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The Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II are indicated for precise positioning of surgical instruments or spinal implants during general spine surgery when reference to a rigid anatomical structure, such as the vertebra, can be identified relative to a patient's fluoroscopic or CT imagery. It is intended as a planning and intraoperative guidance system to enable open or percutaneous image guided surgery by means of registering intraoperative 2D fluoroscopic projections to pre-operative 3D CT imagery. Example procedures include: Posterior-approach spinal implant procedures, such as pedicle screw placement, with the lumbar region.

The subject devices, Image calibrator-21F and Image calibrator-31F are designed for use with Anatase Spine Surgery Navigation System (K230783) and Remex Spine Surgery Navigation System II (K233513). The subject devices are modified from previously cleared devices to be compatible with the 21 cm/ 31 cm flat panel C-arm for CT image position and calibration.

The software upgrade is due to these newly added Image calibrators and one added function of auto-labeling for CT/C-arm image registration.

This 510(k) clearance letter and summary discuss the Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II. However, the provided document does not contain the detailed acceptance criteria and the specific study data proving the device meets these criteria in the format requested.

The document states:

• "Verification and validation activities have been completed to provide sufficient assurance that the subject device meets the performance requirements under its indications for use conditions."
• "The test methods are the same as the previously cleared 510(k), K233513."
• "All the results are passed."

This indicates that performance testing was conducted and passed, but the specific metrics, criteria, and the results themselves are not enumerated in this public summary. This level of detail is typically found in the full 510(k) submission, which is not publicly released in its entirety.

Therefore, I cannot extract the information needed to fill out the requested table and answer the specific questions about the study design, sample sizes, expert qualifications, and ground truth establishment from the provided text.

Based on the provided text, here's what can be inferred or explicitly stated regarding performance testing, but not the detailed acceptance criteria or results:

• Type of device: Spine Surgery Navigation System. These systems are typically evaluated based on their accuracy in guiding surgical instruments or implants relative to anatomical structures.
• Performance Data Section: The document mentions "Verification and validation activities have been completed" for the subject device.
• Test Descriptions mentioned:
  • Software: Verified and validated in accordance with FDA guidance for software in medical devices and IEC 62304.
  • Risk Assessment: Effectiveness of risk control measures verified in accordance with ISO 14971.
  • Design Verification: Design output fulfills design input requirements.
• Comparison to Predicate: "The intended use and fundamental technology of the subject device are identical to the predicate devices and could share the same testing methods as the predicate devices. All the results are passed." This implies that the performance was at least as good as the predicate device (K233513).
• Nature of changes: The current 510(k) is for a modification to the device, including compatibility with new Image Calibrators (21F and 31F for flat panel C-arm CT imaging) and an auto-labeling function for CT/C-arm image registration. Performance testing would have focused on verifying these changes do not adversely affect safety and effectiveness, and that the existing fundamental performance (e.g., accuracy of navigation) is maintained.

Conclusion: The provided text confirms that performance testing was conducted and passed, but does not provide the specific acceptance criteria or the reported performance data in a quantifiable manner. The document acts as a summary and approval letter, not a detailed study report.

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The Anatase Spine Surgery Navigation System is indicated for precise positioning of surgical instruments or spinal implants during general spinal surgery when reference to a rigid anatomical structure, such as the vertebra, can be identified relative to a patient's fluoroscopic or CT imagery. It is intended as a planning and intraoperative guidance system to enable open or percutaneous image guided surgery by means of registering intraoperative 2D fluoroscopic projections to pre-operative 3D CT imagery.

Example procedures include but are not limited to:

Posterior-approach spinal implant procedures, such as pedicle screw placement, within the lumbar region.

The Anatase Spine Surgery Navigation System, also known as an Image Guided System, is comprised of a platform, clinical software, surgical instruments, and a referencing system. The system uses wireless optical tracking technology to track the position of instruments in relation to the surgical anatomy and identifies this position on diagnostic or intraoperative images of a patient. The system helps guide surgeons during spine procedures such as spinal fusion. The software functionality in terms of its feature sets are categorized as imaging modalities, registration, planning, interfaces with medical devices, and views.

The provided text describes the Anatase Spine Surgery Navigation System and its 510(k) submission to the FDA. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with detailed clinical performance data, acceptance criteria, and ground truth establishment for a specific AI-driven diagnostic or prognostic task.

However, based on the Accuracy section under "Performance Data Verification and validation activities," we can infer the acceptance criteria and the nature of the study for positional accuracy.

Here's an analysis based on the provided text, while acknowledging limitations due to the nature of the document (a 510(k) summary for device clearance):

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states that the positional accuracy of the system is evaluated in accordance with ASTM F2554-18. While the specific numerical acceptance criteria and the reported performance values are not provided in this summary document, the fact that it passed verification and validation implies that it met predefined criteria based on this standard.

To get the specific values, one would need to consult a more detailed technical report or the full 510(k) submission, which is not fully available here.

