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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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