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A. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis.
B. Failed osteotomy or unicompartmental replacements.
C. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.
D. The non-porous (uncoated and coated with CoCr beads without Titanium) components may only be used with cement.
E. The porous coated (CoCr beads with Titanium) components may be used with or without cement.
F. Stemmed baseplates of the CKS Plus Knee System are intended for cemented use only

The CKS Plus extension to the Consensus Knee System (CKS) is a primary fixed bearing total knee system offering flexibility to restore knee function using either cruciate retaining (CR) or posterior stabilizing (PS) components with the option of tibial cancellous screw, tibial intramedullary (IM) stem fixation, and tibial augments

The provided text describes a 510(k) premarket notification for the "CKS Plus Knee System." It details the device, its indications for use, and claims substantial equivalence to predicate devices. Crucially, as a 510(k) summary for a medical device (a knee prosthesis), the focus is on demonstrating substantial equivalence through comparison to existing devices and bench testing, not on clinical performance studies involving AI or complex statistical analyses of diagnostic accuracy. Therefore, many of the requested elements for an AI/diagnostic device study (like sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, and detailed ground truth establishment) are not applicable to this type of document.

The document primarily discusses non-clinical performance data (bench testing) to verify the safety and effectiveness of the CKS Plus Knee System's components, focusing on mechanical properties and stability rather than diagnostic accuracy or human interpretation.

Here's an attempt to address the request based only on the provided text, highlighting what is (and isn't) present:

A. Table of Acceptance Criteria and Reported Device Performance

The document does not present acceptance criteria in a formal table with reported performance side-by-side, as would be typical for a diagnostic device's clinical study. Instead, it lists the types of bench tests performed and implies that the device "meets" the requirements by stating it passed. The criteria are implicit in the ASTM standards and other specified tests.

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

• Sample Size for Test Set: Not specified in terms of number of devices or components tested. The document mentions "bench testing" was carried out, but does not provide specific sample quantities for each test.
• Data Provenance: The tests are "bench testing," meaning they are performed in a laboratory setting on components or full devices, not on human subjects. Thus, there is no country of origin for human data, nor is it retrospective or prospective in that context.

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

• Experts: Not applicable. This is not a study requiring expert consensus for ground truth on diagnostic performance. The "ground truth" for mechanical testing is adherence to validated ASTM standards and engineering principles.

D. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This is not an image-based or diagnostic study requiring adjudication of expert interpretations.

E. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size.

• MRMC Study: No, an MRMC study was not done. This device is a knee prosthesis, not an AI or diagnostic tool that relies on human interpretation of cases. Therefore, there is no "effect size of how much human readers improve with AI vs without AI assistance" to report.

F. If a Standalone (algorithm only without human-in-the-loop performance) was done

• Standalone Performance: Not applicable. This is a physical medical device (knee implant), not an algorithm or AI system.

G. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for the performance claims for this device is based on engineering standards, ASTM specifications, and mechanical testing results. For example, ASTM F1800-12 defines criteria for tray fatigue, and success is determined by meeting those predefined engineering benchmarks.

H. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This document describes the testing of a physical medical device, not the training of an AI algorithm.

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

• Ground Truth for Training Set Establishment: Not applicable, as there is no training set mentioned or implied for an AI algorithm.

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The PS2 KNEE SYSTEM is designed as a system and is not intended for substitution of components from other systems.

The indications for use are:

• A. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis.
• B. Failed osteotomy or unicompartmental replacements.
• C. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.
• D. The PS2 KNEE SYSTEM is intended for cemented use.

The PS2 Knee System is a primary fixed bearing total knee system offering flexibility to restore knee function using either cruciate retaining (CR) or posterior stabilizing (PS) components with the option of tibial cancellous screw and tibial stem fixation. The uncoated femoral components (CR and PS) and uncoated tibial baseplates (pegged, pegless, and holed) are made from cast CoCr alloy (ASTM F75), and are intended for cemented use only. The tibial inserts (CR and PS) and all-poly patellar components (oval and round) are made from UHMWPE (ASTM F648) or VitalitE (ASTM F2695). The PS2 tibial baseplate employs a modular keel, which is compatible with the previously cleared Consensus Revision Knee System (CRKS) stem and taper plug made from Titanium alloy (ASTM F1472). The PS2 holed baseplate is compatible with the previously cleared Consensus Knee System (CKS) 6.5mm cancellous bone screw made from Titanium alloy (ASTM F136). The PS2 baseplate is supplied with four preassembled cement dams made from UHMWPE and supplied with a distal plug made from UHMWPE intended for assembly in the operating room when stems are not desired.

The provided document describes the PS2 Knee System, a medical device, and its substantial equivalence to legally marketed predicate devices, rather than detailing the acceptance criteria and the study proving it meets those criteria in the context of an AI/ML device.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, ground truth, or MRMC comparative effectiveness studies because this document is for a traditional medical device (knee prosthesis), not an AI/ML device.

