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The Naviswiss Knee Navigation System is a computer-controlled system intended to assist the surgeon in determining reference alignment axes to aid in the positioning of orthopedic implant system components where a reference to a rigid anatomical structure can be identified. The system aids the surgeon in performing intra-operative measurements of femoral and tibial alignment axes to assist in executing the distal femoral and proximal tibial resections. The equipment is intended for use by trained surgeons in operating theaters.

The Naviswiss Knee is a surgical navigation system which assists the orthopaedic surgeon during the implantation of an artificial knee joint. It consists of a navigation unit which is first used to register the patient's anatomy. Subsequently the navigation system supports the surgeon in guiding the surgical instruments with the implant according to the pre-operative planning. The navigation unit includes an infrared stereo camera which measures the position and orientation of small NAVItags.

The Naviswiss Knee is a surgical navigation system that assists orthopedic surgeons in knee joint implantation.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance:

• Test Set: No specific numerical sample size (e.g., number of cases or patients) is provided for the simulated use or cadaver testing.
  • Simulated Use: Performed on a metallic bone simulator.
  • Cadaver Simulated Use: Performed in multiple cadaver wet labs.
• Data Provenance: The study appears to be entirely benchtop and simulated-use based, not involving human patients in a clinical setting. Therefore, there is no country of origin for patient data, and it is not retrospective or prospective in a typical clinical trial sense.

3. Number of Experts and Qualifications:

• For the Anatomical Phantom Simulated Use, "orthopedic surgeons" were involved. No specific number or years of experience are detailed.
• For Cadaver Simulated Use, "trained surgeons" were involved. No specific number or qualifications are detailed.

4. Adjudication Method:

The document does not specify an adjudication method like 2+1, 3+1, or none. The assessment seems to be based on direct comparison of measurements to known values in the simulated environment and verification of meeting clinical use requirements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was mentioned. The study focused on the performance of the device itself rather than comparing human reader performance with and without AI assistance.

6. Standalone Performance:

Yes, a standalone performance assessment was conducted through "Benchtop Accuracy" testing, where the device's accuracy was verified using calibrated test fixtures.

7. Type of Ground Truth Used:

• For Benchtop Accuracy and Anatomical Phantom Simulated Use, the ground truth was "known values" or "calibrated test fixtures." This implies established, precise measurements for comparison.
• For Cadaver Simulated Use, the ground truth was likely expert assessment by the trained surgeons on whether the system "satisfies clinical use requirements and performed as intended on human specimens."

8. Sample Size for Training Set:

The document does not provide any information regarding a training set sample size. This is typical for a navigation system where the core technology is based on precise physical measurements and algorithms rather than machine learning models that require distinct training data.

9. How Ground Truth for Training Set Was Established:

Not applicable, as no information on a training set or machine learning model is provided.

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Naviplan is indicated for pre-operative planning for surgical procedures related to hip, such as artificial joint replacement (3D templating of implants).

NAVIPLAN - CT Planning Software for Total Hip Replacement, or "Naviplan", is a software which assists in the pre-operative planning of total hip replacement surgery based on three dimensional CT-images (computed tomography). The Naviplan allows the user to process CT DICOM images which are automatically segmented. The user gets an automatic identification of anatomical landmarks as an output, which is normally used in hip surgery. The Naviplan automatically computes an initial planning (implant type and size selection as well as positioning) which can be inspected and edited by the user until the optimal configuration is established. The user can export the plan as a pdf report and as a navigation archive to be used with the Naviswiss Hip Navigation System. The export steps are optional, whereas the report serves a documentation purpose.

Here's a breakdown of the acceptance criteria and study information for the NAVIPLAN - CT Planning Software for Total Hip Replacement, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list "acceptance criteria" with numerical targets and then directly provide "reported device performance" in a separate section. Instead, it describes a software verification and validation testing approach. The "reported device performance" is summarized by the statement: "Dedicated software verification testing has been conducted to compare manual segmentation and landmark positioning to the NAVIPLAN - CT Planning Software for Total Hip Replacement automated segmentation and planning." And the overall conclusion: "the applicant concludes, that substantial equivalence between the new and the predicate device has been demonstrated and that the new device, NAV-IPLAN - CT Planning Software for Total Hip Replacement, is at least as safe and as effective as the legally marketed predicate device, Zedview (K133022)."

Based on the information, the acceptance criteria are implicitly tied to the performance of manual segmentation and landmark positioning. The device is expected to perform at a level comparable to, or as accurate as, manual methods.

2. Sample Size for Test Set and Data Provenance

The document states: "Dedicated software verification testing has been conducted to compare manual segmentation and landmark positioning to the NAVIPLAN - CT Planning Software for Total Hip Replacement automated segmentation and planning." However, it does not specify the sample size used for this testing. It also does not mention the country of origin of the data or whether it was retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth

The document does not specify the number of experts used to establish the ground truth for the test set or their specific qualifications (e.g., "radiologist with 10 years of experience"). It only implies the use of "manual segmentation and landmark positioning" as a reference for comparison.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. Therefore, there is no information on the effect size of how much human readers improve with AI vs. without AI assistance. The study described focuses on comparing the automated software's performance to manual methods, not on human reader performance with or without the software.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

Yes, a standalone performance assessment was done. The software verification testing "compare[d] manual segmentation and landmark positioning to the NAVIPLAN - CT Planning Software for Total Hip Replacement automated segmentation and planning." This implies the algorithm's performance in segmentation and planning was evaluated independently against manual ground truth without a human in the loop of the algorithm's output. The device itself is described as primarily standalone for planning, though its output can be used with a navigation system.

