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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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The Revision Knee System Components are indicated for rheumatoid arthritis; post-traumatic arthritis; osteoarthritis; degenerative arthritis; and failed osteotomies, unicompartmental replacement; or total knee arthroplasties. The components are designed for use 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. The Revision Knee Components are for single use only and are intended for implantation with bone cement.

These indications are the same as currently used for the Genesis II Constrained Knee System and Revision Knee System cleared via K962137 and K041106.

The Smith & Nephew Revision Knee System contains femoral knee components, tibial components, angled and offset couplers, stem attachments and wedges. The designs of these devices are based upon existing components of the Genesis II Total Knee System and Revision System, previously cleared for market under K951987, K953274, K962137, and K041106.

This is a 510(k) premarket notification for a medical device, specifically the SMITH & NEPHEW REVISION KNEE SYSTEM. These types of submissions typically demonstrate "substantial equivalence" to a predicate device rather than presenting a detailed study proving the device meets specific performance acceptance criteria through clinical trials and statistical analysis.

Therefore, the provided document does not contain the information requested in your prompt regarding acceptance criteria, device performance tables, sample sizes for test sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, type of ground truth, training set sample size, or how ground truth for the training set was established.

Here's why and what information is present:

• Substantial Equivalence: The core of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This means it has the same intended use and the same technological characteristics as the predicate device, or, if it has different technological characteristics, that the differences do not raise different questions of safety and effectiveness.
• Focus of this Document: The document describes the device's intended use, its components, and lists predicate devices to which it claims substantial equivalence. It also lists general safety and effectiveness characteristics.
• No Clinical Study Details: It does not mention any clinical study conducted to establish performance metrics against acceptance criteria. The focus is on comparing the new device to existing, already cleared devices.

Summary of available information related to your prompt, and why other requested information is not present:

1. A table of acceptance criteria and the reported device performance: This is not present. The document doesn't define specific numerical acceptance criteria for performance; rather, it asserts similarity to predicate devices.
2. Sample size used for the test set and the data provenance: This is not present. There's no mention of a "test set" in the context of clinical or performance data for this submission. The submission relies on the established safety and efficacy of predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not present. No such "ground truth" establishment is described for a performance study.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: This is not present. No adjudication method for a test set is mentioned.
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 is not present. This device is a knee implant, not an AI-assisted diagnostic tool. MRMC studies are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is not present. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): This is not present, as no specific performance study with ground truth data is detailed.
8. The sample size for the training set: This is not present. This is not an AI/algorithm-based device that would require training data.
9. How the ground truth for the training set was established: This is not present.

In conclusion, the provided 510(k) summary is a regulatory document focused on proving "substantial equivalence" of a medical device (a knee implant) to already approved predicate devices, rather than a clinical study report detailing performance against specific acceptance criteria.

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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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The porous components of the Genesis II Total Knee System are single use devices for use without cement. The devices are indicated for:

1. Rheumatoid arthritis.
2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity levels are compatible with an adequate long-term result.
3. Failed osteotomies, unicompartmental replacement, or total knee replacement.
4. The posterior stabilized knee system is 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 porous coated components of the Genesis II Total Knee System are designed for use with existing tibial and patellar components and accessories of the Genesis II Total Knee Systems cleared via K951987 and K953274. The subject components are porous coated metal alloy devices.

The provided document is a 510(k) premarket notification for the Smith & Nephew, Inc. Genesis II Total Knee System. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical trial data with predefined acceptance criteria for device performance.

Therefore, many of the requested elements for a study proving acceptance criteria are not directly applicable or available in this document.

Here's a breakdown based on the information provided and the nature of a 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable in the context of this 510(k) submission. Mechanical testing was performed, but specific sample sizes and data provenance for these internal tests are not detailed. The submission relies on a comparison to existing devices, not a new clinical trial with a "test set" of patients.

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

Not applicable. Ground truth in a clinical sense (e.g., diagnosis, outcome) is not established within this 510(k) submission. The "ground truth" for the submission is the regulatory acceptance of existing predicate devices.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical "test set" requiring adjudication in this submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This document does not describe any MRMC comparative effectiveness study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This device is a physical implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth used for this 510(k) submission is the regulatory acceptance and established safety/effectiveness profile of predicate devices that were already legally marketed. The submission demonstrates that the new device is "substantially equivalent" to these predicates.

8. The Sample Size for the Training Set

Not applicable. This device is a physical implant, not a machine learning model. There is no "training set" in this context.

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

Not applicable (as above).

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