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CoreLink Navigation Instruments is indicated for use during the preparation and placement of Siber Ti Sacroiliac Joint Fusion System implants and Entasis Dual-Lead Sacroiliac Implant System implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation S8 System (V1.2.0), which 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 a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

CoreLink Navigation Instruments are non-sterile, re-usable manual surgical instruments made from stainless steel for use with CoreLink pedicle screw and sacroiliac screw systems. These instruments are designed to interface with the Medtronic StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures.

The purpose of this submission is to offer compatibility of the previously cleared CoreLink Navigation Instruments for sacroiliac fusion implants with additional CoreLink Sacroiliac Screws and to update the sacroiliac navigation instrument set.

The provided text describes a 510(k) premarket notification for the CoreLink Navigation Instruments. However, it does not contain the detailed information required to answer your specific questions regarding acceptance criteria and the study that proves the device meets those criteria, especially in the context of an AI/ML-driven device.

This document is a regulatory submission for a manual surgical instrument (CoreLink Navigation Instruments) designed to assist in locating anatomical structures during spinal surgery, used in conjunction with a separate navigation system (Medtronic StealthStation S8 System). It's not a submission for an AI/ML-driven device that would typically involve acceptance criteria related to algorithmic performance (e.g., sensitivity, specificity, F1-score), ground truth establishment by experts, or MRMC studies.

Therefore, I cannot extract the information asked for in your prompt (e.g., acceptance criteria table, sample sizes for test/training sets, number of experts for ground truth, adjudication methods, MRMC study details, standalone performance, type of ground truth, etc.) from the given text.

The closest information provided is:

• Device Type: Non-sterile, re-usable manual surgical instruments.
• Purpose: To assist surgeons in precisely locating anatomical structures.
• Performance Data: "Performance testing per ASTM F2554 has been conducted to evaluate positional accuracy of the CoreLink Navigation Instruments as submitted under previous submissions of the CoreLink Navigation Instruments (K212825). An engineering analysis has been performed to show that the subject instruments present no new worst case for positional accuracy and that the previous testing is representative of the subject instruments."

This indicates that the "performance" here refers to the physical and mechanical accuracy of the manual instruments, not the diagnostic or predictive performance of an AI model.

To answer your questions, I would need a different type of document, specifically one that describes a clinical or technical validation study for an AI/ML medical device.

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CoreLink Navigation Instruments are intended to be used in the preparation and placement of CoreLink screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation® System S8 (V1.2.0), which 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 vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

CoreLink Navigation Instruments are non-sterile, re-usable manual surgical instruments made from stainless steel for use with CoreLink pedicle screw and sacroiliac screw systems. These instruments are designed to interface with the Medtronic StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures.

The purpose of this submission is to add instruments to the previously cleared CoreLink Navigation Instruments set to offer navigation compatibility with additional CoreLink pedicle screws.

The provided text describes a 510(k) summary for CoreLink Navigation Instruments. This document does not contain information about an AI/ML powered device, but rather a set of non-sterile, reusable manual surgical instruments designed to interface with a navigation system. As such, the specific criteria requested for AI/ML powered devices, such as performance metrics like ROC curves, sensitivity, specificity, and detailed study designs involving AI performance, are not applicable here.

However, I can extract information related to the performance evaluation of the CoreLink Navigation Instruments based on the provided text.

Here's an analysis of the available information regarding acceptance criteria and performance:

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

The document mentions "Performance testing per ASTM F2554 has been conducted to evaluate positional accuracy of the CoreLink Navigation Instruments". It also states that "An engineering analysis has been performed to show that the subject instruments present no new worst case for positional accuracy and that the previous testing is representative of the subject instruments."

However, the specific acceptance criteria (e.g., a defined threshold for positional accuracy) and the quantitative reported device performance values are not explicitly stated in this summary. It only indicates that testing per a standard was conducted and an engineering analysis confirmed representativeness.

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

The document refers to "Performance testing per ASTM F2554". ASTM F2554 is a standard for "Standard Test Method for Positional Accuracy of Computer-Assisted Surgical Systems." This standard outlines methods for testing, but the specific sample size (e.g., number of tests, number of instruments tested) used in the CoreLink study is not provided in this summary.

Similarly, the data provenance (e.g., country of origin, retrospective/prospective) related to this performance testing is not mentioned.

