(25 days)
The Remex Spine Surgery Navigation instrument is designed for use with Anatase Spine Surgery Navigation System(K230783) and Remex Spine Surgery Navigation System II(K233513). The Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II are indicated for precise positioning of surgical instruments or spinal implants during general spine surgery when reference to a rigid anatomical structure, such as the vertebra, can be identified relative to a patient's fluoroscopic or CT imagery. It is intended as a planning and intraoperative guidance system to enable open or percutaneous image guided surgery by means of registering intraoperative 2D fluoroscopic projections to pre-operative 3D CT imagery. Example procedures include: Posterior-approach spinal implant procedures, such as pedicle screw placement, with the lumbar region.
The Remex Spine Surgery Navigation Instrument is designed for use with Anatase Spine Surgery Navigation System (K230783) and Remex Spine Surgery Navigation System II (K233513).
The Remex Spine Surgery Navigation Instrument consists of the Nav Awl, Nav Drill Guide, Nav Tap, Nav Screwdriver and Nav Handle.
- Nav Awl: The subject device is intended to support the surgeon to create an entry point before implanting the screw.
- Nav Drill Guide: The subject device is intended to assist in drilling holes to a desired depth and ensuring proper orientation.
- Nav Tap: The subject device is intended to create screw threads.
- Nav Screwdriver: The subject device is intended to driver the screw into the vertebra.
Nav Handle: The subject device is intended to connected with Nav Awl, Nav Tap or Nav Screwdriver for navigation tracking purpose.
This document is focused on the Remex Spine Surgery Navigation Instrument and its substantial equivalence to predicate devices (K233513, K230783). It primarily addresses the design and functional aspects of the instrument itself, rather than presenting a performance study of an AI-powered diagnostic device or a navigation system that relies on sophisticated algorithms validated with clinical outcomes.
Therefore, the provided text does not contain the detailed information required to answer many of the specific questions regarding acceptance criteria and a study proving device performance as typically understood for an AI/ML-driven diagnostic or image analysis device. The "Performance Data" section discusses general design verification, software verification (in accordance with general FDA guidance and IEC 62304), risk assessment (ISO 14971), and biocompatibility (ISO 10993). It states that "[a]ll the results are passed" but doesn't provide specific numerical acceptance criteria or performance metrics related to diagnostic accuracy, sensitivity, specificity, or reader improvement.
Based on the provided text, I can extract the following limited information:
1. A table of acceptance criteria and the reported device performance:
The document doesn't provide specific numerical acceptance criteria in the format of a table with quantitative performance metrics for a diagnostic device (e.g., accuracy, sensitivity, specificity). Instead, it lists general verification and validation activities designed to demonstrate that the instrument performs safely and effectively.
| Test Category | Acceptance Criteria (General) | Reported Performance |
|---|---|---|
| Software | Verified and validated in accordance with FDA guidance for software in medical devices and IEC 62304. | "[A]ll the results are passed." (Implies software met requirements for functionality, reliability, and safety based on its intended use within the navigation system, but no specific performance metrics like latency, throughput, or accuracy of algorithmic output are given for an AI component). |
| Risk Assessment | Effectiveness of all risk control measures verified in accordance with ISO 14971. | "[A]ll the results are passed." (Implies risks were identified, evaluated, and mitigated to an acceptable level). |
| Design Verification | Design output fulfills all design input requirements. | "[A]ll the results are passed." (Implies the physical components of the instrument meet their design specifications). |
| Biocompatibility Evaluation | No rejection, allergic, and adverse reactions, evaluated in accordance with FDA guidance (ISO 10993-1). | "[A]ll the results are passed." (Implies the materials used in the instrument are biologically safe for human contact as intended). |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document refers to "verification and validation activities" and "performance tests" but does not detail the sample size (e.g., number of instruments tested, number of patients/cases used for a clinical performance study if one were relevant to this specific instrument).
- Data Provenance: Not specified. (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable/not specified. The testing described is primarily engineering and materials verification for a physical medical instrument, not a study requiring expert readers to establish ground truth for image interpretation or diagnosis.
- Qualifications of Experts: Not applicable/not specified.
4. Adjudication method for the test set:
- Adjudication Method: Not applicable/not specified. This type of detailed adjudication process (e.g., 2+1, 3+1) is typically relevant to studies involving human reading of medical images where ground truth is established by consensus, which is not the subject of this document.
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:
- MRMC Study: No, an MRMC comparative effectiveness study was not done, or at least not described in this document. This document pertains to a physical surgical instrument, not an AI-assisted diagnostic or image analysis system that would typically undergo such a study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This document describes a surgical instrument. While it works with navigation systems (K230783, K233513) that likely have software components, the focus here is the physical instrument itself, not an AI algorithm whose standalone performance needs to be measured.
7. The type of ground truth used:
- Type of Ground Truth: Not applicable in the conventional sense of clinical ground truth (pathology, outcomes data, expert consensus). For a surgical instrument, "ground truth" would relate to engineering specifications, material properties, and functional performance (e.g., precision of fit, sterility, tracking accuracy within the navigation system). Measurements and observations against these pre-defined specifications serve as the "ground truth" for verification.
8. The sample size for the training set:
- Training Set Sample Size: Not applicable. This document describes a physical medical device (surgical instrument), not an AI/ML algorithm that would undergo training on a data set.
9. How the ground truth for the training set was established:
- Ground Truth Establishment for Training Set: Not applicable. There is no mention of an AI/ML training set in this document.
In summary: The provided document is an FDA 510(k) clearance letter and synopsis for a medical instrument (Remex Spine Surgery Navigation Instrument), which is a physical device used with existing navigation systems. It is not a submission for an AI/ML-driven diagnostic or image analysis device. Therefore, the detailed performance study and acceptance criteria questions related to artificial intelligence and clinical diagnostic performance are largely not applicable to the content provided. The "performance data" section focuses on standard engineering and biocompatibility testing to ensure the instrument's safety and effectiveness.
§ 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).