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Triathlon® Hinge Knee System:
Rotating Hinge Knee System is intended to be implanted with bone cement for the following condition(s):

• · 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/or
• · Revision is required of a failed prosthesis where has been gross instability, with or without bone loss or inadequate soft tissue.
• · And/or where segmental resection and replacement of the distal femur is required.

Triathlon® Revision Insert X3®:
General Total Knee Arthroplasty (TKR) Indications:
· Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis.
· Post-traumatic loss of knee joint configuration and function.
· Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
· Revision of previous unsuccessful knee replacement or other procedure.
· Fracture of the distal femur and/or proximal tibia that cannot be standard fracture-management techniques. Additional Indications for Total Stabilizer (TS) Components:

• · Ligamentous instability requiring implant bearing surface geometries with increased constraint.
• · Absent or non-functioning posterior cruciate ligament.
• · Severe anteroposterior instability of the knee joint.
• · Severe instability of the knee secondary to compromised collateral ligament integrity or function.

The previously cleared Triathlon® Hinge Knee (THK) System (K223528) is a tricompartmental knee system consisting of a stemmed femoral component and a stemmed tibial bearing component connected by a set of Modular Rotating Hinge (MRH) bushings and MRH axle (K222056, K002552, K994207). A bumper locks this assembly. This assembly provides motion through the MRH axle/bushing combination in the flexion/extension plane. The articulation between bearing surfaces on the underside of a tibial bearing component and a hinge tibial insert provide motion in the rotating plane. A hinge tibial insert is assembled to a revision tibial baseplate which incorporates a longitudinal bore to accept a Triathlon® tibial sleeve or an MRH tibial sleeve. Optional distal femoral and tibial augments are available to fill bone defect. The Instructions for Use and package labels for the THK components are being updated to bear the MR Conditional symbol and MR Conditional parameters.

The subject Triathlon® Bushing and Axle (Standard Assembly Pack) contains sterile, singleuse devices that are being added to the previously cleared THK System (K223528) as an alternate option to MRH bushings and MRH axle to connect a stemmed femoral component and a stemmed tibial bearing component and provide motion through the flexion/extension plane.

This premarket notification also introduces the subject Triathlon® Revision Insert X3®, which is a sterile, single-use device that is intended for use in a total knee arthroplasty with the previously cleared Triathlon® Revision Tibial Baseplate (K223528) and Triathlon® TS Femoral Component (K172326, K141056, K070095) as part of the Triathlon® Total Knee System. The subject insert is available in seven sizes, and each size is available in seven different thicknesses. The subject insert is packaged together with Cobalt-Chrome (CoCr) stabilizer pin and filler bushing subcomponents that are assembled intraoperatively. The subject insert is assembled to the previously cleared Triathlon® Revision Baseplate (K223528), which incorporates a longitudinal bore to accept the filler bushing subcomponent. The stabilizer pin is inserted through the subject Triathlon® Revision Insert X3® and extends into filler bushing assembled within the Triathlon® Revision Tibial Baseplate to provide additional stability in the insert post.

This FDA K-number document (K230416) is for a medical device, specifically orthopaedic implants (knee systems), and thus does not involve acceptance criteria or studies related to AI/ML device performance. The document only lists pre-clinical (non-clinical) testing performed on the device components, such as materials characterization, wear analysis, fatigue testing, and biocompatibility, to demonstrate substantial equivalence to predicate devices. There is no mention of an algorithm or AI model, nor any associated acceptance criteria, study designs, or ground truth establishment relevant to AI/ML performance.

Therefore, I cannot fulfill your request for information related to AI/ML device acceptance criteria and study details based on the provided document. The document explicitly states: "Clinical testing was not required as a basis for substantial equivalence."

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This Rotating Hinge Knee System is intended to be implanted with bone cement for the following condition(s):

• · 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/or
• · Revision is required of a failed prosthesis where there has been gross instability, with or without bone loss or madequate soft tissue.
• · And/or where segmental resection and replacement of the distal femur is required.

