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Knee3 is intended to be an intraoperative localization system used during orthopedic knee surgery. It links a navigated instrument, tracked by a passive marker sensor system, to virtual computer image space on an individually acquired model of the patient's anatomical axes, which are generated through acquiring multiple anatomical bony landmarks. The system is indicated for medical conditions in which the use of stereotaxic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the femur and tibia, can be identified relative to the acquired anatomical landmarks. The system aids the surgeon to plan resections, measure cutting block alignment, measure bone resections, and/or leg alignment. The device is indicated for total and uni-compartmental knee replacement.

The Knee3 is a software application module intended to be used on compatible navigation platforms that assist in the implantation of prosthetic knee implants. It uses instruments and accessories such as reference arrays, pointers and plane tools, which are tracked by an infrared camera of the respective platform, to determine femur and tibia anatomical landmarks as well as instrument positions in relation to the registered bones. The resulting navigation measurements support the user with the placement of the cutting guides.

The provided document, a 510(k) summary for Brainlab's Knee3 device, outlines the device's intended use, technological characteristics, and performance data to support its substantial equivalence to predicate devices. However, it does not present a formal table of acceptance criteria and reported device performance as typically seen in a clinical study report. Instead, it describes general accuracy limits for the system's technical navigation and mentions clinical validation through literature review.

Based on the provided text, here's what can be extracted and inferred regarding the device's acceptance criteria and the study proving it meets them:

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

The document does not provide a formal table with acceptance criteria side-by-side with reported performance for clinical validation. It offers a general statement about the system's technical accuracy:

It's important to note that this is described as "technical navigation accuracy (bench accuracy)" and not a clinical accuracy directly on patients.

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

The document does not specify a sample size for a test set in the context of a prospective clinical study involving the Knee3 device itself. It states: "Clinical data gathered from literature was used to validate the accuracy of the predecessor software device versions (predicate devices) and respective workflows." This indicates a retrospective review of existing literature rather than a new prospective study with a dedicated test set for the Knee3.

Therefore, the data provenance is from literature regarding predicate devices, not specifically from a new study on Knee3. The country of origin of this literature data 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)

Since the clinical validation was based on "clinical data gathered from literature" related to predicate devices, the document does not provide information on the number or qualifications of experts used to establish ground truth for this validation. This likely refers to the aggregated data and conclusions from various studies in the literature, not a specific panel of experts reviewing a test set for Knee3.

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

Given that the clinical validation relied on "literature" and not a bespoke test set with expert ground truth establishment for Knee3, no adjudication method is described or implied.

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

The document does not indicate that an MRMC comparative effectiveness study was done. The Knee3 is an "intraoperative localization system" and a "software application module" that "aids the surgeon to plan resections, measure cutting block alignment, measure bone resections, and/or leg alignment." It's a navigation system for surgery, not an AI for image interpretation that would typically involve human readers. Therefore, there is no mention of "human readers" or "AI assistance" in the context of improving their performance.

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

The "technical navigation accuracy (bench accuracy)" measured on a "bench model" can be considered a form of standalone performance evaluation for the system's core accuracy without surgeon interaction on a patient. It showed the system to be "within limits of ± 2° for angles and ± 2mm for distances in 95% of cases."

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

For the "technical navigation accuracy," the ground truth was presumably physical measurements on a bench model, comparing the system's output to known, precisely measured values.

For the "clinical validation," the ground truth described as being derived from "clinical data gathered from literature" for predicate devices. This implies that the effectiveness and accuracy of the workflows were established through patient outcomes or established surgical accuracy metrics reported in prior clinical studies for those predicate devices. The exact nature of this "ground truth" (e.g., post-operative imaging, clinical assessments) is not detailed in this summary.

8. The sample size for the training set

The document does not mention a training set size. This device is described as a "software application module" and a "stereotaxic instrument" that links physical instruments to virtual models. While it undoubtedly has software components, the description does not explicitly state it utilizes machine learning or AI that would typically require a distinct training set for model development in the way that, for example, an image interpretation AI would. The "software verification and validation testing" refers to general software quality assurance, not a machine learning model's training.

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

As no training set is described in the context of machine learning, there is no information on how ground truth for such a set was established.

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Knee Fusion Nails are intended for intramedullary knee arthrodesis.