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

This question is geared towards AI/ML device evaluations where expert consensus often establishes ground truth for image interpretation or diagnosis. For a surgical instrument like the CoreLink Navigation Instruments, "ground truth" would typically relate to physical measurements of accuracy. Therefore, the concept of "experts establishing ground truth" in the diagnostic sense is not directly applicable. The ground truth would be established by the measurement methods defined in ASTM F2554, likely involving precision measurement instruments and qualified test operators, but specifics are not provided.

4. Adjudication method for the test set

Similarly, adjudication methods (like 2+1 or 3+1) are common in studies where multiple human readers assess medical data for diagnostic agreement. For performance testing of a physical instrument's accuracy, a formal adjudication method among experts is not typically used. The "ground truth" is based on the precision of the measurement system itself. Details of any such process are not provided.

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

An MRMC study is relevant for evaluating the impact of an AI system on human diagnosticians. Since the CoreLink Navigation Instruments are physical surgical tools and not an AI diagnostic system, an MRMC comparative effectiveness study in the context of "human readers improve with AI" is not applicable. The device aids surgeons in locating anatomical structures in spinal surgery with the Medtronic StealthStation® System, not in diagnostic interpretation.

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

This question is also specific to AI/ML software. The CoreLink Navigation Instruments are physical instruments. Therefore, a standalone performance evaluation of an "algorithm only" is not applicable.

7. The type of ground truth used

As mentioned in point 3, for physical surgical instruments, ground truth for performance testing (e.g., positional accuracy) would typically be established through highly accurate physical measurement systems and methodologies, often prescribed by standards like ASTM F2554. This is distinct from "expert consensus, pathology, or outcomes data" which are common for diagnostic AI/ML systems. The specific type of ground truth measurement system used is not detailed beyond reference to ASTM F2554.

8. The sample size for the training set

This question refers to the training of an AI/ML model. Since the CoreLink Navigation Instruments are physical surgical tools and not an AI system, there is no training set in the context of machine learning.

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

As there is no training set for this device, how its ground truth was established is not applicable.

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CoreLink Navigation Instruments are intended to be used in the preparation and placement of CoreLink screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation® System S8 (V1.2.0), which 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 vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

CoreLink Navigation Instruments are non-sterile, re-usable manual surgical instruments made from stainless steel. These instruments are designed to interface with the Medtronic StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures. The purpose of this submission is to add instruments to the previously cleared CoreLink Navigation Instruments set to offer navigation compatibility with more CoreLink pedicle screws.

The FDA document K220973 concerns the "CoreLink Navigation Instruments" and includes a brief summary of performance data. However, it does not contain the detailed information necessary to fully address all the points in your request regarding "acceptance criteria" and a "study that proves the device meets the acceptance criteria" for an AI/device performance evaluation.

This 510(k) submission is for navigation instruments, which are described as non-sterile, re-usable manual surgical instruments designed to interface with a navigation system (Medtronic StealthStation® System S8). The performance data section states: "CoreLink, LLC has conducted an engineering analysis to demonstrate that the system modifications provide adequate and substantially equivalent accuracy for their intended use."

This implies a mechanical/engineering performance evaluation, not a study involving AI assistance for human readers, nor detailed clinical outcome data in the context of an AI-driven diagnostic or prognostic device. Therefore, many of the requested fields are not applicable or cannot be extracted from the provided text.

Here's a breakdown based on the information available:

Acceptance Criteria and Device Performance (Based on provided text)

The document primarily focuses on demonstrating substantial equivalence to predicate devices through an engineering analysis, rather than setting specific quantitative acceptance criteria for a new AI application.

Study Details (Based on provided text)

Most of the requested study details are not applicable or not provided in this 510(k) summary, as it describes an engineering analysis for mechanical instruments, not an AI performance study.

1. Sample size used for the test set and the data provenance: Not explicitly stated for performance testing; the "engineering analysis" suggests bench testing or simulations rather than a clinical dataset in the context of AI.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable; ground truth establishment as typically understood in AI studies (e.g., for image interpretation) is not relevant for this device's type of performance evaluation.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
4. 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 not an AI-assisted diagnostic or prognostic device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a manual surgical instrument intended to be used by a surgeon in conjunction with a navigation system.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For mechanical accuracy, ground truth would typically refer to known physical measurements or engineering specifications against which the instrument's performance is compared. Details are not provided in this summary.
7. The sample size for the training set: Not applicable for this type of device and performance evaluation.
8. How the ground truth for the training set was established: Not applicable.

In summary:

The provided FDA letter and 510(k) summary pertain to a Class II surgical instrument (CoreLink Navigation Instruments) used with a separate navigation system. The "performance data" mentioned refers to an "engineering analysis" to demonstrate mechanical accuracy and substantial equivalence to existing devices, not the performance of an AI algorithm based on clinical data. Therefore, the detailed questions about AI study design, ground truth establishment, reader studies, and training/test sets are outside the scope of the information provided in this regulatory document.

