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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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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 Episealer Patellofemoral System is intended to be used in patients with osteoarthritis limited to the distal patellofemoral joint, patients with a history of patellar dislocation or patellar fracture, and those patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release, etc.) where pain, deformity or dysfunction persists.

The device is intended for cemented fixation.

The Episealer Patellofemoral System is a patient-individualized arthroplasty device which replaces a damaged patellofemoral joint. The subject device consists of two components:

• . Episealer PF
• Patellar Component ●

The Episealer PF component is implanted centrally in the trochlear area of the distal femur. The Patellar Component is implanted on the backside of the patella and articulates with the Episealer PF.

The provided text describes a 510(k) premarket notification for the Episealer® Patellofemoral System, an orthopedic device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a new device's safety and effectiveness through extensive clinical trials with pre-defined acceptance criteria.

As such, detailed information regarding acceptance criteria for a specific performance metric, and a study proving those criteria were met in the same way one would assess an AI/ML algorithm, is not available in this document.

However, I can extract the information that is present regarding performance testing, even though it's not structured around explicit acceptance criteria and corresponding performance metrics in the way you've requested for an AI model.

Here's an attempt to answer your request based on the provided text, highlighting what is included and what is explicitly not mentioned:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics like "sensitivity", "specificity", "AUC", or "agreement" as would be seen for an AI/ML device. Instead, it describes general performance testing and analyses.

Summary of Performance Testing:

The document states: "Performance Testing Summary: Wear testing of the Episealer Patellofemoral System was performed. In addition, analyses of contact area and cantilever bending strength were conducted. A cadaver study was conducted to demonstrate that the components of the patient-matched Episealer Patellofemoral System can be accurately placed relative to the pre-planned position, with proper recession and engagement of the Episealer PF and Patellar components. The testing, engineering analyses, and cadaver study demonstrate the ability of the Episealer Patellofemoral System to perform as intended in the target population."

This section indicates that the device underwent standard engineering and mechanical testing relevant to orthopedic implants, as well as a cadaver study to verify surgical placement. However, specific acceptance criteria (e.g., "wear rate must be less than X," "contact area must be within Y range") and the quantitative results against those criteria are not provided in this 510(k) summary. The conclusion is a qualitative statement: "demonstrate the ability... to perform as intended."

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

• Sample Size for Test Set: Not specified in the provided summary. The text only mentions "wear testing," "analyses of contact area and cantilever bending strength," and "A cadaver study." The number of cadavers or individual test repetitions is not given.
• Data Provenance: Not specified.

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 is not applicable in the context of this device. A medical device like the Episealer Patellofemoral System undergoes engineering, mechanical, and cadaveric testing, not evaluation against expert-defined "ground truth" labels in the way an AI/ML diagnostic tool would.

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

This is not applicable for the type of testing described (mechanical testing, cadaver study).

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 is not applicable. This is an orthopedic implant, not an AI-assisted diagnostic tool.

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

This is not applicable. This is an orthopedic implant, not an algorithm. The device itself is a standalone implant that is surgically placed.

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

The concept of "ground truth" as used for AI/ML evaluation does not directly apply here. Instead, performance is assessed through:

• Engineering measurements (wear, contact area, bending strength) against industry standards or internal specifications.
• Cadaveric surgical validation, where the "truth" would be successful implantation according to surgical protocols and demonstration of intended function.

8. The sample size for the training set

This is not applicable. This is not an AI/ML device that requires a training set.

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

This is not applicable. This is not an AI/ML device that requires a training set.

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RESTORIS™ Multicompartmental Knee (MCK) System is indicated for single or multi-compartmental knee replacement used in conjunction with RO®, the Robotic Arm Interactive Orthopedic System, in individuals with osteoarthritis or posttraumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces. The specific knee replacement configurations include:

• · Medial unicondylar
• · Lateral unicondylar
• · Patellofemoral
• · Medial bi-compartmental (medial unicondylar and patellofemoral)

RESTORIS™ Multicompartmental Knee (MCK) System is for single use only and is intended for implantation with bone cement.

The purpose of this Changes Being Effected premarket notification is to add a contraindication for the Restoris Multicompartmental Knee (MCK) System. Additionally, minor modifications are being made to the contraindications for clarity. There is no change to the intended use, indications, design, technological characteristics or operational principles for the devices. The subject implant components are identical to the predicate components. The Restoris MCK system was most recently cleared in K180612, and has also been cleared previously in K172326, K150307, K090763, K082172, K082088, K082081, and K080368.

