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Acetabular Liners:
The Trabecular Metal™ Revision Shell Liner is indicated for cemented use in the Trabecular Metal Revision Shell for initial placement or as an in situ replacement polyethylene bearing surface for joint instability, wear and/or damage.

Constrained Liners:
The Trabecular Metal Acetabular Revision System Cemented Constrained Liner is intended to be cemented into a Trabecular Metal Acetabular Revision System shell; the shell is intended for cementless fixation into the acetabulum. The Trabecular Metal Acetabular Revision System Cemented Constrained Liner is indicated for use as a component of a total hip prosthesis in complex primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intraoperative instability and for whom all other options to constrained acetabular components have been considered.

The Trabecular Metal Acetabular Revision System (TMARS) Acetabular Liner and Cemented Constrained Liner are polyethylene/metal acetabular liners, which, when used with a Trabecular Metal Acetabular Revision System Shell, forms the acetabular component of a total hip prosthesis. The acetabular liner constructs are manufactured from Longevity highly cross-linked ultra-high molecular weight polyethylene (UHMWPE). The cemented constrained liners are manufactured from Longevity highly cross-linked UHMWPE and contain a titanium alloy constraining ring. All devices in the scope of this 510(k) are sterile, single-use items.

The provided FDA 510(k) clearance letter (K243571) for the Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance acceptance criteria through the kind of study layout often associated with novel AI/software devices.

This submission is for a medical device (hip joint prosthesis components) and the "studies" conducted are non-clinical bench tests to ensure the new device performs similarly and safely to already approved devices. Therefore, the response will reflect the information provided, which is typical for a traditional medical device 510(k) clearance.

Here's an analysis of the provided document against your requested criteria:

Acceptance Criteria and Device Performance for Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners (K243571)

Based on the provided 510(k) summary, the device's acceptance criteria are primarily demonstrated through non-clinical bench testing, ensuring the new device's performance is comparable to its predicate devices and meets relevant material standards. The goal is to establish substantial equivalence, not to demonstrate a specific improvement in performance over a human baseline or a novel AI-driven diagnostic accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not detail specific sample sizes for each non-clinical test (e.g., how many liners were tested for push-out). These are typically bench tests conducted on a sufficient number of samples to statistically validate the mechanical properties. The "data provenance" in this context is from laboratory bench testing, not patient data. Therefore, concepts like country of origin or retrospective/prospective don't apply as they would for clinical studies.

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

This information is not applicable (N/A) for this type of device submission. Ground truth, typically established by expert consensus or pathology in diagnostic studies, is not a concept used for evaluating mechanical components of a hip prosthesis in a 510(k) de novo submission. The "ground truth" here is adherence to engineering standards and comparison to predicate device performance through physical testing.

4. Adjudication Method for the Test Set

This information is not applicable (N/A). Adjudication methods (like 2+1, 3+1, none) are relevant for studies involving human interpretation (e.g., radiologists reviewing images) where disagreements need resolution to establish a ground truth. For mechanical bench testing, the results are objectively measured against defined criteria or compared to predicate performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic algorithms, often comparing human readers with and without AI assistance on a set of cases. This 510(k) is for an orthopedic implant, not a diagnostic AI device.

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

This information is not applicable (N/A). This product is a physical medical device (an acetabular liner), not an AI algorithm. Therefore, "standalone algorithm" performance is not relevant.

7. The Type of Ground Truth Used

As mentioned in point 3, the concept of "ground truth" in the diagnostic AI sense (expert consensus, pathology, outcomes data) is not applicable here. The "truth" or reference for this device's performance is established by:

• Engineering specifications and material standards (e.g., ASTM F648).
• Performance of legally marketed predicate devices (demonstrating substantial equivalence through comparative bench testing).
• Biocompatibility standards (ISO 10993-1).

8. The Sample Size for the Training Set

This information is not applicable (N/A). This device is not an AI/ML algorithm that requires a "training set."

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

This information is not applicable (N/A). As there is no training set for an AI algorithm, there is no ground truth to establish for it.

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Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, atthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.

Total hip systems may be indicated for use (i) without bone cement, or (ii) for use with or without bone cement. Refer to the product labeling and literature for specific applications.

The Anthology Hip System, CPCS Cemented Hip System, and Synergy Hip System are for primary surgeries only.

The TANDEM Unipolar and Bipolar Hip System is indicated for use in patients not suitable for total hip arthroplasty, with a non-functional femoral head due to femoral neck fracture.

Acetabular Hip Components are individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of degenerative joint disease or any of its composite diagnoses of osteoarthritis, avascular necrosis, and traumatic arthritis.

Hip components are also indicated for inflammatory degenerative joint disease including theumatoid arthritis, congenital dysplasia. femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques, and fracture-dislocations of the hip.

The Constrained Liners are indicated for primary or revision patients at hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease or intraoperative instability and for whom all other options to constrained acetabular components have been considered.

The purpose of this Traditional 510(k) is the following:

• 1. To add the MR safety information to the product labels and update the MR information within the package insert for the Smith & Nephew Hip Systems included within the scope of this 510(k), and
• 2. To address several iterative legacy design changes made to the subject hip system components.

