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ERGO++ is a treatment planning system. It is an accessory to linear accelerators used for radiation therapy. It is indicated for use in the planning of 3 dimensional radiation therapy.

description of the device such as might be found in the labeling or promotional material for the device, including an explanation of how the device functions, the scientific concepts that form the basis for the device, and the significant physical and performance characteristics of the device, such as device design, material used, and physical properties is in Appendix 2 and Appendix 3 of this notification.

This document is a 510(k) submission for the ERGO++ Treatment Planning System. It does not contain information about acceptance criteria or a study that proves the device meets those criteria for the reasons outlined below.

This 510(k) submission is for a Traditional 510(k) for ERGO++, a modification of existing devices (ERGO, ERGO SRS, and ERGO EVTOOL). The submission states in the cover letter that the modifications are "not eligible for the Special 510(k) process" and that "the conclusions drawn from the nonclinical tests that demonstrate that the device is as safe, as effective, and performs as well as or better than the predicate device are in Appendix 6 of this notification."

The provided text does not include Appendix 6, nor does it describe specific acceptance criteria or performance results from any studies. The FDA's letter in response confirms that the device is "substantially equivalent" to predicate devices, which means it relies on the safety and effectiveness of those previously cleared devices rather than requiring new clinical studies with defined acceptance criteria.

Therefore, I cannot provide the requested information from the given text.

The document does not contain the following information:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI vs. without AI assistance. (This device is a Treatment Planning System, not an AI-assisted diagnostic tool, so this type of study is unlikely to be relevant or included).
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

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Argos is intended as an aid to the surgeon for precisely locating anatomical structures on the human body in either open or percutaneous procedures. It links tracked probes to virtual computer image space on a patient's preoperative or intraoperative image data. The system is indicated for any medical condition in which the use of stereotactic surgery may appropriate and where the reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra can be identified relative to medical images such as CT, MR , fluoroscopic or ultrasound images. Example procedures include but are not limited to: Cranial Procedures: Cranial biopsies Tumor resection Craniotomies/Craniectomies Skull base procedures Thalamotomies/Pallidotomies Spinal Procedures: Spinal implant procedures such as pedicle screw placement ENT procedures: Transsphenoidal procedures Intranasal procedures Sinus procedures, such as Maximillary anstrostomies. Ethmoidectomies Sphenoidotomies/Sphenoid explorations, Turbinate resection and Frontal sinusotomies

Argos is a system for computer-assisted stereotactic surgery. It is designed to be used as an aid to the location of, and surgical approach to, lesions within the anatomical structures on the human body and to help define the exact anatomical relations of such lesions to surrounding structures. Prior to the brain surgery, the Argos system acquires contiguous MRI or CT scans of the area containing the lesion and uses them to construct an accurate three-dimensional representation of the patient's anatomy used initially to facilitate surgical planning. During the operation the Argos system continuously monitors the position of a pointing instrument, used by the surgeon, and visualizes it on a monitor screen in relation to the three-dimensional virtual anatomy of the patient. It is therefore possible to verify during the operation that the real position of various anatomical reference points, including the lesion, corresponding to those identified during surgical planning.

The provided text is a 510(k) Summary of Safety and Effectiveness for the ARGOS image-guided surgery system. It details the device's description, intended use, and a comparison to a predicate device (VECTORVISION). However, it does not contain any information about specific acceptance criteria, studies proving performance, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

The document focuses on establishing substantial equivalence to a legally marketed predicate device, which is a regulatory pathway for medical devices in the United States. This pathway typically relies on demonstrating that the new device is as safe and effective as a predicate device, rather than requiring extensive clinical trials with detailed performance metrics and statistical analyses.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer most of your detailed questions based on the provided text.

Here's an overview of what can be extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

• Information not available in the provided text. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific performance metrics against defined acceptance criteria.

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

• Information not available in the provided text. There is no mention of a test set or data provenance for performance evaluation.

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

• Information not available in the provided text. There is no discussion of expert involvement in establishing ground truth for a test set.

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

• Information not available in the provided text. No adjudication method is mentioned as a test set is not described.

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:

• Information not available in the provided text. The ARGOS device is an image-guided surgery system, not an AI diagnostic tool primarily involving human readers interpreting images. An MRMC study is not relevant in this context and is not mentioned.

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

• The ARGOS system is described as an "aid to the surgeon" that "continuously monitors the position of a pointing instrument, used by the surgeon, and visualizes it on a monitor screen." This clearly indicates a human-in-the-loop system. Therefore, a standalone algorithm-only performance study would not be applicable or described for this type of device.

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

• Information not available in the provided text. No ground truth establishment is described. The system utilizes "three-dimensional representation of the patient's anatomy" constructed from "MRI or CT scans," implying that these medical images serve as the basis for anatomical representation.

8. The sample size for the training set:

• Information not available in the provided text. There is no mention of a training set as the document does not describe a machine learning or AI model development process with a distinct training phase.

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

• Information not available in the provided text. As there is no mention of a training set, the establishment of its ground truth is also not discussed.

Summary of the Study (as described for regulatory purposes):

The "study" presented here is a Substantial Equivalence determination, which is a regulatory review process rather than a scientific performance study. The core of this determination is a comparison between the ARGOS device and a legally marketed predicate device, BRAINLAB VECTORVISION (K003589).

• Methodology: The submission compares key characteristics of ARGOS to VECTORVISION, including:

  • Indications for Use (found to be similar)
  • Device main components (similar components, some differences in physical configuration like camera separability)
  • Physical characteristics (differences in dimensions and weight acknowledged, but not considered to affect safety or effectiveness significantly for substantial equivalence)
  • Localization technology (both use optical tracking based on infrared cameras and retro-reflective markers for 3D coordinate calculation by triangulation).

• Conclusion: Based on this comparison, the FDA concluded that ARGOS is "substantially equivalent" to BRAINLAB VECTORVISION, implying it is as safe and effective as the predicate device for its intended use. This conclusion is documented in the FDA's letter (APR 5 - 2007).

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