This FDA 510(k) submission [K220930] for the Restoris Multi-Compartmental Knee System does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

The document explicitly states:

• "The purpose of this Changes Being Effected premarket notification is to add a contraindication for the Restoris Multicompartmental Knee (MCK) System. Additionally, minor modifications are being made to the contraindications for clarity." (Page 4)
• "There is no change to the intended use, indications, design, technological characteristics or operational principles for the devices." (Page 4)
• "No additional testing was performed as part of this submission, as the only changes being made are to the labeling for the devices. There is no impact to the device design or the physical characteristics of the devices. Testing submitted as part of previously cleared premarket notifications is applicable to this submission." (Page 5)

Therefore, based on the provided text, I cannot fill in the requested information about acceptance criteria and study results because this particular 510(k) submission is for a labeling change and explicitly states that no new testing was performed. The performance data and acceptance criteria would have been part of previous 510(k) submissions (e.g., K180612, K172326, etc.) referenced in this document.

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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 stabilized by standard fracture-management techniques.

The Triathlon Tritanium Tibial Baseplate and Tritanium Metal-Backed Patella components are indicated for both uncemented and cemented use.

The Triathlon Total Knee System beaded and beaded with Peri-Apatite components are intended for uncemented use only.

The Triathlon All Polyethylene tibial components are indicated for cemented use only.

Additional Indications for Posterior Stabilized (PS) and 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.

Additional Indications for Total Stabilizer (TS) Components:

• Severe instability of the knee secondary to compromised collateral ligament integrity or function.

Indications for Bone Augments:

• Painful, disabling joint disease of the knee secondary to: degenerative arthritis, rheumatoid arthritis, or post-traumatic arthritis, complicated by the presence of bone loss.
• Salvage of previous unsuccessful total knee replacement or other surgical procedure, accompanied bone loss.

Additional Indications for Cone Augments

• Severe degeneration or trauma requiring extensive resection and replacement
• Femoral and tibial bone voids
• Metaphyseal reconstruction

The Triathlon Tritanium® Cone Augments are intended for cemented or cemented or cementless use.

The Triathlon® Posterior Stabilized (PS) Femoral Component - beaded with Peri-Apatite (PA) and Triathlon® Cruciate Retaining (CR) Femoral Component - beaded with Peri-Apatite (PA) are components of the Triathlon® Total Knee System previously cleared via 510(k)s K051380, K141056 and K172326. The subject Triathlon® Femoral Components are components of the Triathlon® Total Knee System and are used in total knee arthroplasty procedures. The subject Triathlon® Femoral Components are available in 8 different sizes and in left and right configurations that are anatomically suited to the left or right knee. The subject Triathlon® Femoral Components are manufactured from cast cobalt-chrome-molybdenum alloy (ASTM F75) with a cobalt-chrome-molybdenum alloy (ASTM F75) double layer porous coating (beading) on the femoral fixation surface. Additionally, the subject Triathlon® Femoral Components are coated with Peri-Apatite (ASTM F1185).

The design and materials of the subject Triathlon® Femoral Components are identical to the predicate Triathlon® Femoral Components cleared via 510(k)s K051380, K141056 and K172326. The proposed modification is to introduce automated equipment for the first and second porous coating (beading) application process steps for the subject Triathlon® Femoral Components. There are no modifications proposed to the other components of the Triathlon® Total Knee System previously cleared via 510(k)s K051380, K141056 and K172326. The subject Triathlon® Femoral Components will have the same performance specifications as the predicate Triathlon® Femoral Components cleared via 510(k)s K051380, K141056 and K172326.

This document describes the Stryker Corporation's 510(k) submission for the Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite and Triathlon Cruciate Retaining Femoral Component - beaded with Peri-Apatite. The submission, K200782, aims to demonstrate substantial equivalence to previously cleared devices.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to predicate devices and the performance of non-clinical testing. The device is considered to meet these criteria if it demonstrates "substantial equivalence" and the proposed modification does not affect safety or effectiveness.

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

The document does not explicitly state a sample size in the context of a test set for clinical performance. The evaluation conducted here is primarily non-clinical, focusing on the comparison of an updated manufacturing process against existing devices.

• Test Set: Not applicable in the traditional sense of a clinical test set with patient data. The "test set" consists of the subject Triathlon Femoral Components undergoing non-clinical testing.
• Data Provenance: The testing was non-clinical laboratory testing. No geographical or temporal (retrospective/prospective) information is provided as it's not human subject data.

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

Not applicable. This submission relies on non-clinical testing for performance characteristics, specifically for the porous coating process. The "ground truth" is established through physical and material science testing standards, not expert consensus on medical images or diagnoses.

4. Adjudication Method for the Test Set

Not applicable. As described above, the evaluation is based on non-clinical laboratory testing, not a human reader assessment requiring adjudication.