This document is a 510(k) premarket notification for hip system components and does not describe an AI medical device. Therefore, I cannot provide information on acceptance criteria or studies related to AI algorithms.

The document primarily focuses on demonstrating substantial equivalence of the described hip system components to previously cleared predicate devices. The "Performance Data" section specifically mentions Magnetic Resonance Imaging (MRI) compatibility testing and "additional testing [...] to assess the modifications made to the subject Smith & Nephew Hip Systems devices against their predicates." This indicates performance data related to physical device properties, not AI performance.

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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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DALL-MILES Cable System
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.

Femoral Heads
The indications for use for total hip and hemi hip arthroplasty include:

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.

Femoral Mesh
The indications for use for total hip and hemi hip arthroplasty include:

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.
   Surgical Mesh. Surgical Mesh is intended to be used to reinforce bone or tissue in any situation where additional strengthening and support is required due to poor bone/tissue quality.

Intramedullary Plug, Centralizer
The indications for use of total hip replacement prostheses include:
· 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,
· 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 be used 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.

Exeter X3 RimFit Cups
The indications for use for total hip arthroplasty include:

1. Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
2. Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
3. Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
4. 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.

Femoral Stems
The indications for use for total hip and hemi hip arthroplasty include:

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 V40 Femoral Stem is intended for use in total or hemi hip replacement. It is intended for cemented use only.

The devices covered by this bundled submission are Stryker Total Hip Systems which include Dall-Miles cable system components, femoral heads, femoral mesh, Intramedullary Plug, Centralizer, acetabular cups, and femoral stems. All devices are commercially available and have been cleared in prior 510(k) submissions.

This FDA 510(k) letter and summary (K240418) is for a "Stryker Orthopaedics Hip Systems Labeling Update." This submission is not for a new medical device or an AI/software device that requires performance evaluation. Instead, it is a "Change Being Effected" bundled submission to add a contraindication to the labeling of existing, already cleared Stryker Orthopaedics Hip Systems.

Therefore, the provided document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. It explicitly states under "Non-Clinical Testing" and "Clinical Testing" that these were not required as a basis for substantial equivalence because the technological characteristics of the subject devices are identical to those of the predicate devices.

In summary, the request for information regarding acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone performance is not applicable to this document, as it pertains to a labeling update for previously cleared devices, not a new device or a device requiring new performance data.

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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.

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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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Total hip replacement is indicated in the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, rheumatoid arthritis, or congenital hip dysplasia.
2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head or neck.
4. Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
5. Certain cases of ankylosis.
   The C-Stem AMT LE Hip Prosthesis is indicated for cemented use only.

The C-Stem AMT LE Hip Prosthesis is a collarless, triple-tapered, cemented femoral stem designed to be used as one component of a system of prostheses in hip arthroplasty. It is manufactured from wrought stainless steel conforming to ISO 5832-9 (Ortron-90®) and is polished overall. It is designed to be used with commercially available modular femoral heads, either metal or ceramic. The subject device is compatible with DePuy acetabular shells and liners.
The C-Stem AMT LE Hip Prosthesis is a line extension of the predicate C-Stem AMT Hip Prosthesis cleared under 510(k) numbers K042959 and K082239.
The subject C-Stem AMT LE Hip Prosthesis and the predicate C-Stem AMT Hip Prosthesis are comprised of identical materials and share common design features, including a polished full-length triple tapered intramedullary geometry, 12/14 Articul/EZE Mini Taper and a raised lateral shoulder.

The provided text is a 510(k) Summary for the C-Stem AMT LE Hip Prosthesis. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices through non-clinical testing and comparison of technological characteristics. It explicitly states that no clinical tests were conducted.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, and ground truth establishment for a clinical study proving device meets acceptance criteria cannot be extracted from this document. This type of information is typically found in documents detailing clinical trials or performance evaluations of AI/ML-based devices.

The document discusses non-clinical tests and their adherence to ISO standards and other specifications, which function as acceptance criteria for those specific tests to demonstrate substantial equivalence, but not for overall device clinical performance against established clinical acceptance criteria.

However, I can provide the following based on the document:

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

The document doesn't present a table of specific acceptance criteria for overall device performance and corresponding clinical results. Instead, it describes non-clinical tests performed to demonstrate substantial equivalence to predicate devices. The "reported device performance" in this context refers to the device meeting the requirements of these standards.

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

This information is not applicable as the document explicitly states "No clinical tests were conducted to demonstrate substantial equivalence." The non-clinical tests would have involved specific test articles (physical devices or components), but the sample sizes of these are not detailed in the summary. Data provenance is not relevant as it's not clinical 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)

This information is not applicable as no clinical tests were conducted and thus no "ground truth" established by experts in a clinical context. The non-clinical tests are evaluated against predefined engineering and material standards.

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

This information is not applicable as no clinical tests were conducted.

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

This information is not applicable. This describes a device for hip replacement surgery, not an AI/ML-based diagnostic or assistive technology that would involve "human readers" or "AI assistance."