The subject THK System is a line extension to the existing Triathlon® Knee System and will be a modified version of the predicate Modular Rotating Hinge (MRH) Knee System and Triathlon® Total Knee System. The THK System is a tricompartmental knee system consisting of a new hinge femoral component and a new tibial bearing component connected by a set of previously cleared MRH bushings and an MRH axle (K994207, K002552). A new bumper locks this assembly. This assembly provides motion through the MRH axle/bushings combination in the flexion/extension plane. The articulation between the bearing surfaces on the underside of the new tibial bearing component and a new hinge tibial insert provides motion in the rotating plane. The hinge tibial insert is assembled to a new revision tibial baseplate which incorporates a longitudinal bore to accept a new tibial sleeve or previously cleared MRH tibial sleeve (K994207, K002552). Optional new distal femoral and tibial augments are available to fill bone defects.

The THK System is designed to provide varus/valgus stability throughout the range of motion, internal/external rotation about the tibial axis, constraint by the bearing surface radius on the tibial bearing component, and an extensive range of size, modularity, and resection options. The subject THK System consists of:

• Hinge Femoral Components in six sizes and in left and right configurations o
• Revision Tibial Baseplates in seven sizes O
• Hinge Inserts in seven sizes and five thicknesses each hinge insert is packaged with a O standard sleeve subcomponent
• Tibial Bearing Components in three sizes O
• Bumper inserts in neutral and three degree flexion options O
• Revision Tibial Augments in eight sizes, two thicknesses and in right medial/left lateral and O right lateral/left medial options
• o Femoral Distal Augments in six sizes and two thicknesses.

The components of the subject THK System are sterile, single-use devices intended for cemented use only. They can be used with previously cleared Modular Rotating Hinge (MRH) Knee components (K994207, K002552), the Global Modular Replacement System (GMRS) (K023087), and Triathlon® Knee System components (K172634, K172326, K190991, K143396, K141056. K132624. K070095. K061521. K053514. K052917. K051948. K051146. K040267).

This document is a 510(k) Premarket Notification from the FDA regarding the "Triathlon® Hinge Knee System". It describes a medical device, specifically a knee replacement system, and outlines the non-clinical testing performed to establish its substantial equivalence to previously cleared predicate devices.

Crucially, this document states: "Clinical testing was not required as a basis for substantial equivalence."

This means that a study proving the device meets acceptance criteria involving human performance or clinical outcomes was not conducted or submitted for this 510(k) clearance due to the nature of the device (a modification/line extension of existing, cleared devices) and the regulatory pathway followed.

Therefore, I cannot provide the information requested in your prompt regarding:

• A table of acceptance criteria and reported device performance (in a clinical context)
• Sample sizes for a test set (clinical)
• Number of experts for ground truth establishment (clinical)
• Adjudication method (clinical)
• MRMC comparative effectiveness study
• Standalone (algorithm only) performance
• Type of ground truth used (clinical)
• Sample size for a training set (clinical)
• How ground truth for a training set was established (clinical)

All the testing described in the document under "Non-Clinical Testing" (pages 6-7) relates to engineering analysis, materials characterization, mechanical fatigue testing, wear analysis, biocompatibility, and shelf-life validation. These are physical and mechanical performance tests comparing the new device to the established performance characteristics of predicate devices, not studies involving human subjects or AI performance.

The document's conclusion reinforces this: "Based upon a comparison of the intended use, indications for use, design, materials and sterilization method, performance characteristics, and operational principles, the components of the subject THK System are substantially equivalent to those of the predicate devices identified in this premarket notification." The substantial equivalence is based on non-clinical data.