The Knee Fusion Nail is inserted in the medullary canal of long bones for knee arthrodesis. The Knee Fusion Nail features holes/slots on both ends of the nail for optional locking screws. The nails and screws are made of Stainless Steel. The screws were previously cleared in 510(k) K983942.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Knee Fusion Nail, formatted as requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

The review states "an analysis of bending strength and flexural rigidity based on the cross-sectional geometry of the nail's shaft region and the material strength properties using hand calculations." This implies a theoretical analysis based on design specifications and material properties rather than a test performed on a sample set of physical devices. Therefore, a traditional "sample size" for a test set and associated data provenance (country of origin, retrospective/prospective) are not applicable to this type of analysis.

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

• Number of Experts: Not applicable. The "ground truth" was established through engineering calculations and material property comparisons.
• Qualifications of Experts: Not applicable. The analysis was based on engineering principles and material science, not expert consensus on observations.

4. Adjudication Method for the Test Set

Not applicable, as there was no test set requiring expert adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission describes a device (Knee Fusion Nail) which is a physical implant, not a diagnostic or assistive technology that would be used by human readers for interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone performance study was not done. The "device" in question is a physical medical implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation was established using engineering principles, material strength properties, and design specifications (cross-sectional geometry of the nail's shaft region). The performance of the subject device was then compared against these established properties for predicate devices.

8. The Sample Size for the Training Set

Not applicable. The submission describes a physical medical device, not a machine learning model, so there is no concept of a "training set."

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

Not applicable. There was no training set.

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Knee Fusion Nails are for intramedullary knee arthrodesis.

A Knee Fusion Nail is inserted into the medullary canal of long bones for knee arthrodesis. The design of the Knee Fusion Nail is based on Smith & Nephew's (formally Richards Medical) experience with intramedullary nail systems, which dates back to the 1950's. The Knee Fusion Nail includes intramedullary interlocking nails with corresponding screws. The Knee Fusion Nail and corresponding screws are made of Ti-6Al-4V titanium alloy with holes/slots for optional locking screws on both ends of the nail. Locking screws are available for optional and distal locking. Screws are available in 5.0mm, and 6.4mm diameters with varying lengths. The screws were previously cleared in 510(k) K981529. The device is intended for single use.

The provided document is a 510(k) summary for a medical device called "Knee Fusion Nail". It states that the device is substantially equivalent to legally marketed predicate devices. However, the document does not contain information regarding acceptance criteria for performance, clinical study data involving a test set, expert adjudication, or AI/human reader studies.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence to existing devices, not on detailed performance metrics from a dedicated clinical study with specific acceptance criteria.

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The Imaging Therapeutics, Inc. Knee Interpositional Mini-Repair System (KIMRS) is intended for use in the osteoarthritic knee, where substantial amounts of articular cartilage have degenerated as a result of the disease, and in patients who are candidates for total and/or uni-compartmental arthroplasty procedures. The implant is indicated for the un-cemented treatment of the medial and/or lateral tibial articulating surfaces of the following:

Moderate degeneration of the medial or lateral compartment of the knee (grade II-IV chondromalacia) and minimal degeneration (grade I-II chondromalacia, no loss of joint space) in the patellofemoral compartments.

The Imaging Therapeutics, Inc. Knee Interpositional Mini-Repair System is intended to be implanted in the knee as a non-fixated, intra-articular support with minimal to no movement of the device after implantation.

Imaging Therapeutics, Inc. Knee Interpositional Mini-Repair System is a minimally invasive, bone preserving, approach for the treatment of the osteoarthritic knee. Developed from patient Magnetic Resonance (MR) scans a patient specific implant is designed.

The treatment allows for the placement of an un-cemented metallic device designed from the patient's natural cartilage and meniscal geometry that is implanted into the joint space either in the medial or lateral compartment above the affected tibial plateau. The femur then articulates against the smooth implant surface. The implant is manufactured from cobalt chromium molybdenum alloy.

The provided document describes a 510(k) premarket notification for the "Knee Interpositional Mini-Repair System (KIMRS)" by Imaging Therapeutics, Inc. The primary purpose of this submission is to demonstrate substantial equivalence to predicate devices, rather than to prove that the device meets specific acceptance criteria through a clinical study. The study conducted is a bench test on cadaveric knees comparing the mechanical movement of the KIMRS with a predicate device, the Centerpulse Unispacer.

