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Image Guided Surgical Instruments for Knee Applications are intended to assis the surgeon in precisely locating anatomical structures in either open or percutaneous procedures. Image Guided Surgical Instruments for Knee Applications are indicated for use in total knee procedures, including but not limited to, primary and revision total knee arthroplasty and unicompartmental knee arthroplasty, in which the use of stereotactic surgery may be appropriate, and where a reference to a rigid anatomical structure. such as a long bone. can be identified relative to a CT or MR based model or fluoroscopy images of the anatomy.

Image Guided Surgical Instruments for Knee Applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Image Guided Surgical Instruments for Knee Applications are indicated for any medical condition of the knee in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as a long bone can be identified relative to a CT or MR based model or fluoroscopy images of the anatomy.

Example procedures include, but are not limited to:

Orthopedic Procedures:

Primary Total Knee Arthroplasty

Revison Total Knee Arthroplasty

Unicompartmental Knee Replacement

The Smith & Nephew Image Guided Instruments for Knee Applications are commercially available instruments that have been modified by incorporating a dovetail mount that will allow infrared LED (light emitting diodes) or passive markers image guided arrays to be fixed onto the instruments. This will allow the instruments to be tracked in real time in the surgical field.

Image Guided Surgical Instruments for Knee Applications are similar to currently legally marketed Class II stereotactic instruments in that they incorporate infrared LED (light emitting diodes) or passive markers onto the instruments that allow the instruments to be tracked in real time in the surgical field.

The provided text is a 510(k) Summary for Image Guided Surgical Instruments for Knee Applications. It details the device description, intended use, and substantial equivalence to predicate devices. However, it does not contain any information about acceptance criteria, device performance, a study conducted to prove performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The document states that the new device is "similar to currently legally marketed Class II stereotactic instruments in that they incorporate infrared LED (light emitting diodes) or passive markers onto the instruments that allow the instruments to be tracked in real time in the surgical field." This indicates that the 510(k) submission relied on demonstrating substantial equivalence to existing devices, rather than presenting a new study with performance metrics against acceptance criteria.

Therefore, I cannot populate the requested table or answer the specific questions about a study, as the provided text does not contain that information.

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The product is intended to be used in fixation of femoral fractures occurring from the base of the femoral neck extending distally to a point approximately 10 cm proximal to the intracondylar notch. Fracture types include basilar neck, intertrochanteric, subtrochanteric fractures and femoral shaft fractures. These femoral fractures may occur as a result of trauma, non-union, malunion, pathological fractures, and impending pathological fractures.

This Special 510(k) submission is intended to address a material modification and design modifications to the predicate Long Length Gamma® Nail System. The subject device, named the Long Length Dyax Nail System, is a line extension of the Long Length Gamma® Nail System. The predicate Long Length Gamma® Nail System is fabricated from stainless steel. The subject Long Length Dyax Nail System is fabricated from titanium alloy. The design change for the nail involves changing the proximal diameter, changing the distal screw hole diameters and distal hole configuration and adding additional lengths of nails. The 5 mm diameter fully threaded locking screws from the T2 Nail System will be compatible with the Long Length Dyax Nails.

The predicate Long Length Gamma® Nail is an intramedullary rod intended to be used in the fixation of femoral fractures' occurring from the base of the femoral neck extending distally to a point approximately 10 cm proximal to the intercondylar notch. The predicate design is cannulated, with a medial/lateral and anterior/posterior curve.

The provided document is a 510(k) summary for a medical device called the "Long Length Dyax Nail System." This is a line extension to an existing device (Long Length Gamma® Nail System). The document describes the device, its intended use, and its substantial equivalence to a predicate device, but it does NOT contain information about acceptance criteria, detailed performance data, or a specific study designed to prove the device meets acceptance criteria as would be found in a clinical trial or performance study report.

The core of a 510(k) submission is to demonstrate "substantial equivalence" to a legally marketed predicate device, not necessarily to prove effectiveness or safety through a new clinical effectiveness study. Substantial equivalence is often established through technological comparison, material comparison, and sometimes mechanical testing, rather than human expert-based performance evaluations like those described in your request.