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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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Artisan Bone Plug: These bone plugs are intended to be placed in the femoral canal prior to the introduction of bone cement in a cemented hip procedure. The plug is placed distally to the femoral stem to help allow cement pressurization and to help prevent cement migration further down the femoral canal.
Universal Cement Restrictor: For cement spacers, mid-shaft restrictors and Cement Plugs: In cemented hip arthroplasty, when the cement spacer, restrictor and/or plug is thought to be advantageous.

The Artisan Bone Plug and Universal Cement Restrictor are commercially available devices that have been determined substantially equivalent in previous 510(k) premarket notifications. The purpose of this submission is to modify the labeling of these devices to add MR Conditional labeling and make other minor labeling updates.

Based on the provided text, the document is a 510(k) summary for a medical device (Artisan Bone Plug and Universal Cement Restrictor). It describes a labeling update for these devices, specifically adding "MR Conditional" labeling.

Crucially, the text explicitly states:

• "Clinical Testing: Clinical testing was not required as a basis for substantial equivalence."
• "There have been no changes to the technological characteristics of the subject devices as a result of the revision to the labeling. The subject devices have the same design and are manufactured from the same materials as the predicate devices."

Therefore, the document does not contain information about acceptance criteria or a study proving the device meets performance criteria in the context of clinical or AI-based performance. Instead, it relies on non-clinical testing for MR compatibility and the substantial equivalence to previously cleared predicate devices.

Here's why the requested information cannot be provided from the given text:

1. AI/Algorithm Performance: The device (Bone Plug/Cement Restrictor) is a physical implant, not an AI or software-based medical device. The concepts of "device performance" in terms of AI metrics (like sensitivity, specificity, accuracy), test sets, expert ground truth, adjudication, MRMC studies, or standalone algorithm performance are not applicable to the information provided.
2. Clinical Performance Study: The document explicitly states that clinical testing was not required for the substantial equivalence determination for this labeling update. The non-clinical testing mentioned is solely for MR compatibility (displacement, torque, image artifact, heating).
3. Acceptance Criteria Table: Since there are no clinical performance studies or AI-based performance metrics discussed, there are no acceptance criteria for such metrics. The "acceptance criteria" here would relate to regulatory compliance and the results of the non-clinical MR testing, which are described in a qualitative manner ("do not create a new worst case").

Summary of what can be extracted related to "study" and "criteria":

• Study type: Non-clinical testing for MR compatibility.
• Tests performed:
  • Magnetically Induced Displacement Force (ASTM F2052-15)
  • Magnetically Induced Torque (ASTM F2213-17)
  • Image Artifact (ASTM F2119-07, Reapproved 2013)
  • Heating by RF Fields (ASTM F2182-19)
  • Bacterial endotoxin testing (BET) per ANSI/AAMI ST72:2019 for pyrogenicity.
• "Proves device meets acceptance criteria": An engineering analysis was conducted which determined that the subject devices "do not create a new worst case" compared to devices previously tested for MR compatibility (K153345). For BET, the acceptance criterion was an "endotoxin limit of

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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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· Painful, disabling joint disease of the hip from: degenerative arthritis, theumatoid arthritis, posttraumatic 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 Liner:
· 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 Restoration Anatomic Shell is indicated for cementless use only.

The Restoration Anatomic Shell is a sterile, single-use device that is intended for cementless fixation into a prepared acetabulum for either primary or revision Total Hip Arthroplasty. The subject device substrate is manufactured from Ti-6Al-4V ELI alloy and has a porous CP-Ti coating. The materials, design features and screw hole locations of the subject Restoration Anatomic Shell are identical to the predicate device cleared via premarket notifications K153345, K151264, and K142462.

The provided text is a 510(k) summary for the Restoration Anatomic Shell, a hip joint prosthesis. It does not describe any acceptance criteria or a study that proves the device meets those criteria from a performance or clinical standpoint.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device based on material, design, and intended use, with the only changes being to the packaging configuration.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details, as this information is not present in the provided text.

