).

8. The sample size for the training set

   Not applicable. There is no training set mentioned as this is not an AI/machine learning device.

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

   Not applicable. There is no training set and therefore no ground truth described for a training set.

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Indications:

In cemented or cementless hip arthroplasty, when an acetabular shell plug is thought to be advantageous. Indications for use when used with the Trident II Acetabular Shells.

· Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatic arthritis or late stage avascular necrosis.

• · Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
  · Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.

· Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

When used with MDM Liners

· Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

• Dislocation risks

When used with Constrained Liners

• The Trident® Constrained Acetabular Insert is indicated for use in primary and revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.

The Trident II Acetabular Shells are indicated for cementless use only.

The Acetabular Dome Hole Plug, originally cleared via K942809, is an optional device used to seal acetabular shells. The Acetabular Dome Hole Plug has a threaded disc profile that can be screwed into the threaded dome hole of an acetabular shell sealing the device. Once assembled, the inferior face of the Acetabular Dome Hole Plug will be flush with the internal surface of the acetabular shell.

This Special 510(k) submission proposes labeling modifications to the package insert that was previously cleared in K191358 for the Acetabular Dome Hole Plug for use with the compatible Stryker Acetabular Shells. Specifically, the proposed labeling change is to remove the contraindication related to obesity and replace it with a warning statement concerning patient weight.

There is no change to the design (e.g., materials, dimensions, etc.) of the Acetabular Dome Hole Plug and no change to the direction for use of the device. The intended use, packaging, and sterilization of the Acetabular Dome Hole Plug device also remain unchanged.

The provided document is a 510(k) Premarket Notification from the FDA regarding an Acetabular Dome Hole Plug. This document does not describe an AI medical device or a study proving that an AI device meets acceptance criteria.

The submission is for a material medical device (a plug for hip implants) and specifically states:

• "Performance testing was not required in support of the labeling modifications..." (Page 6)
• "Clinical testing was not required as a basis to demonstrate substantial equivalence." (Page 7)

Therefore, I cannot extract the information required to answer your prompt, as the document does not contain any information about: studies with test sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets, or AI acceptance criteria.

The document primarily focuses on a labeling modification for an existing physical medical device, arguing for substantial equivalence based on the fact that no changes were made to the device's design, materials, or function, only to its warning labels regarding patient weight.

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The Restoration® Modular Hip System is indicated for use in:

• · Noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
• Rheumatoid arthritis:
• · Correction of functional deformity;
• · Revision procedures where other treatments or devices have failed; and
• · Nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Additional indications specific to the Restoration Modular Hip System:

The Restoration® Modular Hip System is intended to be used for primary and revision total hip arthroplasty, as well as in the presence of severe proximal bone loss. These femoral stems are designed to be press fit into the proximal femur.

The Restoration Modular Hip System is a modular femoral replacement system. It is comprised of a proximal femoral body, a distal stem, and a locking bolt. The system is assembled utilizing a male/female taper, and a locking bolt to lock the proximal femoral body and distal stem. Many of the components are available in a wide variety of sizes, lengths and geometries to satisfy anatomical requirements and surgeon needs. The implants are fabricated from Titanium alloy (Ti-6AI-4V-ELI);some implants feature a plasma sprayed titanium and plasma sprayed Hydroxyapatite coating. The implants are intended for cementless use.

PROXIMAL FEMORAL BODIES
The proximal femoral bodies are available in three different styles: Cone, Broached, and Calcar, in a range of sizes. Each proximal femoral body features a plasma-sprayed Hydroxyapatite coating over plasmasprayed Titanium.

DISTAL STEMS
The stems are available in a range of diameters and lengths, straight or curved, to fit various patient anatomical requirements. The distal stems are available in two different styles: Plasma Distal Stems and Conical Distal Stems. The Plasma Distal Stems are fabricated from Titanium alloy (Ti-6Al-4V-ELI) and feature a plasma-sprayed Hydroxyapatite coating over plasma-sprayed Titanium. The Conical Distal Stems are fabricated from Titanium alloy (Ti-6Al-4V-ELI) and are grit blasted, fluted components with a taper extending the length of the stem. The Conical Distal Stems do not have a plasma sprayed Titanium or plasma sprayed Hydroxyapatite coating.

This document describes a 510(k) premarket notification for the Restoration® Modular Hip System, primarily focused on modifying the labeling to add MR Conditional language. It does not involve an AI/ML medical device. Therefore, the information required to answer your specific questions about acceptance criteria and a study proving device meets these criteria (especially in the context of AI/ML) is not present in this document.

