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U2 Total Knee System - PF+ is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, primary and secondary traumatic arthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral joint surface erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. This device may also be indicated in the salvage or previously failed surgical attempts or for knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. Femoral Component, PF+, Tibial Baseplate, PF+ and Tibial Extension Stem are indicated for both cemented and cementless use.

There are three components included in U2 Total Knee System- PF+ for this 510k, (1)Femoral Component, PF+, (2)Tibial Baseplate, PF+, and (3)Tibial Extension Stem. Both Femoral Component, PF+ and Tibial Baseplate, PF+ can collocate with U2 Total Knee System tibial insert and patellar component (K021657, K051640, K082469, K103733, K131864, K132752, K150829, K152430, K161705, and K210961). This system includes Cruciate Retained (CR) type and Posterior Stabilized (PS) type.

• Femoral Component, PF+
There are two types of Femoral Component, PF+ : Cruciate Retaining type and Posterior Stabilized type. Femoral Component, PF+ is manufactured from cast Co-Cr-Mo alloy conforming to ASTM F75. The inner surface is coated with Co-Cr-Mo beads and Co-Cr-Mo powder (ASTM F75) to provide a porous surface to achieve biological fixation.

• Tibial Baseplate, PF+
Tibial Baseplate, PF+ is manufactured from titanium alloy (ASTM F620) which is forged by titanium alloy bars (ASTM F136). The backside of the subject device is coated with Titanium powder (ASTM F1580).

• Tibial Extension Stem
Tibial Extension Stem is collocated with tibial baseplate. The subject device is made of titanium alloy conforming to ASTM F136.

The provided document (K221705) is a 510(k) summary for a medical device called the "U2 Total Knee System-PF+". This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices.

It is crucial to understand that this document describes a mechanical orthopedic implant (knee replacement components), not an AI-powered or software-based medical device. Therefore, the concepts of acceptance criteria for AI performance, training and test sets for AI models, expert ground truth for imaging, MRMC studies, or standalone algorithm performance are not applicable to this submission.

The document discusses acceptance criteria and proof of meeting them, but these relate to the mechanical and material properties, biocompatibility, and sterilization of the knee implant components, not to the performance of an AI algorithm.

Therefore, I cannot provide the requested information for an AI-powered device based on this document.

However, I can extract information relevant to the device's performance, which is related to its mechanical and material integrity:

Information from the document relevant to the device's "performance" (mechanical/material):

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

The document broadly states that "the test results indicated that this device is safe and effective" and that "Verification activities on Subject devices demonstrated equivalent safety and effectiveness as compared to the predicate devices."

Specific acceptance criteria (e.g., "fatigue strength must exceed X N at Y cycles") and the exact reported values are not explicitly provided in a table format within this 510(k) summary. The summary typically refers to the fact that these tests were conducted and met the necessary standards for substantial equivalence.

However, the types of performance tests conducted are listed:

2. Sample sized used for the test set and the data provenance:

• Sample Size: Not explicitly stated for each mechanical test. For mechanical testing of components, samples typically refer to a number of physical units or prototypes tested, not patient data.
• Data Provenance: The tests are performed by the manufacturer, United Orthopedic Corporation (located in Hsinchu City, Taiwan). The testing is primarily laboratory-based mechanical and material characterization, not clinical data. Therefore, concepts like "country of origin of the data" or "retrospective/prospective" in the clinical sense are not applicable.

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 question is not applicable. This device is a mechanical implant, not an AI system interpreting medical images. "Ground truth" in this context would be defined by engineering specifications, material standards (e.g., ASTM F75, F136, F620, F1580), and validated test methodologies (e.g., fatigue testing standards). The "experts" involved would be materials scientists, mechanical engineers, and quality assurance professionals, whose qualifications are implicit in the adherence to recognized standards.

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

This question is not applicable. Mechanical tests have specific physical or chemical endpoints determined by validated methods and equipment, not human subjective interpretation 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:

This question is not applicable. MRMC studies are for assessing diagnostic accuracy of imaging or AI systems with human readers. This device is a mechanical implant.

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

This question is not applicable. This device is a mechanical implant.

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

The "ground truth" for this device's performance is established by:

• Adherence to international and national standards for materials (e.g., ASTM F75, F136, F620, F1580).
• Validated mechanical testing methodologies (e.g., fatigue testing, surface finish measurements).
• Biocompatibility standards (e.g., USP for endotoxin).
• Comparison to the established performance characteristics of predicate devices.

8. The sample size for the training set:

This question is not applicable. There is no AI model or "training set" for this mechanical device.

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

This question is not applicable.

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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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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 Tritaium® Metal-Backed Patella components are indicated for both uncemented and cemented use.

The Triathion® 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 by bone loss.

The Triathlon® Tritanium® Metal-Backed Patella is an extension of the Triathlon® Total Knee System product line for use in primary and revision Total Knee Arthroplasty. It is a sterile, single-use, non-modular metal-backed patella that is manufactured from UHMWPE (ASTM F648) and commercially pure titanium (ASTM F1580). The device is offered in symmetric and asymmetric designs that are available in multiple sizes. The metalbacking features a porous-coated posterior surface and three porous-coated pegs to provide cemented or cementless fixation to bone.

This document, a 510(k) Summary for the Triathlon® Tritanium® Metal-Backed Patella, focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study of a device meeting specific acceptance criteria through performance data. Therefore, many of the requested elements for describing an acceptance criteria study are not present in this submission.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not contain a table of acceptance criteria with corresponding device performance metrics in the typical sense of a clinical or analytical performance study. Instead, it lists non-clinical laboratory tests performed to demonstrate substantial equivalence to predicate devices. The "reported device performance" in this context is the successful completion of these tests, implying that the new device performs comparably to the predicates.

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

• Sample Size: Not explicitly stated for each test. For non-clinical laboratory testing, the sample size typically refers to the number of test articles (patellar components) subjected to each specific test. This tends to be much smaller than clinical study sample sizes and is dependent on the specific ASTM standard or internal protocol used.
• Data Provenance: The tests are non-clinical laboratory tests, likely conducted by the manufacturer (Stryker Orthopaedics) or a contract laboratory. The "country of origin of the data" would typically be the location of the testing facility, which is not specified but presumed to be a regulated environment. The data is retrospective in the sense that these are engineering and material characterization tests performed on manufactured devices.

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

This information is not applicable as this submission is for a medical device and relies on engineering and material testing standards (ASTM) to demonstrate substantial equivalence, not on expert ground truth for an AI or diagnostic device.

4. Adjudication Method for the Test Set

This is not applicable. The "test set" here refers to physical components undergoing laboratory testing, not, for example, medical images requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is used for diagnostic or AI-assisted devices to assess human reader performance. This submission is for a physical orthopedic implant.

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

No, a standalone algorithm performance study was not done. This concept applies to AI/software as a medical device, which this orthopedic implant is not.

7. The Type of Ground Truth Used

The "ground truth" for this submission are the established engineering and material specifications, as well as the performance characteristics of the predicate devices. The new device is tested against these benchmarks (often defined by ASTM standards) to show that its properties are within acceptable ranges and comparable to the predicates.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of an orthopedic implant submission based on substantial equivalence through non-clinical testing. This term is relevant for machine learning algorithms.

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

This is not applicable for the same reasons as point 8.

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