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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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Smith & Nephew Total Knee Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Total Knee Systems and their cleared Indications for Use.

Indications for Cruciate Retaining Cemented Knee Replacement:

1. Rheumatoid arthritis.
2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
3. Failed osteotomies, unicompartmental replacement, or total knee replacement.
   Cruciate Retaining Cemented Knee components are indicated for use with cement and are single use devices.

Indications for Cruciate Retaining Cementless Knee Replacement:

1. Rheumatoid arthritis.
2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
3. Failed osteotomies, unicompartmental replacement, or total knee replacement.
   Cruciate Retaining Cementless Knee components are indicated for use without cement and are single use devices.

Indications for Posterior Stabilized Cemented Knee Replacement:

1. Rheumatoid arthritis.
2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
3. Failed osteotomies, unicompartmental replacement, or total knee replacement.
4. Primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
   Posterior Stabilized Cemented Knee components are indicated for use with cement and are single use devices.

Indications for Posterior Stabilized Cementless Knee Replacement:

1. Rheumatoid arthritis.
2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
3. Failed osteotomies, unicompartmental replacement, or total knee replacement.
4. Primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
   Posterior Stabilized Cementless Knee components are indicated for use without cement and are single use devices.

Indications for Constrained Total Knees:

1. Rheumatoid arthritis.
2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
3. Failed osteotomies, unicompartmental replacement, or total knee replacement.
4. Constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are incompetent.
   Constrained Total Knee components are indicated for use with cement and are single use devices.

Indications for Hinged Total Knees:

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.
5. Hinge knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are absent or incompetent.
   Hinged Total Knee components are indicated for use with cement and are single use devices.

Subject of this Traditional 510(k) Premarket Notification are the Smith & Nephew, Inc. Total Knee System Instruments. The subject devices are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Total Knee Systems and their cleared Indications for Use. Smith & Nephew Total Knee System Instruments can be organized into instrument families which are categorized as follows: Trials, Cutting Instruments and Cutting Guides; Cutting Blocks, Alignment and Sizing Instruments, Impactors and Handles, Clamps, Extraction, Torque, Instrument Guides, and Covers and Protectors.

This document is a 510(k) Summary of Safety and Effectiveness for the Smith & Nephew Total Knee System Instruments. It explicitly states that these instruments are "accessory devices" used to assist in the implantation of Smith & Nephew Total Knee Systems.

The document does not contain any information regarding acceptance criteria or a study proving the device meets those criteria, nor does it provide details about any AI-related performance metrics.

The content is focused on:

• Device classification and regulatory information.
• Listing predicate devices (previously cleared knee systems).
• Device description (types of instruments).
• Intended use and Indications for Use for various knee replacement types (Cruciate Retaining, Posterior Stabilized, Constrained, Hinged).
• FDA clearance letter.

Therefore, I cannot provide the requested information. The document is for mechanical surgical instruments, not an AI/Software as a Medical Device (SaMD) that would typically involve performance studies with ground truth and expert reviews for diagnostic accuracy.

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