The provided text from the FDA 510(k) submission states: "Clinical testing was not required as a basis for substantial equivalence." This is a crucial piece of information indicating that no clinical study (including MRMC or standalone performance studies, or ground truth establishment relevant to AI/ML) was performed or submitted for this particular 510(k). The device is a physical implant, not a software algorithm.

Therefore, I cannot fulfill your request for the following information based on the provided document:

1. A table of acceptance criteria and the reported device performance: Not applicable for an AI/ML device, and no performance criteria/results beyond MR compatibility testing are provided for this physical device.
2. Sample sized used for the test set and the data provenance: No clinical test set data or provenance is provided.
3. Number of experts used to establish the ground truth... and qualifications: Not applicable, as there's no AI/ML ground truth establishment.
4. Adjudication method: Not applicable.
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 study was done, as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable, as there's no AI/ML training set.
9. How the ground truth for the training set was established: Not applicable.

The document focuses on demonstrating substantial equivalence to a predicate device for a physical orthopedic implant, specifically addressing MR compatibility. The "Non-Clinical Testing" section describes in-vitro tests performed according to ASTM standards to characterize the device's compatibility in the MR environment. These tests involved:

• Magnetically Induced Displacement Force Test (per ASTM F2052-15)
• Magnetically Induced Torque Test (per ASTM F2213-17)
• Image Artifact Test (per ASTM F2119-07)
• Heating by RF Fields Test (per ASTM F2182-19e1)

The "acceptance criteria" here would be the successful demonstration that the device's magnetic properties, torque, image artifacts, and heating during MR scans are within acceptable limits as defined by these ASTM standards, allowing for "MR Conditional" labeling. The specific numerical results of these tests (e.g., precise temperature rise, displacement force) are not provided in this summary, only the methods used.

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The indications for use for total hip arthroplasty include:

• Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late-stage avascular necrosis.
• Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
• Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
• Where bone stock is of poor quality or inadequate for other reconstructive techniques, such as cementless fixation, as indicated by deficiencies of the acetabulum.
  The Exeter X3 RimFit Cup is intended for cemented use only.

This submission covers the subject Exeter X3 RimFit Cups, terminally sterilized by gas plasma (GP) or ethylene oxide (EtO).
The Exeter X3-GP RimFit Cup, terminally sterilized by gas plasma (GP), was previously cleared in K193429 and K111848. It features three subcomponents: a cup manufactured from X3 UHMWPE, a radiopaque wire manufactured from Rex 734 Stainless Steel (Orthinox), and cement spacers manufactured from SG-10 PMMA.
The Exeter X3-EtO RimFit Cup, terminally sterilized by ethylene oxide (EtO), was previously cleared in K193429. It features three subcomponents: a cup manufactured from X3 UHMWE, a radiopaque wire manufactured from Rex 734 Stainless Steel (Orthinox), and cement spacers manufactured from TS2270 PMMA.
The subject Exeter X3-GP RimFit Cup and Exeter X3-EtO RimFit Cup are compatible for use with Stryker Orthopaedics V40 femoral heads, universal taper femoral heads, and C-Taper femoral heads as previously cleared in K111848.
The purpose of the submission is to modify the labeling to remove a contraindication for obesity.

This document is a 510(k) premarket notification for the "Exeter® X3® RimFit® Cup" by Howmedica Osteonics Corp., dba Stryker Orthopaedics. The submission's primary purpose is to modify the labeling by removing a contraindication for obesity, stating that obesity should be a warning rather than a contraindication.

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

This document describes a labeling modification (removing obesity as a contraindication) for an already cleared device. Therefore, a table of acceptance criteria with specific performance metrics for the device itself is not provided and is not applicable to this submission. The submission asserts that the device is substantially equivalent to predicates, meaning its performance has already been established and accepted. The device's performance is implicitly accepted as meeting the performance of the predicate devices.

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

No new test set was used, and therefore no sample size or data provenance information is provided for the device performance itself, as this submission is not about new performance data. The decision to remove obesity as a contraindication is based on interpretation of FDA guidance regarding labeling, not new clinical or non-clinical testing of the device's physical performance.

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. No new test set or ground truth on device performance was established for this labeling modification. The decision regarding the change in contraindication/warning for obesity is based on regulatory guidance and medical judgment, not expert review of a specific test set.

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

Not applicable. No new test set requiring adjudication was performed.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is not an AI/software device, and no MRMC study was conducted.