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

This information is not applicable as this device is a physical hip prosthesis and not an algorithm.

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

This information is not applicable as no clinical tests were conducted requiring a "ground truth." The product's compliance is demonstrated through adherence to engineering and material standards.

8. The sample size for the training set

This information is not applicable as this is a physical medical device, not an AI/ML system requiring a training set.

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

This information is not applicable as this is a physical medical device, not an AI/ML system requiring a training set and ground truth establishment.

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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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MicroPort hip instruments are accessory devices and are intended to be used to assist in the implantation of MicroPort Hip Systems in their cleared indications for use.

MicroPort total hip systems are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients:

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
2. inflammatory degenerative ioint disease such as rheumatoid arthritis:
3. correction of functional deformity; and,
4. revision procedures where other treatments or devices have failed

Rough grit blast surfaces and the hydroxyapatite and titanium plasma spray coatings applied to implant surfaces are intended for uncemented arthroplasty.

Shells with BIOFOAM® metal foam coating are intended only for uncemented arthroplasty. LINEAGE® and DYNASTY® modular shells with porous metal bead coating are intended only for uncemented arthroplasty.

PRIME shells are intended only for uncemented arthroplasty.

The device modification consists of an alteration to the sterilization instructions for FDAcleared MicroPort Orthopedics' (MPO) non-sterile hip orthopedic joint replacement instruments. The subject instruments are part of MicroPort Orthopedics' hip product lines and are required to facilitate total hip arthroplasty procedures. The modification will allow the option to sterilize the subject instruments using an FDA-cleared containment device. The subject devices will be placed in an FDA-cleared containment device, which will be wrapped in an FDA-cleared CSR wrap or similar type nonwoven, medical grade wrapping material, and then steam sterilized.

The modified sterilization process of the subject instruments was successfully challenged and validated through worst-case load configurations using an FDA-cleared containment device. The intended use and sterilization parameters, such as cycle, temperature, and exposure time, remain identical to the predicate devices.

The review document provides details on the 510(k) submission for MicroPort Orthopedics Inc.'s MPO Hip Instruments, focusing on a modification to their sterilization instructions.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the specific sample sizes (number of instruments) used for the sterilization validation or vibration testing. It refers to "worst-case load configurations" for the sterilization validation, implying that a representative selection of instruments was tested under challenging conditions. The data provenance is not specified, but it would typically be generated from internal testing conducted by MicroPort Orthopedics, Inc.

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

This information is not provided. The evaluations for sterilization validation and vibration testing rely on established standards (AAMI ST77, AAMI ST79, ISTA 2A), where "ground truth" is determined by meeting the specified physical and biological parameters within the standards, not by expert consensus in the typical sense of clinical image interpretation.

4. Adjudication Method for the Test Set:

Not applicable. The tests performed are compliance-based (meeting standards) rather than requiring adjudication of subjective interpretations.

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

No MRMC study was done. This device is an orthopedic instrument, and its effectiveness is not assessed through human interpretation of cases. The study focuses on the safety and efficacy of its reprocessing (sterilization).

6. Standalone Performance:

Standalone performance was implicitly assessed through the non-clinical testing. The instruments themselves, within the specified containment devices and sterilization cycles, directly underwent the validation tests to demonstrate their ability to achieve sterility and withstand integrity challenges. There is no "algorithm only without human-in-the-loop performance" as this is not an AI/software device.

7. Type of Ground Truth Used:

The ground truth used for these tests is based on accepted industry standards and scientific principles for sterilization and product integrity:

• Sterility: Achieved by demonstrating a Sterility Assurance Level (SAL) through biological indicators and physical parameters outlined in AAMI ST77 and AAMI ST79.
• Physical Integrity: Maintained by demonstrating the instrument's ability to withstand vibration during transit as per ISTA 2A.

8. Sample Size for the Training Set:

Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set" in the context of the reported studies. The modification is related to the reprocessing of physical instruments.

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

Not applicable, as there is no training set.

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VerSys Cemented Revision/Calcar is indicated for total hip arthroplasty in patients: Whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck, or portions of the proximal femur. Arthroplasty should be performed only when more conservative methods of treatment have failed to provide symptomatic relief and when there is progressive disability.

The VerSys CRC Hip System includes femoral stems and build-up blocks that are permanent hip implants and provided sterile via gamma irradiation. The VerSys CRC Hip System include femoral stems in a variety of body sizes and lengths and build-up blocks in heights of 10mm, 20mm, and 30mm. The block is attached to the femoral stem by inserting two Tivanium® Ti-6Al-4V alloy screws into the holes provided. Only one build-up block can be attached to a femoral stem The modular connection of the femoral stem is a Morse-type 12/14 taper designed to mate with the corresponding bore of a femoral head.

This is a medical device 510(k) premarket notification and does not contain information on the acceptance criteria and study design for an AI/ML device. The document primarily focuses on demonstrating substantial equivalence of a hip prosthesis (VerSys Cemented Revision/Calcar Hip System) to a legally marketed predicate device through non-clinical performance testing.

Therefore, the requested information regarding acceptance criteria for an AI/ML device, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not present in the provided text.

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