(27 days)
Precision Spine S-COMP Reform® POCT Navigated Instruments are indicated for use during the preparation and placement of Precision Spine Reform® POCT Polyaxial Screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The navigated instruments are reusable and are specifically 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 a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. Use of the S-COMP Reform® POCT Navigated Instruments with the Medtronic StealthStation® System is limited to use with the Reform® POCT Spinal Fixation System when the correct Infinity™ tool cards are selected.
The S-COMP Reform® POCT Navigation Instruments are non-sterile, re-usable surgical instruments made from stainless steel. These instruments are designed to interact 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 Precision Spine Navigation Instrumentation set to offer compatibility with the Reform® POCT System.
The provided document is a 510(k) premarket notification for the Precision Spine S-COMP Reform® POCT Navigated Instruments. It asserts substantial equivalence to predicate devices based on engineering analysis and geometric comparison, rather than a clinical study with acceptance criteria.
Therefore, many of the requested details, such as specific acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, and MRMC study details, are not applicable or not available in this type of submission.
Here's a breakdown of the information that can be extracted or deduced from the document:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated as pass/fail thresholds against specific performance metrics (e.g., accuracy in mm). The submission relies on "engineering analysis and geometric comparison to predicate devices to establish the safety and efficacy for accuracy performance."
- Reported Device Performance: "The results of the engineering analysis show that the subject is substantially equivalent to the cleared predicates." This implies that the device is expected to perform comparably to the predicate devices, which are already considered safe and effective for their intended use. Specific numerical performance data is not provided.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. No test set of cases (e.g., patient images or surgical data) was used for evaluating software performance. The evaluation was based on engineering analysis and geometric comparison of the instruments themselves.
- Data Provenance: Not applicable, as there was no data set for performance evaluation in the traditional sense.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: Not applicable. Ground truth was not established by experts on a test set of data.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No test set requiring expert adjudication was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The submission focuses on device characteristics and engineering analysis, not reader performance with or without AI assistance. The device is a surgical instrument, not an AI software.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Standalone Performance: Not applicable. The device is a physical surgical instrument intended to be used with a navigation system and by a surgeon. It is not an algorithm that performs actions standalone.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not applicable in the context of clinical performance data. The "truth" in this submission relies on the established safety and efficacy of the predicate devices and the engineering analysis demonstrating that the new instruments are geometrically similar and function comparably.
8. The Sample Size for the Training Set
- Training Set Size: Not applicable. This is not an AI/ML algorithm that requires a training set. The device is a physical surgical instrument.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for this 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).