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

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

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

For the labeling modification, the "ground truth" or basis for the change is the FDA Device Labeling Guidance #G91-1, which guides the classification of contraindications versus warnings. The manufacturer's interpretation of this guidance led to the proposed change.

8. The sample size for the training set:

Not applicable. There is no "training set" in the context of this device and submission, as it relates to updating labeling based on regulatory interpretation, not developing a new performance model.

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

Not applicable. As there is no training set, there is no ground truth establishment for it.

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Intended Use: The subject Restoration Modular 115mm Conical Distal Stem is a sterile, single-use device intended for use in total hip arthroplasty.

Indications for Use:

• Noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
• Rheumatoid arthritis;
• Correction of functional deformity;
• Revision procedures where other treatments or devices have failed; and,
• Nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
• Primary and revision total hip arthroplasty as well as in the presence of severe proximal bone loss. These femoral stems are designed to be press-fit into the proximal femur.

The subject Restoration Modular 115mm Conical Distal Stem is a line extension to the Restoration Modular Hip System. The Restoration Modular Hip System is a modular femoral replacement system comprised of three main components: the Restoration Modular Proximal Femoral Body, the Restoration Modular Distal Stem, and the Locking Bolt. Each of these components feature unique design iterations and are offered in a range of sizes, allowing for independent sizing of the proximal femoral body and the distal stem. The distal stem addresses fixation and stability, and the proximal femoral geometry allows for adjustments to anteversion, height, and offset. The Restoration Modular Hip System is designed to attain fixation and restore hip biomechanics.

The subject device is a sterile, single-use device designed to be press-fit into a prepared femoral canal for either primary or revision total hip arthroplasty and is labeled as MR Conditional. The Restoration Modular 115mm Conical Distal Stem utilizes a male locking taper for mating with one of the compatible Restoration Modular Proximal Femoral Bodies and Locking Bolt.

The furnished document is a 510(k) premarket notification from the FDA, specifically concerning a medical device called "Restoration Modular 115mm Conical Distal Stem." This document focuses on demonstrating substantial equivalence to an existing predicate device rather than presenting a study of a novel device's performance against specific acceptance criteria.

Therefore, the document does not contain any information related to:

• Acceptance criteria directly tied to device performance outcomes (e.g., accuracy, sensitivity, specificity) for a new AI/software device. This notification is for a physical orthopedic implant.
• A study that proves the device meets specific performance acceptance criteria in terms of clinical or algorithmic performance. The document focuses on non-clinical testing (fatigue, biocompatibility, shelf-life, MR safety) to demonstrate equivalence in design and material, not on a clinical performance study.
• Sample sizes for test or training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment. These elements are relevant to the evaluation of AI/software as a medical device (SaMD) where performance is measured against clinical outcomes or expert consensus.

In summary, the provided text does not describe the kind of acceptance criteria or performance study typically associated with AI/software medical devices or diagnostic tools. It is a regulatory submission for an orthopedic implant that demonstrates substantial equivalence through engineering analyses and non-clinical testing.

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The Avon Patello-femoral Joint Prosthesis is intended to be used in cemented patellofemoral arthroplasty in patients with degenerative arthritis in the distal femur and patella, patients with a history of patellar dislocation or patella fracture, or patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release) where pain, deformity or dysfunction persists.

These components are single use only and are intended for implantation with bone cement.

This submission covers the Avon femoral and patellar components of the Avon Patello-femoral Joint Prosthesis. The femoral components are manufactured from Cobalt Chrome (CoCr) and the patellar components are manufactured from Ultra-high Molecular Weight Polyethylene (UHMWPE) materials.

The purpose of this submission is to add Magnetic Resonance (MR) Conditional labeling to the labeling of the Avon femoral and patellar components of the Avon Patello-femoral Joint Prosthesis. Additionally, minor labeling and packaging updates, as detailed in the respective sections, are also included in this submission.

The provided text is a 510(k) Summary for a medical device (Avon Patello-femoral Joint Prosthesis) seeking clearance for minor labeling and packaging updates, specifically to add Magnetic Resonance (MR) Conditional labeling. This submission does not describe a study to prove the device meets acceptance criteria related to its clinical effectiveness or performance in a patient.

Instead, it describes non-clinical testing to demonstrate that the device is "MR Conditional" as per relevant ASTM standards. Therefore, many of the requested categories are not applicable to the information provided.

