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Triathlon® 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 inadequate soft tissue.

When used with MRH femur and/or MRH tibial baseplate replacement indicated in revision of an existing prosthesis:

• Revision is required of a failed prosthesis where there has been gross instability, with or without bone loss or inadequate soft tissue.

When used with compatible GMRS components:

• Where segmental resection and/or replacement of femur and/or proximal tibia is required

The subject THK components are a line extension of the previously cleared Triathlon® Hinge Knee System (K223528, K230416). The THK System (K223528, K230416) is a tricompartmental knee system consisting of a stemmed femoral component and a stemmed tibial bearing component connected by a set of previously cleared MRH or THK Bushings and an MRH or THK Axle (K994207, K002552, K223528, K230416). A bumper locks this assembly. This assembly provides motion through the MRH or THK Axle/Bushings combination in the flexion/extension plane. The articulation between the bearing surfaces on the underside of a tibial bearing component and a tibial insert provides motion in the rotating plane. A hinge tibial insert is assembled to a Triathlon® Hinge Revision Tibial Baseplate that incorporates a longitudinal bore to accept a previously cleared MRH Tibial Sleeve (K994207, K002552) or Triathlon Tibial Sleeve (K223528, K230416). Optional distal femoral and tibial augments are available to fill bone defects.

The subject Triathlon® Hinge Small Proximal Tibial Bearing Component and Triathlon® End Cap are sterile, single use devices intended for cemented use only and are being added to the previously cleared THK system (K223528, K230416) as an extension. They can be used with previously cleared MRH Knee components (K994207, K002552), GMRS (K023087, K222056), and Triathlon® Knee System components (K172634, K172326, K190991, K143393, K141056, K132624, K070095, K061521, K053514, K052917, K051948, K051146, K040267).

This FDA 510(k) clearance letter is for a mechanical medical device (a knee implant system), not an AI/software as a medical device. Therefore, the request for "acceptance criteria and the study that proves the device meets the acceptance criteria" using metrics relevant to AI/software (like sensitivity, specificity, MRMC studies, ground truth for training/test sets, etc.) is not applicable here.

The document provided details about the substantial equivalence of the "Triathlon® Hinge Knee System" to previously cleared predicate devices. The "study" proving the device meets acceptance criteria for a mechanical implant typically involves non-clinical (benchtop) testing and engineering analyses to demonstrate performance, material compatibility, and safety, rather than clinical trials or AI performance evaluations with ground truth.

Here's how the provided information relates to the typical evaluation of such a device, addressing the closest analogues to your requested points:

Acceptance Criteria and Device Performance for a Mechanical Implant:

For mechanical implants like the Triathlon® Hinge Knee System, "acceptance criteria" are generally tied to the successful completion of various non-clinical (benchtop) tests and analyses. These tests simulate the physical stresses and conditions the implant will experience in the human body. The "study" proving the device meets these criteria is the execution and successful outcome of these non-clinical tests.

No direct table of "acceptance criteria" vs. "reported device performance" in the AI sense is provided in this 510(k) summary. Instead, the summary lists the types of non-clinical tests performed to demonstrate performance and substantial equivalence to predicate devices. The implied acceptance is that the device passed these tests, meaning its performance in these simulated scenarios was deemed acceptable and comparable to existing, legally marketed devices.

Table of Non-Clinical Tests (Analogous to Performance Metrics):

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The ATTUNE Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology are intended for cementless use within the ATTUNE® Total Knee Replacement System. Porous coated implants may be used with or without cement.

Candidates for total knee replacements with a severely painful and/or impaired knee function resulting from osteoarthritis, post-traumatic arthritis, or a failed previous implant (provided that adequate bone is present).

The ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology are compatible with the ATTUNE Knee System composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint. The femoral component is a metal implant without porous coating. The tibial component may be comprised of a metal tibial base with or without porous coating, and a polyethylene insert and locking components, or be an all polyethylene device. The patella component may be of an all polyethylene design or a polyethylene patella with porous metal backing.

The ATTUNE Porous FB Tibial Base with AFFIXIUM 3DP Technology is manufactured from Titanium alloy (Ti-6Al-4V), available in sizes 1-10, and intended for cemented use within the ATTUNE Total Knee Replacement System. The bone apposing surfaces are comprised of 3D printed fixation features with a porous and solid geometry that enable biological fixation of the bone. The proximal surface is designed to work with currently available ATTUNE FB tibial inserts.

The ATTUNE Porous Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology are manufactured from 3D printed Titanium alloy (Ti-6Al-4V) substrate for the bone opposing surfaces with the articulation surface being produced from AOX ultra high molecular weight polyethylene (UHMWPE). The patellae are available in sizes 32, 35, 38, and 41mm and are intended for cementless or cemented use within the ATTUNE Total Knee Replacement System. The articular surface is designed to work with currently available ATTUNE Femoral Components.

This document is a 510(k) summary for the ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology. It outlines the device description, intended use, and comparative analysis with predicate devices to demonstrate substantial equivalence, rather than providing a study proving specific performance criteria for the device itself.

Therefore, the requested information regarding acceptance criteria and a study proving device performance in the context of an AI/human reader study (items 1-9) is not applicable to this document. This document pertains to the regulatory clearance of a medical implant, not an AI or diagnostic software.

However, based on the non-clinical tests performed to demonstrate substantial equivalence (as described on page 7), we can infer the types of performance aspects considered for regulatory approval of such a device:

The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section on page 7 lists the following tests performed:

• Peg Fatigue Testing for ATTUNE Cementless Patella
• Stryker Peg Fatigue Benchmark Testing for ATTUNE Cementless Patella
• Biocompatibility Evaluation Report (Patella)
• MRI Testing (Tibial Base & Patella)

These tests are designed to assess the safety and efficacy of the implant in terms of its mechanical properties, material compatibility with the human body, and compatibility with MRI imaging. The acceptance criteria for these tests would typically be defined by relevant ASTM or ISO standards for orthopedic implants, and the device would be considered to 'meet' these criteria if its performance falls within the established limits of these standards or is demonstrated to be equivalent to the predicate device.