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

The document does not specify the sample size used for the positional accuracy test set nor the data provenance (e.g., country of origin, retrospective/prospective). This information is typically found in detailed test reports, not a 510(k) summary.

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

The document does not mention the use of experts to establish ground truth for the positional accuracy testing. Positional accuracy testing typically relies on metrology equipment and precise physical measurements, not expert human evaluation.

4. Adjudication Method for the Test Set:

Not applicable, as ground truth for positional accuracy is established by metrological methods, not human adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The document states "The Anatase Spine Surgery Navigation System is indicated for precise positioning of surgical instruments or spinal implants..." suggesting it is a tool for surgeons rather than an AI diagnostic device that assists human readers in interpreting images.

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

Yes, a standalone performance evaluation regarding positional accuracy was conducted for the device. The text states, "Accuracy: Positional accuracy of the system is evaluated in accordance with ASTM F2554-18." This refers to the objective measurement of the system's tracking and navigation capabilities.

7. Type of Ground Truth Used:

For positional accuracy, the ground truth would be established through metrological measurements using calibrated instruments and reference standards, as dictated by ASTM F2554-18. It is not expert consensus, pathology, or outcomes data in this context.

8. Sample Size for the Training Set:

The document does not mention a "training set" in the context of machine learning or AI. This device is a navigation system that uses optical tracking and image registration, implying a more traditional engineering validation process rather than a deep learning model requiring a large training dataset for a diagnostic task.

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

Not applicable, as there is no mention of a training set for an AI/machine learning model to establish ground truth.

Summary of Device Performance Study Information based on the provided text:

The information primarily focuses on regulatory conformity and substantial equivalence. For specific performance studies, the key takeaway is:

• Study Type for Accuracy: Evaluation of positional accuracy.
• Standard Used: ASTM F2554-18.
• Ground Truth for Accuracy: Metrological measurements (implied by the standard).
• Result: The device met performance requirements, indicating it passed the accuracy criteria.

The document does not provide the detailed numerical results, sample sizes, or specifics of the test setup beyond referencing the standard.

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The Anatase Spine Surgery Navigation System is indicated for precise positioning of surgical instruments or spinal implants during general spinal surgery when reference to a rigid anatomical structure, such as the vertebra, can be identified relative to a patient's fluoroscopic or CT imagery. It is intended as a planning and intraoperative guidance system to enable open or percutaneous image guided surgery by means of registering intraoperative 2D fluoroscopic projections to pre-operative 3D CT imagery.

Example procedures include but are not limited to:

Posterior-approach spinal implant procedures, such as pedicle screw placement, within the lumbar region.

The Anatase Spine Surgery Navigation System, also known as an Image Guided System, is comprised of a platform, clinical software, surgical instruments, and a referencing system. The system uses optical tracking technology to track the position of instruments in relation to the surgical anatomy and identifies this position on diagnostic or intraoperative images of a patient. The system helps guide surgeons during spine procedures such as spinal fusion. The software functionality in terms of its feature sets is categorized as imaging modalities, registration, planning, interfaces with medical devices, and views.

The modified Anatase Spine Surgery Navigation System, the subject of these 510(k) applications, introduces software, hardware and instruments modifications to the original Surgery Navigation System cleared in 510(k) K180523.

The Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S and SNS-Spine2-V, is indicated for precise positioning of surgical instruments or spinal implants during general spinal surgery.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The provided document does not specify sample sizes for any test sets nor the data provenance (e.g., country of origin, retrospective/prospective). The studies are non-clinical, meaning they did not involve patient data.

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

This information is not provided in the document as these were non-clinical tests.

4. Adjudication method for the test set:

This information is not provided in the document as these were non-clinical tests.

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 clinical testing, including MRMC studies, was conducted. The document explicitly states: "No clinical testing has been conducted."

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

The provided information focuses on the entire system's performance, which is an image-guided navigation system that would inherently involve human interaction (a surgeon). While software verification and validation were performed, the document does not distinguish between human-in-the-loop and algorithm-only performance for a standalone assessment in a manner that would typically be seen for an AI diagnostic device. The "Accuracy" test implies an assessment of the system's ability to track and display positions, which is a standalone performance metric for the navigation component, but it's not described as an AI-specific algorithm performance.

7. The type of ground truth used:

For the accuracy testing, the ground truth would likely be established through precise physical measurements to determine the true positional accuracy of the system against a known standard. However, the document does not specify the exact methodology for establishing the ground truth beyond referencing ASTM F2554-18. For other tests like electrical safety, EMC, and sterilization, the "ground truth" is defined by compliance with the referenced standards.

8. The sample size for the training set:

As this is a navigation system and not explicitly an AI diagnostic device in the context of machine learning model training, the concept of a "training set" in that sense is not directly applicable or discussed in the document. Software verification and validation were performed, but details on data used for these processes are not provided.

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

Same as above, the concept of a "training set" with established ground truth as typically understood in AI/machine learning is not applicable here. Software verification and validation would use various testing methods to ensure the software performs as designed and meets requirements.

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