The document discusses:

• Indications for Use: What the device is intended for.
• Substantial Equivalence: How the device is similar to previously cleared devices.
• Non-Clinical Performance Data: Bench testing performed on the device's components to ensure safety and effectiveness, following various ASTM standards and FDA guidance for traditional medical devices. This includes topics like fatigue testing, joint stability, contact characteristics, locking mechanisms, and wear testing.

This information is typical for a 510(k) submission for a non-AI/ML device where the primary pathway to market is demonstrating substantial equivalence to a predicate device based on material properties, design, and mechanical performance.

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The Materialise TKA Guide System is intended to be used as a surgical instrument to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.

The Materialise TKA Guide System is to be used with Zimmer NexGen CR-Flex fixed bearing, Zimmer NexGen CR fixed bearing, Zimmer NexGen LPS-Flex fixed bearing, Zimmer NexGen LPS fixed bearing, Zimmer Gender Solutions Natural - Knee Flex fixed bearing, Zimmer Persona™ CR fixed bearing, Zimmer Persona™ PS fixed bearing, Zimmer Persona™ Trabecular Metal™, Vanguard® Complete Knee System, Vanguard® SSK 360, Vanguard® SSK Revision Knee System, Regenerex® Primary Tibial System, Offset & Microplasty Tibial Systems, Maxim® Complete Knee System, Ascent™ Total Knee System, and AGC® Complete Knee system, and Consensus Knee System prostheses families only.

The Materialise TKA Guides are intended for single use only.

Materialise TKA Guides are patient-specific medical devices that are designed to implant the following knee prostheses:

Zimmer NexGen CR-Flex fixed bearing, Zimmer NexGen CR fixed bearing, Zimmer NexGen LPS-Flex fixed bearing, Zimmer NexGen LPS fixed bearing, Zimmer Gender Solutions Natural - Knee Flex fixed bearing, Zimmer Persona™ CR fixed bearing, Zimmer Persona™ PS fixed bearing, Zimmer Persona ™ Trabecular Metal ™, Vanguard® Complete Knee System, Vanguard® SSK 360, Vanguard® SSK Revision Knee System, Regenerex® Primary Tibial System, Offset & Microplasty Tibial Systems, Maxim® Complete Knee System, Ascent™ Total Knee System, and AGC® Complete Knee system, and Consensus Knee System.

The Materialise TKA Guides must only be used in conjunction with the implants listed above. Consult the prosthesis labeling and instructions for use for specific patient indications, associated risks, information for use, warnings and precautions. Materialise TKA Guides is an instrument set containing a femur and/or tibia template(s).

The provided text describes a 510(k) premarket notification for the Materialise TKA Guide System. While it states that "non-clinical tests using saw bones" and "Cadaver testing" were performed to verify the system's adequacy and demonstrate equivalent product performance, it does not provide specific quantitative acceptance criteria or detailed results of a study designed to prove the device meets those criteria.

Therefore, many of the requested details cannot be extracted from this document.

Here's what can be inferred and what is missing:

1. Table of acceptance criteria and reported device performance:

The document mentions "accuracy and performance of the system is adequate to perform as intended" and "demonstrated equivalent product performance as the existing predicate devices," but it does not specify what those performance metrics or their acceptance criteria are.

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

• Sample Size: Not specified for "saw bones" or "cadaver testing."
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The tests were non-clinical, so human patient data provenance is not applicable here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided. The term "ground truth" as typically used for AI/ML validation (e.g., expert consensus) is not directly applicable to the non-clinical hardware testing described.

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

This information is not provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No, an MRMC comparative effectiveness study is not mentioned. The studies described are non-clinical (saw bones, cadaver) rather than clinical studies involving human readers or decision-making.

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

The document mentions "non-clinical tests using saw bones" and "Cadaver testing." These tests evaluate the physical guide's accuracy in transferring the surgical plan (generated by the software) to the bone. This represents a form of standalone performance evaluation for the physical guide's output accuracy based on the plan. However, the performance of the software algorithm itself in producing the initial plan is not detailed as a separate standalone study with specific metrics. The software is used "pre-operatively by a qualified surgeon to inspect, fine-tune and approve the pre-surgical plan," implying human-in-the-loop for the planning phase.

7. The type of ground truth used:

For the "saw bones" and "cadaver testing," the ground truth would likely be based on physical measurements of the actual cut/drill locations relative to the intended surgical plan. This is a form of physical measurement/dimensional accuracy rather than expert consensus, pathology, or outcomes data typically used for diagnostic or predictive AI.

8. The sample size for the training set:

The document describes the Materialise TKA Guide System, which involves software for pre-surgical planning and 3D printed surgical guides. It doesn't explicitly mention an AI/ML component with a separate "training set" in the context of a typical AI/ML development pipeline. The "Materialise TKA Planner" is software device, but its development methodology (e.g., machine learning training) is not detailed.

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

Not applicable, as a discrete training set and its ground truth establishment are not described for an AI/ML model.

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