No information regarding AI performance, human reader studies, or associated metrics like sensitivity, specificity, or effect sizes for AI assistance is present in this product clearance document.

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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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The Stryker Spine Tritanium® PL Cage is an intervertebral body fusion device indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.

Additionally, the Tritanium® PL Cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.

The Tritanium® PL Cage is to be implanted via a posterior approach.

The Tritanium® PL Cage is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.

The Tritanium® PL Intervertebral Body Fusion Cage is intended for use as an aid in lumbar spinal fixation. The cage is a hollow, rectangular implant that consists of a unique configuration of both solid and porous structures that are simultaneously built using Laser Rapid Manufacturing (LRM) method applying Stryker's proprietary Tritanium® In-Growth Technology. The lordotic angles to adapt to a variety of patient anatomies. It has serrations on the superior and inferior porous surfaces of the implant for fixation, an ergonomically shaped anterior edge, and a flat posterior edge. The implant is designed to be used with supplemental fixation cleared for use in the lumbosacral spine. The Tritanium® PL cages are constructed from Titanium alloy: Ti-6Al-4V (ASTM F1472-08) and are provided sterile.

The provided text is related to a 510(k) premarket notification for a medical device called the "Tritanium® PL Cage," an intervertebral body fusion device. The document primarily focuses on demonstrating substantial equivalence to predicate devices and does not detail a study involving AI or human reader performance. Therefore, I cannot provide information on the majority of the requested points.

However, I can extract the acceptance criteria and the summary of non-clinical testing for the device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes non-clinical testing performed in compliance with specific guidance and ASTM standards to demonstrate substantial equivalence. The "reported device performance" is the successful compliance with these tests, indicating that the device met the required mechanical and material properties.

The following points cannot be answered based on the provided text, as the document describes a 510(k) submission for an intervertebral body fusion device focusing on mechanical and material testing, not a study involving AI for image analysis or human reader performance.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable/Not provided. The testing described is mechanical and material testing of the device itself, not a clinical study with patients or data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not applicable/Not provided. Ground truth in the context of AI or diagnostic studies is not relevant to the mechanical device testing described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/Not provided.
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. This type of study was not conducted or reported.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable/Not provided. The "ground truth" for this device would be its physical and mechanical properties as measured against established standards.
8. The sample size for the training set: Not applicable/Not provided. This is not an AI algorithm, so there is no training set.
9. How the ground truth for the training set was established: Not applicable/Not provided.

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The Triathlon® Tritanium® Cone Augment is intended for use in primary or revision total knee arthroplasty where there is a femoral and/or tibial metaphyseal defect secondary to trauma, failed previous prosthesis, or severe degeneration. The Triathlon Cone Augment is intended to be affixed to the mating femoral and/or tibial component using bone cement. The cones are intended for fixation as an assembled construct in the distal femur and/or proximal tibia, with or without bone cement.

The Triathlon® Tritanium® Cone Augment is an extension of the Triathlon® Total Knee System product line intended to be used as an optional accessory component in primary or revision Total Knee Arthroplasty. It is a sterile, single-use device that is compatible for use with other Triathlon® Total Knee System components. The Tritanium® Cone Augment is composed of commercially pure titanium (raw material per ASTM F1580, processed material per ASTM F67).

The subject device is designed to be used with the Triathlon® TS femoral components and Triathlon® Universal baseplates and is compatible with other Triathlon® Total Knee System components. The cones are intended to be cemented to the respective Triathlon femoral and/or tibial component, and are intended for fixation within the proximal tibia or distal femur with or without bone cement. Tritanium Femoral and Tibial Cones are intended to be used where there is a femoral and/or tibial metaphyseal defect secondary to trauma, failed previous prosthesis, or severe degeneration.

There are three designs of Triathlon Tritanium Cone Augments:

• Femoral Cone Augments
• Symmetric Tibial Cone Augments
• Asymmetric Tibial Cone Augments

The provided FDA 510(k) summary for the Triathlon® Tritanium® Cone Augments indicates that no clinical studies were performed or required to establish substantial equivalence. Instead, the determination was based on non-clinical (laboratory) testing, a comparison of technological characteristics, intended use, and materials to predicate devices.

Therefore, the requested information regarding acceptance criteria, device performance from a clinical study, sample size for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details cannot be provided from this document as no such clinical studies were conducted or reported.

However, I can extract the non-clinical acceptance criteria and the reported performance from the laboratory testing:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical Testing):

The following information cannot be provided from this document as no clinical studies were performed:

2. Sample size used for the test set and the data provenance: Not applicable, as no clinical test set was used. The non-clinical tests involved various laboratory setups and simulated environments, often comparing against predicate devices or regulatory standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical test set requiring expert ground truth was used.
4. Adjudication method for the test set: Not applicable, as no clinical test set was used.
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, as this device is a physical implant and not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this device is a physical implant and not an algorithm.
7. The type of ground truth used: Not applicable for clinical ground truth. For non-clinical tests, the "ground truth" was established by engineering standards, material specifications (e.g., ASTM F67, ASTM F1800), and compliance with FDA guidance documents.
8. The sample size for the training set: Not applicable, as no machine learning algorithm was involved, hence no training set.
9. How the ground truth for the training set was established: Not applicable, as no machine learning algorithm was involved.

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