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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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• 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 Triathlon® PKR System is a modular unicondylar knee prostheses consisting of sterile, single-use components intended for replacement of the medial or lateral femoral condyle regions for either the right or left knee.

This document, K071881, pertains to the 510(k) summary for the Triathlon® PKR System, a knee prosthesis. It focuses on demonstrating substantial equivalence to predicate devices rather than providing performance data against specific acceptance criteria for a novel device. Therefore, much of the requested information regarding acceptance criteria, study details, and ground truth establishment is not present in this type of submission.

Here's a breakdown of the available information based on your request:

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

• Acceptance Criteria: Not explicitly stated as quantifiable metrics. The submission's primary "acceptance criteria" for the 510(k) clearance process is demonstrating substantial equivalence to legally marketed predicate devices in terms of intended use, design, materials, and operational principles.
• Reported Device Performance: The document states that "Based upon the mechanical testing, the Triathlon® PKR System is substantially equivalent for its intended use to other femorotibial replacement knees currently on the market." However, no specific performance metrics (e.g., wear rate, fatigue strength values, range of motion, clinical outcomes) or a comparison table against acceptance criteria are provided in this summary. Instead, it refers to "mechanical testing" generally.

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

• This information is not provided in the 510(k) summary. The submission focuses on demonstrating substantial equivalence through design and material comparisons and the mention of general mechanical testing, not a clinical study with a test set of patients.

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 information is not applicable/not provided. Ground truth establishment by experts for a test set is typically relevant for studies evaluating diagnostic or AI-driven devices. This submission concerns a physical implant (knee prosthesis).

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

• This information is not applicable/not provided for the same reasons as point 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

• This information is not applicable/not provided. MRMC studies are relevant for diagnostic devices, particularly those involving human interpretation of images with or without AI assistance. This submission does not describe such a study.

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

• This information is not applicable/not provided. This device is a physical knee implant, not an algorithm.

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

• For the purpose of substantial equivalence for a physical implant, the "ground truth" is typically established through:
  • Material properties and design specifications: Demonstrating that the materials and design conform to established standards and are equivalent to predicate devices.
  • Mechanical testing: In vitro laboratory tests (e.g., fatigue, wear, strength) serve as the "ground truth" for demonstrating the physical robustness and performance characteristics under simulated conditions. The summary mentions "mechanical testing" but does not detail the specific tests or their results.
  • Clinical history of predicate devices: The long-standing safe and effective use of the predicate devices implicitly forms a "ground truth" for the intended use and performance expectations.

8. The sample size for the training set

• This information is not applicable/not provided. A "training set" is relevant for machine learning algorithms, not for the regulatory submission of a physical medical device like a knee prosthesis.

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

• This information is not applicable/not provided for the same reason as point 8.

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