(98 days)
The ATEC Lateral Navigation Instruments are intended to facilitate discectomy, boney resection, implant selection, and access during spinal surgery. Navigated instruments 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 vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. The Stimulating Initial Dilator may also be utilized in spine surgical procedures to assist in location of the nerves during or after preparation and placement of implants (intervertebral fusion cages and pedicle screw fixation devices) in open and percutaneous minimally invasive approaches.
The ATEC Lateral Navigation Instruments are surgical instruments that are designed to be compatible with Medtronic's StealthStation Surgical Navigation System. The navigated disc preparation and dilator instruments are intended to facilitate discectomy, boney resection, access, and nerve location during spinal surgery. The navigated trials are intended to facilitate implant size selection of Alphatec intervertebral body fusion devices during spinal surgery. All instruments are reusable or single-use and are offered either nonsterile to be cleaned and steam sterilized by the end user or sterile packaged.
The provided FDA document, K223765, describes a premarket notification for ATEC Lateral Navigation Instruments. It is important to note that this document does not describe an AI/ML powered device, nor does it present an acceptance criteria table or a study with detailed performance metrics in the way typically found for AI-driven technologies.
Instead, the document focuses on establishing substantial equivalence to predicate devices based on design, intended use, and technological comparison. The performance data presented are for the instruments themselves in conjunction with a existing navigation system, not for an AI algorithm.
Therefore, for aspects related to AI/ML powered devices (like sensitivity, specificity, MRMC studies, ground truth type, training data, etc.), the answer will be "Not applicable" or "Not provided" based on the content of this specific document.
Here's the breakdown of the information requested, based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated with quantifiable thresholds for performance metrics typically seen in AI/ML performance studies. The testing focused on functional compatibility and dimensional equivalence to existing instruments. | Dimensional analysis: Confirmed instrument dimensions compared to Medtronic instruments. |
| Performance and safety: Confirmed performance and safety when used with the Medtronic® StealthStation™ System. | |
| Testing results demonstrated substantial equivalence. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable/Not provided. The performance testing described is for the physical instruments (dimensional analysis, compatibility with a navigation system), not for an AI algorithm evaluated on a data test set.
- Data Provenance (country of origin, retrospective/prospective): Not applicable/Not provided.
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)
- Not applicable. This device is a set of surgical instruments, not an AI diagnostic/prognostic tool that requires expert ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
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
- Not applicable. This document is for surgical instruments, not an AI system intended to assist human readers/clinicians, nor does it describe an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. The "ground truth" for the performance of these instruments would be their physical dimensions meeting specifications and their functional compatibility with the Medtronic StealthStation System, not a clinical "ground truth" established by experts or pathology for diagnostic accuracy.
8. The sample size for the training set
- Not applicable. No AI algorithm is being trained as part of this submission.
9. How the ground truth for the training set was established
- Not applicable.
§ 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).