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The Anatase Navi Disposable Instrument is designed for use with Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II. 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 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 quidance system to enable open or percutaneous image guided surgery by means of registering intraoperative 2D fluoroscopic projections to pre-operative 3D CT imagerv. Example procedures include : Posterior-approach spinal implant procedures, such as pedicle screw placement, within the lumbar region.

Device Description

The Anatase Navi Disposable Instrument is designed for use with Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II. The Guiding awl is intended to support the surgeon to create an entry point before implanting the screw. The Spine pin with DRF-D and MIS LOC with DRF are both intended to fix the DRF on the vertebra by boned pins or the clamp. Once the DRF is fixed on the vertebra, the system can track the position of the patient's vertebra and instruments.

AI/ML Overview

This document is a 510(k) summary for the Anatase Navi Disposable Instrument. It primarily focuses on demonstrating substantial equivalence to a predicate device by addressing changes in material, packaging, and sterilization due to a change from repeat-use to single-use. The acceptance criteria and performance data provided are related to these specific changes, rather than clinical performance metrics of an AI/algorithm-based device.

Therefore, many of the requested details regarding AI/algorithm performance (e.g., sample size for the test set, data provenance, number of experts for ground truth, MRMC studies, standalone performance, training set details) are not applicable to this submission as it describes a physical medical instrument, not a software or AI device.

Here's a breakdown of the available information based on your request, highlighting where information is not present in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria listed here are primarily for the changes related to the device being single-use and sterilized, rather than clinical performance of an AI/algorithm.

Test	Acceptance Criteria (Implicit from "Description" and "Compliance")	Reported Device Performance
Package	Sterile barrier integrity over intended shelf-life (validated per FDA-recognized standards).	"Validation is confirmed by the demonstration of sterile barrier integrity over the intended shelf-life." "all the results are passed."
Sterilization	Effective sterilization process per ISO 11135.	"The sterilization process must be controlled and validated in compliance with ISO 11135 to ensure the effectiveness of the sterilization process." "all the results are passed."
Biocompatibility Evaluation	No rejection, allergic, or adverse reactions when in contact with human tissue, blood, or bone, as per FDA guidance and ISO 10993-1.	"The subject device is evaluated in accordance with FDA guidance for the use of international standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process' issued on June 16, 2016 and ISO 10993-1:2009." (Implied acceptance through "all the results are passed.")
Risk Assessment	Effectiveness of all risk control measures, in accordance with ISO 14971:2007.	"The effectiveness of all risk control measures is verified in accordance with ISO 14971:2007." (Implied acceptance through "all the results are passed.")
Design Verification	Design output fulfills all design input requirements.	"The design output fulfills all design input requirements." (Implied acceptance through "all the results are passed.")

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

This document describes a physical instrument and its manufacturing/sterilization validation. It does not involve a clinical "test set" in the context of an AI/algorithm performance study. Therefore, this information is not applicable.

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 is not applicable as the submission is for a physical medical instrument, not an AI/algorithm requiring expert ground truth in a clinical context.

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

This is not applicable as there is no clinical "test set" and no need for expert 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

This is not applicable as the device is a physical instrument, not an AI or software device.

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

This is not applicable as the device is a physical instrument, not an AI or software device.

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

For the physical and process validation tests (package, sterilization, biocompatibility, risk assessment, design verification), the "ground truth" would be established by relevant scientific and engineering standards and validated laboratory test results, rather than clinical outcomes or expert consensus on medical images.

8. The sample size for the training set

This is not applicable as the device is a physical instrument and does not involve AI model training.

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

This is not applicable as the device is a physical instrument and does not involve AI model training or a "training set" in that context.

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