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 a submission for an orthopedic implant (knee femoral component), not an AI-powered diagnostic or assistive device that would involve human readers.

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

Not applicable. This is not an algorithm or AI device. The "performance" being evaluated is the physical and material characteristics of a medical implant after a manufacturing process change.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth used for proving the device meets acceptance criteria is based on non-clinical laboratory testing standards and direct comparison of material properties and design to legally marketed predicate devices. Specifically, it mentions "Testing for porous coating type a. beaded, sintered cobalt-chrome coatings on a cobalt-chrome substrate as per FDA guidance document, 'Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,' dated April 28, 1994."

8. The Sample Size for the Training Set

Not applicable. Since there's no clinical study or AI algorithm involved, there is no "training set" in the context of this submission. The device is a physical implant.

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

Not applicable as there is no training set.

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Indications for Use:

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.

The Triathlon® Tritanium® Total Knee System components are indicated for both uncemented use.

The Triathlon® Total Knee System beaded with Per-Apatite components are intended for uncemented use only.

The Triathlon® All Polyethylene tibial components are indicated for cemented use only.

Additional Indications for Posterior Stabilized (PS) and 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.

Additional Indications for Total Stabilizer (TS) Components:

· Severe instability of the knee secondary to compromised collateral ligament integrity or function.

Indications for Bone Augments:

· Painful, disabling joint disease of the knee secondary to: degenerative arthritis, rheumatoid arthritis, or post-traumatic arthritis, complicated by the presence of bone loss.

· Salvage of previous unsuccessful total knee replacement or other surgical procedure, accompanied by bone loss.

Additional Indications for Cone Augments:

• Severe degeneration or trauma requiring extensive resection and replacement
• · Femoral and Tibial bone voids
• · Metaphyseal reconstruction

The Triathlon TS Cone Augments are intended for cemented or cementless use.

The additional components being added to the Triathlon Total Knee System are:

• Size 0 Cruciate Retaining Femoral Component (cemented use) .
• o Size 0 Primary Cemented Tibial Baseplate
• Size 0 Tritanium Tibial Baseplate for cemented/cementless use ●
• Size 0 CR, CS, and PS Tibial Inserts in X3 ETO and N2Vac ●
• New PS Femoral Component with modified intercondylar PS box (cemented use) ●
• o New PSR (Posterior Stabilizing Rotation ) tibial insert in sizes 0-8 in X3 ETO

Additionally, engineering analyses and finite element analyses were presented to document the range of motion available with the Triathlon Total Knee System.

This document is a 510(k) summary, which is a premarket notification to the FDA to demonstrate that a device is at least as safe and effective as a legally marketed predicate device. It is not a clinical study report that would typically include detailed acceptance criteria and performance data for an AI/ML device.

Therefore, the provided text does not contain the information needed to describe acceptance criteria and a study proving a device meets them, especially for an AI-based medical device. The document concerns modifications to an existing total knee system (implants), not an AI/ML device.

The questions you've asked are highly relevant for the regulatory approval of AI/ML medical devices. If this document were for an AI/ML device, here's how I would break down why the requested information is missing:

Reasoning for Missing Information (Applicable if this were an AI/ML device submission):

The provided text is a 510(k) summary for a "Triathlon Total Knee System - Additional Components." This is a premarket notification for an orthopedic implant (knee replacement components), not an AI/ML (Artificial Intelligence/Machine Learning) device.

The questions posed are specifically for describing the regulatory submission and study design for an AI/ML medical device, which often requires:

• Demonstrating performance metrics (e.g., sensitivity, specificity, AUC) against established acceptance criteria.
• Detailing the ground truth establishment process (expert consensus, pathology, etc.).
• Describing the size and provenance of training and test datasets.
• Explaining human-in-the-loop studies (multi-reader multi-case studies).

Since the device under review is a physical medical implant (knee components), these types of studies and acceptance criteria are not applicable. The sponsor instead provides:

• Engineering analyses and finite element analyses: To document range of motion.
• Non-clinical testing: Fatigue testing, static shear testing, contact area/stress analysis, range of constraint, sterilization validation, and MR Conditional status.
• Bacterial endotoxin testing.

The document explicitly states: "Clinical Testing: Clinical testing was not required as a basis for substantial equivalence." This further confirms that the type of performance evaluation relevant to AI/ML devices was not conducted or required for this orthopedic implant.

In summary, none of the requested information regarding acceptance criteria, study design for AI/ML device performance, sample sizes for training/test sets, ground truth establishment, or human expert involvement is present in this 510(k) summary because it pertains to a mechanical orthopedic implant, not an AI/ML software device.

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