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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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The Modular Rotating Hinge Knee System is intended to be implanted with bone cement for the following conditions:

• · 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 prostheses where there has been gross instability, with or without bone loss or inadequate soft tissue

Indication for Use for Duracon Components (Cobalt Chrome & Titanium Stems, and Tibial Wedges) and Stryker Stem Components:
Indications for use of total knee replacement prostheses include:

• · noninflammatory degenerative joint disease including osteoarthritis or avascular necrosis;
• rheumatoid arthritis;
• · correction of functional deformity;
• · revision procedures where other treatments or devices have failed;
• · post-traumatic loss of joint anatomy, particularly when there is patello-femoral erosion, dysfunction or prior patellectomy: and
• · irreparable fracture of the knee.

Indications for US and Rest of World for Total Stabilizer Offset Adapter:
Indications for use of total knee replacement prostheses include:

1. Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis or avascular necrosis;

• 2. Rheumatoid arthritis;

3. Correction of functional deformity:
4. Revision procedures where other treatments or devices have failed;
5. Post-traumatic loss of joint anatomy, particularly when there is patello-femoral erosion, dysfunction or prior patellectomy: and.
6. Irreparable fracture of the knee
   When the Total Knee Replacement Prosthesis is used with the components of the Modular Rotating Hinge Knee System, the indication for the Modular Rotating Hinge Knee with Offset Adapters is as follows:
   The Rotating Hinge Knee Systems are intended to be implanted with bone cement for the following condition(s):
7. There is destruction of the joint surfaces, with or without significant bone deformity.
8. The cruciate and/or collateral ligaments do not stabilize the knee joint.
9. The ligaments are inadequate and/or the musculature is weak and/or,
10. Revision is required of a failed prosthesis where there has been gross instability, with or without bone loss or inadequate soft tissue.

GMRS Pediatric Tibial Bearing Component:
Replacement of the distal femur and/or proximal tibia in Oncology cases where radical resection and replacement of bone is required, and in limb salvage procedures where radical resection and replacement of the bone is required. Limb salvage procedures would include surgical intervention for severe trauma, failed previous prosthesis, and/or Oncology indications. This smaller size component is intended to be used in patients with a smaller bone structure, or in skeletally immature patients. This component is intended for use with bone cement.

MRS Pediatric All Poly Tibial Component:
MRS Pediatric All Polyethylene Tibial Component is intended to be used in oncology patients where radical resection of the distal femur/proximal tibia is required. Additional indications include limb salvage procedures where radical resection and replacement of the distal femur/proximal tibia is required. Limb salvage includes surgical intervention for severe trauma, failed previous knee arthroplasties, and/or oncology indications.

The Modular Rotating Hinge (MRH) Knee System is a tri-compartmental knee system that consists of a stemmed femoral component and a stemmed tibial rotation component, connected by a set of bushings and an axle. A bumper locks this assembly. This assembly provides motion through the axle/bushing combinations in the flexion/extension plane. The articulation between the cylindrical bearing surfaces on the underside of the tibial rotating component and a tibial insert provide motion in the rotation plane. The tibial insert is assembled to a tibial stemmed tray which incorporates a longitudinal bore to accept a tibial sleeve.
The Modular Rotating Hinge Knee System is designed to provide varus/valgus stability throughout the range of motion, internal/external rotation about the tibial axis, constrained by the bearing surface radius on the tibial rotating component, and an extensive range of size, modularity and resection options. The implant system consists of a femoral component in five sizes, a tibial rotating component in five sizes, tibial crossover bearing components in various sizes, bumper inserts, tibial and femoral augmentation components and a tibial sleeve. The MRH Knee System is compatible with components of the Kinemax/Kinematic Knee System, Duracon Knee System, Howmedica Total Stabilizer Knee System, and the GMRS/MRS System.

This document is a 510(k) premarket notification for several knee joint prostheses and related components. The submission's purpose is to modify the labeling of these devices to include "MR Conditional" information. Therefore, the "device" in question for this prompt is the MR Conditional labeling for the existing knee implant systems, not a new or modified implant design itself. The study discussed relates to the safety of these existing implants in an MRI environment.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a "sample size" in terms of number of physical devices tested or a number of patients or images. The testing described is non-clinical testing (phantom/bench testing) performed on the device components themselves to evaluate their interaction with MRI fields.