7. Type of Ground Truth Used

The ground truth used was based on manual segmentation and landmark positioning. This can be interpreted as a form of expert consensus or expert-derived ground truth, as manual methods in such a clinical context would typically be performed by trained medical professionals or experts.

8. Sample Size for the Training Set

The document does not provide information on the sample size used for the training set.

9. How Ground Truth for the Training Set was Established

The document does not provide information on how the ground truth for the training set was established.

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The Naviswiss Hip Navigation System is a computer-controlled system intended to assist the surgeon in determining reference alignment axes to aid in the positioning of orthopedic implant system components where a reference to a rigid anatomical structure can be identified. The system is only compatible with acetabular cup impactors that have a parallel and straight segment. The system aids the surgeon in performing intra-operative measurements of leg length, offset, and cup inclination/anteversion.

An example of a stereotaxic orthopedic surgical procedure includes Total Hip Arthroplasty: Lateral/Supine.

The equipment is intended for use by trained surgeons in operating theaters.

The Naviswiss Hip Navigation System is an image-free surgical navigation system intended to assist the orthopedic surgeon during the implantation of an artificial joint (hip). The device consists of a handheld navigation device, used to register the patient's anatomy into a software platform. Subsequently the navigation system helps the surgeon maneuver the surgical instruments with precision. Thus, the surgeon can position the implant in accordance to pre-operative planning.

The Naviswiss Hip Navigation System is comprised of two major sub-systems: the Naviswiss Hip (M42) and Naviswiss Platform (M59).

The Naviswiss Hip (M42) is composed of:

• . NAVItags used for reference and registration
• . Ancillary instruments
• . Application Software

The Naviswiss Platform (M59) is composed of:

• . Computer
• Camera ●
• . Software

The M42 employs the base computing, power supply, and programing in the M59 Platform. The NAVItags allow the surgeon to determine anatomical landmarks or navigate an instrument.

The camera utilizes application and tracking software to guide the surgeon through a workflow process for the surgery. The camera is covered by a sterile, single use drape for use of the navigation device in a sterile environment.

The provided text does not contain a specific table detailing acceptance criteria and reported device performance. It states broadly that "All performance tests were passed successfully" for both the subject and predicate devices.

However, based on the Summary of Testing section and the Indications for Use, we can infer some details related to accuracy and successful operation for the Naviswiss Hip Navigation System.

Here's an attempt to structure the information you requested based on the available text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• System Accuracy (ASTM F2554-18): Not explicitly stated, but the testing simulated "normal conditions, and a variety of worst-case use scenarios and realistic tracking disturbances."
• Benchtop Accuracy: Not explicitly stated, but verified using "calibrated test fixtures."
• Anatomical Phantom Simulated Use: Not explicitly stated how many phantom tests were conducted, but it was stated that the test was performed on a "metallic bone simulator." The data provenance is a "simulated use" scenario.
• Cadaver Simulated Use: "multiple cadaver wet labs" were used. The data provenance is human cadaver specimens.
• OUS Prospective Clinical Study: The study was designed to evaluate 35 patients undergoing elective THA surgery. The data provenance is prospective, clinical study data from Australia.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Anatomical Phantom Simulated Use: Tests were performed by "orthopedic surgeons." The number of surgeons is not specified, nor are their specific qualifications (e.g., years of experience). Ground truth for this test was "known values" from the metallic bone simulator.
• Cadaver Simulated Use: Tests were performed by "trained surgeons." The number of surgeons and their specific qualifications are not specified. Ground truth for this test is implied to be the intended clinical use and performance on human specimens.
• OUS Prospective Clinical Study: The primary outcome involved agreement between intraoperative data from the Naviswiss system and post-operative CT measurements. This suggests the ground truth was based on objective imaging data (CT scans), not expert consensus from the study. The surgeons were involved in using the device but not specifically for establishing ground truth post-operatively. The number of experts interpreting the CT scans is not mentioned.

4. Adjudication method for the test set

• The document does not describe a formal adjudication method (like 2+1 or 3+1 expert review) for any of the performance tests. For the clinical study, the primary outcome involved comparing system measurements to post-operative CT measurements, which is an objective measurement rather than a consensus-based adjudication.

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

• A MRMC comparative effectiveness study, as typically understood in the context of reader performance with and without AI assistance, was not explicitly described in the provided text. The OUS Prospective Clinical Study focuses on system accuracy against CT measurements, not on comparing human reader performance with and without the system's assistance. The device assists the surgeon, but there's no study detailed on the improved performance of surgeons due to the assistance quantified as an effect size.

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

• The Naviswiss Hip Navigation System is described as a "computer-controlled system intended to assist the surgeon." Its indications for use clearly state it "aids the surgeon." Therefore, it is inherently designed for human-in-the-loop performance. While "System Accuracy" and "Benchtop Accuracy" tests evaluate the algorithm and hardware, they are still within the context of a system that provides guidance to a human surgeon. A purely standalone (algorithm-only) performance evaluation independent of surgeon interaction is not described.

7. The type of ground truth used

• System Accuracy (ASTM F2554-18) & Benchtop Accuracy: Verified against objective, known values provided by calibrated test fixtures and simulated conditions.
• Anatomical Phantom Simulated Use: Compared measurements obtained with the system against known values of the phantom.
• OUS Prospective Clinical Study: Ground truth for component positioning was established by post-operative CT measurements.

8. The sample size for the training set

• The document does not explicitly mention a training set or its sample size. The tests described are primarily verification and validation studies to demonstrate the device's accuracy and performance. If there was a machine learning component for which a training set was used, it is not detailed in this summary.

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

• Since a training set and its sample size are not mentioned, the method for establishing its ground truth is also not provided in this document.

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