Here's a breakdown of what the document does say regarding testing, which relates to the packaging change:

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

• Acceptance Criteria: The document mentions that packaging configuration changes necessitated specific testing. The criteria for these tests would be defined within the referenced standards.
• Reported Device Performance: The document states that a "ship test study was completed on the subject device to qualify the proposed packaging configuration." It also mentions "Product bioburden and cytotoxicity testing were executed as the proposed packaging configuration constitutes a change in packaging materials that contact the product after final cleaning."
  • Packaging Performance: "Testing was completed per ISO 11607-1, ASTM F1886, ASTM D4169, ASTM F2825, ASTM F88/F88M, and ASTM F2096, and ASTM F2097." The outcome is implicitly positive, as the device received 510(k) clearance, suggesting the packaging met the requirements of these standards.
  • Bioburden Performance: "Bioburden testing was completed per ISO 11737-1."
  • Cytotoxicity Performance: "Cytotoxicity testing was completed per ISO 10993-5."
  • Results: The conclusion that "The proposed modifications do not affect safety or effectiveness" implies these tests were passed, but specific performance metrics are not detailed in the provided text.

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 in the document as it did not involve clinical or performance studies for the device itself, only packaging validation.

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 there was no test set requiring expert ground truth establishment for clinical performance.

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

• This information is not applicable as there was no test set requiring adjudication for clinical performance.

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 as this is a hip joint prosthesis, not an AI-assisted diagnostic device, and no MRMC study was conducted or required.

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

• This information is not applicable as this is a hip joint prosthesis, not an algorithmic diagnostic device, and no standalone performance study was conducted or required.

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

• This information is not applicable as there was no clinical performance study for the device described. The "ground truth" for the packaging validation would be the physical and biological integrity after testing, as per the specified ISO and ASTM standards.

8. The sample size for the training set

• This information is not applicable as no training set was involved (no AI or analytical model development for device performance was described).

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

• This information is not applicable for the reasons mentioned above.

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The Trident® II Acetabular System is intended for use in total hip arthroplasty and is intended for either primary or revision Total Hip Arthroplasty.

Indications for Use:
• Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, posttraumatic 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 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 Trident® II Acetabular Shells, 6.5mm Low Profile Hex Screws and Hex Dome Hole Plug are sterile, single-use devices that are intended for cementless fixation into a prepared acetabulum for either primary or revision Total Hip Arthroplasty. The Trident® II Acetabular System is an extension of the Trident System product line and features the same locking mechanism as the current Trident® and Trident® II Tritanium® product lines. The Trident® II Acetabular Shells are intended to be used with existing Trident® polyethylene inserts, Trident Constrained Acetabular Inserts, MDM® liners and both new and existing surgical instruments.

The Trident® II Tritanium® implant consists of a unique configuration of both solid and porous sections that are simultaneously built using a Laser Rapid Manufacturing (LRM) method of additive manufacturing, applying Stryker's proprietary Tritanium® In-Growth Technology. Tritanium® is a novel highly porous titanium material designed for biological fixation. The Trident® II PSL® Clusterhole HA and Trident® II Clusterhole HA Acetabular Shells feature hydroxylapatite coating over a Commercially Pure Titanium plasma sprayed surface for cementless fixation.

This document describes a 510(k) premarket notification for the "Trident® II Acetabular System," a medical device for total hip arthroplasty. The submission asserts substantial equivalence to previously marketed predicate devices, and therefore, clinical testing was not required. The information provided focuses on non-clinical testing.

Here's an analysis of the provided text in relation to your request:

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

The document does not explicitly present acceptance criteria in a table format with corresponding reported performance for each criterion. Instead, it lists a series of non-clinical tests performed, implying that the device "meets the requirements" or was "characterized according to methods" outlined in various ASTM standards and FDA guidance documents.

Here's a partial reconstruction of what could be inferred as acceptance criteria and "device performance" based on the text:

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