• Sample Size: Not specified as typically understood for clinical studies (e.g., number of patients/images). This refers to physical samples of the device components or simulated constructs used in bench testing.
• Data Provenance: This is non-clinical/bench testing data, likely generated in a laboratory setting by the manufacturer or a contract testing facility. "Country of origin" for non-clinical testing is not specified, but the applicant is based in Mahwah, New Jersey, USA. The testing is retrospective in the sense that it's performed on manufactured devices, but it's a prospective evaluation of their MRI safety characteristics.

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

For this type of non-clinical, MRI safety testing, "ground truth" is not established by human experts in the same way it would be for diagnostic image interpretation. The "ground truth" is determined by the physical measurements against established safety standards (e.g., ASTM standards for magnetic force, torque, heating, and artifact). The "experts" involved would be technicians and engineers skilled in conducting these specific non-clinical tests and interpreting their results against the predefined standard limits. Their qualifications would involve expertise in materials science, biomechanics, and MRI physics, along with knowledge of the relevant ASTM standards and FDA guidance documents. The document does not specify the number or specific qualifications of these individuals.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are typically for clinical studies where human reviewers assess data. For non-clinical, objective measurements against established standards, the test results themselves, when within the specified limits of the standards, serve as the "adjudication."

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

No. The document explicitly states: "Clinical testing was not required as a basis for substantial equivalence." This is a non-clinical evaluation of device safety with MRI, not a comparative study of diagnostic performance or human reader improvement.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a physical knee implant component, not an algorithm or AI software. The testing evaluated the physical device's interaction with MRI machines.

7. Type of Ground Truth Used

The ground truth used in this submission is based on established engineering and medical device safety standards (specifically ASTM standards F2052-15, F2213-17, F2119-07, F2182-19e1) and FDA guidance documents (e.g., "Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment..." and the May 2021 guidance document for heating in tissue). The "truth" is whether the measured physical properties (displacement, torque, artifact, heating) fall within the acceptable limits defined by these recognized standards and guidance.

8. Sample Size for the Training Set

Not applicable. This is not a machine learning or AI-based device, so there is no "training set." The testing performed is non-clinical for MRI safety.

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

Not applicable, as there is no training set for this type of device.

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The Duracon® Posteriorly Stabilizer (PS) Lipped Tibial Inserts are intended to be used with legally marketed Duracon® tibial baseplates and wedges, femoral components, and patellar components as part of a total knee system in primary or revision cemented total knee arthroplasty. These inserts are intended to be used in cases where there is destruction of the joint surfaces with or without bone deformity, where the cruciate ligaments are inadequate, not present, or cannot be preserved during the operative procedure, especially when anterior-posterior stability is impaired due to absence of the patella. The collateral ligaments may or may not be used for revision of a failed prosthesis.

Indications

• Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis or avascular necrosis,
• Rheumatoid arthritis,
• Correction of functional deformity,
• Revision procedures where other treatments or devices have failed,
• Post-traumatic loss of joint anatomy, particularly when there is patello-femoral erosion, dysfunction or prior patellectomy; and,
• Irreparable fracture of the knee

The Duracon® PS Lipped tibial inserts share the same critical design features as the predicate Duracon® Stabilized tibial inserts. They both have the same snap-fit locking mechanism, augmented by a locking screw, for mating with the current Duracon® tibial baseplates (K915512). The subject Duracon inserts are intended to be used with current Duracon® femoral and patellar components. The subject inserts will be available in the same range of sizes and thicknesses and are manufactured from the same materials as the current Duracon® Stabilized inserts.

The subject inserts have an anterior/posterior (A/P) lipped feature to enhance femoral/tibial implant anterior stability in full extension. In addition, the subject inserts incorporate a patellar cut-out feature to improve patellar tracking.

This document, K012172, is a 510(k) Summary for the Duracon® PS Lipped Tibial Insert. This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. As such, it focuses on comparing the new device to existing ones rather than presenting novel clinical study data.

Therefore, the provided text does not contain the detailed information required to fill out the requested table regarding acceptance criteria and a study proving those criteria are met.