Here's the breakdown of what can be extracted:

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

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

This information is not provided. The testing was non-clinical (laboratory testing of the device components), not involving human subjects or patient data.

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. The ground truth for the MR Conditional testing is established by the ASTM standards themselves, which define methodologies and criteria for measurement. No human experts were involved in establishing "ground truth" for this non-clinical testing.

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

Not applicable. This was non-clinical, objective testing against predefined engineering 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

Not applicable. This document is not about AI or diagnostic imaging interpretation. It is for a joint prosthesis and its MR compatibility.

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

Not applicable. This document is not about an algorithm, but a physical medical device.

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

The "ground truth" for the non-clinical testing was defined by adherence to published ASTM standards for MR compatibility. These are objective engineering and physics standards.

8. The sample size for the training set

Not applicable. This was non-clinical testing, not a machine learning study.

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

Not applicable. This was non-clinical testing, not a machine learning study.

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The DALL-MILES System is indicated for reattachment of the trochanter in any hip procedure using the trochanteric osteotomy (total or partial) approach.

The DALL-MILES Mini Cleat is indicated for vertical reattachment or reinforcement of the trochanter in any situation where the surgeon feels that the trochanter is at risk for detachment.

The Mini Cleat is intended for use with the DALL-MILES System for trochanteric reattachment only.

The DALL-MILES Cables and Cable Sleeves are indicated for trochanteric reattachment and trauma surgery of the hip; to stabilize bone graft material; and for supplementary cerclage fixation with plates and screws for fracture fixation.

The DALL-MILES Trochanteric Grips and Grip Plates are indicated for use in the fixation of the greater trochanter due to trochanteric fracture or osteotomy with intramedullary fixation as the primary device.

The DALL-MILES Trochanteric Grip Plate is additionally indicated for use in the fixation of the greater trochanter due to extended trochanteric osteotomies.

The devices covered by this submission include cables, beaded cables, cable sleeves, trochanteric grips, trochanteric grip plates, and mini cleat. All devices have been previously determined substantially equivalent in prior 510(k) submissions and are commercially available. The Dall-Miles Cable System components are manufactured from stainless steel or cobalt chromium alloy (Vitallium®) materials.

The purpose of this submission is to modify the labeling of the Dall-Miles Cable System to add MR Conditional labeling.

This document is a 510(k) premarket notification for the Dall-Miles® Cable System, focusing on adding MR Conditional labeling. It does not describe an AI/ML-driven medical device requiring human performance studies for its acceptance criteria. Therefore, most of the requested information (sample sizes, expert qualifications, ground truth establishment, MRMC studies, standalone performance, training set details) is not applicable to this submission.

However, I can extract the relevant information regarding the device's acceptance criteria and the study performed to meet them, specifically for its MR Conditional labeling.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them for its MR Conditional labeling:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as a numerical 'sample size' of patients or data points in the clinical sense. Instead, the "test set" pertains to the physical Dall-Miles Cable System components themselves, tested in a laboratory setting. The typical approach for device material testing like this involves testing a sufficient number of representative samples of each device configuration to ensure robust and reproducible results according to the specified ASTM standards. The document doesn't specify the exact number of physical samples tested.
• Data Provenance: This was non-clinical laboratory testing conducted to characterize the compatibility of the device in the MR environment. The document does not specify a country of origin for the data; it would be generated in a lab setting where the physical tests are performed. It is analogous to "prospective" testing as it's specifically conducted for this submission.

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

• Number of Experts: Not applicable. The "ground truth" for MR compatibility is established by adherence to recognized engineering standards (ASTM) and FDA guidance documents. These standards define the methodologies and acceptable limits for MR environments.
• Qualifications of Experts: The work is implicitly performed by engineers, physicists, and technicians with expertise in medical device testing, MR physics, and relevant ASTM standards.

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

• Adjudication Method: Not applicable. This is not a human reader study requiring adjudication of interpretations. The tests are objective measurements against defined 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:

• MRMC Study: No. This submission does not involve an AI/ML-driven device or a human reader study.

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

• Standalone Performance: No. This is not an AI/ML algorithm.

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

• Type of Ground Truth: The ground truth for MR Compatibility in this context is defined by scientific principles, relevant engineering standards (ASTM), and FDA guidance documents that specify the acceptable parameters and methodologies for evaluating device behavior in an MR environment. It's essentially "physical laws and established engineering standards."

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable. There is no AI/ML model or training set involved.

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

• Ground Truth Establishment for Training Set: Not applicable. There is no training set involved.

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