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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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Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result; failed osteotomies, unicompartmental replacement, or total knee replacement. Posterior stabilized knee systems are designed for use in primary and revision surgery, where the anterior and posterior cruciate ligaments are absent or incompetent and the collateral ligaments remain intact. The Smith & Nephew Legion Porous Plus HA Primary Femoral Components are indicated for use without bone cement and are single use devices.

Legion Porous Plus HA Primary Femoral Components are geometrically identical to the Legion Porous Primary femoral components cleared via K073325. This premarket notification seeks only to add a hydroxylapatite (HA) coating to the porous coated areas of the femoral implants. The subject devices will be initially offered in both cruciate retaining (CR) and posterior stabilizing (PS) designs in sizes 1-8 in right and left hand configurations. The subject devices will utilize the same articular inserts as the non-HA coated Legion Porous Primary femoral components cleared via K073325 and will use existing Genesis II tibial baseplate and patellar components cleared via K030612.

This 510(k) premarket notification for the LEGION Porous Plus HA Primary Femoral Components does not present a study proving the device meets specific acceptance criteria in the way a clinical study for diagnostic accuracy would.

Instead, this submission establishes substantial equivalence to previously cleared predicate devices through a comparison of design, indications, and mechanical testing. The acceptance criteria here are related to demonstrating this equivalence, rather than a quantifiable performance metric for a new claim.

Here's a breakdown of the requested information based on the provided document, noting where information is not applicable due to the nature of this 510(k):

1. Table of Acceptance Criteria and Reported Device Performance

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 in the context of a clinical test set. The provided document describes mechanical testing and a comparison to predicate devices, not a clinical study with a test set of patient data. The "test set" here would refer to the samples of the device undergoing mechanical evaluation. The document does not specify the number of samples used for mechanical testing. Data provenance is not specified.

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 submission relies on engineering and regulatory review (mechanical testing, equivalence to predicate device specifications), not expert clinical adjudication of a test set for diagnostic performance.

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

• Not applicable. See 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

• No. This is not a diagnostic AI device.

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

• No. This is not an algorithm or AI device.

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

• The "ground truth" in this context is established by:
  • Mechanical Engineering Standards: The ability of the device to withstand expected in vivo loading, demonstrated through standard mechanical tests.
  • Predicate Device Specifications: The established design, indications, materials, and HA coating of previously cleared devices (K073325 and K032683).

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device that requires a training set.

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

• Not applicable. See point 8.

Summary of the Study/Evidence:

The "study" in this 510(k) is primarily a comparison of the new device (Legion Porous Plus HA Primary Femoral Components) to legally marketed predicate devices and verification through mechanical testing. The core argument is manufactured equivalence and performance consistency with devices already on the market.

The key "evidence" presented is:

• Geometric identity to the Legion Porous Primary femoral components (K073325).
• Use of the same HA coating as devices in the Genesis II Porous Plus HA Knee System (K032683).
• Mechanical testing results showing the device is capable of withstanding expected in vivo loading without failure, indicating equivalence to clinically used devices.
• Similar overall design, indications, and materials to the predicate device.

This approach is typical for 510(k) submissions where a new device is very similar to an already cleared one, with minor modifications (in this case, the addition of an HA coating to an existing femoral component design). The "acceptance criteria" are met by demonstrating this substantial equivalence.

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Smith & Nephew's Patient Matched Cutting Blocks are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking of bone before cutting.

The Patient Matched Cutting Blocks are intended for use with existing Smith & Nephew, Inc. knee systems and their cleared indications for use.

The Patient Matched Cutting Blocks are intended for single use only.

Subject of this premarket notification are Smith & Nephew's Patient Matched Cutting Blocks. The Patient Matched Cutting Blocks are designed and manufactured from patient imaging data (MRI, CT, X-Ray).

This 510(k) submission for Smith & Nephew's Patient Matched Cutting Blocks is for a physical medical device (patient-specific surgical instrumentation) and not an AI/ML powered device. Therefore, the questions related to AI/ML device performance, such as acceptance criteria, study details, human reader improvement with AI assistance, standalone algorithm performance, training set, and ground truth establishment, are not applicable here.

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The Genesis II Posterior Stabilized High Flexion Articular Insert is indicated for:

1. Rheumatoid arthritis.
2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result.
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 absent or incompetent and the collateral ligaments remain intact.

The Genesis II Posterior Stabilized High Flexion Articular Insert is used with existing cemented femoral, tibial tray, and patellar components of the Genesis II Total Knee System cleared via K951987 and K953274. The Genesis II Posterior Stabilized High Flexion Articular Insert is for single use only.

The Genesis II Posterior Stabilized High Flexion Articular Insert is used with existing cemented patellar and uncemented porous tibial trays and femoral components of the Genesis II Total Knee System cleared via K030612. The Genesis II Posterior Stabilized High Flexion Articular Insert is for single use only.

The Genesis II Posterior Stabilized High Flexion Articular Inserts are URMWPE tibial components which provide the ability for greater flexion to those patients who have the anatomical capability to allow a greater flexion range. The insert is used with existing cemented femoral, tibial tray, and patellar components of the Genesis II Total Knee System cleared via K951987 and K953274 or with the system's porous, uncemented femoral and tibial tray components cleared in K030612.

This document describes the Genesis II Posterior Stabilized High Flexion Articular Insert, a knee implant component.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document refers to "mechanical test data," but it does not specify the sample size used for these tests.
The provenance of the data (country of origin, retrospective/prospective) is not mentioned.

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

The document does not mention any experts being used to establish a "ground truth" for the mechanical test data. The determination appears to be based on direct mechanical evaluation and comparison to existing devices.

4. Adjudication Method for the Test Set

There is no mention of an adjudication method as this type of study is not applicable to the mechanical testing described.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed, nor is it applicable for this type of medical device (knee implant component). The focus is on mechanical and design equivalence, not interpretative tasks.

6. Standalone (Algorithm Only) Performance

A standalone performance study was not done, nor is it applicable as this is a physical medical device, not an algorithm or AI.

7. Type of Ground Truth Used

The ground truth used for the acceptance criteria appears to be:

• Mechanical performance standards/benchmarks: The device's mechanical test data was compared against "expected in vivo loading" and demonstrated equivalence to "devices currently used clinically."
• Predicate device characteristics: Substantial equivalence relies on comparisons in "indications for use, design features, operational principles, and material composition" to existing legally marketed devices.

8. Sample Size for the Training Set

This information is not applicable. The device is a physical knee implant component, not an AI or machine learning model that would require a training set.

9. How the Ground Truth for the Training Set Was Established

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

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