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Total Knee components are indicated for rheumatoid arthritis, osteoarthritis, osteoarthritis, or degenerative arthritis; failed osteotomies, unicompartment, or total knee replacement. LEGION Porous CR Narrow Femoral Components are indicated for use without bone cement and are single use devices.

The subject devices of this premarket notification are the LEGION Porous CR Narrow Femoral Components, which include catalog item offerings with and without HA Coating. These Femoral Components are indicated for use without bone cement applications. The subject devices are a line extension of the predicate devices listed, which are cleared under 510(k) submission numbers K073325 and K091543, with a modification in their femoral components' outer dimensions making them Narrow Femoral Components (similar to the cleared reference device: LEGION Narrow Oxinium CR and PS Femoral Components and Device Specific Instruments cleared under K112941). The overall design of the subject device is geometrically identical to the predicate devices LEGION Porous Femoral Components (K073325, K091543) with their outer dimensional changes making them Narrow Femoral Components (Reference device K112941).

The provided text describes a 510(k) premarket notification for a medical device, specifically LEGION Porous CR Narrow Femoral Components. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials as would be required for a PMA. As such, the information you're requesting regarding acceptance criteria and performance studies in the context of AI/algorithms, human readers, and ground truth is not applicable to this document.

This document pertains to a Class II orthopedic implant (knee joint prosthesis), which is a physical device, not a software or AI-driven diagnostic tool. The performance testing conducted is engineering bench testing to ensure mechanical equivalence, not statistical performance metrics typically associated with AI.

Here's why the specific questions are not answered by the provided text:

• 1. A table of acceptance criteria and the reported device performance: The document states that "the bench performance testing met the predefined acceptance criteria," but it does not provide the specific acceptance criteria or the quantitative results of the tests (e.g., maximum stress, fatigue cycles, contact area measurements). It lists the types of tests conducted (Tibiofemoral constraint analysis, Tibiofemoral contact area analysis, Patellofemoral resistance to lateral subluxation testing).
• 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. This refers to bench testing of physical components, not data-driven studies.
• 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" for this device is established through engineering specifications and physical measurements, not expert human interpretation.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. There are no human adjudicators for the mechanical performance of this implant.
• 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 is not an AI device.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For bench testing, the "ground truth" would be the engineering specifications and physical measurements obtained from calibrated testing equipment. The document does not detail these specifics.
• 8. The sample size for the training set: Not applicable. There is no training set for this type of physical device.
• 9. How the ground truth for the training set was established: Not applicable.

In summary: The provided document is for a medical device clearance based on substantial equivalence to predicate devices, supported by engineering bench testing. It does not involve AI, image analysis, or clinical studies with human readers, and therefore, the questions you've posed are not addressed by this specific regulatory submission.

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The Smith & Nephew ANTHEM PS Total Knee System is intended for total knee arthroplasty.

Indications for Use:

1. Rheumatoid arthritis.
2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
3. Failed osteotomies, unicompartmental replacement, or total knee replacement.
4. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.

The ANTHEM PS Total Knee System is indicated for use only with cement and is a single use device.

The subject ANTHEM PS Total Knee System is a posterior stabilized implant design that includes cobalt chromium (ASTM F75) femoral components and titanium (ASTM F1472) tibia baseplate components that are intended to be used with existing GENESIS II components to complete the total knee construct. The femoral components are based on the LEGION Narrow PS (K112941) and GENESIS II PS (K951987) designs, and are available in two categories: ANTHEM Standard (Sizes: 3-8; left and right options) and ANTHEM Narrow (Sizes 1-6; left and right options). The ANTHEM Tibia Baseplates are leveraged from the GENESIS II Tibia Baseplate (K951987) design, with a modification to the stem, and provided in sizes 1-8 with left and right options. All of the implants are gamma sterilized single-use prescription devices intended to be used under the guidance of a physician at a healthcare facility.

This document is a 510(k) Premarket Notification for a medical device (ANTHEM PS Total Knee System) and focuses on demonstrating substantial equivalence to previously cleared predicate devices. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way a clinical study would for an AI/software device.

Therefore, the requested information elements related to AI device performance evaluation, such as sample size, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, are not present in this document.

However, I can provide the available information regarding the "study" that proves the device meets requirements, which in this context refers to preclinical bench testing to establish substantial equivalence.

Here's a breakdown of the available information:

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

This document does not provide a table of acceptance criteria with specific quantitative performance metrics. Instead, it relies on demonstrating substantial equivalence to predicate devices through biomechanical testing. The "acceptance criteria" here is implicitly that the device performs comparably to the predicate devices in the described tests.

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

• Sample Size: Not explicitly stated in terms of number of devices tested, but the testing was "non-clinical bench (mechanical) testing" done on "the proposed femoral and tibial components." This typically involves a set number of test samples for each device variant and test type, as per ASTM standards, but specific numbers are not detailed here.
• Data Provenance: The testing was conducted as part of the regulatory submission process for Smith & Nephew, Inc., located in Memphis, TN, USA. This is preclinical (bench) data, not clinical data from 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):

Not applicable. This is a mechanical device, and "ground truth" for mechanical testing is established by the test setup, calibration, and adherence to ASTM standards by engineers and technicians, not clinical experts for diagnostic accuracy.

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

Not applicable. This is a mechanical device; there's no "adjudication" in the clinical sense for determining ground truth.

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 document pertains to a total knee system, not an AI or software device.

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

Not applicable. This document pertains to a total knee system, not an AI or software device.

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

For this mechanical device, the "ground truth" used for testing aligns with established ASTM (American Society for Testing and Materials) standards for orthopaedic implants. These standards define the methodology and expected performance characteristics for evaluating factors like contact area and constraint. The "truth" is whether the device's mechanical performance conforms to these scientific/engineering benchmarks and is comparable to predicate devices.

8. The sample size for the training set:

Not applicable. This document pertains to a mechanical device, not an AI/ML algorithm that requires a training set.

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

Not applicable. No training set is involved for this type of device submission.

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