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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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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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1. noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
2. rheumatoid arthritis;
3. correction of functional deformity;
4. revision procedures where other treatments or devices have failed; and,
5. treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

The EXETER Centralizer is intended to be used to centralize the femoral stem within the intramedullary canal and is intended to be used with bone cement.

The EXETER 2.5mm Intramedullary Bone Plug is intended to restrict the migration of bone cement down the femoral canal and permit cement pressurization during total hip arthroplasty and is intended to be used with bone cement.

The subject devices, EXETER Centralizer and EXETER 2.5mm Intramedullary Plug, are a modified version of the predicate EXETER Centralizer and EXETER 2.5mm Intramedullary Plug. The subject devices are identical to the predicate devices in design and geometry. The subject centralizers and plugs will be manufactured from Acrylic Resin Colacry1® TS2270, an alternate PMMA material.

The labeling for the modified devices is being updated to add MR Conditional labeling. This labeling was previously cleared in K171768.

The provided text describes a 510(k) premarket notification for two devices: the EXETER Centralizer and the EXETER 2.5mm Intramedullary Plug. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving device performance against specific clinical acceptance criteria through a study with experts and ground truth.

Therefore, the input text does not contain the information requested in points 1-9 of your prompt regarding acceptance criteria, study design, expert involvement, or ground truth establishment in a diagnostic or clinical performance study. The 510(k) summary explicitly states: "Clinical testing was not required as a basis for substantial equivalence."

Instead, the submission relies on:

• Comparison to predicate devices: The subject devices are stated to be identical to predicate devices in intended use, indications, design, and operational principles.
• Material change: The primary difference is a change in the PMMA material used for manufacturing.
• Non-clinical testing: This testing was performed to evaluate the new material and device mechanics, not to establish clinical performance in a human study.

The non-clinical testing performed includes:

• Biological Evaluation per ISO 10993-1: 2018
• IM Plug Off-Axis Impaction testing
• Centralizer Insertion (fracture) testing
• Centralizer retention (pull-out) testing
• Centralizer wing flexibility testing
• Material Characterization (Tensile Modulus, Ultimate Tensile Strength, Elongation at Break, Flexural Modulus, Flexural Strength, Izod Impact Strength)
• MRI Analysis

Since no clinical study with human data, expert evaluation, or ground truth establishment was conducted for this 510(k) submission, I cannot provide the requested information for points 1-9.

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