Therefore, most of the information requested cannot be extracted from this specific document. However, I can confirm what is available:

1. A table of acceptance criteria and the reported device performance

• Not Available. The document does not provide a table of acceptance criteria or reported device performance data in the context of human-expert evaluation, clinical outcomes, or AI performance metrics. It focuses on device description and substantial equivalence.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Available. This information pertains to a study involving a test set, which is not described in this 510(k) summary.

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 Available. This information pertains to a study involving human experts, which is not described in this 510(k) summary.

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

• Not Available. This information pertains to a study involving adjudicated ground truth, which is not described in this 510(k) summary.

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/Not Available. The device is an intramedullary nail for fracture fixation, not an AI or imaging diagnostic device that would typically undergo an MRMC study comparing human reader performance with and without AI assistance. The document does not mention any such study.

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

• Not Applicable/Not Available. This question relates to AI algorithm performance. The device is a physical surgical implant, not an algorithm.

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

• Not Applicable/Not Available. This question relates to a study that would establish ground truth for performance evaluation of a diagnostic or predictive device. No such study or ground truth is discussed for this intramedullary nail. The "truth" for this device's efficacy would be clinical outcomes (e.g., successful fracture healing), but such outcomes data are not presented in this 510(k) summary, which is focused on substantial equivalence.

8. The sample size for the training set

• Not Applicable/Not Available. This question relates to AI algorithm training data. The device is a physical surgical implant, not an AI algorithm.

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

• Not Applicable/Not Available. This question relates to AI algorithm training data. The device is a physical surgical implant, not an AI algorithm.

What the document does provide in relation to "proof" or "study":

The document states that the new device (Long Length Dyax Nail System) is a "line extension" and demonstrates "substantial equivalence" to a "predicate Long Length Gamma® Nail System" through:

• Technological Comparison: The primary "study" implicitly referenced is a comparison of materials and design.
  • Predicate device material: Stainless steel.
  • Subject device material: Titanium alloy.
  • Design changes: Proximal diameter, distal screw hole diameters, distal hole configuration, and additional nail lengths.
• Intended Use Comparison: "There is no change in intended use for the modified device when compared to the previously cleared product."
• Compatibility: The 5 mm diameter fully threaded locking screws from the T2 Nail System will be compatible.

Essentially, the "study" proving the device meets its acceptance criteria (which is "substantial equivalence" for a 510(k)) is a documented comparison of its features and materials to those of a previously cleared device, rather than a clinical trial with specific performance metrics against pre-defined acceptance criteria. Mechanical testing would typically be performed as part of demonstrating substantial equivalence for an orthopedic implant, but the details of such testing (e.g., fatigue strength, bending rigidity) are not included in this summary.

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The Paragon Lens Carrier is indicated for the chemical disinfection and storage of Rigid Gas Permeable and Hard contact lenses.

Not Found

This document is a 510(k) summary for the Paragon Lens Carrier, a contact lens case. It is important to note that this document does not describe an AI/ML medical device. Therefore, many of the requested categories are not applicable.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance

Since this is not an AI/ML device, typical performance metrics like sensitivity, specificity, or AUC are not applicable. The device is a contact lens carrier, and its "performance" is implicitly tied to safety and substantial equivalence to a predicate device.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided. For a physical device like a contact lens case, "test set" typically refers to the number of units manufactured and tested for toxicology, sterility, or durability. The document only mentions toxicology testing was submitted, but not the specifics of the sample size or provenance.

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" in this context would relate to the scientific methods and regulatory standards for toxicology testing, not expert consensus on medical images or diagnoses.

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

Not applicable. This is not an AI/ML diagnostic device that requires adjudication of expert opinions for a test set.

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 a physical contact lens case, not an AI-assisted diagnostic tool.

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

Not applicable. This is a physical contact lens case, not an algorithm.

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

The "ground truth" for the safety of the device would be established through toxicological testing results following recognized scientific and regulatory standards. For substantial equivalence, the "ground truth" is a comparison against the predicate device's design, materials, and intended use as per FDA regulations.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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