(28 days)
The ChoiceSpine Navigation reusable instruments are intended to be used during preparation and placement of ChoiceSpine Lancer", Thunderbolt", and Blackbird™ system during spinal surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The ChoiceSpine Navigation reusable instruments are specifically designed for use with the Medtronic Stealth Station System (V2.1.0), 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 skull, along bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.
The ChoiceSpine Navigation instruments are non-sterile, reusable instruments designed to function with the Medtronic® StealthStation® System and SureTrak® II System. Refer to the appropriate navigation system Instructions for Use and/or Surgical Technique Guide for details regarding navigation system use. The ChoiceSpine Navigation instruments are for use with ChoiceSpine screw systems, specifically, Lancer™, Thunderbolt™, and Blackbird™ Spinal Systems.
The provided text is a 510(k) Summary for the ChoiceSpine Navigation System. It describes the device, its intended use, and argues for substantial equivalence to a predicate device. However, it explicitly states that no new testing was performed for this specific submission to add Blackbird instruments. Instead, it relies on the previous testing of the predicate device.
Therefore, the following information cannot be fully extracted based on the provided text for the current submission:
- A table of acceptance criteria and reported device performance (for the current submission).
- Sample size used for the current test set.
- Data provenance for the current test set.
- Number of experts used to establish ground truth for the current test set and their qualifications.
- Adjudication method for the current test set.
- Whether a multi-reader, multi-case (MRMC) comparative effectiveness study was done for the current submission.
- Whether a standalone performance study was done for the current submission.
- The type of ground truth used for the current test.
- Sample size for the current training set.
- How ground truth for the current training set was established.
Based on the provided text, here is what can be inferred about the original testing that established "substantial equivalence" for the predicate device, which this submission leverages:
1. A table of acceptance criteria and the reported device performance
The text does not explicitly state acceptance criteria in a table format. It only mentions that the "Navigation System has been tested per ASTM F2554-10, 'Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems'." It concludes that "The results of this non-clinical testing show that performance of the Navigation System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." Without the actual report of the ASTM F2554-10 testing, specific numerical acceptance criteria and reported performance values cannot be provided here.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the text for either the predicate device's testing or the current submission.
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 information is not provided in the text. The testing mentioned (ASTM F2554-10) is a standard for positional accuracy of computer-assisted surgical systems, which is typically an engineering performance test and may not involve expert review in the same way clinical studies do.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the text.
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 was not performed for this submission, as no new testing was conducted. The text describes an engineering performance test (ASTM F2554-10) for positional accuracy, not a comparative effectiveness study with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The submission states that the "ChoiceSpine Navigation System" was tested per ASTM F2554-10. This is a standard for evaluating the accuracy of computer-assisted surgical systems. This would be considered a standalone performance test of the device's accuracy, as it measures the system's ability to precisely locate anatomical structures. However, it's not an "algorithm only" test in the sense of an AI/ML algorithm being evaluated in isolation, but rather the integrated navigation system's performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the ASTM F2554-10 test would likely be based on physical measurements and precise anatomical models used to assess the positional accuracy of the surgical system. It would not typically involve expert consensus, pathology, or outcomes data in the traditional sense of clinical ground truth.
8. The sample size for the training set
This information is not provided as the submission refers to an engineering performance test, not a machine learning model that would require a training set.
9. How the ground truth for the training set was established
This information is not provided as no machine learning training set is relevant to the described testing.
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).