Here’s why and what can be extracted:

• Acceptance Criteria and Reported Device Performance: The document states, "Mechanical testing has been performed to demonstrate the substantial equivalence of the subject inserts to the predicate inserts." It does not provide specific quantitative acceptance criteria (e.g., specific thresholds for wear, fatigue strength, range of motion) or the actual results of these tests. It only asserts that the new device shares critical design features and uses the same materials and manufacturing methods as the predicate device.
• Study That Proves the Device Meets Acceptance Criteria: The study mentioned is "Mechanical testing." No further details about this testing (e.g., type of tests, parameters, results, sample sizes) are provided.

Therefore, it is not possible to complete the requested table and answer many of the questions based on the provided text.

However, I can extract the general nature of the evidence and the claim made:

Summary of Device Performance Evidence (Based on available information):

• Claim: The Duracon® PS Lipped Tibial Inserts are substantially equivalent to the predicate Duracon® Stabilized Tibial Inserts (K932070 and K936292).
• Evidence Type: Mechanical testing.
• Rationale for Equivalence:
  • Shared critical design features (snap-fit locking mechanism, augmented by a locking screw).
  • Intended use is identical.
  • Available in the same range of sizes and thicknesses.
  • Manufactured from the same materials.
  • Fundamental scientific technology, basic design concepts, and manufacturing methods have not changed.

Unable to Extract from the Provided Text:

• Specific Acceptance Criteria: Not detailed.
• Specific Reported Device Performance: Not detailed beyond the assertion of substantial equivalence.
• Sample size used for the test set: Not mentioned.
• Data provenance (e.g. country of origin of the data, retrospective or prospective): Not mentioned.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for mechanical testing.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for mechanical testing.
• 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 medical device, not an AI diagnostic tool).
• If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable for mechanical testing.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

In essence, this document is a regulatory submission demonstrating substantial equivalence based on design, materials, and mechanical testing that supports that equivalence, rather than a detailed report of a clinical study or specific acceptance criteria for performance.

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The Duracon®, P.C.A.® and Kinemax® Plus Tibial Inserts, All Plastic Tibial Components and Patellar Components (proviously cleared in K915512, K923573, K910235, K922048, K932070, K913188, K872735, K871772 and K921640) are intended to be used with Duracon®, P.C.A.® or Kinemax® femoral components, tibial baseplates and patellar components in primary or revision cemented total knee arthroplasty.

This submission includes wear testing data on UHMWPE Knee Components sterilized by the method previously cleared in 510(k) submission K936292. This data is provided to substantiate claims of improved wear due to the processing of the devices. The submission includes Duracon®, P.C.A.® and Kinemax® Plus Tibial Inserts, All Plastic Tibial Components and Patellar Components which are intended to be used with Duracon®, P.C.A.® or Kinemax® Plus femoral components, tibial baseplates and patellar components in primary or revision cemented total knee arthroplasty.

This submission details the wear testing of Howmedica's Duration™ Stabilized UHMWPE Knee Components to substantiate claims of improved wear. The study compares the wear performance of the stabilized UHMWPE against conventionally gamma sterilized UHMWPE in various in vitro wear tests.

Here is an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The submission does not explicitly state pre-defined acceptance criteria in numerical terms (e.g., "must show at least X% reduction"). Instead, the reported device performance is the claim being substantiated, implying that any measured reduction in wear would be considered a positive outcome. The FDA's substantial equivalence determination suggests acceptance of these claims.

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

• Sample Size: The document refers to "a block" and "a 9mm thick circular disk" for the unaged tests, and "a 9 mm thick circular disk" for the aged test, both for the Duration™ Stabilized UHMWPE and the conventionally gamma sterilized UHMWPE for comparison. This phrasing suggests a sample size of one test article for each condition (stabilized vs. conventional, unaged vs. aged) for each type of test. However, wear testing typically involves multiple samples to ensure reproducibility and statistical significance. The limited detail provided here implies either a single sample per comparison or a simplified reporting of the outcome from multiple samples.
• Data Provenance: The tests were conducted as "in vitro tests" in an "independent laboratory test." The country of origin is not specified but is presumably the USA, given the FDA 510(k) submission. The data is prospective in the sense that these were controlled experiments specifically designed to test the wear properties.

