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Smith & Nephew's VISIONAIRE™ Disposable Instruments are intended to be used to further prepare the bone and assist in the positioning of total knee replacement components intraoperatively. Smith & Nephew VISIONAIRE™ Disposable Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Genesis II and Legion knee systems and their cleared Indications for Use.

The contraindications, potential adverse events, precautions, and warnings for the knee systems can be found in the Smith & Nephew Knee System package insert. The VISIONAIRE™ Patient Matched Cutting Blocks and Disposable instruments are intended for single use only. Do not reuse due to risks of breakage, failure or patient infection.

Per U.S. Food and Drug Administration (FDA) regulation, device-specific instruments are accessory devices and take on the classification of the device(s) with which they are used. Although these instruments are similar in design to 510(k)-exempt orthopaedic manual instruments classified under 21 CFR 888.4540, instruments which assist in the implantation of Class II Smith & Nephew Total Knee Systems and are classified as Class II devices are subject to pre-market notifications and regulations.

The Smith & Nephew Disposable Instruments include line additions to the Smith & Nephew Disposable Knee Instruments that were cleared in K123159. The subject devices are intended prepare the bone for Total Knee Arthroplasty.

The provided text does not contain information about the acceptance criteria or a study proving that a device meets those criteria, as it relates to a typical AI/ML device submission for medical imaging. The document is an FDA 510(k) clearance letter for VISIONAIRE™ Disposable Instruments, which are surgical instruments used for total knee replacement.

The clearance is based on substantial equivalence to predicate devices, not on meeting specific performance criteria through a study in the sense typically associated with AI/ML device evaluation (e.g., accuracy, sensitivity, specificity on a test set).

Here's a breakdown of why the requested information cannot be extracted and what information is available:

• Device Type: This is a physical surgical instrument, not an AI/ML software device.
• Approval Basis: The approval is based on "substantial equivalence" to existing legally marketed predicate devices, meaning it is similar in intended use, technological characteristics, and safety and effectiveness.
• Clinical Data: The document explicitly states: "Clinical data was not needed to support the safety and effectiveness of the subject devices." This further confirms that a performance study as would be done for an AI/ML device was not conducted or required for this clearance.

Therefore, I cannot populate the requested table and answer the specific questions about acceptance criteria, study design, ground truth, or expert involvement, as these elements are not relevant to the 510(k) clearance process for this type of medical device as described in the provided text.

The closest information available related to "performance" is:

• "Biocompatibility testing for the new colorants and materials was conducted per the recommendations of ISO 10993-1."
• "A review of the results indicates that the Disposable Instruments are equivalent to existing, legally marketed predicate instrumentation with regards to mechanical performance and that there are no new issues related to the safety and effectiveness of the subject devices."

This refers to engineering and material testing, not a clinical performance study using a test set against a ground truth as would be relevant for an AI/ML diagnostic or prognostic tool.

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Smith & Nephew Disposable Fin Punch is an accessory device and is intended to be used to assist in the implantation of Smith & Nephew Total Knee Systems including Legion and Genesis II Knee Systems and their cleared Indications for Use.

Indications for Total Knee Replacement

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 incompetent and the collateral ligaments remain intact.
5. 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 absent or incompetent.

The Smith & Nephew Disposable Fin Punch is a line addition to the Smith & Nephew Disposable Knee Instruments that were cleared in K123159. The subject device is intended to cut the bone to prepare the tibia to accept the tibial base implant.

The provided text is related to a 510(k) premarket notification for a medical device called the "Smith & Nephew Disposable Fin Punch." This document is a regulatory submission for a device, not a study report proving the device meets specific acceptance criteria through a clinical or algorithmic performance study in the way typically associated with diagnostic AI/ML products.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not applicable to this type of regulatory submission.

The document primarily focuses on demonstrating substantial equivalence to predicate devices through technical characteristics, intended use, and materials, rather than a performance study with defined numerical acceptance criteria for diagnostic accuracy.

Here's how the available information relates to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the context of a diagnostic AI/ML device.

The "acceptance criteria" discussed in this document are primarily related to mechanical safety and biocompatibility, not diagnostic performance. The document states:

• "Mechanical testing has been conducted to address the intraoperative impact loads expected to be experienced by the fin punch."
• "Biocompatibility testing for the black Polyetherimide (PEI) material was conducted per the recommendations of ISO 10993-1."
• "A review of the results indicates that the Disposable Fin Punch is equivalent to existing, legally marketed predicate instrumentation with regards to mechanical performance and that there are no new issues related to the safety and effectiveness of the subject devices."

There are no specific numerical performance metrics (like sensitivity, specificity, AUC) reported in this document that would typically be found for an AI/ML diagnostic device study against defined acceptance criteria. The "performance" here refers to the device's ability to withstand mechanical stresses and be biocompatible.

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

Not applicable. This document describes mechanical and biocompatibility testing for a surgical instrument, not a test set of data points for an algorithm. Therefore, there's no "test set" in the sense of patient data, nor data provenance (country of origin, retrospective/prospective). The "testing" refers to lab-based mechanical and material evaluations.

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

Not applicable. There is no "ground truth" in the context of expert consensus on patient data for this device. Mechanical and biocompatibility tests are assessed against established engineering standards and material properties, not expert clinical interpretations.

4. Adjudication Method 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, an MRMC comparative effectiveness study was not done. This is a surgical instrument, not an AI diagnostic tool that human readers would use.

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

Not applicable. This is a physical surgical instrument, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For mechanical testing, the "ground truth" would be engineering specifications and established mechanical properties of the materials and design, verified through physical testing. For biocompatibility, the "ground truth" is adherence to ISO 10993-1 standards for material safety.

8. The Sample Size for the Training Set

Not applicable. This is a physical surgical instrument, not an AI/ML algorithm. There is no training set mentioned or implied.

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

Not applicable. (See point 8).

In summary: The provided document is a 510(k) clearance letter and summary for a surgical instrument (Smith & Nephew Disposable Fin Punch), not a study demonstrating the performance of a diagnostic AI/ML device. The "acceptance criteria" and "testing" referred to are for mechanical properties and biocompatibility, not for diagnostic accuracy evaluated against patient data or expert ground truth.

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