Here's the breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note regarding Acceptance Criteria: The document does not explicitly state numerical acceptance criteria. Instead, it relies on demonstrating comparability to a legally marketed predicate device (Centerpulse Unispacer). The "acceptance criteria" are thus implicitly that the KIMRS performs similarly or better than the predicate device in terms of movement within the cadaveric knee. The text concludes that "The ImaTx Knee Interpositional Mini-Repair System performed comparably to the Unispacer implant."

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

• Sample Size for Test Set: Two cadaveric knee specimens.
• Data Provenance: Retrospective (cadaveric specimens), location not specified.

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

• This study did not involve experts establishing ground truth in the traditional sense of clinical assessment. It was a biomechanical test comparing implant movement. No information is provided regarding human experts for this specific comparative testing.

4. Adjudication Method for the Test Set

• Not applicable. This was a biomechanical measurement study, not an assessment requiring adjudication of human observations or diagnoses.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study focuses on the mechanical performance of the device in cadavers, not on human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

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

7. The Type of Ground Truth Used

• The "ground truth" in this context refers to the direct physical measurement of implant excursion within the cadaveric knee using fluoroscopy. This is akin to direct measurement/physical observation rather than expert consensus, pathology, or outcomes data. The predicate device's performance serves as a comparative benchmark.

8. The Sample Size for the Training Set

• Not applicable. This is a physical medical device, not an AI or algorithm-based system that requires a "training set."

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

• Not applicable (as above).

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The StealthStation® System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation® System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, 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:

Cranial Procedures:

Cranial biopsies Tumor resections Craniotomies/ Craniectomies Skull base procedures Thalamotomies/Pallidotomies Pituitary Tumor Removal CSF Leak Repair

ENT Procedures:

Transphenoidal procedures Intranasal procedures Orbital Decompression Procedures Optic Nerve Decompression Procedures Polyposis Procedures Endoscopic Dacryocystorhinostomy Encephalocele Procedures Sinus procedures, such as Maxillary antrostomies, Ethmoidectomies, Sphenoidotomies/Sphenoid explorations, Turbinate resections, and Frontal sinusotomies Orthopedic Procedures:

pedicle screw placement.

Spinal Procedures:

Total Knee Arthroplasty (Primary and Revision) Unicompartmental Knee Arthroplasty

Spinal implant procedures, such as

This submission describes a modification to the StealthStation® System FluoroNav™ III. Module to provide for image guided knee surgery and orthopedic indications.

The provided text is a summary of safety and effectiveness for the Knee Module for the StealthStation® System, focusing on its substantial equivalence to predicate devices rather than a detailed study report with specific acceptance criteria or performance metrics. Therefore, much of the requested information cannot be extracted directly from this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. Table of acceptance criteria and the reported device performance

This document does not specify quantitative acceptance criteria or detailed performance metrics from a study. It states that "Performance data was provided to support the claim of substantial equivalence," but the data itself is not presented.

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

This information is not available in the provided text.

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)

This information is not available in the provided text.

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

This information is not available in the provided text.

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 a navigation system for surgery, not an AI-assisted diagnostic tool for "human readers." Therefore, an MRMC comparative effectiveness study involving human readers with or without AI assistance is not applicable in this context. The document does not mention any studies in this vein.

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

The device is a "Knee Module for the StealthStation® System," described as an "aid for precisely locating anatomical structures in either open or percutaneous procedures." This strongly implies human-in-the-loop performance during surgical navigation. The document does not describe a standalone performance study of an algorithm without human interaction.

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

This information is not available in the provided text. For a surgical navigation system, "ground truth" would typically relate to the accuracy of anatomical localization compared to actual anatomical structures, but the method of establishing this is not detailed here.

8. The sample size for the training set

This information is not available in the provided text.

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

This information is not available in the provided text.

In summary, the provided document focuses on the regulatory submission and FDA's determination of substantial equivalence for the Knee Module for the StealthStation® System. It does not contain the detailed study information regarding acceptance criteria, performance data, sample sizes, or ground truth establishment that would typically be found in a comprehensive clinical study report.

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