(182 days)
The ChoiceSpine Navigation reusable instruments are intended to be used during preparation and placement of ChoiceSpine system implants during spinal surgery to assist the 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 StealthStation S7 (V2.1.0) and S8 (V1.2.0) systems, which are 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, a long 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. 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 any ChoiceSpine systems equipped with the appropriate and necessary features and geometry. These features and geometry have been tested for compatibility with the Medtronic® StealthStation®.
The provided text is a 510(k) summary for the ChoiceSpine Navigation System. It describes the device, its intended use, and substantial equivalence to predicate devices, supported by performance testing.
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the performance testing described. The study aimed to demonstrate substantial equivalence to the predicate devices. The key performance characteristic assessed was "dimensional analysis and positional accuracy" per ASTM F2554.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Dimensional Analysis (compatible with Medtronic StealthStation) | Validated in side-by-side testing of the Medtronic® StealthStation® system and predicate device. |
| Positional Accuracy (per ASTM F2554) | Validated in side-by-side testing of the Medtronic® StealthStation® system and predicate device. |
| Substantial Equivalence to Predicate | "The test results demonstrate that the ChoiceSpine Navigation system performance is substantially equivalent to the predicate." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a numerical sample size for the test set. It mentions "side-by-side testing," which implies that the ChoiceSpine Navigation instruments were tested alongside the Medtronic® StealthStation® system and a predicate device.
- Sample Size: Not explicitly stated as a number of unique cases. It refers to testing of the "ChoiceSpine Navigation system" itself against the predicate system. This suggests a physical testing setup rather than a dataset of patient cases.
- Data Provenance: Not specified in terms of country of origin. The study appears to be a laboratory-based performance validation of the instrument's compatibility and accuracy, rather than a clinical study with patient data. It is a "performance data" section, not a "clinical data" section. The document states it was a "side-by-side testing" with a "predicate device".
- Retrospective/Prospective: Not applicable, as it's a device performance validation, not a clinical data study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention the use of human experts to establish ground truth for the test set. The ground truth for this type of device (surgical navigation instruments) is typically established through engineering measurements and comparisons to known standards or predicate device performance, not through expert interpretation of clinical data.
4. Adjudication Method for the Test Set
Not applicable. The study appears to be an engineering performance validation, not one requiring adjudication of clinical interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study described is a technical performance validation of a medical device's accuracy and compatibility, not a study assessing the impact of AI assistance on human reader performance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not directly applicable in the context of this device. The "ChoiceSpine Navigation System" is a set of instruments designed to work with an existing navigation system (Medtronic StealthStation). It is not an AI algorithm in the traditional sense that would operate "standalone" to produce an interpretation or diagnosis. Its performance is intrinsically linked to its use with the Medtronic system. The performance data focuses on the accuracy and compatibility of the instruments when integrated with the navigation system.
7. The Type of Ground Truth Used
The ground truth used appears to be engineering measurements and direct comparison to a predicate device's performance, specifically for dimensional analysis and positional accuracy as defined by ASTM F2554. This is a technical validation against established engineering standards and existing device performance, not clinical outcomes, pathology, or expert consensus on a clinical condition.
8. The Sample Size for the Training Set
Not applicable. This device is a set of physical surgical instruments, not an AI/ML algorithm that requires a training set of data.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device.
§ 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).