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

Not applicable. This study involves in vitro mechanical wear testing, not a clinical study or diagnostic device assessment where expert opinion would establish ground truth. The "ground truth" for wear is established by the measured weight loss or volume displacement during the mechanical tests.

4. Adjudication Method for the Test Set

Not applicable. This is an in vitro mechanical test, not a clinical review requiring adjudication. The measurements of wear are objective.

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

No, an MRMC comparative effectiveness study was not done. This study is an in vitro mechanical wear test of materials, not a diagnostic imaging study involving human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done

Yes, in a way. The tests performed are standalone in the sense that they are material property tests performed in a lab setting, independent of human interaction once initiated. There is no "algorithm" in the context of AI, but the measurements of wear are objective outcomes of the material's performance under simulated conditions.

7. The Type of Ground Truth Used

The ground truth used is measured volumetric wear. This is an objective measurement obtained through laboratory testing (reciprocating ring-on-block wear test and reciprocating pin-on-disk wear evaluations) using established scientific methods (weight loss to calculate volume change, or direct volume measurement if applicable).

8. The Sample Size for the Training Set

Not applicable. This study does not involve a "training set" in the context of machine learning or AI algorithms. It is an in vitro study of material properties.

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

Not applicable, as there is no training set for an AI algorithm in this context.

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The Duracon® Femoral Posterior Spacer is intended to be used with the femoral components of the Duracon® Total Knee System (reference premarket notifications K910235, K920034, K932070, and K954138) to augment bone loss in the area of the posterior condyle of the femur. Posterior bone loss that requires augmentation by spacers may be noted in primary or revision total knee arthroplasty cases.

The Duracon® Femoral Posterior Spacer is cemented to the femoral component, and then the spacer-femoral component assembly is cemented into place.

The provided 510(k) summary for the Duracon® Femoral Posterior Spacer Device (K963242) is a premarket notification for a medical device. This type of document is filed with the FDA to demonstrate that a medical device is substantially equivalent to a legally marketed predicate device.

It is important to understand that 510(k) summaries, especially from 1996, typically do not contain the type of detailed performance criteria and study results that would be found in a current regulatory submission for an AI/ML-based diagnostic device. The regulatory landscape and expectations for evidence of performance have evolved significantly since 1996, particularly concerning software as a medical device and AI.

Therefore, most of the requested information regarding acceptance criteria and detailed study data (like sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance of an algorithm) is not present in the provided text. The device described is a physical implant, not an AI diagnostic tool.

Below is an attempt to answer your questions based only on the provided text, acknowledging its limitations for an AI/ML context:

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

2. Sample sized 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 document does not describe a "test set" in the context of an AI/ML study. Clinical data or testing that would typically be described with sample sizes, provenance, or retrospective/prospective nature is not included in this 510(k) summary for a physical implant. The basis for clearance is substantial equivalence to predicates, not specific clinical trial data described here.

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. This information is relevant for validating diagnostic algorithms, not for the clearance of a physical orthopedic implant. No ground truth establishment by experts for a "test set" is mentioned.

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

• Not Applicable / Not Provided. See response to question 3.

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 / Not Provided. This device is a physical knee implant component, not an AI system or an aid for human interpretation. Therefore, an MRMC study related to AI assistance is not relevant or described.

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

• Not Applicable / Not Provided. This device is a physical product, not an algorithm.

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

• Not Applicable / Not Provided. Given this is a physical implant, "ground truth" for its performance would implicitly relate to its mechanical properties, biocompatibility, and clinical outcomes (e.g., in vivo stability, wear characteristics, patient function). However, these are not quantified or discussed as "ground truth" in this summary. The primary "ground truth" for its regulatory acceptance is its substantial equivalence to predicate devices, which have already demonstrated appropriate safety and effectiveness.

8. The sample size for the training set

• Not Applicable / Not Provided. The concept of a "training set" is for AI/ML models. This document refers to a physical device.

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

• Not Applicable / Not Provided. See response to question 8.

Summary of Limitations:

The provided document (K963242) is a 1996 510(k) summary for an orthopedic implant. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study data or performance metrics using methodologies common for AI/ML devices in today's regulatory environment. Therefore, most of the questions, particularly those pertaining to AI/ML validation (test sets, training sets, expert consensus, adjudication, MRMC studies), cannot be answered from the given text.

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