(140 days)
The Acumen™ Surgical Navigation System is intended to assist the surgeon in providing orientation and reference information to anatomical structures during open or percutaneous orthopedic procedures. The Acumen™ Navigation System is indicated for use in surgical knee and trauma procedures, in which the use of stereotaxic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT or MRI based model, fluoroscopy or an imageless model of the anatomy. These procedures include, but are not limited to knee arthroplasty or trauma reconstructive procedures.
The Acumen™ Surgical Navigation System includes general instrumentation that is utilized with application specific software developed and supplied by Z-KAT, Inc. (Hollywood, Florida).
Passive markers (spheres) are attached onto the Acumen™ instrumentation. An infrared light source generated by the camera reflects off of the passive markers to allow their position and orientation to be identified. The Acumen™ instruments are used as: 1) an independent instrument, 2) connected to instruments, which are attached to the patient, or 3) connected to the associated implant preparation and insertion instrumentation.
All Acumen™ instruments will have a minimum of three (3) passive markers to be tracked by the camera system. They will also be rigidly connected to the instrumentation. Each Acumen™ instrument, utilized in the surgical procedure, will have a defined geometry of the passive marker position for a unique identification by the camera and software system.
The instruments can be utilized with knee and trauma applications. The Acumen™ instruments are designed as one-time use components.
This FDA 510(k) summary for the Acumen™ Surgical Navigation System indicates that no clinical testing was performed to establish substantial equivalence. Therefore, there is no study provided within this document that demonstrates the device meets specific acceptance criteria based on clinical performance.
The document primarily focuses on demonstrating substantial equivalence through non-clinical testing, specifically software verification and validation.
Here's the breakdown based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
Since no clinical study was performed and no specific performance metrics with acceptance criteria are listed for the non-clinical testing, this table cannot be populated from the provided text. The document only states that "Software verification and validation was performed to establish substantial equivalence to the predicate devices." This implies that the acceptance criteria for software verification and validation were met, but these criteria are not detailed (e.g., accuracy tolerances, latency, reliability metrics).
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | "Software verification and validation was performed to establish substantial equivalence to the predicate devices." |
2. Sample size used for the test set and the data provenance:
- Test Set Size: Not applicable as no clinical test set was used.
- Data Provenance: Not applicable as no clinical data was used.
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 as no clinical test set requiring expert ground truth was used.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable as no clinical test set was used.
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. The document explicitly states "Clinical testing was not used to establish substantial equivalence." This type of study would fall under clinical testing.
- Effect Size: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance Study: No. While the device is a navigation system that uses software, a standalone performance study in the context of clinical outcomes (e.g., surgical accuracy based on the algorithm's output alone) was not done. The "software verification and validation" addresses the functional correctness of the algorithm but not its clinical performance as a standalone tool.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Ground Truth Type: Not applicable for clinical performance. For the software verification and validation, the ground truth would typically be the expected functional behavior and output defined by the software requirements and design specifications.
8. The sample size for the training set:
- Training Set Size: Not applicable. The document does not describe any machine learning or AI components that would require a "training set" in the traditional sense for learning from data. The software described is an established navigation system using defined geometries and calculations for tracking.
9. How the ground truth for the training set was established:
- Ground Truth Establishment: Not applicable as no training set was used.
In summary:
The provided document relies entirely on non-clinical software verification and validation to establish substantial equivalence for the Acumen™ Surgical Navigation System. It explicitly states that no clinical testing was performed. Therefore, information regarding acceptance criteria derived from clinical studies, expert-adjudicated ground truth, or study methodologies for clinical performance is not available in this document.
§ 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).