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· Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis
· Revision of previous unsuccessful surgical procedures, either involving, or not involving, previous use of a unicompartmental knee prosthesis
· As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis
· Where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated by deficiencies of the femoral condyle/tibial plateau.

These components are intended for implantation with bone cement.

The subject Triathlon® PKR System X3® Tibial Inserts (5630-G-XXX-E) are unchanged since the last premarket notification for the devices in K180612. The subject Triathlon® PKR System X3® Tibial Inserts (5630-G-XXX), Triathlon® PKR Unicompartmental Femoral Component, and Triathlon® PKR Unicompartmental Tibial Baseplate are unchanged since the last premarket notification for the devices in K172326.

The subject Triathlon® PKR System X3® Tibial Inserts (5630-G-XXX-E), Triathlon® PKR System X3® Tibial Inserts (5630-G-XXX), Triathlon® PKR Unicompartmental Femoral Component, and Triathlon® PKR Unicompartmental Tibial Baseplate are collectively referred to throughout this submission as the subject devices.

The purpose of this "Change Being Effected" premarket notification is to add a contraindication for the Triathlon® PKR X3® Tibial Inserts, Triathlon® PKR Unicompartmental Femoral Component, and Triathlon® PKR Unicompartmental Tibial Baseplate. Additionally, minor clarifications are being made to the labeling.

The provided text is a 510(k) summary for the Triathlon PKR System, which describes a partial knee joint replacement device. This document is a regulatory submission to the FDA and primarily focuses on establishing substantial equivalence to previously cleared predicate devices.

Crucially, the document explicitly states: "No additional testing was conducted for this submission, as the only changes being made are the addition of a contraindication and minor labeling clarifications. Testing performed in the previously cleared premarket notifications is applicable to this submission."

Therefore, this specific 510(k) submission (K203099) does not contain independent studies or data proving the device meets new acceptance criteria. Instead, it relies on the acceptance criteria and studies from its predicate devices (referenced as K180612, K172326, K082567, and K071881). Without access to those specific predicate 510(k) summaries, a detailed answer to your request cannot be fully provided based solely on the text you've supplied.

However, I can extract information regarding the device's indications for use and the general statement about relying on prior testing:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this submission did not involve new testing, there are no new acceptance criteria or reported performance data specific to this submission. The device is considered to meet the same performance criteria as its predicates due to "identical in intended use, indications, design, technological characteristics and operational principles."

Missing Information (Cannot be answered from the provided text as this submission relies on predicate data):

• Sample sizes used for the test set
• Data provenance for the test set
• Number of experts used to establish ground truth for the test set
• Qualifications of those experts
• Adjudication method
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done
• Effect size of human reader improvement with AI vs. without AI assistance
• Whether a standalone (algorithm only) performance study was done
• Type of ground truth used (e.g., pathology, outcomes data)
• Sample size for the training set
• How ground truth for the training set was established

Key Takeaway from this Document:

This 510(k) submission (K203099) for the Triathlon PKR System is primarily an administrative update to add a contraindication and clarify labeling. It does not present new performance data or studies. Instead, it asserts substantial equivalence by retaining the intended use, indications, design, technological characteristics, and operational principles of its previously cleared predicate devices, thereby leveraging the testing and acceptance criteria established in those earlier submissions (K180612, K172326, K082567, and K071881). To answer the more detailed questions about acceptance criteria and study designs, one would need to review the 510(k) summaries for the predicate devices.

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The Smith & Nephew, Inc. Journey Select Knee System is intended to be used for those patients whereby conditions exist that may not be solely addressed by a device that treats a single compartment. The Journey Select Knee System is intended to replace the patellofemoral and either the medial or lateral condyle of the knee joint in patients where there is evidence of sufficient sound bone to seat and support the components. Indications include:

1. Post-traumatic arthritis;
2. Degenerative arthritis; and
3. Failed osteotomies and unicompartmental replacement.
   These indications will be used for the Journey Select Knee System, whereby a single condyle and patellofemoral regions of the knee have been affected by one or more of these conditions. The implant devices of the Smith & Nephew, Inc. Journey Select Knee System are single use only and are intended for implantation only with bone cement.

The Smith & Nephew, Inc. Journey Select Knee System is composed of existing unicompartmental femoral components, patellofemoral implant components, and unicompartmental tibial components previously cleared by FDA. These components may be used in various combinations to create a bicompartmental knee replacement prosthesis and allow the physician to choose the most appropriate option to treat the patient.

This document is a 510(k) premarket notification for the "Smith & Nephew, Inc. JOURNEY Select Knee System." It is a submission for a medical device that aims to demonstrate substantial equivalence to previously cleared devices, rather than establishing acceptance criteria and proving performance through a study in the same way one would for a novel device with a new intended use.

Here's an analysis based on the provided text, addressing your questions to the best of my ability given the nature of a 510(k) summary:

The core of this document is a claim of "Substantial Equivalence," not a study proving the device meets specific performance acceptance criteria via a clinical trial or algorithm performance study. The device is a combination of existing components already cleared by the FDA.

1. Table of Acceptance Criteria and Reported Device Performance

Strict acceptance criteria and the results of a performance study proving adherence to them are not explicitly detailed in the provided text in the manner you might expect for a novel device. Instead, the "performance" is demonstrated through substantial equivalence to predicate devices and mechanical testing.

Regarding Questions 2-7, 8, 9, these types of studies and details are generally not part of a 510(k) submission for substantial equivalence based on mechanical testing and existing components.

• No clinical study to establish these points was conducted for this 510(k) submission. The entire premise of a 510(k) is to demonstrate that a new device is as safe and effective as an already legally marketed device (the predicate).

Specifically:

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 for this type of 510(k) submission, as it relies on mechanical testing of components and equivalence to existing devices, not a clinical "test set" of patient 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. Ground truth as typically defined for diagnostic or prognostic devices (e.g., expert interpretation of images) is not relevant here. The ground truth for this device's safety and effectiveness is established by the prior FDA clearances of its individual components and the predicate devices.

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

• Not applicable. No clinical test set with adjudicated outcomes or diagnoses was described.

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 device is a knee prosthesis system, not an AI-assisted diagnostic tool.

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

• Not applicable. This device is a knee prosthesis system, not an algorithm.

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

• The "ground truth" in the context of this 510(k) is effectively the prior FDA clearance and established safety/effectiveness profiles of the individual components and the predicate devices. Mechanical testing also serves as an engineering "ground truth" for the device's physical capabilities.

8. The sample size for the training set

• Not applicable. There is no "training set" in the context of this 510(k) for a knee prosthesis system.

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

• Not applicable.

In summary: The provided document is a 510(k) premarket notification for a new combination of existing, cleared components for a knee prosthesis system. The "proof" it meets acceptance criteria (primarily safety and effectiveness) is primarily through demonstrating substantial equivalence to predicate devices that are already legally marketed and through mechanical testing showing the integrated system can withstand expected in-vivo loads. It does not involve a clinical efficacy study with patient data, expert ground truth, or AI performance metrics as would be seen for a diagnostic or prognostic device or a novel therapeutic with new mechanism of action.

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