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CoreLink Navigation Instruments are intended to be used in the preparation and placement of Tiger OCT screw implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation® System S8 (V1.2.20), which 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 vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

CoreLink Navigation Instruments are non-sterile, re-usable manual surgical instruments made from stainless steel. These instruments are designed to interface with the Medtronic StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures.

The purpose of this submission is to add instruments to the previously cleared CoreLink Navigation Instruments set to offer compatibility with CoreLink OCT pedicle screws.

The provided text describes a 510(k) premarket notification for "CoreLink Navigation Instruments." This submission does not relate to an AI/ML powered device, but rather to traditional surgical navigation instruments. Therefore, the information requested in the prompt regarding acceptance criteria and studies for an AI/ML device cannot be extracted from the provided text.

The text focuses on demonstrating substantial equivalence to a predicate device for the purpose of adding new instruments to an existing navigation system. The performance data mentioned specifically refers to "confirmatory positional accuracy testing per ASTM F2554" and "engineering analysis including tolerance stack analysis," which are standard for mechanical medical devices, not AI/ML algorithms.

Therefore, I cannot fulfill the request as the provided document does not contain information about an AI/ML powered device or its associated acceptance criteria and validation studies.

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CoreLink Navigation Instruments are intended to be used in the preparation and placement of CoreLink screws (Tiger and Entasis) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation® System S8 (V1.2.20), which 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 vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

CoreLink Navigation Instruments are non-sterile, re-usable manual surgical instruments made from stainless steel. These instruments are designed to interface with the Medtronic StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures.

The purpose of this submission is to clear the CoreLink Navigation Instruments for use with additional versions of the StealthStation software and to add instruments to the previously cleared CoreLink Navigation Instruments set.

This is a 510(k) premarket notification for CoreLink Navigation Instruments.
Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions "confirmatory positional accuracy testing per ASTM F2554" but does not explicitly state the acceptance criteria (e.g., a specific tolerance in mm) or the numerical results of this performance testing. It only states that the testing was done to "demonstrate that the system modifications provide adequate and substantially equivalent accuracy for their intended use."

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

The document does not specify the sample size used for the positional accuracy testing. It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective).

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

This information is not provided in the document. The testing described focuses on device performance against a standard (ASTM F2554) rather than human expert-established ground truth.

4. Adjudication Method for the Test Set

This information is not provided in the document. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which isn't explicitly described here.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned. The document describes testing of the navigation instruments' accuracy, not a study comparing human reader performance with and without AI assistance.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone study of the device's performance was done. The document states that CoreLink, LLC "conducted confirmatory positional accuracy testing per ASTM F2554 with Medtronic StealthStation® System S8 Version 1.2.0 (1.2.0-20)." This refers to testing the device itself for accuracy, independent of a human surgeon's interaction in a clinical setting for the purpose of this particular performance data section.

7. The Type of Ground Truth Used

The ground truth for the positional accuracy testing would be established by the specifications and methodology of ASTM F2554, which defines how to measure and assess the accuracy of navigated surgical instruments. This standard typically involves objective measurements against a known reference or ideal position, rather than expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

This device is a set of manual surgical instruments that interface with a navigation system, not an AI or machine learning algorithm that requires a training set in the conventional sense. Therefore, the concept of a "training set" is not applicable here.

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

As explained above, a training set is not applicable for this type of device.

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CoreLink Navigation Instruments are intended to be used in the preparation and placement of CoreLink screws (Tiger and Entasis) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation® System, which 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 vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

CoreLink Navigation Instruments are non-sterile, reusable manual surgical instruments made of surgical stainless steel. These instruments are designed to interface with the already-cleared Medtronic StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures.

The provided text describes the CoreLink Navigation Instruments, but it does not contain the specific information requested about acceptance criteria and the detailed study that proves the device meets those criteria.

The document is a 510(k) Premarket Notification from the FDA, which primarily focuses on establishing substantial equivalence to a legally marketed predicate device. While it mentions "Performance Data" and "Testing to ASTM F2554-10," it does not elaborate on the specific acceptance criteria, reported performance values, study design details (sample size, data provenance, ground truth establishment, expert qualifications, adjudication, MRMC studies, standalone performance), or training set information.

Therefore, I cannot fulfill your request as the necessary details are not present in the provided text.

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